21 CFR 200.10
Contract facilities (including consulting laboratories) utilized as extramural facilities by pharmaceutical manufacturers
21 CFR 200.10 is the regulation titled “Contract facilities (including consulting laboratories) utilized as extramural facilities by pharmaceutical manufacturers” in 21 CFR Part 200, General. Since 2021, 41 FDA warning letters have cited it.
- Letters citing it
- 41 since 2021
- Jan 1 to Oct 30, 2026
- 8 against 10 on the same dates in 2025
- Most often cited with
- 21 CFR 210.1, in 41 letters
- Closed out
- 10% of these letters have a published close-out
Letters citing it, by year issued
All are drug letters. 2026 runs to Oct 30, 2026. Pick a year to see its letters.
The regulation
Read the text of 21 CFR 200.10 (eCFR, as of Sep 1, 2026)
(a) Section 704(a) of the Federal Food, Drug, and Cosmetic Act specifically authorizes inspection of consulting laboratories as well as any factory, warehouse, or establishment in which prescription drugs are manufactured, processed, packed, or held.
(b) The Food and Drug Administration is aware that many manufacturers of pharmaceutical products utilize extramural independent contract facilities, such as testing laboratories, contract packers or labelers, and custom grinders, and regards extramural facilities as an extension of the manufacturer's own facility.
(c) The Food and Drug Administration reserves the right to disclose to the pharmaceutical manufacturer, or to the applicant of a new drug application (NDA) or to the sponsor of an Investigational New Drug (IND) Application, any information obtained during the inspection of an extramural facility having a specific bearing on the compliance of the manufacturer's, applicant's, or sponsor's product with the Federal Food, Drug, and Cosmetic Act. The Food and Drug Administration's position is that by the acceptance of such contract work, the extramural facility authorizes such disclosures.
(d) The Food and Drug Administration does not consider results of validation studies of analytical and assay methods and control procedures to be trade secrets that may be withheld from the drug manufacturer by the contracted extramural facility.
[40 FR 13996, Mar. 27, 1975, as amended at 55 FR 11576, Mar. 29, 1990]
Text from eCFR as of Sep 1, 2026.
Cited alongside it
Regulations that appear in the same letters as 21 CFR 200.10.
- 21 CFR 210.1Status of current good manufacturing practice regulations41 letters cite both
- 21 CFR 211.192Production record review31 letters cite both
- 21 CFR 201.115New drugs or new animal drugs30 letters cite both
- 21 CFR 211.113Control of microbiological contamination29 letters cite both
- 21 CFR 211.42Design and construction features28 letters cite both
- 21 CFR 211.100Written procedures; deviations14 letters cite both
- 21 CFR 211.22Responsibilities of quality control unit11 letters cite both
- 21 CFR 211.165Testing and release for distribution10 letters cite both
Latest letters citing it
The 3 letters citing 21 CFR 200.10 that FDA posted most recently.
- DrugsView SCA Pharmaceuticals, LLCCompounded sterile drug productsIssuedSep 14, 2026PostedOct 13, 2026
- DrugsView Pine Pharmaceuticals, LLCsterile compounded drug productsIssuedAug 7, 2026PostedOct 6, 2026
- DrugsView Empower Clinic Services, LLC dba Empower Pharmacycompounded semaglutide and tirzepatide products, including TIRZEPATIDE/NIACINAMIDE (4 ML)(17/2 MG/ML), SEMAGLUTIDE/CYANOCOBALAMIN (1…IssuedSep 18, 2026PostedSep 22, 2026
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Counts include every citation in a letter, as the Letters filter does. How this database is built.