How to Verify a Compounding Pharmacy

Step 1 — Identify the legal entity and pathway

Find the registered legal entity behind the brand or website. A marketing name can differ from the corporate entity, and the entity determines which pathway — 503A pharmacy or 503B outsourcing facility — its compounding runs under. If you cannot resolve the entity, nothing downstream can be verified.

Step 2 — If it claims 503B, check FDA registration

Registered outsourcing facilities appear on FDA's official registered outsourcing facilities list. If the entity is absent from that list, it is not a registered 503B regardless of what its website says. Registration is not an approval of any compounded drug.

Step 3 — Check the state pharmacy license

Pharmacy licensure is state-by-state; there is no single federal registry. Use the state board of pharmacy licensee lookup for the facility's home state, and check for disciplinary actions there. If it claims nonresident licensure in other states, those states' boards are separate checks.

Step 4 — Review FDA inspection and action records

• FDA warning letters — search the entity name and its brand names.
• FDA recalls, market withdrawals, and safety alerts — search by facility and product names.

Read what any found document actually says. An inspection or a letter is a record of an event, not a determination about every product a facility makes.

Step 5 — Match the exact compound claim

A facility's authorization covers specific practices — for example, sterile versus non-sterile compounding, and specific dosage forms. A claim that a compound is "made at a 503B" says nothing about whether that facility is authorized for that exact substance, form, and route. That match is what our registry records, substance by substance.