REPORT 1 OF THE COUNCIL ON SCIENTIFIC AFFAIRS (A-01)
Pharmaceutical Expiration Dates
(Reference Committee E)
EXECUTIVE SUMMARY
Objective. To evaluate the issue of drug expiration dates and the clinical and fiscal consequences
of setting such dates.
Methods. Letters sent to the Food and Drug Administration (FDA), the United States
Pharmacopeia (USP), and the Pharmaceutical Research and Manufacturers of America (PhRMA)
elicited information on how expiration dates are determined for pharmaceutical products, whether
the actual shelf life of many drug products exceeds the posted expiration date, and whether data
exist on the clinical or fiscal impact of expiration dates. In addition, literature searches were
conducted in the MEDLINE and HealthSTAR databases, and the Web sites of the FDA, USP,
PhRMA and Defenselink were searched for information.
Data Synthesis. Pharmaceutical manufacturers are required to place an expiration date on the
container/label of a drug product as a prerequisite to marketing the product in the United States.
Expiration dates are determined by stability assessments that follow scientifically based
procedures that have been harmonized by the International Conference on Harmonization of
Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) guidance.
Expiration dates only apply when the drug product is stored under defined conditions. For most
U.S. drug products, expiration dating ranges from 12 to 60 months from the time of original
manufacture.
Based on the Shelf-Life Extension Program (SLEP), a stability testing program the FDA has
administered for the United States military, the actual shelf lives of some drug products may be
longer than their labeled expiration dates. The Department of Defense has reportedly saved
substantial money as the result of extending pharmaceutical expiration dates.
Currently, there are no reliable data on the clinical or fiscal impact of pharmaceutical expiration
dates in the civilian environment. PhRMA has informed our American Medical Association
(AMA) that lengthening expiration dating for drug products in the civilian environment would
not provide the same economic benefits that SLEP has provided to the military; that additional
stability testing would add substantial costs to drug development and manufacturing; that most
innovator drug products that are close to expiration can be returned to the manufacturer for credit;
and that, whereas the military stores its drug products under optimal conditions, this would be far
less likely in the civilian environment.
Once the manufacturer’s container is opened and drug product is transferred to another container
for dispensing or repackaging, the expiration date no longer applies. The USP has developed
recommendations for pharmacists to place a “beyond-use” date on the label of the new container.
There is little scientific basis for “beyond-use” dates. However, the American Pharmaceutical
Association (APhA) encourages, and 17 states require, that pharmacists place a “beyond-use”
date on the label of the prescription container that is dispensed to the patient.
Conclusions. The Council on Scientific Affairs recommends that AMA Policy H-115.983 (AMA
Policy Database) be modified.
1
2Action of the AMA House of Delegates 2001 Annual Meeting: Council on Scientific
3Affairs Report 1 Recommendation Adopted as Amended and the Remainder of the Report
4filed.

 1
REPORT OF THE COUNCIL ON SCIENTIFIC AFFAIRS
CSA Report 1-A-01
Subject:

Pharmaceutical Expiration Dates

Presented by:

Michael A. Williams, MD, Chair

Referred to:

Reference Committee E
(Richard R. Johnston, MD, Chair)

-----------------------------------------------------------------------------------------------------------------2At the 2000 Annual Meeting, the House of Delegates adopted amended Resolution 527,
3Pharmaceutical Expiration Dates. This resolution asks our American Medical Association
4(AMA) to urge that the Food and Drug Administration (FDA), the United States Pharmacopeia
5(USP), and the pharmaceutical industry evaluate the issue of drug expiration dates, the clinical
6consequences of setting such dates, and the fiscal impact. Furthermore, the Council on Scientific
7Affairs (CSA) was asked to monitor this activity and report back to the House of Delegates at the
82001 Annual Meeting.
9
10Methods
11
12Subsequent to the adoption of amended Resolution 527, our AMA sent letters to the FDA, the
13USP, and the Pharmaceutical Research and Manufacturers of America (PhRMA), the trade
14association that represents the research-based pharmaceutical industry. These letters raised the
15question of whether the actual “shelf life” of many pharmaceutical products might be
16considerably longer than the expiration date that appears on the manufacturer’s container, which
17could result in unnecessary waste, higher pharmaceutical costs, and possibly reduced access to
18necessary drugs for some patients. Specifically, the letters asked each organization to provide
19relevant information on how expiration dates are determined for pharmaceutical products,
20whether the actual shelf life of many products is greater than the posted expiration date, and if
21there were any data on either the clinical or fiscal impact of expiration dates at this time.
22
23Literature searches were conducted in the MEDLINE and HealthSTAR databases for English24language articles published between 1966 (or 1993 for HealthSTAR) and January 2001 using the
25terms “expiration date” and “drug.” The MEDLINE database also was searched using the terms
26"dosage forms,” “drug stability,” “chemistry, pharmaceutical,” “drug storage,” and
27“pharmaceutical preparations.” Additionally, the Web sites of the FDA, USP, PhRMA and
28Defenselink were searched for information.
29
30Scope of Report
31
32Based on the responses from the FDA, the USP, and PhRMA, as well as the limited published
33research on this subject, this report is intended to inform the House of Delegates about the
34following:
35
36
 How expiration dates are determined for prescription drug products;
1
2Action of the AMA House of Delegates 2001 Annual Meeting: Council on Scientific
3Affairs Report 1 Recommendation Adopted as Amended and the Remainder of the Report
4filed.

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CSA Rep. 1 – A-01 — page 3

1
 Whether the actual shelf lives of many drug products are greater than their labeled
2
expiration dates;
3
 Whether there are any data on the clinical or fiscal impact of expiration dates; and
4
 How expiration dates differ from “beyond-use” dates that appear on prescription drug
5
containers dispensed to patients by pharmacies.
6
7How are expiration dates determined for prescription drug products?
8
9Under Section 501(a)(2)(B) of the federal Food, Drug and Cosmetic Act (FDCA), manufacturers
10of prescription drug products must establish controls for the manufacture, processing, packing,
11and holding of drug products to ensure their safety, identity, strength, quality, and purity.
12Requirements for these controls, also known as current good manufacturing practices (CGMPs),
13are established and monitored by the FDA.
14
15As part of the CGMP regulations, the FDA requires that drug products bear an expiration date
16determined by appropriate stability testing (21 CFR 211.137 and 211.166). The FDA defines an
17expiration date as “the date placed on the container/labels of a drug product designating the time
18during which a batch of the product is expected to remain within the approved shelf life
19specifications if stored under defined conditions, and after which it may not be used.” 1
20
21Part of the technical documentation that must be submitted by a manufacturer to the FDA in a
22New Drug Application (NDA) is a stability assessment of both the new drug substance and the
23new drug product (the dosage form, including the new [active] drug substance and [inactive]
24excipients, in the final immediate packaging intended for marketing). The stability assessment
25follows scientifically based technical procedures that have been agreed to by the United States,
26the European Union, and Japan under the International Conference on Harmonization of
27Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The most
28recent guidance on this subject is entitled, “Draft Revised Guidance on Q1A(R) Stability Testing
29of New Drug Substances and Products,” which was published in the Federal Register on April 21,
302000.1
31
32The purpose of stability testing is to provide evidence on how the quality of a drug substance or
33drug product varies with time under the influence of a variety of environmental factors, such as
34temperature, humidity, and light, and enables recommended storage conditions, retest periods,
35and shelf lives (expiration dates) to be established. Stability information should cover, as
36appropriate, the physical, chemical, biological, and microbiological attributes of the drug
37substance and the drug product.1
38
39The stability assessment starts with stress testing of the new drug substance. This establishes the
40inherent stability characteristics of the molecule, such as degradation pathways, and leads to
41identification of degradation products and, therefore, supports the suitability of proposed
42analytical procedures. The nature of these studies depends on the individual drug substance, but
43usually the effects of elevated temperature and humidity, oxidation and photolysis, and hydrolysis
44over a wide range of pH values (when the drug substance is in solution or suspension) are
45evaluated.1
46
47The new drug substance and, subsequently the new drug product, are then subjected to formal
48stability testing over time under rigorously defined storage conditions of temperature and
49humidity. Initially, at least three batches of the drug substance must be subjected to stability
50testing. All three batches should be manufactured to a minimum of pilot scale and the synthetic

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CSA Rep. 1 – A-01 — page 4

1route and method of manufacture should simulate the final process to be used on a full
2manufacturing scale. Similarly, at least three batches of the new drug product, preferably from
3different batches of drug substance, also must be subjected to stability testing. At least two of the
4three batches should be manufactured to a minimum of pilot scale and the manufacturing process
5should simulate that to be applied to full production batches and, furthermore, should provide
6product of the same quality and meet the same specifications as that intended for marketing.
7Stability testing should be conducted on the dosage form stored in the packaging proposed for
8marketing.1
9
10Typically, both the new drug substance and the new drug product are subjected to long-term
11stability testing (storage conditions, 25 oC +/- 2 oC/60% RH +/- 5% RH) for a minimum of 12
12months and also to accelerated stability testing (storage conditions, 40 oC +/- 2 oC/75% RH +/135% RH) for six months. In some cases, intermediate stability testing also may be necessary. The
14storage condition at which the long-term testing is conducted will be reflected in the labeling and
15expiration date. Data from the accelerated storage condition may be used to evaluate the impact
16of short-term excursions outside the label storage conditions (such as might occur during
17shipping).1
18
19According to the FDA, expiration dates for prescription drugs (and over-the-counter drugs) that
20are subject to premarket approval requirements generally are based on the amount of real-time
21data available at the time of FDA approval of the NDA. However, the expiration date may be
22extended a maximum of six months, provided the accelerated stability data submitted with the
23NDA are acceptable, and such an extension must be verified with actual real-time data at a later
24date.2 According to PhRMA, the initial expiration dating for prescription drug products usually
25falls between 18 and 24 months.3
26
27Since stability data submitted with an NDA commonly are based on pilot scale batches of drug
28product, the expiration date granted at the time of FDA approval is generally considered to be a
29tentative one. The FDA expects that stability study data from the first three production batches
30will be submitted in annual reports from the drug’s manufacturer. The expiration date may be
31extended by the manufacturer with notification to the FDA in an annual report based on data from
32these batches; the FDA emphasizes that this period applies to drug product stored under
33controlled conditions as discussed above. The expiration date may be extended as many times as
34requested by the manufacturer as long as adequate data are provided. 2 Because manufacturers
35can extend expiration dating periods based on satisfactory long-term stability data on full
36production batches accumulated years after the original approval, mature products tend to have
37longer expiration dating periods than those products that have been on the market for a short
38period of time. It should be emphasized, however, that extension of drug product expiration
39dating periods is strictly voluntary for pharmaceutical manufacturers. 4
40
41The amount of stability testing required for generic drug products subject to Abbreviated New
42Drug Applications (ANDAs) depends on the availability of significant information and
43experience with the stability profile of the innovator product and on the complexity of the drug
44product/dosage form. For “simple dosage forms,” the FDA typically will accept three months of
45accelerated stability testing for one batch (pilot scale) to support a tentative expiration dating
46period of 24 months.3,5
47
48According to PhRMA, marketed prescription drug products in the United States have expiration
49dating ranging from 12 months to up to 60 months from the time of original manufacture.
50PhRMA is unaware of expiration dating for drug products beyond 60 months. 3

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CSA Rep. 1 – A-01 — page 5

1Are the actual shelf lives of many prescription drug products greater than their labeled expiration
2dates?
3
4The FDA defines shelf life as “the time interval that a drug product is expected to remain within
5the approved shelf life specification provided that it is stored under conditions defined on the
6label in the proposed containers and closures.”1 Using this definition, it appears that the actual
7shelf lives of some drug products are greater than their labeled expiration dates on
8containers/packages. The best evidence to support this comes from the Shelf-Life Extension
9Program (SLEP).6
10
11In 1985, the United States Air Force was faced with a large (war reserve) stockpile of drugs that
12were approaching their expiration dates. The Air Force asked the FDA if it could determine if the
13drugs were safe and potent beyond the expiration dates set by the manufacturers. Since 1986, the
14FDA has administered SLEP for the United States military. According to the FDA, this is an
15internal program for conducting real-time and accelerated stability tests for drug products based
16on the same procedures that are outlined in the NDAs and the United States Pharmacopeia and
17National Formulary (USP 24/NF 19) (official January 1, 2000).2 The SLEP program only applies
18to “stockpiled” drugs and not to other prescription (and over-the-counter) drugs that the military
19purchases each year. Also, every batch of a to-be-stockpiled drug product purchased by the
20military is tested and tracked in order to extend the expiration date for that batch. 4
21
22To date, the SLEP program has evaluated and tested 312 drug products to determine if specific
23drugs maintained their stability profiles past their labeled expiration dates. Many of the drug
24products tested did maintain their stability profiles well past their expiration date, up to as much
25as an additional 107 months. However, not all of the tested products maintained their stability
26profiles past the labeled expiration dates. Furthermore, certain lots of some drug products did not
27maintain their stability profiles past the expiration date, while other lots of the same drug product
28did. The reason for this disparity between lots of single drug products is not always evident. No
29other aspects of drug product safety and effectiveness are evaluated and tested under SLEP. 2
30
31It is imperative to note that the military stores these drugs under optimal conditions, either in
32carefully monitored controlled room temperature warehouses or, when appropriate, in
33refrigeration devices.6 However, it is unclear whether SLEP would have applicability to the
34civilian environment. The actual shelf life of a drug product depends on the conditions under
35which it is stored, among other factors. A drug product stored in an unopened container under
36recommended conditions of temperature, relative humidity, and light likely will have a longer
37shelf life than the same drug product stored in an opened container under less than ideal
38conditions. Thus, while pharmaceutical manufacturers could probably get longer expiration
39dating for some drug products by extending stability testing for longer periods of time, once the
40drug product leaves the domain of the manufacturer, variable storage conditions (e.g., in
41pharmacies and especially in patients’ homes) could negatively impact product stability. In its
42response to the AMA, PhRMA emphasized these important differences between the military and
43civilian environments and its potential impact on public safety. 3

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CSA Rep. 1 – A-01 — page 6

1Are there data on the clinical and fiscal impact of pharmaceutical expiration dates?
2
3The FDA and PhRMA were unaware of any comprehensive studies that addressed the clinical
4impact of pharmaceutical expiration dates and no such studies were found in the peer reviewed
5scientific literature.2,3
6
7It is important to emphasize that the FDA, USP, PhRMA, and various pharmacy organizations
8recommend that drug products not be used after their expiration dates. 1,7,8 This also is the current
9policy of our AMA (Policy H-115.983, AMA Policy Database). Because the potency and other
10quality attributes of a drug product cannot be reliably predicted after its expiration date, there is
11the potential for a suboptimal therapeutic response or some other safety problem.
12
13Reliable data, available in the public domain, on the fiscal impact of expiration dates also appear
14to be very limited. The CSA did not identify any comprehensive studies in its literature searches.
15Also, the FDA and PhRMA were unaware of any comprehensive studies that addressed this issue.
16The FDA noted that it lacks the resources to pursue such studies. 2,3
17
18News media articles on SLEP report that, on a cost-benefit basis, the Department of Defense has
19saved substantial amounts of money on drug expenses for a relatively small investment. 6,8
20According to an article in The Wall Street Journal, the military claims it spent $3.9 million on
21stability testing and saved $263.4 million on drug expenses from 1993 through 1998. 8 In its
22article, The Wall Street Journal suggests that similar savings could be achieved for consumers in
23the civilian environment, but that pharmaceutical manufacturers deliberately put shorter
24expiration dates on their drug products for marketing, rather than scientific, reasons. 8 However,
25the author of this article did concede that it is not known how much of the $120 billion-plus spent
26annually in the United States on prescription and over-the-counter medicines goes to replace
27those that have expired.8
28
29In its response to the AMA, PhRMA vigorously disputed the assertions made in The Wall Street
30Journal article. PhRMA emphasized a number of points in its letter. First, PhRMA argued that
31the development of stability data to support the original or an extended expiration dating period
32for a given lot of drug product is costly and time consuming. This cost is added to an already
33expensive drug development and manufacturing process and ultimately has to be passed on to
34patients. PhRMA also emphasized that most innovator drug products in the distribution stream
35are subject to take-back-for-credit arrangements (within about six months of remaining shelf life)
36for “nearly expired” drug products. Pharmacies can take advantage of these return arrangements
37either directly with the manufacturer or through a distributor/wholesaler. Finally, PhRMA argues
38that the consumer market lacks the military’s logistical capability to properly store drug products
39for prolonged periods of time. PhRMA believes this poses potential problems of reduced efficacy
40and safety for patients. As noted in the above discussion of SLEP, the military stores these drug
41products under optimal conditions. However, in the civilian environment, this often is not
42necessarily the case. For example, hospitals may repackage bulk drug product into unit dose
43containers, retail pharmacies usually transfer drug product from a large stock bottle to a small
44prescription container that is given to the patient, and patients are known to store their
45prescription drugs in bathrooms where storage conditions are far from optimal. 3
46
47PhRMA and the FDA also noted the important differences between the needs and operations of
48the military when compared to the private sector. While the military stockpiles drugs for
49disasters, the private sector generally prefers a high turnover rate of stock to minimize inventories
50and the capital tied up with it.3,4
2

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CSA Rep. 1 – A-01 — page 7

1Based on the limited information available, it remains unclear whether lengthier expiration dates
2on pharmaceuticals would ultimately lower the cost of drug products for patients.
3
4How do expiration dates differ from “beyond-use” dates?
5
6As discussed above, pharmaceutical expiration dates are placed on containers/labels of
7manufacturers’ drug products. Expiration dates are determined by stability assessments that
8follow scientifically based technical procedures that have been harmonized under ICH guidance.
9Expiration dates only apply when the drug product is stored in the manufacturer’s original,
10unopened container under defined conditions. The FDA approves the expiration date for a drug
11product and, the USP 24/NF 19 requires that the label of an official drug product bear an
12expiration date.
13
14A “beyond-use” date is different from an expiration date. By removing a drug product from the
15manufacturer’s marketed container or bulk dosage container and placing the drug product in a
16different container for dispensing to a patient or for repackaging (e.g., into unit dose packages for
17further dispensing in a hospital), pharmacists may be altering the expiration date. In such
18instances, the USP has developed recommendations to place a “beyond-use” date on the label of
19the new container, as follows:
20
21
The beyond-use date placed on the label shall be no later than the expiration date
22
on the manufacturer’s container. The beyond-use date is a date after which an
23
article [drug product] must not be used. Based on the information supplied by
24
the manufacturer, the dispenser shall place on the label of the prescription
25
container a suitable beyond-use date to limit the patient’s use of the article.
26
27
For articles requiring constitution prior to use, a suitable beyond-use date for the
28
constituted product shall be identified in the labeling.
29
30
For all other dosage forms, in determining an appropriate period of time during
31
which a prescription drug may be retained by a patient after its dispensing, the
32
dispenser shall take into account, in addition to any other relevant factors, the
33
nature of the drug; the container in which it was packaged by the manufacturer
34
and the expiration date thereon; the characteristics of the patient’s container, if
35
the article is repackaged for dispensing; the expected storage conditions to which
36
the article may be exposed; any unusual storage conditions to which the article
37
may be exposed; and the expected length of time of the course of therapy. The
38
dispenser shall, on taking into account the foregoing, place on the label of a
39
multiple-unit container a suitable beyond-use date to limit the patient’s use of the
40
article. Unless otherwise specified in the individual monograph, or in the
41
absence of stability data to the contrary, such a beyond-use date shall be no later
42
than (a) the expiration date on the manufacturer’s container, or (b) one year from
43
the date the drug is dispensed, whichever is earlier. For nonsterile solid and
44
liquid dosage forms that are packaged in single-unit and unit-dose containers, the
45
beyond-use date shall be one year or less, unless stability data or the

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CSA Rep. 1 – A-01 — page 8

1
manufacturer’s labeling indicate otherwise. * For all other types of nonsterile
2
dosage forms, the beyond-use date is one year or the time remaining of the
3
expiration date.
4
5
The repackager must maintain the repackaging facility at a temperature, such that
6
the mean kinetic temperature is not greater than 25 o. The repackaged dosage
7
forms are similarly stored. The plastic material used in repackaging must afford
8
better protection than polyvinyl chloride, which does not provide adequate
9
protection against moisture permeation.7
10
11Unlike the substantial, scientifically derived stability data that determine an expiration date, there
12is little scientific basis for “beyond-use” dating. However, the recommendations of the USP on
13“beyond-use” dates generally are well accepted within the pharmacy community. The American
14Pharmaceutical Association (APhA) encourages, and 17 states require by either law or regulation,
15that pharmacists place a “beyond-use” date on the label of the prescription container that is
16dispensed to the patient.8,9 Current AMA policy (H-115.983) also recommends that pharmacists
17place a “beyond-use” date on the labeling of all prescription medications dispensed to patients
18and, that the “beyond-use” date be based on USP recommendations.
19
20Summary
21
22Pharmaceutical manufacturers are required by federal law and regulation to place an expiration
23date on the container/label of a drug product as a prerequisite to marketing the product in the
24United States. Expiration dates are determined by stability assessments that follow scientifically
25based technical procedures that have been harmonized under ICH guidance. Expiration dates
26only apply when the drug product is stored in the manufacturer’s original, unopened container
27under defined conditions. For most drug products in the United States, expiration dating ranges
28from 12 months to up to 60 months from the time of original manufacture.
29
30Based on SLEP, a stability testing program that the FDA has administered for the United States
31military, it appears that the actual shelf lives of some drug products are longer than their labeled
32expiration dates. Furthermore, it has been reported that the Department of Defense has saved
33substantial amounts of money on drug expenses as the result of extending pharmaceutical
34expiration dates.
35
36Currently, there essentially are no reliable data on the clinical or fiscal impact of pharmaceutical
37expiration dates in the civilian environment. PhRMA, the trade association representing the
38research-based pharmaceutical industry, has informed our AMA that lengthening expiration
39dating for drug products in the civilian environment would not provide the same economic
40benefits that SLEP has provided to the military. PhRMA contends that additional stability testing
41would add substantial costs to drug development and manufacturing. Furthermore, PhRMA notes
42that most innovator drug products that are close to expiration can be returned to the manufacturer
43for credit. Finally, PhRMA argues that, whereas the military stores its drug products under
44optimal conditions, this would be far less likely in the civilian environment. PhRMA believes
45this poses potential problems of reduced efficacy and safety for patients.
2* The FDA commented that the USP’s “beyond-use” dating recommendations do not apply to drug products
3repackaged into unit dose containers by manufacturers and commercial repackagers. For solid and liquid
4oral dosage forms, FDA’s Compliance Policy Guide 7132.b11 applies, and it allows repackagers to assign
5up to 25% of the remaining expiry on the manufacturer’s bulk container, not to exceed six months, to the
6repackaged unit.4
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CSA Rep. 1 – A-01 — page 9

1Once the manufacturer’s container is opened and drug product is transferred to another container
2for dispensing or repackaging, the expiration date no longer applies. The USP has developed
3recommendations for pharmacists to place a “beyond-use” date on the label of the new container.
4The “beyond-use” date can be no longer than the manufacturer’s expiration date and often may be
5shorter, i.e., one year. Unlike expiration dates, there is little scientific basis for “beyond-use”
6dates. However, the APhA encourages, and 17 states require, that pharmacists place a “beyond7use” date on the label of the prescription container that is dispensed to the patient. Current AMA
8policy (H-115.983) also recommends that pharmacists place a “beyond-use” date on labels of
9prescription containers dispensed to patients and, that the “beyond-use” date be based on the
10USP’s recommendations.
11
12RECOMMENDATION
13
14The Council on Scientific Affairs recommends that AMA Policy H-115.983 be modified as
15follows and that the remainder of this report be filed.
16
17H-115.983 Expiration Dates and Beyond-Use Dates of Prescription Drugs Products
18
19
Our AMA: (1) supports the inclusion of expiration dates on the containers/labels of
20
prescription drug products and recommends that expiration dates be determined by
21
pharmaceutical manufacturers using scientifically based stability testing with subsequent
22
approval by the Food and Drug Administration (FDA); (2) urges the pharmaceutical
23
industry, in collaboration with purchasers, the FDA, and the United States Pharmacopeia
24
(USP), to determine whether lengthening of expiration dates will provide clinical and/or
25
economic benefits or risks for patients and, if this is the case, to conduct longer stability
26
testing on their drug products; (3) (1) recommends that pharmacists place a beyond-use
27
date on the labeling of all prescription medications dispensed to patients, and that the
28
beyond-use date be based on the recommendations in the most recent edition of the
29
United States Pharmacopeia and National Formulary (currently USP 24-NF 19) (official
30
January 1, 2000) (USP 23-NF 18) (official January 1, 1995); and (4) (2) encourages the
31
United States Pharmacopeial Convention, Inc., in collaboration with pharmaceutical
32
manufacturers, pharmacy organizations, and the FDA Food and Drug Administration, to
33
continue to explore the development of appropriate stability tests for the determination of
34
more scientifically sound beyond-use dates for repackaged products. (3) urges that the
35
FDA, United States Pharmacopeia, and the pharmaceutical industry evaluate the issue of
36
drug expiration dates, the clinical consequences of setting such dates, and the fiscal
37
impact. (Modify Current HOD Policy)

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CSA Rep. 1 – A-01 — page 10
References
1. International Conference on Harmonization; Draft Revised Guidance on Q1A(R) Stability
Testing of New Drug Substances and Products. Federal Register. April 21, 2000;
65(78):21446-21453.
2. Letter from Janet Woodcock, MD, Director, Center for Drug Evaluation and Research, Food
and Drug Administration. December 15, 2000.
3. Letter from Alan F. Holmer, President, Pharmaceutical Research and Manufacturers of
America. November 17, 2000.
4. Letter from Jeffrey E. Shuren, MD, JD, Food and Drug Administration. March 28, 2001.
5. [Draft] Guidance for Industry; Stability Testing of Drug Substances and Drug Products. Food
and Drug Administration. June 1998 Available at:
http://www.fda.gov/cder/guidance/1707dft.pdf.
6. Garamone J. Program extends drug shelf-life. American Forces Press Service. March 29,
2000 Available at: http://www.defenselink.mil/news/Mar2000/n03292000_20003292.html.
7. Supplement 1 to The United States Pharmacopeia, 24th Rev., and the National Formulary, 19th
Rev. (USP 24/NF 19). Rockville, MD: The United States Pharmacopeial Convention;
1999:2589-2590.
8. Cohen LP. Many medicines prove potent for years past their expiration dates. The Wall
Street Journal. March 28, 2000.
9. Report 1 of the Board of Trustees, Prescription labeling. Proceedings of the 144th Annual
Meeting of the House of Delegates. Chicago, IL: American Medical Association; June 1822, 1995;31-36.

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