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 practice. Pharmacists are required to affix beyond-use dates and not expiration 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 until the expiration date, whichever is less, to one year. The type of packaging 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. USP standards for product dating, packaging, and temperature monitoring have changed, and pharmacists must educate themselves about these revisions.
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General Policies Requirements, Nomenclature, and Labeling Division, United States Pharmacopeia, Rockville, MD 20852, USA.
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Medwick
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Grady
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D004348:Drug Labeling; D004349:Drug Packaging; D004356:Drug Storage; D010602:Pharmacopoeias as Topic; D013696:Temperature; D014481:United States