Home › Compounded semaglutide
Last reviewed 2026-09-30 · FDA and Federal Register text read 2026-09-30 · Compiled and edited by Darrel Donaghy
Compounded semaglutide: what the FDA has published, as of September 2026
Compounded semaglutide is made by a compounding pharmacy or outsourcing facility; it is not the FDA-approved product. Its shortage ended February 21, 2025; grace periods for compounders ran out by May 22, 2025. It is on neither the shortage list nor the 503B bulks list, and the FDA's example of an “essentially a copy” product is semaglutide with vitamin B12.
Status as reviewed 2026-09-30 · every line is the regulator's, with its date
- Is the FDA-approved semaglutide product in shortage?
- No. FDA, February 21, 2025: “FDA has determined the shortage of semaglutide injection products, a glucagon-like peptide 1 (GLP-1) medication, is resolved.” (FDA, FDA clarifies policies for compounders as national GLP-1 supply begins to stabilize, read 2026-09-30)
- Is semaglutide on the 503B bulks list?
- No, and not on the shortage list either, per the FDA's April 1, 2026 entry (quoted in the timeline below). An outsourcing facility therefore may not compound from bulk semaglutide. (FDA, FDA clarifies policies for compounders as national GLP-1 supply begins to stabilize, read 2026-09-30)
- Enforcement discretion for compounders after the shortage
- Ended. The FDA first gave 503A pharmacies until April 22, 2025 and 503B facilities until May 22, 2025, then extended the 503A period to the court's ruling. After the court denied the preliminary injunction on April 24, 2025, the FDA's April 28, 2025 entry states that for 503A compounding of semaglutide “the period of enforcement discretion (described below) has ended.” (FDA, FDA clarifies policies for compounders as national GLP-1 supply begins to stabilize, read 2026-09-30)
- Proposal to keep it off the 503B bulks list
- On May 1, 2026 the FDA published a notice proposing not to include semaglutide on the 503B bulks list (91 FR 23431); the comment period was extended to July 30, 2026 (91 FR 38719). (91 FR 23431 (May 1, 2026), docket FDA-2018-N-3240, read 2026-09-30)
- Adverse-event reports the FDA has received
- As of May 31, 2026, the FDA says it has received “990 reports of adverse events associated with compounded semaglutide”. It adds that such reports are likely underreported and that “it is not always possible to determine if the adverse event directly resulted from use of the drug or if other factors may have contributed to these adverse events”. (FDA, FDA's Concerns with Unapproved GLP-1 Drugs Used for Weight Loss, read 2026-09-30)
- Latest document on the 503B bulks-list docket (FDA-2018-N-3240)
- List of Bulk Drug Substances for Which There Is a Clinical Need Under Section 503B of the Federal Food, Drug, and Cosmetic Act; Extension of Comment Period, 91 FR 38719, published 2026-06-26. No final determination on semaglutide had been published as of the build's docket check on 2026-10-15.
What this box does not say: whether any product is right for you, or what it costs. It says what the regulator has published, and when. The pharmacy on your label is the next thing to check: look it up.
What the FDA has said, in order
The FDA keeps a dated log of its compounding policy for GLP-1 drugs. These are its entries for semaglutide, quoted with the FDA's own dates.
FDA has determined the shortage of semaglutide injection products, a glucagon-like peptide 1 (GLP-1) medication, is resolved. Semaglutide injection products have been in shortage since 2022 due to increased demand.
FDA confirmed with the drug's manufacturer that their stated product availability and manufacturing capacity can meet the present and projected national demand. Patients and prescribers may still see intermittent and limited localized supply disruptions as the products move through the supply chain from the manufacturer and distributors to local pharmacies.
To avoid unnecessary disruption to patient treatment, the agency does not intend to take action against compounders for violations of the FD&C Act arising from conditions that depend on semaglutide injection products' inclusion on FDA's drug shortage list:
For a state-licensed pharmacy or physician compounding under section 503A of the FD&C Act: compounding, distributing or dispensing semaglutide injection products that are essentially a copy of an FDA-approved product within 60 calendar days from today's announcement, until April 22, 2025.
For outsourcing facilities under section 503B of the FD&C Act: compounding, distributing or dispensing semaglutide injection products that are essentially a copy of an FDA-approved drug product within 90 calendar days from today's announcement, until May 22, 2025.
On April 24, 2025, the district court denied the plaintiffs' preliminary injunction motion in Outsourcing Facilities Association v. FDA, 4:25-cv-00174 (N.D. Tex.) regarding compounded semaglutide.
For a state-licensed pharmacy or physician compounding, dispensing or distributing semaglutide injection products under section 503A of the FD&C Act, the period of enforcement discretion (described below) has ended.
For outsourcing facilities compounding, distributing or dispensing semaglutide injection products under section 503B, FDA does not intend to take action for violations of the FD&C Act arising from conditions that depend on semaglutide injection products' inclusion on FDA's drug shortage list until May 22, 2025.
Tirzepatide and semaglutide do not currently appear on the 503B bulks list or on FDA's drug shortage list.
Which pharmacy made your semaglutide?
Type the name printed on the semaglutide label. The FDA's warnings about compounded GLP-1 drugs, with its adverse-event caveats, are on is compounded semaglutide safe?
Compounded semaglutide with vitamin B12
The FDA's April 1, 2026 entry uses this combination as its example of “essentially a copy”:
For example, FDA may consider a compounded drug product that combines semaglutide API and another API, such as vitamin B12 (cyanocobalamin), to be essentially a copy of a commercially available drug product when the:
- drug products are used by the same route of administration – the compounded drug product is given the same way as the commercially available drug products, such as an injectable
- drug products are the same, similar or easily substitutable strength – the amounts of semaglutide and vitamin B12 in the compounded drug product are within 10% of the strengths of the respective commercially available drug products.
The test in that example is the route and the strength of each ingredient. It gives no exception for adding an ingredient. The same entry sets the monthly number a 503A pharmacy can stay under; that sentence, and the statute it applies, are on 503A vs 503B.
What compounded semaglutide is
Semaglutide is the active ingredient in FDA-approved injection products. A compounded version is made from a bulk drug substance or another starting material by one of two kinds of compounder: a state-licensed pharmacy filling one patient's prescription under section 503A, or an FDA-registered outsourcing facility under section 503B. Semaglutide was on the FDA's shortage list from 2022 until February 2025. The copy limits in both sections turn on that list: once a shortage is resolved, the FDA generally treats the approved drug as commercially available again. Since then a 503A pharmacy is held to the “essentially a copy” limit and a 503B facility may not compound from bulk semaglutide, because semaglutide is not on the 503B bulks list; the FDA proposed on May 1, 2026 to keep it off.
Common questions
Is compounded semaglutide still legal?
The FDA's published position is a set of conditions, not a yes or no, and this site does not make that call. The dates: the shortage ended on February 21, 2025; the court denied the outsourcing facilities' preliminary injunction on April 24, 2025, which ended the FDA's grace period for 503A pharmacies; 503B facilities had until May 22, 2025. Since then a 503A pharmacy may not compound essentially a copy of the approved drug regularly or in inordinate amounts, and a 503B facility may not compound from bulk semaglutide unless it returns to the shortage list or is added to the 503B bulks list.
Can compounded semaglutide be combined with vitamin B12?
The FDA uses that combination as its example of a product it may consider essentially a copy: given the same way as the commercially available drug, such as an injection, with the semaglutide and the vitamin B12 each within 10% of the strength of the commercially available products. Adding B12 is not, in the FDA's example, what decides it.
Is compounded semaglutide the same as the FDA-approved product?
Not as a regulatory matter. The FDA's October 2, 2024 entry puts it this way: "Compounded drugs are not approved by FDA. FDA-approved drugs go through FDA's rigorous review for safety, effectiveness, and quality as part of the premarket approval process." This site does not compare the two products beyond that.
What was the semaglutide court case?
Outsourcing Facilities Association v. FDA, 4:25-cv-00174 in the Northern District of Texas. The FDA tied the end of its 503A grace period to the court's ruling on the plaintiffs' preliminary injunction motion. The court denied that motion on April 24, 2025, and the FDA's April 28, 2025 entry closed the 503A period.
Each quotation links its source, read 2026-09-30; the proposal is also in the FDA press release, April 30, 2026 and its extension in 91 FR 38719 (June 26, 2026). The docket is re-queried from the Federal Register API at every build. Not medical advice; see methodology.