FDA Releases Compounding Policy Documents

by BakerHostetler

The U.S. Food and Drug Administration (FDA) has released five policy documents regarding compounded human drug products in connection with its continued implementation of the compounding provisions of the Drug Quality and Security Act (DQSA), enacted in November 2013. According to Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research, as quoted in the FDA’s press release, the policy documents represent “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 policy documents, all of which were released on July 1, 2014, include the following:

  1. Draft Interim Guidance Regarding Current Good Manufacturing Practices, which describes the FDA’s expectations regarding compliance with current good manufacturing practice (cGMP) requirements for entities registered as outsourcing facilities under Section 503B of the Federal Food, Drug, and Cosmetic Act (FFDCA) and, specifically, the cGMP requirements related to sterility assurance and general safety for compounded drug products. Comments to the Interim Guidance will be accepted for 60 days following publication in the Federal Register.
  2. Proposed Rule Regarding List of Drug Products That May Not Be Compounded, which includes proposed revisions to the FDA’s current list of drug products that may not be compounded because the drug products were found to be unsafe or ineffective and have been removed or withdrawn from the market. Specifically, the Proposed Rule would revise the description for one drug product and add 25 additional drugs to the list, which would be applicable to both compounders and outsourcing facilities under Sections 503A and 503B respectively. Comments to the Proposed Rule will be accepted for 60 days following publication in the Federal Register.
  3. Final Guidance Regarding Compounding Under Section 503A, which includes information and guidance for individuals or pharmacies that intend to compound drugs under Section 503A, as amended by the DQSA. Specifically, the Guidance includes information regarding interim policies with respect to certain provisions requiring additional regulatory action (such as the five percent interstate shipment limitation discussed previously here) as well as a nonexhaustive list of potential enforcement actions that may be brought against individuals or pharmacies that compound drugs in violation of the FFDCA.
  4. Request for Nominations Regarding Bulk Drug Substance List for Section 503A, which, in response to improper nominations pursuant to the FDA’s December 2013 request for nominations, has been reopened to the public for input regarding the bulk drug substances (or active pharmaceutical ingredients) that may be used to compound drug products pursuant to Section 503A (also known as “traditional” compounding). Nominations will be accepted for 90 days following publication in the Federal Register.
  5. Request for Nominations Regarding Bulk Drug Substance List for Section 503B, which, like its sister request described above, has been reopened to the public for input regarding the bulk drug substances that may be used to compound drug products pursuant to Section 503B (which applies to “outsourcing facilities”). Nominations will be accepted for 90 days following publication in the Federal Register.

These long-awaited policy documents promise to answer many of the questions that have lingered within the compounding industry since enactment of the DQSA; however, given the preliminary status of the majority of these documents, they also may raise additional questions that can only be clarified by final FDA action.

A more in-depth analysis of each policy document will be provided in future issues of the Health Law Update newsletter and blog.


DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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