How to judge compounded GLP‑1 quality

Two compounding standards

What to ask before you buy

1. 1. Is this a 503A or 503B facility? (503B is the higher standard.)
2. 2. Can you provide a Certificate of Analysis for my batch? (Potency + sterility.)
3. 3. What is the source of your semaglutide/tirzepatide active ingredient? (FDA-registered API supplier?)
4. 4. Are you LegitScript certified? (Verify on the LegitScript registry.)
5. 5. Is the prescriber licensed in my state? (State board lookup.)
6. 6. Is this semaglutide base or a salt form (acetate/sodium)? (Salt forms are not the FDA-studied molecule.)

Want to see who actually answers these questions? Our pharmacy transparency scorecard rates the major compounded-GLP-1 sellers on whether they name their pharmacy, cite accreditation, and disclose testing.

Frequently asked

What is the difference between 503A and 503B compounding?

503A pharmacies compound patient-specific prescriptions in smaller volumes under state board oversight. 503B outsourcing facilities are FDA-registered, follow cGMP (current Good Manufacturing Practice), undergo FDA inspection, and can compound in larger batches. 503B is the higher quality-control standard.

Is compounded semaglutide FDA-approved?

No. Compounded medications are not FDA-approved. They are legal to compound under 503A/503B rules, but the FDA does not verify their safety, efficacy, or quality the way it does for branded Wegovy or Ozempic. Once the FDA declared those shortages resolved — tirzepatide in December 2024, semaglutide in February 2025 — population-scale compounding of copies lost the shortage exemption that had made it broadly permissible.

How do I verify a compounding pharmacy is legitimate?

Check: (1) state board of pharmacy license lookup, (2) for 503B, the FDA registered outsourcing facility list, (3) LegitScript certification, (4) whether they provide third-party potency and sterility test results (Certificate of Analysis) on request.

What is a Certificate of Analysis (COA)?

A COA is a third-party lab document confirming the compounded product’s potency (actual mg vs labeled), purity, and sterility. Reputable compounders provide COAs on request. If a provider cannot or will not produce one, treat that as a red flag.