FDA Releases DQSA Compounding Rules and Guidance Documents

Food and Drug Administration (FDA) has released several policy documents related to compounding as part of the agency’s implementation of the Drug Quality and Security Act (DQSA). The documents include:

• Draft interim guidance (PDF) describing FDA’s expectations for compliance with current good manufacturing practice requirements for compounding facilities registered as outsourcing facilities with FDA
• A proposed rule (PDF) that would revise FDA’s current list of drug products that may not be compounded due to withdrawal from the market or because they were found to be unsafe or ineffective
• Final guidance (PDF) for pharmacies and individuals that intend to compound drugs under Section 503A, including FDA’s interim policies and a non-exhaustive list of potential enforcement actions against pharmacies or individuals that compound in violation of the Food, Drug, and Cosmetic Act
• Two Federal Register notices that reopen FDA’s request for nominations for the bulk drug substances lists for compounding in relation to Section 503A (PDF) and Section 503B (PDF) respectively

The draft interim guidance and proposed rule are available for public comment for 60 days, and the dockets are open for the public to nominate bulk drug substances for compounding under section 503A or 503B for 90 days. Additional information is available in a press release on the FDA website.