Issue Date: November 6, 2020
Issued by: Center for Drug Evaluation and Research
Topic(s): Administrative / Procedural, Compounding
Status: Final
Insanitary Conditions at Compounding Facilities Guidance for Industry
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.
Download the Guidance Document
