Compounding Quality Act: Critical Implementation Begins Now For Stakeholders


On Wednesday, December 4, FDA will publish six key documents in the implementation of the Compounding Quality Act, signed into law by President Obama on Monday, December 2. In addition, FDA has withdrawn its current guidance entitled "Enforcement Policy During Implementation of Section 503A of the Federal Food, Drug, and Cosmetic Act," as well as CPG Section 460.200 of the Compliance Program Guidance Manual entitled "Pharmacy Compounding," which had until today represented FDA's stance on, and enforcement of, human drug compounding. Stakeholders are urged to review the documents, which will directly affect their businesses. FDA strongly requests all stakeholders to provide FDA with lists of what bulk APIs should be continued to be permitted to be used in compounding, what compounding practices will still be permitted under state pharmacy law, and other issues critical to the continuation of their businesses.

Advance copies of these proposed rules and notices are available here:


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DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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