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On January 19, 2018, FDA Commissioner Scott Gottlieb, M.D. released FDA’s 2018 Compounding Policy Priorities Plan. The plan provides an overview of the key priorities FDA will pursue in 2018 to implement the federal law on compounding. These priorities include (1) issuing proposed regulations on current good manufacturing practice (CGMP) requirements that 503B facilities must meet and publishing revised draft guidance in the interim describing a new flexible risk-based approach to CGMP; (2) publishing two final guidance documents restricting compounding drugs that are essentially copies of FDA-approved drugs; (3) issuing draft guidance, in March 2018, proposing criteria for making clinical need determinations for purposes of establishing the 503B bulks list; (4) issuing a significantly revised draft MOU between FDA and states regarding compounding under section 503A; and (5) publishing final guidance regarding the mixing, diluting or repackaging of biological products outside the scope of an approved biologics license application.

Authors: Rachael G. Pontikes John D. Kendzior Natalie R. Salazar

On January 19, 2018, FDA Commissioner Scott Gottlieb, M.D. released FDA’s 2018 Compounding Policy Priorities Plan. The plan provides an overview of the key priorities FDA will pursue in 2018 to implement the federal law on compounding. These priorities include:

  • Issuing proposed regulations on current good manufacturing practice (CGMP) requirements that 503B facilities must meet and publishing revised draft guidance in the interim describing a new flexible risk-based approach to CGMP.
  • Publishing two final guidance documents restricting compounding drugs that are essentially copies of FDA-approved drugs.
  • Issuing draft guidance, in March 2018, proposing criteria for making clinical need determinations for purposes of establishing the 503B bulks list.
  • Issuing a significantly revised draft MOU between FDA and the states regarding compounding under section 503A.
  • Publishing final guidance regarding the mixing, diluting or repackaging of biological products outside the scope of an approved biologics license application.

The plan, however, does not bind the agency, and FDA could change its priorities throughout the year.