Updated 503B Guidance for Drug Compounding Facilities: What You Need to Know

The FDA’s December 2018 version of the Current Good Manufacturing Practice—Guidance for Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act, was updated in January 2020 in part to clarify cGMP requirements for drug compounding facilities.

Previously, the guidance referenced section 501(a)(2)(B) of the FD&C Act which states “a drug is deemed to be adulterated if it is not produced in accordance with cGMP” and pointed to 21 CFR parts 210 and 211 for regulations regarding cGMP requirements for the preparation of drug products — which left abundant confusion among compounders.

The January 2020 draft guidance for industry seeks to rectify the confusion surrounding cGMP compliance for drug compounding outsourcing facilities. Specifically, the new draft guidance states:

“FDA intends to promulgate more specific cGMP regulations for outsourcing facilities. Until these final regulations are promulgated, outsourcing facilities are subject to the cGMP requirements in parts 210 and 211. This guidance provides for conditions under which FDA generally does not intend to take regulatory action against an outsourcing facility regarding certain cGMP requirements in parts 210 and 211 during this interim period. This guidance applies to drugs compounded in accordance with section 503B. In addition, this guidance generally applies to drugs that outsourcing facilities repackage and biological products that outsourcing facilities mix, dilute, or repackage in accordance with relevant guidance for outsourcing facilities.”

Essentially, the FDA is declaring that until further details are developed and approved, compounding facilities are required to adhere to 21 CFR parts 210 and 211.