Revised USP standards for product dating, packaging, and temperature monitoring

Revisions in the standards of the United States Pharmacopeia (USP) related to product dating, packaging, and temperature monitoring are discussed. USP has revised product dating specifications as they relate to pharmacy pr actice. Pharmacists are required to affix beyond-use dates and not expirati on dates to the prescription or repackaged vial. With respect to beyond-use dates for nonsterile products that are repackaged into unit dose or single -unit containers, the requirement has been changed from the previous period of six months from the date of repackaging or 25% of the time remaining un til the expiration date, whichever is less, to one year. The type of packag ing container, the material used in packaging, and the permeability of the container to moisture are important issues for pharmacists to consider. USP requires that the pharmacy facility where dispensing or repackaging occurs be maintained at controlled room temperature such that the calculated mean kinetic temperature does not exceed 25 degrees C.