Arca
Skip to content

21 CFR 211.167

Special testing requirements.

  • Inspections citing it: 165
  • Of those classified, ended OAI: 76%
  • Last cited: FY2026

Inspections Citing It by Fiscal Year

Sites in and outside the US, FY2017 to Oct 20, 2026.

Paragraphs Cited

As FDA posts them, all years.

211.167(a)
158 · Sterility/pyrogen-free testing
211.167(c)
7 · Controlled release dosage form testing

Regulation Text

eCFR, as of Nov 6, 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.

Open 21 CFR 211.167 on eCFR

Recently Cited Sites

Newest inspections citing this section; each opens the site

Counts are inspections with posted citations that cite any paragraph of the section, once per inspection, from FDA's Data Dashboard. OAI share is over inspections FDA finally classified. Text from eCFR, the official online CFR. FDA Data Dashboard and eCFR

Logos are each company's own site icon, matched by name through Wikidata.Company names and logos identify the companies in public FDA and registry records and do not imply endorsement.