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USP Announces Delay and Revision of Sterile Drug Compounding Standards

Recently, ASCRS, the American Medical Association, and many members of the medical community sent a letter to the United States Pharmacopeia (USP) leadership expressing concerns over revisions made to Chapter 797. USP’s revisions to Chapter 797 would classify the reconstitution and/or diluting of a sterile drug as compounding. As a result, physicians would be subject to new burdensome requirements for compounding sterile drugs.

In the letter, we argue that preparation of sterile drug products is not a compounding activity and falls well within the scope of medical practice. In addition, we argue that the regulatory requirements of Chapter 797 would require both significant capital expenditures and construction projects for physicians’ practices. This could significantly impact patient access to sterile drugs.

Following the submission of our letter, USP announced that they are working on a revised draft of Chapter 797 that they anticipate being available for public comment in September 2018, with a final chapter becoming effective December 1, 2019. We will keep you updated.