Compounded medications are not FDA approved. FDA does not review compounded medications for safety, effectiveness, or quality before they are marketed.

Pharmacy verification hub

Verify a microdose compounding pharmacy

The four-step check — identity, license, 503A/503B, and recalls — and why registration isn't approval.

Verifying the compounding pharmacy behind a program is the single most useful safety step a consumer can take. It means confirming the pharmacy's legal identity, license, and 503A/503B status, and checking for recalls or disciplinary actions. Facility registration is not the same as FDA product approval.

The four-step check

(1) Get the dispensing pharmacy's exact legal name from the provider. (2) Look up its license and status with the state board of pharmacy. (3) Determine whether it operates as a 503A pharmacy or a 503B outsourcing facility — and remember neither status makes a compounded product FDA approved. (4) Check for recalls or disciplinary actions. The detailed workflow is on how to verify.

Frequently asked questions

Does 503B registration mean FDA approved?

No. 503B facilities are FDA-registered and follow CGMP, but registration is not product approval; compounded products are still not FDA approved.

Not medical advice. This page is consumer education, not medical advice, and does not recommend a dose, product, or provider. Compounded medications are not FDA approved. Talk with a licensed clinician about your situation.