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GUIDANCE DOCUMENT

Insanitary Conditions at Compounding Facilities Guidance for Industry September 2018

Draft

Not for implementation. Contains non-binding recommendations.

Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research
Center for Biologics 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.
 


Submit Comments

Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All comments should be identified with the title of the guidance.