TEXAS STATE BOARD OF PHARMACY Re: Greenpark Compounding Pharmacy Address: 4061 F Bellaire Boulevard Houston, Texas 77025 License No.: 14713 Date Issued: December 31, 1991 Licensure Status: Probation Expiration Date: December 31, 2019 Type of Pharmacy: Community Sterile Compounding Prior Disciplinary Orders: Yes The Texas State Board of Pharmacy maintains records regarding licensure and disciplinary action against a licensee. Greenpark Compounding Pharmacy (Texas Pharmacy License #14713) has been subject to disciplinary action by the Texas State Board of Pharmacy (see attached). Form Completed by: _________________________________________ Megan G. Holloway Assistant General Counsel Texas State Board of Pharmacy September 17, 2018 Date The Texas Department of State Health Services, Drugs and Medical Devices Division, Wholesaler Registration, 1100 W. 49th Street, Austin, TX 78756, is responsible for issuing registrations to wholesale drug distributors and drug manufacturers in Texas. 333 Guadalupe Street Suite 3-500 Austin, Texas 78701-3943 512-305-8000(voice) 512-305-6778(fax) www.pharmacy.texas.gov AGREED BOARD ORDER #H-16-006-B RE: INTHEMATTEROF GREENPARK COMPOUNDING PHARMACY BEFORE THE TEXAS STATE BOARD OF PHARMACY (PHARMACY LICENSE #14713) On this day came on to be considered by the Texas State Board of Pharmacy (Board) the matter of pharmacy license number 14713 issued to Greenpark Compounding Pharmacy (Respondent), 4061 F Bellaire Boulevard, Houston, Texas 77025. By letter dated August 17, 2016, the Board gave preliminary notice to Respondent of its intent to take disciplinary action. This action was taken as a result of an investigation which produced evidence indicating that Respondent may have violated: Sections 565.001(a)(l), (2), (12) and (13); 565.002(a)(3) and (6); and 568.003(a)(l), (7) and (10) ofthe Texas Phatmacy Act, TEx. Occ. CoDE ANN. Title 3, Subtitle J (2015); Sections 281.7(a)(12), (13) and (29)(A); 281.8(b)(4)(A); 281.9(b)(3); 291.31(1), (15), (16) and (17); 291.32(c)(1)(E) and (F); 291.32(c)(2)(D); 291.131(b)(3); 291.131(c)(2)(B) and (C); 291.131(c)(3)(C); 291.131(d)(8)(E); 291.131(d)(9)(B); 291.131(e)(2)(B)(ii)(VIII); and 295.3(b) of the Texas Pharmacy Board Rules, 22 TEx. ADMIN. CoDE (2015); and Sections 431.021(a), (b) and (r); and 431.112(a)(1) ofthe Texas Food, Drug, and Cosmetic Act, TEx. HEALTH & SAFETY CoDE ANN. (20 15), in that allegedly: COUNTS On or about September 4, 2015, a pharmacist of Greenpark Compounding Pharmacy, 4061 F Bellaire Boulevard, Houston, Texas 77025, failed to verifY or inconectly verified the correct identity of an ingredient used in compounding a batch preparation, in that lorazepam was used in the preparation of a compounded batch preparation calling for lansoprazole. The compounded batch preparation was assigned lot number 09042015@20, and was labeled 480 ml lansoprazole 3mg/ml suspension. Subsequently, three pediatric patients were dispensed prescriptions from the batch preparation, as follows: (1) On or about September 8, 2015, the pharmacy dispensed 40 ml of the preparation to patient J.N. The prescription bottle was labeled lansoprazole 3mg/ml suspension with directions to "take 1ml (3mg) by mouth every day." The prescription was assigned prescription number 249233. Agreed Board Order #H-16-006-B Greenpark Compounding Pharmacy Page2 (2) On or about September 8, 2015, the pharmacy dispensed 140 ml of the preparation to patient S.B. The prescription bottle was labeled lansoprazole 3mg/ml suspension with directions to "take 2.5 ml (7.5 mg) by mouth every day for 8 w~eks." The prescription was assigned prescription number 249234. (3) On or about September 10, 2015, the pharmacy dispensed 300 ml of the preparation to patient S.P. The prescription bottle was labeled 300 mllansoprazole 3mg/ml suspension with directions to "give 2.5 ml (7.5 mg) by mouth every day." Patient S.P. was given the medication and received emergency treatment in a hospital after experiencing adverse effects, including drowsiness, lack of coordination and initability. The prescription was assigned prescription number 246935. On or about September 16, 2015, two samples of the compounded preparation were analyzed, and the results indicated that the samples contained lorazepam (measured at 2.38 mg/ml and 1.28 mg/ml) and did not contain lansoprazole. (4) On or about September 4, 2015, Cindy Lee Rodriguez, while acting as an employee (pharmacy technician) of Greenpark Compounding Pharmacy, 4061 F Bellaire Boulevard, Houston, Texas 77025, failed to keep and maintain complete and accurate compounding records for lot number 09042015@20 previously described. Specifically, Ms. Rodriguez forged the initials "R.P.," indicating Ranjeet Patel, a pharmacy technician, on the compounding preparation worksheet as having performed in process checks, when Mr. Patel did not do so. An informal conference was held in the Board's office on October 4, 2016, with Kenneth Lee Hughes, R.Ph., Pharmacist-in-Charge and President of Prescription Labs, Inc., on behalf of Respondent; and Michele Quattlebaum, Legal Counsel for Respondent, in attendance. The informal conference was heard by a Board panel comprised of: Jenny Downing Yoakum, R.Ph., Board Member; and Carol Fisher, R.Ph., M.P.A., Director of Enforcement; with Kerstin Arnold, General Counsel. Megan Holloway, Staff Attorney, was also in attendance. By appearing at the informal conference and by signing this Order, Kem1eth Lee Hughes, and Respondent's counsel neither admit nor deny the truth of the matters previously set out in this Order, and agree that the Board has jurisdiction in this matter and waive the right to notice of hearing, formal administrative hearing, and judicial review of this Order. The patties acknowledge that this Order resolves the allegations set forth herein, and agree to the terms and conditions set fmth in the ORDER OF THE BOARD below. Agreed Board Order #H-16-006-B Greenpark Compounding Pharmacy Page3 ORDER OF THE BOARD THEREFORE, PREMISES CONSIDERED, the Board does hereby ORDER that: (1) Respondent's license shall be placed on probation for a period of two (2) years, with such period to commence thirty (30) days after the entry of this Order. During the period of probation, Respondent shall abide by the terms of tllis Order, and shall not violate any pharmacy or drug statute or rule of this state, another state, or the United States with respect to pharmacy, controlled substances, and dangerous drugs. (2) Respondent shall pay a probation fee of one thousand two hundred dollars ($1,200) due one hundred twenty (120) days after the entry of this Order. (3) Respondent shall pay an administrative penalty of one thousand dollars ($1,000) due one hundred twenty (120) days after the entry of this Order. (4) Respondent shall develop and implement policies and procedures for a Continuous Quality Improvement Program for purposes of preventing and handling dispensing errors. The Continuous Quality Improvement Program shall include pharmacist peer review in compliance with guidelines approved by Board staff. In addition, the policies and procedures for pharmacist peer review shall state that: (a) The peer review committee will: • • • • review incident reports; determine what caused errors; make recommendations to correct the problem that caused the enors; and monitor the changes to determine if the changes have improved the operation of Respondent and reduced errors. (b) The peer review committee must be comprised of at least two employees of Respondent, including the pharmacist-in-charge and other pharmacist(s) or personnel who are employees of Respondent. The committee shall not be solely comprised of a district or regional manager/supervisor and the pharmacist-incharge and shall not be used for personnel evaluation purposes. (c) The peer review committee will meet regularly, and no less than quarterly. (d) The peer review committee will make a record indicating: • date of meeting • location of meeting; • names of persons attending the meeting; • description of activities; • discussion of problems in Respondent's operation (e.g., work flow, dispensing process); • findings; Agreed Board Order #H-16-006-B Greenpark Compounding Pharmacy Page4 • • description of recommendations; and review of actions or changes relating to individuals, systems, or processes made as a result of previous recommendations. (5) Respondent shall submit a report and/or documentation of such policies and procedures to Board staff within one hundred twenty (120) days after the entry of this Order. Copies of forms used by Respondent to collect the data on enors committed at the pharmacy (i.e., incident report forms) must be submitted to Board staff, as well as any other peer review forms that have been developed by Respondent. Additionally, records of the peer review committee, as described in subparagraph (d) above, shall be maintained for two (2) years at the location of Respondent and made available for inspection by Board employees. (6) Respondent shall be responsible for all costs relating to compliance with the requirements of this Order. (7) Respondent shall allow Board staff to directly contact Respondent on any matter regarding the enforcement of this Order. (8) Failure to comply with any of the requirements in this Order constitutes a violation and shall be grounds for further disciplinary action. The requirements of this Order are subject to the Texas Pharmacy Act, TEX. Occ. CODE ANN., Title 3, Subtitle J (2015), and Texas Pharmacy Board Rules, 22 TEX. ADMIN. CODE (2016). .I greed Board Order 1111- I (). ()()(i [) Grc('llpark ( 'omprmruliuJ: Plwrmacy Pa~e 5 And it is :;o ORDERED. llllS ORDER IS 1\ I,UBLIC RECORD. SIGNED AND ENTERED ON HilS_!_!~- day nf November MEMBER,. A1TEST: · · -~ rrccltlriSccrclury ND AGREED TO: Kerstin Arnold. General Counsel l'cxns Stntc nnard or Pharmacy ----------------- ---------- 2016 TEXAS STATE BOARD OF PHARMACY August 17, 2016 VIA U.S. FIRST CLASS MAIL & CERTIFIED MAIL RETURN RECEIPT REQUESTED NO. 7196 9008 9115 5519 2150 Greenpark Compounding Pharmacy c/o Kenneth Lee Hughes, R.Ph. Pharmacist-in-Charge 4061 F Bellaire Boulevard Houston, Texas 77025 RE: Greenpark Compounding Pharmacy, Pharmacy License #14713 PRELIMINARY NOTICE LETTER Dear Mr. Hughes: This letter is notice to Greenpark Compounding Pharmacy that the Texas State Board of Pharmacy (Board) is instituting disciplinary action against the pharmacy. Enclosed is an Informal Conference Packet that includes a Statement of Allegations alleging one or more violations of the following laws and rules governing the practice of pharmacy: Sections 565.001(a)(1), (2), (12) and (13); 565.002(a)(3) and (6); and 568.003(a)(1), (7) and (10) of the Texas Pharmacy Act, TEX. OCC. CODE ANN. Title 3, Subtitle J (2015); Sections 281.7(a)(12), (13) and (29)(A); 281.8(b)(4)(A); 281.9(b)(3); 291.31(1), (15), (16) and (17); 291.32(c)(1)(E) and (F); 291.32(c)(2)(D); 291.131(b)(3); 291.131(c)(2)(B) and (C); 291.131(c)(3)(C); 291.131(d)(8)(E); 291.131(d)(9)(B); 291.131(e)(2)(B)(ii)(VIII); and 295.3(b) of the Texas Pharmacy Board Rules, 22 TEX. ADMIN. CODE (2015); and Sections 431.021(a), (b) and (r); and 431.112(a)(1) of the Texas Food, Drug, and Cosmetic Act, TEX. HEALTH & SAFETY CODE ANN. (2015). 333 Guadalupe Street Suite 3-600 Austin, Texas 78701-3943 512-305-8000(voice) 512-305-8061(fax) www.pharmacy.texas.gov Greenpark Compounding Pharmacy August 17, 2016 Page 2 The laws and rules listed above are incorporated by reference as part of this letter, as though fully set forth herein, and can be located on the Board’s website at http://www.pharmacy.texas.gov/rules/. A copy of the cited laws and rules is also included in the enclosed packet. OPPORTUNITY TO RESPOND In accordance with the Texas Administrative Procedure Act, the Board is offering you the opportunity to respond to the matters set forth in this letter and the attached allegations in person through an Informal Conference. The Informal Conference will afford you the opportunity to show compliance with all requirements of the laws and rules governing the practice of pharmacy. INFORMAL CONFERENCE SCHEDULED An Informal Conference has been scheduled as follows: DATE: Tuesday, October 4, 2016 TIME: 1:30 p.m. PLACE: Office of the Texas State Board of Pharmacy William P. Hobby Building 333 Guadalupe Street, Suite 3-600 Austin, Texas 78701-3943 Telephone No. (512) 305-8060 PROCEDURE You may employ an attorney to represent the pharmacy in this matter. Enclosed is an explanation of the disciplinary process including a description of the Informal Conference and other information that you should be aware of during the disciplinary process. Additionally, procedural laws and rules that may affect this matter, including Sections 565.056 and 565.051 of the Texas Pharmacy Act, TEX. OCC. CODE ANN. Title 3, Subtitle J (2015), and Section 281.22 of the Texas Pharmacy Board Rules, 22 TEX. ADMIN. CODE (2016), can be located at http://www.pharmacy.texas.gov/rules/. • You or your attorney should contact the Board's office at (512) 305-8060 no later than September 19, 2016, to confirm attendance at the Informal Conference. • Although the law does not require you to submit a rebuttal, if you choose to submit a written rebuttal to the allegations for the Board’s consideration, it must be received by the Board by September 19, 2016. Your written rebuttal submission will not be considered if it is received after this date. Greenpark Compounding Pharmacy August 17, 2016 Page 3 DEFAULT FAILURE TO RESPOND TO THE ALLEGATIONS, BY EITHER PERSONAL APPEARANCE AT THE INFORMAL CONFERENCE OR IN WRITING, WILL RESULT IN THE ALLEGATIONS BEING ADMITTED AS TRUE AND THE RECOMMENDED SANCTION MADE AT THE INFORMAL CONFERENCE BEING GRANTED BY DEFAULT. If you do not respond to this letter on or before October 4, 2016, the Informal Conference panel will recommend that the Board enter a default Order based upon the allegations set out in the Statement of Allegations. The Board would consider the default Order at the next regularly scheduled meeting. The enclosed allegations are being furnished to you so that you will be aware of the specific matters to be discussed at the Informal Conference or presented at a contested case hearing at the State Office of Administrative Hearings, if it is necessary to schedule such a hearing. For your convenience, I have also enclosed a map with directions to our office. Sincerely, Megan G. Holloway Staff Attorney megan.holloway@pharmacy.texas.gov MGH/atg Enclosures Cc: Prescription Labs, Inc. c/o Kenneth Lee Hughes, R.Ph., President 2623 Lakeside Village Drive Missouri City, Texas 77459 S:\Attorneys\PNLs 0116 - 1216\Greenpark Compounding Pharmacy\Case Prep\Greenpark Compounding Pharmacy_PNL.docx TEXAS STATE BOARD OF PHARMACY Re: Greenpark Compounding Pharmacy License #14713 INDEX TO INFORMAL CONFERENCE PACKET 1. Explanation of Disciplinary Process 2. Statement of Allegations 3. Applicable Statutes and Rules 4. Map S:\Attorneys\PNLs 0116 - 1216\Greenpark Compounding Pharmacy\Case Prep\Greenpark Compounding Pharmacy_index.docx 333 Guadalupe Street Suite 3-600 Austin, Texas 78701-3943 512-305-8000(voice) 512-305-8061(fax) www.pharmacy.texas.gov TEXAS STATE BOARD OF PHARMACY EXPLANATION OF INFORMAL CONFERENCE PROCEDURES I. Informal Conference The Informal Conference is conducted as follows: II. (A) You and/or your attorney will meet with a Board panel, including a Board Member, the Executive Director, and the Director of Enforcement. The General Counsel will serve as the Board panel’s legal counsel. (B) The General Counsel will explain the procedures of the Informal Conference. (C) The Board’s attorney (i.e. the attorney who sent the Preliminary Notice Letter) will: (1) present the allegations set forth in the Preliminary Notice Letter and the supporting documentary evidence that would be introduced in a public hearing, if scheduling a hearing is necessary; and (2) answer any questions that the Board panel may have regarding the allegations against you and/or the supporting documentary evidence. (D) Any complainant who chooses to attend the Informal Conference will be given an opportunity to speak to the Board panel. (E) You and/or your attorney will be given the opportunity to discuss any matter relating to the case and to show your compliance with the law. In this regard, the following is applicable: (1) if compliance with the law is shown, no further action is taken by the Board concerning this matter and the case is dismissed; or (2) if compliance is not shown, you are presented an opportunity to discuss informal settlement. (F) The Board panel will deliberate to make a recommendation for resolution of the case, in accordance with the discipline authorized by the Texas Pharmacy Act, such as denial of licensure, reprimand, administrative penalty, restriction, probation, suspension, revocation, or retirement. Informal Settlement - Proposed Agreed Board Order At the conclusion of the Informal Conference, you will be notified of the panel’s recommendation for resolution. You may either accept or reject the panel's recommendation for informal settlement. (A) If you reject the recommendation of the Board panel, the matter will be scheduled for a public hearing. 333 Guadalupe Street Suite 3-600 Austin, Texas 78701-3943 512-305-8000(voice) 512-305-8061(fax) www.pharmacy.texas.gov (B) If you accept the recommendation of the Board panel, the following is applicable: (1) A proposed Agreed Board Order (ABO) will be drafted and mailed to you and/or your attorney for review and approval. If you sign and return the proposed ABO, Board staff will present the proposed ABO to the Board (for approval or rejection) at its next scheduled meeting. (2) If the proposed ABO is approved by the Board, the matter is settled. (3) If the proposed ABO is rejected by the Board, the matter will be scheduled for a public hearing All proposed ABOs are considered by the Board in open meetings, except ABOs concerning pharmacists who are impaired by chemical abuse or mental or physical illness and certain ABOs involving applications for pharmacy and pharmacist licensure. (The Board considers ABOs relating to impaired pharmacists in a non-public Executive Session under the confidentiality provisions in the Texas Pharmacy Act. The Executive Director has authority to approve certain applicant ABOs according to guidelines set by the Board). III. General Considerations You should understand that: (1) It is your choice to attend an Informal Conference. (2) It is your choice to accept or reject the recommendation of the Board panel at the Informal Conference. (3) It is the decision of the Board itself whether to accept or reject any proposed resolution. (4) The Board panel has the authority only to recommend a proposed resolution; the panel may not enter an Order resolving the case. (5) You have the right to terminate the Informal Conference at any time and the right to appear in a public hearing. The results of any informal disposition (Agreed Board Order or default Order) or formal disposition (Board Order entered as a result of a public hearing) is public information. Results of informal or formal disposition will appear in the Board's newsletter and website. The only exception is an Order concerning a pharmacist impaired by chemical abuse or mental or physical illness. (6) A default Order, based upon the allegations set out in the Preliminary Notice Letter, will be entered by the Board if you do not respond to this letter either by your attendance at the Informal Conference or in writing. (7) The case will be scheduled for a public hearing if one of the following occurs:  you inform the Board in writing that you decline to schedule an Informal Conference;  you reject the recommendation of the Board panel after the Informal Conference; or  the proposed ABO is rejected by the Board. S:\Attorneys\Forms\PNLs\Pharmacies & Pharmacist Packet Forms Rev: 05/25/2012 TEXAS STATE BOARD OF PHARMACY Re: Greenpark Compounding Pharmacy License #14713 STATEMENT OF ALLEGATIONS COUNTS On or about September 4, 2015, Angelica Avila, while acting as an employee (staff pharmacist) of Greenpark Compounding Pharmacy, 4061 F Bellaire Boulevard, Houston, Texas 77025, failed to verify or incorrectly verified the correct identity of an ingredient used in compounding a batch preparation, in that lorazepam was used in the preparation of a compounded batch preparation calling for lansoprazole. The compounded batch preparation was assigned lot number 09042015@20, and was labeled 480 ml lansoprazole 3mg/ml suspension. Subsequently, three pediatric patients were dispensed prescriptions from the batch preparation, as follows: (1) On or about September 8, 2015, the pharmacy dispensed 40 ml of the preparation to patient J.N. The prescription bottle was labeled lansoprazole 3mg/ml suspension with directions to “take 1ml (3mg) by mouth every day.” The prescription was assigned prescription number 249233. (2) On or about September 8, 2015, the pharmacy dispensed 140 ml of the preparation to patient S.B. The prescription bottle was labeled lansoprazole 3mg/ml suspension with directions to “take 2.5 ml (7.5 mg) by mouth every day for 8 weeks.” The prescription was assigned prescription number 249234. (3) On or about September 10, 2015, the pharmacy dispensed 300 ml of the preparation to patient S.P. The prescription bottle was labeled 300 ml lansoprazole 3mg/ml suspension with directions to “give 2.5 ml (7.5 mg) by mouth every day.” Patient S.P. was given the medication and received emergency treatment in a hospital after experiencing adverse effects, including drowsiness, lack of coordination and irritability. The prescription was assigned prescription number 246935. On or about September 16, 2015, two samples of the compounded preparation were analyzed, and the results indicated that the samples contained lorazepam (measured at 2.38 mg/ml and 1.28 mg/ml) and did not contain lansoprazole. 333 Guadalupe Street Suite 3-600 Austin, Texas 78701-3943 512-305-8000(voice) 512-305-8061(fax) www.pharmacy.texas.gov Greenpark Compounding Pharmacy (4) License #14713 On or about September 4, 2015, Cindy Lee Rodriguez, while acting as an employee (pharmacy technician) of Greenpark Compounding Pharmacy, 4061 F Bellaire Boulevard, Houston, Texas 77025, failed to keep and maintain complete and accurate compounding records for lot number 09042015@20 previously described. Specifically, Ms. Rodriguez forged the initials “R.P.,” indicating Ranjeet Patel, a pharmacy technician, on the compounding preparation worksheet as having performed in process checks, when Mr. Patel did not do so. S:\Attorneys\PNLs 0116 - 1216\Greenpark Compounding Pharmacy\Case Prep\Greenpark Compounding Pharmacy_statement.docx TEXAS STATE BOARD OF PHARMACY Re: Greenpark Compounding Pharmacy License #14713 APPLICABLE STATUTES AND RULES A. ALLEGED VIOLATIONS The allegations summarized in the enclosed counts provide evidence of violations of the following laws and rules relating to the practice of pharmacy: Texas Pharmacy Act, TEX. OCC. CODE ANN. Title 3, Subtitle J (2015): Section 565.001. Applicant for or Holder of License to Practice Pharmacy. (a) The board may discipline an applicant for or the holder of a current or expired license to practice pharmacy if the board finds that the applicant or license holder has: (1) violated this subtitle or a board rule adopted under this subtitle; (2) engaged in unprofessional conduct as defined by board rule; ••• (12) violated any pharmacy or drug statute or rule of this state, another state, or the United States; (13) been negligent in the practice of pharmacy; ••• Section 565.002. Applicant for or Holder of Pharmacy License. (a) The board may discipline an applicant for or the holder of a pharmacy license, including a Class E pharmacy license subject to Section 565.003(b), if the board finds that the applicant or license holder has: ••• (3) violated any provision of this subtitle or any rule adopted under this subtitle or that an owner or employee of a pharmacy has violated any provision of this subtitle or any rule adopted under this subtitle; ••• (6) sold an adulterated or misbranded prescription or nonprescription drug; ••• 333 Guadalupe Street Suite 3-600 Austin, Texas 78701-3943 512-305-8000(voice) 512-305-8061(fax) www.pharmacy.texas.gov Greenpark Compounding Pharmacy License #14713 Section 568.003. Grounds for Disciplinary Action. (a) The board may take disciplinary action under Section 568.0035 against an applicant for or the holder of a current or expired pharmacy technician or pharmacy technician trainee registration if the board determines that the applicant or registrant has: (1) violated this subtitle or a rule adopted under this subtitle; ••• (7) violated the pharmacy or drug laws or rules of this state, another state, or the United States; ••• (10) engaged in negligent, unreasonable, or inappropriate conduct when working in a pharmacy; ••• Texas Pharmacy Board Rules, 22 TEX. ADMIN. CODE (2015): Section 281.7. Grounds for Discipline for a Pharmacist License. (a) For the purposes of the Act, § 565.001(a)(2), “unprofessional conduct” is defined as engaging in behavior or committing an act that fails to conform with the standards of the pharmacy profession, including, but not limited to, criminal activity or activity involving moral turpitude, dishonesty, or corruption. This conduct shall include, but not be limited to: ••• (12) dispensing controlled substances or dangerous drugs in a manner not consistent with the public health or welfare; (13) failing to practice pharmacy in an acceptable manner consistent with the public health and welfare; ••• (29) selling, purchasing, or trading, or offering to sell, purchase, or trade of: (A) misbranded prescription drugs; or ••• Section 281.8. Grounds for Discipline for a Pharmacy License. (b) ••• For the purposes of §565.002(a)(3) of the Act, it is grounds for discipline for a pharmacy license when: ••• (4) the pharmacy engages in the sale, purchase, or trade or the offer to sell, purchase, or trade of: (A) misbranded prescription drugs; or ••• 2 Greenpark Compounding Pharmacy License #14713 Section 281.9. Grounds for Discipline for a Pharmacy Technician or a Pharmacy Technician Trainee. (b) ••• For the purposes of the Act, §568.003(a) (10), “negligent, unreasonable, or inappropriate conduct” shall include, but not be limited to: ••• (3) failing to perform the duties of a pharmacy technician or pharmacy technician trainee in an acceptable manner consistent with the public health and welfare, which contributes to a prescription not being dispensed or delivered accurately; ••• Section 291.31. Definitions. The following words and terms, when used in this subchapter, shall have the following meanings, unless the context clearly indicates otherwise. (1) Accurately as prescribed—Dispensing, delivering, and/or distributing a prescription drug order: (A) to the correct patient (or agent of the patient) for whom the drug or device was prescribed; (B) with the correct drug in the correct strength, quantity, and dosage form ordered by the practitioner; and (C) with correct labeling (including directions for use) as ordered by the practitioner. Provided, however, that nothing herein shall prohibit pharmacist substitution if substitution is conducted in strict accordance with applicable laws and rules, including Chapter 562 of the Texas Pharmacy Act. ••• (15) Dispense—Preparing, packaging, compounding, or labeling for delivery a prescription drug or device in the course of professional practice to an ultimate user or his agent by or pursuant to the lawful order of a practitioner. (16) Dispensing error—An action committed by a pharmacist or other pharmacy personnel that causes the patient or patient’s agent to take possession of a dispensed prescription drug and an individual subsequently discovers that the patient has received an incorrect drug product, which includes incorrect strength, incorrect dosage form, and/or incorrect directions for use. (17) Dispensing pharmacist—The pharmacist responsible for the final check of the dispensed prescription before delivery to the patient. ••• Section 291.32. Personnel. ••• (c) Pharmacists. (1) General. ••• 3 Greenpark Compounding Pharmacy License #14713 (E) (2) All pharmacists, while on duty, shall be responsible for the legal operation of the pharmacy and for complying with all state and federal laws or rules governing the practice of pharmacy. (F) A dispensing pharmacist shall be responsible for and ensure that the drug is dispensed and delivered safely, and accurately as prescribed, unless the pharmacy’s data processing system can record the identity of each pharmacist involved in a specific portion of the dispensing processing. If the system can track the identity of each pharmacist involved in the dispensing process, each pharmacist involved in the dispensing process shall be responsible for and ensure that the portion of the process the pharmacist is performing results in the safe and accurate dispensing and delivery of the drug as prescribed. The dispensing process shall include, but not be limited to, drug regimen review and verification of accurate prescription data entry, including data entry of prescriptions placed on hold, packaging, preparation, compounding, transferring, and labeling, and performance of the final check of the dispensed prescription. An intern has the same responsibilities described in this subparagraph as a pharmacist but must perform his or her duties under the supervision of a pharmacist. Duties. Duties which may only be performed by a pharmacist are as follows: ••• (D) performing the final check of the dispensed prescription before delivery to the patient to ensure that the prescription has been dispensed accurately as prescribed; ••• Section 291.131. Pharmacies Compounding Non-Sterile Preparations. (b) ••• Definitions. In addition to the definitions for specific license classifications, the following words and terms, when used in this section, shall have the following meanings, unless the context clearly indicates otherwise. ••• (3) Compounding—The preparation, mixing, assembling, packaging, or labeling of a drug or device: (A) as the result of a practitioner’s prescription drug or medication order, based on the practitioner-patient-pharmacist relationship in the course of professional practice; (B) for administration to a patient by a practitioner as the result of a practitioner’s initiative based on the practitioner-patientpharmacist relationship in the course of professional practice; 4 Greenpark Compounding Pharmacy (C) (D) (c) (d) (e) License #14713 in anticipation of prescription drug or medication orders based on routine, regularly observed prescribing patterns; or for or as an incident to research, teaching, or chemical analysis and not for sale or dispensing, except as allowed under § 562.154 or Chapter 563 of the Occupations Code ••• Personnel. ••• (2) Pharmacists. Special requirements for non-sterile compounding. ••• (B) A pharmacist shall inspect and approve all components, drug product containers, closures, labeling, and any other materials involved in the compounding process. (C) A pharmacist shall review all compounding records for accuracy and conduct in-process and final checks to ensure that errors have not occurred in the compounding process. ••• (3) Pharmacy technicians and pharmacy technician trainees. All pharmacy technicians and pharmacy technician trainees engaged in non-sterile compounding shall: ••• (C) perform compounding duties under the direct supervision of and responsible to a pharmacist. ••• Operational Standards. ••• (8) Compounding process. ••• (E) At each step of the compounding process, the pharmacist shall ensure that components used in compounding are accurately weighed, measured, or subdivided as appropriate to conform to the formula being prepared. ••• (9) Quality Assurance. ••• (B) Finished preparation checks. The prescription drug and medication orders, written compounding procedure, preparation records, and expended materials used to make compounded nonsterile preparations shall be inspected for accuracy of correct identities and amounts of ingredients, packaging, labeling, and expected physical appearance before the non-sterile preparations are dispensed. ••• Records. ••• (2) Compounding records ••• 5 Greenpark Compounding Pharmacy (B) License #14713 Compounding records when batch compounding or compounding in anticipation of future prescription drug or medication orders. ••• (ii) Preparation work sheet. The preparation work sheet for each batch of preparations shall document the following: ••• (VIII) name, initials, or electronic signature of the person(s) involved in the preparation; ••• Section 295.3. Responsibility of Pharmacist. (b) ••• All pharmacists while on duty, shall be responsible for complying with all state and federal laws and rules governing the practice of pharmacy. Texas Food, Drug, and Cosmetic Act, TEX. HEALTH & SAFETY CODE ANN. (2015): Section 431.021. Prohibited Acts. The following acts and the causing of the following acts within this state are unlawful and prohibited: (a) the introduction or delivery for introduction into commerce of any food, drug, device, or cosmetic that is adulterated or misbranded; (b) the adulteration or misbranding of any food, drug, device, or cosmetic in commerce; ••• (r) dispensing or causing to be dispensed a different drug in place of the drug ordered or prescribed without the express permission in each case of the person ordering or prescribing; ••• Section 431.112. Misbranded Drug or Device. A drug or device shall be deemed to be misbranded: (a) (1) if its labeling is false or misleading in any particular; or ••• B. PROCEDURAL Texas Pharmacy Act, TEX. OCC. CODE ANN. Title 3, Subtitle J (2015): Section 565.056. Informal Proceedings. (a) The board by rule shall adopt a procedure governing: (1) informal disposition of a contested case under Chapter 2001, Government Code; and 6 Greenpark Compounding Pharmacy (2) License #14713 an informal proceeding held in compliance with Chapter 2001, Government Code. (b) A rule adopted under this section must: (1) provide the complainant, if applicable and permitted by law, and the license holder an opportunity to be heard; (2) require the presence of an attorney to advise the board or a board employee; and (3) if an informal meeting will be held, require notice of the time and place of the informal meeting to be given to the license holder not later than the 45th day before the date the informal meeting is held. (c) The attorney must be a member of the board’s legal staff, if the board has a legal staff. If the board does not have a legal staff, the attorney must be an employee of the office of the attorney general. (d) The notice required by Subsection (b)(3) must be accompanied by a written statement of the nature of the allegations against the license holder and the information the board intends to use at the informal meeting. If the board does not provide the statement or information when the notice is provided, the license holder may use that failure as grounds for rescheduling the informal meeting. The license holder must provide to the board the license holder's rebuttal not later than the 15th day before the date of the meeting in order for that information to be considered at the meeting. (e) On request by a license holder under review, the board shall make a recording of the informal meeting. The recording is a part of the investigative file and may not be released to a third party unless authorized under this subtitle. The board may charge the license holder a fee to cover the cost of recording the meeting. The board shall provide a copy of the recording to the license holder on the license holder's request. Texas Pharmacy Board Rules, 22 TEX. ADMIN. CODE (2016): Section 281.22(a), (b)(1)-(4), (c), (d), (h)-(k). Informal Disposition of a Contested Case. (a) Unless precluded by law, informal disposition may be made of any contested case by stipulation, agreed settlement, consent order, default, or dismissal. (b) Prior to the imposition of disciplinary sanction(s) against a respondent, the board shall provide the respondent with written notice of the matters asserted, including: (1) a statement of the legal authority, jurisdiction, and alleged conduct under which the enforcement action is based, with a reference to the particular section(s) of the statutes and rules involved; (2) information the board staff intends to use at an informal conference; 7 Greenpark Compounding Pharmacy License #14713 (3) (c) (d) (h) (i) an offer for the respondent to attend an informal conference at a specified time and place and show compliance with all requirements of law, in accordance with §2001.054(c) of the Administrative Procedure Act; and (4) a statement that the respondent has an opportunity for a hearing before the State Office of Administrative Hearings on the allegations; ••• The respondent will be provided the opportunity to appear at an informal conference prior to a hearing at the State Office of Administrative Hearings. The notice of the time and place of the informal conference, along with the written notice required in subsection (b) of this section, will be given to the respondent at least 45 days before the date of the informal conference. If such notice is not timely provided, the respondent may reschedule the informal conference. The respondent shall respond either by personal appearance at the informal conference, or by providing a rebuttal in writing no later than 15 days before the date of the informal conference. If the respondent chooses to respond in writing, the response shall admit or deny each of the allegations. If the respondent intends to deny only a part of an allegation, the respondent shall specify so much of it is true and shall deny only the remainder. The response shall also include any other matter, whether of law or fact, upon which the respondent intends to rely upon as a defense. If the respondent fails to respond to the notice specified in subsection (b) of this section, the matter will be considered as a default case and the respondent will be deemed to have: (1) admitted all the factual allegations in the notice specified in subsection (b) of this section; (2) waived the opportunity to show compliance with the law; (3) waived notice of a hearing; (4) waived the opportunity for a hearing on the allegations; and (5) waived objection to the recommended sanctions made at the informal conference. ••• Informal conferences shall be attended by the executive director/secretary or designated representative, legal counsel of the agency or an attorney employed by the office of the attorney general, and other representative(s) of the agency as the executive director/secretary and legal counsel may deem necessary for proper conduct of the conference. The respondent and/or the respondent's authorized representative(s) may attend the informal conference and shall be provided an opportunity to be heard. All communications from the respondent shall be directed to the legal counsel of the agency. In any case where charges are based upon information provided by a person (complainant) who filed a complaint with the board, the complainant may attend the informal conference, unless the proceedings are confidential under §564.002 and §564.003 of the Texas Pharmacy Act or other applicable law. A complainant who chooses to attend an informal conference shall be provided an opportunity to be heard with regard to charges based upon the information provided by the complainant. Nothing herein requires a complainant to attend an informal conference. 8 Greenpark Compounding Pharmacy License #14713 (j) Informal conferences shall not be deemed meetings of the board, and no formal record of the proceedings at such conferences shall be made or maintained unless the respondent requests such a recording in writing at least 15 days before the informal conference. Board staff will arrange for the presence of a court reporter to make the recording. The respondent shall be responsible for the cost of the recording. The recording will be part of the board's investigative file and will not be released to a third party unless authorized under §565.055 of the Act. The board will provide a copy of the recording to the respondent upon request. (k) Any proposed consent order shall be presented to the board in open meeting for its review. At the conclusion of its review, the board shall approve or disapprove the proposed consent order. Should the board approve the proposed consent order, the appropriate notation shall be made in minutes of the board and the proposed consent order shall be entered as an official action of the board. Should the board disapprove the proposed consent order, the matter shall be scheduled for public hearing. If the Texas State Board of Pharmacy finds that grounds exist for discipline, the Board may assess penalties pursuant to Section 565.051 of the Texas Pharmacy Act, TEX. OCC. CODE ANN. Title 3, Subtitle J (2015). Section 565.051. Discipline Authorized. On a determination that a ground for discipline exists under Subchapter A, or that a violation of this subtitle or a rule adopted under this subtitle has been committed by a license holder or applicant for a license or renewal of a license, the board may: (1) suspend the person’s license; (2) revoke the person’s license; (3) restrict the person’s license to prohibit the person from performing certain acts or from practicing pharmacy or operating a pharmacy in a particular manner for a term and under conditions determined by the board; (4) impose an administrative penalty under Chapter 566; (5) refuse to issue or renew the person’s license; (6) place the offender’s license on probation and supervision by the board for a period determined by the board and impose a requirement that the license holder: (A) report regularly to the board on matters that are the basis of the probation; (B) limit practice to the areas prescribed by the board; (C) continue or review professional education until the license holder attains a degree of skill satisfactory to the board in each area that is the basis of the probation; or (D) pay the board a probation fee to defray the costs of monitoring the license holder during the period of probation; (7) reprimand the person; (8) retire the person’s license as provided by board rule; or (9) impose more than one of the sanctions listed in this subsection. 9 Greenpark Compounding Pharmacy C. License #14713 DEFAULT Texas Pharmacy Board Rules, 22 TEX. ADMIN. CODE (2016): Section 281.22(b)(5), (e), (f) and (g). Informal Disposition of a Contested Case. (b) (e) (f) ••• Prior to the imposition of disciplinary sanction(s) against a respondent, the board shall provide the respondent with written notice of the matters asserted, including: ••• (5) the following statement in capital letters in 12 point boldface type: FAILURE TO RESPOND TO THE ALLEGATIONS, BY EITHER PERSONAL APPEARANCE AT THE INFORMAL CONFERENCE OR IN WRITING, WILL RESULT IN THE ALLEGATIONS BEING ADMITTED AS TRUE AND THE RECOMMENDED SANCTION MADE AT THE INFORMAL CONFERENCE BEING GRANTED BY DEFAULT. The notice shall be served by delivering a copy to the respondent in person, by courier receipted delivery, by first class mail, or by certified or registered mail, return receipt requested to the respondent's last known address of record as shown by agency records. ••• Default orders. (1) The informal conference panel may recommend that the board enter a default order, based upon the allegations set out in the notice specified in subsection (b) of this section, adopting the recommended sanctions made at the informal conference. Upon consideration of the case, the board may enter a default order under §2001.056 of the Administrative Procedure Act or direct that the case be set for a hearing at the State Office of Administrative Hearings. (2) For a contested case before the State Office of Administrative Hearings, the judge may announce a default upon receiving the required showing of proof to support a default, and then recess the hearing, issue an order dismissing the case from the docket of the State Office of Administrative Hearings, and return the file to the board for informal disposition on a default basis in accordance with §2001.056 of the Administrative Procedure Act. The board may then enter a default order or direct the case back to the State Office of Administrative Hearings. Any default judgment granted under this section will be entered on the basis of the factual allegations in the notice specified in subsection (b) of this section, and upon proof of proper notice to the respondent's address of record. For purposes of this section, proper notice means notice sufficient to meet the provisions of §2001.054 of the Administrative Procedure Act and §281.30 of this title (relating to Pleadings and Notice in a Contested Case). 10 Greenpark Compounding Pharmacy (g) License #14713 A motion for rehearing which requests that the board vacate its default order under this section shall be granted if the motion presents convincing evidence that the failure to respond to the notice specified in subsection (b) of this section was not intentional or the result of conscious indifference, but due to accident or mistake, provided that the respondent has a meritorious defense to the factual allegations contained in the notice specified in subsection (b) of this section and the granting thereof will not result in delay or injury to the public or the board. S:\Attorneys\PNLs 0116 - 1216\Greenpark Compounding Pharmacy\Case Prep\Greenpark Compounding Pharmacy_laws.docx 11 University of Texas Downtown Austin 15th St. Not to Scale Capitol Guadalupe N Lavaca I.H. 35 Congress 6th St. Texas State Board of Pharmacy W.P. Hobby Jr., State Office Bldg. 333 Guadalupe, Suite 3-600 (Tower 3 – 6th Floor) Austin, Texas 512/305-8000 4th St. 3rd St. Colorado River W.P. Hobby Jr., State Office Building: The entrance to the W.P. Hobby Jr. State Office Building is on Guadalupe between 3rd and 4th Street. Security Procedures All visitors to the William P. Hobby Building will be required check in at the Security Guard Station to sign a log and receive a visitor’s pass. Any individual attending an Informal Conference will need to inform the building’s security officer that he/she will be attending an Informal Conference with the Texas State Board of Pharmacy, and provide the officer with a government-issued photo ID. Please allow additional time to go through the security process. Failure to provide a government-issued photo ID may result in delaying an individual’s arrival to the Informal Conference. Parking: Limited visitor parking is located in the open lot immediately to the west of the facility.