Data investigation

We Read FDA's Register of Compounding Facilities. 40 of 98 Have Never Been Inspected.

Original analysis of FDA's published 503B register: 98 facilities, 40 never inspected — and why that headline number is the misleading one.

By Ruth Calder · Enforcement Editor
Editorially reviewed & fact-checked against primary sources · How we verify contentLast reviewed
6 min read·2 citations

If a compounded GLP-1 arrives at your door, some pharmacy made it, and you are entitled to know which one and whether anyone has ever walked through the building. For one half of the compounding market there is a federal answer, published and free. We pulled the whole register and went through it.

What the register is

FDA maintains a list of every facility registered under section 503B of the Food, Drug, and Cosmetic Act — outsourcing facilities, the larger compounders that make medication in batches. For each one it publishes the name, the city and state, the date it first registered, the date it most recently re-registered, and the date it was last inspected.[1] On our pull it held 98 facilities.

Not being on this list means nothing on its own. The other route, 503A, covers pharmacies compounding for one patient against one prescription, and those are licensed by state boards rather than registered with FDA. A perfectly ordinary 503A compounder is correctly absent here. If a seller’s pharmacy is not on the federal register, the question that follows is which state licenses it — not whether it is hiding.

Forty of the ninety-eight have never been inspected

FDA does not bury this. The inspection column says, in plain words, “Not yet inspected”, and it says it for 40 of the 98 — 41% of the register. That is the number most people would publish, and on its own it is misleading.

The distribution says something different

We checked how long each uninspected facility had been registered. Almost all of them are recent. Of the 40 that have never been inspected, only three have been on the register for three years or more, and none for five. The rest registered within the last two years.

Never inspected, longest on the register (FDA data, pulled August 14, 2026)
FacilityLocationRegistered sinceYears
Bennett Pharmaceuticals of America LLCHudson, WIApril 19, 20224.3
Denver Solutions, LLC, dba Leiters HealthBuena, NJJuly 1, 20224.1
McGuff Pharmaceuticals, Inc. dba McGuff Outsourcing SolutionsSanta Ana, CAJanuary 11, 20233.6

Read the other way round, the register looks like an agency keeping up rather than one that has lost track. Of the 58 facilities that have been inspected, 55 were last inspected in 2025 or 2026. Only two have gone more than two years since an inspector was there.

Why we are saying this rather than the scarier version. “41% of federally registered compounders have never been inspected” is a true sentence we could have run as a headline. It would also have left you with a false impression, because the number is mostly made of facilities that registered last year. A figure with the qualification stripped off is the thing this site exists to catch, and that applies to our own writing first.

Where they are

The register concentrates in a handful of states: Texas (17), Florida (15), New Jersey (10) and California (9) hold just over half of it between them. That matters mainly because a facility’s state is the thing you can look up next.

How to use this as a buyer

  1. Ask which pharmacy fills the prescription, by name. Most sellers we track do not publish this. An unnamed pharmacy is a finding in itself.
  2. Look for that name on the federal register. If it is there, you can see when it registered and when it was last inspected.
  3. If it is not there, ask which state board licenses it. That is the right follow-up, not an accusation — 503A pharmacies belong to state boards.
  4. Treat “not yet inspected” as context, not a verdict. On this register it usually means recently registered.
We record which sellers name a dispensing pharmacy and which do not, in the seller register. At the last count, 28 of the 577 sellers we track named one at all.

Frequently Asked Questions

References

  1. 1.U.S. Food and Drug Administration Registered Outsourcing Facilities FDA Human Drug Compounding. 2026. https://www.fda.gov/drugs/human-drug-compounding/registered-outsourcing-facilities
  2. 2.U.S. Food and Drug Administration Human Drug Compounding Laws FDA Human Drug Compounding. 2026. https://www.fda.gov/drugs/human-drug-compounding/compounding-laws-and-policies

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