FDA Outlines Expectations for Human Drug Compounders, Including Registered Outsourcing Facilities

FDA has 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.

“Providing clarity to the compounding industry on the agency’s expectations for these unapproved drug products is a priority for the agency,” said Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research. “These actions are essential next steps in providing the compounding industry with the appropriate tools to comply with the law and advancing the FDA’s efforts to continue protecting patients.”

The documents available are

• Draft interim guidance that describes the FDA’s expectations regarding compliance with current good manufacturing practice (CGMP) requirements for facilities that compound human drugs and register with the FDA as outsourcing facilities under section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act). The guidance focuses on CGMP requirements related to sterility assurance of sterile drug products and the general safety of compounded drug products. 

• A proposed rule that would revise the FDA’s current list of drug products that may not be compounded because the drug products have been withdrawn or removed from the market because they were found to be unsafe or not effective. The proposed rule would modify the description of one drug product on the list and add 25 drug products to the list.

The list set forth in the proposed rule would apply to both compounders and outsourcing facilities seeking to compound drugs for human use under sections 503A and 503B, respectively.

• 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 FDA’s 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. In response to a December 2013 request for nominations, the agency received nominations that were not for bulk drug substances used in compounding, and that did not provide sufficient information to justify inclusion of the substances on the lists.

The FDA is providing more detail on what information is needed to evaluate the nominations for placement on the lists.

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.