21 CFR 211.167
Special testing requirements
21 CFR 211.167 is the regulation titled “Special testing requirements” in 21 CFR Part 211, Current Good Manufacturing Practice for Finished Pharmaceuticals. Since 2021, 9 FDA warning letters have cited it.
- Letters citing it
- 9 since 2021
- Jan 1 to Oct 30, 2026
- 1 against 4 on the same dates in 2025
- Most often cited with
- 21 CFR 211.113, in 7 letters
- Closed out
- 22% of these letters have a published close-out
Letters citing it, by year issued
Most are drug letters (7 of 9). 2026 runs to Oct 30, 2026. Pick a year to see its letters.
What FDA writes when it cites it
The finding headings that cite 21 CFR 211.167 most often, as written in the letters.
- 2 lettersYour firm failed to conduct laboratory testing to determine whether each batch of drug product purporting to be sterile and pyrogen-free conforms to such requirements (21 CFR 211.167(a))
- 1 letterYour firm failed to conduct appropriate laboratory testing to determine whether each batch of drug product purporting to be sterile and pyrogen-free conforms to such requirements (21 CFR 211.167(a))
- 1 letterYour firm failed to conduct appropriate laboratory testing to determine whether each batch of drug product purporting to be sterile conforms to such requirements (21 CFR 211.167(a))
The regulation
Read the text of 21 CFR 211.167 (eCFR, as of Sep 1, 2026)
(a) For each batch of drug product purporting to be sterile and/or pyrogen-free, there shall be appropriate laboratory testing to determine conformance to such requirements. The test procedures shall be in writing and shall be followed.
(b) For each batch of ophthalmic ointment, there shall be appropriate testing to determine conformance to specifications regarding the presence of foreign particles and harsh or abrasive substances. The test procedures shall be in writing and shall be followed.
(c) For each batch of controlled-release dosage form, there shall be appropriate laboratory testing to determine conformance to the specifications for the rate of release of each active ingredient. The test procedures shall be in writing and shall be followed.
Text from eCFR as of Sep 1, 2026.
Cited alongside it
Regulations that appear in the same letters as 21 CFR 211.167.
- 21 CFR 211.113Control of microbiological contamination7 letters cite both
- 21 CFR 211.100Written procedures; deviations6 letters cite both
- 21 CFR 211.166Stability testing6 letters cite both
- 21 CFR 211.192Production record review5 letters cite both
- 21 CFR 200.10Contract facilities (including consulting laboratories) utilized as extramural facilities by pharmaceutical manufacturers3 letters cite both
- 21 CFR 210.1Status of current good manufacturing practice regulations3 letters cite both
- 21 CFR 211.160General requirements3 letters cite both
- 21 CFR 211.165Testing and release for distribution3 letters cite both
Latest letters citing it
The 3 letters citing 21 CFR 211.167 that FDA posted most recently.
- DrugsView New Life Pharma LLCSemaglutide Sterile Multi-Dose Vial and Tirzepatide Sterile Multi-Dose VialIssuedApr 14, 2026PostedApr 21, 2026
- DrugsView Acme United CorporationTopical OTC antiseptic wipes, sterile and non-sterileIssuedOct 10, 2025PostedOct 21, 2025
- DrugsView Exela Pharma Sciences, LLCmultiple drug products including ephedrine sulfate injection, sodium bicarbonate injection, and othersIssuedJul 2, 2025PostedJul 3, 2025
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Counts include every citation in a letter, as the Letters filter does. How this database is built.