Year: 2015
Resolution Number: 41
Action Taken: Approved
Status: Complete
Author(s): Robert Levine, MD
Sponsor: Robert Levine, MD
On behalf of:
Committee: E (Science and Education Affairs)
Resolved Section(s):
H-115.983 Expiration Dates and Beyond-Use Dates of Prescription AND OVER-THE-COUNTER Drug ProductsOur AMA: (1) supports the inclusion of expiration dates on the containers/labels of prescription AND OVER-THE-COUNTER drug products and recommends that expiration dates be determined by pharmaceutical manufacturers using scientifically based stability testing with subsequent approval by the Food and Drug Administration (FDA); (2) urges the pharmaceutical industry, in collaboration with purchasers, the FDA, and the United States Pharmacopeia (USP), to determine whether lengthening of expiration dates will provide clinical and/or economic benefits or risks for patients and, if this is the case, to conduct longer stability testing on their drug products; (3) URGES THE FDA TO WORK WITH THE PHARMACEUTICAL INDUSTRY AND THE USP TO DEVELOP A SCHEDULE FOR THE REVIEW AND RE-EVALUATION OF EXPIRATION DATES OF PRESCRIPTION AND OVER-THE-COUNTER DRUG PRODUCTS; (4) recommends that pharmacists place a beyond-use date on the labeling of all prescription medications dispensed to patients, and that the beyond-use date be based on the recommendations in the most recent edition of the United States Pharmacopeia and National Formulary; and (5) encourages the USP, in collaboration with pharmaceutical manufacturers, pharmacy organizations, and the FDA, to continue to explore the development of appropriate stability tests for the determination of scientifically sound beyond-use dates for repackaged products.
H-115.983 Expiration Dates and Beyond-Use Dates of Prescription AND OVER-THE-COUNTER Drug ProductsOur AMA: (1) supports the inclusion of expiration dates on the containers/labels of prescription AND OVER-THE-COUNTER drug products and recommends that expiration dates be determined by pharmaceutical manufacturers using scientifically based stability testing with subsequent approval by the Food and Drug Administration (FDA); (2) urges the pharmaceutical industry, in collaboration with purchasers, the FDA, and the United States Pharmacopeia (USP), to determine whether lengthening of expiration dates will provide clinical and/or economic benefits or risks for patients and, if this is the case, to conduct longer stability testing on their drug products; (3) URGES THE FDA TO WORK WITH THE PHARMACEUTICAL INDUSTRY AND THE USP TO DEVELOP A SCHEDULE FOR THE REVIEW AND RE-EVALUATION OF EXPIRATION DATES OF PRESCRIPTION AND OVER-THE-COUNTER DRUG PRODUCTS; (4) recommends that pharmacists place a beyond-use date on the labeling of all prescription medications dispensed to patients, and that the beyond-use date be based on the recommendations in the most recent edition of the United States Pharmacopeia and National Formulary; and (5) encourages the USP, in collaboration with pharmaceutical manufacturers, pharmacy organizations, and the FDA, to continue to explore the development of appropriate stability tests for the determination of scientifically sound beyond-use dates for repackaged products.
Fiscal Note: NULL
Resolution: View PDF for Medication Expiration Dates
For More Information, Contact: