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GUIDANCE DOCUMENT

Insanitary Conditions at Compounding Facilities Guidance for Industry November 2020

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-2016-D-2268
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

Under section 501(a)(2)(A) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 351(a)(2)(A)), a drug is deemed to be adulterated “if it has been prepared, packed, or held under insanitary conditions whereby it may have been contaminated with filth, or whereby it may have been rendered injurious to health . . .” Drug products prepared, packed, or held under insanitary conditions could become contaminated and cause serious adverse events, including death. 

 

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All written comments should be identified with this document's docket number: FDA-2016-D-2268.

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