Outsourcing Facility Compounded Human Drug Product (Exempt From Approval Requirements)

**Semantic type:** Qualitative Concept

**Definition:** A drug product compounded by an establishment registered under 503B as a Human Drug Compounding Outsourcing Facility, reported in a HUMAN COMPOUNDED DRUG LABEL submission, which when compounded in compliance with Section 503 of the FFDCA (Federal Food, Drug, and Cosmetic Act), the drug product qualifies for the exemption from Sections 502(f)(1) and 505 pertaining to FDA approval requirements.