Yesterday, the U.S. Food and Drug Administration (FDA) released five documents outlining the FDA’s current policies regarding compounded drug products for human use.  All of the documents are available through the FDA’s website.  Tuesday’s issuances were part of the FDA’s continued implementation of the Drug Quality and Security Act (DQSA), enacted in 2013 in response to a 2012 outbreak of fungal meningitis that was traced back to a compounding pharmacy.  Among other things, Title I of the DQSA gave the FDA stronger statutory authority to regulate certain compounding pharmacies, and removed provisions previously found unconstitutional.  Specifically, the FDA released the following documents:

  • 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)”;
  • A proposed rule, published in today’s Federal Register, “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would revise the FDA’s current list of drug products that may not be compounded because the drug products have been withdrawn or removed from the market because they were found to be unsafe or not effective”.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 also withdrew the January 4, 2000 proposed rule (65 Fed. Reg. 256) effective today (July 2, 2014);
  • 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”; and
  • “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.”

Comments are due on the proposed rule by September 2, 2014. In addition, although comments are accepted on guidances at any time, the FDA recommends that comments on the draft interim guidance be received by September 2, 2014, “to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.”  Comments on the final guidance may be submitted at any time.  Written or electronic nominations for the bulk drug substances lists should be submitted by September 30, 2014.


Posted by Kathleen Peterson

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