USP delays official effective dates of new and revised compounding standards

Sep 23, 2019 - 03:14 PM
compliance-deadline

The United States Pharmacopeia today notified stakeholders that it is postponing the official effective dates of several new and revised standards pertaining to pharmaceutical handling until further notice while it reviews appeals to the standards. Those standards include general chapters <795> (Pharmaceutical Compounding – Nonsterile Preparations), <797> (Pharmaceutical Compounding – Sterile Preparations), and <825> (Radiopharmaceuticals – Preparation, Compounding, Dispensing, and Repackaging). In addition, due to the pending appeals, USP new general chapter <800> (Hazardous Drugs Handling in Healthcare Settings) will remain official, but only informational and will not be applicable until the appeals process is complete. The AHA in November 2018 urged USP to delay the official dates of both USP <797> and <800> due to expedited implementation and compliance concerns.

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