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  1. Guidance, Compliance, & Regulatory Information

FDA clarifies compounding policies

FDA has received questions and feedback on several of its current policies and is providing the following information to stakeholders to clarify its current thinking. FDA is reviewing the complex issues raised in these comments and taking them into consideration as the agency works to update, revise and finalize several guidance documents. The agency reminds stakeholders they may provide comments to FDA guidance documents at any time and the agency will take comments into consideration.

Hospital and health systems guidance

  • The agency’s draft hospital and health systems guidance, which includes the “one mile radius” provision, is still in draft and we are planning to issue a revision. This draft guidance was issued for public comment and has not been implemented.

Memorandum of understanding

  • Although federal law specifies a 5 percent limit on distribution out of state of drugs compounded by pharmacies and physicians regulated under section 503A of the Federal Food, Drug and Cosmetic Act, the agency does not intend to enforce the 5 percent limit until after the agency has finalized a Memorandum of Understanding (MOU) and given states an opportunity to sign it.

“Essentially a copy” guidances

  • The agency does not consider a compounded drug produced by an outsourcing facility to be “essentially a copy” if it is identical or nearly identical to an FDA-approved drug that is on FDA’s drug shortage list. The agency also does not intend to take action under this provision if the facility fills orders for a compounded drug that is essentially a copy of an approved drug that has been discontinued and is no longer marketed.
  • The agency has received questions and comments related to its policies for applying the “essentially a copy” provision when outsourcing facilities compound drugs starting with an approved drug rather than a bulk drug substance. FDA plans to address these comments in an upcoming revision to its guidance for outsourcing facilities. The agency also intends to address compounding from approved drugs in revisions to its guidance for pharmacy and physician compounders

Insanitary conditions guidance

  • The agency anticipates finalizing its guidance on insanitary conditions at compounding facilities in 2020.
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