Sign in Join the beta My account Open Compliome

21 CFR Part 211 · Current Good Manufacturing Practice for Finished Pharmaceuticals

§ 211.176 Penicillin contamination

Subpart I - Laboratory Controls Official text on eCFR Amendment history

If a reasonable possibility exists that a non-penicillin drug product has been exposed to cross-contamination with penicillin, the non-penicillin drug product shall be tested for the presence of penicillin. Such drug product shall not be marketed if detectable levels are found when tested according to procedures specified in ‘Procedures for Detecting and Measuring Penicillin Contamination in Drugs,’ which is incorporated by reference. Copies are available from the Division of Research and Testing (HFD-470), Center for Drug Evaluation and Research, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, or available for inspection at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html .

Independent copy, not an official legal edition. 21 CFR is a U.S. Government work in the public domain; this text comes from the eCFR and the annual CFR edition, and may lag recent amendments. The authoritative version is on ecfr.gov. Compliome is not affiliated with or endorsed by FDA. Not legal advice.

What FDA inspectors cite under § 211.176

Form FDA 483 observations citing this section, fiscal years 2009–2025 (Drugs).

  • Failing to test for penicillin cross-contamination 16

Warning letters citing § 211.176

5 FDA warning letters since 2017 cite this section :

FDA guidance that cites § 211.176

Amendment history

Federal Register documents that created or amended this section.