ABSTRACT
PART I-BACKGROUND General APIs are subject to the adulteration provisions of section 501(a)(2)(B) of the act, which requires all drugs to be manufactured in conformance with cGMP. No distinction is made between an API and a finished pharmaceutical in the act and the failure of either to comply with cGMP constitutes a violation of the act. FDA has not promulgated cGMP regulations specifically for APIs or drug components (as we have for finished pharmaceuticals). Thus, the use of “cGMP” in this document refers to the requirements of the act rather than the requirements of 21CFR Parts 210 and 211 regulations for finished pharmaceuticals.
