Drug Information Update - FDA outlines expectations for human drug compounders, including registered outsourcing facilities

FDA Division of Drug Information: Know the Moment It Happens

The Division of Drug Information (DDI) is CDER's focal point for public inquiries. We serve the public by providing information on human drug products and drug product regulation by FDA.


Today, the U.S. Food and Drug Administration issued several policy documents regarding compounded drug products for human use, as part of the agency’s continuing effort to implement the compounding provisions of the Drug Quality and Security Act (DQSA), enacted in November 2013. The policy documents consist of a draft interim guidance, a proposed rule, a final guidance, and two revised requests for nominations for the bulk drug substances lists. 

For more information, please visit: compounding


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