Does “compounded” mean FDA-approved?

What FDA says

FDA's Questions and Answers page, last updated Sept. 16, 2025, states that compounded drugs are not FDA-approved. FDA does not review them for safety, effectiveness or quality before they are marketed. That is the main difference from an approved drug, whose application FDA reviews before sale.

Two kinds of compounder

• Section 503A: state-licensed pharmacies, federal facilities and physicians that compound under the conditions in section 503A. FDA says they are not subject to current good manufacturing practice (CGMP) requirements, and that state boards of pharmacy have primary oversight of state-licensed pharmacies.
• Section 503B: outsourcing facilities, created by the Drug Quality and Security Act of 2013. They must register with FDA, follow CGMP, and are inspected on a risk-based schedule.

What a compounder may start from

FDA's January 2025 interim policy on bulk drug substances under section 503A describes three routes for a bulk substance: it complies with a USP or National Formulary monograph, it is a component of an FDA-approved drug, or it appears on the 503A bulks list. The peptides in our Category 2 explainer are being considered for that list. We read the policy document through a summary, so check its wording.

What it does not mean

• It is not a finding about any single compounded product or pharmacy.
• A pharmacy's state license shows it may operate. It does not show a product was reviewed by FDA.
• Sellers labeled “research use only” are a separate matter. See our research-use-only explainer.