21 CFR 211.176: Penicillin contamination
Requires manufacturers to test non-penicillin drug products for penicillin when cross-contamination is reasonably possible, and prohibits marketing any product with detectable penicillin per the FDA-incorporated detection and measurement procedures.
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 211.176, from the 483s we hold.
Non-penicillin drug products were not tested for the presence of penicillin, when a reasonable possibility existed that a non-penicillin drug product has been exposed to a cross-contamination with penicillin.Most used
Recent 483s citing 211.176
- Chartwell Pharmaceuticals Carmel, LLC · Carmel, New YorkNon-penicillin drug products were not tested for the presence of penicillin, when a… Dec 20, 2024
- Chartwell Pharmaceuticals Congers, LLC · Congers, New YorkNon-penicillin drug products were not tested for the presence of penicillin, when a… Dec 19, 2024
- BIOLOGISCHE HEILMITTEL HEEL GMBH · Baden Baden, Germanydrug products were not tested for the presence of 2 when a reasonable possibility… Feb 1, 2019
- Latina Pharma S.P.A · Sermoneta, Latina, ItalyNon-penicillin drug products were not tested for the presence of penicillin, when a… Apr 21, 2017
The regulation text
§ 211.176 Penicillin contamination.
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.
[43 FR 45077, Sept. 29, 1978, as amended at 47 FR 9396, Mar. 5, 1982; 50 FR 8996, Mar. 6, 1985; 55 FR 11577, Mar. 29, 1990; 66 FR 56035, Nov. 6, 2001; 69 FR 18803, Apr. 9, 2004; 81 FR 49897, July 29, 2016]
Questions
What does 21 CFR 211.176 require?
Requires manufacturers to test non-penicillin drug products for penicillin when cross-contamination is reasonably possible, and prohibits marketing any product with detectable penicillin per the FDA-incorporated detection and measurement procedures.
How do FDA investigators word a 211.176 observation?
The most common opening is: “Non-penicillin drug products were not tested for the presence of penicillin, when a reasonable possibility existed that a non-penicillin drug product has been exposed to a cross-contamination with penicillin.”
Which sections are cited alongside 211.176?
In the same 483s, investigators most often also cite 211.165 (Testing and release for distribution), 211.188 (Batch production and control records), 211.192 (Production record review), 211.63 (Equipment design, size, and location).