Pharmacy verification checklist
A practical checklist to confirm a telehealth program uses a legitimate, licensed compounding pharmacy.
Pharmacy verification checklist
- ☐ The pharmacy partner is named on the provider's site
- ☐ Its state license (503A) or FDA registration (503B) can be verified
- ☐ A licensed prescribing clinician is named
- ☐ A real telehealth visit and medical review are required
- ☐ Formulation and concentration are disclosed
- ☐ No "research use only" or "not for human consumption" language
If any box is unchecked, treat the provider with caution. An unnamed pharmacy is a red flag.
Registration is per-facility, not per-company: one company can operate both. Source: FDCA sections 503A and 503B; FDA compounding guidance.
The regulatory reality every provider glosses over
| Date | What happened | Why it matters to you |
|---|---|---|
| 15 Dec 2022 | Tirzepatide added to the FDA drug shortage list. | The shortage exception opens. This is what created the compounded market. |
| 2 Oct 2024 | FDA declares the tirzepatide shortage RESOLVED. | The legal basis for compounding tirzepatide as an 'essentially a copy' drug begins to close. |
| 19 Dec 2024 | FDA reaffirms resolution in a declaratory order. | Sets a 60-day (503A) and 90-day (503B) transition. |
| 18 Feb 2025 | 503A enforcement discretion for tirzepatide ENDS. | State-licensed pharmacies must stop compounding tirzepatide copies. |
| 19 Mar 2025 | 503B enforcement discretion for tirzepatide ENDS. | Outsourcing facilities must stop too. |
| 24 Apr / 7 May 2025 | Courts deny the Outsourcing Facilities Association injunction. | OFA v. FDA, N.D. Tex. The FDA's determination stands. |
| 30 Apr 2026 | FDA proposes excluding tirzepatide, semaglutide and liraglutide from the 503B bulks list. | Finding: no clinical need. Comment period closed 29 Jun 2026. |
The rule that governs everything: “essentially a copy”
Sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act bar compounders from producing a drug that is essentially a copy of a commercially available FDA-approved product. While a drug sits on the FDA shortage list, that bar is lifted. When the shortage resolves, it snaps back.
Both shortages are over. So routine compounding of tirzepatide is no longer lawful on the basis that created the market — a fact several comparison sites still describe as “permanent legitimacy through 503A/503B.” That claim is simply wrong.
Why every provider suddenly sells “personalized” and “microdose” doses
One narrow route survives. A compounded product is not an “essentially a copy” if the prescriber determines — and documents on the prescription — a significant clinical difference for that individual patient. Changing the strength so it is not “the same, similar, or easily substitutable” for an approved dose is what keeps the product outside the copy definition.
That is the legal mechanism behind the industry-wide pivot to “personalized dosing” and “microdose” programmes. The timing tracks the end of enforcement discretion in early 2025 almost exactly. It is a regulatory workaround, not a clinical innovation, and nobody selling it will tell you so.
The FDA gives examples of a genuine clinical difference — removing an excipient because of a documented allergy, or switching a tablet to a liquid for a patient who cannot swallow — and expressly notes such changes are not necessarily applicable to GLP-1 drugs. That is a pointed signal about how much weight the agency gives this workaround.
Registration is per-facility, not per-company. Source: FDCA §503A and §503B; FDA compounding guidance.
A pharmacy is either state-licensed (503A) or an FDA-registered outsourcing facility (503B). Registered is not approved. Neither status makes the compounded drug it produces FDA-approved, and the FDA has specifically warned telehealth companies against implying otherwise.
If you see ‘FDA-approved pharmacy’, ‘FDA-licensed pharmacy’, or ‘generic Zepbound’ on a provider's site, treat everything else on that site with suspicion. It tells you they are either careless with regulatory language or willing to mislead — and you cannot tell which.
The seven-question pharmacy verification checklist
The pharmacy matters more than the brand on the front of the website. The telehealth company arranges your consultation; the pharmacy makes the medicine you inject. Ask these seven, in writing.
- Which specific pharmacy will fill my prescription? Not “our network of licensed pharmacies” — the name of the facility.
- Is it a 503A state-licensed pharmacy or a 503B FDA-registered outsourcing facility? These are different regulatory categories with different oversight, and registration is per-facility, not per-company — one company can operate both.
- In which state is it licensed, and can I look up the licence? State boards of pharmacy publish searchable licensee databases. Use them.
- What is the exact salt form and concentration?
- Is the vial single-dose or multi-dose? A multi-dose vial requires you to measure each dose yourself — the most common source of the reported adverse events above.
- Will you provide a certificate of analysis? And note the limitation: a CoA reflects the batch that was tested, not necessarily the vial in your hand.
- Has the pharmacy received any FDA warning letter or state board action?
A provider that answers all seven in writing is demonstrating something real. A provider that will not name its pharmacy has already answered your question, whether it intended to or not.
Adverse events: the figure almost every site gets wrong
Source: FDA GLP-1 webpage, reporting 1,700+ adverse events associated with compounded semaglutide and tirzepatide as of May 21, 2026 — against the 775 total, Feb 2025 figures from February 2025 that almost every comparison site is still quoting. Reports are voluntary and do not establish causation, but the trend is the point.
As of 21 May 2026, the FDA reports having received more than 1,700 adverse events associated with compounded semaglutide and tirzepatide. That is more than double the figure still in circulation, in roughly fifteen months.
Adverse-event reports are voluntary, are not adjudicated, and do not by themselves establish causation. That caveat is real and we will not drop it. But a site that quotes the 2025 number in mid-2026 is not being cautious — it is being out of date, and in a direction that flatters the product it is paid to sell.
This matters far beyond one study, because it exposes the flaw in the whole ‘personalized dosing’ defence. Adding B12 was one of the commonest ways compounders argued their product was not “essentially a copy” of the approved drug — a clinical difference that kept them inside the law. The finding shows that the additive did not merely differentiate the product on paper. It chemically changed it, into something nobody has tested in a human being.
What to do: if you are taking a compounded tirzepatide that contains B12 — and many do, often marketed as ‘tirzepatide + B12’ or ‘with methylcobalamin’ — ask your provider and your pharmacy, in writing, whether they have tested for adduct formation. Most will not have. That answer is itself information.
In the 30 April 2026 Federal Register notice (docket 2026-08552), the agency stated that there is no clinical need for outsourcing facilities to compound semaglutide, tirzepatide or liraglutide from bulk — and went out of its way to clarify that supply and affordability are not what the statute means by clinical need.
In plain terms: there are FDA-approved products; they work; patients can be treated with them. Whether a patient can afford them is a different problem, with a different set of policy tools.
That single sentence does enormous work. Every compounded-GLP-1 marketing page in America is, at bottom, an affordability argument. The agency has now said, on the record, that affordability is not a legal basis for compounding these drugs. If you are choosing a compounded programme because it is cheaper, you should know that the regulator has explicitly said that reason does not count.