FDA announces cGMP guidances on drug compounding

The U.S. Food and Drug Administration (FDA) has released five documents outlining the FDAs policies regarding compounded drug products for human useas part of the agencys implementation of the Drug Quality and Security Act (DQSA). Drug Quality and Security Act (DQSA) was passed in response to a deadly fungal meningitis outbreak linked to a sterile compounded injectable drug shipped across the country and responsible for more than 750 infections and 60 deaths.The documents include the following:

•  Draft interim guidance that describes the FDAs expectations regarding compliance with current good manufacturing practice (cGMP) requirements for facilities that compound human drugs and registered with the FDA as outsourcing facilities under section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act)

•  A proposed rule that would revise the FDAs current list of drug products that may not be compounded because the drug products have been withdrawn or removed from the market because they were found to be unsafe or not effective.

•  Final guidance for individuals or pharmacies that intend to compound drugs under section 503A, now that the FD&C Act has been amended by the DQSA. The guidance generally restates the provisions of section 503A, describes the FDAs interim policies with respect to specific provisions that require implementing regulations or other actions, and contains a non-exhaustive list of potential enforcement actions against individuals or pharmacies that compound human drug products in violation of the FD&C Act

•  Two Federal Register Notices stating the FDA is reopening the nomination process for two lists of bulk drug substances (active pharmaceutical ingredients) that may be used to compound drug products. One list is for drug products compounded in accordance with section 503A, and the other list is for drug products compounded in accordance with section 503B of the FD&C Act.

Although the guidances are recommendations rather than legally enforceable documents, the FDA maintained it has a lot of flexibility to pursue enforcement actions if it suspects a problem.FDA has issued several warning letters in the past few months to pharmacies for producing compounded drugs in unsanitary facilities. A warning letter was issued in March for allegedly producing a version of Johnson & Johnson gastrointestinal drug Motilium even though the drug was not approved in the U.S.