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Last reviewed 2026-09-01 · FDA and Federal Register text read 2026-09-01
Compounded semaglutide: what the FDA has published, as of September 2026
Compounded semaglutide is semaglutide made by a compounding pharmacy or an outsourcing facility rather than the FDA-approved product. The FDA declared the semaglutide shortage resolved on February 21, 2025, and as of April 1, 2026 lists it on neither the shortage list nor the 503B bulks list. Below: the FDA's dated statements, the pending proposal, and the pharmacy lookup.
Status as reviewed 2026-09-01 · 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 2026-09-01)
- Is semaglutide on the 503B bulks list?
- No. FDA, April 1, 2026: “Tirzepatide and semaglutide do not currently appear on the 503B bulks list or on FDA's drug shortage list.” (FDA, FDA clarifies policies for compounders as national GLP-1 supply begins to stabilize, read 2026-09-01)
- Enforcement discretion for compounders after the shortage
- Ended. The FDA gave 503A pharmacies until April 22, 2025 and 503B facilities until May 22, 2025; its April 1, 2026 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 2026-09-01)
- 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 2026-09-01)
- 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 2026-09-01)
- 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 2026-09-02.
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.
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.
Tirzepatide and semaglutide do not currently appear on the 503B bulks list or on FDA's drug shortage list.
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.
What the statute allows now, in the FDA's words
With the shortage resolved, the question for both kinds of compounder is the “essentially a copy” restriction. The FDA's April 1, 2026 entry states it for each:
Section 503A of the FD&C Act includes restrictions on compounding drugs that are essentially copies of a commercially available drug. When a drug shortage is resolved, FDA generally considers the drug to be commercially available. Certain amounts are permissible under the law as long as the compounding is not done “regularly or in inordinate amounts.”
Section 503B of the FD&C Act restricts outsourcing facilities from making compounded drugs that are essentially a copy of one or more FDA-approved drugs. Among other things, this means the compounded drug may not be identical or nearly identical to an FDA-approved drug unless the approved drug is on FDA's drug shortage list.
Whether a particular pharmacy's semaglutide falls inside or outside those sentences is a determination for the FDA and the state board, not for this site. What this site can show you is which kind of compounder made yours, and its record. 503A vs 503B, in the statute's words explains the two.
How to read your label
A compounded prescription is labelled with the pharmacy or outsourcing facility that made it, which is often not the telehealth brand that sold it. Type that name below. If it matches, the maker is an FDA-registered 503B facility and its inspection record is on this site with the FDA's date. If it does not match, it is most likely a state-licensed 503A pharmacy, whose license lives at its state board of pharmacy.
What the FDA says about compounded GLP-1 drugs
A compounded drug might be appropriate if a patient's medical need cannot be met by an FDA-approved drug, or the FDA-approved drug is not commercially available. However, compounded drugs are not FDA approved. This means the agency does not review compounded drugs for safety, effectiveness or quality before they are marketed.
FDA has received reports of adverse events related to compounded versions of semaglutide and tirzepatide. However, federal law does not require state-licensed pharmacies that are not outsourcing facilities to submit adverse events to FDA so it is likely that adverse events from compounded versions of these drugs are underreported. Many of the adverse events reported for compounded products appear to be consistent with adverse events related to the FDA-approved versions of these products.
The agency urges consumers to be vigilant when purchasing drugs online and only purchase from state-licensed pharmacies.
If you have had a problem with a compounded drug, the FDA's reporting channel is MedWatch; the pharmacy's state board takes complaints about the pharmacy itself.
What compounded semaglutide is
Semaglutide is the active ingredient in FDA-approved injection products. A compounded version is made by a pharmacy or an outsourcing facility from a bulk drug substance or another starting material, under one of two sections of federal law: section 503A, for a state-licensed pharmacy filling one patient's prescription, or section 503B, for an FDA-registered outsourcing facility. The two are inspected by different regulators and held to different standards; 503A vs 503B, in the statute's words lays them out. The FDA's own one-sentence description of every compounded drug applies here: it is not FDA-approved, and the agency does not review it for safety, effectiveness or quality before it is marketed. What the FDA does publish is the inspection record of every 503B facility, and that is what the lookup above searches.
Common questions
Is compounded semaglutide legal?
This site does not make that call, and the FDA's published position is a set of conditions rather than a yes or no. With the shortage resolved and the enforcement-discretion period over, section 503A restricts a pharmacy from compounding drugs that are essentially copies of a commercially available drug, with the FDA noting that "certain amounts are permissible under the law as long as the compounding is not done regularly or in inordinate amounts"; section 503B restricts outsourcing facilities from compounding a drug that is essentially a copy of an FDA-approved drug unless the approved drug is on the shortage list. Whether a particular pharmacy is within those conditions is for the FDA and its state board.
Why can a pharmacy still offer compounded semaglutide?
Because the restrictions above are conditional, and because a 503A pharmacy answers first to its state board rather than to the FDA. The FDA's own questions-and-answers page says it "does conduct surveillance and for-cause inspections of state-licensed pharmacies that are not registered as outsourcing facilities". A pharmacy offering it is not, by that fact alone, in or out of compliance; its record is what you can check.
Is compounded semaglutide the same as the FDA-approved product?
The FDA's sentence is the one to keep: "compounded drugs are not FDA approved. This means the agency does not review compounded drugs for safety, effectiveness or quality before they are marketed." This site does not compare the two beyond that.
What happens if the FDA finalises the bulks-list proposal?
The proposal concerns whether outsourcing facilities (503B) may compound semaglutide from bulk drug substances. A final determination will be published in the Federal Register on the same docket, FDA-2018-N-3240. The status box on this page shows the newest document on that docket at every build, and the page's text will be re-reviewed when one appears.
How do I find out which pharmacy made mine?
It is printed on the label of the compounded product, and usually in the telehealth brand's paperwork. Type that name into the lookup on this page. A match means an FDA-registered 503B facility with its inspection record here; no match usually means a state-licensed 503A pharmacy, whose license the state board holds.
Sources, all read 2026-09-01: FDA, FDA clarifies policies for compounders as national GLP-1 supply begins to stabilize (content current as of 04/01/2026); FDA, FDA's Concerns with Unapproved GLP-1 Drugs Used for Weight Loss (content current as of 09/01/2026); FDA press release, April 30, 2026; 91 FR 23431 (May 1, 2026), docket FDA-2018-N-3240; 91 FR 38719 (June 26, 2026). The docket is re-queried from the Federal Register API at every build. Nothing on this page is medical advice; see methodology.