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The guidance document describes the agency’s temporary policy for the compounding of drugs during the COVID-19 pandemic.
FDA issued a guidance document on April 16, 2020 explaining the agency’s temporary policy for the compounding of drugs for hospitalized patients by outsourcing facilities that have registered with FDA under section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 353b). The temporary policy is part of FDA’s actions in response to the COVID-19 pandemic and will “remain in effect only for the duration of the public health emergency related to COVID-19 declared by the Department of Health and Human Services (HHS), including any renewals made by the HHS Secretary in accordance with section 319(a)(2) of the Public Health Service Act (42 U.S.C. 247d(a)(2)).”
The guidance states that FDA will not take action against “an outsourcing facility for compounding a drug product that is essentially a copy of an approved drug, for using a bulk drug substance that is not on FDA’s 503B Bulks List, or for not meeting current good manufacturing practice (CGMP) requirements with regard to product stability testing and the establishment of an expiration date, when all of the following circumstances are present:
While the guidance is being implemented immediately, it is still subject to comment.