How to verify a compounding pharmacy

The short answer: To verify a compounding pharmacy, check 5 things — that its state pharmacy license is active, whether it is a 503A or FDA-registered 503B facility, whether it holds LegitScript certification and PCAB accreditation, whether it provides a batch certificate of analysis for potency and sterility, and its FDA inspection history. A provider that will not name its pharmacy makes every one of these impossible to check.

Why the pharmacy is the thing to check

When a medication is FDA-approved, the FDA has reviewed its manufacturing for safety, effectiveness, and quality. Compounded semaglutide and tirzepatide have not been through that review. That shifts the burden of quality assurance onto the compounding pharmacy that prepares your specific medication — its licensing, its testing, and its track record become the signals you have to rely on.

This is not hypothetical. In the compounded-GLP-1 market, pharmacy quality has varied enough to draw regulatory action: one telehealth company's former compounding pharmacy, Aequita, closed in April 2025 after a Washington State Department of Health "Immediate Jeopardy" finding. That is exactly why knowing — and being able to check — which pharmacy makes your medication matters so much.

Step 1: Know whether it's a 503A or a 503B

U.S. compounding pharmacies fall into two regulatory categories under the Federal Food, Drug, and Cosmetic Act, and the difference tells you how much oversight applies.

Neither category makes an FDA-approved drug when it compounds. A 503B facility carries additional federal oversight and must follow CGMP, which many patients treat as a stronger baseline for a sterile injectable. A well-run 503A can still be an excellent, appropriately licensed choice — the point is to know which one you are dealing with so you can apply the right checks.

Step 2: Confirm the license is active

Every legitimate compounding pharmacy holds a license with the board of pharmacy in its home state, and typically in the states it ships to. State boards publish online license-lookup tools; search the pharmacy's name and confirm the license is active and in good standing, with no recent disciplinary action. This is the single most basic check, and it takes about two minutes.

Step 3: Look for LegitScript and PCAB

Two third-party credentials are worth looking for. LegitScript certification vets pharmacies and telehealth sites for regulatory compliance and is required for advertising on major platforms like Google, so its absence on a pharmacy is a flag. PCAB accreditation (the Pharmacy Compounding Accreditation Board, part of ACHC) specifically evaluates compounding quality against recognized standards. As a real-world example, Hallandale Pharmacy — which Henry Meds names as a partner — is PCAB-accredited. Accreditation is not a guarantee of a perfect batch, but it signals the pharmacy has submitted to outside review.

Step 4: Ask for a certificate of analysis (COA)

A certificate of analysis is a lab report for a specific batch of medication. For a compounded injectable, the two results that matter most are:

• Potency — confirmation that the active ingredient is present at the labeled strength (not under- or over-dosed).
• Sterility and endotoxins — confirmation that an injectable batch is free of microbial contamination, tested to recognized standards for sterile products.

The strongest COAs come from an independent third-party lab rather than only the pharmacy's own testing. Ask which pharmacy prepared your medication and request the COA for that batch; a quality operation should be able to provide it. Testing of injectables ties back to two USP chapters you can ask about by name: USP <797>, which governs sterile compounding practices, and USP <85>, the standard bacterial-endotoxins test.

Step 5: Check FDA inspection and warning-letter history

The FDA publishes warning letters and inspection outcomes on fda.gov. Search the pharmacy's name for any recent warning letter, particularly ones citing good-manufacturing-practice or sterility problems. The compounded-GLP-1 space has seen enforcement here — the FDA issued a warning letter in June 2025 to a 503B facility, MedisourceRx, citing GMP violations. A clean record is reassuring; an unaddressed warning letter is a serious flag worth raising with your provider.

Questions to ask before you buy

You can run most of the checklist above by asking a provider a short list of direct questions. If a provider deflects on these — especially the first one — treat that as an answer in itself:

• Which specific compounding pharmacy will prepare my medication?
• Is it a 503A pharmacy or an FDA-registered 503B outsourcing facility?
• Is the pharmacy licensed in my state, and can I look that up?
• Is it LegitScript-certified and PCAB-accredited?
• Can you provide a certificate of analysis (potency and sterility) for my batch, from an independent lab?
• Where does the active pharmaceutical ingredient come from, and is the source FDA-registered?
• Has the pharmacy had any FDA warning letters or state disciplinary actions?

Red flags to walk away from

A few patterns should give you real pause: a provider that will not name its pharmacy at all; no certificate of analysis available on request; no verifiable state license; medication marketed as identical to Ozempic®, Wegovy®, Mounjaro®, or Zepbound® (it is not — compounded is a different, non-FDA-approved product); or any claim that a compounded drug is "FDA-approved," which is never accurate. Pressure to prepay for long plans before you can verify any of this is another reason to slow down.

The bottom line

Verifying a compounding pharmacy comes down to visibility: you can only check what a provider is willing to name. Confirm the license, learn whether it is 503A or 503B, look for LegitScript and PCAB, get a certificate of analysis for potency and sterility, and check FDA history. A provider that answers these questions readily is giving you the tools to make an informed decision — which is the whole point.