What does a certificate of analysis actually prove?

A certificate of analysis reports what a specific tested sample contained. It is meaningful only if it names the product and lot you received and comes from an independent laboratory. It says nothing about sterility of your vial, storage in transit, or clinical appropriateness.

What is a red flag I can spot myself?

Anything sold "for research use only" is not a medicine and is not prescribed to you. So is any seller that ships without a prescription written in your name, will not name the compounding pharmacy, or claims its product is equivalent to an FDA-approved drug.

Should I stop a compounded prescription I am already on?

That is a decision for you and your prescriber, and stopping or switching a GLP-1 has its own consequences. Take the questions on this page to them; nothing here is medical advice or a recommendation to start or stop anything.

Is Compounded Semaglutide Safe? What You Can Actually Verify

Q: Is compounded semaglutide FDA approved?

No. The FDA states that "compounded drugs are not FDA approved" and that "the agency does not review compounded drugs for safety, effectiveness or quality before they are marketed". Vendors advertising compounded GLP-1s generally state the same thing on their own pages.

The honest answer first

There is no checklist that turns a compounded product into an approved one. The FDA's position is flat: "Compounded drugs are not FDA approved. This means the agency does not review compounded drugs for safety, effectiveness or quality before they are marketed." Every item below narrows the range of things that can go wrong. None of them closes it.

With that said, the difference between a prescription filled by a licensed pharmacy you can look up and a vial bought from a website that will not name its source is enormous, and it is checkable in an afternoon.

The checklist

1. The pharmacy's state licence

Every US compounding pharmacy holds a licence from a state board of pharmacy, and most state boards publish a free online licensee lookup. You need the pharmacy's actual name — not the telehealth brand on the box.

That last point is exactly what the FDA raised on 3 March 2026 when it wrote to 30 telehealth companies about "obscuring product sourcing by advertising drug products branded with the telehealth firm's name or trademark without qualification", the agency's concern being that firms implied they were the compounders when they were not. If a company will not tell you which pharmacy compounded your prescription, that is the answer to the question.

Proves: the pharmacy exists, is licensed, and its disciplinary history is visible. Does not prove: anything about your specific vial.

2. Whether it is a 503A pharmacy or a registered 503B facility

503A: state-licensed, compounds against individual prescriptions.
503B: an outsourcing facility that registers with the FDA, is subject to current good manufacturing practice requirements, and appears on the FDA's published register of outsourcing facilities.

503B registration is checkable against the FDA's own list, and it means the facility is subject to CGMP inspection. It is not an approval of the product it makes.

3. The exact ingredient named on the label

The FDA has said that semaglutide salt forms — "including semaglutide sodium and semaglutide acetate" — "are different active ingredients than are used in the approved drugs", and that it lacks safety information for them. The label and the paperwork should name the base form. If the paperwork says "semaglutide sodium", that is a different active ingredient from what is in Wegovy or Ozempic, on the FDA's own reading.

4. Ingredient grade and source

Ask whether the active pharmaceutical ingredient is USP grade and where it was sourced. A pharmacy that compounds professionally can answer this without hesitation. Compare that with the sellers described in the next section, who cannot.

5. Testing documentation, read properly

A certificate of analysis is only as good as the questions you ask of it:

Does it name your product and lot number, or a different one?
Is the testing laboratory independent of the seller?
Does it cover potency and sterility and endotoxins for an injectable?
Is it dated near your fill?

A generic PDF with no lot number is decoration.

6. The prescriber

You should be able to name the clinician who wrote your prescription and verify their licence in your state through that state's medical board lookup. A prescription written after an asynchronous questionnaire with nobody identifiable behind it is a different thing from a consultation.

7. The claims being made to you

The FDA's March 2026 letters targeted "claims implying sameness with FDA-approved products". A seller telling you its product is Wegovy, is "the same as" Ozempic, or is "FDA-approved" is making a claim the agency has already written to companies about. Take that as information about the seller.

Hard stops

Some things are not a matter of degree.

"Research use only" / "not for human consumption." These are not medicines. They are not prescribed to you, they carry no pharmacy accountability, and buying them puts you outside the prescription system entirely.
No prescription in your name. If a website will ship without one, whatever it is shipping is not a compounded prescription drug for you.
Unapproved compounds entirely. The FDA has stated that consumer sales of retatrutide and other unapproved GLP-1 versions are illegal and cannot lawfully be compounded — a category apart from compounded copies of approved drugs.
Dosing beyond the approved label. The FDA has specifically flagged doses "beyond what is in the FDA-approved drug label", including higher single doses, increased frequency, or accelerated titration, and has reported adverse events "some requiring hospitalization, that may be related to dosing errors associated with compounded injectable semaglutide products". We give no dosing guidance of any kind; this belongs with your prescriber.

What to do with the answers

Write them down. The value of this list is not that it produces a verdict — it produces a set of facts you can put in front of a clinician or a pharmacist, who can weigh them in a way a checklist cannot.

If you keep a log, record the pharmacy name, the lot number, and the expiry for each vial as it arrives, alongside your doses. That turns a vague "something felt different this month" into a checkable question about a specific lot. TrackPep's inventory records vial identity and expiry alongside the doses drawn from it; the reconstitution calculator covers the arithmetic side.