503B outsourcing facility
A 503B outsourcing facility is a larger compounding operation that registers with the FDA and is inspected by the FDA. It is held to factory-style quality standards. The category was created by US law in 2013.
For experts
Outsourcing facilities were established by the Drug Quality and Security Act of 2013 under section 503B of the FD&C Act. They are primarily overseen by FDA, inspected on a risk-based schedule and subject to current good manufacturing practice (CGMP) requirements. A 503B facility may not compound from a bulk drug substance unless the substance appears on the 503B bulks list or the drug appears on FDA's drug shortage list at the time of compounding, distribution and dispensing.
Sources (2)
- 01Compounding and the FDA: Questions and AnswersU.S. Food and Drug Administration · 2025-09-16 · accessed 2026-09-29
- 02Bulk Drug Substances Used in Compounding Under Section 503B of the FD&C ActU.S. Food and Drug Administration · 2025-01-07 · accessed 2026-09-29