Outsourcing Facility Compounded Human Drug Product (Not Marketed - Not Distributed)

**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 qualifies for the exemption from Sections 502(f)(1) and 505 pertaining to FDA approval requirements and which the outsourcing facility has not distributed and has not advised any person of its intent or ability to compound the drug.