Where compounded semaglutide stands with the FDA, with the dates
The shortage that made mass-compounded semaglutide lawful ended on February 21, 2025. Enforcement discretion for pharmacies ran out on April 22, 2025 and for outsourcing facilities on May 22, 2025. Eighteen months later the compounded market is still here, because the rules that replaced the shortage exemption leave room that sellers have moved into — different strengths, different routes, and combinations with another ingredient.
What this comes down to
- Tirzepatide's shortage was declared resolved on October 2, 2024, remanded, then re-determined resolved on December 19, 2024. Semaglutide's was declared resolved on February 21, 2025.
- Neither drug appears on the 503B bulks list or the drug shortage list. On April 30, 2026 the FDA proposed to exclude semaglutide, tirzepatide and liraglutide from that bulks list outright.
- The essentially-a-copy test has a published example involving a GLP-1 combined with vitamin B12 within 10% of the approved strengths, and a stated threshold of four or fewer prescriptions per calendar month.
- A 2026 secret-shopper study of 75 weight-loss clinics and medical spas in two states found 56% still offering a compounded GLP-1 combined with B vitamins.
The timeline, from the agency's own page
The FDA keeps one page for this, updated in place, with each entry stamped by the date it was posted. The version we read carries a face date of April 1, 2026[1]. Reading it from the bottom up is the only way it makes sense, because the newest entry sits at the top and the reasoning is at the bottom.
| Date on the entry | What it says |
|---|---|
| October 2, 2024 | Tirzepatide injection shortage determined resolved. |
| October 22, 2024 | The decision to remove tirzepatide from the shortage list is remanded to the agency for reevaluation as part of litigation. |
| December 19, 2024 | A new decision determines the tirzepatide shortage resolved; discretion runs 60 days for 503A and 90 days for 503B. |
| February 21, 2025 | Semaglutide injection shortage determined resolved; discretion to April 22 for 503A and May 22 for 503B. |
| March 5 and April 24, 2025 | The district court denies the plaintiffs' preliminary injunction motions in the tirzepatide and then the semaglutide cases. |
| April 1, 2026 | Neither tirzepatide nor semaglutide appears on the 503B bulks list or on the drug shortage list. |
| April 30, 2026 | The agency proposes to exclude semaglutide, tirzepatide and liraglutide from the 503B bulks list, with comments due June 29, 2026. |
Dates as posted on the FDA compounding page, read September 11, 2026
A state-licensed pharmacy compounds under section 503A, for an individual patient, on a prescription. An outsourcing facility registers under section 503B and can compound without patient-specific prescriptions, but only from substances on a published list or from a drug that is in shortage[6]. That is why the two deadlines were 30 days apart, and why the bulks list proposal matters more to one kind of company than the other.
That proposal is the newest thing on this timeline and the most consequential for outsourcing facilities. On April 30, 2026 the agency announced it was proposing to exclude semaglutide, tirzepatide and liraglutide from the 503B bulks list, saying it did not identify a clinical need for outsourcing facilities to compound them from bulk drug substances, and opened comments through June 29, 2026[2]. A proposal isn't a final determination, and the agency says it will consider the comments before making one.
The essentially-a-copy test, and the room in it
With the shortage over, the constraint is the rule against compounding what is essentially a copy of a commercially available drug. The agency's page states the test: same active ingredient, in the same, similar or an easily substitutable strength, usable by the same route — unless a prescriber determines and documents that the compounded product contains a change producing a significant difference for that individual patient[1].
The page then gives a worked example that names the exact product this site sees most: a compounded drug combining semaglutide and vitamin B12 may be considered essentially a copy when it is given the same way as the approved products and the amounts of semaglutide and B12 are within 10% of the strengths of the respective commercially available products. It also states a threshold — the agency does not intend to act against a compounder that fills four or fewer prescriptions of such a product in a calendar month.
A formulation the approved products don't have is not a copy of them. That's the gap the market moved into after the shortage ended, and it is a legal argument about the product's form rather than evidence that the form works. A 2026 review of 33 compounded products found 17 single-ingredient ones, of which 82% were sublingual and 18% orally disintegrating tablets, and concluded that whether those offer any advantage over the approved oral tablets has not been determined[5].
That is visible on our own roster. Sellers publish sublingual drops and oral tablets alongside injections — Wisp prices sublingual semaglutide drops, DrMedHealth prices oral semaglutide and tirzepatide tablets at a flat monthly rate, and Twenty lines across nine sellers are a GLP-1 mixed with B12. Which of those is which is named on each company's page in the roster.
What cannot be compounded at all
Two names come up on telehealth menus that the agency addresses directly. Retatrutide and cagrilintide cannot be used in compounding under federal law; they are not components of FDA-approved drugs and have not been found safe and effective for any condition[3]. The agency says it has warned telehealth companies for marketing retatrutide, active ingredient distributors for selling it to compounders, and outsourcing facilities for repackaging it. The same page also names products sold as research chemicals or labeled not for human consumption, which is a separate market from the one our reviews cover.
What the market did after the deadline
It did not disappear. A cross-sectional secret-shopper study ran between August and October 2025 across brick-and-mortar weight-loss clinics and medical spas in West Virginia and Oklahoma, two states chosen for obesity rate and insurance mix. It identified 75 businesses offering compounded GLP-1 products. Of those, 42, or 56%, offered a compounded GLP-1 combined with B vitamins, and 7, or 9.3%, offered an oral formulation[4]. Twenty-three compounding facilities were identified as suppliers; of 21 whose licensure could be assessed, 4 were not licensed to perform sterile compounding.
PubMed, via the E-utilities API
("compounded semaglutide"[tiab] OR "compounded tirzepatide"[tiab] OR "compounded GLP-1"[tiab]) AND "randomized controlled trial"[pt] AND "humans"[mh]Returned 0. Positive control — semaglutide or tirzepatide, identical filter — returned 413 through the identical filter in the same session.
The legal question and the evidence question are separate, and this is the evidence one. A sublingual or combination product may be perfectly lawful to compound and still have no trial behind the specific thing being sold. The control shows the filter finds these molecules by the hundred.
None of this decides whether a particular company is worth buying from. That is a question about what it publishes, what it charges and whether it says who compounds its drug, which is what our grading standard measures. The underlying difference between a compounded preparation and an approved one is in compounded versus brand, and what has been measured inside the vial is in the impurities article.
Questions people actually ask
Is compounded semaglutide still legal in 2026?
Compounding itself remains lawful under sections 503A and 503B, but the shortage exemption that allowed mass production of copies ended. Semaglutide's shortage was declared resolved on February 21, 2025, and the agency's stated periods of enforcement discretion ran out on April 22 and May 22, 2025. What is left is compounding for an individual patient where a prescriber documents a significant difference, plus formulations the approved products do not have.
Why do sellers add B12 to semaglutide?
The usual explanation offered is tolerability. The regulatory effect is that a combination is a different product from the approved single-ingredient one, which matters to the essentially-a-copy test. The FDA's own page addresses that directly, saying a semaglutide and B12 combination may still be considered essentially a copy when the route matches and both amounts fall within 10% of the approved strengths.
What is the 503B bulks list?
The list of bulk drug substances an outsourcing facility may use in compounding. Without a place on it, an outsourcing facility generally cannot compound from that substance unless the drug is on the FDA's shortage list at the time. On April 30, 2026 the agency proposed to exclude semaglutide, tirzepatide and liraglutide from the list, finding no clinical need for outsourcing facilities to compound them from bulk substances.
Can a compounder legally sell retatrutide?
The FDA's position is no. Its page states that retatrutide and cagrilintide cannot be used in compounding under federal law, that they are not components of FDA-approved drugs, and that they have not been found safe and effective for any condition. The agency says it has issued warnings to telehealth companies, ingredient distributors and outsourcing facilities over retatrutide.
Sources
Every source here was fetched and read for this article, with the identifier taken off the record that came back and the claim it supports written down beside it. All of it was read in September 2026, the same session the rest of this page draws on.
- 1.FDA clarifies policies for compounders as national GLP-1 supply begins to stabilize. U.S. Food and Drug Administration, 2026. Source · Document dated April 2026The dated entries for October 2 and 22 and December 19, 2024, February 21 and March 5 and April 24, 2025, and April 1, 2026; the 60-day and 90-day discretion windows and their end dates of April 22 and May 22, 2025; the essentially-a-copy test including the semaglutide and vitamin B12 example at within 10% of the approved strengths; the four-or-fewer-prescriptions-per-calendar-month threshold; and the statement that tirzepatide and semaglutide appear on neither the 503B bulks list nor the drug shortage list.
- 2.FDA Proposes to Exclude Semaglutide, Tirzepatide, and Liraglutide on 503B Bulks List. U.S. Food and Drug Administration, 2026. Source · Document dated April 2026The April 30, 2026 proposal to exclude semaglutide, tirzepatide and liraglutide from the 503B bulks list on a finding of no clinical need, and the June 29, 2026 deadline for comments.
- 3.FDA's Concerns with Unapproved GLP-1 Drugs Used for Weight Loss. U.S. Food and Drug Administration, 2026. Source · Document dated September 2026That retatrutide and cagrilintide cannot be used in compounding under federal law, are not components of FDA-approved drugs, and have not been found safe and effective for any condition; and the warnings issued to telehealth companies, active ingredient distributors and outsourcing facilities.
- 4.Postshortage Compounded GLP-1 RA Market in 2 States With Potentially High Demand. JAMA Health Forum, 2026. PMID 42467450 · doi:10.1001/jamahealthforum.2026.2207A secret-shopper study conducted August to October 2025 in West Virginia and Oklahoma identifying 75 weight-loss clinics and medical spas offering compounded GLP-1 products, of which 42 (56.0%) offered combinations with B vitamins and 7 (9.3%) offered oral formulations; 23 compounding facilities identified as suppliers, 4 of 21 not licensed to perform sterile compounding.
- 5.Compounded Semaglutide and Tirzepatide Products Use Unique Formulations but Efficacy and Safety Largely Unknown. Annals of Pharmacotherapy, 2026. PMID 41689811 · doi:10.1177/10600280261421979Of 33 unique compounded products identified, 17 contained a single active ingredient and were provided sublingually (82%) or as orally disintegrating tablets (18%), and the authors' conclusion that whether these formulations offer advantages over the approved oral tablets has not been determined.
- 6.Compounding and the FDA: Questions and Answers. U.S. Food and Drug Administration, 2025. Source · Document dated September 2025The statutory framework for compounding under sections 503A and 503B and the statement that compounded drugs are not FDA approved.
Key figures