FDA Issues Final and Revised Draft Documents for Compounding Facilities Under DQSA

Food and Drug Administration (FDA) has issued three additional guidance documents to help compounding entities register as outsourcing facilities. The policy documents also provide guidance for complying with other provisions of the Drug Quality and Security Act (DQSA). The new documents are:

• Final guidance (PDF) on registration of human drug compounding outsourcing facilities under Section 503B of the FD&C Act
• Final guidance (PDF) on fees for human drug compounding outsourcing facilities under Sections 503B and 744K of the FD&C Act
• Revised draft guidance on electronic drug product reporting for human drug compounding outsourcing facilities under Section 503B of the FD&C Act

The revised draft guidance is available in the Federal Register and open for public comment for 60 days. Additional information is available in a press release on the FDA website.