Survey of expiration dating policies for repackaged pharmaceuticals.
A national survey was conducted to determine the policies of hospital pharmacies regarding expiration dates for repackaged pharmaceuticals. A cover letter, questionnaire, and self-addressed stamped envelope were mailed to the directors of pharmacy of 360 randomly selected hospitals. Definitions of bulk and extemporaneous repackaging were provided. The response rate was 57%. Less than one third of the responding institutions followed the current FDA recommendations for dating oral solids repackaged in bulk. Almost one quarter used the manufacturer's date. Only 5.6% of the hospitals used more conservative dating. Similar percentages were found for the dating of oral liquids. One third of the hospitals used 30-90 days to date repackaged injectables ; however, a large range of expiration dates was reported. Almost one third of the hospitals applied the current FDA bulk repackaging dating recommendations to extemporaneous repackaging . A large percentage (29% for oral solids and 31% for oral liquids) used the manufacturer's date. A wide variety of arbitrarily assigned expiration dates are being used by hospital pharmacists in the bulk and extemporaneous repackaging of oral solids, liquids, and injections.
D003625:Data Collection; D004349:Drug Packaging / Q000592:standards; D004356:Drug Storage / Q000592:standards*; D010607:Pharmacy Service, Hospital / Q000592:standards*; D013997:Time Factors; D014481:United States