Are there data on the clinical and fiscal impact of pharmaceutical expiration dates?
The FDA and PhRMA were unaware of any comprehensive studies that addressed the clinical impact of pharmaceutical expiration dates and no such studies were found in the peer reviewed scientific literature.2,3 It is important to emphasize that the FDA, USP, PhRMA, and various pharmacy organizations recommend that drug products not be used after their expiration dates.1,7,8 This also is the current policy of the AMA (Policy H-115.983, AMA Policy Database). Because the potency and other quality attributes of a drug product cannot be reliably predicted after its expiration date, there is the potential for a suboptimal therapeutic response or some other safety problem. Reliable data, available in the public domain, on the fiscal impact of expiration dates also appear to be very limited. The CSA did not identify any comprehensive studies in its literature searches. Also, the FDA and PhRMA were unaware of any comprehensive studies that addressed this issue. The FDA noted that it lacks the reso
