CURRENT NAVIGATION POINTS IN DRUG DIVERSION LAW (DRAFT)

MARQUETTE LAW REVIEW VOL. 101

CURRENT NAVIGATION POINTS IN DRUG
DIVERSION LAW:
HIDDEN ROCKS IN SHALLOW, MURKY,
DRUG-INFESTED WATERS†
JOHN J. MULROONEY, II* & KATHERINE E. LEGEL**
I.INTRODUCTION ................................................................................................ 2
II.CONGRESS AND THE PRESIDENT .................................................................... 4
A. The Corrective Action Plan (CAP) ................................................. 4
1. The EPAEDEA’s CAP Provision’s Additions, Justifications,
and Problems ............................................................................. 4
2. The Agency’s Treatment of the CAP Provisions ........................ 9
B. Imminent Danger to Public Health and Safety for Immediate
Suspension Orders ......................................................................... 12
C. Defining “Factors As May Be Relevant to and Consistent
with the Public Health and Safety” ............................................... 15
III.AGENCY PRECEDENT .................................................................................. 18
A. The Public Interest Factors for Practitioners ................................. 18
1. The Re-Re-Tweaking of Public Interest Factor One ................. 19
2. Is Public Interest Factor Two Shrinking, Melding, Both, or
Neither? .................................................................................... 24
3. The Blurring of the Factors ....................................................... 33
4. The X Factor? ............................................................................ 35
B. The Pharmacy’s Corresponding Responsibility and Willful
Blindness ....................................................................................... 36
1. Red Flags and Willful Indifference ........................................... 37
2. Willful Indifference and Evidence/Absence of Red Flag
Resolution ................................................................................ 38
3. Verification of a Prescriber’s Registration ................................ 42
4. Can Prescriber’s Actions Immunize Pharmacy Registrants? .... 46
C. Medical Practice Standards ........................................................... 48
1. Investigators as Experts? ........................................................... 50
† This draft Article is being made available under the sole discretion of the Marquette Law
Review Editorial Board. It will undergo further, minor modifications during the editorial process
before its final publication in the Winter Issue of Volume 101. Cite this version as: John J. Mulrooney,
II & Katherine E. Legel, Current Navigation Points in Drug Diversion Law: Hidden Rocks in Shallow,
Murky, Drug-Infested Waters, 101 MARQ. L. REV. (forthcoming Feb. 2018).

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2. When “Should” Means “Must” ................................................. 50
3. “General” Practice Standards? .................................................. 52
D. When “Legitimate Medical Purpose” Means “Outside the Usual
Course of Professional Practice” and Vice Versa. ........................ 55
E. DEA-222s and the Absence of Delivery/Receipt Evidence .......... 58
F. The Rebirth of Community Impact Evidence ............................... 62
G. The Sins of Our Relatives ............................................................. 65
H. Ninety-Day Prescription Rule Narrowed? .................................... 66
I. To Stay or Not to Stay ................................................................... 69
J. Summary Disposition and State Due Process ............................... 71
K. Notice This, Consent to That ........................................................ 72
1. Notice Requirements ................................................................. 72
2. Litigation by Consent ................................................................ 77
3. Notice and Lack of State Authority ........................................... 79
L. Proceedings ................................................................................... 81
1. Regulation by Adjudication ....................................................... 82
2. Representations by Counsel ...................................................... 85
3. Requested Hearings, Subsequent Waivers, and Statements of
Position .................................................................................... 87
4. Administrator’s Staff as Pseudo-ALJs ...................................... 89
5. Excluded by The ALJ Means Excluded .................................... 94
6. Official Notice in Final Agency Orders .................................... 96
M. Is the Agency Marginalizing its ALJs, and its Due Process
Hearings? ..................................................................................... 106
1. Restraining (and Overruling) Decisional Independence ......... 106
2. Summary Disposition Without Motion or ALJ
Recommendation ................................................................... 109
IV.GOING FORWARD ..................................................................................... 112
I.

INTRODUCTION

Drug diversion litigation continues to grow and evolve by leaps and bounds.
While the practice has seen an increase in complexity over the years, the speed
and scope of some recent developments have been striking, and in some
respects confounding. Since the publication of the 2015 article about diversion
practice in the Albany Law Review,1 diversion practice under the Administrative
* Judge Mulrooney is the Department of Justice, Drug Enforcement Administration Chief
Administrative Law Judge, and co-author of Drug Diversion Administrative Revocation and
Application Hearings for Medical and Pharmacy Practitioners: A Primer for Navigating Murky, DrugInfested Waters, 78 ALB. L. REV. 327 (2015). He has previously practiced law as an Assistant United
States Attorney, a Department of Justice/INS Trial Attorney, an Assistant District Attorney, a Navy
Judge Advocate, and a Judicial Law Clerk, as well as a Judge on the Navy-Marine Corps Court of

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Procedure Act (APA) 2 has been buffeted by the accounts in the press, 3
Congress,4 and swerves in legal interpretation in the published final orders
issued by the Drug Enforcement Administration (the DEA or the Agency). 5
Whether viewed as clarifications, enhancements, or afflictions, the
modifications visited on diversion enforcement by Congress and the DEA itself
will require some significant course adjustments by the practicing bar on both
sides of the litigation equation.
This update is divided into three sections: Part II will address diversion law
alterations crafted by Congress and signed by President Barack Obama; Part III
will analyze new legal interpretations by the Agency in its final orders; and Part
IV will parse the legal landscape for a current location check, some possible
clues for what lies over the horizon for the enforcers, the regulated community,
and the attorneys on both sides of the aisle, as well as some thoughts about why
where we are now seems so different from where we were previously headed.
Even without legal sonar or a crystal ball, there is merit to engaging in a
measured level of informed reckoning about where rocks and hazards are likely
to linger below the surface of the murky, drug-infested waters of diversion
litigation.

Criminal Appeals and an Administrative Law Judge at the Social Security Administration. Judge
Mulrooney received his Juris Doctorate (cum laude) at Albany Law School in 1985. The views and
legal analysis expressed in this article reflect the views of the authors in their private, not official
capacities, and not the Department of Justice and/or the Drug Enforcement Administration. Cases are
decided by existing legal authority and the facts presented by the parties. This article is not intended
to indicate, and does not reflect, how a particular issue of law or fact will be (or has been) decided in
any litigation where the author is (or was) the assigned judge.
** Ms. Legel was a Judicial Law Clerk at the Drug Enforcement Administration, Department of
Justice from 2015 to 2017. She received her Juris Doctorate (magna cum laude) at Marquette
University Law School, where she served as a Comment Editor on the Marquette Law Review. The
views and legal analysis expressed in this article reflect the views of the authors in their private, not
official capacities, and not the Department of Justice and/or the Drug Enforcement Administration.
1. John J. Mulrooney, II & Andrew J. Hull, Drug Diversion Administrative Revocation and
Application Hearings for Medical and Pharmacy Practitioners: A Primer for Navigating Murky, DrugInfested Waters, 78 ALB. L. REV. 327 (2015).
2. Administrative Procedure Act, 5 U.S.C. §§ 551–59 (2012).
3. See, e.g., Lenny Bernstein & Scott Higham, Investigation: The DEA Slowed Enforcement
While the Opioid Epidemic Grew Out of Control, WASH. POST, Oct. 23, 2016, at A1; Editorial Board,
Locating Blame in the Opioid Epidemic, WASH. POST: THE POST’S VIEW (Oct. 30, 2016),
https://www.washingtonpost.com/opinions/is-the-dea-partly-to-blame-for-the-opioidepidemic/2016/10/30/ (insert URL into Google.com search engine; then follow “Locating blame in the
opioid epidemic – The Washington Post” hyperlink) [hereinafter, THE POST’S VIEW].
4. See infra Part II.
5. See infra Part III.

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II. CONGRESS AND THE PRESIDENT
On April 19, 2016, President Obama signed the Ensuring Patient Access
and Effective Drug Enforcement Act of 2016 (EPAEDEA) into law. 6 The cosponsors of the EPAEDEA touted the amendment as a measure to “bring muchneeded clarity to several key provisions of the Controlled Substances Act” and
to “facilitate greater collaboration between registrants and relevant federal
actors in combatting prescription drug abuse.” 7
The EPAEDEA amends the Controlled Substances Act (CSA) in three
respects: (1) any registrant served with an order to show cause (OSC) may now
submit a corrective action plan (CAP) to the Agency, which the Agency must
consider in order to determine whether it justifies the discontinuance or deferral
of administrative proceedings; (2) the term “imminent danger to the public
health or safety,”8 a prerequisite finding to justify the issuance of an immediate
suspension order, has been defined, or some would say, born; and (3) the phrase
“factors as may be relevant to and consistent with the public health and safety,”
which is the language used in the catch-all public interest factors to be
considered by the Agency in determining whether to register or maintain
registration for manufacturers 9 and distributors 10 of controlled substances, has
been defined.11
A. The Corrective Action Plan (CAP)
1. The EPAEDEA’s CAP Provision’s Additions, Justifications, and Problems
Previously, the OSC to be served on the applicant or registrant was only
required to “contain a statement of the basis” for the Agency’s proposed denial,
revocation, or suspension of registration, and to provide a time and place for
the applicant or registrant to appear.12 The EPAEDEA added the requirement
that every OSC issued by the DEA must “notify the applicant or registrant of
the opportunity to submit a corrective action plan on or before the date of

6. Ensuring Patient Access and Effective Drug Enforcement Act of 2016, Pub. L. No. 114-145,
130 Stat. 353 (to be codified at 21 U.S.C. §§ 823(j), 824(c), (d)).
7. 162 CONG. REC. S954 (daily ed. Feb. 23, 2016) (statement of Sen. Hatch).
8. Ensuring Patient Access and Effective Drug Enforcement Act of 2016 § 2 (to be codified at
21 U.S.C. § 824(d)(1)).
9. 21 U.S.C. § 823(a)(6), (d)(6) (2012).
10. Id. § 823(b)(5), (e)(5). The language is also similar to the catch-all factor for distributors of
List I chemicals, but is not exactly the same. Id. § 823(h)(5) (“[S]uch other factors as are relevant to
and consistent with the public health and safety.”) (emphasis added).
11. Ensuring Patient Access and Effective Drug Enforcement Act of 2016 § 2 (to be codified at
21 U.S.C. §§ 823(j), 824(c), (d)).
12. 21 U.S.C. § 824(c).

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appearance.”13 The EPAEDEA also added the requirement that, if a CAP is
timely filed by a registrant, the Agency is required to consider it to “determine
whether denial, revocation, or suspension proceedings should be discontinued
or deferred for the purposes of modification, amendment, or clarification to
such plan.”14 Stated differently, before the DEA can proceed to secure an
administrative sanction against a registration holder or deny an application for
registration, it must now consider a written improvement plan, filed by the
registrant or applicant, which outlines that registrant or applicant’s intentions
to correct the regulatory transgressions alleged in the OSC. 15
Co-sponsors of the EPAEDEA promoted the CAP provisions as
“provid[ing] the DEA with the clarity to collaborate with the very people
responsible for ensuring that [controlled substances] get to the patients who
need them without hurting and harming th[e] distribution chain and while
clamping down on diversions and abuse.” 16 It was touted as “a mechanism for
companies17 who inadvertently violate the Controlled Substances Act . . . to
remediate the violation before their registration is suspended and the supply of
drugs to patients is interrupted.” 18 It was explained that the EPAEDEA would
“encourage greater self-reporting of violations,” while helping to “ensure that
supply chains remain intact for legitimate uses such as the alleviation of pain
and illness.”19 One co-sponsor described the CAP as “a mechanism for
companies that violate the Controlled Substances Act to correct their practices”
before their registration is suspended or revoked, noting that “[e]ven
inadvertent violations may lead to suspension or revocation, disrupting the
supply chain for the company’s prescription drugs[, which] in turn can cause
hardship for patients who rely on the company’s drugs for treatment and
cure.”20 In sum, the CAP was touted primarily as a method to ensure that
patients continue to retain access (hence the “ensuring patient access” feature
of the bill’s cumbersome title) to controlled substances in the event of

13. Ensuring Patient Access and Effective Drug Enforcement Act of 2016 § 2 (to be codified at
21 U.S.C. § 824(c)(2)(C)).
14. Id. (to be codified at 21 U.S.C. § 824(c)(3)).
15. Id.
16. 161 CONG. REC. H2330 (daily ed. Apr. 21, 2015) (statement of Rep. Blackburn).
17. While the co-sponsors repeatedly emphasized the benefits of the CAP for “companies,” the
bill does not limit the classes of registrants or applicants who can submit a CAP, and thus all registrants
and applicants—individual practitioners, pharmacies, distributors, and manufacturers—can submit a
CAP to the Agency.
18. 162 CONG. REC. S954-02 (daily ed. Feb. 23, 2016) (statement of Sen. Hatch).
19. Id.
20. 162 CONG. REC. S2006 (daily ed. Apr. 13, 2016) (statement of Sen. McConnell).

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“inadvertent violations”21 of the Controlled Substances Act by “companies” 22
in the distribution supply chain. 23
The stated justification for the CAP is significantly undermined, however,
by an absence of evidence in the Congressional Record or elsewhere to support
the position that pending administrative proceedings in any way limit even a
single patient’s access to medication, the purported reason the bill was
introduced in the first place. 24 By the terms of the statute, the CAP provisions
do not apply to the Administrator’s determination regarding an immediate
suspension pending resolution, 25 and in every other adjudication, registrants
retain their authority to conduct regulated activities until the Agency issues its
final order. 26 Stated differently, if a registrant or applicant is served with an
OSC but believes that it has made sufficient improvements to its operating
procedures to ensure that the transgressions charged do not re-occur (or if it
believes that the transgressions charged did not actually occur), it has—and had
before the EPAEDEA—the right to request an administrative hearing and
present evidence on its own behalf before any sanction can be imposed upon
it.27 Registrants and applicants have always been afforded the opportunity to
present evidence of any corrective actions they have taken to ensure that the
charged conduct does not continue, including plans to avoid future
21. Id.; 162 CONG. REC. S954 (daily ed. Feb. 23, 2016) (statement of Sen. Hatch).
22. 162 CONG. REC. S2006 (daily ed. Apr. 13, 2016) (statement of Sen. McConnell); see 162
CONG. REC. S954 (daily ed. Feb. 23, 2016) (statement of Sen. Hatch).
23. 162 CONG. REC. S2006 (daily ed. Apr. 13, 2016) (statement of Sen. McConnell); see 162
CONG. REC. S954 (daily ed. Feb. 23, 2016) (statement of Sen. Hatch).
24. See generally 162 CONG. REC. S2006 (daily ed. Apr. 13, 2016) (statement of Sen.
McConnell); 162 CONG. REC. S954 (daily ed. Feb. 23, 2016) (statement of Sen. Hatch).
25. Ensuring Patient Access and Effective Drug Enforcement Act of 2016, Pub. L. No. 114-145,
§ 2, 130 Stat. 353 (to be codified at 21 U.S.C. § 824(c)(5)). When served on a registrant, an Immediate
Suspension Order (ISO/OSC) is accompanied by an OSC, affording the opportunity for postdeprivation due process. See Mulrooney & Hull, supra note 1, at 364–65 (describing Immediate
Suspension proceedings). The decision to immediately suspend a registration is a final decision by the
Agency, and while a registrant could potentially submit a CAP in response to the accompanying OSC,
a determination on that CAP could in no way affect the already-final decision to immediately suspend
the registration. However, inasmuch as every ISO/OSC has an accompanying OSC, the CAP
provisions are available to respondents in all administrative proceedings, whether commenced with an
ISO/OSC or an OSC. It would, thus, be inaccurate to broadly state that the CAP provisions do not
apply to immediate suspension cases.
26. Ensuring Patient Access and Effective Drug Enforcement Act of 2016 § 2 (to be codified at
21 U.S.C. § 824(c)(1)) (“Before taking action pursuant to this section, or pursuant to a denial of
registration under [21 U.S.C. § 823], the Attorney General shall serve upon the applicant or registrant
an order to show cause why registration should not be denied, revoked, or suspended.”) (emphasis
added). See also 21 U.S.C. § 824(c) (2012).
27. Ensuring Patient Access and Effective Drug Enforcement Act of 2016 § 2 (to be codified at
21 U.S.C. § 824(c)(1)); see also 21 U.S.C. § 824(c).

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transgressions, and the Agency has always considered such evidence in making
its final determination on whether to preclude or curtail the applicant or
registrant’s regulated activities.28 Similarly, the parties have always been able
to discuss the merits of the case amongst themselves, either before a request for
a hearing is made or during the pendency of the administrative proceedings,
and if an applicant or registrant offers a proposed plan of corrective action and
the Agency (through counsel representing it in the administrative proceeding)
determines that it is no longer prudent to continue administrative proceedings,
then the Agency (the party which initiated proceedings in the first place) is free
to seek termination of the case, which the DEA Administrative Law Judge
(ALJ) will grant. Inasmuch as DEA administrative proceedings are remedial 29
and non-punitive in nature, 30 a written proposal to correct alleged deficiencies
should, of course, merit special consideration by the Agency in its evaluation
of the prudence and expense of continuing to seek preclusion or curtailment of
regulated activity, but there was no apparent reason for the EPAEDEA to direct
that such a proposal be considered and ruled upon in isolation, outside of an
ongoing administrative proceeding. If, in the Agency’s view, a proposed plan
of action merits discontinuation or deferral of proceedings, it is (and has always
been) free to seek termination of administrative proceedings at any time, or it
can decide by final order that no sanction is appropriate based on all of the facts,
including any remedial actions taken and plans put in place. Thus, the
EPAEDEA’s CAP provisions present as a solution to a problem that did not
(and does not) seem to exist.
Furthermore, the CAP provisions create no incentive (and potentially create
a disincentive) for regulated companies or individuals to “selfreport[] . . . violations,”31 to correct wrongdoing before an OSC is filed, or even
to follow or continue following whatever plan is deemed sufficient to
discontinue or defer proceedings once the proceedings are discontinued or
deferred. Instead, the EPAEDEA is akin to a state legislature mandating that
law enforcement authorities allow shoplifting suspects caught in the act to
28. See, e.g., Farmacia Yani, 80 Fed. Reg. 29053, 29066 (Drug Enf’t Admin. May 20, 2015);
Terese, Inc., 76 Fed. Reg. 46843, 46848 (Drug Enf’t Admin. Aug. 3, 2011). While the Agency only
considers evidence of remedial measures if a registrant accepts responsibility for past transgressions,
Jayam Krishna-Iyer, 74 Fed. Reg. 459, 464 (Drug Enf’t Admin. Jan. 6, 2009) (“Because of the grave
and increasing harm to public health and safety caused by the diversion of prescription controlled
substances, even where the Agency’s proof establishes that a practitioner has committed only a few
acts of diversion, this Agency will not grant or continue the practitioner’s registration unless he accepts
responsibility for his misconduct.”), a registrant who submits a corrective action plan is necessarily
admitting that there is something to be corrected.
29. Farmacia Yani, 80 Fed. Reg. at 29066.
30. Samuel S. Jackson, D.D.S., 72 Fed. Reg. 23848, 23853 (Drug Enf’t Admin. Apr. 24, 2007).
31. 162 CONG. REC. S954 (daily ed. Feb. 23, 2016) (statement from Sen. Hatch).

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outline how they intend to replace purloined items on store shelves; allow
intoxicated drivers to pull to the side of the road and park their previously
swerving vehicles; or perhaps allow bank robbers to round up and return inkstained money and agree not to rob any more banks—all before any of those
wrongdoers actually admit fault and without any consequence that might deter
such behavior in the future. Such mandates sound absurd because they would
be absurd. The ability to submit a written plan for improvement may provide
incentive for registrants to step up their compliance once charges are filed—or
at least, outline a plan and promise to do so—but before that time, they can act
freely knowing that they can always come up with a convincing plan to fix their
problems later and avoid sanction. 32 And, even in cases where the Agency does
elect to discontinue proceedings based on a CAP, the statutory mechanism
designed by Congress in the EPAEDEA provides no guarantee that the
promises made in the CAP will be fulfilled, or for how long. 33 Assurances by
the CAP filers are not required, and the EPAEDEA provides no consequences
to unfulfilled CAP representations—even in cases where those representations
result in the discontinuation of proceedings. 34 The only thing assured by the
Agency’s discontinuance of proceedings through the acceptance of a CAP is
that administrative proceedings will be discontinued. 35 The benefits for
industry are plain, but for the public, the benefits are not as clear.
To the extent the legislation was driven by the hypothetical potential that
the flow of painkillers could be interrupted due to improvident Agency
revocations supported only by inadvertent, even minor, isolated violations, the
law could have been crafted to achieve that objective. For example, the focus
of the bill could have been directed to imbuing the CSA with a sanctions
32. One co-sponsor explained that “the best example of why [the EPAEDEA] is needed is a story
that comes from home,” going on to detail an account of a constituent who tried to obtain seizure
medications for her son in anticipation of an ice storm (lamenting that it was one of many that winter,
which “seemed as if [they] would never stop”), but—although the pharmacist was sympathetic—the
pharmacy would not fill the prescription because “it was too early” and “there would be problems with
the DEA and other agencies” if it were filled. 161 CONG. REC. H2330 (daily ed. Apr. 21, 2015)
(statement of Rep. Blackburn). It is unclear exactly how such a registrant (if an OSC was filed for
filling such prescriptions) would propose any convincing corrective action for that violation, other than
maybe the pharmacist would feel less sympathetic next time and would refuse to fill the prescription.
A considered reflection of the story reveals it to be a sort of advocacy for an after-the-fact forgiveness
for actions founded in sympathy which ultimately result in “ensur[ing] that patients who have a
legitimate need for medications can receive them,” even if those actions are clear, intentional violations
of the CSA. Id. Whatever heart strings are pulled by the story of the reluctantly compliant pharmacist,
it would be challenging to fashion the morale of the tale into any objectives supported by the provisions
of the EPAEDEA as it was enacted.
33. See generally Ensuring Patient Access and Effective Drug Enforcement Act of 2016, Pub.
L. No. 114-145, 130 Stat. 353 (to be codified at 21 U.S.C. §§ 823(j), 824(c), (d)).
34. Id.
35. Id.

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framework founded in Congress’s assessment of the seriousness of specific
violations. Congress could have supplied guidance to the exercise of Agency
discretion in particular types of cases or where conduct rose to a certain level.
Likewise, the Agency could have been directed to give additional weight to
remedial evidence in weighing the sanction decision, or Congress could have
otherwise modified the CSA to address concerns regarding medication
availability when a registration is ultimately revoked or limited by the Agency.
The list of possible methods to address patient access to controlled substances
under these limited circumstances is potentially limitless, but the path chosen
instead was to enact legislation that created new rights for industry, and left the
Agency without guidance as to how to implement the new laws.
2. The Agency’s Treatment of the CAP Provisions
The new legislation provides only that, “[u]pon review of any [CAP]
submitted by an applicant or registrant . . . the Attorney General shall determine
whether denial, revocation, or suspension proceedings should be discontinued,
or deferred for the purposes of modification, amendment, or clarification to
such plan.” 36 It does not specify what date is meant by the filing deadline of
“on or before the date of appearance,” 37 and it provides neither a procedure for
the filing of a CAP, nor the standards to be applied to adjudicate it. The
EPAEDEA likewise does not provide guidance to the Agency about the
supervisory level within the organization at which the CAP should be
evaluated, and it does not provide an indication of the criteria by which the
Agency is to evaluate filed CAPs, or the procedure or timeline for the Agency
to follow once it determines whether (or not) to discontinue or defer
proceedings. The CAP legislation provides for no review of the plan by a DEA
ALJ in the event that proceedings are not discontinued or deferred, and it is
silent on whether administrative proceedings should be abrogated or delayed in
the event of a CAP filing, or if they should continue to proceed concurrently
with whatever timeline on which the CAP review proceeds.
Enabling regulations have not yet been promulgated. In the absence of
regulations, the Agency has supplied instructions regarding EPAEDEA CAP
rights (CAP advisals) on OSCs it has issued since EPAEDEA became
effective.38 However, at least in one case, the manner in which the Agency has
adjudicated a CAP raises an interesting issue.

36. Id. (to be codified at 21 U.S.C. § 824(c)(3)).
37. Id. (to be codified at 21 U.S.C. § 824(c)(2)(C)).
38. See generally, e.g., Marcus W. Anderson, M.D., 82 Fed. Reg. 42117, 42118–19 (Drug Enf't
Admin. Sept. 6, 2017); Binh M. Chung, M.D., 82 Fed. Reg. 40601, 40602 (Drug Enf’t Admin. Aug.
25, 2017); Arnold E. Feldman, M.D., 82 Fed. Reg., 39614, 39616 (Drug Enf’t Admin. Aug. 21, 2017).

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In Thomas Horiagon, M.D., the Agency explained that its OSC “notified
[r]espondent of his right under 21 U.S.C. § 824(c)(2)(C) to submit a [CAP] to
the Deputy Assistant Administrator and [provided] the procedure for doing
so.” 39 This is a strong indicator of the Agency’s intent to avoid the creation of
an appealable final order by having the CAP issue decided by the Deputy
Assistant Administrator, rather than the Administrator. The Horiagon final
order noted that the Deputy Assistant Administrator did issue a CAP decision,
but it also included a CAP determination by the Administrator that was based
on an alternate legal theory.40 Thus, the CAP determination was ultimately
rendered by the Agency head.
The APA provides that:
[a]gency action made reviewable by statute and final agency
action for which there is no other adequate remedy in a court
are subject to judicial review. A preliminary, procedural, or
intermediate agency action or ruling not directly reviewable is
subject to review on the review of the final agency action. 41
Apart from interlocutory appeals considered and decided by the
Administrator, 42 administrative decisions rendered by its ALJs43 and program
heads44 have historically been considered preliminary, procedural, or
intermediate—and thus, are not directly reviewable. If the Agency elected to
leave a decision regarding the CAP up to the Deputy Assistant Administrator
(or some other subordinate official)—rather than the Administrator—it would
39. Thomas Horiagon, M.D., 81 Fed. Reg. 79051, 79051 (Drug Enf’t Admin. Nov. 10, 2016).
40. Id. at 79052 (concluding “that there [were] adequate grounds for denying [the CAP]” and
that Administrator therefore “rejecte[ed] [the r]espondent’s CAP.”).
41. 5 U.S.C. § 704 (2012).
42. 21 C.F.R. § 1316.62 (2017).
43. E.g., id. § 1316.47(b) (giving ALJ discretion to rule upon a request to enlarge the time
granted to a respondent to answer an OSC); id. § 1316.50 (giving ALJ discretion to require notarized
power of attorney from representative regarding scope of authority); id. § 1316.52 (providing nonexhaustive list of discretionary determinations entrusted to ALJs during DEA administrative
proceedings); id. § 1316.57 (giving ALJ discretion to exclude, or upon good cause, admit evidence not
timely disclosed by a party); id. § 1316.58 (giving ALJ discretion to direct pre-hearing summaries of
proposed witness testimony); id. § 1316.62 (giving ALJ discretion to rule upon a motion seeking leave
to file an interlocutory appeal).
44. E.g., id. § 1301.16 (requiring permission from the Agency for certificate of registration
application withdrawals after the issuance of an OSC); Matthew Valentine/Liar Catchers, 80 Fed. Reg.
50042, 50043 (Drug Enf’t Admin. Aug. 18, 2015) (noting that DEA Administrator had previously
remanded case involving application withdrawal denial issued by the Deputy Assistant Administrator
for Diversion Control (DAADC) for additional detail, reviewed and disregarded the discretionary
decision issued by the DAADC, granted the applicant’s withdrawal application, and determined that
the entire case was moot); see also Bobby D. Reynolds, N.P., 80 Fed. Reg. 28643, 28643 n.2 (Drug
Enf’t Admin. May 19, 2015) (reviewing application withdrawal request that had been filed exclusively
with the DAADC sua sponte, DEA Administrator acted absent any request by either party to do so).

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likely avoid the unintentional issuance of an appealable final order. However,
to the extent the Agency has already issued written CAP denials signed by the
Agency head (in addition to ruling on a CAP in a final order dispositive of a
whole case), it may have inadvertently created a path for ready review by the
federal courts. If a CAP denial issued by the DEA Administrator constitutes a
final order of the Agency, a denial of the requested relief (discontinuance or
deferral of proceedings) could be subject to potential review in the courts.
Congress has authorized “any person aggrieved by a final decision of the [DEA
Administrator]” under the CSA to seek review “in the United States Court of
Appeals for the District of Columbia or for the circuit in which his principal
place of business is located . . . .” 45
If an order issued by the Administrator is not a final action, under the APA,
then it must be “preliminary, procedural, or intermediate action” that is “subject
to review on the review of the final agency action.” 46 However, the final agency
action in DEA administrative cases is the ultimate determination by the
Administrator regarding the disposition of administrative sanction action. 47 The
final action may be informed by a recommended decision by a DEA ALJ where
a hearing was requested and held.48 Because the CAP is filed separately from
a request for hearing (or waiver),49 it is not automatically part of the
administrative record to be reviewed by the Agency—and neither is any
decision issued regarding the CAP. In order for the CAP and the Agency’s
decision to continue proceedings despite a filed CAP to even be considered in
the Agency’s final order, the aggrieved party would need to somehow appeal
the “preliminary” decision made to continue proceedings 50 to the Administrator
through the process of the administrative hearing. In the instance where the
Administrator signed a decision wherein the Agency declined to discontinue or
defer proceedings at some point prior to consideration of the administrative
record, this would place the parties in the position of appealing the
Administrator’s own determination to the same Administrator to determine
whether to affirm his previous decision, or would at least create the anomalous
result of having the DEA Administrator review his own decision at the time a
final order is issued—with no warrant for doing so in the EPAEDEA or the
regulations. While the APA affords an agency head authority to issue a final
45. 21 U.S.C. § 877 (2012).
46. 5 U.S.C. § 704.
47. 21 C.F.R. §§ 1301.46, 1316.67.
48. Id. §§ 1301.43, 1316.47, 1316.65(a).
49. See id. § 1301.43 (authorizing responses to an OSC); Thomas Horiagon, M.D., 81 Fed. Reg.
79051, 79051 (Drug Enf’t Admin. Nov. 10, 2016) (referencing the OSC instruction to “submit a [CAP]
to the Deputy Assistant Administrator and the procedure for doing so.”).
50. See 21 C.F.R. § 1301.43; Horiagon, 81 Fed. Reg. at 79051.

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order in administrative proceedings, the specter of having an appeal of the
Administrator’s decision to himself risks an imprudent buffeting of the
Supreme Court’s admonition that “no man can be a judge in his own case.” 51
The CAP is a new phenomenon, and it is reasonable to assume that the
Agency’s approach will benefit from some level of evolution. That said, to the
extent that the DEA elects to have its Administrator review CAP submissions
in the first instance, it enhances the opportunity for judicial review of any
decision declining to discontinue or defer proceedings.
In view of the highly-regulated and technical nature of the registrants who
engage in controlled substance regulated activity, the determination by
Congress that the regulating agency is required (not merely permitted) to
consider a remedial plan that is submitted to it, 52 by even the most egregious
violators of standards that have been static and in place for decades, before
proceeding with administrative proceedings, is a remarkable step. The CAP
decision to discontinue or defer proceedings—a decision entirely separate from
the formal administrative process that affords pre- or post-deprivation due
process to all registrants and potential registrants of the Agency 53—is
undoubtedly now an important one for the Agency. If, as may well be the case,
CAP submissions and the Agency’s decision of whether to discontinue or defer
proceedings based upon those submitted CAPs are ultimately subject to review
by the courts, the regulated community may eventually enjoy the benefits of an
evolving body of case law that mandates the discontinuation or deferral of
administrative proceedings where various levels of remediation are
convincingly proposed. To the extent it blossoms, judicial review of CAP
determinations will likely provide decades of fertile litigation opportunities for
the regulated community and will add an additional litigation burden on DEA
regulators.
B. Imminent Danger to Public Health and Safety for Immediate Suspension
Orders
Under the CSA, the DEA Administrator has authority54 to immediately
suspend a registration, and to keep that registration suspended during the
pendency of administrative revocation proceedings, in any case “where he finds

51. In re Murchison, 349 U.S. 133, 136 (1955).
52. Ensuring Patient Access and Effective Drug Enforcement Act of 2016, Pub. L. No. 114-145,
§ 2, 130 Stat. 353 (to be codified at 21 U.S.C. § 824(c)(2)(c)).
53. Id.
54. The statute assigns this authority to the Attorney General, who has delegated it to the DEA
Administrator. 28 C.F.R. § 0.100(b), 0.103(a) (2017).

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that there is an imminent danger to the public health or safety.” 55 The
EPAEDEA created, for the first time, a statutory definition for the phrase
“imminent danger to public health and safety.” 56
The Administrator has always been required to determine that an “imminent
danger to the public health or safety” exists before immediately suspending a
registration.57 However, before the EPAEDEA, that language was not
specifically defined in the statute, 58 and was broad enough to afford the Agency
head with latitude to make a determination as to whether, informed by the
Agency’s expertise and experience, particular conduct or circumstances posed
such a threat.59 In fact, given that this extraordinary measure depends on postdeprivation due process, it is remarkable that during the more than four decades
that a long line of Administrators had been determining whether there was an
“imminent danger to the public health and safety” to justify immediately
suspending a registration before that phrase was defined in the EPAEDEA,
apart from a forty-year-old case from the Fifth Circuit Court of Appeals,60 and
a small handful of isolated unpublished exceptions from the district courts, 61
the courts have historically sustained the Administrators’ pre-EPAEDEA
determinations of an imminent threat to public health and safety. 62 It is equally
remarkable that, notwithstanding the dearth of court review of this public-safety
tool, or any other readily apparent reason, Congress determined that the
“imminent danger to public health and safety” standard required a statutory
definition that imposed a dramatic diminution of the Agency’s authority to issue

55. 21 U.S.C. § 824(d) (2012); see 21 C.F.R. § 1301.36(e) (2017).
56. Ensuring Patient Access and Effective Drug Enforcement Act of 2016 § 2 (to be codified at
21 U.S.C. 824(d)).
57. Comprehensive Drug Abuse Prevention and Control Act of 1970, Pub. L. No. 91-513, 84
Stat. 1256 (codified at 2 U.S.C. § 304).
58. See 21 U.S.C. § 824(d) (2012).
59. The regulations provide that the immediate suspension order “shall contain a statement of
[the Administrator’s] findings regarding the danger to the public health or safety.” 21 C.F.R.
§ 1301.36(e) (2017).
60. Norman Bridge Drug Co. v. Banner, 529 F.2d 822, 824–25, 828 (5th Cir. 1976) (finding that
the Administrator’s ISO was unsupported due to staleness based on a seven-month delay in its
issuance).
61. See, e.g., Bates Drug Stores, Inc. v. Holder, 2011 WL 1750066 *3 (E.D. Wash. 2011);
Apothecary Arts Pharmacy, Inc. v. Gonzales, Civ. No. 06-119 (D.D.C. Feb. 3, 2006), ECF No. 5;
MacKay v. Bolman, No. 2:09cv285 (D. Utah Apr. 7, 2009), ECF No. 13.
62. See, e.g., Novelty Distribs. v. Leonhart, 562 F. Supp. 2d 20, 27–28 (D.D.C. 2008); Neil
Laboratories, Inc., v. Ashcroft, 217 F. Supp. 2d 80, 87 (D.D.C. 2002).

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Immediate Suspension Orders (ISOs) 63 at a time when, by all accounts, opioid
abuse, addiction, and deaths were increasing markedly. 64
In an effort to supply additional definition to the phrase “imminent danger
to public health and safety,” EPAEDEA enhanced the required showing to
secure an ISO with the following language:
[T]he phrase “imminent danger to public health or safety”
means that, due to the failure of the registrant to maintain
effective controls against diversion or otherwise comply with
the obligations of a registrant under [the CSA], there is a
substantial likelihood of an immediate threat that death, serious
bodily harm, or abuse of a controlled substance will occur in
the absence of an immediate suspension of the registration. 65
In the post-EPAEDEA era, for the Agency to support the Administrator’s
determination that the public health and safety is imperiled without a cessation
of regulated activity while (often lengthy) administrative revocation
proceedings are conducted, the Agency now bears the high burden of
establishing that there is a “substantial likelihood” that a registrant’s failure “to
maintain effective controls against diversion,” or non-compliance with the
CSA, will result in an “immediate threat” of specific, enumerated harms, to wit:
“death, serious bodily harm, or abuse of a controlled substance.”66
Even apart from the onerous task of demonstrating a link between a
registrant’s alleged transgressions and an impending death, serious bodily
harm, or abuse, the Agency now must shoulder the burden of showing that the
“likelihood” of those evils, based on the purported transgressions, is
“substantial.”67 The courts have concluded in other contexts that “substantial
likelihood” means that the referenced event or circumstance is “considerably
more likely.” 68 Thus, before a single witness is produced or any piece of
evidence admitted at a hearing, to sustain its ISO, the DEA is now required to
establish by substantial evidence that the transgression(s) or violation(s) it has
encountered will render death, serious bodily harm, or abuse considerably and
imminently more likely. 69 However unlikely the Agency is to successfully bear
63. See Ensuring Patient Access and Effective Drug Enforcement Act of 2016, Pub. L. No. 114145, § 2, 130 Stat. 353 (to be codified at 21 U.S.C. § 824(d)(2)).
64. See,
e.g.,
Centers
for
Disease
Control
and
Prevention,
https://www.cdc.gov/drugoverdose/epidemic (last visited Sept. 21, 2017).
65. Ensuring Patient Access and Effective Drug Enforcement Act of 2016 § 2 (to be codified at
21 U.S.C. § 824(d)(2)).
66. Id.
67. Id.
68. See, e.g., United States v. Thorn, 317 F.3d 107, 117 (2d Cir. 2003), aff’d 446 F.3d 378, 383
(2d Cir. 2006) (considering the term “substantial likelihood” in the context of the U.S. Sentencing
Guidelines); United States v. Mathis, 738 F.3d 719, 740 (6th Cir. 2013) (same).
69. Mathis, 738 F.3d at 740.

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this heavy burden in the case of individual practitioners or pharmacies, it is all
but logically impossible, due to the obvious attenuation between the distributor
or manufacturer registrant and the potential victims, to make the requisite
showing up the production chain, in the case of a distributor or manufacturer.
Stated differently, there are simply too many levels between distributors and
manufacturers to logically establish any causation of death, serious bodily
harm, or abuse to a specific patient down the chain to support an immediate
suspension after the EPAEDEA. If it had been the intent of Congress to
completely eliminate the DEA’s ability to ever impose an immediate
suspension on distributors or manufacturers, it would be difficult to conceive
of a more effective vehicle for achieving that goal.
C. Defining “Factors As May Be Relevant to and Consistent with the Public
Health and Safety”
The new definition of “imminent danger to the public health and safety”
and the CAP provisions received the most attention when the EPAEDEA was
signed by President Obama on April 19, 2016. 70 In fact, even the White House
Statement that issued on the day that the EPAEDEA was signed by President
Obama fails to mention the third change that the EPAEDEA made to the CSA.71
Although it received scant attention when compared with the other two
changes, the EPAEDEA’s addition of a definition for “factors as may be
relevant to and consistent with the public health and safety,” which is the
language used in the catch-all public interest factor to be considered by the
Agency in determining whether to register or maintain registration72 for
manufacturers73 and distributors 74 (but not prescribers, pharmacies, and
researchers) 75 of controlled substances, is worth examining.
Under the CSA, the Agency “shall register an applicant” to manufacture
controlled substances in schedule I or II “if [it] determines that such registration
is consistent with the public interest and with [the country’s] obligations under
international [agreements],”76 and “shall register an applicant” to distribute a
70. See Harriet Ryan and Kim Christensen, Amid Opioid Epidemic, Rules for Drug Companies
are Loosened, L.A. TIMES, July 27, 2016 at A1; Gardiner Harris and Emmarie Huetteman, Actions by
Congress on Opioids Haven’t Included Limiting Them, N.Y. TIMES, May 18, 2016 at A1.
71. Statement by the Press Secretary on S. 192, S. 483, S.2512, 2016 WL 1567506 (White
House) (Apr. 19, 2016).
72. Ensuring Patient Access and Effective Drug Enforcement Act of 2016 § 2 (to be codified at
21 U.S.C. §§ 823(j)), 824(c), (d)); 21 U.S.C. § 823(a)–(f) (2012).
73. 21 U.S.C. § 823(a)–(a)(6), (d)–(d)(6) (2012).
74. Id. § 823(b)–(b)(5), (e)–(e)(5).
75. Id. § 823(f)(5).
76. Id. § 823(a).

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controlled substance in schedules I–IV or manufacture controlled substances in
schedules III–V “unless [it] determines that the issuance of such registration is
inconsistent with the public interest.”77 The CSA provides six factors that
“shall be considered” in determining the public interest with regard to
manufacturers,78 and five factors that “shall be considered” in determining the
public interest with regard to distributors.79 For both manufacturers and
distributors, one of the factors to be considered is a catch-all factor that
encompasses “such other factors as may be relevant to and consistent with the
public health and safety.” 80 The separate section of the CSA addressing
suspension and revocation of existing registrations lists, as one of the grounds
for suspension or denial, “a finding that the registrant . . . has committed such
acts as would render his registration under section 823 . . . inconsistent with the
public interest as determined under such section,”81 and thus the public interest
factors in Title 21, Section 823 are relevant to the inquiry of whether applicants
shall be registered as well as the inquiry regarding whether current registrations
should be suspended or revoked. Therefore, for both (and only) manufacturer
and distributor applicants and registrants, the Agency can consider “factors as
may be relevant to and consistent with the public health and safety,” 82 in
addition to other enumerated factors, when reviewing whether to grant an
application or sanction a registration. 83
Before EPAEDEA, “factors as may be relevant to and consistent with the
public health and safety” was not statutorily defined. 84 EPAEDEA adds the
following: “In this section, the phrase ‘factors as may be relevant to and
consistent with the public health and safety’ means factors that are relevant to
and consistent with the findings contained in [21 U.S.C. § 801].”85
Co-sponsors of the EPAEDEA, like the media and the White House in its
press release, did not emphasize the new definition to the extent they did the
other two changes. One co-sponsor, apparently referencing this new definition,
77. Id. § 823(b), (d), (e).
78. Id. § 823(a), (d).
79. Id. § 823(b), (e).
80. Id. § 823(a)(6), (b)(5), (d)(6), (e)(5). There are similar catch-all factors for practitioner
(doctor and pharmacy) registrants and List I distributor registrants, but they do not contain the same
language that was defined by the EPAEDEA. See id. § 823(f)(5) (“Such other conduct which may
threaten the public health and safety.”); id. § 823(h)(5) (“[S]uch other factors as are relevant to and
consistent with the public health and safety.”) (emphasis added).
81. Id. § 824(a)(4).
82. Id. § 823(a)(6), (b)(5), (d)(6), (e)(5).
83. Id. § 823(a).
84. See id. § 823.
85. Ensuring Patient Access and Effective Drug Enforcement Act of 2016, Pub. L. No. 114-145,
§ 2, 130 Stat. 353, 354 (to be codified at 21 U.S.C. § 823(j)).

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stated that the EPAEDEA “will better delineate the standards a company must
satisfy in order to obtain a [CSA] registration,” 86 although he did not explain
why such delineation was needed. A few months later, at another session, he
more explicitly explained that the EPAEDEA “makes three important changes
to the [CSA],” and, as relevant to this definition, explained that “it clarifies the
factors that the Attorney General is required to consider when deciding whether
to register an applicant to manufacture or distribute controlled substances.”87
He continued:
The current text of the [CSA] instructs the Attorney General to
consider factors that ‘may be relevant to and consistent with
the public health and safety,’ but it does not provide any
guidance as to what those factors might be. This vague
language creates uncertainty among advocates regarding the
standards they must meet to obtain a registration. [The
EPAEDEA] reduces this uncertainty by tying those standards
to Congress’s findings in [21 U.S.C. § 801] regarding the
benefits, harms, and commercial impact of controlled
substances. This change will bring clarity to the registration
process and provide better guidance to regulators as they
consider applications to manufacture or distribute controlled
substances.88
Therefore, the single basis of support offered for the addition of this
definition was that it would purportedly make the factors to be considered in
that catch-all factor clearer for potential registrants. 89
To the extent that this portion of the EPAEDEA was aimed at providing a
supplemental definition because the catch-all factors used by the Agency were
too vague, it is not altogether clear why the insertion of a definition that extends
only to manufacturers and distributors was adequate to achieve that goal. It
might seem that if the catch-all language for manufacturers and distributors
created such “uncertainty among advocates” 90 for those registrants that it
required a more specific definition linking it to certain congressional findings,
then it is likely that advocates for pharmacies, physicians, and List I distributors
would also be uncertain about the catch-all language in the equivalent factors
applicable to those applicants/registrants, as the language is remarkably similar,
but Congress elected to leave the existing catch-all language for practitioners91

86.
87.
88.
89.
90.
91.

162 CONG. REC. S954 (daily ed. Feb. 23, 2016) (statement of Sen. Hatch).
162 CONG. REC. S2006 (daily ed. Apr. 13, 2016) (statement of Sen. McConnell).
Id. at S2006-07.
Id.
Id.
21 U.S.C. § 823(f)(5) (2012).

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and List I distributors 92 in place—and to leave it undefined. Thus, the
EPAEDEA either created an enhanced definition for two types of
applicants/registrants that was not truly necessary, or it created an enhanced
definition only for those types of registrants, while failing to address the same
problem for the remaining applicants and registrants covered by the CSA.
Additionally, to the extent that Congress had perceived a need to do so, it
certainly had the ability to supplement the public interest factors with specific,
enumberated sub-factors.
While it has yet to be tested, this newly-defined factor should be watched
closely in the years to come. Time will tell if the CSA enhancements supplied
by Congress in the EPAEDEA achieved its espoused beneficial objectives, or
whether the entire effort proves to have been a solution in search of a problem.
Whether the new language serves as a helpful clarifier or creates wide potential
for manufacturers and distributors—but, notably, not other types of
registrants—to dramatically constrict the range of evidence available for
regulators to properly consider within the confines of § 801 (or whether it will
do both or neither) will only be discernible after all sides take the new statute
for a test drive.
III. AGENCY PRECEDENT
Agency legal thinking, as expressed through the final orders it has issued
recently, has taken dramatic swings and detours that are certain to affect
diversion litigation, the options chosen by prosecutors, and the advice given to
clients. Both sides of the litigation equation should be familiar with other
nuanced details, set forth only in Agency final orders, that may affect the
parties’ relative positions.
The most tectonic shifts in recent Agency legal interpretation arguably
occurred in the field of practitioners in general, and pharmacies in particular.
In a relatively brief period of time, the DEA, through its final order precedent,
has modified numerous legal standards, the bulk of which may ultimately
increase the challenges faced by its own agents and prosecutors to prevail in its
enforcement efforts.
A. The Public Interest Factors for Practitioners
In the course of supplying a framework for the granting and sanctioning of
DEA controlled substance registrations for practitioners, Congress directed that

92. Id. § 823(h)(5).

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the Attorney General93 must consider and balance five factors (the Public
Interest Factors). 94 The Public Interest Factors regarding practitioners are as
follows:
(1)The recommendation of the appropriate State licensing
board or professional disciplinary authority;
(2)The applicant’s [or registrant’s] experience in dispensing,
or conducting research with respect to controlled substances;
(3)The applicant’s [or registrant’s] conviction record under
Federal or State laws relating to the manufacture, distribution,
or dispensing of controlled substances;
(4)Compliance with applicable State, Federal, or local laws
relating to controlled substances; and
(5)Such other conduct which may threaten the public health
and safety.95
While the text of the CSA relating to the Public Interest Factors has not
been changed, the Agency’s interpretation of the public interest standard for
practitioners generally, and certain aspects of Public Interest Factors One and
Two96 in particular, have been evolving.
1. The Re-Re-Tweaking of Public Interest Factor One
In Wesley Pope, M.D., the Agency directed some attention to explaining
how it intends to handle evidence under Public Interest Factor One in the
future.97 Public Interest Factor One requires the Agency to consider, in
determining the public interest, “[t]he recommendation of the appropriate State
licensing board or professional disciplinary authority.” 98 Inasmuch as the
ultimate responsibility to determine whether a registration is consistent with the
public interest has been delegated exclusively to the DEA and not to entities
within a state government, 99 it is not surprising that the actions of state licensing
and disciplinary authorities have not historically played a case-dispositive role
in diversion cases under Factor One. 100 Notwithstanding the seeming simplicity
93. This authority has been delegated to the Administrator. 28 C.F.R. § 0.100(b), 0.103(a)
(2017). The Administrator, in turn, may delegate this authority to the Deputy Administrator. Id.
§ 0.104.
94. 21 U.S.C. §§ 823(f), 824(a)(4).
95. Id. § 823(f)(1)–(5).
96. Id. § 823(f)(1)–(2).
97. Wesley Pope, M.D., 82 Fed. Reg. 14944, 14965 n.36 (Drug Enf’t Admin. Mar. 23, 2017).
98. 21 U.S.C. § 823(f)(1).
99. Edmund Chein, M.D., 72 Fed. Reg. 6580, 6590 (Drug Enf’t Admin. Feb. 12, 2007), aff’d,
Chein v. DEA, 533 F.3d 828, 835 (D.C. Cir. 2008), cert. denied, 555 U.S. 1139 (2009).
100. See, e.g., George Mathew, M.D., 75 Fed. Reg. 66138, 66145 (Drug Enf’t Admin. Oct. 27,
2010) (declining to adopt as dispositive under Factor One the state medical board’s sanction of

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of the language utilized by Congress in this straightforward provision, final
orders from the Agency regarding this factor have presented a surprising level
of inconsistency. 101
The plain language of Public Interest Factor One reflects that Congress
made the existence of a “recommendation of the appropriate State licensing
board or professional disciplinary authority” 102 the clear condition precedent
for consideration of evidence under this factor. Where a “recommendation” by
one of those bodies exists and is part of the record, 103 it is to be considered in
the Agency’s determination of whether granting or continuing a registration is
in the public interest, and where the record does not contain a recommendation
from a state licensing authority or disciplinary board, no evidence may be
considered under Factor One. 104 The plain language of the statute thus renders
a binding, binary choice based on whether or not the appropriate state agency
has made a recommendation. 105
Notwithstanding the apparent clarity of congressional intent, over time
some, but not all, agency precedent progressively morphed into a broader view

suspending respondent’s medical license, the Agency then stayed the suspension, in a case where
respondent was prescribing controlled substances without physically examining patients or
maintaining medical records); Patrick W. Stodola, M.D., 74 Fed. Reg. 20727, 20730 (Drug Enf’t
Admin. May 5, 2009) (considering the Agency’s acknowledgement that “the record contain[ed] no
evidence that the [state] ha[d] taken action against [r]espondent’s medical license” as a Factor One
consideration and dismissing the issue without analysis). This is not to say that state licensing and
disciplinary actions do not ever play a case-dispositive role. In situations where a registrant or
applicant lacks the requisite authority to handle controlled substances in his or her state, the Agency
has determined that revocation or denial is mandatory. E.g., Rezik A. Saqer, M.D., 81 Fed. Reg. 22122,
22126 (Drug Enf’t Admin. Apr. 14, 2016); see Mulrooney & Hull, supra note 1, at 333–34.
101. See Mulrooney & Hull, supra note 1, at 338–43.
102. 21 U.S.C. § 823(f)(1) (emphasis added).
103. See, e.g., John Porter Richards, D.O., 61 Fed. Reg. 13878, 13878 (Drug Enf’t Admin. Mar.
28, 1996) (relying upon a recommendation from the Ohio State Board of Medicine).
104. See 21 U.S.C. § 823(f)(1).
105. Even if the straightforward language used by Congress did not render resort to legislative
history regarding Factor One superfluous, a review of the legislative history does not alter the result.
An isolated reference to a House Committee hearing notes that the inclusion of the state
recommendation among the mandatory factors to be considered by the DEA, and the placement of it
first among the Factors, was designed to ensure that “deference would continue to be given to the
opinions of the state licensing authorities.” Diversion of Prescription Drugs to Illegal Channels and
Dangerous Drug Diversion Control Act: Hearing on H.R. 4698 Before the Subcomm. on Crime of the
H. Comm. on the Judiciary, 98th Cong. 122–23 (1984) (statement of Gene R. Haslip, Director, Office
of Diversion Control, Drug Enforcement Administration). This testimony supports the obvious intent
of the language to incorporate the “recommendation” of state authorities regarding the disposition of
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of the term “recommendation.” 106 This broader view embraced the principle
that, through an analysis of the actions of state licensing authorities, the Agency
may be able to divine what the state would have recommended to the DEA
regarding the disposition of a registration application or revocation if it had
actually made a recommendation, in cases where it did not actually make such
a recommendation. 107 Under the broader interpretation, the Agency has, at
times, found that various forms of disciplinary action108 provide evidence from
which a ‘recommendation’ against registration or continued registration may
somehow be extrapolated and then considered under a Factor One analysis. 109
Similarly, under this broad approach, the Agency has held that the restoration
of a respondent’s state license,110 or the mere fact that a respondent holds a state
medical license, 111 can be interpreted as a recommendation in favor of
registration or continued registration.
106. Compare Ralph J. Chambers, M.D., 79 Fed. Reg. 4962, 4969 (Drug Enf’t Admin. Jan. 30,
2014) (quoting Tony T. Bui, M.D., 75 Fed. Reg. 49979, 49986 (Drug Enf’t Admin. Aug. 16, 2010))
(internal quotation marks omitted), with Scott D. Fedosky, M.D., 76 Fed. Reg. 71375, 71377 (Drug
Enf’t Admin. Nov. 17, 2011) and Gilbert Eugene Johnson, M.D., 75 Fed. Reg. 65663, 65666 n.3 (Drug
Enf’t Admin. Oct. 26, 2010).
107. Johnson, 75 Fed. Reg. at 65666 n.3.
108. E.g., Saihb S. Halil, M.D., 64 Fed. Reg. 33319, 33320–21 (Drug Enf’t Admin. June 22,
1999) (state license revoked); Myrtle L. Miller, D.O., 58 Fed. Reg. 64005, 64006 (Drug Enf’t Admin.
Dec. 3, 1993) (state license revoked); Tyson D. Quy, M.D., 78 Fed. Reg. 47412, 47417 (Drug Enf’t
Admin. Aug. 5, 2013) (state license placed on probation); Gregory D. Owens, D.D.S., 67 Fed. Reg.
50461, 50463 (Drug Enf’t Admin. Aug. 2, 2002) (state license placed on probation); Jude R. Hayes,
M.D., 59 Fed. Reg. 41785, 41786 (Drug Enf’t Admin. Aug. 15, 1994) (state license placed on
probation); Daniel Koller, D.V.M., 71 Fed. Reg. 66975, 66981 (Drug Enf’t Admin. Nov. 17, 2006)
(state license suspended); Wilbert McClay, Jr., M.D., 59 Fed. Reg. 30612, 30614 (Drug Enf’t Admin.
June 14, 1994) (state license suspended); Robert M. Golden, M.D., 65 Fed. Reg. 5663, 5664 (Drug
Enf’t Admin. Feb. 4, 2000) (state license subjected to consent order).
109. Chambers, 79 Fed. Reg. at 4969 (quoting Bui, 75 Fed. Reg. at 49986) (“DEA precedents
have typically taken a broader view as to the scope of [Factor One].”) (internal quotation marks
omitted); Kenneth Harold Bull, M.D., 78 Fed. Reg. 62666, 62672 (Drug Enf’t Admin. Oct. 22, 2013)
(“DEA has interpreted [F]actor [O]ne more broadly and thus considers disciplinary actions taken by a
state board as relevant in the public interest determination . . . .”).
110. E.g., Quy, 78 Fed. Reg. at 47417; Vincent J. Scolaro, D.O., 67 Fed. Reg. 42060, 42064–65
(Drug Enf’t Admin. June 20, 2002); William E. Brown, D.O., 58 Fed. Reg. 64004, 64005 (Drug Enf’t
Admin. Dec. 3, 1993).
111. E.g., Margy Temponeras, M.D., 77 Fed. Reg. 45675, 45684 (Drug Enf’t Admin. Aug. 1,
2012) (“Although not dispositive, [r]espondent’s possession of a valid unrestricted medical
license . . . weighs against a finding that [r]espondent’s registration would be inconsistent with the
public interest.”); but see Farmacia Yani, 80 Fed. Reg. 29053, 29058 n.13 (Drug Enf’t Admin. May
20, 2015) (ruling by Agency where it “considered” evidence that the respondent pharmacy was
registered with the state and that the state board took no action against the pharmacist license of its
owner and pharmacist-in-charge, but stated that the evidence does not “constitute a
recommendation . . . as to whether the DEA should grant the [pharmacy’s] application” for a DEA
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In Pope, the Agency included a footnote that may signal about how it will
consider state actions that do not constitute recommendations to the DEA, 112 at
least insofar as those actions ultimately result in the registrant or applicant
retaining state authority. 113 Citing two cases decided by the Agency in 2002, 114
the Agency explained that “[t]o be sure, the Agency’s case law contains some
older decisions which can be read as giving more than nominal weight in the
public interest determination to a [s]tate [b]oard’s decision (not involving a
recommendation to the DEA) either restoring or maintaining a practitioner’s
state authority to dispense controlled substances,” 115 but noted that “these cases
cannot be squared with the Agency’s longstanding holding” that the
Administrator must make a determination independent from any state
determination as to whether controlled substance privileges would be in the
public interest. 116 In the same footnote, the Agency, referencing several more
recent cases, acknowledged that “in other cases [it] has given some weight to a
[state board’s] action in allowing a practitioner to retain his state authority even
in the absence of an express recommendation,” 117 but noted that “the Agency
has repeatedly held that a practitioner’s retention of his state authority is not
dispositive of the public interest inquiry.”118
Based on its language in the footnote in Pope, the Agency appears to be
signaling that it may be willing to consider evidence that a state license has
reinstated (or not acted upon) a registrant or applicant’s state license under
Factor One, but that it may give such evidence no more than “nominal
weight,”119 and, in any event, such evidence will not be dispositive. Inasmuch
as the Agency has long held that retention of state authority is a threshold

112. Wesley Pope, M.D., 82 Fed. Reg. 14944, 14965 n.36 (Drug Enf’t Admin. Mar. 23, 2017).
113. Id. While Pope only explicitly addressed how a state authority’s reinstatement of a state
license (or inaction as to a state license) would be considered, if the state board revokes or suspends
the practitioner’s ability to handle controlled substances in the state in which the practitioner is
registered with the DEA, the Agency routinely holds that such practitioner “does not meet the CSA’s
essential requirement for maintaining a practitioner’s registration,” e.g., Steven Bernhard, D.O., 82
Fed. Reg. 23298, 23300 (Drug Enf’t Admin. May 22, 2017), and thus no consideration under Factor
One is necessary to the disposition of the case.
114. Pope, 82 Fed. Reg. at 14965 n.36 (citing Gregory D. Owens, 67 Fed. Reg. 50461, 50463
(Drug Enf’t Admin. Aug. 2, 2002) and Scolaro, 67 Fed. Reg. at 42065 (Drug Enf’t Admin. June 20,
2002)).
115. Pope, 82 Fed. Reg. at 14965 n.36 (citing Owens, 67 Fed. Reg. at 50463).
116. Id. (citing Mortimer Levin, 57 Fed. Reg. 8680, 8681 (Drug Enf’t Admin. Mar. 11, 1992)).
117. Id. (citing Paul Weir Battershell, N.P., 76 Fed. Reg. 44359, 44366 (Drug Enf’t Admin.
July 25, 2011)).
118. Id. (citing Battershell, 76 Fed. Reg. at 44366.)
119. Id. (citing Owens, 67 Fed. Reg. at 50463 (Drug Enf’t Admin. Aug. 2, 2002) and Scolaro,
67 Fed. Reg. at 42065 (Drug Enf’t Admin. June 20, 2002)).

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statutory requirement for entitlement to hold a DEA registration, 120 this analysis
may result in more confusion than clarity, because the line between assessing
threshold state controlled substance authority and evidence to be considered
under Factor One is arguably somewhat blurred. If this footnote signals a
deliberate navigation to a more consistent application of how evidence will be
considered (or not considered) under Factor One, this aspect of Pope would
likely be welcomed by the practicing bar and the regulated community. After
many years and no small amount of vacillation, it now appears that the Agency
may be considering a swerve back to the plain language provided by Congress
relative to Factor One, meaning that for a state action to be considered with any
measurable weight under Factor One, it must constitute a recommendation from
a state licensing or disciplinary board, not merely some action related to state
licensure. The Factor One language in Pope does specifically note that the
respondent’s state board “has not made a recommendation to the Agency with
respect to whether his [DEA registration] application should be granted,”121
which sounds like some movement towards a plain-language Factor One
approach, but the decision stopped short of settling the matter. However, a
subsequent final order, David D. Moon, D.O, does provide some reason to
believe that the Agency is moving in a cognizable direction back towards a
plain-language requirement for an actual state recommendation, with less
reliance on trying to distill intent from non-recommendations.122 For all sides
of the litigation aisle, less dependence on legal alchemy is likely welcome.
Another interesting Factor One question addressed by the Agency is
whether an adverse action taken or recommendation given by a state authority
other than the state in which the applicant seeks to be registered or the registrant
seeks to maintain his registration could ever be considered by the Agency and,
if so, what weight it would be given. In Zizhuang Li¸M.D., the Agency rejected
the Government’s argument that revocation of the practitioner’s state license in
Mississippi should be considered in determining whether to grant an application
for licensure in California, 123 holding that the Mississippi Medical Board was
not the “appropriate” state licensing board. 124 Li thus appears to foreclose
consideration of adverse actions taken in states other than the state in which a
respondent seeks a new or continued registration under Factor One. The
practicing bar on both sides will likely wonder why the Agency’s interpretation

120. James L. Hooper, M.D., 76 Fed. Reg. 71371, 71372 (Drug Enf’t Admin. Nov. 17, 2011),
pet. for rev. denied, Hooper v. Holder, 481 F. App’x 826 (4th Cir. 2012).
121. Pope, 82 Fed. Reg. at 14965 n.36.
122. See, e.g., David D. Moon, D.O., 82 Fed. Reg. 19385, 19387 n.5 (Drug Enf’t Admin. Apr.
27, 2017).
123. Zizhuang Li, M.D., 78 Fed. Reg. 71660, 71663 (Drug Enf’t Admin. Nov. 29, 2013).
124. Id.

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seems to preclude any consideration of an adverse action taken by a state,
merely because it is a different state than the one in which the registrant seeks
to hold a DEA registration. However, it is still unclear whether the Agency
would extend Li so far as to ignore such evidence if it were in the format of an
actual recommendation made to the DEA regarding a registration by a different
state’s licensing authority.
Although rarely pursued by litigants on either side, a recommendation
garnered from a state tribunal for or against a DEA sanction, depending on the
facts of the case and the strength of the recommendation, could potentially
constitute powerful evidence for the Government or a respondent, and Pope at
least suggests that from now on, such a recommendation may be the only
evidence that will be considered with any weight under Factor One. The
takeaway here is that, in a post-Pope world, both sides should be looking harder
at Factor One.
2. Is Public Interest Factor Two Shrinking, Melding, Both, or Neither?
The Pope case also presented a fascinating next chapter in what could
arguably be characterized as the Agency’s progressive constricting of evidence
properly considered “experience” under Public Interest Factor Two in
practitioner cases. 125 Factor Two compels consideration of “[t]he applicant’s
experience in dispensing, or conducting research with respect to controlled
substances.” 126 Inasmuch as the statutory definition of “dispense” includes
“prescribing” and “administering,” 127 this section addresses experience
regarding those regulated activities as well. 128
Before discussing the Factor Two aspects of Pope, a consideration of the
language and history of Factor Two is pertinent. It is axiomatic that the
interpretation of any statute begins and ends with an examination of clear,
directive language. 129 “Unless otherwise defined, words will be interpreted as
125. 21 U.S.C. § 823(f)(2); Pope, 82 Fed. Reg. at 14965.
126. 21 U.S.C. § 823(f)(2).
127. Id. § 802(10).
128. For general background regarding the language and reach of Factor Two, see Mulrooney &
Hull, supra note 1, at 343–46.
129. See Consumer Prod. Safety Comm’n v. GTE Sylvania, Inc., 447 U.S. 102, 108 (1980) (“We
begin with the familiar canon of statutory construction that the starting point for interpreting a statute
is the language of the statute itself. Absent a clearly expressed legislative intention to the contrary,
that language must ordinarily be regarded as conclusive.”); see also Woods v. Standard Ins. Co., 771
F.3d 1257, 1265 (10th Cir. 2014) (stating that if a court finds statutory language clear, its inquiry ends;
only if language is “ambiguous” does court turn to legislative history); Falvo v. Owasso Indep. Sch.
Dist. No. I-011, 233 F.3d 1201, 1203 n.2 (10th Cir. 2000) (same). It is well-settled that “words [should
be given] their ordinary meaning,” Moskal v. United States, 498 U.S. 103, 108 (1990) (internal
quotations omitted), and that “[w]here the language is clear and unambiguous, it must be followed

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taking their ordinary, contemporary, common meaning,” 130 and “where
language is clear and unambiguous, it must be followed, except in the most
extraordinary situation where the language leads to an absurd result contrary to
clear legislative intent.” 131 The plain language of Factor Two supplies a
mandate by Congress for the Agency, in determining the public interest, to
consider “[t]he applicant’s experience in dispensing, or conducting research
with respect to controlled substances.”132 The simplicity of the language directs
no more than a mandatory evaluation of the experience that an applicant brings
to the regulated activity the applicant seeks to conduct within the scope of a
DEA certificate of registration. Congress did not limit or qualify the experience
that the Agency is required to consider under this factor, nor did Congress
authorize the Agency to ignore offered evidence on the subject by caprice. If a
party to an administrative registration adjudication offers relevant evidence
regarding the applicant or registrant’s experience that is not otherwise
inadmissible, the language selected by Congress appears to unequivocally
require its admission and consideration under Factor Two.
It could be persuasively argued that the precision of the language employed
by Congress in Factor Two all but precludes resort to any source beyond the
statute itself, but even if it were not so, a review of the legislative history
specific to this provision reveals no intention to impose limitations on the
evidence to be considered under this Factor. The single reservation evident in
the legislative history was a clarification that an absence of any prior
experience, at least in the case of a recently-graduated practitioner, should not
be considered negatively against such a practitioner. 133
except in the most extraordinary situation where the language leads to an absurd result contrary to clear
legislative intent.” United States v. Plotts, 347 F.3d 873, 876 (10th Cir. 2003) (citing United States v.
Tagore, 158 F.3d 1124, 1128 (10th Cir. 1998)); see Griffin v. Oceanic Contractors, 458 U.S. 564, 572
(1982); Comm’r v. Brown, 380 U.S. 563, 571 (1965).
130. Perrin v. United States, 444 U.S. 37, 42 (1979).
131. Plotts, 347 F.3d at 876 (citing Tagore, 158 F.3d at 1128); see Griffin, 458 U.S. at 572;
Brown, 380 U.S. at 571.
132. 21 U.S.C. § 823(f)(2).
133. Specifically, a House of Representatives committee hearing report clarifies that Factor Two
“shall not, of course, be construed in [any way] to hinder registration of recent graduates of professional
schools who may have no professional experience dispensing or conducting research with controlled
substances.” H.R. REP. NO. 98-835, pt. 1, at 14 (1984). This brief statement resulted from input by the
American Pharmaceutical Association (APhA), stemming from its concern that the absence of
experience would bar the registration of recent pharmacy school graduates. Diversion of Prescription
Drugs to Illegal Channels and Dangerous Drug Diversion Control Act: Hearing on H.R. 4698 Before
the Subcomm. on Crime of the H. Comm. on the Judiciary, 98th Cong. 326, 334 (1984) (statement of
Maurice Q. Bectel, Interim President, American Pharmaceutical Association). Thus, it is clear that the
Factor Two language signified to the APhA that, unless its concerns on the point were addressed, the
draft language chosen (and ultimately adopted) by Congress would require the Agency to consider the

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Some context regarding the Agency’s and the courts’ treatment of Factor
Two is also helpful in navigating the Agency’s current course. Historically,
Agency final orders placed evidence of an applicant’s past experience engaging
in the regulated activity under its Factor Two discussion, but eventually
reasoned that a robust level of benign, or even commendable, experience could
be easily outweighed by other evidence demonstrating that granting a
registration application was inconsistent with the public interest. 134 Even
though the Agency has considered the experience of List 1 applicants 135 on the
issue of whether they possess the level of experience and subject area
knowledge to discharge effectively the obligations of a registrant, 136 it has
dismissed the notion of applying this rationale to practitioner cases.137
In 2006, in its discussion of Factor Two in Krishna-Iyer, M.D., the Agency
discussed only the established transgressions, and did not mention evidence in
the record regarding other experience or weigh the wrongdoings against such

applicant’s prior experience in the regulated field—or lack thereof—in order to gauge applicant
suitability. During the legislative hearing process, the American Veterinary Medical Association
(AVMA) also expressed a reservation that the draft Factor Two language (ultimately retained by
Congress) would address conduct also covered by Factor Three (conviction of a felony related to
controlled substances) and Factor Four (compliance with laws relating to controlled substances), thus
rendering consideration of evidence under this factor duplicative. Id. at 425. As discussed later in this
section, the interpretive evolution currently embraced by the Agency regarding the application of the
Public Interest Factors to all evidence of record has rendered the AVMA prescient in this regard. See
discussion infra pp. 31–33.
134. See, e.g., Paul J. Caragine, Jr., 63 Fed. Reg. 51592, 51600 (Drug Enf’t Admin. Sept. 28,
1998) (acknowledging, in its discussion of Factor Two, that during twenty years of practice, the
respondent saw over 15,000 patients, but noting that, “even though the patients at issue are only a small
portion of [r]espondent’s patient population, his prescribing of controlled substances to [the patients at
issue] raises serious concerns regarding [his] ability to responsibly handle controlled substances in the
future”); Med. Shoppe–Jonesborough, 73 Fed. Reg. 364, 386 (Drug Enf’t Admin. Jan. 2, 2008)
(acknowledging, under its discussion of Factor Two, that the respondent had 17,000 patients, but
finding that established misconduct, which related to only a relatively small portion of the respondent’s
patient population, outweighed any other conduct); see also Ivan D. Garcia-Ramirez, M.D., 69 Fed.
Reg. 62092, 62093 (Drug Enf’t Admin. Oct. 22, 2004) (finding Factor Two irrelevant to public interest
determination because “there is no information in the investigative file relative to [r]espondent’s lawful
handling of controlled substances in his professional practice” where practitioner pled guilty to one
felony count of possession with intent to import heroin).
135. 21 U.S.C. § 823(h).
136. TNT Distribs., Inc., 70 Fed. Reg. 12729, 12731 (Drug Enf’t Admin. Mar. 15, 2005); Volusia
Wholesale, 69 Fed. Reg. 69409, 69410 (Drug Enf’t Admin. Nov. 29, 2004); K & Z Enters., Inc., 69
Fed. Reg. 51475, 51476 (Drug Enf’t Admin. Aug. 19, 2004); Island Wholesale, Inc., 68 Fed. Reg.
17406, 17407 (Drug Enf’t Admin. Apr. 9, 2003).
137. See, e.g., Cynthia M. Cadet, M.D., 76 Fed. Reg. 19450, 19450 n.3 (Drug Enf’t Admin. Apr.
7, 2011) (noting only that List 1 distributors are “a different category of registrant[s],” the Agency
dismissed the comparative rationale).

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evidence.138 On appeal, in Krishna-Iyer v. DEA,139 the United States Court of
Appeals for the Eleventh Circuit (in an unpublished per curiam decision) noted
that “the DEA is required to consider the [Public Interest Factors] to determine
if continued certification is against the public interest,” 140 and criticized the
Agency for failing to adequately consider evidence admitted to the record of
proceedings under Factor Two. 141 In its decision, the Eleventh Circuit held:
In considering Petitioner’s experience in dispensing controlled
substances under [F]actor 2, the DEA identified only four visits
by three undercover “patients,” who were all attempting to
make a case against her. The DEA failed to consider
Petitioner’s experience with twelve patients whose medical
charts were seized by the DEA, or with thousands of other
patients. In short, the DEA did not consider any of Petitioner’s
positive experience in dispensing controlled substances. This
is an arbitrary and unfair analysis of the Petitioner’s
experience. We vacate the order of the [Agency] and remand
the case for reconsideration of this factor, where the DEA
should pay particular attention to the entire corpus of
Petitioner’s record in dispensing controlled substances, not
only the experience of the undercover officers. The five factors
should accordingly be rebalanced. 142
The court’s directive to the Agency seemed clear enough: on remand,
rebalance the evidence considered under Factor Two in light of the entire
corpus of the prescriber’s experience, and rebalance the five factors
accordingly. 143 The Agency could have easily done what it had historically
done: briefly discuss the evidence under Factor Two, but ultimately find that
the established misconduct outweighed the positive or benign conduct,144 but
instead, the Agency pushed back somewhat on the Eleventh Circuit’s analysis,
stating, inter alia, that:
[E]vidence that a practitioner has treated thousands of patients
does not negate a prima facie showing that the practitioner has
committed acts inconsistent with the public interest. While

138. Jayam Krishna-Iyer, M.D., 71 Fed. Reg. 52148, 52158 (Drug Enf’t Admin. Sept. 1, 2006).
In its findings of fact, the Agency noted that the practitioner testified that she had around 800 to 1000
recurring patients and saw around 3,000 patients per year. Id. at 52149. It also made findings regarding
her education, training, and experience at various hospitals. Id.
139. 249 F. App’x 159 (11th Cir. 2007).
140. Id. at 159.
141. Id. at 160.
142. Id.
143. Id.
144. Paul J. Caragine, Jr., 63 Fed. Reg. 51592 (Drug Enf’t Admin. Sept. 28, 1998).

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such evidence may be of some weight in assessing whether a
practitioner has credibly shown that she has reformed her
practices, where a practitioner commits intentional acts of
diversion and insists she did nothing wrong, such evidence is
entitled to no weight.145
Thus, the Agency’s reply to the Circuit Court of Appeals was essentially
that it would obey its directive to consider positive experience, but that it would
only do so as a matter of sanction discretion in cases where the respondent
accepts responsibility for the transgressions alleged against it, not under Factor
Two when determining whether the Government has met its prima facie burden
that registration is not in the public interest. 146 The Agency emphasized its
qualified acceptance of the court’s mandate with this additional statement:
[E]ven where the Agency’s proof establishes that a practitioner
has committed only a few acts of diversion, this Agency will
not grant or continue the practitioner’s registration unless he
accepts responsibility for his misconduct. Put another way,
even where the Government proves only a few instances of
illegal prescribing in the “entire corpus” of a practitioner’s
experience, the Government has nonetheless made out a prima
facie case and thus shifted the burden to the registrant to show
why he should be entrusted with a new registration. 147
Thus, in its second order, the Agency essentially adhered to its previous
(pre-remand) analysis, with the additional wrinkle that, in a case where the
Government had established acts of intentional misconduct, the Agency would
not consider the entire corpus of a practitioner’s experience in its analysis of
Factor Two, nor would it consider experience at all unless the respondent has
manifested an unconditional acceptance of responsibility. 148 While true that, if
writing upon a clean slate, it may not have been unreasonable for the Agency
to insist upon an acceptance of responsibility to render evidence of benign or
commendable conduct more probative to a registrant’s defense that established
misconduct was an aberration and he should be entrusted with a registration,
the analysis is remarkable in that it risks the appearance of the Agency
substituting its own structure of analysis for that created by Congress (the body
that required consideration of this evidence without qualification in Factor
Two) and for the legal interpretation set forth in the decision of the Eleventh
Circuit.

145. Jayam Krishna-Iyer, M.D., 74 Fed. Reg. 459, 463 (Drug Enf’t Admin. Jan. 6, 2009)
(emphasis added).
146. See id.
147. Id. at 464 (footnotes omitted).
148. See id.; 21 U.S.C. § 823(f)(2) (2012).

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Inasmuch as the Agency’s second final order in Krishna-Iyer granted the
doctor in that case a registration with conditions,149 the case was never reappealed to the Eleventh Circuit, and the final order was maintained as a
recurrent bedrock of Agency precedent. 150 In MacKay v. DEA, the Tenth
Circuit upheld an Agency final order that included the Agency-created KrishnaIyer analysis, but the Agency’s failure to consider experience evidence under
Factor Two was not a significant focus of the court’s affirmance opinion; 151
instead, the Tenth Circuit found that the Agency “considered the entire record”
to include the hypothetical situation that the doctor “had provided proper
medical care to all of his other patients” and found that it did not outweigh the
evidence of negative experience. 152 Likewise, in McNichol v. DEA153 the
Eleventh Circuit found that the Agency’s decision, which had included the
Krishna-Iyer analysis, was supported by substantial evidence and was not
arbitrary and capricious.154 However, the Eleventh Circuit did not mention the
Krishna-Iyer analysis, or even Factor Two specifically, in its unpublished
decision.155
After Krishna-Iyer, the Agency’s reliance upon its own interpretation of
Factor Two has become increasingly restrictive, and the Agency has become
increasingly critical of any ALJ who recommends a different analysis of it to
the Administrator when considering the facts of a particular case.156 In JM
149. Krishna-Iyer, 74 Fed. Reg at 464.
150. See, e.g., Dewey C. Mackay, M.D., 75 Fed. Reg. 49956, 49973–78 (Drug Enf’t Admin.
Aug. 16, 2010); Beau Boshers, M.D., 76 Fed. Reg. 19401, 19402–13 (Drug Enf’t Admin. Apr. 7,
2011); Wesley Pope, M.D., 82 Fed. Reg. 14944, 14982–85 (Drug Enf’t Admin. Mar. 23, 2017); T.J.
McNichol, M.D., 77 Fed. Reg. 57133, 57144–49 (Drug Enf’t Admin. Sept.17, 2012).
151. See MacKay v. DEA, 664 F.3d 808, 819 (10th Cir. 2011).
152. Id.
153. 537 F. App’x 905 (11th Cir. 2013).
154. McNichol, 77 Fed. Reg. at 57144–46.
155. See McNichol, 537 F. App’x at 906. In Pope, the Agency discussed another case, Lynch v.
DEA., which it said also rejected an alternative view of the Agency’s Krishna-Iyer analysis. Pope, 82
Fed. Reg. at 14983. While the Agency discussed arguments raised by the practitioner in his briefs
before the Eleventh Circuit in that case, neither the Agency’s decision nor the Eleventh Circuit’s
unpublished decision mentions Krishna-Iyer or discusses the Agency’s decision to not consider
evidence of positive experience under Factor Two. See Ronald Lynch, M.D., 75 Fed. Reg. 78745
(Drug Enf’t Admin. Dec. 16, 2010); Lynch v. DEA, 480 F. App’x 946 (11th Cir. 2012).
156. See, e.g., Syed Jawed Akhtar-Zaidi, M.D., 80 Fed. Reg. 42962, 42962 n.2 (Drug
Enforcement Admin. July 20, 2015) (scolding of ALJ by Agency, saying that “every Administrator
and Deputy Administrator who has exercised [Agency authority] has rejected the ALJ’s view”); Clair
L. Pettinger, M.D., 78 Fed. Reg. 61591, 61597 (Drug Enf’t Admin. Oct. 3, 2013) (describing ALJ’s
reasoning as “illogical” for analyzing Factor Two in terms of “both the qualitative and quantitative
volume of the [r]espondent’s experience”); Randall L. Wolff, M.D., 77 Fed. Reg. 5106, 5121 (Drug
Enf’t Admin. Feb. 1, 2012) (rejecting respondent’s contention that he was prejudiced by the denial of
his ability to access his own seized medical charts to establish his experience under Factor Two in light

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Pharmacy, the Agency held that it was error for the DEA ALJ to find in a
recommended decision that Factor Two calls for the Agency to analyze “the
qualitative manner and the quantitative volume in which an applicant has
engaged” in regulated activity. 157 By placing italics on the “quantitative
volume” aspect of the recommended decision, the Agency presumably signaled
that, under Factor Two, it only wishes to receive and consider evidence
regarding the “qualitative manner” in which regulated activity has been
conducted, and exclude any consideration relative to the “quantitative
volume.” 158 Based on that language, it now seems apparent that a registrant
seeking to demonstrate that the established non-compliance was an anomaly
can no longer introduce evidence that the misconduct represented only a small
percentage of the registrant’s body of compliant regulated activity that
Congress mandated be considered under Factor Two.
In Pope, the Agency vehemently rejected the suggestion that the Agency
had narrowed Factor Two beyond its plain meaning and in contravention of
Congress and the Eleventh Circuit’s directives.159 In doing so, the Agency cited
multiple definitions of the word “experience” from two dictionaries,160 and
distilled no obligation to consider the quantity of benign regulated activity to
any extent.161 Confusingly, in addressing Congress’s reservation regarding new
registration applicants in the legislative history, the Agency posited that “if
Factor Two’s meaning was so plain,” there would have been “no need to
express that it should not be construed to deny registrations to newly-licensed
practitioners, most of whom can point to no volume of dispensing other than by

of the purported irrelevance of such evidence under Krishna-Iyer); McNichol, 77 Fed. Reg. at 57144
(excoriating ALJ publicly throughout the Agency final order for legal and factual analysis, to include
the ALJ’s attempt to follow the directives of the Eleventh Circuit in Krishna-Iyer v. DEA, 249 Fed.
App’x at 160), aff’d, T.J. McNichol v. DEA, No. 12-15292, slip op. at 3 (11th Cir. Oct. 17, 2013) (per
curiam) (lacking discussion in affirmance regarding Factor Two analysis); Jeri Hassman, M.D., 75
Fed. Reg. 8194, 8235 (Drug Enf’t Admin. Feb. 23, 2010) (characterizing ALJ’s analysis as “erroneous”
for including a comparison between the two acts of substandard prescribing with the over nine-hundred
presumably benign prescribing events).
157. JM Pharmacy Grp, Inc., 80 Fed. Reg. 28667, 28667 n.2 (Drug Enf’t Admin. May 19, 2015).
158. Id.
159. Pope, 82 Fed. Reg. at 14982.
160. Id. at 14982 n.54. The definitions provided by the Agency as “those most relevant in
assessing” the meaning of “experience” in the context of Factor Two are: “(1) The ‘direct observation
of or participation in events as a basis for knowledge,’ (2) ‘the fact or state of having been affected by
or gained knowledge through direct observation or participation,’ (3) ‘practical knowledge, skill, . . . or
participation in events or in a particular activity,’ and (4) ‘the length of such participation.’” Id. (citing
Merriam-Webster’s Collegiate Dictionary 409 (10th ed. 1998)).
161. Id. at 14982.

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observing a physician during clinical rotations.”162 Additionally, the Agency
bristled at the notion that the Agency failed to follow the Eleventh Circuit’s
direction in Krishna-Iyer, proposing instead that “the Administrator carefully
reviewed” the additional files in evidence and assumed that the rest of the
prescriptions the practitioner had issued were lawful, but that “they did not
negate the Government’s prima facie showing that the physician had knowingly
diverted drugs to others.”163
By adjusting the analysis through its adjudications, the Agency has, in
essence, decided that its examination of a registrant’s experience under Factor
Two will be generally limited to the Government’s established allegations
regarding the quality of an applicant’s activities.164 Stated differently, the only
experience to be considered will be the transgressions supported by the
preponderant evidence of record. 165 Further, to the extent the universe of
experience is further constricted, Factor Two analysis, in the majority of
Agency cases, consists largely of a reprise of adverse evidence also considered
under Factor Four (compliance with laws pertaining to controlled
substances),166 to wit: experience that shows proven misconduct in violation of
state and federal laws. The Agency’s affinity for the merging of Public Interest
Factors Two and Four was signaled in Syed Jawed Akhtar-Zaidi, M.D., a recent
case where the Agency held that “[p]roof that a physician knowingly diverted
controlled substances is the best evidence for assessing his experience in
dispensing controlled substances, although it is also relevant in assessing his
compliance with applicable laws related to controlled substances.”167 Thus, the
Agency’s precedent has, in effect, morphed Factor Two into a consideration
where the only evidence to be considered is evaluated once under Factor Two,
and then again under Factor Four.
By framing its analysis in terms of whether the registrant or applicant can
“negate the Government’s prima facie showing” 168 with evidence of positive
dispensing experience, the Agency has signaled that evidence of positive
experience will not be considered in the Public Interest Factor analysis—the
analysis which determines whether the Government has met its prima facie
burden—but will instead be considered at some later point, once the Agency
162.
statement.
163.
164.
165.
166.
167.
20, 2015).
168.

Id. at 14982 n.55. It is difficult to understand what the Agency intended to convey by this
Id. at 14982–83.
See id. at 14982.
See id.
21 U.S.C. § 823(f) (2012).
Syed Jawed Akhtar-Zaidi, M.D., 80 Fed. Reg. 42962, 42962 n.2 (Drug Enf’t Admin. July
Pope, 82 Fed.Reg. at 14983.

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has shifted the burden to the respondent. 169 In Pope, the Agency noted that,
“[a]s in past cases, the parties may continue to introduce evidence as to the
extent of both a practitioner’s lawful or unlawful dispensing activities,”170 but
also reminded litigants that, “in past cases, [the] Agency has given no more than
nominal weight to a practitioner’s evidence that he has dispensed controlled
substances to thousands of patients in circumstances which did not involve
diversion.”171 A practitioner may understandably be left to wonder whether to
seek the introduction of evidence of positive experience at all and, if so, how to
demonstrate the extent of such lawful dispensing to the ALJ when the Agency
has previously declared such evidence to be essentially irrelevant. If, as JM
Pharmacy concluded, analysis of the “quantitative volume” of benign,
compliant conduct is per se irrelevant,172 then it may not be altogether clear how
to establish admissibility for the evidence such that the Agency would be able
to consider it in its sanction determination. Additionally, if the volume of
benign, compliant conduct is not relevant to the Agency’s analysis, then a
practitioner who seeks to juxtapose several acts that fall below the applicable
standard with evidence of an expansive otherwise-compliant history stands in
the same position no matter whether the registrant has practiced for decades or
for less than a month.
While not altogether clear how the Agency intends to consider evidence of
a history of benign conduct outside of Factor Two, the Agency has provided
some clues. In Roy S. Schwartz, the Agency, in discussing the issue of sanction
in a non-hearing case, utilized language that was eerily similar to Factor Two
analysis language and found that “the Government produced no evidence that
the Registrant has engaged in any other misconduct related to controlled
substances during the course of his professional career, which has spanned
more than fifty years.”173 In Pope, the Agency more explicitly stated that “in
these proceedings, the Agency will assume, without requiring the production of
any evidence by a respondent, that the practitioner has lawfully issued every
prescription other than those alleged by the Government to be unlawful.” 174 In
Roberto Zayas, M.D., the Agency stated that the Public Interest Factors
simply shape the scope of the relevant evidence in the
proceeding, and given the nature of this inquiry, the Agency
properly considers a respondent’s evidence of a lengthy history
of compliance after the Government makes out its prima facie
169.
170.
171.
172.
173.
174.

See id.
Id. at 14982.
Id.
JM Pharmacy Grp, Inc., 80 Fed. Reg. 28667, 28667 n.2 (Drug Enf’t Admin. May 19, 2015).
Roy S. Schwartz, 79 Fed. Reg. 34360, 34363 (Drug Enf’t Admin. June 16, 2014).
Pope, 82 Fed. Reg. at 14984.

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case, as determining what sanction is necessary to protect the
public interest is the ultimate purpose of these provisions.175
Thus, the Agency has signaled to the regulated community that, where the
Government produces no evidence of other misconduct over the course of a
lengthy career as a registrant, the Agency, in its final order, may be willing to
assume it to be benign and may be willing to consider it as a matter of sanction
discretion. 176 Both sides of the litigation equation should thus be prepared to
make their case for the Agency to exercise its discretion—apparently outside
the bounds of the Public Interest Factors—in their favor.
3. The Blurring of the Factors
Perhaps foreshadowed by the blurring of the line between Factor Two and
Factor Four over time, 177 in Zayas, the Agency announced what many
experienced practitioners may have quietly feared: that it does not matter to the
Agency which factor or factors evidence is considered under, and the Agency
believes that it has no obligation to parse out which evidence is considered
under what factor. 178 This is so, the Agency posits, because “misconduct is
misconduct whether it is relevant under Factor Two, Factor Four, or Factor
Five, or multiple factors,” and because “the inquiry focuses on protecting the
public interest; what matters is the seriousness of the registrant’s or applicant’s
misconduct.”179 Regarding the danger that, under such an interpretation, the
Agency could consider the same evidence multiple times under multiple
factors, the Zayas order tenders the Agency’s assurance that, because its own
prior final orders “ha[ve] repeatedly explained that it does not mechanically
count up the [Public Interest F]actors and determine how many favor the
Government versus how many favor the respondent,” there is no danger to the
regulated community that their transgressions will be given additional weight
if considered multiple times under multiple factors. 180 A representation that the
Agency is disinclined to “mechanically count up the [Public Interest
F]actors,” 181 even if accepted at its face value, is not a phrase that is readily

175. Roberto Zayas, M.D., 82 Fed. Reg. 21410, 21422 n.27 (Drug Enf’t Admin. May 8, 2017).
176. See id.
177. E.g., Randall L. Wolff, M.D., 77 Fed. Reg. 5106, 5121 n.26 (Drug Enf’t Admin. Feb. 1,
2012) (“[W]hether conduct is considered under [F]actor [T]wo—the experience factor, or [F]actor
[F]our—the compliance factor, or both factors, is of no legal consequence because the fundamental
question is whether the registrant ‘has committed such acts as would render [his]
registration . . . inconsistent with the public interest.’”).
178. Zayas, 82 Fed. Reg. at 21420.
179. Id. at 21422.
180. Id.
181. Id.

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understandable in the context of a legislative format that requires the balancing
of public interest factors. It is challenging to perceive why this phrase would
supply comfort to litigants and courts concerned about the risk that the same
evidence will be or has been considered more than once under multiple factors,
yielding results that militate in favor of the sanction sought by the enforcement
arm of the Agency. For example, in a hypothetical case where the same
evidence is considered under both Factors Two and Four, and the Agency final
order explains that both of these factors weigh in favor of a sanction, legal and
evidentiary analysis on appeal can become obfuscated, and assurances by the
Agency that it “does not mechanically count up the [Public Interest F]actors”182
or that “misconduct is misconduct” 183 will bring little to the analysis.
The Zayas analysis is potentially nettlesome in several respects. Congress,
obviously recognizing the potential that the term “public interest” could be
viewed as sufficiently amorphous as to unfairly deprive the regulated
community of fair notice, or unfairly empower the regulators with too broad a
role in interpretation, supplied a specific definitional framework to the term as
it is used in determining whether to register (or continue the registration of)
practitioners under the CSA. 184 At least at first blush, it is difficult to perceive
where blurring the lines cast by Congress would be helpful in guiding either
regulators or the regulated community in discerning the limits of acceptable
activity conducted under the authority of a DEA registration. There is a
potentially huge divide between consideration of evidence in specific categories
supplied by the statute,185 and a blanket pronouncement that “misconduct is
misconduct”186 could conceivably authorize a level of after-the-fact Agency
discretion that well exceeds congressional intent. Further, in terms of defending
adjudications on appeal, a past willingness by the courts to affirm sanctions
based on evidence considered under any one or more of the Public Interest
Factors,187 which is the rationale tendered by the Agency in its analysis of why
it need not specify what evidence is being considered under which factors,188

182. Id.
183. Id.
184. 21 U.S.C. § 823(f) (2012). Similar frameworks are used in determining whether to register
or sanction manufacturers, distributers of controlled substances, as well as distributors of List I
chemicals. See generally id. § 823. It is not altogether clear whether the Agency would follow the
same path that it has taken with practitioners if faced with similar cases regarding the other types of
registrants.
185. See Mulrooney & Hull, supra note 1, at 336–37.
186. Zayas, 82 Fed. Reg. at 21422.
187. See, e.g., Trawick v. DEA, 861 F.2d 72, 76 (4th Cir. 1988); Hoxie v. DEA, 419 F.3d 477,
482 (6th Cir. 2005); Morall v. DEA, 412 F.3d 165, 173–74 (D.C. Cir. 2005).
188. Zayas, 82 Fed. Reg. at 21422.

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may not translate into a willingness by the courts to embrace a “misconduct is
misconduct” approach to determining whether granting or maintaining
registration status is “inconsistent with the public interest.”189 Additionally,
despite the Agency’s assurance that it does not count up the factors to determine
which weigh in favor of or against the respondent, where Congress has declared
that the public interest is defined by consideration of record evidence under
specific factors, 190 those factors must inescapably be weighed and balanced
against each other. The assurance that the Agency “does not mechanically
count up the [Public Interest F]actors”191 may provide scant comfort to the
regulated community, and even less guidance to regulators and the diversion
bar, about how misconduct will be considered against them.
4. The X Factor?
While Zayas suggested that the Agency is moving away from
differentiating between the factors when considering evidence of misconduct,
the Pope decision also contained a statement that was brief in terms of verbiage,
but potentially extremely consequential. In the same footnote where the
Agency discussed Factors One and Three, which it found to be insignificant to
its determination that the Government satisfied its prima facie burden, the
Administrator included the following statement: “While I have considered
[F]actor [F]ive, I deem it unnecessary to make any findings.” 192 The
Administrator’s choice of words signals that the Agency apparently considered
evidence under Factor Five but “deem[ed] it unnecessary” 193 to explain what
evidence was considered or in what manner it was analyzed, because it
ultimately concluded that “the Government’s evidence with respect to Factors
Two and Four satisfies its prima facie burden.”194 While the failure to consider
all Public Interest Factors has not garnered negative attention from the courts
on review,195 and the absence of any evidence offered or considered under a
particular factor is not uncommon, the declaration that the factor was
considered but its significance is not explained raises a potential analytical red
flag. The Supreme Court has made it clear that, in reviewing administrative
determinations rendered by federal agencies, “[t]he grounds upon which an
administrative order must be judged are those upon which the record discloses
189. 21 U.S.C. § 823(f).
190. Id. (“In determining the public interest, the following factors shall be considered . . . .”)
191. Zayas, 82 Fed. Reg. at 21422.
192. Wesley Pope, M.D., 82 Fed. Reg. 14944, 14965 n.36 (Drug Enf’t Admin. Mar. 23, 2017).
193. Id.
194. Id. at 14965.
195. See, e.g., Trawick v. DEA, 861 F.2d 72, 76 (4th Cir. 1988); Hoxie v. DEA, 419 F.3d 477,
482 (6th Cir. 2005); Morall v. DEA, 412 F.2d 165, 173–74 (D.C. Cir. 2005).

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that its action was based,” and that review in the courts will be
“confin[ed] . . . to a judgment upon the validity of the grounds upon which [an
agency] itself based its action.” 196 If no consideration was given to Factor Five,
or if no evidence was offered or considered under Factor Five, then no review
would be necessary. But with the chosen language, it may be analytically
impossible to determine the total body of considerations upon which the
sanction was based. This language, or similar language that omits or obscures
the bases upon which an Agency sanction is based, is particularly unhelpful in
reviewing its legal sufficiency, and renders its defense in the courts potentially
unwieldy. Stated differently, there is no analytical flaw in a final Agency order
that determines that no evidence is relevant under a given Public Interest Factor,
but where an Agency has indicated that evidence has been considered under a
Factor, it must explain what evidence was considered and how it was analyzed
under that Factor. 197
B. The Pharmacy’s Corresponding Responsibility and Willful Blindness
The DEA regulations have long explained that the responsibility required
of a pharmacy registrant in ensuring that controlled substance prescriptions are
legitimately issued is not identical to the responsibility of prescribers, but is
instead a “corresponding responsibility.”198 Recent final orders issued by the
Agency have increased the quantum and nature of evidence that now must be
demonstrated to establish a violation of a pharmacy registrant’s corresponding
responsibility.199 In JM Pharmacy, the Agency set forth that it must establish
“willful blindness” in order to meet its (own) burden to demonstrate a violation
of a pharmacy’s corresponding responsibility. 200 This is a higher standard than
it required of itself in prior cases. 201 The willful blindness standard requires
that, at the time of the alleged transgression(s), the pharmacy registrant
(generally through its pharmacists) subjectively believed that there was a high
probability that a particular fact existed, and took deliberate actions to avoid
learning that fact. 202 The Agency’s adoption of the higher standard in

196. SEC v. Chenery Corp., 318 U.S. 80, 87–88 (1943).
197. See id.
198. 21 C.F.R. § 1306.04(a) (2017).
199. E.g., JM Pharmacy Grp., Inc., 80 Fed. Reg. 28667, 28672 (Drug Enf’t Admin. May 19,
2015).
200. Id. at 28670.
201. See Holiday CVS, L.L.C., 77 Fed. Reg. 62316 (Drug Enf’t Admin. Oct. 12, 2012); see also
Mulrooney & Hull, supra note 1, at 354–56 (discussing the corresponding responsibility of pharmacy
registrants).
202. JM Pharmacy, 80 Fed. Reg. at 28672 (citing Global-Tech Appliances, Inc. v. SEB S.A.,
563 U.S. 754, 769 (2011)).

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administrative pharmacy enforcement cases was unexpected, particularly given
that in Global-Tech,203 the single authority cited by the Agency to support this
increased standard, 204 the court dealt exclusively with the doctrine to be applied
in civil lawsuits for induced patent infringement under 35 U.S.C. § 271(b), a
statute that bears no readily-apparent relation to the Controlled Substances
Act205 or the corresponding responsibility regulation. 206
In fact, the
corresponding responsibility regulation and the patent infringement statute do
not share common elements, structure, or language. 207
This was a considerable, voluntary step up from the Agency’s previous
interpretation, which required only a demonstration that a pharmacy’s
controlled substance dispensing fell below the standard of care for dispensing
in the particular state.208 This higher standard may make it less burdensome for
pharmacy registrants to defend enforcement actions brought against them, and
harder for the Agency enforcers to bring and prevail in actions based on a
violation of the corresponding responsibility. Litigants representing members
of the regulated community who are careless or sloppy (even very sloppy) with
required paperwork obligations under the regulations will doubtless find
comfort in JM Pharmacy and the Agency’s interpretation that it is no longer
sufficient for the Government to merely demonstrate practice below the
prevailing state standard, but that it instead must demonstrate willful blindness.
1. Red Flags and Willful Indifference
The Agency has long held that a pharmacy can violate its corresponding
responsibility by ignoring red flags raised by prescriptions and the
circumstances in which they are presented. 209 However, in Superior Pharmacy
I and Superior Pharmacy II, again citing Global-Tech, the Agency held that, to
satisfy its new willful indifference standard for corresponding responsibility
violations, it is not enough to show that a pharmacist dispensed a controlled

203. Global-Tech, 563 U.S. at 760 (discussing 35 U.S.C. § 271(b)).
204. JM Pharmacy, 80 Fed. Reg. at 28672.
205. Controlled Substances Act of 1970, Pub. L. No. 91-513, 84 Stat. 1236 (codified as amended
at 21 U.S.C. §§ 801-904 (2012)).
206. 21 C.F.R. § 1306.04(a) (2017).
207. Compare 21 C.F.R. § 1306.04(a), with 35 U.S.C. § 271(b) (2012).
208. See, e.g., Holiday CVS, L.L.C., 77 Fed. Reg. 62316 (Drug Enf’t Admin. Oct. 12, 2012).
209. The Agency has defined a “red flag” to mean “a circumstance that does or should raise a
reasonable suspicion as to the validity of a prescription.” Superior Pharmacy I and Superior Pharmacy
II, 81 Fed. Reg. 31310, 31335 (Drug Enf’t Admin. May 18, 2016) (citing discussion in Government’s
brief of Holiday CVS, 77 Fed. Reg. at 62341).

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substance prescription in the face of a red flag. 210 This is because, according to
the Agency, “[a]ll red flags do not have the same hue,”211 and although some
red flags may create only a “reasonable suspicion” that a prescription lacks
legitimate medical purpose—which is less than what is required to show willful
blindness212—“where there are multiple red flags, none of which alone would
establish the requisite scienter, the combination of red flags may well create a
subjective belief that there is a high probability that a prescription lacks a
legitimate medical purpose.” 213 Hills Pharmacy L.L.C., citing liberally to
Superior I & II, likewise held that “establishing the requisite scienter for a
violation requires more than simply showing that a [controlled substance]
prescription presented a[n unresolved] red flag.” 214 Thus, to meet the new
requisite scienter, the Agency has decided that it will now impose upon its
prosecutors the requirement to demonstrate more than pharmacy registrants
were doling out controlled substances below the state standard; DEA
prosecutors must now show that the medications were dispensed in the face of
willful indifference on the part of the registrant. 215
2. Willful Indifference and Evidence/Absence of Red Flag Resolution
The evidence required by the Agency regarding willful indifference is also
undergoing some measure of evolution. In Superior I & II, notwithstanding the
unrefuted testimony of the Government’s expert that, “in the practice of
pharmacy, a red flag which is resolved must be documented and that the
documentation should be placed on the prescription itself,”216 the Agency held
that the failure to document red flags on prescriptions is not alone sufficient to
establish that the pharmacists failed to resolve the red flags, and thus, that they
deliberately failed to avoid learning that the prescriptions lacked a legitimate
medical purpose. 217 The Agency stated that, “while evidence of a custom
certainly has probative value, it is not conclusive proof,” 218 and that
[w]hile it would be reasonable to draw an adverse inference
that a pharmacist failed to resolve a red flag (or flags) from the

210. Superior I & II, 81 Fed. Reg. at 31335 n.5 (citing Global-Tech Appliances, Inc. v. SEB
S.A., 563 U.S. 754 (2011)).
211. Id.
212. Id. (“[A]s the Supreme Court’s decision in Global-Tech makes plain . . . a ‘reasonable
suspicion’ . . . is not enough to establish that a pharmacist acted with the requisite scienter.”).
213. Id.
214. Hills Pharmacy, L.L.C., 81 Fed. Reg. 49816, 49839 (Drug Enf’t Admin. July 28, 2016).
215. See Superior I & II, 81 Fed. Reg. at 31335; Hills Pharmacy, 81 Fed. Reg. at 49839.
216. Superior I & II, 81 Fed. Reg. at 31335.
217. Id.
218. Id. at 31335 n.55.

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failure to document the resolution in any manner, the
Government offered no evidence that the [investigators] even
asked the pharmacists . . . if they documented their resolution
of red flags, and if so, where they did so.219
Thus, although the Government’s expert provided unmet evidence that the
failure to document red flag resolution on the back of prescriptions meant that
those red flags were not resolved, the Agency announced that it is incumbent
upon Agency investigators to query pharmacy employees about where else the
information could be documented, essentially calling upon them to prove the
negative.220 No witness testified that red flag resolution was or should be
documented elsewhere, but because the prosecution’s case did not eliminate
other potential repositories at the pharmacy, its evidence came up short. 221
In Hills Pharmacy, the Agency held to its position that a lack of
documentation alone is insufficient to establish that the pharmacy failed to
fulfill its corresponding responsibility by resolving red flags, again despite the
Government’s expert’s testimony that any resolution should have been
documented on the prescriptions themselves. 222 Unlike in Superior I & II,
however, the Agency went on to discuss “additional evidence, which
establishes by a preponderance of the evidence” the requisite scienter—
evidence that included a pharmacist’s testimony, which was offered by the
respondent and partial medical records, also supplied by the respondent. 223 The
Agency acknowledged that it rejected similar allegations in Superior I & II,
where the evidence only included absence of documentation, noting that “in
that matter, neither party called any of the pharmacists who dispensed the
prescriptions” and that the respondent “had the option of not putting forward
evidence on the dispensing allegations [but] nonetheless chose to present [the
pharmacist’s] testimony and submit the partial medical records.”224 Thus, the
Agency held that documents submitted as part of the respondent’s case, as well
as the testimony of a pharmacist—put on the stand by the respondent
pharmacy—can be used to shore up the Government’s case when it otherwise
relies upon a lack of documentation. 225
What made the Agency’s announcement that it would use evidence
presented in the respondent’s case in Hills Pharmacy particularly poignant, and
particularly painful for the respondent, is that at the hearing, the respondent’s
219.
220.
221.
222.
223.
224.
225.

Id. at 31335.
Id. at 31337 n.60.
Id. at 31336–37.
Hills Pharmacy, L.L.C., 81 Fed. Reg. 49816, 49835–36 (Drug Enf’t Admin. July 28, 2016).
Id. at 49836.
Id. at 49840 n.41.
Id. at 49836.

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counsel, in an exercise of caution, moved for a partial summary disposition
based on its (ultimately vindicated) position that the Government had not
established its case because there was no evidence that red flags had not been
resolved.226 The ALJ denied the motion, not because it was devoid of merit,
but because the ALJ was unable to identify a basis in the hearing regulations to
grant the requested relief.227 Notwithstanding the cautious manner in which the
respondent’s counsel proceeded, the Agency was at once unsympathetic and
ambiguous as to the availability of a summary disposition motion in similar
circumstances in the future. The following analysis was set forth by the
Administrator in his final order:
Even if the ALJ committed error when she denied
[r]espondent’s motion, [r]espondent had the option of not
putting forward evidence on the dispensing allegations.
[r]espondent nonetheless chose to present . . . testimony and
submit [exhibits]. Cf. United States v. Sherod, 960 F.2d 1075,
1076 (1992) (“It is the universal rule in the federal circuits that
‘a criminal defendant who, after denial of a motion for
judgment of acquittal at the close of the government’s case-inchief, proceeds to the presentation of his own case, waives his
objection to the denial.”) (quoting United States v. Foster, 783
F.2d 1082, 1085 (D.C. Cir. 1986) (en banc)). Thus, I am not
required to ignore this evidence in adjudicating the dispensing
allegations.228
This analysis is of particular significance in light of the fact that the Agency,
as already discussed, has previously created an evidentiary framework in
enforcement cases wherein the respondent is precluded from avoiding a
sanction if the Government has established its prima facie case and the evidence
is not met with an acceptance of responsibility and a demonstration of remedial
steps aimed at the avoidance of future transgressions. 229 The Agency has also
embraced the viability of adverse inferences borne of missing evidence, even
where a respondent declines to testify based on self-incrimination concerns at
the advice of counsel.230 Thus, the respondent faces the unpleasant specter of a
three-option choice: (1) presenting no evidence on a given charge and having a
prima facie case established with the assistance of an adverse inference; (2)

226. Id. at 49840 n.41.
227. Id.
228. Id.
229. Jeri Hassman, M.D., 75 Fed. Reg. 8194, 8236 (Drug Enf’t Admin. Feb. 23, 2010); See supra
Part III.A.2.
230. Joseph Baumstarck, M.D., 74 Fed. Reg. 17525, 17528 n.3 (Drug Enf’t Admin. Apr. 15,
2009).

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presenting no evidence and having an established prima facie case stand
unrebutted by an absence of any demonstration of acceptance of responsibility
or remedial steps; or (3) presenting evidence, only to have it used to potentially
shore up a deficient Government presentation. 231 In an environment (more fully
discussed elsewhere in this Article) 232 where virtually all factual and legal
determinations rendered by the ALJ are increasingly supplanted by the Agency,
it would seem that some measure of clairvoyance has become a required skill
for the registrants’ bar in evaluating whether and how to meet the Government’s
case. Even if a conscientious respondent’s counsel were to procure a ruling on
a timely-rendered motion for a partial summary disposition, there is no present
guarantee that such a motion is authorized, or even that counsel possesses the
luxury of assuming that the Agency would uphold the ALJ’s determination.
The only two fixed points of certainty seem to be that the respondent cannot
prevail if the Agency finds that the Government has met its prima facie burden
without the respondent meeting the evidence, and that the Agency will
supplement the Government’s prima facie case with the respondent’s evidence
if any is presented. 233
The approach for both parties to the litigation equation must shift along
with this new Agency precedent. For its part, the Government can no longer
rely on an expert’s testimony regarding where the resolution of red flags should
be documented under applicable state standards. Instead, to prevail now, it
must insure that its agents and investigators scour through all documentation
that exists in a pharmacy and, if its case is based upon an absence of evidence
that red flags—or at least those which, in combination, can establish the
requisite scienter—the Government must be prepared to show proof that the red
flags were not resolved and documented anywhere in the pharmacy operation,
paper files, or computer databases. The respondent, on the other hand, must be
prepared to counsel his client and determine whether offering the testimony of
any pharmacists or staff members could potentially backfire in support of the
Government’s case. Whether the availability of a motion for a summary
disposition based on the Government’s failure to meet its burden exists in DEA
administrative proceedings remains an open question.
The new willful indifference standard embraced by the DEA in its
pharmacy final orders is positive news for pharmacy registrants and those who
represent them, but the Agency’s newly expressed willingness to shore up its
case with the respondents’ evidence, coupled with its unwillingness to provide
a reliable framework for summary disposition motions made at administrative
231. See id.; Hassman, 75 Fed. Reg. at 8236; Jayam Krishna-Iyer, M.D., 74 Fed. Reg. 459, 463
(Drug Enf’t Admin. Jan. 6, 2009).
232. See infra Part III.L–M.
233. Hills Pharmacy, L.L.C., 81 Fed. Reg. 49817, 49818 (Drug Enf’t Admin. July 28, 2016).

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hearings, presents new perils for the regulated community. Government
counsel should expect to defend the higher patent-infringement/Global-Tech
standard of willful blindness, and registrant’s counsel should be seeking to
demonstrate that the higher burden has not been met—before calling its first
witness.
3. Verification of a Prescriber’s Registration
In a further tightening of the standards applied to its own enforcement
efforts, the Agency has announced that it will no longer rely on a pharmacy
registrant’s failure to verify that a prescriber possessed a valid DEA registration
prior to dispensing in finding a violation of the pharmacy’s corresponding
responsibility.234
About a decade ago, in United Prescription Services, the Agency called the
testimony of an expert “nonsense” 235 when that expert testified “that it was
‘probably’ not inappropriate to fill a prescription for controlled substances
issued by a practitioner whose DEA registration had expired even if the
pharmacy had a copy of the expired registration on file.”236 The Agency opined
that “filling a prescription issued by a practitioner whose registration has
recently expired might be excusable,” but admonished the pharmacy
respondent for filling prescriptions “long after the expiration” of the
practitioner’s registration, stating that it “clearly was not appropriate and was
unlawful.” 237 This statement, that the Agency might excuse a pharmacy’s
failure to refuse prescriptions when a registration issue arose “recently,” but not
“long after” it arose, suggested that the Agency expected pharmacies to verify
registrations at least somewhat regularly.
Shortly thereafter, in Medicine Shoppe—Jonesborough, the Agency stated
unequivocally that “[a] pharmacy has a duty to periodically check to see that a
practitioner retains the authority to practice medicine and dispense a controlled
substance.” 238 Four years later in Holiday CVS, without referencing Medicine
Shoppe—Jonesborough, the Agency stated that “[i]t would be difficult to
imagine a duty of a pharmacy registrant that is more fundamental to the law and
spirit of the CSA than the obligation to ensure that controlled substance
prescriptions are issued only on the authority of those empowered to prescribe

234.
235.
2007).
236.
237.
238.

See JM Pharmacy Grp, Inc., 80 Fed Reg. 28667, 28671 (Drug Enf’t Admin. May 19, 2015).
United Prescription Services, Inc., 72 Fed. Reg. 50397, 50408 (Drug Enf’t Admin. Aug. 31,
Id. at 50406.
Id. at 50408–09.
Med. Shoppe–Jonesborough, 73 Fed. Reg. 363, 381 n.45 (Drug Enf’t Admin. Jan. 2, 2008).

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by the DEA.” 239 However, the Agency went on to explain that “the expiration
of a COR is a clear red flag that a prescription issued pursuant to that COR is
invalid,” and stated that “the question becomes whether the expirations of the
CORs were recognized, or should have been recognized, by the
[pharmacies].”240 After finding that the pharmacies “knew or should have
known of the relevant registration statuses,” the Agency addressed the “third
prong of the inquiry—resolution,” and determined that the pharmacies did not
conclusively resolve the red flag prior to dispensing. 241 Thus, the Agency
concluded that the pharmacies dispensed controlled substances in the face of
red flags “that put them on notice that the controlled substance prescriptions
were not issued in the usual course of a professional practice,” and held that
“[s]uch acts are sufficient for the Government to sustain its burden in
establishing its prima facie case for revocation.”242 The Agency’s statement
that the “obligation to ensure that controlled substance prescriptions are issued
only on the authority of those empowered to prescribe by the DEA” is
“fundamental” seemed to contrast with its three-prong approach in determining
whether a violation occurred, because a registrant that never attempted to verify
a prescriber’s registration could seemingly shield itself by arguing that it did
not know—and had no reason to know—that the registration had expired.243
Holiday CVS therefore left the regulated pharmacy community with the
conflicting impressions that the duty to determine that a prescriber is
appropriately registered is “fundamental,” but that a pharmacy registrant with
no knowledge or reason to know of a problem with the prescriber’s registration
status can seemingly escape liability for filling prescriptions from that
prescriber.244
Two and a half years later, the DEA explicitly stated in JM Pharmacy that
“a pharmacist is not obligated to verify whether every prescription he fills has
been issued by a practitioner who holds a valid DEA registration.” 245 The JM
Pharmacy decision specifically acknowledged the Agency’s statement in
Medicine Shoppe–Jonesborough requiring pharmacy registrants to
“periodically” check the dispensing authority of prescribing practitioners, 246
and even held that a failure to verify a controlled substance prescriber’s
239. Holiday CVS, L.L.C., 77 Fed. Reg. 62316, 62341 (Drug Enf’t Admin. Oct. 12, 2012).
240. Id. at 62342.
241. Id.
242. Id. (citing 21 C.F.R. § 1306.04(a) (2017)) (emphasis added).
243. Id. at 62341.
244. See generally id.
245. JM Pharmacy Grp, Inc., 80 Fed Reg. 28667, 28671 (Drug Enf’t Admin. May 19, 2015).
246. Id. at 28671 n.18 (citing Med. Shoppe–Jonesborough, 73 Fed. Reg. 363, 381 n.45 (Drug
Enf’t Admin. Jan. 2, 2008)).

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registration at any time during a three-year period (where prescrber’s
prescriptions were dispensed pursuant thereto) is a breach of that duty, 247 but
rejected the Government’s allegations that such failure constituted a violation
of federal law or regulations. 248 In coming to that conclusion, the Agency stated
that, just because there is no duty to verify the prescriber’s status on every
prescription, the pharmacy still must meet its corresponding responsibility
obligation to fill only those prescriptions that conform to the requirements of
the CSA and DEA regulations, including the requirement that the prescribing
practitioner be appropriately registered, 249 but faulted the Government’s case
because it “did not prove that [the pharmacy’s] misconduct was intentional or
knowing.” 250 In discussing the duty to verify a prescriber’s registration, the
Agency stated that it would “place only nominal weight on this aspect of the
[pharmacies’] misconduct” in part because “the lack of specific guidance as to
what steps are necessary to comply with this duty diminished its egregiousness
to some degree.”251 It then lectured (itself) that, “if the Agency intends to
enforce this duty in other cases, it must provide the regulated community with
guidance as to its scope,” but declined to offer any guidance in the decision. 252
In Farmacia Yani, a decision released the day after JM Pharmacy, the
Agency reemphasized that “no Agency regulation requires that a pharmacist
ascertain that each prescription presented to [him or her] has been issued by a
practitioner who possesses a valid DEA registration,”253 and again noted that
the Agency has not “published any guidance to the regulated community setting
forth the parameters of [the] duty.” 254 The Agency then explicitly stated that
“the corresponding responsibility does not impose strict liability on pharmacists
but rather requires proof that a pharmacist filled a controlled-substance
prescription either knowing that it was unlawful or with willful blindness or
deliberate ignorance of the fact that the prescription was unlawful.” 255 It also
noted, in a footnote, that liability may potentially arise if the pharmacy acted

247. Id. at 28673.
248. Id.
249. Id. at 28671.
250. Id. at 28673.
251. Id.
252. Id.
253. Farmacia Yani, 80 Fed. Reg. 29053, 29063 (Drug Enf’t Admin. May 20, 2015).
254. Id. at 29063 n.26.
255. Id. at 29063. It then rejected the Government’s allegations that a pharmacy that filled more
than two hundred controlled substance prescriptions issued by a practitioner whose registration had
been expired for more than seven months violated its corresponding responsibility because there was
no evidence that the pharmacist who filled the prescriptions “either knew or was willfully blind to the
fact that [the prescriber] was no longer registered.” Id.

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outside the usual course of professional practice in failing to verify a
prescriber’s registration, but dismissed that possibility because the Government
did not rely on that theory. 256
Inasmuch as the Agency has not yet published a standard for the intervals
at which prescribing authority must be checked, actual knowledge (or willful
blindness) appears to be the applicable standard for demonstrating a breach of
corresponding responsibility based on dispensing controlled substances on a
prescription signed by a prescriber who is no longer authorized to prescribe. 257
The Agency’s suggestion in Farmacia Yani that failure to verify the
prescriber’s registration might potentially render dispensing “outside the usual
course of professional practice,” 258 leaves some opportunity for the
Government to rely on that theory, but it will need to establish, likely through
expert testimony, that there is an applicable standard for how often a
prescriber’s registration must be verified. In light of the Agency’s intriguing
pronouncement in JM Pharmacy that “while [prescriber license check
frequency] guidance can be announced in an adjudicatory proceeding, the
process of adjudication is not well suited for doing so,”259 it appears that the
enforcement of this issue must wait for duly promulgated regulations following
APA notice and comment proceedings. 260 Until then, Government counsel
should come prepared to argue the patent unreasonableness of long periods of
unlicensed conduct or other factors that show that the pharmacy’s pharmacists
knew or were willfully blind to the prescriber’s registration issue. Pharmacy

256. Id. at 29063 n.26.
257. In Jones Total Health Care Pharmacy, L.L.C., the Agency offered the observation that
[w]hile it is true that in Holiday CVS the Agency found that pharmacies
knowingly filled prescriptions issued by two physicians who were no longer
registered and did so well after the pharmacies should have known that the
physicians were no longer registered, that was only a small part of the case.
Jones Total Health Care Pharmacy, L.L.C., 81 Fed. Reg. 79188, 79198 (Drug Enf’t Admin. Nov. 10,
2016) (referencing Holiday CVS, L.L.C., 77 Fed. Reg. 62315, 62316–17 (Drug Enf’t Admin. Oct. 12,
2012)). Interestingly, it would be challenging to tease that nuance from the actual language in the cited
portion of the Holiday CVS decision, which states that “[i]t is manifest that [r]espondent’s conduct in
filling prescriptions issued by a practitioner whose registration had been revoked undermines the
Congressional [comprehensive and closed system for regulating the distribution of . . . controlled
substances].” Holiday CVS, 77 Fed. Reg. at 62317.
258. Farmacia Yani, 80 Fed. Reg. at 29063 n.26; 21 C.F.R. § 1306.06 (2017).
259. JM Pharmacy Grp., Inc., 80 Fed. Reg. 28667, 28673 (Drug Enf’t Admin. May 19, 2015).
260. See Administrative Procedure Act, 5 U.S.C. § 553 (2012). While it is likely that such
parameters likely could have been correctly issued through an adjudication with appropriate facts, the
Agency’s determination that regulations must precede enforcement would seem to foreclose
adjudication as an appropriate vehicle. At the very least, notwithstanding the arguably cumbersome
APA rulemaking process, in light of the strident manner in which the Agency addressed the issue in
JM Pharmacy, sorting out the issue through an adjudication would, at the very least, be confusing.

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registrant counsel should come equipped with a copy of JM Pharmacy and a
motion to exclude evidence of dispensing on prescriptions issued by prescribers
with expired registrations.
4. Can Prescriber’s Actions Immunize Pharmacy Registrants?
In continuing the torrent of seemingly heartening news for the pharmacy
bar, in Hills Pharmacy, the Agency’s final order contained the declaration that
“it is true that a pharmacist [sic] 261 cannot violate his corresponding
responsibility if a [controlled substance] prescription was nonetheless issued
for a legitimate medical purpose . . . .”262 This seemingly unequivocal
proposition runs contrary to one of the central tenets that all parts of diversion
regulation and litigation had understood: a pharmacy registrant’s actions are
judged by what he or she knew or should have known at the time a controlled
substance was dispensed. 263 Because the training and execution of the duties
of the pharmacist have historically controlled the question of whether the
pharmacy registrant has complied with his or her obligations,264 it was
theoretically possible for a pharmacy registrant who dispensed a prescription
issued by a doctor in good faith to be non-compliant by not identifying,
addressing, resolving, and documenting red flags. Contrariwise, if all red flags
encountered were resolved within the parameters of state standards, and a
pharmacist otherwise complied with his or her obligations, even a bad
prescription that was issued by a non-compliant prescriber should not result in
a sanction on a pharmacy registrant. Prior to the Hills Pharmacy final order,
the touchstone for assessing whether the regulatory corresponding
responsibility265 had been satisfied had always been an objective analysis of
whether the pharmacy registrant (through pharmacists and other key
employees) had acted within the standard of care based on the indicia presented
or available.266 Now, unless the Agency issues a clarification of the language
it utilized in Hills Pharmacy, it appears that even a patently non-compliant,
reckless pharmacy registrant could potentially be immunized by a validlyissued prescription, irrespective of what was done or not done prior to or at the
261. DEA issues registrations to practitioners, which include pharmacies, not pharmacists. 21
U.S.C. §§ 802(21), 823(f) (2012).
262. Hills Pharmacy, L.L.C., 81 Fed. Reg. 49816, 49836–37 n.33 (Drug Enf’t Admin. July 28,
2016).
263. JM Pharmacy, 80 Fed. Reg. at 28681.
264. Id. at 28681 n.24.
265. 21 C.F.R. § 1306.04(a) (2017).
266. Holiday CVS, L.L.C., 77 Fed. Reg. 62316, 62322 (Drug Enf’t Admin. Oct. 12, 2012) (“[I]t
is clear that if the red flags presented by a prescription could not be resolved, then the Government
satisfied the third element of its prima facie burden.”).

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moment controlled substances are dispensed. 267 Stated differently: if the
prescriber issued a good prescription, dispensing it can bring no liability on the
pharmacy registrant.
This sea change comes with a potentially powerful procedural ramification.
It is currently routine practice for ALJs to deny sometimes copious subpoena
requests for prescribing physicians and their patients.268
Under the
longstanding theory that it is the knowledge available to the pharmacy at the
time of dispensing that controls the assessment of whether its corresponding
responsibility has been breached, testimony regarding the actual medical
purpose and legitimacy of a prescription was irrelevant, and patients are
incompetent to offer opinions about whether dispensing was compliant with
applicable regulations and standards. 269 However, this new language in Hills
Pharmacy calls the current approach into serious question. If it is true that a
pharmacy cannot, as a matter of law, violate its corresponding responsibility
obligations whenever a controlled substance prescription was, in fact, issued
for a legitimate medical purpose—no matter how illegitimate it appears to be
at the time of dispensing—then the irrelevancy argument long-utilized by ALJs
to eschew the issuance of en masse subpoena requests to compel the attendance
of every prescriber and every patient whose prescriptions are at issue in the
hearing by compulsory process to establish the legitimacy of those prescriptions
is substantially undermined. If a witness can support a potential defense raised
by a party in the proceeding, and the testimony is likely to elicit evidence that
is “competent, relevant, material, and not unduly repetitious,” it would be
manifest error to deny the subpoena request.270 This may mean that in a postHills Pharmacy world, dozens or even hundreds of prescribers and patients are
potentially subject to compulsory process. 271 Inasmuch as the Administrative
Procedure Act (APA) affords every respondent at a hearing the right “to present
his case or defense,” 272 it may be difficult for ALJs to justify denying registrants
the ability to present the defense, suggested by the Agency for the first time in

267. Hills Pharmacy, 81 Fed. Reg. at 49836–37 n.33.
268. Id. at 49817; Superior Pharmacy I and Superior Pharmacy II, 81 Fed. Reg. 31310, 31312–
13, 31317 (Drug Enf’t Admin. May 18, 2016); see Administrative Procedure Act, 5 U.S.C. § 555(d)
(2012).
269. See 21 C.F.R. § 1316.59(a).
270. Humphreys v. DEA, 96 F.3d 658, 663 (3d Cir. 1996); See also 21 C.F.R. § 1316.59(a); 5
U.S.C. § 555(d).
271. For example, in Hills Pharmacy, the respondent proposed calling 1,461 patients whose
prescriptions had been seized by DEA as witnesses, along with more than 130 doctors. Hills
Pharmacy, 81 Fed. Reg. at 49817. The respondent estimated that it would require 45 to 60 days to
present its case-in-chief. Id.
272. 5 U.S.C. § 556(d).

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Hills Pharmacy, that all of the prescriptions under scrutiny were, in fact,
legitimately issued.
Government counsel should be prepared to distinguish Hills Pharmacy, or
minimize its exposure by bearing down on those aspects of the hearing
regulations that limit “unduly repetitious” evidence,273 and be prepared to
persuade the assigned ALJ to exercise his authority to “regulate the course of
the hearing.” 274 Respondent’s counsel should spend their pre-hearing hours
tracking down the names and addresses of all prescribers and patients that
pertain to the allegations, and determining whether those otherwise-uninvolved
persons might be able to supply a defense for the pharmacy client. The ALJs
should prepare for longer hearings and an increased level of subpoena litigation.
C. Medical Practice Standards
More than a decade ago, in Gonzales v. Oregon,275 the Supreme Court
categorically dictated that Congress and the CSA do not regulate the practice
of medicine generally, noting the following:
The [Controlled Substances Act] and our case law amply
support the conclusion that Congress regulates medical
practice insofar as it bars doctors from using their prescriptionwriting powers as a means to engage in illicit drug dealing and
trafficking as conventionally understood. Beyond this,
however, the statute manifests no intent to regulate the practice
of medicine generally. The silence is understandable given the
structure and limitations of federalism, which allow the States
great latitude under their police powers to legislate as to the
protection of the lives, limbs, health, comfort, and quiet of all
persons.276
Thus, in regulating its registrants, the DEA is required to apply medical
practice standards that emanate from the states as part of their police powers. 277
This division of regulatory power is particularly important when the Agency
seeks to rely on an allegation that a registrant or applicant fell below a state
medical standard in its administrative enforcement proceedings. 278

273. 21 C.F.R. § 1316.59(a).
274. 5 U.S.C. § 556(c)(5).
275. 546 U.S. 243 (2006).
276. Id. at 269–70 (internal citations and quotation marks omitted) (emphasis added).
277. Id. at 270 (“The structure and operation of the CSA presume and rely upon a functioning
medical profession regulated under the States’ police powers.”).
278. See 21 C.F.R. § 1306.04(a) (“A prescription for a controlled substance to be effective must
be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of
his professional practice . . . .”) (emphasis added).

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Where a sanction is sought by DEA’s regulators based on a failure to
comply with an applicable state standard, it is incumbent upon the Government
to demonstrate both what the state standard is and that a registrant has
committed acts or practiced in a manner that falls short of that standard. 279 This
is typically, but not always, accomplished through the use of expert
testimony.280 However, expert testimony is not always required, and in Jack A.
Danton, D.O. the Agency outlined the other ways in which cases without expert
testimony can be proved:
[W]here the Government fails to provide expert testimony to
support a finding that a practitioner acted outside of the usual
course of professional practice and lacked a legitimate medical
purpose, it can nonetheless prove a violation by: (1) providing
evidence that a practitioner committed a violation of a state
medical practice standard which is sufficiently tied to a state
law finding of illegitimacy to support a similar finding under
federal law[;] (2) providing evidence showing that [a
registrant] knowingly diverted drugs[; or, (3) providing
evidence that a registrant] violat[ed] a state medical practice
standard which has a substantial relationship to the CSA’s
purpose of preventing substance abuse and diversion. 281
In Lawrence E. Stewart, M.D., the Agency recently reaffirmed that expert
testimony is “typically necessary” to establish that a physician fell below the
standard for writing controlled substance prescriptions when the physician
made “some attempt to comply with various state medical practice standards
and the adequacy of those efforts is at issue,” but that “the facts and
circumstances surrounding the issuance of the prescription” established on the
record in that case could also support such a charge. 282 As discussed below,
other recent Agency cases have added additional nuances to the area of medical
practice standards in DEA proceedings that both sides should be aware of.

279. T.J. McNichol, M.D., 77 Fed. Reg. 57133, 57147–48 (Drug Enf’t Admin. Sept. 17, 2012).
280. Id. at 57147 (“[W]here a physician makes some attempt to comply with various state
medical practice standards and the adequacy of those efforts is at issue, expert testimony is typically
necessary to establish that a physician violated 21 C.F.R. § 1306.04(a).”) (internal quotation and
citation omitted).
281. Jack A. Danton, D.O., 76 Fed. Reg. 60900, 60901 (Drug Enf’t Admin. Sept. 30, 2011); see
also Joe W. Morgan, D.O., 78 Fed. Reg. 61961, 61978 (Drug Enf’t Admin. Oct. 8, 2013) (reaffirming
Danton).
282. Lawrence E. Stewart, M.D., 81 Fed. Reg. 54822, 54824 (Drug Enf’t Admin. Aug. 17, 2016)
(citing McNichol, 77 Fed. Reg. at 57147–48) (additional citation omitted).

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1. Investigators as Experts?
In Jones Total Health Care Pharmacy, L.L.C., the Government’s expert
testified regarding payment in cash as an indicator of diversion, specifically
testifying that it is indicative of diversion when a patient asks the pharmacy not
to bill his or her insurance and instead requests to pay cash. 283 Based on that
testimony, the ALJ found that paying cash was a red flag, but the respondent
pharmacy challenged that finding because there was no evidence that patients
requested that the pharmacy not bill their insurance—a seemingly essential
component of what the expert testified constitutes a red flag.284 In the Agency’s
final order, with no apparent prior warning to the respondent, the Agency held
that a diversion investigator, who, at the hearing, also “testified that ‘paying
cash’ is a ‘red flag of diversion,’”285 possessed sufficient expert knowledge to
supplement the expert’s opinion in order to find that when a pharmacy customer
pays cash it constitutes a red flag of diversion that should have been
acknowledged and acted upon by the pharmacy registrant. 286 While, in Jones
Total Health, the diversion investigator’s testimony was used to bolster the
expert’s opinion,287 the decision suggests that the Agency may be amenable to
finding that its investigators possess sufficient knowledge and experience such
that they may offer expert testimony on certain subjects in future cases. This is
something for both sides of the litigation equation to consider as they prepare
their cases.
2. When “Should” Means “Must”
While the Agency disagreed with the Government’s expert and the findings
of the ALJ that certain documentation should exist in a certain location in
Superior Pharmacy I & Superior Pharmacy II,288 in Wesley Pope, M.D., the
283. Jones Total Health Care Pharmacy, L.L.C., 81 Fed. Reg. 79188, 79191 (Drug Enf’t Admin.
Nov. 10, 2016).
284. Id.
285. Id. (internal punctuation omitted).
286. Id.
287. Id.
288. As discussed, in Superior I & II, the Agency discounted the unchallenged testimony of the
Government’s expert witness (the only expert witness to testify at the hearing) that a pharmacy
encountering circumstances that raise suspicion about the validity of a prescription must be resolved
prior to dispensing, and that such resolution would customarily be documented on the prescription
itself. See Part III.B.2.; Superior Pharmacy I & Superior Pharmacy II, 81 Fed. Reg. 31310 (Drug Enf’t
Admin. May 18, 2016). The Agency, while not outright rejecting the testimony, emphasized that the
expert did not (and conceded that he could not) point to any statute or regulation requiring such
documentation in any particular location, and held that just because documenting resolution of a red
flag on the prescription is “customary in the profession . . . does not make it improper to document the
resolution somewhere else.” Id. at 31335 n.55.

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Agency was willing to agree with the Government’s expert—over the ALJ’s
findings—that certain documentation that state code provisions provided
should exist was, in fact, mandatory. 289 In Pope, the Government’s expert
testified that the practitioner’s documentation deficiencies placed him outside
of the standard of care, as that standard is described in certain provisions of the
Oklahoma Administrative Code. 290 The Oklahoma provisions at issue directed
that “[a] medical history and physical examination must be obtained, evaluated
and documented in the medical record,” and went on to list specific areas that
the “medical record should document,” 291 and further directed that “[r]ecords
should remain current” and that “[t]he physician should keep accurate and
complete records.”292 The Government’s expert testified that all of the
documentation requirements listed in the code provision are mandatory (and
that such documentation was missing from the prescriber’s records), despite the
fact that the code provisions used the word “should,” rather than “shall” or
“must,” in describing numerous aspects of the documentation to be kept. 293
While finding the expert credible, the ALJ declined to give weight to certain
aspects of the expert’s testimony interpreting the code provisions, instead
finding that his testimony was based upon a mistaken understanding of the
Oklahoma Board’s documentation and recordkeeping standards in finding that
“should” was mandatory, not permissive. 294
The Agency disagreed with the ALJ’s interpretation of the Oklahoma
provisions, and held that “should” does not really mean “should,” at least in
those provisions, but actually means “must,” and connoted a mandatory
obligation in the context of the provisions at issue.295 The Agency based its
decision on its interpretation of cases from the Seventh Circuit, the D.C. Circuit,
a federal district court in Florida, and a dictionary definition of “should,” as
well as an analysis of the Oklahoma Medical Practice Act and a Policy
Statement.296 Interestingly, a Tenth Circuit (which includes Oklahoma) case
which held that “‘should’ indicates a recommended course of action, but does
not itself imply the obligation associated with ‘shall,’” received no mention in
the Agency’s decision in Pope.297 Thus, contrary to the Agency’s view, the
289. Wesley Pope, M.D., 82 Fed. Reg. 14944, 14945 (Drug Enf’t Admin. Mar. 23, 2017).
290. Id.
291. Id. (citing Okla. Admin. Code § 435:10-7-11(1) (2016)).
292. Id. (citing Okla. Admin. Code § 435:10-7-11(6)).
293. Id.
294. Id. at 14946.
295. Id.
296. Id. at 14945–46.
297. Qwest Corp. v. FCC, 258 F.3d 1191, 1200 (10th Cir. 2001). In Qwest, the Tenth Circuit
considered an FCC statute which, like the Oklahoma Administrative Code provisions at issue in Pope,

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pertinent Circuit Court of Appeals holds the view that the most reasonable
interpretation of the word “should” is really “should”—a discretionary term. 298
The Agency did not discuss the fact that there is some level of conflict in the
circuit courts about whether to treat “should” as mandatory or permissive, 299
but the Agency has apparently taken the position that, if the state law supplying
the practice standard in a DEA case uses the word “should,” the Agency is
likely to read that word as “must,” irrespective of federal circuit law on the
issue.300
While Pope dealt with codified evidence of a standard which dictated that
certain information “should” be documented and Superior I & II dealt with
testimonial evidence of a standard which dictated that certain information
“should” be documented in a certain location, the Agency found that one
standard was mandatory, while the other was permissive. 301 On that backdrop,
if the Government’s theory of a case is grounded in the absence of certain
documentation, both parties will need to dedicate substantial energy to a
thorough examination of the codified standards to determine what aspects are
mandatory or merely permissive, and both parties will need to narrowly focus
their expert witnesses—or the other party’s expert witnesses on cross
examination—to the full extent of any given standard.
3. “General” Practice Standards?
Although, as previously discussed, the Supreme Court has unambiguously
clarified that the authority to set medical standards rests exclusively with the
states, and is nowhere within the purview of the DEA, 302 some recent Agency
final orders have embraced the application of what the Agency has termed
“general practice standards” in ascertaining whether a practitioner has acted in
the course of a professional practice. 303 In one such case, Fiaz Afzal, M.D., the
Agency accepted the findings and legal conclusions of a state medical board,
which, in a decision that occurred after the close of the DEA administrative
began with an overarching “shall,” a mandatory instruction, followed by a subset of items that “should”
be considered under that “shall” provision. Id. at 1199–1200.
298. Id. at 1200.
299. E.g., United States v. Maria, 186 F.3d 65, 72–73 (2d Cir. 1999) (discussing circuit split and
declining to follow decisions of the First, Fifth, and Ninth Circuits, which found that the use of the
word “shall” in a sentencing guideline imposed a mandatory requirement).
300. Pope, 82 Fed. Reg. at 14945.
301. Id.; Superior Pharmacy I and Superior Pharmacy II, 81 Fed. Reg. 31310 (Drug Enf’t Admin.
May 18, 2016).
302. Gonzales v. Oregon, 546 U.S. 243, 274 (2006).
303. See, e.g., Grider Drug #1 & Grider Drug, #2, 77 Fed. Reg. 44070, 44093 n.73 (Drug Enf’t
Admin. July 26, 2012); Bienvenido Tan, M.D., 76 Fed. Reg. 17673, 17681 (Drug Enf’t Admin. Mar.
30, 2011).

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hearing, suspended the respondent’s state medical privileges. 304 In the course
of its reliance on the state board, citing its own prior final orders and a criminal
diversion case,305 the Agency held that:
[T]he prescribing of a controlled substance (and the continued
prescribing of a controlled substance) under the following
circumstances establishes that a physician lacked a legitimate
medical purpose and acted outside the usual course of
professional practice and therefore violated the CSA:
• [w]ithout performing an appropriate physical examination,
• without utilizing appropriate diagnostic testing,
• failing to devise and document a written treatment plan,
• failing to periodically reassess the effectiveness of the
treatment,
• continuing to prescribe controlled substances without
pursuing alternative therapies,
• repeatedly and continually prescribing without referring
the patient to appropriate specialists, and
• failing to keep and maintain records which contain
adequate findings to support a diagnosis and the need to
prescribe one or more medications. 306
The Agency has also indicated a willingness to use its own prior final orders
to establish that registrants should know that particular circumstances are
suspicious, particularly in the area of establishing a pharmacy’s corresponding
responsibility in filling prescriptions with “red flags” of diversion. In Jones
Total Health Care Pharmacy, L.L.C., the Agency found that it was unnecessary
to determine whether anyone had discussed with the pharmacists their duties
and obligations under the Agency’s corresponding responsibility rule, declaring
that “the Agency’s corresponding responsibility rule has been in force for
decades and numerous decisions of both the courts and the Agency have
provided ample guidance as to the scope of a pharmacists duty under the
rule.” 307 Also, in Jones Total Health, the Agency, seemingly separate from
those “red flags” outlined by the Government’s expert,308 found “additional

304. Fiaz Afzal, M.D., 79 Fed. Reg. 61651, 61652 (Drug Enf’t Admin. Oct. 14, 2014). The
Government filed notice of the state board’s action with the Administrator’s office after the conclusion
of hearing procedures before the Agency ALJ, and it was considered over the objection of the
respondent. Id.
305. Id. at 61653 (citing United States v. Moore, 423 U.S. 122, 135, 142–43 (1975)).
306. Id. at 61654.
307. Jones Total Health Care Pharmacy, L.L.C., 81 Fed. Reg. 79188, 79190 (Drug Enf’t Admin.
Nov. 10, 2016) (citations omitted).
308. Id. at 79218–19 (discussing expert’s testimony regarding “red flags”).

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indicators of diversion,” 309 including a finding that “high prices and copious
dispensing of controlled substances can be an indicator of possible diversion
because it elucidates a customer base willing to pay exorbitant prices for a drug
the customer could otherwise purchase at a nearby pharmacy for much less,”
based on “federal court precedent” evidently cited by the Government in its
brief.310 In Hills Pharmacy, the Agency rejected testimony by a pharmacist that
he was unfamiliar with the concept and significance of a “drug cocktail,” citing
prior Agency orders where the “DEA had identified this combination of
drugs . . . as being highly abused” before the pharmacist filled the prescriptions
at issue.311
In Pope, the Agency further tested the limits of the Supreme Court’s
holding in Gonzales312 with the inclusion of the following language:
[W]hile [s]tates have the primary responsibility for the
regulation of the medical profession, many of the profession’s
norms were created by the profession itself. Thus, on such
issues as the adequacy of a clinical evaluation for a particular
pain complaint and the necessary documentation to support the
prescribing of controlled substances, the standard of medical
practice would not seem to vary to any material degree
between [s]tates, especially between [s]tates that border each
other.313
Read broadly, these cases may provide an indication that the Agency,
Gonzales notwithstanding, is willing to draw from its own body of prior final
orders and court precedents to establish “general practice standards” applicable
to all DEA registrants. Pope is not a case where comparison of multiple state
standards was in issue and litigated, but a case where the Agency drew a general
conclusion, with no evidentiary support in the record of the pertinent
proceeding, and included it as a sort of rumination. To the extent the Agency
continues to test the waters of establishing a set of the DEA’s own medical
standards, it risks confusion where its standards conflict with those of the states
where misconduct is alleged to have occurred. While it is a safe bet that the
courts will follow Gonzales and apply the state standard where it conflicts with
any “general practice standards” created by the DEA, 314 not every case will
make it to the courts, and litigants on both sides of the aisle will need to stay
vigilant in discerning which standards are argued and supported by record
evidence. If there is a take away from the recent Agency decisions regarding
309.
310.
311.
312.
313.
314.

Id. at 79219.
Id. at 79219 & n.67.
Hills Pharmacy, L.L.C., 81 Fed. Reg. 49816, 49837 (Drug Enf’t Admin. July 28, 2016).
Gonzales v. Oregon, 546 U.S. 243, 269–70 (2006).
Wesley Pope, M.D., 82 Fed. Reg. 14944, 14976 (Drug Enf’t Admin. Mar. 23, 2017).
See Gonzales, 546 U.S. at 269–70.

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state medical practice standards, it probably is that where state standards are in
issue, both sides would be prudent to support their relative positions with
identifiable state medical standards expressed in statute, regulation, state board
opinions, and secure competent expert testimony.
D. When “Legitimate Medical Purpose” Means “Outside the Usual Course
of Professional Practice” and Vice Versa.
Under longstanding regulations drafted by the Agency, “[a] prescription for
a controlled substance to be effective must be issued for a legitimate medical
purpose by an individual practitioner acting in the usual course of his
professional practice.” 315 Among the more striking of the Agency’s recent final
orders is its pronouncement in Pope,316 that “legitimate medical purpose” and
“outside the course of professional practice,” two terms listed separately as
requirements under the regulations, and thus forming a conjunctive requirement
in order for a prescription to be “effective,”317 have the same meaning—not
similar meanings, but the same meaning318—rendering them interchangeable
and indistinct.
The dichotomy present in the regulatory definition of an “effective”
controlled substance prescription is reasonably rooted in the reality that
controlled-substance prescribing accomplished outside a prescriber’s
professional practice is as potentially dangerous as controlled-substance
prescribing accomplished within a prescriber’s professional practice where
there is no legitimate purpose for the medication. While both features are
required to render a prescription legitimate, 319 the components are distinct and
are separately delineated for good reason. By way of example, a practitioner
registrant who prescribes an opioid to someone who demonstrates an etiology
consistent with a need for pain treatment (e.g., a broken back, recent surgery,
intractable pain) may have prescribed the medication for a legitimate medical
purpose, but when it is done without the establishment of a bona fide doctorpatient relationship, without the creation of a chart, or without the requisite
documentation, it is likely to have been issued outside the course of a
professional practice. Conversely, a practitioner who has a bona fide doctorpatient relationship with a patient and who keeps meticulous and detailed notes
315. 21 C.F.R. § 1306.04(a) (2017).
316. Pope, 82 Fed. Reg. at 14967 n.38.
317. United States v. Nelson, 383 F.3d 1227, 1233 (10th Cir. 2004) (“[A] practitioner is
authorized to dispense controlled substances only if he acts with a legitimate medical purpose and in
the usual course of professional practice. Conversely, a practitioner would be unauthorized to dispense
a controlled substance if he acts without a legitimate medical purpose or outside the usual course of
professional practice.”).
318. Pope, 82 Fed. Reg. at 14967 n.38.
319. See 21 C.F.R. § 1306.04(a).

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about controlled pain medications that the practitioner prescribes where there
is no apparent organic pain source, the potency and frequency of the medication
are unwarranted, or the patient has manifested objective indications of
addiction, may well be prescribing in the usual course of a professional practice,
but not for a legitimate medical purpose. The two bases may be (and frequently
are) co-morbidly present, but that does not support the proposition that the
phrases are interchangeable.
In Pope, the Government noticed its case exclusively on the theory that the
prescriptions in issue were issued outside the usual course of professional
practice.320 No allegation was tendered that the prescriptions were not for a
legitimate medical purpose. 321 In essentially rolling over any notice issue, the
Agency held that “there is no material difference between the phrases ‘usual
course of a professional practice’ and ‘legitimate medical purpose,’”322 relying
on criminal cases where, it said, “the courts have sustained convictions for
violating the regulation . . . notwithstanding that an indictment charged the
defendant” with violating only one of the two elements, “as well as where the
jury instructions only referenced” one of the two elements. 323 Ignoring the
Tenth Circuit’s statement that it was “hesitant to say that [the distinction
between the two phrases] never could make a difference,” 324 as well as the fact
that the court in that case considered the argument rather than rejecting it
outright and holding that the phrases mean the same thing, 325 the Agency quoted
only the court’s statement that “it is difficult to imagine circumstances in which
a practitioner could have prescribed controlled substances” in violation of one
element, but not the other. 326 However, the cited cases may not reach as broadly
as the Agency suggests, and importantly, the cited cases are not cases where the
Government alleged only one theory, to the exclusion of the other, as was the
situation in Pope.327 The cases stand only for the irrefutable proposition that
evidence under either theory will suffice to prove a violation of 21 C.F.R.
§ 1306.04(a).

320. Pope, 82 Fed. Reg. at 14967 n.38.
321. Id.
322. Id.
323. Id. (citing United States v. Fuchs, 467 F.3d 889, 898–901 (5th Cir. 2006)).
324. United States v. Nelson, 383 F.3d 1227, 1231 (10th Cir. 2004).
325. Id. at 1231–33.
326. Pope, 82 Fed. Reg. at 14967 n.38 (quoting Nelson, 383 F.3d at 1231).
327. Id. (citing the ALJ’s recommended decision, which provided that “the Government noticed
a theory based in the issuance of prescriptions outside the course of a professional practice . . . not that
any prescriptions were not issued for a legitimate medical purpose,” wherein the ALJ held that a
violation under the unnoticed theory, which was alleged for the first time in the Government’s post
hearing brief, was unavailable to support a sanction).

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Both elements—that a prescription was issued in a usual course of
professional practice and for a legitimate medical purpose—are required for a
prescription to be “effective.”328 It is true that the Government only needs to
prove that one of the elements was missing in order to support its prima facie
case that the prescription was not “effective,”329 but this is not the same as
holding (as the Agency did) that a respondent had sufficient notice as to both
theories if the Government only relies on one theory in its charging document
and prehearing filings. 330 Courts have not been willing to extend Chevron331
deference to the Agency’s view that certain words in phrases used in the CSA
constitute mere surplusage, 332 but if the Agency’s interpretation of its
prescription regulation is challenged, it will be interesting to see if the courts
are more inclined to extend regulatory deference to the DEA in this regard
under Skidmore.333
In view of the frequency with which both aspects of illegitimate
prescriptions are alleged and established in practice, as a practical matter, there
may be little risk to the Agency in electing to merge the terms—and using one
phrase interchangeably to actually mean both phrases—even in the face of a
clearly-drafted regulation which requires both elements to be present for a
prescription to be legitimate. In terms of the practicing bar, both sides would
do well to prepare theories in support of and against each aspect of the
legitimate prescription equation. A practitioner whose prescriptions are only
alleged to have been issued without a legitimate medical purpose may wish to
defend himself quite differently than a practitioner whose prescriptions are only
alleged to have been issued outside the usual course of professional practice,
but Pope should serve as a warning for respondents’ counsel to prepare a
defense to both theories, even if only one is charged. For the time being, the
Agency has indicated its willingness to treat the dual components as an
amalgam and support a sanction based on either, irrespective of which is alleged

328. 21 C.F.R. § 1306.04(a)(2017); Nelson, 383 F.3d at 1233 (“[A] practitioner is authorized to
dispense controlled substances only if he acts with a legitimate medical purpose and in the usual course
of professional practice.”).
329. 21 C.F.R. § 1306.04(a); Nelson, 383 F.3d at 1233 (“[A] practitioner would be unauthorized
to dispense a controlled substance if he acts without a legitimate medical purpose or outside the usual
course of professional practice.”).
330. Pope, 82 Fed. Reg. at 14947.
331. See SEC v. Chenery Corp., 332 U.S. 194, 200 (1947).
332. In Novelty, Inc. v. DEA, 571 F.3d 1176, 1187–88 (D.C. Cir. 2009) (Tatel, J., concurring), a
majority of the D.C. Circuit was unwilling to extend Chevron deference so far as to assume that
“principal” as used by Congress in the phrase “principal place of business” in 21 U.S.C. § 822(e)
(2012), constituted surplusage.
333. Skidmore v. Swift & Co., 323 U.S. 134 (1944).

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in the OSC. 334 But if the Government intends to proceed on a theory that a
particular practitioner violated both or either of the elements, it may want to
consider charging the elements in the disjunctive, in the event that its evidence
only supports one of the theories.
E. DEA-222s and the Absence of Delivery/Receipt Evidence
To track the movement of schedule I and II controlled substances within
the closed regulatory system, the DEA requires the use of a Controlled
Substance Order Form (hereinafter DEA-222).335 In keeping with its trend of
requiring additional evidence to sustain allegations against pharmacy
registrants regarding the exercise of their corresponding responsibility, the
Agency has also recently imposed heightened requirements on its prosecutors
for allegations relating to DEA-222s.336
A long and established body of Agency final orders held that evidence of
DEA-222s maintained in a purchaser’s files that were not completed in
334. Pope, 82 Fed. Reg. at 14967 n.38.
335. 21 C.F.R. §§ 1305.03, 1305.12 (2017).
336. Upon request by an authorized registrant-purchaser, the DEA sends the registrant-purchaser
DEA-222 forms with the purchaser’s name, address, registration number, and authorized activity and
schedule information pre-printed. Id. § 1305.11. Each individually-numbered order form comes in a
three-copy stack—a brown copy (Copy 1), a green copy (Copy 2), and a blue copy (Copy 3)—with
interleaved carbon sheets so that anything written on the top copy (Copy 1) transfers to the lower two
copies. Id. §§ 1305.11, 1305.12. Aside from their color and copy number, Copies 1 and 2 are identical.
Each of them contains two sections, one “to be filled in by purchaser” and another “to be filled in by
supplier.” The information “to be filled in by supplier” on Copies 1 and 2 includes the supplier’s DEA
registration number, the National Drug Code, and “Packages Shipped” and “Date Shipped”
information for each item that the supplier sends to the purchaser. The purchaser’s copy, Copy 3, does
not have an area “to be filled in by supplier.” Instead, in that section of the form where Copies 1 and
2 reflect that they are “to be filled in by supplier,” Copy 3 contains correspondingly-located National
Drug Code, packages, and date columns, but on Copy 3, the packages and date columns, entitled “No.
of Packages Received” and “Date Received,” indicate that they are “to be filled in by purchaser.” To
order controlled substances, the purchaser fills in all portions of the form except the area designated
“to be filled in by supplier” on Copy 1 and signs and dates the form. Id. § 1305.12. Because of the
interleaved carbon sheets, all of the information written by the purchaser in those designated areas is
also reflected on Copies 2 and 3. Pursuant to DEA regulations, the purchaser then separates the bottom
copy, Copy 3, from the stack; retains that copy in the purchaser’s files; and sends Copies 1 and 2 to the
supplier, with the carbon sheets intact. Id. § 1305.13(a). When the supplier fills the order, it annotates
both of its copies with details of the controlled substances that it shipped and the date on which each
was shipped. Id. § 1305.12(b). The supplier then retains Copy 1 for its records and sends Copy 2 to
the DEA. Id. § 1305.13(d). When the purchaser receives the shipment from the supplier, the purchaser
is required to record the number of packages received and the date the packages were received on its
copy, Copy 3, which was retained at the time of the order. Id. § 1305.13(e). When viewed together,
the various copies should reflect that each package shipped by the supplier was received by the
purchaser, which creates a record reflecting which controlled substances each registrant is accountable
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accordance with the regulations could constitute a basis for a registration
sanction.337 However, in Superior Pharmacy I & Superior Pharmacy II, the
Agency added an apparently new element to the mix. Reading the plain
language of the regulation, the Agency divined that incomplete forms alone
could not prove a regulatory violation; instead, it required additional proof that
the purchaser actually had an obligation, triggered by the receipt of the ordered
drugs, to complete the forms, but that it did not do so.338 This interpretation
was reaffirmed by the Agency in Hills Pharmacy.339
In Superior I & II, the Government presented evidence demonstrating that
several DEA-222s on file at the pharmacies were missing information regarding
the number of packages received and the date on which they were received. 340
There, the Agency declared the Government’s case infirm because the
“Government offered no evidence that any portion of the two orders listed on
the form were filled.” 341 The Agency was unpersuaded by the testimony
presented by the Government that an absence of a shipment should have yielded
an entry on the form of “a zero and the date they put the zero[] on the form” to
indicate that nothing ever arrived; the Agency simply noted that the regulations
do not require that step. 342 Thus, because the Government “did not identify a
single instance in which a line item had actually been shipped to [the
r]espondent and the entry had not been made,” the Agency found that the
Government had not proven that the forms were incorrectly filled out such that
they would warrant a sanction. 343
Shortly after Superior I & II was issued, the Agency issued its decision in
Hills Pharmacy, reaffirming the requirement of additional proof that an order
was actually filled, shipped, and received in order to sustain a finding that an
incomplete DEA-222 was in violation of the regulations’ requirements.344 In
337. The Medicine Shoppe, 79 Fed. Reg. 59504, 59516 (Drug Enf’t Admin. Oct. 2, 2014);
Alexander Drug Co., Inc., 66 Fed. Reg. 18299, 18303 (Drug Enf’t Admin. Apr. 6, 2001); D-Tek
Enters., 56 Fed. Reg. 28926, 28926 (Drug Enf’t Admin. June 25, 1991); Wayne Nichols, D.V.M., 54
Fed. Reg. 37167, 37167–68 (Drug Enf’t Admin. Sept. 7, 1989); York Pharmacy, Inc., 41 Fed. Reg.
10933, 10933 (Drug Enf’t Admin. Mar. 15, 1976); David M. Higgins, 39 Fed. Reg. 26758, 26759
(Drug Enf’t Admin. July 23, 1974).
338. Superior Pharmacy I and Superior Pharmacy II, 81 Fed. Reg. 31310, 31335, 31338 (Drug
Enf’t Admin. May 18, 2016).
339. Hills Pharmacy, L.L.C., 81 Fed. Reg. 49816, 49842–43 (Drug Enf’t Admin. July 28, 2016).
340. Superior I & II, 81 Fed. Reg. at 31338.
341. Id. Interestingly, there is no indication that the potential that the orders were not filled was
even raised by the respondent in that case. Id.
342. Id. (internal punctuation and quotation marks omitted).
343. Id.
344. Hills Pharmacy, 81 Fed. Reg. at 49843. The Agency’s decision in Hills Pharmacy does
not cite the Superior I & II decision for its requirement that additional evidence be provided to show

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Hills Pharmacy, the Agency again rejected a diversion investigator’s testimony
that, if the registrant did not “‘receive a drug,’ . . . it was required ‘to write a
zero’ in the column for the number of packages received.”345 Like in its
decision in Superior I & II, the Agency did not sustain the allegations regarding
all of the DEA-222s in evidence which contained no entries whatsoever in the
“No. of Packages Received” or “Date Received” columns.346 However, unlike
in Superior I & II, two of the DEA-222s in evidence in Hills Pharmacy
contained a number in the “No. of Packages Received” column, but did not
contain an entry for the date that the package(s) were received. 347 The Agency
sustained those allegations, apparently accepting the registrant’s notations in
the “No. of Packages Received” column as sufficient evidence that the
registrant actually received the drugs and, therefore, that it had the obligation
to fill out the DEA-222s completely. 348 Thus, under the Agency’s current
interpretation of its regulations, the existence of an entirely incomplete form is
superfluous in the absence of evidence that the controlled substance order was
actually filled and shipped to the purchaser, while a partially complete DEA222 may be sufficient to support the Government’s allegation regarding the
same.
The Agency’s own precedent in Superior I & II and Hills Pharmacy
presents at least the potential for something of an evidentiary conundrum for
the Government. Although the burden imposed by Superior I & II is couched
in terms of whether the order was “filled” 349 or “shipped,” 350 the purchaser’s
obligation to complete the form only arises when it receives the order, as
that the registrant “had actually received any of the drugs listed in the line items which were left blank.”
Id. at 49843 n.49. Instead, it references only the language of the regulation, 21 C.F.R. § 1305.13(e).
Id. at 49843.
345. Id.
346. Id. at 49843 & n.49.
347. Id. at 49843.
348. Id. Although the Agency found that the two forms violated the regulations, it noted that
they (along with one violation of the requirement that the registrant keep the original DEA-222 Copy
3, not a copy) were “of minor consequence.” Id. It is unclear whether that statement, which arguably
stands in some tension to its prior precedent regarding the importance of accurate recordkeeping, see,
e.g., Satinder Dang, M.D., 76 Fed. Reg. 51424, 51429 (Drug Enf’t Admin. Aug. 18, 2011); Paul H.
Volkman, 73 Fed. Reg. 30630, 30644 (Drug Enf’t Admin. May 28, 2008), reflects a determination on
the part of the Agency that multiple violations of like nature are “of minor consequence” or that this
type of violation of the DEA-222 recordkeeping requirement is “of minor consequence.”
349. Superior Pharmacy I and Superior Pharmacy II, 81 Fed. Reg. 31310, 31338 (Drug Enf’t
Admin. May 18, 2016) (“[T]he Government points to no provision which requires, where no portion
of a line entry has been filled . . . the purchaser to notate on the form that no portion of that entry was
received.”).
350. Id. (“[The investigator] did not identify a single instance in which a line item had actually
been shipped to [the r]espondent and the entry had not been made.”).

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recognized in Hills Pharmacy.351 While, in theory, the Government could
provide the copy of the DEA-222 sent to it by the supplier that shows when the
controlled substances order was filled,352 that would not demonstrate when or
whether controlled substances were received by the pharmacy, but only that the
vendor shipped them. The best logical evidence for the Government to meet
its burden under Superior I & II would be the purchaser’s copy of the DEA222.353 However, when all of the receipt information is missing from the
purchaser’s forms, it will still remain incumbent upon the Government to
present reliable evidence that the controlled substances described in the DEA222 were actually received by the respondent pharmacy. 354 Under Superior I
& II, where the only repository for product receipt information is the incomplete
DEA-222, establishing a prima facie case for a violation of this obligation will
not be without its challenges when the registrant leaves the forms entirely blank.
The Agency’s precedent could cynically be read to create something of a
potential disincentive to fully complete the DEA-222 form, particularly where
no other available paperwork maintained by a pharmacy registrant (or at least
no paperwork shared with or available to the DEA) establishes the receipt of
the controlled medication ordered on the DEA-222. If a pharmacy registrant
declines to present testimony and presents no paperwork demonstrating
delivery of the controlled substances, it creates the potential for a virtual
absolution of culpability related to incomplete paperwork. 355 Contrariwise, the
same purchaser who makes an inadvertent mistake on a DEA-222 (such as
recording the “No. of Packages Received,” but leaving off the “Date Received”)
but otherwise keeps meticulous records (such as a separate inventory document
that reflects all controlled substances received and the date on which they were
received) is arguably rendered more vulnerable to a potential sanction because
the incomplete entries will facilitate the Government’s ability to demonstrate
receipt.356 In the first scenario, there is simply no way to determine whether the
351. Hills Pharmacy, 81 Fed. Reg. at 49843 n.49 (“The Government put forward no
evidence . . . that [r]espondent had actually received any of the drugs listed in the line items which
were left blank.”) (emphasis added).
352. 21 C.F.R. § 1305.13(b) (2017) (“A supplier . . . must record on Copies 1 and 2 the number
of commercial or bulk containers furnished on each item and the date on which the containers are
shipped to the purchaser.”); id. § 1305.13(d) (“The supplier must . . . forward Copy 2 to the Special
Agent in Charge of the Drug Enforcement Administration in the area in which the supplier is located.”).
353. Id. § 1305.13(e).
354. Hills Pharmacy, 81 Fed. Reg. at 49843.
355. See generally Superior Pharmacy I and Superior Pharmacy II, 81 Fed. Red. 31310 (Drug
Enf’t Admin. May 19, 2016).
356. Hills Pharmacy, 81 Fed. Reg. at 49843 (“Two of the order forms contain a notation that a
number of packages were received but no entry for the date the package was received . . . thus
violat[ing] 21 C.F.R. § 1305.13(e) by failing to notate the date these two packages were received.”);

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substances have stayed within the closed regulatory system; in the latter, at least
the (albeit technically non-compliant) records can be put together to determine
whether or not there is a leak in the system.
F. The Rebirth of Community Impact Evidence
Agency pharmacy precedent took another fascinating turn in Perry County
Food & Drug, where the Agency’s final order held that long-disfavored
community impact evidence can potentially be used by a pharmacy registrant
to defend against a sanction proposed by the Agency. 357 By way of background,
the Agency was once willing to consider evidence of community impact in
determining whether the public interest would best be served by revoking or
maintaining a registration. 358 In 1999, in Pettigrew Rexall Drugs,359 the Agency
considered the pharmacy’s value to an underserved area to the registrant’s
benefit.360 Over time, however, the Agency developed a body of final orders
that have consistently declined to consider community impact evidence offered
by practitioners.361 In Gregory D. Owens, D.D.S., the Agency compellingly
justified its decision to abandon the practice of considering community impact
evidence.362 The Agency set forth its rationale this way:
The diversion of prescription drugs has become an increasingly
serious societal problem, which is particularly significant in
poorer communities whether they are located in rural or urban
areas. . . . The residents of the Nation’s poorer areas are as
deserving of protection from diverters as are the citizens of its
wealthier communities, and there is no legitimate reason why
practitioners should be treated any differently because of
where they practice or the socioeconomic status of their
see Alexander Drug Co., Inc., 66 Fed. Reg. 18299, 18303 (Drug Enf’t Admin. Apr. 6, 2001) (finding
a violation of the regulations because, although the respondent kept records which “arguably detailed
sufficient information to determine that the controlled substances were not diverted to an illicit
purpose,” it did not properly execute its DEA-222s).
357. Perry County Food & Drug, 80 Fed. Reg. 70084, 70091–92 (Drug Enf’t Admin. Nov. 12,
2015).
358. Marta I. Blesa, M.D., 60 Fed. Reg. 53434, 53436 (Drug Enf’t Admin. Oct. 13, 1995)
(“[T]estimony given which described the medical services provided by the [r]espondent to her
community impacts upon the need for her continued medical contributions to that community.”).
359. Pettigrew Rexall Drugs, 64 Fed. Reg. 8855, 8859–60 (Drug Enf’t Admin. Feb. 23, 1999)
(ameliorating a sanction based upon a finding by Agency that the respondent pharmacy was one of
only two pharmacies “serving a poor, medically underserved population”).
360. Id. at 8859–60.
361. Kwan Bo Jin, M.D., 77 Fed. Reg. 35021, 35021 (Drug Enf’t Admin. June 12, 2012); Linda
Sue Cheek, M.D., 76 Fed. Reg. 66972, 66972–73 (Drug Enf’t Admin. Oct. 28, 2011); Gregory D.
Owens, D.D.S., 74 Fed. Reg. 36751, 36757 (Drug Enf’t Admin. July 24, 2009).
362. Owens, 74 Fed. Reg. at 36757.

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patients.363
Significantly, the CSA definition of “practitioners” includes both
prescribers (e.g. physicians, dentists, veterinarians) and pharmacies, 364 and the
justification for the abandonment of community impact evidence referenced
practitioners.365 It thus appeared that the Agency was no longer willing to
consider community impact evidence when adjudicating any practitioner cases.
Two years after Owens, in Linda Sue Cheek, M.D., the Agency reaffirmed
its position that “community impact evidence is not relevant” in determining
whether to grant or revoke “a prescribing practitioner’s” registration, and held
that, “to the extent . . . any . . . case involving a prescribing practitioner[]
suggests otherwise, it is overruled.” 366 In that decision, the Agency noted that
“there are no workable standards for determining whether other doctors are
reasonably available” and that it is “unworkable” to determine “what
constitutes a patient with a limited income or finances and how many patients
(or what percentage of patients) a [prescribing] practitioner must have” to claim
an impact.367
Cheek neither stated that Pettigrew was being specifically overruled, nor
carved out an exception for pharmacy registrants. 368 It just said that community
impact evidence would no longer be considered on behalf of prescribing
practitioners.369 However, Physicians Pharmacy, L.L.C., a pharmacy case
published one year after Cheek, suggested that the Agency would not consider
community impact relating to pharmacy registrants, for the same reasons
provided in Cheek and Owens.370 In that case, the Government urged the
Agency to consider the “nature and amount of diversion of controlled
substances in a geographical area when determining whether an applicant
should be granted a DEA registration,” but the Agency held that such evidence
“is simply the other side of the community impact coin,” evidence of which the
“DEA has held . . . is not relevant to any of the public interest factors and
[consideration of which] is completely unworkable.” 371 While the signals from
the Agency were admittedly mixed, Physician’s Pharmacy provided a none363. Id. (citations omitted).
364. 21 U.S.C. § 802(21) (2012).
365. Owens, 74 Fed. Reg. at 36757.
366. Cheek, 76 Fed. Reg. at 66972–73.
367. Id. at 66973 n.4.
368. See id. at 66972.
369. Id. at 66973.
370. Physician’s Pharmacy, L.L.C., 77 Fed. Reg. 47096, 47096 n.2 (Drug Enf’t Admin. Aug. 7,
2012).
371. Id. (citing Cheek, 76 Fed. Reg. at 66973 n.4 (quoting Gregory D. Owens, D.D.S., 74 Fed.
Reg. 36751, 36757 n.22 (Drug Enf’t Admin. July 24, 2009))).

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too-subtle signal that the Agency was no longer interested in considering
community impact evidence to meet a registration sanction sought by the
Government against any practitioners.
Given this background, the Agency’s recent decision re-embracing
community impact for pharmacy practitioners is surprising. In Perry County
Food & Drug, the Agency acknowledged that it had, “in multiple cases[,]
rejected the contention that community impact is a relevant consideration” in
prescriber practitioner cases, and noted that “the reasoning of these decisions
calls into question the continuing vitality of [Pettigrew] even as applied to a
pharmacy,” but emphasized that, contrary to the ALJ’s conclusion, the Agency
“has not formally overruled the case.”372 The Agency, referring to its
discussion of community impact in Physicians Pharmacy as dicta, points out
that no reference was made to Pettigrew in that decision, and thus it “cannot be
read as overruling” Pettigrew.373 The Agency then explicitly stated that “the
Agency’s reasons for rejecting consideration of community impact evidence in
cases involving prescribing practitioners apply with equal force to
pharmacies,” 374 and discussed Owens, but faulted the Government for not
addressing whether Pettigrew “remains viable as precedent,” and ultimately
considered the evidence but found it unpersuasive. 375
The obvious contention between its statements that the reasons for rejecting
consideration of community impact in prescribing practitioner cases “apply
with equal force to pharmacies,” 376 but that Pettigrew “remains viable
precedent,” 377 leaves significant ambiguity as to how community impact
evidence will be considered by the Agency in future cases. Analytically, the
Agency now appears to be sending the message that underserved communities
are not better served by prescriber practitioners who commit acts inconsistent
with the public interest, but are still benefitted by pharmacy practitioners who
commit acts inconsistent with the public interest. If an inherent danger
associated with all practitioners who commit acts that are inconsistent with the
public interest is the potential for controlled substance diversion, it is
challenging to distinguish why dangerous and powerful narcotics diverted due

372. Perry County Food & Drug, 80 Fed. Reg. 70084, 70091 (Drug Enf’t Admin. Nov. 12, 2015).
373. Id. at 70091 n.20. The Agency added, in another footnote, that while it “decline[d] to
overrule” Pettigrew, it found the reasoning in that decision to be “problematic” due to the weight given
to the community impact evidence, particularly given other evolving Agency case law since that
decision was issued, including the addition of the requirement that the registrant/applicant
acknowledge misconduct to rebut the Government’s prima facie case and the Agency’s emphasis on
candor. Id. at 70092 n.23.
374. Id. at 70091.
375. Id. at 70092.
376. Id. at 70091.
377. Id. at 70092.

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to pharmacies’ conduct are somehow more beneficial to underserved
communities than those same drugs diverted due to prescribing doctors’
conduct. Counsel on both sides of pharmacy litigation (and, perhaps, litigation
involving manufactures or distributors) should remain prepared to provide and
address community impact evidence. By specifically declining to overrule
Pettigrew, the Agency has left open the ability of pharmacy registrants to
introduce community impact evidence and arguments, and conscientious
Government counsel must now once again introduce evidence that the
community impact of revoking (or not granting) registration is nominal when
juxtaposed against the potential risks. In addition to affecting pharmacy
litigation, Perry County has potentially reopened the door for counsel on both
sides of prescriber-registrant cases as well. Counsel for prescribers should have
their equal protection arguments at the ready, because the view that underserved
communities are no more benefitted by drug-diverter-prescribers than those
more affluent neighborhoods would seem to apply with equal analytical force
to drug-diverter-pharmacies, and the Government should be prepared to defend
the continuing vitality of Owens and its progeny in the face of Perry County.
G. The Sins of Our Relatives
In Cove Inc., the Agency re-affirmed its longstanding willingness to
negatively consider CSA violations committed by relatives in denying an
application for registration. 378 In Cove, the Agency denied a registration
application because the applicant’s husband had previously “violated his
corresponding responsibility and the CSA,”379 while employed by a formerlyregistered pharmacy. 380 Interestingly, Cove represents another installment in
an increasingly-expanding complement of cases where, notwithstanding the
absence of exceptions filed by either side to the ALJ’s recommended decision,
the Agency issued its own, contrary factual findings and legal conclusions. 381
In its final order, the Administrator “reject[ed] the ALJ’s conclusion that the
378. Cove Inc., 80 Fed. Reg. 29037, 29043 (Drug Enf’t Admin. May 20, 2015); see, e.g., City
Drug Co., 64 Fed. Reg. 59212, 59214 (Drug Enf’t Admin. Nov. 2, 1999); Monk’s Pharmacy, 52 Fed.
Reg. 8988, 8989 (Drug Enf’t Admin. Mar. 20, 1987); Carriage Apothecary, Inc., 52 Fed. Reg. 27599,
27599 (Drug Enf’t Admin. July 22, 1987); Unarex of Plymouth Road and Unarex of Dearborn, 50 Fed.
Reg. 6077, 6079 (Drug Enf’t Admin. Feb. 13, 1985); Lawsons & Sons Pharmacy, 48 Fed. Reg. 16140,
16141 (Drug Enf’t Admin. Apr. 14, 1983); see also Terese, Inc., 76 Fed. Reg. 46843, 46846–47 (Drug
Enf’t Admin. Aug. 3, 2011) (showing that the Agency emphasized that the only reason it did not revoke
based on the misconduct of the applicant’s husband was that the record did not adequately support
violations of the CSA or state controlled substance laws on his part).
379. It is the pharmacy that is registered with the DEA, not the pharmacist. 21 U.S.C.
§§ 802(21), 823(f) (2012).
380. Cove, 80 Fed. Reg. at 29041.
381. See id. at 29043.

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links between the applicant and [her former registrant-employed husband] are
sufficiently attenuated to conclude that he will exercise no influence or control
over [r]espondent.”382
This area of familial imputation basis for sanction remains available to
Agency prosecutors contemplating the opposition of registration applications,
and is an important concept for the bar to consider when providing advice to
prospective registration holders.
H. Ninety-Day Prescription Rule Narrowed?
In Wesley Pope, M.D., the Agency addressed an argument made under one
of its regulations that allows multiple controlled substance prescriptions to be
issued simultaneously, and potentially narrowed the availability of that
regulation as a defense for unwitting prescriber registrants. 383 Under
longstanding DEA regulations, a prescriber registrant may issue multiple
controlled substance prescriptions at one time that will provide controlled
substances for up to a ninety-day period, provided that five conditions are
met:384 (1) “[e]ach separate prescription is issued for a legitimate medical
purpose by an individual practitioner acting in the usual course of professional
practice;” (2) the prescriber must provide written instructions on each
prescription to indicate the earliest date on which a pharmacy may fill each
prescription; (3) the prescriber must conclude that providing multiple
prescriptions “does not create an undue risk of diversion or abuse;” (4) state
law allows “[t]he issuance of multiple prescriptions as described in this
section;” and (5) the prescriber “complies fully with all other applicable
requirements” under the CSA, the regulations, and state law.385
In Pope, a prescriber registrant took over care of a patient in a practice and
saw the patient for three visits, each about two weeks apart, 386 before the
prescriber decided that the patient could “go into the three-month” schedule for
his prescriptions.387 For the two months following that visit, 388 the patient
would request a new prescription when his prior 30-day-supply ran out, a PMP
report would be obtained, the patient’s file would be pulled, and the prescription

382. Id.
383. Wesley Pope, M.D., 82 Fed. Reg. 14944, 14973 (Drug Enf’t Admin. Mar. 23, 2017).
384. 21 C.F.R. § 1306.12(b) (2017).
385. Id. § 1306.12(b)(i)–(v).
386. Pope, 82 Fed. Reg. at 14954 (September 22, 2011 visit), 14956 (October 6, 2011 visit),
14957 (October 20, 2011 visit).
387. Id. at 14973 (quoting the prescriber’s testimony).
388. Id. (November and December, 2011).

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would be issued by the prescriber and left for the patient to pick up. 389 The
prescriber registrant argued that, under the regulation, he did not need to see the
patient every month, and he could issue up to a 90-day-supply based on the visit
at the beginning of the three months (and those visits that occurred prior). 390
The Agency held that the 90-day-supply regulation “does not provide a
safe harbor”391 for the registrant, in part because the provision “contemplates
the issuance of multiple prescriptions at one time,” 392 so “it is not directly
applicable” to the registrant’s situation,393 and in part because the
Administrator, contrary to the ALJ’s findings, concluded that all of “the
prescriptions [r]espondent issued at the three previous office visits were issued
outside of the usual course of professional practice and lacked a legitimate
medical purpose.”394 Thus, the Agency found that the regulation’s first
condition—that each separate prescription is issued for a legitimate medical
purpose by a prescriber acting in the usual course of professional practice 395—
was not met because the prescriber “acted outside the usual course of
professional practice and lacked a legitimate medical purpose in issuing the
[controlled substance] prescriptions without requiring an office visit.” 396 The
Agency faulted the prescriber for not insisting upon an office visit, and for not
considering two aberrant drug screens from several months prior to the
prescriptions issued without an office visit, which the Agency said constituted
a “fail[ure] to determine whether issuing the prescriptions created an undue risk
of diversion.” 397
During a subsequent ninety day time period, the prescriber registrant again
saw the patient on day one of the ninety-day period, issued a thirty-day supply,
and then issued new thirty-day-supply prescriptions for the two months that
followed, without additional office visits. 398 The Agency again held that there
should have been an office visit each month and faulted the prescriber for not
considering the same aberrant drug screens from over six months prior, also
crediting the Government’s expert testimony that the prescriber “needed to
obtain a consultation with a specialist in addiction.” 399 In addition to the
389.
390.
391.
392.
393.
394.
395.
396.
397.
398.
399.

Id.
Id.
Id.
Id. at 14973 n.44.
Id. at 14973.
Id. at 14973.
21 C.F.R. § 1306.12(b)(i) (2017).
Pope, 82 Fed. Reg. at 14973.
Id.
Id. at 14958–14961 (January, February, and March 2012 visits).
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conduct that it deemed deficient to establish legitimate medical purpose at the
visit on day one, the Agency also noted that, by the two later dates where the
respondent wrote new prescriptions without an office visit—based on the idea
that the first visit justified the subsequent ninety days of prescribing—the
prescriber “likely had the results” of a drug screen obtained at the first visit,
which it found to be aberrant. 400 Had the prescriber issued all of the controlled
substance prescriptions simultaneously at the initial visit, labeled appropriately
to designate the earliest date on which each could be filled, and not seen the
patient again for ninety days, the evidence of the aberrant drug screen that was
used against him in regards to the two subsequent dates would not have been
available to the Government to support a sanction.
The implications for attorneys advising prescriber clients are not yet
altogether clear, and Pope may signal potential adverse consequences to a
prescriber registrant regardless of the prescriber’s choice of how to proceed.
One choice is for the prescriber to issue all three prescriptions at one single
visit, as the Agency says 21 C.F.R. § 1306.12(b) contemplates, in which case
only that visit (and presumably only the circumstances known to the prescriber
on that visit date) would be properly considered when evaluating the legality of
all three prescriptions covering the subsequent ninety-day period. While this
choice seemingly insulates a prescriber from having negative circumstances
that arise after the visit considered against him, if the Agency finds the first visit
to be deficient then it will undoubtedly find all three prescriptions to be
deficient. Another choice is for the prescriber to issue only one prescription at
the first visit, then issue two additional prescriptions at thirty-day intervals,
without seeing the patient again. But as the prescriber in Pope discovered, the
Agency may find that an office visit should have occurred during the two latter
months and will consider the lack of an office visit and any circumstances that
arise between prescription issuances against the registrant. 401 The third choice
is for the prescriber to simply not avail himself of the 90-day prescription option
and write one prescription per visit per thirty days. His patients may not
appreciate having to return (and pay for a visit) so frequently, but he may be
better situated to justify prescribing with records that correspond with each
prescribing event date, unless, of course, those records are found to be
insufficient. If the prescriber chooses the last option and sees his patients every
thirty days, it is unclear based on Pope whether the Agency might be amenable
to his notes from visit day one potentially serving as a safety net for the
subsequent two visits—such that the latter two visits are considered in the
aggregate with visit one—since he could have issued all three prescriptions at
visit one, anyway. Clients will likely be asking whether seeing their patients
400. Id. at 14976.
401. Id.

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and issuing prescriptions more frequently than once every ninety days
demonstrates attention to their responsibilities, or whether it merely creates an
enhanced source of adverse evidence available to the Government in
enforcement proceedings, and they will almost certainly be asking why the
DEA is in a superior position to dictate how frequently an office visit is required
in connection with prescribing controlled substances.
I.

To Stay or Not to Stay

Judson J. Somerville, M.D, a case involving no more than the relatively
routine adjudication of a matter where the registrant lost his state authority,
morphed into another interesting final order. 402 In Somerville, the Agency reclarified its prior statement from Grider Drug #1 & Grider Drug #2,403 where
the Agency had indicated that “a stay in administrative enforcement
proceedings is unlikely ever to be justified due to ancillary proceedings
involving the [r]espondent,” 404 and sought to distinguish its prior precedent in
Odette L. Campbell,405 wherein it granted lengthy stays of proceedings based
on an ancillary criminal matter and an ancillary state board matter involving the
respondent. 406
The respondent in Somerville sought a stay of DEA administrative
proceedings because state board proceedings—which had resulted in the
summary suspension of his state controlled substance privileges and, in turn,
the commencement of the DEA revocation action—were ongoing.407 The ALJ
denied the respondent’s request for a stay of proceedings, citing the Agency’s
prior statement in Grider #1 & #2 that stays are “unlikely ever to be justified

402. Judson J. Somerville, M.D., 82 Fed. Reg. 21408, 21409 & n.3 (Drug Enf’t Admin. May 8,
2017).
403. Grider Drug #1 & Grider Drug, #2, 77 Fed. Reg. 44070, 44104 n.97 (Drug Enf’t Admin.
July 26, 2012); see also Lawrence E. Stewart, M.D., 81 Fed. Reg. 54822, 54827 (Drug Enf’t Admin.
Aug. 17, 2016).
404. Somerville, 82 Fed. Reg. at 21409 n.3 (citation and internal punctuation omitted).
405. Odette L. Campbell, M.D., 80 Fed. Reg. 41062, 41064 (Drug Enf’t Admin. July 14, 2015).
406. While the Grider final order contains no specific dates or other indications as to when the
Administrator issued specific stays or abeyance orders in the proceedings, it is worthy of note that the
ALJ’s (second) recommended decision was issued on October 26, 2010 and the final order was issued
nearly five years later, on July 14, 2015. The only dates referenced in the final order are an August 27,
2010 date where the state medical board initiated administrative proceedings, a “new formal complaint
against the [r]espondent” filed by the state medical board on September 19, 2014, and a March 27,
2013 pre-trial diversion agreement relating to the pending criminal matter. Id. at 41063–64.
407. Somerville, 82 Fed. Reg. at 21408.

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due to ancillary proceedings,”408 but also citing Campbell as contrary
authority. 409
The Agency did not dispute that it issued a lengthy stay for state
administrative proceedings and federal criminal proceedings in Campbell, but
explained that three features about the Campbell case made it “the rare case
where withholding the issuance of a final decision was warranted:” (1) the
Campbell case involved a DEA registration that had expired shortly after the
evidentiary hearing, so it was an application case, rather than a revocation case;
(2) the state criminal charges, which were brought shortly before the
evidentiary hearing, could have resulted in an additional basis for sanction if
the respondent had been convicted; and (3) the state administrative proceedings
could have resulted in suspension or denial of her state license, and “denial of
her application would have been required under the CSA.”410
However, upon objective, comparative analysis of Campbell and
Somerville, it is challenging to reconcile the sua sponte granting of the lengthy
stay by the Administrator in Campbell from the denial of the stay sought in
Somerville. Under the Agency’s analysis in Grider #1 & #2,411 there is nothing
facially apparent about proceedings that involve only an application, as opposed
to a revocation, that would render a long stay more appealing, particularly when
a registrant is effectively unable to conduct any regulated activity under the
registrant’s existing DEA registration due to limitations on practice imposed at
the state level.412 Similarly, the fact that the ancillary proceedings in Campbell
could conceivably have raised additional grounds for sanction that had not been
noticed in the present DEA proceedings, a potential that was not discussed but
was also potentially present in Somerville and other cases where ancillary
proceedings are ongoing, bears no readily apparent logical relationship to the
wisdom of granting or denying a stay of proceedings. If the Agency can revoke
based upon the grounds existing before a stay is requested, any additional
grounds that ultimately arise will be superfluous; and alternatively, if additional
grounds ultimately arise out of the ancillary matters, they can be charged
against a respondent in future proceedings brought to revoke a registration or
deny an application, if necessary. While Somerville’s discussion of Campbell
408. Id. at 21409 n.3 (quoting Grider #1 & #2, 77 Fed. Reg. at 44014 n.97) (discussing ALJ
decision) (internal punctuation omitted).
409. Id. (citing Campbell, 80 Fed. Reg. at 41062).
410. Id. (discussing Campbell, 80 Fed. Reg. at 41063).
411. Grider #1 & #2, 77 Fed. Reg. at 44104 n.97.
412. In Campbell, the Agency had issued an Immediate Suspension Order, so the practitioner
could not have continued regulated activity during the pendency of administrative proceedings, even
before her registration expired. Campbell, 80 Fed. Reg. at 41063 n.3. Thus, it cannot be that the
Agency is worried about lengthy delays where the registrant maintains the ability to conduct authorized
activity pursuant to his DEA registration.

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provided little clarity as to the Agency’s reasoning for granting stays in that
case, it remains apparent that the Agency disfavors stays and is unlikely to grant
lengthy stays as a matter of course.
J. Summary Disposition and State Due Process
In addition to the discussion regarding the imposition of a stay, another key
aspect of Campbell also reared its head in the Somerville case. In Campbell,
the ALJ initially granted summary disposition, but the Agency remanded the
matter back to the ALJ because “[o]n review, the Administrator noted that it
appeared that under Texas law and regulations, [r]espondent was not entitled to
a hearing before [the state board that suspended her controlled substance
privileges] to challenge [the board’s] suspension or the denial of her application
for a new [state] registration.”413 Under Texas state law, Dr. Campbell was
unequivocally deprived of the state authority required to handle controlled
substances, but the lack of state authority was due to the issuance of the DEA
immediate suspension order, creating an apparent circular problem for the
Agency.414 The Agency sent the case back to the ALJ for a determination as to
whether the state “would provide [the respondent] with a hearing on the
allegations,” and ruled that she would only be subject to summary disposition
based on her lack of state authority if the state afforded her the ability to
challenge the state board action (of suspending her based on the DEA ISO) at
a state board hearing. 415 Thus, the Administrator remanded the matter back to
the ALJ to essentially conduct a due process analysis regarding Texas state
law.416
In Somerville, in contrast, although the respondent made the argument that
the state board was acting in violation of Texas law by failing to provide him
with an informal settlement conference or formal administrative proceedings
within the time frame required under Texas law, the Agency adopted the ALJ’s
summary disposition recommendation and cited another previously-issued final
order,417 stating that the DEA “accepts as valid and lawful the actions of a state
regulatory board unless that action is overturned by a state court . . . pursuant
to state law.” 418 Thus, while the Agency has indicated that it will not generally
entertain a respondent’s allegations related to purported infirmities in state law

413. Id.
414. Id.
415. Id.
416. Id.
417. Judson J. Somerville, M.D., 82 Fed. Reg. 21408, 21409–10 (Drug Enf’t Admin. May 8,
2017) (citing Kamal Tiwari, M.D., 76 Fed. Reg. 71604, 71607 (Drug Enf’t Admin. Nov. 18, 2011)).
418. Somerville, 82 Fed. Reg. at 21409–10.

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and board proceedings as bases to withhold summary disposition, 419 it has also
signaled that, where the Agency believes that state proceedings do not measure
up to some undefined DEA standard of due process, no summary disposition
based on an absence of state authority will issue. 420
Given the limited authority of the Agency in enforcement adjudications, 421
litigators on both sides of the aisle can likely assume that the Agency will not
lightly re-travel into adjudications which evaluate the legality of state licensing
schemes, but both sides should be vigilant to brief the issue where there is a
possibility that state due process does not measure up to the DEA’s standards
with state law features similar to those Texas provisions that the DEA found
violative of due process.
K. Notice This, Consent to That
The issue of notice and the related issue of litigation by consent have
received some level of attention in recent Agency final orders, but still exist in
some level of flux. Admittedly, the Agency’s handling of notice under the APA
in the past has not been marked with unwavering consistency,422 but more
recent Agency precedent on the issue of notice bears a marked level of new
potential dangers for practitioners on both sides of the litigation aisle.
1. Notice Requirements
The level and specificity of notice that the Agency is required to furnish
those it seeks to sanction has been the subject of a fair amount of recent
attention in Agency final orders. 423 Inasmuch as the current state of what notice
is required in DEA administrative proceedings is not entirely clear, a proper
analysis is best commenced with an examination of the bedrock sources of
authority that underpin the requirements. The notice requirements that
Congress placed on agency administrative practice under the APA are actually
relatively modest.424 APA notice in this context requires only that “[p]ersons
entitled to notice of an agency hearing shall be timely informed of—(1) the
419. Id. at 21408.
420. Id.
421. Gonzales v. Oregon, 546 U.S. 243, 274 (2006).
422. Compare, e.g., Jose Raul S. Villavicencio, M.D., 80 Fed. Reg. 3624, 3630 (Drug Enf’t
Admin. Jan. 23, 2015) (showing loss of state authority considered without notice) and Fiaz Afzal, 79
Fed. Reg. 61651, 61655 (Drug Enf’t Admin. Oct. 14, 2014) (same), with Ideal Pharmacy Care, Inc.,
76 Fed. Reg. 51415, 51416 n.1 (Drug Enf’t Admin. Aug. 18, 2011) (showing loss of state authority not
considered due to lack of Government notice).
423. See e.g. Farmacia Yani, 80 Fed. Reg. 29053, 29064 (Drug Enf’t Admin. May 20, 2015);
Jana Marjenhoff, D.O., 80 Fed. Reg. 29067, 29068 (Drug Enf’t Admin. May 20, 2015).
424. See Administrative Procedure Act, 5 U.S.C. § 554(b) (2012).

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time, place, and nature of the hearing; (2) the legal authority and jurisdiction
under which the hearing is to be held; and (3) the matters of fact and law
asserted.”425 The Attorney General’s Manual on the APA426 provides that the
APA notice requirement in this provision “is not required to set forth
evidentiary facts or legal argument. All that is necessary is to advise the parties
of the legal and factual issues involved.” 427
The notice requirements included in the DEA’s longstanding implementing
regulations are similarly modest, providing only that “[t]he [OSC]
shall . . . contain a statement of the legal basis for such hearing and for the
denial, revocation, or suspension of registration and a summary of the matters
of fact and law asserted.” 428 In evaluating its obligations under the APA and its
own regulations, the Agency, in some of its more vintage precedent, has long
held that in DEA administrative proceedings, “the parameters of the hearing are
determined by the prehearing statements.” 429 While the Agency has previously
embraced the principle that “pleadings in administrative proceedings are not
judged by the standards applied to an indictment at common law,”430 and the
rules governing DEA hearings do not require the formality of amending a show
cause order to comply with the evidence, 431 some newer Agency precedent
imposed what appears to be significantly tighter notice requirements on the
Government.432
In Farmacia Yani, for example, the Agency scolded its prosecutors because
the charging document and prehearing statement did not include a citation to a
particular regulation subsection, and the Agency addressed the issue by parsing
each subsection, finding that no evidence was put forth under one subsection,
and another subsection did not apply to the facts of the case. 433 The Agency

425. Id.
426. TOM CLARK, U.S. DEP’T OF JUSTICE, ATTORNEY GENERAL’S MANUAL ON THE
ADMINISTRATIVE PROCEDURE ACT (1947) [hereinafter ATTORNEY GENERAL’S MANUAL].
427. Id. § 5(a)(3), at 47.
428. 21 C.F.R. § 1301.37(c) (2017) (emphasis added).
429. CBS Wholesale Distribs., 74 Fed. Reg. 36746, 36750 (Drug Enf’t Admin. July 24, 2009)
(citing Darrell Risner, D.M.D., P.S.C., 61 Fed. Reg. 728, 730 (Drug Enf’t Admin. Jan. 10, 1996)).
430. Clair L. Pettinger, M.D., 78 Fed. Reg. 61591, 61596 (Drug Enf’t Admin. Oct. 3, 2013)
(quoting Aloha Airlines, Inc. v. Civil Aeronautics Bd., 598 F.2d 250, 262 (D.C. Cir. 1979)).
431. Id.; Roy E. Berkowitz, M.D., 74 Fed. Reg. 36758, 36759–60 (Drug Enf’t Admin. July 24,
2009).
432. Farmacia Yani, 80 Fed. Reg. 29053, 29053 n.1 (Drug Enf’t Admin. May 20, 2015).
433. Id. at 29064 & n.28. To the extent that the Agency found that the evidence supported a
successful Government theory under any subsection, the message to the parties from the Agency
appears to be that an allegation that does not specify the specific subsection will be rejected based on
lack of adequate notice. Discounting the improbable possibility that this aspect of the decision
reflected some manner of gratuitous grousing at its prosecutors, where the Agency has determined that

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then found that the conduct alleged violated an entirely different regulatory
section, leaving the reader to ponder the purpose for the scolding. 434 In another
final order, Jana Marjenhoff, D.O., the Agency refused to allow the
Government to rely on certain noticed conduct, 435 which it found was “clearly
probative of [an] allegation [set forth in the OSC] that [the] [r]espondent
engaged in obtaining controlled substances through fraud,”436 because it failed
to specify that the conduct would be specifically considered under Factor
Five.437 This was a somewhat eyebrow-raising development in view of Clair
L. Pettinger, M.D., a final order issued two years earlier, wherein the Agency
had indicated that the Government was not required to specify which Public
Interest Factor noticed misconduct was to be considered under.438 Thus,
without specifically saying as much, it appeared that the Agency was indicating
either that it is not necessary to specify the public interest factor relied upon,
unless it sought to rely on Factor Five, or saying (also without saying) that it
was now increasing the notice requirements imposed on its prosecutors in
administrative proceedings in general.
Although it appeared after Marjenhoff that evidence to be considered under
Factor Five, if not the other factors also, required particularly detailed notice,
the Agency then issued Roberto Zayas, M.D. In Zayas, upon its review of the
respondent’s hearing testimony, the Agency determined that the respondent
gave “false testimony” at his hearing in support of his actions (i.e., in presenting
his defense) and held that “his provision of false testimony . . . constitutes
actionable misconduct under Factor Five. 439 No notice, no problem. So it thus
appears that, under the Agency’s current precedent when considered as a whole,
Factor Five allegations may require enhanced notice even when the conduct
itself is alleged to be against the public interest generally, unless the
Administrator decides, during the preparation of the final order, that the Agency
does not believe the respondent’s explanation for his or her conduct, in which
case the testimony—the provision of the respondent’s defense itself—will be
deemed adverse conduct held against the respondent under Factor Five with no

no subsection can be sustained as a factual matter, pointing out the absence of a specified subsection
in the OSC would have little other utility in the final order.
434. Id.
435. Jana Marjenhoff, D.O., 80 Fed. Reg. 29067, 29068–69 (Drug Enf’t. Admin. May 20, 2015).
The Agency found that the “Respondent clearly had notice that her conduct . . . would be at issue in
the proceeding” because the Government provided the respondent with notice in its prehearing
statement that it would elicit testimony from the pharmacist regarding the conduct. Id.
436. Id. at 29068.
437. Id. at 29068–69.
438. Clair L. Pettinger, M.D., 78 Fed. Reg. 61591, 61596 (Drug Enf’t Admin. Oct. 3, 2013).
439. Roberto Zayas, M.D., 82 Fed. Reg. 21410, 21428 (Drug Enf’t Admin. May 8, 2017).

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opportunity to respond at all beyond petition to the courts. 440 Further
confounding the issue, in Peter F. Kelly, D.P.M., the Agency considered
conduct under Factor Five that was not noticed by the Government, based on
its assessment that “[n]otwithstanding that the Government did not cite Factor
Five with reference to this allegation, [r]espondent clearly knew that his
conduct . . . was at issue.” 441 So the rule presently appears to be that notice of
the specific factor the evidence is to be offered under is not important—unless
the evidence is offered under Factor Five—unless the Agency says notice is not
important there either.442
Perhaps lending support to the old wisdom that continuously sawing off
pieces of chair legs seldom leads to a more balanced chair, the Agency issued
a lengthy final order in Wesley Pope M.D., in which it sought, inter alia, to
clarify its position on both the administrative notice requirements and,
relatedly, litigation by consent. 443 In Pope, the Agency insisted that it has not
tightened notice requirements, that it has not changed its litigation-by-consent
requirements, and that any claims to the contrary are the unfortunate product of
misreading its precedents. 444 With regards to its view of notice, the Agency
focused on Farmacia Yani and Marjenhoff, declaring that “[a] review of these
[two] decisions shows . . . that the Agency has not imposed an increased
standard of notice but simply applied the extensive body of judicial precedent
that addresses the adequacy of notice in administrative adjudication . . . .” 445
The presented explanation—that it has not increased notice standards, but has
chosen to now apply what it describes as an “extensive body of judicial
precedent” 446 on the issue of notice—presents at least a risk of some level of
440. While the ALJ’s recommended decision regarding the same testimony concluded that “it is
clear that he made it up” and the respondent could have filed exceptions relating to that finding, the
ALJ only considered the respondent’s testimony incredible, not as actionable misconduct, and
therefore the respondent had no notice that his testimony would be considered against him under Factor
Five. See id. (discussing the ALJ’s characterization of the respondent’s testimony).
441. Peter F. Kelly, D.P.M., 82 Fed. Reg. 28676, 28687 n.30 (Drug Enf’t Admin. June 23, 2017).
442. Id.
443. Wesley Pope, M.D., 82 Fed. Reg. 14944, 14946-48 (Drug Enf’t Admin. Mar. 23, 2017).
444. Id. at 14946–47.
445. Id. (internal quotation marks and footnote omitted).
446. In NLRB v. I.W.G., Inc., one of the two cases that comprise the Agency’s “extensive body
of judicial precedent,” the Tenth Circuit, in discussing the bounds of acceptable notice and whether
one of the parties could be sanctioned where an administrative charging document was at variance with
the findings, reaffirmed its long-held view that, “variation between an unfair labor practice charged in
the complaint and one found by the [NLRB] does not deprive a respondent of due process where it is
clear that the respondent understood the issue and was afforded full opportunity to justify its actions.
144 F.3d 685, 687 (10th Cir. 1998) (internal punctuation and citations omitted). The court clarified
that, “[t]he introduction of evidence relevant to an issue already in the case may not be used to show
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confusion. It could potentially be viewed as incongruous to maintain that
Agency notice requirements were indeed remaining static, while
simultaneously announcing a sudden reliance on a body of judicial precedent
(extensive or otherwise) to justify them. Further, in contravention of the
longstanding principle that “[t]he grounds upon which an administrative order
must be judged are those upon which the record discloses that its action was
based,” 447 the Pope final order cites internal procedural filings by the parties in
those cases that the bar and regulated community have no reasonable ability to
review.448 Unavailable references cited in defense of otherwise-unexplainable
shifts in Agency precedent risk the perception that the Agency is telling the
practicing bar: ‘Move along, folks, nothing to see here.’
As already mentioned in greater detail, 449 the Zayas final order, which came
after Pope, held that “misconduct is misconduct” and that because “the inquiry
focuses on protecting the public interest[,] what matters is the seriousness of
the registrant’s or applicant’s misconduct.”450 Thus, it is unclear whether Yani,
Marjenhoff, Pope, or some combination thereof currently represents the
Agency’s view of required notice, as the Agency now appears to be of the view
that it does not matter whether misconduct is considered under any, some, or
all of the Public Interest Factors. If specificity is vital as to all Public Interest
Factors, to only Factor Five, or to none of the Public Interest Factors because
“misconduct is misconduct,”451 it will be difficult to divine what the applicable
notice requirements are in any reliable way. Even with the help of a scorecard,
managing litigation under this evolving notice standard will likely present
challenges on both sides of the litigation aisle, and it is difficult to know
whether another Agency order seeking to “clarify” this issue will help or saw a
little more off another chair leg.

attempting to raise a new issue. Id. at 688 (internal punctuation and citations omitted). In Pergament
United Sales, Inc. v. NLRB, the other half of the “extensive body of judicial precedent” relied upon by
the Agency, the court sustained NLRB’s charge, notwithstanding a variation that it characterized as “a
minor distinction without significant legal consequences on the facts of th[e] case.” 920 F.2d 130, 135
(2d Cir. 1990). Interestingly, the Pergament court focused on the second prong of the litigation-byconsent principle, to wit, whether the case had been fully and fairly litigated based on a review of the
record. The court instructed that “whether a charge has been fully and fairly litigated is so peculiarly
fact-bound as to make every case unique; a determination of whether there has been a full and fair
litigation must therefore be made on the record in each case.” Id. at 136
447. SEC v. Chenery Corp., 318 U.S. 80, 88 (1943).
448. Pope, 82 Fed. Reg. at 14946 n.4 (citing in final order to hearing briefs in final order filed
by the parties before the ALJ).
449. See supra Part III.A.3.
450. Roberto Zayas, M.D., 82 Fed. Reg. 21410, 21422 (Drug Enf’t Admin. May 8, 2017).
451. Id.

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Reliability in legal interpretation helps representatives on both sides of the
aisle in providing advice and planning strategy. The very real risk of the
Agency’s current approach to notice is the inadvertent creation of a perception
that the Agency may retroactively choose which Public Interest Factor(s)
require increased notice scrutiny well after proceedings are completed. The
absence of a consistently articulated approach carries the potential of
complicating the business of formulating a coherent litigation strategy for both
sides of the litigation equation. Further, the Agency’s determination that a
registrant’s testimony that is not found credible by the Administrator will
constitute adverse conduct considered under Factor Five 452 bears potentially
serious consequences for members of the bar advising clients about the wisdom
of testifying, and also for the Government in assessing the investment
appropriately devoted to cross examination. Both sides of the litigation
equation must be cognizant of these precedents in crafting hearing strategy,
challenging and defending notice sufficiency, and presenting arguments in
post-hearing submissions. The status of the level of notice required in DEA
administrative enforcement proceedings will likely be the subject of litigation,
adjustment, and additional clarification in the future.
2. Litigation by Consent
The notice-related issue of litigation by consent also saw some attention in
recent Agency precedent. It has long been the case under Agency practice that
a failure on the part of the Government to disclose an allegation in the OSC can
be rectified if it discloses such allegation in its prehearing statements or
“otherwise timely notifies a [r]espondent of its intent to litigate the issue.”453
Moving a step further, the Agency explicitly embraced the concept of litigation
by consent in its own administrative enforcement proceedings a few years ago
in Grider Drug #1 & Grider Drug #2.454 There, the Agency announced that
where the Government has failed to adequately notice its intent to litigate an
issue, the parties, in the absence of objection, can be deemed to have litigated
an unnoticed basis for sanction by consent where they fully litigate the issue. 455
Thus, the two basic elements required for the application of the concept are: (1)
lack of objection to insufficiently noticed misconduct; and (2) a full litigation
of the issue in question. 456

452. Id. at 21428.
453. CBS Wholesale Distribs., 74 Fed. Reg. 36746, 36750 (Drug Enf’t Admin. July 24, 2009).
454. Grider Drug #1 & Grider Drug #2, 77 Fed. Reg. 44070, 44077 n.23 (Drug Enf’t Admin.
July 26, 2012).
455. Id.
456. Id.

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In further refinement of its litigation-by-consent adoption, the Agency
issued Cove Inc., a case where the ALJ recommended that certain evidence be
considered against the respondent as a materially false statement. 457
Notwithstanding the absence of any objection by the respondent to either the
introduction of the evidence at the hearing or the ALJ’s consideration of it as a
materially false statement in his recommended decision, the Agency rejected
the ALJ’s recommendation, citing inadequate notice of the allegation, and
further held that a litigation-by-consent theory was unavailable to the
Government because it did not pursue that position in its closing brief or its
exceptions to the ALJ’s decision.458 Shortly thereafter, in Odette Campbell, the
ALJ declined to consider certain evidence because the Government did not
provide notice of the evidence. 459 Even though, once again, there was no
corresponding respondent objection to the ALJ’s analysis of the evidence in
Campbell, the Agency again held that the Government waived its ability to rely
on litigation by consent because it did not raise the theory in exceptions to the
ALJ’s decision.460 The Agency recently sought to clarify Campbell in Pope,
noting that, in Pope, the day was saved for the Government by raising litigation
by consent (not before the ALJ), but in its exceptions. 461
Cove and Campbell were particularly remarkable notice cases in that the
respondents in those cases did not interpose a claim of unfair surprise regarding
the issues the Agency ultimately refused to consider based on lack of adequate
notice.462 Even where neither side interposed any objection or raised issues
regarding surprise, prejudice, or even a mistake, the Agency took it upon itself
to issue lengthy final orders in those cases, addressing self-identified legal
topics463—a sort of law review article within an adjudication. These were cases
where the Agency decided to hold the Government’s level of notice to be
inadequate, noted its own prior willingness to embrace litigation by consent,
and then ruled out litigation by consent because the Government (who never
457. Cove Inc., 80 Fed. Reg. 29037, 29039 (Drug Enf’t Admin. May 20, 2015).
458. Id.
459. Odette L. Campbell, 80 Fed. Reg. 41062, 41062 n.2 (Drug Enf’t Admin. July 14, 2015).
460. Id.
461. Wesley Pope, M.D., 82 Fed. Reg. 14944, 14947 n.5 (Drug Enf’t Admin. Mar. 23, 2017).
Interestingly, as a procedural matter, where both parties have filed exceptions and one side raises
litigation by consent for the first time in filed exceptions, no means exists under the regulations for the
opposing party to object or argue contrary law. 21 C.F.R. § 1316.66(c) (2017) (“[E]ach party shall be
entitled to only one filing[:] that is, either a set of exceptions or a response thereto.”).
462. Campbell, 80 Fed. Reg. at 41063 (showing that only the Government filed an exception to
the recommended decision); Cove, 80 Fed. Reg. at 29037 (showing that neither side filed any
exceptions to the recommended decision).
463. See Campbell, 80 Fed. Reg. 41062 (Drug Enf’t Admin. July 14, 2015); Cove Inc., 80 Fed.
Reg. 29037 (Drug Enf’t Admin. May 20, 2015).

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had the opportunity to field a notice objection from the respondents at the
hearing) did not seek to pursue this theory (which it could not have known it
would have needed) in its closing brief or exceptions. 464 Pursuit of unraised
issues by the Agency is at some variance with the adjudicative approach
embraced by the courts. While in reviewing trial court proceedings, the federal
circuit courts of appeal are precluded, in the absence of plain and prejudicial
error, from considering errors and defects; 465 the Agency’s current approach to
litigation by consent and other issues has expanded its reach to expound upon
unraised issues of legal interest on a sua sponte basis.
Theoretically, escalation of notice requirements, coupled with a more
robust application of litigation by consent, could result in something of a wash,
although it does carry the prospect of some level of confusion for those engaged
in the Agency’s administrative litigation. It could be argued that the Agency’s
current approach places the primary analytical emphasis in litigation by consent
cases on the absence of objection and mere introduction of evidence, rather than
whether the record makes it “clear that the respondent understood the issue and
was afforded full opportunity to justify its actions” and whether there was “a
clear indication that the party who introduced the evidence was attempting to
raise a new issue.”466 If subsequent final orders maintain the same trajectory,
this approach could prove unwieldy to both sides of the litigation equation, and
may be challenging for the Agency to defend on appeal.
3. Notice and Lack of State Authority
Supporters and detractors of the current Agency view on the issue likely
found much to be surprised about regarding the Agency’s handling of notice as
it applies (or does not apply) to cases where a registrant lacks state controlled
substance authority. All other Agency analysis tendered on the issue of notice
metaphorically goes out the window with lack of state authority cases. Previous
precedents of the Agency have sometimes considered lack of state authority
against a registrant without prior notice 467 and at other times have declined to

464. While the Government might have been able to pursue the litigation-by-consent theory in
Campbell because the ALJ declined to consider the evidence, it would not have known of the need for
a litigation-by-consent theory in Cove until after the Agency’s final order.
465. Fed. R. Crim. P. 52; Fed R. Civ. P. 61; see O’Neal v. McAninch, 513 U.S. 432, 441 (1995)
(suggesting that the civil and criminal harmless error standards are the same).
466. NLRB v. I.W.G., Inc., 144 F.3d 685, 687–88 (10th Cir. 1998) (internal punctuation and
citations omitted).
467. Jose Raul S. Villavicencio, M.D., 80 Fed. Reg. 3624, 3630 (Drug Enf’t Admin. Jan. 23,
2015); Fiaz Afzal, 79 Fed. Reg. 61651, 61655 (Drug Enf’t Admin. Oct. 14, 2014).

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consider lack of state authority due to lack of notice. 468 It is on this backdrop
that the Agency issued Hatem Ataya, M.D., wherein, over Government
objection based on lack of notice to the registrant,469 the Agency definitively
announced that “[b]ecause the possession of state authority is a prerequisite for
obtaining a registration and for maintaining a registration, the issue [of no state
authority] can be raised sua sponte even [during the preparation of the Agency
final order].”470 Thus, the Agency unequivocally declared that, not only did it
possess the authority to issue conclusive findings and issue sanctions based on
lack of state authority without any prior notice to either party, but it can (and
presumably will continue to) do so on its own motion.471
The Agency’s approach in Ataya creates an intriguing dynamic and an
engaging ethical decision point for Agency prosecutors. If an Agency
prosecutor is aware that a respondent no longer possesses the state authority
required to maintain a registration, but intentionally declines to include that
ground among the bases for sanction charged in the OSC, the respondent will
have no ability to challenge, meet, or even address that ground at a due process
hearing. Thus, it now ironically stands as a basis for sanction that can
theoretically be insulated from challenge by declining to charge it. ALJs’
authority in enforcement matters extends only to matters charged by the Agency
that are the subject of a timely request for hearing, 472 and so, in cases where the
Government has not alleged or introduced evidence on the issue of lack of state
authority, evidence offered by the respondent regarding that issue at an
administrative hearing could correctly be viewed as beyond the scope of the
hearing, notwithstanding its conclusive post-hearing impact when the Agency
renders its final order. Inasmuch as the Agency has indicated its amenability
to taking up the matter sua sponte,473 and, as discussed in greater detail below, 474
has increasingly engaged in the process of having the Administrator’s
468. Ideal Pharmacy Care, Inc., 76 Fed. Reg. 51415, 51416–17 n.1 (Drug Enf’t Admin. Aug. 18,
2011).
469. Hatem M. Ataya, M.D., 81 Fed. Reg. 8221, 8244 (Drug Enf’t Admin. Feb. 18, 2016). In
its opinion, the Agency specifically criticizes the DEA prosecutors’ notice position as being
“fundamentally inconsistent with the position [the Government] ha[d] taken in [past] numerous cases”
where OSCs had been issued. Id. The final order acknowledges that Agency prosecutors had argued
that considering lack of state authority where it had not been noticed “could arguably upend basic
protections afforded to DEA registrants and would surely diminish the perceived fairness of the
administrative process.” Id. The Administrator was unconvinced by the due process arguments the
prosecutor advanced on behalf of this respondent in particular and the regulated community in general.
470. Id.
471. Id.
472. 21 C.F.R. §§ 1301.42–43, 1316.47(a) (2017); see id. § 1301.52.
473. Ataya, 81 Fed. Reg. at 8244 n.55.
474. See supra Part III.L.6.

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adjudication staff check state board websites to determine state licensure
status,475 from a purely tactical standpoint, there is little advantage for
Government counsel to raise the issue during the respondent’s due process
administrative hearing. To the extent that the Agency increasingly relies on
state board websites, the nuances of which Agency staff may not be familiar
with, respondents lose the ability to defend against the legal and factual call that
state authority has been compromised, or completely abrogated. 476 Thus, the
Agency, through its precedent, has arguably created a situation that precludes a
respondent who has timely requested a hearing from defending against a ground
of sanction that the Agency has determined to be conclusive.
The litigation takeaway here is that, where lack of state authority is raised
by the facts within their knowledge, Government prosecutors must decide
whether, as a matter of fairness, to charge lack of state authority in the OSC.
Where it is alleged as a basis for sanction, the respondent can challenge the law
and evidence to defend against the charge. Even where it is not alleged as a
basis for sanction, respondent’s counsel may wish to introduce evidence on the
matter if the status of a client’s state authority is at all questionable, because the
Agency has made it clear that its adjudicative staff will search applicable state
websites, and accept post-hearing filings regarding a lack of state authority.
Beyond state authority, both parties should closely examine both noticed
and unnoticed evidence at the conclusion of a hearing for possible use in pursuit
of a sanction, and both counsel should evaluate multiple permutations of
evidence (particularly those which were the subject of defective notice) for a
potential post-hearing Government litigation-by-consent request. The failure
to do so could well result in a surprise in the Agency’s final order, 477 though it
could be a welcome or unwelcome surprise, depending on where counsel sits
in the ligation equation. Even in the absence of a hearing objection, assignment
of error in a post hearing brief, or in the absence of exceptions filed by either
side, both parties need to consider whether the Agency will potentially preclude
admitted evidence or findings during the preparation of the final order.
Contrariwise, if a registrant or applicant stands at any risk of an interruption of
state controlled substance authority, the parties’ election to brief or ignore
evidence may have little impact on the outcome.
L. Proceedings
While much of the discussion regarding changes in Agency precedent has
focused on the law to be applied by the ALJ and, ultimately, the Agency in its
475. See, e.g., Steven Bernhard, D.O., 82 Fed. Reg. 23298, 23299 (Drug Enf’t Admin. May 22,
2017); David D. Moon, D.O., 82 Fed. Reg. 19385, 19387 n.5 (Drug Enf’t Admin. Apr. 27, 2017).
476. See supra Part III.L.6.
477. See, e.g., Ataya, 81 Fed. Reg. at 8221.

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final orders, there have also been a host of developments related to the hearing
proceedings themselves.
1. Regulation by Adjudication
The fact that the Agency’s rudimentary hearing regulations exist today
substantially as they did when first promulgated over four decades ago tends to
magnify the significance of the increasingly ubiquitous procedural edicts that
the Agency disseminates through adjudication final orders. To be sure, the
concept of creating procedural and substantive rules through adjudication, in
lieu of notice and comment regulation promulgation under the APA,478 can
present a dubious strategy where the regulated community, the bar, and the
public are deprived of the ability to supply input. But even more fundamentally,
the APA’s adjudication apparatus was not designed by Congress to replace
promulgated regulations, is not well suited for doing so, and carries the very
real dangers of inconsistency and confusion. Adjudications are designed to
resolve conflicts between two parties, not set policy and procedure for an
agency and an enormous regulated community. Beyond the tension created
between the Agency’s practice in this regard and the APA, there are powerful
practical considerations that militate against this approach.
It is well settled that “[w]hen Congress has not specified the level of
specificity expected of [an] agency . . . the agency is entitled to broad deference
in picking the suitable level.”479 The APA “does not require that all the specific
applications of a rule evolve by further, more precise rules rather than by
adjudication.” 480 Federal agencies are “not precluded from announcing new
principles in an adjudication proceeding . . . [r]ather, the choice between
rulemaking and adjudication lies in the first instance within the agency’s
discretion.”481 That said, an agency’s authority to issue principles through
rulemaking is by no means absolute. An action that results in a substantive
change to (or abandonment of) an existing rule must proceed through the APA’s
notice and comment procedure.482 While agencies are not permitted to “slip by
the notice and comment rule-making requirements needed to amend a rule by
478. See Administrative Procedure Act, 5 U.S.C. § 553 (2012).
479. Shays v. FEC, 528 F.3d 914, 930 (D.C. Cir. 2008) (citing Cement Kiln Recycling Coal. v.
EPA, 493 F.3d 207, 217 (D.C. Cir. 2007)).
480. Shalala v. Guernsey Mem’l Hosp., 514 U.S. 87, 96 (1995).
481. Cassell v. FCC, 154 F.3d 478, 486 (D.C. Cir. 1998) (internal quotation marks and citations
omitted); see also Kansas Gas & Elec. Co. v. FERC, 758 F.2d 713, 719 (D.C. Cir 1985) (“[I]t
is . . . beyond dispute that an agency may articulate its general policy in a particular
proceeding . . . rather than in a rulemaking.”).
482. U.S. Telecom Ass’n. v. FCC, 400 F.3d 29, 34 (D.C. Cir. 2005); Appalachian Power Co. v.
EPA, 208 F.3d 1015, 1028 (D.C. Cir. 2000).

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merely adopting a de facto amendment to its regulation through adjudication,”
where a genuine ambiguity exists, the courts will permit the resolution of the
issue through an adjudication. 483 However, unless and until an existing
regulation (irrespective of its value) is amended or repealed, it continues to
carry the force of law, and may not be modified by an agency adjudication. 484
A critical factor in ascertaining whether an existing regulation binds the
agency’s action will be whether the subsequent principle in question that has
been delivered by the Agency “spells out a duty fairly encompassed within the
regulation [that the interpretation] purports to construe.” 485
Thus, it is beyond argument that where a regulation contains some level of
ambiguity or flexibility, the courts will endure some level of agency
clarification of its legal interpretation through an adjudication where
warranted.486 But the license to do so is hardly absolute. In Peter F. Kelly,
D.P.M., the Agency blatantly announced that it was creating several new duties
upon prescribing registrants under very specific circumstances with precise
obligations. 487 The language chosen by the Agency in its final order left no
reasonable doubt that the intent was to create new duties upon registrants and
anticipated sanctions for those who run afoul of those requirements in the
future. In his final order, the Administrator stated:
I now hold that where a registrant is provided with credible
information that his state prescribing authority is being used to
divert a state-controlled (but not federally-controlled) drug,
such information triggers the duty to investigate whether his
DEA registration is also being used to divert federally
controlled substances. However, as this is a new and
additional duty beyond that which was announced in [a
previous final order], which applies only to a practitioner’s
receipt of information that his DEA registration is being
misused, I conclude that it cannot be retroactively imposed on
the [r]espondent.488
Regarding the Agency’s intention to impose a new, actionable standard
upon the regulated community, the Administrator’s language that “this is a new

483. Marseilles Land and Water Co. v. FERC, 345 F.3d 916, 920 (D.C. Cir. 2003).
484. Tunik v. Merit Sys. Prot. Bd., 407 F.3d 1326, 1345 (Fed. Cir. 2005) (citing United States
v. Nixon, 418 U.S. 683, 695–96 (1974)); see also Nat’l Family Planning and Reprod. Health Ass’n v.
Sullivan, 979 F.2d 227, 234 (D.C. Cir. 1992) (to same effect).
485. Air Transp. Ass’n of Am., Inc. v. FAA, 291 F.3d 49, 55–56 (D.C. Cir. 2002) (citing
Paralyzed Veterans of Am. v. D.C. Arena, L.P., 117 F.3d 579, 588 (D.C. Cir. 1997)).
486. See Marseilles Land and Water Co., 345 F.3d at 920.
487. Peter F. Kelly, D.P.M., 82 Fed. Reg. 28676, 28685–86 (Drug Enf’t Admin. June 23, 2017).
488. Id. at 28686 (emphasis added).

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and additional duty” 489 leaves precious little to the imagination. The Agency
“now hold[s]” that it has created this new duty, and concedes (as it must) that
based on the fact that this “new and additional duty”490 has been spawned in an
adjudication, due process precludes a sanction in this case. 491 The Kelly final
order also creates other new obligations on the part of registrants. At another
point in the final order, the Administrator renders the following announcement:
[W]here a practitioner receives credible information that
fraudulent prescriptions under his name are being presented for
state but not federally-controlled drugs, and the state
[prescription monitoring program] permits a practitioner to
obtain information as to his controlled substance prescribings
[sic], that practitioner has a duty to obtain that information and
to determine whether unlawful prescriptions for federally
controlled substances are also being dispensed under his
registration. Moreover, even if state law does not authorize a
practitioner to obtain a [prescription monitoring program]
report of the dispensings [sic] which have been attributed to
him, a practitioner is obligated to obtain that information from
a pharmacy that reports a fraudulent prescription to him. If
information obtained from either the [prescription monitoring
program] or a pharmacy shows that one’s registration is being
misused, a registrant must report that information to the DEA
(as well as local law enforcement authorities) even if the
practitioner concludes that no employee or agent is involved in
the misuse of his registration. A practitioner is not excused
from this duty because others, who also have responsibilities
to investigate, such as law enforcement officers and
pharmacists, failed to carry out those responsibilities.492
By dropping new duties unceremoniously in the midst of an adjudication,
the Agency is spared the laborious tasks of publishing its now-established new
registrant duties in the Federal Register, explaining and defending its actions in
annotated commentary, and having to address potentially disquieting comments
from the public, including the regulated community. Likewise, the Agency is
spared the arduous internal approval process attendant upon promulgation,
including review of those in the executive branch charged with evaluating the
possbility for potential responsive congressional action. Under this approach,
those arduous undertakings are supplanted by the more efficient act of placing
the Administrator’s signature on the adjudication. Just like that.
489.
490.
491.
492.

Id.
Id.
Id.
Id. (internal footnote with yet an additional new duty omitted).

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Although this streamlined approach to rulemaking may present obvious
time and effort dividends for the Agency, it is likely that the view from the
regulated community may not be as supportive. Even accepting the Agency’s
oft-quoted position that controlled substance registrants operate in a highlyregulated activity, 493 it strains credulity and every reasonable common-sensebased expectation to assume that busy practitioners will be regularly pouring
over obscure (and increasingly lengthy and esoteric) Agency final orders to
divine the latest outpouring of extra-regulatory obligations upon which
continuation of their registration (and often their livelihood) depends. Busy
practitioners possess neither the legal acumen to understand the Agency’s
increasingly legalistic and nuanced final orders, nor the resources to maintain a
specialized cadre of regulatory attorneys devoted to perpetually scouring the
Federal Register to locate and explain new duties conjured up by the latest
Agency adjudication(s). To require knowledge of, and compliance with, the
applicable regulations should be enough. Regulations require publication,
notice, and comment from the public, 494 which is often a messy process. That
said, there have arguably been more procedural and substantive developments
effected by DEA final orders through adjudications in the last few years than at
any other time during the Agency’s existence.
These concerns notwithstanding, in Masters Pharmaceutical, Inc. v. DEA,
the court was unpersuaded by the distributor respondent’s contention that the
Agency’s imposition of a high volume of new duties imposed on distributors
through adjudication was impermissible, holding that the extensive list of extraregulatory obligations were not new duties at all, but merely an “explan[ation
of] what a distributor in [the respondent’s] position must do” when it elects to
fill an order instead of declining to do so and filing a suspicious order report
with the DEA.495 The explicit nature in which the Agency unambiguously
explained the creation of numerous new obligations in Kelly provides an
enlightening window into the Agency’s actual objectives in this approach and
arguably stands in some tension with the Masters holding.496
2. Representations by Counsel
From the very outset of the most rudimentary litigation at common law,
conventions have developed between the litigants that have given rise to
expectations and the orderly development of issues in virtually every manner
of forum where issues are contested. One of the most basic tenets of any
493.
2015).
494.
495.
496.

See, e.g., Keith Ky Ly, D.O., 80 Fed. Reg. 29025, 29037 n.36 (Drug Enf’t Admin. May 20,
Administrative Procedure Act, 5 U.S.C. § 553(b) (2012).
Masters Pharm., Inc. v. DEA, 861 F. 3d 206, 222 (D.C. Cir. 2017).
Id. at 230.

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litigation is the right of a party on either side to rely on the representations made
by opposing counsel. The courts have long recognized the principle that the
representatives of a party can render binding admissions in a forum. The
principle has been succinctly articulated as follows:
A judicial admission is usually treated as absolutely binding,
but such admissions go to matters of fact which, otherwise,
would require evidentiary proof. They serve a highly useful
purpose in dispensing with proof of formal matters and of facts
about which there is no real dispute. Once made, the subject
matter ought not to be reopened in the absence of a showing of
exceptional circumstances, but a court, unquestionably, has the
right to relieve a party of his judicial admission if it appears
that the admitted fact is clearly untrue and that the party was
laboring under a mistake when he made the admission. 497
Despite the history and practice of both sides relying on concessions of
counsel in contested litigation, the Agency recently indicated its unwillingness
to find itself bound by the concessions of its own prosecutors. In Perry County
Food and Drug, Government counsel conceded the timeliness of the
respondent’s registration renewal application, but the Administrator, in the
Agency’s final order, and without substantive analysis, disregarded that
concession with the dismissive explanation, in a footnote, that “[i]n this matter,
I am not bound by the Government’s agreement not to contest the timeliness of
the [r]espondent’s renewal application.” 498 The impact of this sua sponte ruling
is magnified even further by the fact that at no time did the Government even
ask to be relieved of its concession, 499 and at no time prior to the issuance of
the final order did the respondent have any inkling that the once-settled factual
issue was not only in play, but would be summarily decided to its detriment at
a level where it had no notice or opportunity for input. 500 Irrespective of the
relative merits of the Agency’s apparent disregard of the time-honored
litigation convention of honoring concessions made by the representatives of
the parties, it is presently unclear whether any concession or stipulation
tendered by DEA counsel can be afforded any weight by conscientious
opposing counsel. The effect of this potentially significant procedural sea
change is yet to be determined, but Government counsel must consider whether
and to what extent they are authorized to concede any point, and respondents’
counsel must be wary of accepting any proposed concession stipulation offered
497.
498.
2015).
499.
500.

New Amsterdam Cas. Co. v. Waller, 323 F.2d 20, 24 (4th Cir. 1963).
Perry County Food & Drug, 80 Fed. Reg. 70084, 70089 n.17 (Drug Enf’t Admin. Nov. 12,
Id.
Id.

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by Agency counsel, lest the agreement be disregarded and found against their
clients on review by the Administrator.
3. Requested Hearings, Subsequent Waivers, and Statements of Position
Among the more remarkable procedural cases recently issued by the
Agency is Edge Pharmacy.501 In Edge, the respondent pharmacy timely
requested a hearing through counsel, but subsequent counsel agreed to waive a
hearing so long as his client was afforded the ability to submit a statement of
position.502 As designed, everyone associated with the litigation equation
appeared to benefit. By electing to proceed in that manner, the expenses
associated with conducting a contested hearing could be avoided, the Agency
would avoid the risks inherent in contested litigation and could seek a favorable
final order based on evidence virtually impervious to objection, and the
pharmacy would secure the modest ability to file its position on paper. While
it may have appeared to even an experienced observer that nothing could
possibly go wrong, what actually resulted was continued and protracted
litigation, which was managed—not by the ALJ—but by the Administrator and
his staff. In the course of its review, the Agency reversed the ALJ’s
discretionary decision to allow the pharmacy respondent to file a statement of
position along with its waiver of the hearing that it had previously requested. 503
In Edge, the respondent pharmacy’s counsel sought,504 and the ALJ granted,
additional time to file a statement of position that was to accompany his client’s
hearing waiver.505 While the ALJ found that there was good cause to extend
the respondent’s ability to respond to the OSC and accepted the statement on
behalf of the Agency (along with the hearing waiver), the Agency’s final order
held that the demonstration of good cause by the respondent’s counsel was
insufficient.506 Thus, the only part of the equation that the Agency deemed
worthy of keeping intact was the waiver of the respondent-pharmacy’s hearing
rights.507
The Agency went further, and held that on these facts,

501. Edge Pharmacy, 81 Fed. Reg. 72092 (Drug Enf’t Admin. Oct. 19, 2016).
502. Id. at 72094.
503. Edge Pharmacy, 81 Fed. Reg. at 72098 n.10 (noting that the respondent could have, but did
not, seek an extension of time under 21 C.F.R. § 1316.47(b) (2017)); but see 21 C.F.R. §§ 1309.53(b),
1316.47(b).
504. While the Agency’s order states that the respondent “never requested an extension of time
to file its written statement,” Edge Pharmacy, 81 Fed. Reg. at 72098, it also acknowledges that the
respondent “filed a pleading in which [it] waived its right to a hearing while seeking leave to file a
written statement.” Id. at 72094.
505. Id. at 72098.
506. Id. at 72097–98.
507. Id. at 72108.

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notwithstanding the fact that the pharmacy was permitted by the ALJ to submit
a statement of position, it had (contrary to what it believed it agreed to) “waived
its right to submit any evidence in refutation of the Government’s case.”508 The
practical result here was that the respondent’s counsel (and perforce the hapless
pharmacy respondent) was, in effect, the victim of a bait and switch; the
respondent’s tactical decision to waive a hearing was no doubt informed by the
ALJ’s ruling that its position would be contained in a statement of position
available to the Agency to review in making its final determination, and only
after it had done so was it informed that its position statement would not, in
fact, be considered.509 But the waiver of the pharmacy’s hearing rights stood
firm.510
The Agency’s narrow reading511 of the amount of discretion afforded to the
ALJ in permitting the untimely filed position statement under the regulations 512
thus resulted in the Agency essentially refusing to engage in the arguably
modest exercise of merely considering the respondent’s position in the
preparation of the final order. 513 So, the respondent was at once without the
ability to have affirmatively raised any and all issues, 514 at the same time it
made a bona fides tender of its legal analysis to the Agency so that the final
order could address any potential bases for appeal raised therein; 515 essentially
a legal double whammy. To make matters worse, lending credibility to the old
adage that “no good deed shall go unpunished,” this legal double whammy was
inflicted upon the respondent based on its offer to save the Agency the expense
and risks associated with proving its allegations at a hearing. 516

508. Id. at 72098.
509. Id. at 72094, 72113.
510. Id. at 72098.
511. Interestingly, the Agency’s restrictive interpretation of the ALJ’s authority under 21 C.F.R.
§ 1316.47(b) (2017) in this case arguably stands in some level of tension with a more broad
interpretation of the ALJ’s authority in its recent holding in John P. Moore, III, M.D., 82 Fed. Reg.
10398 (Drug Enf’t Admin. Feb. 10, 2017) (internal citation and punctuation omitted). In Moore, the
Agency held that “where an ALJ receives an untimely hearing request it is within the ALJ’s authority
to conduct such proceedings as are necessary to determine whether the respondent has established good
cause” and that this authority (nowhere set forth in the text of the regulation) continues until “the
Government submits a request for final agency action to [the Administrator].” Id. at 10399 n.2 (internal
citation and punctuation omitted). Thus, at this juncture, it would be difficult to prognosticate whether
the Agency is moving toward a more broad or more restrictive interpretation of the ALJ’s authority
under § 1316.41(b).
512. 21 C.F.R. § 1316.47(b).
513. Edge Pharmacy, 81 Fed. Reg. at 72113–14.
514. Id. at 72099.
515. Id. at 72097.
516. Id. at 72094.

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In an unprecedented procedural environment, the Agency, after refusing to
consider the respondent pharmacy’s statement of position, issued a series of
orders directing briefings on various legal issues, including “whether . . . the
ALJ had authority to admit [the pharmacy’s] [s]tatement of [p]osition,”517 and
whether the Agency should allow the pharmacy to withdraw its renewal
application;518 both of which were (predictably) answered in the negative. 519 To
put this in context, the registrant’s counsel, who conveyed his client’s hearing
waiver, was directed to brief the issue of whether the condition that was
accepted by the Agency’s own ALJ was lawful, and whether it should be
permitted to withdraw the renewal application it submitted as part of its hearing
request on the revocation action. 520
4. Administrator’s Staff as Pseudo-ALJs
The procedural dynamic in an increasing number of Agency final orders
merits particular attention. The structure Congress crafted into the APA,
coupled with the complimentary structure laced into the DEA’s own
regulations, provides a dichotomy of functions created to ensure a just result
and an appearance of fairness. 521 The APA provides federal agencies with the
authority to hire and assign cases to ALJs, but places unalterable duties and
bright-line restrictions on the individuals who hold those positions. 522
The APA provides ALJs presiding at hearings with the authority and
responsibility over specified enumerated powers, to wit:
(1) [to] administer oaths and affirmations; (2) [to] issue
subp[o]enas authorized by law; (3) [to] rule on offers of proof
and receive relevant evidence; (4) [to] take depositions or have
depositions taken when the ends of justice would be served; (5)
[to] regulate the course of the hearing; (6) [to] hold conferences
for the settlement or simplification or the issues by consent of
the parties or by the use of alternative means of dispute
resolution . . . ; (7) [to] inform the parties as the to the
availability of one or more alternative means of dispute
resolution, and encourage the use of such methods; (8) [to]
require the attendance at any conference held . . . ; (9) [to]
dispose of procedural requests or similar matters; (10) [to]

517.
518.
519.
520.
521.
(2017).
522.

Id. at 72095.
Id. at 72102.
Id. at 72095, 72102.
Id. at 72102.
Compare Administrative Procedure Act, 5 U.S.C. § 556 (2012), with 21 C.F.R. § 1316.52
5 U.S.C. §§ 556, 3105.

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make or recommend decisions . . . ; (11) [to] take other action
authorized by agency rule consistent with [the APA].523
A federal “agency is without power to withhold such powers from its
[ALJ]s.”524
The DEA regulations unequivocally direct that DEA ALJs “shall have the
duty to conduct a fair hearing, to take all necessary action to avoid delay, and
to maintain order.”525 The Agency regulations also supply DEA ALJs with
their own set of exclusively-held, enumerated powers, some of which overlap
with those of the APA. 526 The regulations provide that DEA ALJs
shall have all powers necessary to [avoid delay and maintain
order], including (but not limited to) the power to: (a) [a]rrange
and change the date, time, and place of hearings . . . ; (b) [h]old
conferences to settle, simplify, or determine the issues in a
hearing, or to consider other matters that may aid in the
expeditious disposition of the hearing; (c) [r]equire parties to
state their position in writing with respect to the various issues
in the hearing and to exchange such statements with all other
parties; (d) [s]ign and issue subpoenas to compel the
attendance of witnesses and the production of documents and
materials to the extent necessary to conduct administrative
hearings pending before him; (e) [e]xamine witnesses and
direct witnesses to testify; (f) [r]eceive, rule on, exclude, or
limit evidence; (g) [r]ule on procedural items pending before
him; (h) [t]ake any action permitted to the [ALJ] as authorized
by [the DEA regulations] or the provisions of the [APA]. 527
To protect their decisional independence, ALJs enjoy lifetime appointments
and are only subject to removal for good cause.528 ALJs “may not perform
duties inconsistent with their duties and responsibilities as [ALJ]s,”529 may not
be arbitrarily replaced in the midst of commenced litigation, 530 are not subject
to probation531 or performance reviews by the agencies that employ them,532

523.
524.
525.
526.
527.
528.
529.
530.
531.
532.

Id. § 556.
ATTORNEY GENERAL’S MANUAL, supra note 426, § 7(b) at 74.
21 C.F.R. § 1316.52.
Compare 5 U.S.C. § 556, with 21 C.F.R § 1316.52.
21 C.F.R. § 1316.52.
5 U.S.C. § 7521.
Id. § 3105.
See id. § 554(d).
5 C.F.R. § 930.204(a).
5 U.S.C. § 554(d)(2).

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may not consider extra-record533 or ex parte communications,534 are statutorily
ineligible to preside over any case where they have participated in any way in
the investigative or prosecuting functions of the case, 535 and may disqualify
themselves where appropriate.536
In providing a defined structure of adjudicatory duties and insulation,
Congress provided litigants with a built-in assurance that, whatever the ultimate
outcome of an enforcement action might be, the evidence will be amassed and
evaluated by an impartial judge who has the freedom to operate without fear of
reprisal, and, of equal importance, without undue interference by the agency. 537
The DEA regulations provide that, at the conclusion of hearing proceedings,
the ALJ is required to assemble a record of proceedings and a recommended
decision to the DEA Administrator, who is charged with the responsibility to,
“[a]s soon as practicable,” prepare a “final order in the proceeding, which shall
set forth the final rule and the findings of fact and conclusions of law upon
which the rule is based.” 538
It is thus beyond serious argument that both the APA and the DEA
regulations have placed the control of the procedural aspects of administrative
hearings within the exclusive control of the Agency ALJ presiding at the
hearing, and charged the Agency with responsibility for the ultimate
decision.539 In an agency such as the DEA, where there is no formal board
tasked with rendering the final Agency determination, the overwhelming
likelihood is that orders are being managed, prepared, and issued at the final
order level not by the agency head, who bears a myriad of other responsibilities,
but by employees under the agency head’s supervision, who are unknown to
the registrants and the practicing bar. Such agency employees assisting in the
review and preparation of decisions for an agency head enjoy none of the
protections, preclusions, or obligations, enjoyed by and levied on its ALJs.
Despite the defined structure and delineated responsibilities described
previously, with increasing frequency in final orders issued by the Agency,
every credibility, evidentiary, and procedural ruling, is being re-weighed, re533. Id. § 556(e).
534. Id. § 557(d); see also 21 C.F.R. § 1316.51(c) (2017).
535. 5 U.S.C. § 554(d)(2).
536. Id. § 556(b).
537. See generally 21 C.F.R. § 1316.
538. Id. § 1316.67.
539. Even the standard of proof between the two functions is distinguishable. While the standard
of proof at the hearing before the ALJ is a preponderance of the evidence, Steadman v. SEC, 450 U.S.
91, 100–01 (1981), the standard of review of the final agency action is whether the decision is
“supported by and in accordance with the reliable, probative, and substantial evidence.” 5 U.S.C.
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evaluated, and frequently reversed on final order review. 540 Additionally, the
Agency has demonstrated an increasing proclivity for conducting active
litigation outside the reach of the ALJ; it has become increasingly frequent
practice for the Administrator’s staff to direct the parties to submit evidence
and brief legal issues that were not raised in front of the DEA ALJ. In so
directing, the anonymous staff members step into the role of pseudo-ALJs and
manage contested litigation—without offering any of the protections that the
ALJ structure affords to litigants.
The DEA regulations provide no legal mechanism for administrative
litigation to be managed by the Administrator or his staff. The Administrator’s
duties regarding adjudication are specifically enumerated in the regulations, 541
and are restricted to issuing an Agency final order “set[ting] forth the final rule
and the findings of fact and conclusions of law upon which the rule is based,”
publishing the final order in the Federal Register, and accomplishing these
modest tasks “[a]s soon as practicable.” 542 In the APA, Congress has
categorically limited the ability to conduct hearings 543 “in every case of an
adjudication required by statute to be determined on the record after opportunity
for an agency hearing,”544 which specifically include DEA administrative
hearings545 to administrative law judges. 546 When the Administrator or his staff
“preside” over contested administrative proceedings where the statute mandates
on-the-record proceedings with an opportunity to request an agency hearing,
the Agency risks a determination that the “proceedings” were ultra vires and
per se violative of due process. The Administrator could no more delegate the
enumerated powers in the APA to an Agency investigator or prosecutor than he
could retain them to himself or task a legal advisor, special agent, or contract
security guard, to act in the role of an ALJ.547
In Edge, the parties were directed to file briefs as part of the final order
process,548 which is ultra vires under both the APA and the Agency’s
540. See, e.g., Wesley Pope, M.D., 82 Fed. Reg. 14944, 14946–48 (Drug Enf’t Admin. Mar. 23,
2017) (re-weighing, in the Agency final order, every credibility finding rendered by the hearing ALJ,
including the testimony of the Government’s expert witness); Superior Pharmacy I and Superior
Pharmacy II, 81 Fed. Reg. 31310, 31320–25, 31332 (Drug Enf’t Admin. May 18, 2016) (showing
virtually every ruling on every objection ruled upon by the hearing ALJ scrutinized in detail and reweighed and re-ruled upon in the final order without any perceptible deference).
541. 21 C.F.R. §§ 1301.46, 1316.67.
542. Id. § 1316.67.
543. See 5 U.S.C. § 556(c).
544. Id. § 554(a).
545. 21 U.S.C. § 824(c) (2012).
546. 5 U.S.C. § 554(a)(2).
547. See id. § 554(d).
548. Edge Pharmacy, 81 Fed. Reg. 72092, 72095 (Drug Enf’t Admin. Oct. 19, 2016).

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regulations,549 and has little to commend it as a matter of trial practice or even
common sense. Further, the manner in which the practice of conducting
litigation at the final order level has expanded highlights some of the stronger
arguments for expeditiously abandoning the illegal process. An ALJ “shall
have the duty to conduct a fair hearing,”550 but this is an obligation that is not
imposed on other employees of the Agency. Lest it seem to be an unfounded
concern that one party may have an advantage when litigation is conducted by
those who think of themselves as pseudo-ALJs, the Agency’s order in Edge
provides a striking example of the dangers that lurk in such a situation. In Edge,
in vacating the ALJ’s finding of good cause for accepting an untimely statement
of position, the Agency applied the rigorous “excusable neglect” standard
against the registrant’s counsel.551 But that was not the standard applied to both
sides of the litigation equation. In its review of the Government’s submitted
evidence, the Agency discovered that one of the declarations submitted by the
Government was unsigned. 552 The Government was afforded the opportunity
to resubmit a signed version, which was received into the record (apparently by
the non-ALJ employee in his capacity as pseudo-ALJ) over the respondent’s
objection.553 The rigorous “excusable neglect” standard that had been wielded
against the registrant was supplanted—for the Government only—by the
gentler “simple inadvertence” standard,554 and the evidence was successfully
resubmitted by the Government and used against the respondent. 555 Another
example of treatment that risks the perception of being preferential to the
Government can be seen in Robert Clark Maiocco, M.D., wherein, during the
final order preparation process, the Agency sua sponte acted to correct the
Government’s errant reliance on the wrong statutory provision in its charging
document, without even a corresponding request to do so by the Government,
with no more than a passing reference in a footnote. 556 Yet one week earlier, in
William H. Wyttenbach, M.D., the Agency had entirely declined to consider a
motion to reconsider a summary disposition order because it was filed beyond
the authorized regulatory deadline for filing exceptions. 557 Indeed, at a time

549. See 5 U.S.C § 556(e); 21 U.S.C. § 1316.52.
550. 21 C.F.R. § 1316.52 (2017).
551. Edge Pharmacy, 81 Fed. Reg. at 72097–98.
552. Id. at 72100–72101.
553. Id. at 72101.
554. Id.
555. Id.
556. Robert Clark Maiocco, M.D., 82 Fed. Reg. 19383, 19383 n.1 (Drug Enf’t Admin. Apr. 27,
2017).
557. William H. Wyttenbach, M.D., 82 Fed. Reg. 18777, 18777 (Drug Enf’t Admin. Apr. 21,
2017). See 21 C.F.R. § 1316.66(a) (2017).

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when the Agency has been more actively engaged in creating an active
litigation environment at the final order level, it has concomitantly
demonstrated a markedly more aggressive posture in applying technical bases
to disregard issues raised in exceptions filed by respondents. 558
However well intentioned, even copious, highly-nuanced legal verbiage
carefully set out in a final order could do little in dissipating the appearance that
the potential for disparate treatment is exacerbated where evidentiary
determinations and briefings are conducted by those not charged, qualified, or
even permitted under the law to preside over litigation. While this article has
striven to examine both sides of the issues raised by recent shifts in Agency
procedures, it is difficult to perceive a silver lining in tasking non-ALJs with
litigation management and expecting such employees to properly execute
responsibilities where an ALJ is mandated. When acting in its role as neutral
adjudicator, it is imperative for the Agency to be as mindful of optics as it is the
ultimate adjudication. While not always as unambiguous as the disparate
standards imposed on the parties’ mistakes in Edge, the taking of sua sponte
actions at the final order stage of adjudication always enhances the risk of
appearing to favor one side—generally, at least in these cases, the enforcement
side—of the litigation.
5. Excluded by The ALJ Means Excluded
In the APA, Congress was unambiguous in extending to a party the right to
“present his case or defense by oral or documentary evidence, to submit rebuttal
evidence, and to conduct such cross-examination as may be required for a full
and true disclosure of the facts.”559 Simply stated, a respondent in APA
proceedings must be afforded the opportunity to meet the evidence offered by
the Government as a precondition to the Agency’s ability to use that evidence

558. See, e.g., Jones Total Health Care Pharmacy, L.L.C., 81 Fed. Reg. 79188, 79189 n.5 (Drug
Enf’t Admin Nov. 10, 2016) (ruling that the legal issue in timely-filed exceptions was disregarded for
failure to include “specific and complete citations of the pages of the transcript and exhibits”
requirement in 21 C.F.R. § 1316.66(a)); Superior Pharmacy I and Superior Pharmacy II, 81 Fed. Reg.
31310, 31319 (Drug Enf’t Admin. May 18, 2016) (ruling that filed exceptions received two days after
transmission of the record to the Administrator and one year prior to the issuance of the final order
disregarded because it was filed beyond the regulatory 20-day time limit in 21 C.F.R. § 1316.66(a));
Perry County Food & Drug, 80 Fed. Reg. 70084, 70084 (Drug Enf’t Admin. Nov. 12, 2015) (ruling
that filed exceptions received four months prior to the Agency final order were disregarded because
filed beyond the regulatory 20-day time limit in 21 C.F.R. § 1316.66(a)); but see Mark William
Andrew Holder, 80 Fed. Reg. 71618, 71618 (Drug Enf’t Admin. Nov. 16, 2015) (showing that the
respondent’s counsel permitted to file a corrected copy of previously-filed exceptions where, based on
a family emergency and a word processing system breakdown, she had secured prior leave to move to
do so by the assigned ALJ).
559. Administrative Procedure Act, 5 U.S.C. § 556(d) (2012).

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in support of a sanction. In Lawrence E. Stewart, M.D., the Agency reversed
its ALJ’s evidentiary ruling which had excluded a Food and Drug
Administration package insert. 560 Once the package insert had been excluded,
the respondent had no need to challenge it or present evidence to contradict the
document.561 The Agency disregarded the ALJ’s exclusion of the document
and considered it in support of the sanction ultimately imposed. 562
A similar practice was met with disapproval by the court in Masters
Pharmaceutical, Inc. v. DEA, wherein the court found that the DEA committed
error when, in issuing its final order, it considered evidence that had been
excluded by the ALJ at the hearing. 563 The Masters court ultimately found the
error harmless in light of the strength of other admitted evidence and the
representation in the final order that the Administrator did not base his ruling
on the re-included evidence, but the court, in no uncertain terms, held that the
practice of holding ALJ-excluded evidence against a respondent in support of
a sanction constitutes error. 564 The court acknowledged that the Agency had
the authority to overrule the ALJ’s evidentiary ruling, but held that
the Administrator could not proceed to rely on the excluded
evidence of [the respondent’s] misconduct [because] [d]oing
so would be in derogation of [the respondent’s] right to
respond to it. Because the ALJ had excluded the evidence,
however, [the respondent] had no need or opportunity during
the administrative trial to exercise its right to respond. 565
As discussed elsewhere in this article, the revisiting and refashioning of
even the most pedestrian of procedural rulings by the impartial ALJ presents
obvious risks to the perception of fairness that litigants can attach to the due
process actually afforded by the DEA under the APA. 566 The concept that
evidence excluded by the ALJ could only be available to the Agency for
consideration following a remand where the respondent is afforded an
opportunity to respond strikes as self-evident, but to the extent that judicial
precedent was necessary to confirm this principle, it now exists. 567

560.
2016).
561.
562.
563.
564.
565.
566.
567.

Lawrence E. Stewart, M.D., 81 Fed. Reg. 54822, 54822–23 (Drug Enf’t Admin. Aug. 17,
Id.
Id. at 54823.
Masters Pharm., Inc. v. DEA, 861 F. 3d 206, 229 (D.C. Cir. 2017).
Id.
Id.
See supra Part III.K.1.
Id.

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6. Official Notice in Final Agency Orders
Similar dangers lurk for both sides of the litigation equation due to the
Agency’s ever-increasing enamor for the prolific use of official notice. The
taking of official notice (like judicial notice in courts of record) is authorized
by the APA568 and the DEA regulations. 569 In its explanatory commentary, the
Attorney General’s Manual explains that the Agency can take official notice in
its final orders, and that official notice is designed to be broader than “the
traditional matters of judicial notice [and to] extend[] properly to all matters as
to which the agency by reason of its functions is presumed to be expert, such as
technical or scientific facts within its specialized knowledge.”570 However, the
manner in which official notice has been utilized in recent DEA final orders
may be arguably broader than seemingly anticipated by that language,
encompassing an ever-widening scope of matters, and—perhaps more
significantly—it has been exclusively used for the benefit of the Government,
and respondents are often not afforded a real opportunity to contest the facts
before the Agency’s final decision is published in the Federal Register.
On the more benign side of the spectrum, the Agency regularly takes
official notice of its own records regarding a registrant’s registration status. For
example, the Agency has taken official notice of its own records to determine
a registration’s expiration date.571 In cases where a respondent’s registration
expired by its terms while a case was pending and no renewal application or
application for a new registration had been filed by the time the Agency decided
the matter, the Agency has taken official notice of a registration’s expiration

568. Administrative Procedure Act, 5 U.S.C. § 556(e) (2012).
569. 21 C.F.R. § 1316.59(e) (2017).
570. ATTORNEY GENERAL’S MANUAL, supra note 426, § 7(d), at 80.
571. Karen S. Dunning, N.P., 80 Fed. Reg. 28640, 28641 n.1 (Drug Enf’t Admin. May 19, 2015);
Pedro E. Lopez, M.D., 80 Fed. Reg. 46324, 46324 n.1 (Drug Enf’t Admin. Aug. 4, 2015); Adeline
Davies Essien, M.D., 80 Fed. Reg. 46322, 46322 n.1 (Drug Enf’t Admin. Aug. 4, 2015); Devra
Hamilton, N.P., 80 Fed. Reg. 50034, 50034 (Drug Enf’t Admin. Aug. 18, 2015); Christina B. Paylan,
M.D., 80 Fed. Reg. 69979, 69979 n.1 (Drug Enf’t Admin. Nov. 12, 2015); but see James Alvin Chaney,
M.D., 80 Fed. Reg. 57391, 57391 n.1 (Drug Enf’t Admin. Sept. 23, 2015) (taking official notice of the
respondent’s registration record with the Agency to find that his registration was not expired, but noting
that “in the future, where a recommended decision lacks the requisite finding [that the Agency has
jurisdiction to act because the registration is valid], [the Agency] will remand the matter” for the
purpose of determining that the respondent “retains an active registration or has submitted an
application for registration”); Robert Clark Maiocco, M.D., 82 Fed. Reg. 19383, 19384–85 & n.4 (Drug
Enf’t Admin. Apr. 27, 2017) (taking official notice of the respondent’s registration record with the
Agency, but noting that the Government has the burden of providing evidence establishing the
Agency’s jurisdiction as part of its motion and the ALJ is obligated to make findings as to the Agency’s
jurisdiction).

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date in Agency databases. 572 Similarly, in cases where a respondent’s license
expired during the proceedings but he filed an application to renew the license,
the Agency has taken official notice of its own database records to determine
whether the renewal application was timely filed, thus extending the existing
registration,573 or whether it was untimely, in which case only the pending
application remained before the Agency for determination.574 The Agency has
also taken official notice of its own records to determine that the Agency was
not in possession of other documents that could be relevant to the issues, such
as a power of attorney. 575
On the other side of the spectrum, the Agency has shown an increasing
willingness to widen the scope of facts that it is willing to find through the
taking of official notice at the final, post-hearing stage, where it makes its final
determination regarding a respondent’s registration.576 One prevalent example
is the Agency’s increasingly prolific use of state medical board websites to

572. Patricia A. Newton, M.D., 82 Fed. Reg. 26516, 26516 (Drug Enf’t Admin. June 7, 2017);
Rezik A. Saqer, M.D., 81 Fed. Reg. 22122, 22123 (Drug Enf’t Admin. Apr. 14, 2016); Geoffrey D.
Peterson, N.P., 81 Fed. Reg. 49266, 49266 n.1 (Drug Enf’t Admin. July 27, 2016); Victor B. Williams,
M.D., 80 Fed. Reg. 50029 (Drug Enf’t Admin. Aug. 18, 2015); Tin T. Win, M.D., 78 Fed. Reg. 52802,
52803 (Drug Enf’t Admin. Aug. 26, 2013); Donald Brooks Reece II, M.D., 77 Fed. Reg. 35054,
35054–55 (Drug Enf’t Admin. June 12, 2012); James Edgar Lundeen, Sr., M.D., 77 Fed. Reg. 29696,
29696 (Drug Enf’t Admin. May 18, 2012); Lousiana All Snax, Inc., 76 Fed. Reg. 20034, 20034 (Drug
Enf’t Admin. Apr. 11, 2011); Kermit B. Gosnell, M.D., 76 Fed. Reg. 4938, 4938 (Drug Enf’t Admin.
Jan. 27, 2011); Sylvester A. Nathan, 74 Fed. Reg. 17516, 17516–17 (Drug Enf’t Admin. Apr. 15,
2009); Elmer P. Manalo, M.D., 73 Fed. Reg. 50353, 50353 (Drug Enf’t Admin. Aug. 26, 2008);
William W. Nucklos, M.D., 73 Fed. Reg. 34330, 34330 (Drug Enf’t Admin. June 17, 2008); Benjamin
Levine, M.D., 73 Fed. Reg. 34329, 34329–30 (Drug Enf’t Admin. June 17, 2008); David L. Wood,
M.D., 72 Fed. Reg. 54936, 54937 (Drug Enf’t Admin. Sept. 27, 2007).
573. See 21 C.F.R. § 1301.36(i) (“In the event that an applicant for reregistration (who is doing
business under a registration previously granted and not revoked or suspended) has applied for
reregistration at least 45 days before the date on which the existing registration is due to expire, and
the Administrator has issued no order on the application on the date on which the existing registration
is due to expire, the existing registration of the applicant shall automatically be extended and continue
in effect until the date on which the Administrator so issues his or her order.”)
574. Jones Total Health Care Pharmacy, L.L.C., 81 Fed. Reg. 79188, 79188 n.3 (Drug Enf’t
Admin. Nov. 10, 2016); Perry County Food & Drug, 80 Fed. Reg. 70084, 70089 n.17 (Drug Enf’t
Admin. Nov. 12, 2015); Sharad C. Patel, M.D., 80 Fed. Reg. 28693, 28694 (Drug Enf’t Admin. May
19, 2015); Ralph J. Chambers, M.D., 79 Fed. Reg. 4962, 4962 n.2 (Drug Enf’t Admin. Jan. 30, 2014).
575. Glenn R. Unger, D.D.S., 79 Fed. Reg. 49339, 49340 (Drug Enf’t Admin. Aug. 20, 2014)
(taking official notice of the Agency’s registration records to determine that the registrant had not
submitted a power of attorney allowing any person other than himself to sign an application for a
registration and consequently finding that the registration granted pursuant to an application signed by
someone else was void ab initio).
576. See Steven Bernhard, D.O., 82 Fed. Reg. 23298 (Drug Enf’t Admin. May 22, 2017); David
D. Moon, D.O., 82 Fed. Reg. 19385, 19387 n.5 (Drug Enf’t Admin. Apr. 27, 2017); William H.
Wyttenbach, M.D., 82 Fed. Reg. 18777, 18778 (Drug Enf’t Admin. Apr. 21, 2017).

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determine, through official notice, a registrant’s current state licensure status. 577
This practice is of particular concern in view of the fact that there is no
guarantee that the information contained on the various state board websites is
accurate or current, and no transparent ability on the part of the regulated
community to ascertain which DEA employee is making the queries and
whether that employee is correctly interpreting the website entries.
Additionally, even on the best of the state board websites, the information may
be modified or deleted at any moment, making it all but impossible for a
registrant (and, even more importantly, a reviewing court) to determine what
the Agency decision-maker was looking at when he or she took official notice
and whether the “fact” was accurate and interpreted correctly. The problem
here is that, even assuming benign intention, in conducting a search to find a
state board website, crafting and entering a query to the website, and
interpreting the results reflected on the website in order to drop “facts” into a
final order, some unnamed employee 578 is simultaneously conducting an
investigatory function and participating and advising in the Agency
adjudication.579 When an Agency employee embarks upon an internet search
577. Steven Bernhard, D.O., 82 Fed. Reg. 23298; Moon, 82 Fed. Reg. at 19387 n.5; Wyttenbach,
82 Fed. Reg. at 18778; Robert Markman, M.D., 82 Fed. Reg. 11369, 11370 (Drug Enf’t Admin. Feb.
22, 2017); Frank D. Li, M.D., 82 Fed. Reg. 11238, 11239 (Drug Enf’t Admin. Feb. 21, 2017); Paul E.
Pilgram, M.D., 82 Fed. Reg. 11058, 11059 (Drug Enf’t Admin. Feb. 17, 2017); John P. Moore, III,
M.D., 82 Fed. Reg. 10398, 10400 (Drug Enf’t Admin. Feb. 10, 2017); Thomas Horiagon, M.D., 81
Fed. Reg. 79051, 79052 (Drug Enf’t Admin. Nov. 10, 2016); Nicholas J. Nardacci, M.D., 81 Fed. Reg.
47409, 47410 (Drug Enf’t Admin. July 21, 2016); Ibem R. Borges, M.D., 81 Fed. Reg. 23521, 23522
(Drug Enf’t Admin. Apr. 21, 2016); William Mikaitis, M.D., 80 Fed. Reg. 73833, 73834 (Drug Enf’t
Admin. Nov. 25, 2015); Chambers, 79 Fed. Reg. at 4963 n.7; Kamal Tiwari, M.D., 76 Fed. Reg. 71604
(Drug Enf’t Admin. Nov. 18, 2011); Pain Management and Surgery Center of Southern Indiana, 76
Fed. Reg. 71604, 71606 (Drug Enf’t Admin. Nov. 18, 2011); Hicham K. Riba, D.D.S., 73 Fed. Reg.
75773, 75773 (Drug Enf’t Admin. Dec. 12, 2008); Piyush V. Patel, M.D., 72 Fed. Reg. 18274, 18275
(Drug Enf’t Admin. Apr. 11, 2007).
578. As discussed, there is no formal reviewing board at the DEA, and the likelihood of the DEA
Administrator taking time from his massive Agency oversight and management responsibilities to
conduct Internet searches to identify state board websites, query them, and craft the information he
gleans in those sites into Agency final orders in a host of cases can safely be characterized as remote.
Thus, the reality is that the employee tasked with preparing the draft final order is also conducting
investigative functions and simultaneously providing the Administrator with advice and drafting final
orders. Unless an employee on the investigative or Government counsel side is supplying the
information (which is contrary to the apparent language in the decisions and would be ex parte in any
event) this practice, where the same person is drafting and otherwise participating in the final
adjudication, constitutes a violation of the unambiguous prohibition that is set forth in the APA.
Administrative Procedure Act, 5 U.S.C. § 554(d) (2012).
579. In some cases, the Agency issues orders to the parties to provide information, but in others,
it is apparently finding the information on its own. See Gregory White, M.D., 79 Fed. Reg. 24754,
24755 (Drug Enf’t Admin. May 1, 2014) (“An internet search of the [state board’s] public record
actions webpage found . . . ”); Franklyn Seabrooks, M.D., 79 Fed. Reg. 44196, 44197 (Drug Enf’t

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to identify state board websites for inclusion of his or her interpretation of that
search into an Agency final order, it would take a highly-tortured definition to
place that activity outside the realm of conducting an investigatory function.
The Attorney General’s Manual addresses the utilization of agency employees
for the drafting of final orders as follows:
Nothing in the [APA] is intended to preclude agency heads
from utilizing the services of agency employees as assistants
for analysis and drafting. Of course, in adjudicatory cases
subject to [5 U.S.C. § 557(c)], such assistants could not have
performed investigative or prosecuting functions in the cases
(or in factually related cases) in which they are so employed.
Also, the agency heads are free to employ the [ALJ] who heard
a particular case as the draftsman of their final decision and
otherwise to assist in its formulation. 580
To the extent that decision drafters in the Agency are regularly conducting
internet searches to glean information that is seamlessly incorporated into
Agency final orders, this may run in some tension with the restrictions of the
APA.581
Even more tenuous than the Agency’s practice of using state board websites
in an attempt to essentially confirm facts supported in a record have not staled
with time, is its use of official notice to actually add additional facts and
materials to the record, and use those materials against respondents without
providing a meaningful opportunity to challenge them. 582 In four cases where
the Government alleged only that a registrant’s state license had been
suspended,583 state board orders (and their contents) that were issued after the
ALJ transmitted the records to the Administrator were held against the
respondents where the Agency took official notice of the board orders—in one
case even stating that it “made [the order] part of the record”584—and revoked

Admin. July 30, 2014) (“An internet search of the [state board]’s public record actions Web page
reveals . . . ”); William G. Hamilton, Jr., M.D., 71 Fed. Reg. 39129, 39129 (Drug Enf’t Admin. July
11, 2006) (noting that since the time a state suspension order was issued (which was in the investigative
file), Administrator “ha[d] become aware of further proceedings involving [r]espondent’s state medical
license”).
580. ATTORNEY GENERAL’S MANUAL, supra note 427, § 8(b) at 87 (citing Morgan v. United
States, 298 U.S. 468, 481 (1936)).
581. 5 U.S.C. § 554(d).
582. Geoffrey D. Peterson, N.P., 81 Fed. Reg. 49266, 49267 n.3 (Drug Enf’t Admin. July 27,
2016).
583. Id. at 49266; John R. Kregenow, D.D.S., 80 Fed. Reg. 50029, 50030 (Drug Enf’t Admin.
Aug. 18, 2015); Roy Chi Lung, M.D., 74 Fed. Reg. 20346, 20346 (Drug Enf’t Admin. May 1, 2009);
Sheran Arden Yeates, M.D., 71 Fed. Reg. 39130, 39130 (Drug Enf’t Admin. July 11, 2006).
584. Peterson, 81 Fed. Reg. at 49267 n.3.

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the respondents’ DEA registrations based on the later-issued board revocation
orders.585 On one occasion, the Agency limited its official notice of a state
medical board order by only taking official notice of the order to the extent it
established that the respondent was no longer authorized to practice medicine
in the state, while declining to take official notice of the findings of fact and
conclusions of law set forth in that order because, the Agency said, the
Government could have—but did not—give the respondent notice that it
intended to rely on prescribing events at issue in that order. 586 Even more
recently, in responding to an argument interposed by the Government that doing
so would be contrary to due process, the Agency found and took official notice
of evidence of a state license revocation where lack of state authority was not
alleged at any point during the proceeding. 587 The use of official notice to
include information from state board websites can also prove confusing (and
potentially unfairly prejudicial) when the Agency includes information about
state suspensions or revocations that were not only not noticed, but are also
unrelated to the licensure status of the respondent in the state at issue in the
proceeding.588
585. Kregenow, D.D.S., 80 Fed. Reg. at 50030 n.3; Lung, 74 Fed. Reg. at 20347; Yeates, 71 Fed.
Reg. at 39131.
586. Jose Raul S. Villavicencio, M.D., 80 Fed. Reg. 3624, 3627–28 n.5 (Drug Enf’t Admin. Jan.
23, 2015). The Agency concluded that it could take notice of the board’s action on the respondent’s
state medical license because “the Agency has long held that it lacks authority to continue a
practitioner’s registration where a practitioner no longer holds state authority to dispense controlled
substances,” noting that “the Agency has consistently taken official notice of state board decisions
suspending or revoking a practitioner’s state authority notwithstanding that the state did not take action
until after the issuance of a[n OSC].” Id. The Agency added that “adequate notice is provided either
by the Government’s filing of a Motion for Summary Disposition (in a case where a hearing was
requested) or by taking official notice and providing the applicant/registrant with the opportunity to
refute the finding (when no hearing request was filed).” Id. The circular nature of that statement—
that taking official notice, by itself, provides adequate notice that the Agency intends to take official
notice—only adds to the confusion surrounding what notice is adequate for an extra-record fact (or
document) to be held against the respondent.
587. Hatem M. Ataya, M.D., 81 Fed. Reg. 8221, 8244 & n.55 (Drug Enf’t Admin. Feb. 18, 2016)
(taking official notice that a state medical board revoked a respondent’s medical license during the
course of proceedings and relying on that fact in revoking respondent’s registrations and denying
pending applications, despite the Government’s argument that it did not allege lack of state authority
in its OSC and relying on that fact would be contrary to due process because the issue was raised sua
sponte by the Agency).
588. Zizhuang Li, M.D., 78 Fed. Reg. 71660, 71661 n.4 (Drug Enf’t Admin. Nov. 29, 2013)
(taking official notice that the Medical Board of California issued an accusation/petition to revoke a
respondent’s state medical license based on the results of an action taken by the Mississippi Board and
taking official notice that the respondent voluntarily surrendered his Louisiana medical license, without
stating where any of that information was found or why it took official notice of those facts in a case
where the proposed denial of a respondent’s application to be registered in California was based
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In addition to state board licensure information, the Agency has also taken
official notice of the following: facts and circumstances relating to ancillary
criminal proceedings involving a respondent; 589 Food and Drug Administration
National Drug Code (NDC) information; 590 zip code information;591 posthearing Mapquest queries, including determinations of how far patients reside
from prescribing doctor’s offices592 and how many pharmacies exist in a certain
geographic area;593 supplementary information about doctor-prescribers in
pharmacy cases, including whether the prescribers had action taken against

589. Ibem R. Borges, M.D., 81 Fed. Reg. 23521, 23523 (Drug Enf’t Admin. Apr. 21, 2016)
(taking official notice of state court records to establish that the respondent was charged with
committing particular crimes relating to controlled substances and had a jury trial scheduled but then
declining to consider that information because it was not alleged as a basis for revocation in the order
to show cause); Odette L. Campbell, M.D., 80 Fed. Reg. 41062, 41063 n.5 (Drug Enf’t Admin. July
14, 2015) (taking official notice of “the Docket Sheet Entries in [the respondent’s criminal case], as
well as Document # 27 [from that case], which sets forth the disposition of . . . [a] hearing conducted
by the district court on [r]espondent’s violation of the conditions of her pretrial release, wherein the
[district court] modified the conditions of her release to prohibit her from writing any controlled
substance prescriptions,” after the Government alerted the Agency to the indictment of the criminal
case in a post-hearing filing after being directed by the Agency to address the status of state board
proceedings against the respondent); Wayne E. Ellison, and North Stringtown Plaza, Inc., 42 Fed. Reg.
43136, 43136 n.1 (Drug Enf’t Admin. Aug. 26, 1977) (revoking registration based on the respondent’s
conviction of a felony offense relating to controlled substances and taking official notice of the fact
that the U.S. Court of Appeals for the Seventh Circuit affirmed the respondent’s convictions after the
record was certified and transmitted).
590. Jones Total Health Care Pharmacy, L.L.C., 81 Fed. Reg. 79188, 79189 n.7 (Drug Enf’t
Admin. Nov. 10, 2016) (taking official notice that, “according to the FDA’s National Drug Code
Directory website,” a National Drug Code number on a prescription label in evidence is the drug code
for a particular controlled substance).
591. Mark P. Koch, D.O., 79 Fed. Reg. 18714, 18719 n.15 (Drug Enf’t Admin. Apr. 3, 2014)
(taking official notice, “using the Web site of the U.S. Postal Service,” that a particular zip code
corresponds with Erie, Pennsylvania when the Certification of Registration history listed only “Erie”
and the zip code).
592. Jones Total Health, 81 Fed. Reg. at 79194 n.18 (taking official notice of “a query conducted
on Mapquest” to determine approximately how far a patient resided from a prescribing doctor’s office).
593. Perry County Food & Drug, 80 Fed. Reg. 70084, 70092 (Drug Enf’t Admin. Nov. 12, 2015)
(taking official notice of “the results of a Mapquest search for pharmacies in the Perryville[, Arkansas]
area[, which] show that there are six pharmacies located in Morrilton[, Arkansas],” a town “which is
only fourteen miles from Perryville,” to reject the respondent pharmacy’s claim that its closure will
create a monopoly because there is only one other pharmacy in Perryville).

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their licenses,594 whether the doctors held any board certifications, 595 and even
whether the doctors were still alive; 596 statistics “established” by prior agency
orders;597 and, most recently, “that morphine does not metabolize into
oxymorphone” in the human body.598
Some of the facts the Agency now establishes through the use of official
notice might be incontrovertible, such as NDC codes and zip code information.
Some or even all of the information it currently pours into the record at the final
order stage might be accurate, but the registrant that it was used against may
not have had reason (or ability) to access the information, such as doctorprescriber license information. Other information that the Agency has found as
fact through official notice is potentially susceptible to reasonable dispute by
experts, such as whether statistics set forth in a prior Agency order are relevant
to the facts of a newer case, or whether particular controlled substances
metabolize into particular chemicals. 599 And, of course, there is always the
potential that the Agency could simply get the facts wrong when it takes official
notice. The APA offers some ability to challenge the facts found through
official notice, providing that “[w]hen an agency decision rests on official
notice of a material fact not appearing in the evidence in the record, a party is
entitled, on timely request, to an opportunity to show the contrary.” 600
However, a meaningful opportunity and procedure to challenge facts is not
594. Jones Total Health, 81 Fed. Reg. at 79193 n.13 (revoking, through a prior Agency final
order, a practitioner’s license for a doctor whose patients filled their prescriptions at the respondent
pharmacy); id. at 79199 n.31 (suspending and later revoking licenses of several doctors whose patients
filled their prescriptions at the respondent pharmacy); Edge Pharmacy, 81 Fed. Reg. 72092, 72103
n.28 (Drug Enf’t Admin. Oct. 19, 2016) (restricting doctor’s state license—on a date after the DEA’s
inspection of the pharmacy—for cause and ultimately surrendered).
595. Edge Pharmacy, 81 Fed. Reg. at 72103 n.28 (taking official notice that “[a]ccording to the
online records of the Florida Department of Health” a particular doctor whose prescriptions were filled
at the respondent pharmacy was not board certified in pain medicine or anesthesiology).
596. Hills Pharmacy, L.L.C., 81 Fed. Reg. 49816, 49830 (Drug Enf’t Admin. July 28, 2016)
(taking official notice of the date of death of a doctor based on his “online obituary” in a pharmacy
case where the pharmacist in charge testified that many of his customers visited a particular pain clinic
because the (now deceased) doctor was famous).
597. Vernor Prescription Center, 59 Fed. Reg. 6305, 6306 (Drug Enf’t Admin. Feb. 10, 1994)
(taking official notice of a statistic regarding average purchases of a certain drug by pharmacies in
Michigan, which was “established” in a prior agency order issued three years prior, to determine that
the respondent’s purchases remained excessive despite the ALJ’s finding that it was a mitigating factor
that the respondent’s purchases if the drug were declining).
598. Wesley Pope, M.D., 82 Fed. Reg. 14944, 14964 (Drug Enf’t Admin. Mar. 23, 2017) (citing
Edward J. Cone, et al., Evidence that Morphine is Metabolized to Hydromorphone But Not to
Oxymorphone, 32 J. ANALYTIC TOXICOLOGY 319, 319, 323 (2008) (“Pursuant to 5 U.S.C. § 556(e)
(2012), I take official notice that morphine does not metabolize into oxymorphone.”)).
599. Id.
600. Administrative Procedure Act, 5 U.S.C. § 556(e) (2012).

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consistently offered by the Agency, 601 is sometimes not offered at all,602 and has
been offered only in words but not in substance in the Agency’s more recent
decisions, because the final orders have already been published in the Federal
Register before the time offered to the respondent to challenge the facts has
elapsed.603
601. See, e.g., Pope, 82 Fed. Reg. at 14964 n.33 (affording “[twenty] calendar days” from the
date of the order to file “properly supported motion for reconsideration” and affording the Government
twenty days to respond to such a motion); Robert Markman, M.D., 82 Fed. Reg. 11369, 11370 n.1
(Drug Enf’t Admin. Feb. 22, 2017) (affording “[fifteen] calendar days [from] the date of service” to
“file a motion for reconsideration”); Hills Pharmacy, 81 Fed. Reg. at 49823 n.11 (affording fifteen
calendar days from the mailing of the order to “fil[e] a properly supported motion”); Jones Total Health
Care Pharmacy, L.L.C., 81 Fed. Reg. 79188, 79188 n.3 (Drug Enf’t Admin. Nov. 10, 2016) (affording
“ten days” from the date of the order to “fil[e] a properly supported motion”); Piyush V. Patel, M.D.,
72 Fed. Reg. 18274, 18275 n.1 (Drug Enf’t Admin. Apr. 11, 2007) (affording fifteen days after “receipt
of th[e] order” to “fil[e] a request for reconsideration which includes supporting documentation”);
Edmund Chein, M.D., 72 Fed. Reg. 6580, 6583 n.4 (Drug Enf’t Admin. Feb. 12, 2007) (citing 5 U.S.C.
§ 556(e)) (noting that “publication of [the] order will be withheld for a fifteen day period in order to
provide [r]espondent with ‘an opportunity to show to the contrary’”).
602. David D. Moon, D.O., 82 Fed. Reg. 19385, 19387 n.5 (Drug Enf’t Admin. Apr. 27, 2017)
(taking official notice of the online records of two state medical boards to find that the respondent does
not currently possess a license in either jurisdiction, but providing no opportunity to refute that fact);
Edge Pharmacy, 81 Fed. Reg. 72092, 72103 n.58 (Drug Enf’t Admin. Oct. 19, 2016) (citing 5 U.S.C.
§ 557(c)) (taking official notice of the Florida Department of Health “online records,” which provides
that parties are entitled to submit arguments and things to “employees participating in the decision[]
[on agency review],” but which does not provide an opportunity for parties to challenge facts found
through official notice in a final agency decision); Richard J. Settles, D.O., 81 Fed. Reg. 64940, 64944
n. 13 (Drug Enf’t Admin. Sept. 21, 2016) (citing to the New Mexico Board of Osteopathic Medical
Examiners website to state that certain state licenses were expired, but not stating that the Agency is
taking official notice of the expiration dates or offering any opportunity to the respondent to challenge
whether the licenses were, in fact, expired); Gregory White, M.D., 79 Fed. Reg. 24754, 24755 (Drug
Enf’t Admin. May 1, 2014) (citing an “internet search” to establish the respondent’s state licensure
status, but providing no opportunity for the respondent to challenge the finding).
603. See Pope, 82 Fed. Reg. at 14964 n.33 (purporting, in the Agency’s decision signed on
March 16, 2017, to afford the respondent 20 calendar days after that date to “fil[e] a properly supported
motion for reconsideration” with the Office of the Administrator, while affording the Government 20
days to respond to such a motion, if filed, but the final order was published in the Federal Register only
seven days after it was signed, on March 23, 2017.); Frank D. Li, M.D., 82 Fed. Reg. 11238, 11239 &
n.2 (Drug Enf’t Admin. Feb. 21, 2017) (purporting, in the Agency’s decision, which was signed on
February 13, 2017, to afford the respondent 15 calendar days from the date the order was mailed to
“file a motion for reconsideration,” but the final order was published in the Federal Register only eight
days after it was signed, on February 21, 2017.); Hills Pharmacy, 81 Fed. Reg. at 49817, 49823 n.11
(purporting, in the Agency’s decision, which was signed on July 19, 2016, to afford the respondent 15
calendar days from the mailing of the order to dispute the fact found by official notice “by filing a
properly supported motion,” but the final order was published in the Federal Register only nine days
after it was signed, on July 28, 2016.); Jones Total Health, 81 Fed. Reg. at 79188 n.3, 79203
(purporting, in the Agency’s decision, which was signed on October 31, 2016, to afford the respondent
ten days to “dispute . . . any [] finding[s] which [are] the subject of official notice[] by filing a properly
supported motion,” but the final order was published in the Federal Register exactly ten days later, on

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Even when a respondent is provided with an opportunity to rebut the
information found through official notice, Federal Register publication puts the
information in the public domain for the respondent’s patients, customers,
peers, colleagues, and families to see that order before any dispute is resolved
unless the Agency delays publication in order to resolve the dispute. In
practice, the Agency’s final order is published long before a respondent is able
to refute the facts found through official notice. 604 On one occasion where the
Administrator took official notice of numerous documents that were not
included in the administrative record605 the Agency published its final Agency
order seven days after it was signed and eight days before the time afforded to
the respondent to file a motion for reconsideration expired. 606 In that case, the
respondent objected to the inclusion of the extra-hearing documents and
requested an opportunity to respond to that evidence. 607 Even then, the
Administrator did not remand the case to the ALJ to allow the respondent to
introduce new documents in order to refute those documents that were included
via official notice.608 Instead, the Administrator ordered that the parties litigate
the issue via filings—with the Administrator 609—and ultimately took official
November 10, 2016). That the orders sometimes reflect a delayed effective date changes nothing about
the potential injury to fragile professional reputations resulting from this practice.
604. See cases cited supra note 603.
605. Lyle E. Craker, 74 Fed. Reg. 2101, 2108 n.24 (Drug Enf’t Admin. January 14, 2009) (taking
official notice of National Institute on Drug Abuse (NIDA) letter, “which appears on [the
Multidisciplinary Association for Psychedelic Studies (MAPS)]’s website,” to find the bases upon
which NIDA denied a doctor’s application to use marijuana in a research study); id. at 2109 n.30
(taking official notice of two reports available on the MAPS website); id. at 2111 n.41 (taking official
notice “of the FDA’s Guideline for Drug Master Files,” and providing website link); id. at 2115 n.56
(taking official notice of a report authored by the International Narcotics Control Board (INCB); id. at
2116 n.57 (taking official notice of a press release issued by the INCB).
606. Craker, 74 Fed. Reg. at 2133 (order signed on January 7, 2009); id. at 2108 n. 24 (“To allow
[r]espondent the opportunity to refute the facts of which I take official notice, [r]espondent may file a
motion for reconsideration within fifteen days of service of this order which shall commence with the
mailing of this order.”).
607. See Lyle E. Craker, PhD, 76 Fed. Reg. 51403, 51404 (Drug Enf’t Admin. Aug. 18, 2011)
(describing the post-Final Order filings that resulted from the 2009 Agency final order).
608. Id. (filing a motion for reconsideration, respondent including a request “that the
administrative hearing be reopened so that he may call additional witnesses in view of certain
documents of which [the Administrator] took official notice in the final order,” but the Administrator
denied that request).
609. Id. (directing the respondent, in Administrator’s “interim order,” “to submit a list of all
witnesses he would call if his request to reopen the administrative hearing were granted[,] to provide
a summary of the proposed testimony for each witness[,]” and to “indicate precisely which documents
he sought to introduce for purposes of his motion for reconsideration” and whether he was requesting
official notice be taken of the documents or whether they would be introduced through witnesses if his
request to reopen the hearing were granted); id. (“[h]aving ruled on which new documents would be
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notice of several documents submitted by the respondent. 610 The entire process
took more than two years, and during that time the Agency’s final order with
the officially-noticed documents—which was already published—remained
unchallenged, at least in the public’s view.611 Even if a registrant were
ultimately to prevail on an official notice issue, the effects on the registrant’s
patient or customer base would be catastrophic and irreparable.
Also, whether the officially-noticed facts prove to be incontrovertibly true,
probably true, arguably true, sort of true, or not true at all, the ever-escalating
use of official notice still raises the unattractive specter of an unidentified
Government employee sitting at a computer terminal somewhere in the office
of the final adjudicator, performing investigative research into state board
websites, other agency websites, and even biology reference materials and other
sources. This phenomenon runs the risk of violating the APA’s unambiguous
provision that, subject to exceptions not relevant here:
An employee or agent engaged in the performance of
investigative or prosecuting functions for an agency in a case
may not, in that or a factually related case, participate or advise
in the decision, recommended decision, or agency review [of
initial decisions], except as a witness or counsel in public
proceedings.612
The Agency’s decision drafter certainly is not “a witness or counsel in the
public proceedings,” and he or she certainly is “participat[ing] or advis[ing]”
the final Agency decision maker by drafting what will ultimately become the
final decision of the Agency. 613 Therefore, the APA provision unequivocally
prohibits him or her from “engag[ing] in the performance of investigative or
prosecuting functions” for the Agency. 614 But the language of the Agency’s
final orders gives at least the appearance that this dynamic has become standard
operating procedure through the increasingly aggressive use of official
notice.615
the respondent “an additional opportunity to file a final brief” and afforded the Government time to
respond to that brief).
610. Id. (taking official notice of four documents and declining to take official notice of seven
documents, noting that those seven documents “will not be considered part of the administrative record
considered by the agency in this adjudication,” which indicates that the other four were considered to
be part of the record).
611. The first Craker final order was published on January 14, 2009, Craker, 74 Fed. Reg. at
2101, and the second was published on August 18, 2011, Craker, 76 Fed. Reg. at 51403.
612. Administrative Procedure Act, 5 U.S.C. § 554(d) (2012).
613. Id.
614. Id. § 554(d)(2).
615. E.g., Gregory White, M.D., 79 Fed. Reg. 24754, 24755 (Drug Enf’t Admin. May 1, 2014)
(“An internet search of the [state board]’s public record actions Web page found the following . . . ”);

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While official notice is certainly authorized in administrative enforcement
proceedings, the essential question is whether the Agency’s decision makers
(and decision drafters), in their roles as impartial adjudicators, will be able to
resist the temptation to shore up the Government’s case through the use of
official notice in preparing the Agency’s final orders. Even if the bar
representing the regulated community is actually afforded the opportunity (and
instructions for how) to confront officially noticed facts, it does little to dispel
the inescapable sense that the purportedly-neutral Agency final order
adjudicator is being placed in the role of minding that the Government has
dotted its “i’s” and crossed its “t’s,” assisting in filling in gaps at the last
moment where needed. With the current practice, the Government could be
perceived by the regulated community and the public as essentially working
with a safety net in the event that one of its prosecutors misses an important
detail, forgets a declaration signature, or has its evidence staled through the
passage of adjudication time. Respondents, on the other hand, are afforded little
more than a passing moment, if anything, to refute the new evidence used
against them and—even if they did manage to challenge the facts found through
official notice before the final order was published—the Agency has rendered
no hint that it would be willing to defer Federal Register publication in order to
resolve the dispute (which it would presumably need to do by remanding the
matter back to the impartial adjudicator), before the respondents would need to
appeal the entire final order, rather than merely challenging an officiallynoticed fact found within it.
M. Is the Agency Marginalizing its ALJs, and its Due Process Hearings?
1. Restraining (and Overruling) Decisional Independence
There is little doubt that the Agency’s more recent final orders could be
read as conveying an increasing discomfiture with the decisional independence
of its own independent ALJs.616 In one recent line of final orders, the Agency
accepted and published the recommended decisions of its ALJs, but deleted
those portions of the ALJ’s recommended decisions which cited Universal
Camera Corp. v. NLRB,617 a decision wherein the Supreme Court set forth the
level of deference properly accorded to the factual determinations rendered by

Franklyn Seabrooks, M.D., 79 Fed. Reg. 44196, 44197 (Drug Enf’t Admin. July 30, 2014) (“An
internet search of the [state board]’s public record actions Web page reveals . . . ”).
616. See generally, John A. Gilbert and Andrew J. Hull, A Matter of Substantial Discretion: A
Recent Rift Between DEA and Its ALJs Could Significantly Impact Registrants, FOOD AND DRUG L AW
INSTITUTE MAGAZINE, November/December 2015.
617. 340 U.S. 474, 496 (1951).

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federal agency ALJs.618 In JM Pharmacy, the Agency adopted most of the
ALJ’s findings of fact and conclusions of law but, citing the ALJ’s discussion
of Universal Camera, included the statement that “[t]o make clear, the Agency
is the ultimate factfinder . . . .” 619 Even setting aside the fact that the Agency,
by its regulations, has qualified its own authority over aspects of the
adjudication,620 it is not so much the accuracy of the statement that presents an
issue, but the Agency’s election to include the seemingly confrontational
declaration in its final order. Setting aside considerations regarding the wisdom
of supplanting and qualifying clear Supreme Court precedent with
pronouncements ensconced in prior Agency final orders, the Agency’s
decisions risk the appearance of an increasing willingness on the part of the
Agency to disregard facts found by impartial ALJs and substitute its own,
different facts.
There can also be little doubt that the Agency’s precedents have
demonstrated an increasing aggressiveness in publicly scolding its ALJs in final
orders published in the Federal Register. 621 The Agency has also, in a published
618. See, e.g., Trenton F. Horst, D.O., 80 Fed. Reg. 41079, 41079 n.2 (Drug Enf’t Admin. July
14, 2015); Jana Marjenhoff, D.O., 80 Fed. Reg. 29067, 29070 n.9 (Drug Enf’t Admin. May 20, 2015).
619. JM Pharmacy Grp., Inc., 80 Fed. Reg. 28667, 28667 n.2 (Drug Enf’t Admin. May 19, 2015).
620. Administrative Procedure Act, 5 U.S.C. § 557(b) (2012) (“On appeal from or review of the
initial decision, the agency has all the powers which it would have had in making the initial decision
except as it may limit the issues on notice or by rule.”) (emphasis added); 21 C.F.R. § 1316.52, 67
(2017)) (regarding the respective duties of the ALJ and the Administrator as limited by Agency
regulations).
621. See, e.g., Syed Jawed Akhtar-Zaidi, M.D., 80 Fed. Reg. 42962, 42962 n.2 (Drug Enf’t
Admin. July 20, 2015) (criticising the ALJ including the pointed observation that “every Administrator
and Deputy Administrator who has exercised [Agency authority] has rejected the ALJ’s view”);
Farmacia Yani, 80 Fed. Reg. 29053, 29063 (Drug Enf’t Admin. May 20, 2015) (stinging in an Agency
final order that the correct legal analysis was “[c]ontrary to the ALJ’s understanding”); Moore Clinical
Trials, L.L.C., 79 Fed. Reg. 40145, 40157, 40155 (Drug Enf’t Admin. July 11, 2014) (stating that
“[n]ot only is the ALJ’s reasoning counterfactual, it reflects a stunning misunderstanding of the
[Controlled Substances Act],” and, while addressing another portion of the ALJ’s analysis, stating “I
reject the ALJ’S rumination as totally irrelevant”); Clair L. Pettinger, M.D., 78 Fed. Reg. 61591,
61596-61600 (Drug Enf’t Admin. Oct. 3, 2013) (reasoning by ALJ dismissed as “illogical,” that the
correct legal analysis was “[c]ontrary to the ALJ’s understanding,” and that “in future cases [the ALJ]
should rest assured” that the Agency’s legal analysis is the correct one); T.J. McNichol, M.D., 77 Fed.
Reg. 57133, 57144–49 (Drug Enf’t Admin. Sept. 17, 2012) (excoriating ALJ throughout the Agency
final order for legal and factual analysis, with characterizations such as “reflects a stunning disregard
for Federal law,” “[c]ontrary to the ALJ’s ludicrous suggestion,” “absurd,” “ignor[ing] numerous
decisions of both federal and state courts in criminal cases,” and other phrases evincing disdain for the
ALJ’s ability and judgment), aff’d, T.J. McNichol v. DEA, No. 12-15292, slip op. at 3 (11th Cir. Oct.
17, 2013); Grider Drug #1 & Grider Drug #2, 77 Fed. Reg. 44070, 44070, 44082 n.40 (Drug Enf’t
Admin. July 26, 2012) (mocking openly, in Agency’s final order, ALJ by equating the proceedings
conducted by the ALJ to a portion of “Justice Douglas’s dissenting opinion in Sierra Club v. Morton”
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decision, recently reminded its ALJs that “[o]nce the [A]gency has ruled on a
given matter[,] it is not open to reargument by the [ALJ].”622 The effect on the
level of decisional accuracy or fairness resulting from chastising independent
Agency ALJs is not altogether clear, and neither is the purpose for doing so in
published decisions readily apparent. The extent to which a federal agency
head differs in legal analysis from one of the agency’s ALJs seemingly presents
as a concept capable of dispassionate expression without gratuitous vitriol.
Further, an analysis included by an ALJ that differs in some respect from prior
final orders could prove to be more legally correct, and could persuade the
current or future DEA Administrators to engage a legal issue in a different light.
This is particularly so in the recommended decision structure of the APA 623 that
is utilized by the Agency in its decisional structure. 624 It is hardly hyperbole to
observe that the fostering of an environment where the Agency’s final orders
communicate hostility towards recommendations not to its liking by its own
ALJs does not further the purposes of Congress in creating a recommended
decisional structure. The obvious concern in the gratuitous chastisement of
ALJs by their employing agency is that intemperate language set forth in
published Agency final orders risks the perception that the Agency is seeking
an improper means to impact future hearing decisions.
In fact, in Superior Pharmacy I & Superior Pharmacy II, the Agency was
forced to address the respondent’s contention that the Agency’s “public
scolding” of the assigned ALJ in a prior case caused the ALJ to have a general
bias against respondents.625 The Agency did not deny the fact or severity of its
prior reprobation aimed at the ALJ in that case, but dismissed the assignment
of error based on the “extensive protections provided to ALJs under federal law
to ensure their decisional independence, including that they are not subject to
court proceedings, declared that “the ALJ’s sole function is to make findings that are relevant and
material to the allegations raised by the Government,” and accused the ALJ of “fail[ing] to exercise
anything more than minimal control over the parties’ respective presentations”); Randall L. Wolff,
M.D., 77 Fed. Reg. 5106, 5112 n.15 (Drug Enf’t Admin. Feb. 1, 2012) (dismissing ALJ’s legal analysis
as a “rumination”); George Mathew, M.D., 75 Fed. Reg. 66138, 66140 (Drug Enf’t Admin. Oct. 27,
2010) (accusing ALJ of “ignor[ing] extensive Agency precedent,” and dismissed her legal analysis,
stating that the correct legal analysis is “[c]ontrary to the ALJ’s understanding”); East Main Street
Pharmacy, 75 Fed. Reg. 66149, 66150 n.2 (Drug Enf’t Admin. Oct. 27, 2010) (dismissing ALJ’s
analysis as “reflect[ing] a clear misunderstanding of her role,” and characterized her procedural ruling
and case time management as “disturbing”); Jeri Hassman, M.D., 75 Fed. Reg. 8194, 8235 (Drug Enf’t
Admin. Feb 23, 2010) (dismissing ALJ’s legal analysis as “erroneous”). These examples, which are
not intended to constitute an exhaustive list, involve the work of multiple ALJs.
622. Pettinger, 78 Fed. Reg. at 61600 n.13 (internal punctuation omitted).
623. 5 U.S.C. § 557(b).
624. 21 U.S.C. § 824(c) (2012); 21 C.F.R. § 1316.65(a).
625. Superior Pharmacy I & Superior Pharmacy II, 81 Fed. Reg. 31310, 31339 n.66 (Drug Enf’t
Admin. May 18, 2016).

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performance appraisals,[ ]their pay is set . . . independent of any evaluation by
the Agency,[ ]and they are subject to discipline only upon a showing of good
cause by the MSPB.”626 The arguably dismissive attention devoted to this issue
by the Agency misses the point that, although ALJs are endowed with statutory
protections and their own personal integrity, subjecting impartial Agency
judges to gratuitous personal criticism in decisions published in the Federal
Register risks eroding the confidence that the public places in the fairness of
adjudications by the Agency under the APA. In conjunction with the more
recent practice of the Agency revisiting all of the evidence and making findings
without regard to the findings of the ALJ, such practice conveys the message
(accurate or not) that the underlying purpose could be to bully the ALJs into
issuing recommended decisions more in line with the wishes of the Agency and
its Administrator.
2. Summary Disposition Without Motion or ALJ Recommendation
It has long been the practice of the Agency, even in the face of a timely
hearing request, to grant its prosecutors summary disposition against a
respondent where the Government has alleged that the respondent does not
possess the state authority required to issue or maintain a DEA registration. 627
This practice, while authorized nowhere in statute or regulation, is ostensibly
founded in the notion that the CSA authorizes the Agency to issue registrations
to “practitioners,” and that by definition under the CSA, 628 a practitioner must
possess authority under state law to handle controlled substances. 629 Although
in the revocation section of the CSA, Congress provided that the abridgement
of state authority is a discretionary basis for sanction, 630 the Agency has taken
the position that its view of the other provisions essentially renders the
discretionary revocation provisions related to state authority as meaningless
surplusage.631

626. Id. (citations omitted).
627. See, e.g., Emmanuel O. Nwaokocha, M.D., 82 Fed. Reg. 26516, 26518 (Drug Enf’t Admin.
June 7, 2017); Frederick Marsh Blanton, M.D., 43 Fed. Reg. 27616, 27617 (Drug Enf’t Admin. June
26, 1978).
628. 21 U.S.C. § 802(21).
629. James L. Hooper, M.D., 76 Fed. Reg. 71371, 71372 (Drug Enf’t Admin. Nov. 17, 2011),
pet. for rev. denied, Hooper v. Holder, 481 F. App’x 826, 828 (4th Cir. 2012).
630. 21 U.S.C. § 824(a)(3).
631. Rezik A. Saqer, M.D., 81 Fed. Reg. 22122, 22126 (Drug Enf’t Admin. Apr. 14, 2016)
(stating that “[i]t is not clear . . . why using the word ‘shall’ rather than ‘may’ would make any
difference, as [21 U.S.C. §] 824(a) grants the Agency authority to either revoke or suspend,” thus
essentially holding that it was free to use its discretion to revoke in every case—without any exercise
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While summary disposition has been used historically by the Agency’s
prosecutors, the Agency recently confirmed in Phong Tran, M.D. that summary
disposition is also available to respondents. 632 In that case, the Agency alleged
that the respondent lacked the state authority to handle controlled substances
required to maintain his multiple certificates of registration in the state of
California.633 Specifically, the Government alleged that, in response to state
criminal charges relating to unlawful billing which had been levied against the
registrant, the Medical Board of California petitioned the court handling the
criminal charges for an order suspending the registrant’s state medical license
during the pendency of the criminal proceedings, and the court imposed a
condition of bail which prohibited the registrant from practicing medicine
during the pendency of his criminal matter. 634 The Government filed for
summary disposition, but the motion was denied because the prohibition on
practice was uncontrovertibly a condition of bail release, not a suspension or
encumberment of the medical license itself.635 In other words, the ALJ
concluded that “[the] [r]espondent (albeit at the peril of his release conditions)
maintains the state authority requisite to retain his DEA registrations,” despite
the Government’s argument to the contrary. 636 After the Government’s motion
was denied, the respondent was granted leave to file, and did file, a motion for
summary disposition of his own, which was granted by the ALJ. 637 In its final
decision, the Agency likewise concluded that the registrant’s state medical
license was neither suspended nor revoked. 638
While the Agency’s confirmation of the availability of summary disposition
to respondents seemed to somewhat balance the playing field for respondents,
in the case of Richard J. Blackburn, D.O., the Agency took an even more
aggressive stance regarding its ability to find facts without a due process
hearing despite a timely request for such a hearing. 639 In response to a doctor’s
registration application, DEA prosecutors filed an OSC alleging that he lacked

632. Phong Tran, M.D., 82 Fed. Reg. 31070 (Drug Enf’t Admin. July 5, 2017).
633. Id.
634. Id.
635. Id. at 31074.
636. Id. at 31071 (internal punctuation and quotation marks omitted).
637. Id. at 31072.
638. Id. The Agency declined to adopt the decision of the ALJ, id. at 31072 n.10, instead issuing
its own decision with different analysis. The Agency’s decision that the registrant maintained the
requisite state authority despite the bail condition prohibiting practice was based, in part, on the
Government’s concession in its opposition to the respondent’s motion for summary disposition that
the respondent maintained such authority. Id. at 31075.
639. Richard Jay Blackburn, D.O., 82 Fed. Reg. 18669, 18669 (Drug Enf’t Admin. Apr. 20,
2017).

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the requisite state authority and that he had made a materially false statement. 640
The respondent timely requested a hearing on both counts. 641 The ALJ granted
a summary disposition motion filed by the Government regarding lack of state
authority, but, finding the state authority issue case dispositive, declined to
decide the issue of the material false statement allegation and forwarded the
case to the Administrator for a final order. 642 Notwithstanding the fact that the
Government never made a summary disposition motion regarding the material
false statement allegation before the ALJ,643 and the fact that the ALJ declined
to make findings or recommendations on that allegation, the Agency sustained
both the lack of state authority and material false statement allegations. 644 In
support of its factual determinations, the Agency cited “attachments” filed by
the Government in its no-state-authority motion, and referred to the material in
the “attachments” as “reliable and probative evidence.” 645
The ALJ assigned to hear the case had determined that the respondent had
raised a triable issue of fact by asserting that any irregularities were mistakes,
and not intentional false statements. 646 The Agency dismissed the ALJ’s
determination, considered the “attachments” filed by the Government as
evidence in support of its no-state-authority summary disposition motion on the
issue of material false statement, and found against the respondent without
conducting the hearing he had requested. 647
Although the Agency
acknowledged that, in ruling upon summary judgment motions, “the usual rule
is that all doubts are resolved against the moving party,” 648 it was unfettered by
that convention in Blackburn.649 Even though there was not even a motion filed
for summary disposition of the material falsification allegation, the Agency

640. Id.
641. Id.
642. Id. at 18670.
643. The Government styled its request for relief before the ALJ as a “Motion for Partial
Summary Disposition,” and sought merely to press its right to prove up the material false statement
charge at a contested hearing. Id. at 18669. It was not until it filed exceptions to the ALJ’s refusal to
grant a hearing on the material false statement charge that the Government broadened the scope of
relief to include both a remand for the hearing it had requested before the ALJ or a ruling in its favor
as a matter of law. Id. The Agency found that this portion of the Government’s exceptions constituted
sufficient notice to the respondent of the summary disposition issue and ruled in the Government’s
favor. Id. at 18673 n.6.
644. Id. at 18673.
645. Id. at 18672–73. One of the “attachments” relied upon by the Agency was actually a
printout from a state medical board webpage. Id. at 18670.
646. Id. at 18672.
647. Id.
648. Id. at 18673 n.7.
649. Id. at 18673 n.6.

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reasoned that summary disposition on the material falsification issue was
appropriate because the respondent did not “offer counter-affidavits or other
evidentiary material supporting the opposing contention that an issue of fact
remains, [and did not] show a good reason why he [was] unable to present facts
justifying opposition to the motion.” 650 Thus, the respondent and his counsel
were unable to challenge any of the evidence offered against him, despite
having timely requested an evidentiary hearing. 651
Even more concerning than the Agency’s troublesome reliance on
“attachments,” is language in numerous final orders placing conclusive factual
reliance on something even less. In several cases, the Agency found a hearing
waiver based exclusively on the representations by the Government that no
hearing request had been filed.652
The Agency’s decision to embrace a more robust view of its ability to find
facts without a hearing, like its increasing inclination to disregard the factual
and legal findings of its ALJs, may significantly impact the manner in which
both sides litigate administrative enforcement cases before the Agency in the
future. All parties will need to consider whether Blackburn stands for the
proposition that, by merely “attaching” any manner of documents to charging
documents, requests for hearing, or motions, evidentiary challenges as to
reliability, authenticity, or other objections available at a contested hearing, can
be avoided. Further, on this current trajectory, if the Agency is willing to find
a hearing waiver based on no more than a “Government[] representation,” 653 it
will be interesting to see if a more robust level of representations are permitted
to play a larger role in the Agency’s factfinding. The registrants’ bar in
particular will now need to consider whether a request for hearing under the
regulations could potentially result in summary disposition of the matter on
grounds other than lack of state authority, even in cases where the Government
has not made a motion for summary disposition on such other allegations.
IV. GOING FORWARD
It would be difficult to conceive of a world where diversion law would be
in a greater state of flux. The various components that have acted (Congress,
the Agency, and the diversion bar) have not acted as experience might have
predicted. In the face of expressed concern at rising opioid addiction and death,

650. Id. at 18673 n.7 (internal punctuation omitted).
651. Id. at 18672, 18673 n.7.
652. Gentry Reeves Dunlop, M.D., 82 Fed. Reg. 8432, 8432 (Drug Enf’t Admin. Jan. 25, 2017);
Lee B. Drake, M.D., 82 Fed. Reg. 11057, 11057 (Drug Enf’t Admin. Feb. 17, 2017); John Warren
Cox, M.D., 82 Fed. Reg. 29329, 29329 (Drug Enf’t Admin. June 28, 2017).
653. Cox, 82 Fed. Reg. at 29329.

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Congress has imbued the regulated community with the right to submit CAPs,
and imposed upon the Agency the duty to consider those plans. 654 Regarding
manufacturers and distributor registrants—but, notably, not practitioner
registrants—Congress has surgically pared back the evidence that may be
considered by the Agency in Public Interest Factor Five by narrowly redefining
“factors as may be relevant to and consistent with the public health and
safety,” 655 and created a definition of “immediate danger to the public health
and safety” 656 in a manner that renders Agency utilization of an immediate
suspension order against those types of registrants all but impossible to defend
in the federal courts. Whatever the relative merits of the Ensuring Patient
Access and Effective Drug Enforcement Act of 2016, there is little that can be
distilled from the legislation that either ensures patients enhanced access to
controlled medication or makes drug enforcement more effective. Access to
medication will likely remain largely unimpeded by federal enforcement
efforts, and law enforcement efforts aimed at curbing diversion may actually be
hampered by the loss of the DEA’s authority to effectively utilize immediate
suspension orders in cases involving manufacturers and distributors. Further,
if the Agency elects to delay proceedings while it adjudicates corrective action
plans submitted by respondents in administrative proceedings, the process of
enforcing anything could be substantially elongated.
The Agency’s approach has also evolved in a manner that arguably ran
contrary to what many may have expected, and it has seemingly attempted to
effect change through a robust utilization of adjudication in place of
rulemaking. While some news accounts have reported that the Agency’s
administrative enforcement levels have decreased, 657 as discussed throughout
this article, it also appears that the notice and burden standards it places on its
own prosecutors may have increased. That said, once a case has been filed and
reaches the final order stage, the Agency has not been shy about holding the
respondents to strict procedural rules, and in the last few years, has rarely ruled
against the sanctions sought by its regulators. 658 It could be persuasively argued
654. See supra Part II.A.
655. See supra Part II.C.
656. See supra Part II.B.
657. See, e.g., Bernstein & Higham, supra note 3, at A1; THE POST’S VIEW, supra note 3.
658. Of the twenty-eight final orders issued in 2016, all but three resulted in the respondent’s
application being denied or registration being revoked, and the other three were hardly positive for the
applicant/registrants. In one case, the registration at issue had expired and thus no decision was made
on whether the Agency could have revoked based on the facts. Turning Tide, Inc., 81 Fed. Reg. 47411
(Drug Enf’t Admin. July 21, 2016). In the other two non-revocation/denial cases, the Agency restricted
the respondents’ licenses to certain schedules because the relevant state authority had so restricted
those respondents’ state licenses. Ibem R. Borges, M.D., 81 Fed. Reg. 23521 (Drug Enf’t Admin. Apr.
21, 2016); Abolghasem Rezaei, M.D., 81 Fed. Reg. 25425 (Drug Enf’t Admin. Apr. 28, 2016). In both

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that the Agency’s aggressive expansion of the reach of its adjudications may
have extended to a level far beyond the legal or practical limits of that tool.
Agency final orders have more aggressively utilized official notice, summary
disposition, and litigation by consent, and have arguably demonstrated a
voracious appetite for supplanting the facts and law recommended by its
impartial ALJs with the Agency’s own facts and law based on its review of the
record.659 The Agency has even experimented with conducting contested
proceedings outside the reach of its ALJs during the preparation of its final
orders.660 Left on its current trajectory of robust dependence on final orders
over formal APA rulemaking, the future could produce continued struggles
with consistency, temperance, and clarity in the guidance the Agency transmits
to the practicing bar and the regulated community.
The diversion bar has likewise responded in a surprising fashion. In the
face of arguably expansive Agency adjudications, one may argue that the
registrants’ bar has collectively exhibited an almost sheepish complicity in its
pursuit of redress in the courts. 661 Likewise, Government counsel has not
of those cases, the Agency took note that, had allegations been made other than lack of state authority,
the Government would have made a prima facie case for full revocation. Rezaei, 81 Fed. Reg. at 25426
n.2 (finding that the facts “clearly would have supported a prima facie case for revocation under the
public interest standard”); Borges, 81 Fed. Reg. at 23523 (“The conduct . . . could serve as the basis
for a request for total revocation based on public interest grounds . . . [or] conviction of a felony related
to controlled substances.”). In 2015, thirty-seven cases were published, and only ten of those did not
result in denial of an application or revocation of a registration. Two cases were dismissed because
the applications were withdrawn. Chung-Kuang Chen, M.D., 80 Fed. Reg. 57020 (Drug Enf’t Admin.
Sept. 21, 2015); Matthew Valentine/Liar Catchers, 80 Fed. Reg. 50042 (Drug Enf’t Admin. Aug. 18,
2015). One application was granted pursuant to an earlier order setting forth conditions the applicant
had to meet in order to be granted a registration. Abbas E. Sina, M.D., 80 Fed. Reg. 53191 (Drug Enf’t
Admin. Sept. 2, 2015). Two cases were dismissed because the respondents’ registrations expired and
they filed no renewal application or new application. Victor B. Williams, M.D., 80 Fed. Reg. 50029
(Drug Enf’t Admin. Aug. 18, 2015); AIM Pharmacy & Surgical S. Corp., 80 Fed. Reg. 46326 (Drug
Enf’t Admin. Aug. 4, 2015). Two cases were dismissed because the respondents regained state
authority, lack of which was the only allegation in those cases. Nicholas Nardacci, M.D., 80 Fed. Reg.
50032 (Drug Enf’t Admin. Aug. 18, 2015); Jeffrey S. Holverson, M.D., 80 Fed. Reg. 50033 (Drug
Enf’t Admin. Aug. 18, 2015). Two applications for registration were granted with conditions and an
initial suspension. Odette L. Campbell, M.D., 80 Fed. Reg. 41062 (Drug Enf’t Admin. July 14, 2015);
Trenton F. Horst, D.O., 80 Fed. Reg. 41079 (Drug Enf’t Admin. July 14, 2015). One application case
was held in abeyance and the Agency ordered that the application be granted or denied based on certain
conditions. Farmacia Yani, 80 Fed. Reg. 29053 (Drug Enf’t Admin. May 20, 2015).
659. See supra Part III.G–M.
660. See supra Part III.L.4.
661. Since 2015, only five cases (six, if Superior I & II are counted separately) have been
appealed to a federal court of appeals. Of those, two remain pending as of the date of this article: Peter
F. Kelly, D.P.M, No. 17-1175 (D.C. Cir); Jones Total Health Care Pharmacy L.L.C., No. 16-17346
(11th Cir.); three were dismissed because the petitions for review were withdrawn: Stipulation of
Dismissal, Superior Pharmacy I & Superior Pharmacy II v. DEA, No. 16-1167 (D.C. Cir.), ECF No.

 2017]

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sought adjustments to edicts announced in final orders that run contrary to or
otherwise cause detriment to their litigation positions, and sometimes even their
sense of fairness. Mark Twain once famously quoted his close friend, Charles
Dudley Warner, in observing that “Everyone complains about the weather, but
nobody does anything about it.”662 Changes in diversion practice have been
largely treated by the practicing bar with a similar sense of fatalistic
inevitability.
The many changes recently inflicted on diversion litigation present like
dangerous rocks hidden beneath the surface of shallow, murky, drug-infested
waters. Like ship captains negotiating unchartered, shallow waters, litigators
on both sides of the aisle would be wise to navigate slowly and cautiously based
on a study of what we know so far. That said, there are no guarantees that those
with legislating and adjudicating authority will not be adding more perilous
boulders beneath the waterline, and faulting the helmsmen for failing to deduce
their existence and location prior to impact.

1636080; Stipulation of Dismissal, Hills Pharmacy v. DEA, No. 16-1295 (D.C. Cir.), ECF No.
1636081; and one petition was denied in a published per curium order, Syed Jawed Akhtar-Zaidi v.
DEA, 841 F.3d 707 (6th Cir. 2016). Of those cases that were pending at the federal courts in 2015,
one was affirmed and four petitions were denied. Memorandum On Petition for Review of a Final
Order of the Drug Enf’t Admin. at 3; Fred Samimi, M.D., DEA, No.14-71315 (9th Cir. 2017); On
Petition for Review of an Order of the Drug Enf’t Admin. at 6, Michael A. White, M.D. v. DEA, No.
14-60832 (5th Cir. 2015); Memorandum On Petition for Review of an Order of the Drug Enf’t Admin.
at 4, David A. Ruben, M.D. v. DEA, No. 13-72577 (9th Cir. 2015); On Petition for Review of a Final
Order of the Drug Enf’t Admin., The Medicine Shoppe v. Loretta E. Lynch, No. 14-1223 (D.C. Cir.
2015); On Petition for Review of a Final Order of the Drug Enf’t Admin. at 38, Masters Pharmaceutical
Inc. v. DEA., No. 15-1335 (D.C. Cir. 2017).
662. Tim Chuey, Everyone Complains About The Weather, But Nobody Does Anything About It,
EUGENE DAILY NEWS (Apr. 3, 2016), http://eugenedailynews.com/2016/04/everyone-complainsweather-nobody-anything/.