FDA intends to promulgate more specific CGMP regulations for outsourcing facilities. 27 Until final regulations are promulgated, this guidance describes FDA’s expectations regarding. 28 outsourcing facilities and the CGMP requirements in 21 CFR parts 210 and 211 during this. 29 interim period.2 register with FDA as outsourcing facilities under section 503B of the Federal Food, Drug, and. 23 Cosmetic Act (FD&C Act). Under section 501(a)(2)(B) of the FD&C Act, a drug is deemed to be. 24 adulterated if it is not produced in accordance with CGMP.