New Compounding and Outsourcing Facility Guidance Issued

FDA issued a slew of “policy documents” as part of the Agency’s implementation of the Compounding Quality Act (“CQA”) (Title I of the Drug Quality and Security Act (“DQSA”)), which was enacted November 27, 2013.  The policy documents include a draft interim guidance, a proposed rule, a Final Guidance, and two revised requests for nominations for the bulk drug substance lists for both Section 503A and Section 503B compounders. FDA stated in its press release that 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.”

More specifically, the policy documents include the following: 

  • cGMP for Section 503B:  Draft interim guidance describing FDA’s expectations for compliance with current good manufacturing practice (“cGMP”) for voluntarily registered outsourcing facilities under Section 503B of the FDC Act. The draft guidance focuses on cGMP requirements related to sterility assurance of sterile drug products and the general safety of compounded drug products. (More details are included in the FDA Law Blog's separate blog post, and in the Federal Register announcement).
  • Drugs Withdrawn for Safety/Effectiveness; proposed additions: A proposed rule that would revise FDA’s list of drug products that may not be compounded because they have been withdrawn or removed from the market for reasons of safety or effectiveness. The proposed rule seeks to modify the description of one drug product on the current list and add 25 drug products to this list.  The list applies to both compounders under 503A and outsourcing facilities under 503B. 
  • Final Guidance for Section 503A Compounders: Final Guidance for individuals or pharmacies that intend to compound drugs under Section 503A. The non-binding Guidance generally sets forth and restates the provisions of Section 503A, addresses FDA’s interim policies concerning certain provisions that require implementing regulations or other actions, and includes a non-exhaustive list of potential enforcement actions against individuals or pharmacies that compound human drug products in violation of the FDC Act.