21 CFR 211.176, Penicillin Contamination, allows marketing of non-penicillin finished drug products if they are tested using the codified method and found not to be contaminated with penicillin. However, it is not acceptable to release the product unless all other applicable CGMP requirements have been met. In some cases, firms inappropriately apply § 211.176 to market products that have not been produced under CGMP. Notably, 21 CFR 211.42(d) requires that manufacturing operations for penicillin drug products be performed in facilities separate those used for non-penicillin human drug products. Similarly, 21 CFR 211.46(d) requires that air-handling systems for penicillin and non-penicillin drug products be completely separate. For example, if a non-penicillin product is made in a facility that shares equipment or an air-handling system with a penicillin production area (in violation of § 211.46(d)), the non-penicillin product cannot be made CGMP-compliant through testing alone. However, if a door is accidentally left open between a penicillin-dedicated area and other separate production areas, resulting in possible exposure of the other areas to penicillin, testing those other products for penicillin could justify their release for distribution. However, as per 21 CFR 211.165, all sampling plans and acceptance criteria used for testing and release of the non-penicillin product, including any testing for penicillin contamination, must be adequate to ensure the tested product meets all of its specifications.
