December 3, 2013

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 In addition, FDA has withdrawn its current guidance entitled "Enforcement Policy During Implementation of Section 503A of the Federal Food, Drug, and Cosmetic Act," as well as CPG Section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.

To read the full Alert, click here.