The short answer. Semaglutide is FDA-approved, and the shortage that opened broad compounding ended on February 21, 2025. As of September 25, 2026, a 503A pharmacy may compound it only for a named patient and only inside FDA’s limits on copies of a commercially available drug. A 503B outsourcing facility has no bulk pathway, and FDA has proposed making that permanent.
| FDA approved | Yes. Ozempic (2017), Rybelsus (2019), Wegovy (2021), Wegovy tablets (Dec 22, 2025), Wegovy 7.2 mg (Mar 19, 2026). |
|---|---|
| Shortage | Resolved Feb 21, 2025. |
| 503A pharmacy | Eligible as a component of an approved drug, restricted by the essentially-a-copy rules below. |
| 503B outsourcing facility | No bulk pathway. Not on the 503B bulks list or the shortage list. Exclusion proposed at 91 FR 23431; no final action. |
| Latest FDA action | Warning letters to 30 telehealth companies, Mar 3, 2026. |
| MDside position | Our providers prescribe the approved products. A compounded preparation is used only where the prescriber documents a patient-specific difference. |
| Last verified | 2026-09-25 |
Three separate tests decide what a 503A pharmacy may compound
Most vendor summaries collapse these into one rule. FDA’s 2018 guidance keeps them apart, and so should you.
- Is it essentially a copy? A compounded product is a copy if it has the same active ingredient as a commercially available drug, in the same, similar or easily substitutable strength, for the same route. A combination counts too: FDA’s own example is semaglutide with B12, which is still a copy when the strengths sit within 10%.
- Did the prescriber document a significant difference? If the prescriber determines that a change produces a significant difference for an identified patient, and records that on the prescription, the product is not a copy. A prescription carrying only a name and a formulation does not qualify. A lower price never qualifies.
- Is the pharmacy compounding copies regularly or in inordinate amounts? FDA’s enforcement policy is that it will not act if a pharmacy fills four or fewer copy prescriptions of a product in a calendar month. Prescriptions with a documented difference do not count toward the four.
The four-prescription figure is an enforcement policy. It will not support a weight-loss program, and a pharmacy telling you otherwise is describing its own risk appetite.
The grace periods ended in spring 2025
FDA gave 503A pharmacies until April 22, 2025 or the date of the court’s ruling on a preliminary injunction, whichever came later. The court denied the injunction on April 24, 2025, so that is the date 503A discretion actually ended. Outsourcing facilities lost theirs on May 22, 2025.
The 503B pathway is being closed formally
On May 1, 2026 FDA proposed excluding semaglutide, tirzepatide and liraglutide from the 503B bulks list (91 FR 23431, Docket FDA-2018-N-3240). FDA’s reasoning is that supply problems, convenience and cost do not amount to clinical need. The comment period was extended to July 30, 2026. As of September 2026 no final action has been published.
Enforcement is aimed at the marketing
In February 2026 FDA said it intends to act against mass-marketed compounded GLP-1s, and on March 3, 2026 it sent warning letters to 30 telehealth companies over claims that compounded products are the same as the approved drugs and over branding that hides who compounded them. Since September 2025, GLP-1 active ingredients entering the country also face an import green list under Import Alert 66-80.
What this means for you
Default to the approved product. If a patient genuinely needs something different, the prescriber documents why, for that patient, on that prescription, and the pharmacy keeps it. Remove any page that presents a compounded product as Wegovy or Ozempic by another name. If your program economics only work on compounded semaglutide at volume, rebuild them now rather than after the 503B rule is final. Our weight management program is built on that basis.
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Frequently asked questions
Is compounded semaglutide legal in 2026?
Only in narrow circumstances. A 503A pharmacy may compound it for a named patient where the prescriber documents a significant clinical difference, or in small numbers under FDA’s four-a-month enforcement policy. Outsourcing facilities have no bulk pathway. Routine compounding as a standing program sits outside both limits.
Does adding B12 make compounded semaglutide different?
No. FDA’s guidance names semaglutide with B12 as an example of a copy. A combination of the same ingredients as commercially available drugs, within 10% of their strengths, is treated as essentially a copy unless the prescriber documents a significant difference for that patient.
When did the semaglutide shortage end?
FDA’s declaratory order found the shortage resolved on February 21, 2025. The 503A grace period effectively ended April 24, 2025, when the court denied a preliminary injunction, and the 503B grace period ended May 22, 2025. Quotes of other dates usually come from shortage-era vendor material.
Can a 503B outsourcing facility still make semaglutide?
Not from bulk. An outsourcing facility may compound from bulk only if the substance is on the 503B bulks list or the drug is in shortage, and semaglutide is neither. FDA proposed a formal exclusion in May 2026, and no final action had been published as of September 2026.
Primary sources. Last verified September 25, 2026. Corrections are welcome: contact us.
- FDA approval letter, Wegovy tablets, NDA 218316 (Dec 22, 2025)
- FDA press release, higher-dose semaglutide approved under the National Priority Voucher program (Mar 19, 2026)
- FDA declaratory order, semaglutide shortage resolved (Feb 21, 2025)
- FDA, FDA clarifies policies for compounders as national GLP-1 supply begins to stabilize
- FDA guidance, Compounded Drug Products That Are Essentially Copies of a Commercially Available Drug Product Under Section 503A (Jan 2018)
- FDA guidance, Compounded Drug Products That Are Essentially Copies of Approved Drug Products Under Section 503B
- 91 FR 23431 (May 1, 2026), proposal to exclude semaglutide, tirzepatide and liraglutide from the 503B bulks list, Docket FDA-2018-N-3240
- 91 FR 38719 (June 26, 2026), comment period extended to July 30, 2026
- FDA, FDA intends to take action against non-FDA-approved GLP-1 drugs (Feb 6, 2026)
- FDA, FDA warns 30 telehealth companies against illegal marketing of compounded GLP-1s (Mar 3, 2026)
- FDA Import Alert 66-80, GLP-1 active ingredient green list
This is general information, not legal advice. Rules vary by state and change. Confirm your own facts with counsel.