This interim guidance describes FDA’s expectations regarding compliance with current good manufacturing practice (CGMP) requirements for facilities that compound human drugs and register with FDA as outsourcing facilities under section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act). Under section 501(a)(2)(B) of the FD&C Act, a drug is deemed to be adulterated if it is not produced in accordance with CGMP. FDA’s regulations regarding CGMP requirements for the preparation of drug products have been established in 21 CFR parts 210 and 211.FDA intends to promulgate more specific CGMP regulations for outsourcing facilities. Until final regulations are promulgated, this guidance describes FDA’s expectations regarding outsourcing facilities and the CGMP requirements in 21 CFR parts 210 and 211 during this interim period. This guidance is only applicable to drugs compounded in accordance with section 503B. 

 

Posted on the FDA website on 1 July 2014