USP UNIFORM EXPIRATION DATING STANDARDS WILL BE EXPLORED

Executive Summary

USP UNIFORM EXPIRATION DATING STANDARDS WILL BE EXPLORED based on a resolution passed at the 1990 Quinquennial Meeting of the United States Pharmacopeial Convention (USPC) March 11. The resolution, which was hotly debated at the meeting, "encourages" the USPC "to determine the feasibility of developing USP standards for uniform expiration dating and expiration date labeling for all prescription drug products." * The debate on the resolution at the USP meeting generally broke down along pharmacy versus drug manufacturer lines. Expressing the manufacturer's point of view, Nonprescription Drug Manufacturers Association Senior VP and Director of Scientific Affairs William Soller, PhD, maintained that the issue of uniform dating is an economic one relevant to local pharmacies rather than a scientific issue relevant to the USP. Soller pointed to the problems a uniform dating requirement would cause -- compressing manufacturing times, loss of shelf-life, and wastage of drug products before established expiration periods. He also cited FDA concerns about a change from precision in dating based on stability studies, and questioned "whether the USP has the legal authority to establish a labeling program that would be binding on industry and that FDA would be required to enforce." American Society for Hospital Pharmacists official David Anderson emphasized that the review of products for expiration dating "is a monstrous problem in every hospital in this country" involving a considerable "amount of time, effort and expense." Pharmacy reps also argued for USP involvement in developing better standards regarding placement and readability of expiration dates on labels. Emphasizing that the expiration date labeling issue is "one of safety," American Pharmaceutical Association rep Robert McKinney maintained that "there are a lot of instances where expiration dates are placed on packages making them very difficult to read and very easy to make mistakes." Other pharmacy-related resolutions passed at the quinquennial meeting call for USP to develop standard pictograms for directions on drug labels and information materials, and to pursue, in cooperation with FDA, "beyond use" dates for repackaged products. Standards for solid dosage form identification and the handling of unit-dose packaging at the manufacturer and pharmacy level should also be pursued by the USP, the convention agreed. FDA Acting Commissioner James Benson told the meeting that FDA is supportive of greater USP involvement in community and hospital pharmacy issues which lie "outside the area of traditional FDA attention," such as "beyond-use" dating and prescription packaging. Benson noted that drug repackaging has been an area in which FDA has encountered compliance problems, and that USP resolutions dealing with the issue "appear to be on target." Benson also encouraged USP to investigate the adequacy of prescription containers and unit-dose containers used in hospitals and nursing homes as part of the overall effort "to make sure that critical protection for drugs is not compromised." * The acting commissioner pointed to generic drugs as a "key area" for closer USP/FDA cooperation. In the effort to increase uniformity in ANDA review, Benson noted, FDA scientists will be placing more emphasis on compliance with the USP monograph standards.