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Insanitary conditions at compounding facilities
Insanitary conditions at compounding facilities
- Collection:
- Health Policy and Services Research
- Series Title(s):
- Guidance for industry
- Contributor(s):
- United States. Department of Health and Human Services, issuing body.
United States. Food and Drug Administration, issuing body.
Center for Drug Evaluation and Research (U.S.). Office of Compliance, issuing body. - Publication:
- Silver Spring, MD : Center for Drug Evaluation and Research, November 2020
- Language(s):
- English
- Format:
- Text
- Subject(s):
- Drug Compounding
Drug Industry -- standards
Facility Regulation and Control
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration - Genre(s):
- Technical Report
- Abstract:
- 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. Under sections 503A and 503B of the FD&C Act (21 U.S.C. 353a and 353b), compounded human drug products can qualify for exemptions from specified provisions of the FD&C Act if certain conditions are met. However, neither section provides an exemption from section 501(a)(2)(A) of the FD&C Act. Drugs (including biological products) prepared, packed, or held (hereinafter referred to as “produced”) under insanitary conditions are deemed to be adulterated, regardless of whether the drugs qualify for exemptions set forth in sections 503A or 503B of the FD&C Act. This guidance describes examples of insanitary conditions that FDA has observed. This guidance specifically addresses drugs (including biological products) produced by pharmacies, federal facilities, and outsourcing facilities that compound or repackage drugs, or that mix, dilute, or repackage biological products. For purposes of this guidance, we refer to such entities as “compounding facilities.”
- Copyright:
- The National Library of Medicine believes this item to be in the public domain. (More information)
- Extent:
- 1 online resource (1 PDF file (12 pages)).
- NLM Unique ID:
- 9918248909606676 (See catalog record)
- Permanent Link:
- http://resource.nlm.nih.gov/9918248909606676