21 CFR 211.167: Special testing requirements
Requires manufacturers to run written, followed laboratory tests on each batch for sterility and pyrogen-free claims, foreign particles and abrasives in ophthalmic ointments, and active ingredient release rate in controlled-release dosage forms.
Part 211, Current Good Manufacturing Practice for Finished Pharmaceuticals · Subpart I, Laboratory Controls
How FDA words it
The opening lines investigators use most when they cite 211.167, from the 483s we hold.
Each batch of drug product purporting to be sterile and pyrogen-free is not laboratory tested to determine conformance to such requirements.Most used
Each batch of drug product purporting to be sterile is not laboratory tested to determine conformance to such requirements.211.167(a)
Each batch of drug product required to be free of objectionable microorganisms is not tested through appropriate laboratory testing.
Cited over time
483s citing 211.167, by yearMost citations in 2017. Bars are relative to the busiest year. *2026 to date.
Years shown: 2017 to 2026. The busiest year was 2017.
Recent 483s citing 211.167
- Gilead Sciences, Inc · La Verne, CaliforniaTest procedures relative to appropriate laboratory testing for sterility are not… Feb 18, 2026
- Gilead Sciences, Inc. · La Verne, CaliforniaTest procedures relative to appropriate laboratory testing for sterility are not… Feb 9, 2026
- Eugia Pharma Specialities Limited · Sangareddy, IndiaTest procedures relative to appropriate laboratory testing for pyrogens are not… Feb 6, 2026
- Apotek Production & Laboratorier AB · Umea, Vasterbotten, SwedenEach batch of ding product purporting to be sterile and pyrogen-free is not… Jan 29, 2026
- F.H. Investments, Inc. (dba Asteria Health) · Birmingham, AlabamaEach batch of controlled-release dosage form drug product is not laboratory tested… Dec 19, 2025
The regulation text
§ 211.167 Special testing requirements.
(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.
Questions
What does 21 CFR 211.167 require?
Requires manufacturers to run written, followed laboratory tests on each batch for sterility and pyrogen-free claims, foreign particles and abrasives in ophthalmic ointments, and active ingredient release rate in controlled-release dosage forms.
How do FDA investigators word a 211.167 observation?
The most common opening is: “Each batch of drug product purporting to be sterile and pyrogen-free is not laboratory tested to determine conformance to such requirements.”
Which sections are cited alongside 211.167?
In the same 483s, investigators most often also cite 211.113 (Control of microbiological contamination), 211.42 (Design and construction features), 211.28 (Personnel responsibilities), 211.166 (Stability testing).