--- title: "Compounded Semaglutide and Tirzepatide: The 2026 Timeline | Peptyn" description: "The verified FDA dates for compounded semaglutide and tirzepatide, what 503A and 503B actually say, and why your log outlasts a formulation change." canonical: "https://peptyn.orlyn.ai/articles/compounded-glp1-2026-regulatory-changes" last-updated: "2026-08-16" --- # Compounded semaglutide and tirzepatide: the 2026 timeline, and what it means for your records *The verified FDA dates for compounded semaglutide and tirzepatide, what 503A and 503B actually say, and why your log outlasts a formulation change.* Educational · Not medical advice · 18+ Most articles on this question answer it in one word, and the one word is wrong, because the honest answer has a date attached to it and a jurisdiction attached to it. Published 15 August 2026 · 9 min read · 11 sources So here is the dated version. As of this page's review date, August 15, 2026: neither tirzepatide nor semaglutide appears on FDA's 503B bulks list or on FDA's drug shortage list[1]. The enforcement discretion periods that followed the two shortage determinations ended in 2025[1]. In April 2026 FDA proposed not to include semaglutide, tirzepatide, or liraglutide on the 503B bulks list, and at the time of review that proposal was still pending, with comments closed since July 30, 2026 and no final determination published[2][3][4]. And here is the jurisdiction. Every source on this page is a United States federal document: FDA statements, the Federal Register, federal court dockets, and FDA-approved labeling published on DailyMed. If you are outside the United States, none of this describes the law where you are. If you are inside it, none of this overrides the rules of the state you live in. That status is also not the same thing as an answer about what your prescriber and your pharmacy can do for you specifically. The gap between those two questions is most of this page. This page does two things. It lays out the compounding timeline for semaglutide and tirzepatide with every date traced to an FDA or Federal Register document you can open yourself. And it explains why, when a formulation changes underneath you, your own log is the one record that carries across the change, along with an honest account of what a log cannot hold. Everything below is dated. Regulatory status moves; the dates are the point. ## Why a shortage made compounding possible in the first place Compounded drugs are not FDA-approved. They do not go through FDA premarket review for safety, effectiveness, and quality. They are exempt from parts of the law only when specific statutory conditions are met, and one of those conditions is what the GLP-1 situation turned on[1]. The approved products, semaglutide as Ozempic and Wegovy[7][9] and tirzepatide as Mounjaro and Zepbound[8][10], each carry FDA-approved prescribing information you can read in full on DailyMed. A compounded product has no equivalent document. Section 503A of the Federal Food, Drug, and Cosmetic Act restricts state-licensed pharmacies from compounding drugs that are "essentially copies" of a commercially available drug. FDA's position is that when a shortage is resolved, the agency generally considers that drug to be commercially available again[1]. Section 503B, which governs outsourcing facilities, works differently. Outsourcing facilities generally cannot compound from a bulk drug substance unless that substance appears on the 503B bulks list, or the compounded drug is on FDA's drug shortage list at the time of compounding, distribution, and dispensing[1]. That shortage list is a live database you can search yourself[6]. So the shortage was not a regulatory favor. It was the condition that made the exemptions available. When the shortage ended, the condition ended with it. ## The timeline, with sources **Tirzepatide and semaglutide ran on separate clocks.** Almost every summary collapses them into one. They were never the same. ### Tirzepatide **October 2, 2024.** FDA determined the tirzepatide injection shortage resolved. That determination was then remanded back to the agency for reevaluation as part of litigation, and FDA addressed its enforcement approach during the reevaluation period in a letter sent October 17, 2024[1]. **December 19, 2024.** FDA issued a new decision determining the tirzepatide injection shortage resolved. To avoid disrupting patient treatment, FDA said it did not intend to act against compounders for violations arising from conditions that depend on tirzepatide's inclusion on the shortage list: for 503A pharmacies and physicians, until February 18, 2025; for 503B outsourcing facilities, until March 19, 2025[1]. **March 5, 2025.** The district court denied the plaintiffs' preliminary injunction motion in *Outsourcing Facilities Association v. FDA*, 4:24-cv-00953 (N.D. Tex.). FDA then confirmed that the 503A enforcement discretion period for tirzepatide had ended[1]. ### Semaglutide **February 21, 2025.** FDA determined the semaglutide injection shortage resolved, in shortage since 2022, after confirming with the manufacturer that stated availability and manufacturing capacity could meet present and projected national demand[1]. The same announcement set the wind-down windows: 503A pharmacies and physicians within 60 calendar days, until April 22, 2025; 503B outsourcing facilities within 90 calendar days, until May 22, 2025[1]. **April 24, 2025.** The district court denied the preliminary injunction motion in *Outsourcing Facilities Association v. FDA*, 4:25-cv-00174 (N.D. Tex.). FDA confirmed that the 503A period had ended, and that for 503B facilities it did not intend to act on shortage-list-dependent violations until May 22, 2025[1]. **Neither of those two rulings is the last word, and almost nothing written about this says so.** Both went up to the U.S. Court of Appeals for the Fifth Circuit, as No. 25-10600 (the tirzepatide case, filed 12 May 2025) and No. 25-10758 (the semaglutide case, filed 20 June 2025), and both were argued on 30 March 2026.[11] A refusal to grant a preliminary injunction is a decision not to halt the agency while the case runs, not a final judgment that the agency was right. This page describes what FDA has said and what the district courts declined to stop. It cannot tell you how the Fifth Circuit will rule, and a decision in either appeal could change the picture above. Before relying on any of this, check whether those two docket numbers have produced an opinion. **This is the correction worth making explicitly:** those windows were tied to FDA's stated enforcement intentions and to federal court decisions, not to permissions issued by state pharmacy boards. A state board licenses and disciplines pharmacies in its state. It does not extend a federal enforcement discretion period, and no state board granted one here. ### 2026 **April 1, 2026.** In its running update to compounders, FDA stated plainly: "Tirzepatide and semaglutide do not currently appear on the 503B bulks list or on FDA's drug shortage list."[1] **April 30, 2026.** FDA announced it was proposing to exclude semaglutide, tirzepatide, and liraglutide on the 503B bulks list, finding no clinical need for outsourcing facilities to compound these drugs from bulk substances[2]. Note the direction of that action, because it is routinely reported backwards. These substances were not being removed from a list they sat on. FDA evaluated nominations for inclusion and proposed not to include them[3]. FDA's own press release headline uses the word "exclude," which is part of why the reporting went wrong; the Federal Register notice is the precise one, and it says FDA "proposes not to include" them[3]. **May 1, 2026.** The notice published in the Federal Register (91 FR 23431, Docket No. FDA-2018-N-3240), proposing not to include semaglutide, tirzepatide, and liraglutide on the 503B bulks list[3]. **June 26, 2026.** FDA extended the comment period. Comments became due July 30, 2026[4]. If you go looking for the original deadline, you will find two of them. The Federal Register notice set June 30, 2026[3]. FDA's press release said June 29[2]. The extension superseded both, and the Federal Register text is the one that governs. **As of this page's review date, August 15, 2026,** FDA has said it will consider submitted comments before making a final determination[2]. No final determination had been published at the time of review. If you are reading this later, check the docket and the shortage database rather than trusting this paragraph[3][6]. ## What is still true, and what nobody can tell you from a webpage **Still true.** Section 503A still exists as an exemption, and patient-specific compounding under it is still bounded by the same conditions: a prescription for an individual patient, and the restriction on compounding copies of a commercially available drug regularly or in inordinate amounts. FDA's guidance describes an exception where a prescriber determines and documents that the compounded product contains a change producing a significant difference from the commercially available product for an identified individual patient[1]. FDA has also stated that, at this time, it does not intend to act against a compounder for compounding an essentially-a-copy product regularly or in inordinate amounts if the compounder fills four or fewer prescriptions of that product in a calendar month[1]. Both of those are constraints on what a compounder and a prescriber may do. Neither is something a patient can act on, and neither is a route this page is describing for you to pursue. **What a webpage cannot tell you.** Whether a prescriber licensed in your state can lawfully write a compounded prescription for you right now. Whether a given pharmacy can lawfully fill it. Whether the product you receive next month is the same as the one you have. Those answers live with your prescriber, your pharmacist, and your state board, and they are the reason this page stops where it does. ## What FDA has actually found This part is why the exact text on your vial matters more than it sounds like it should. FDA has reported that some semaglutide products sold by compounders may be salt forms, including semaglutide sodium and semaglutide acetate. FDA states these are different active ingredients than the ones used in the approved drugs, that the agency does not have information on whether the salts share the same chemical and pharmacologic properties as the approved active ingredient, and that it is not aware of any lawful basis for their use in compounding[5]. FDA has also described fraudulent compounded semaglutide and tirzepatide carrying false label information. In some cases the compounding pharmacy named on the label did not exist. In others, the label named a real licensed pharmacy that FDA's information indicates did not compound the product[5]. And FDA has reported adverse event counts for these products: as of May 31, 2026, 990 reports associated with compounded semaglutide and more than 730 associated with compounded tirzepatide. FDA notes that state-licensed pharmacies that are not outsourcing facilities are not federally required to submit adverse events, so these are likely undercounts, and that it is not always possible to attribute an event to the drug[5]. And FDA has reported adverse events, some requiring hospitalization, that may be related to dosing errors with compounded injectable semaglutide. The agency describes those errors as arising from patients measuring and self-administering incorrect amounts, and in some cases from health care professionals miscalculating[5]. That last finding is the reason the next section reads the way it does. None of that is a sourcing guide, and this page will not give you one. It is the reason a line reading "the semaglutide I get" is worth less in a clinical conversation than the words actually printed on the vial. ## What your log can and cannot carry Here is the honest version, including where the app stops. Peptyn records the compound from its catalog, the amount you entered in mg, the date and time, and the injection site on the body map. Its mix log records what went into a vial, peptide mg and bacteriostatic water ml, as a plain record. It computes nothing from those two numbers: no concentration, no volume, no dose. That is deliberate and it is not going to change, and the paragraph above about miscalculated amounts is why. There is no dedicated field for a lot number or a supplier name, no free-text field to put either one in, and no place to attach a photograph of your label. So if the exact wording on a label matters to you, and after a supply change it usually does, keep the pharmacy label and paperwork itself. Physical or photographed, outside the app. The two records answer different questions and you want both. What the log gives you is the shape of the protocol over time: that you ran one thing on a consistent schedule from February through July, that there was a break in August, that something different started in September. Dates, sites, and continuity. That is the part memory reconstructs badly and the part a clinician asks about first. A log is not a license to keep doing what you were doing. It is evidence of what you were actually doing, which is a different and more useful thing. ## Taking it to your prescriber If a formulation becomes unavailable to you, the useful question is not how to keep obtaining it. That is a sourcing question and it sits outside what any app, article, or product should be answering. The useful version is closer to: here is my dated history, here is the label from what I have been given, the compounding rules have moved, what are my options. Bring the log for the shape of it. A dated record answers three things that recall answers badly: when you actually started, how consistent the schedule really was rather than how consistent it felt, and whether any gap lines up with something else that changed. Those are the questions that get asked first, and they are the ones people reconstruct worst from memory. Bring the label and paperwork for the specifics the log does not hold: the product name exactly as printed, the pharmacy that dispensed it, and the dates on the container. A prescriber licensed where you live, who knows your history, can work with both. A webpage, including this one, cannot. ## References 1. FDA clarifies policies for compounders as national GLP-1 supply begins to stabilize - U.S. Food and Drug Administration. 2. FDA Proposes to Exclude Semaglutide, Tirzepatide, and Liraglutide on 503B Bulks List - FDA News Release, April 30, 2026. 3. List of Bulk Drug Substances for Which There Is a Clinical Need Under Section 503B of the Federal Food, Drug, and Cosmetic Act - Federal Register notice, May 1, 2026 (91 FR 23431), Docket No. FDA-2018-N-3240. 4. List of Bulk Drug Substances ... Extension of Comment Period - Federal Register notice, June 26, 2026. 5. FDA's Concerns with Unapproved GLP-1 Drugs Used for Weight Loss - U.S. Food and Drug Administration. 6. FDA Drug Shortages database - U.S. Food and Drug Administration. 7. OZEMPIC (semaglutide) injection - DailyMed Prescribing Information. 8. MOUNJARO (tirzepatide) injection - DailyMed Prescribing Information. 9. WEGOVY (semaglutide) injection and tablet - DailyMed Prescribing Information. 10. ZEPBOUND (tirzepatide) injection - DailyMed Prescribing Information. 11. U.S. Court of Appeals for the Fifth Circuit, Opinion Search. Docket Nos. 25-10600 and 25-10758, *Outsourcing Facilities Association v. FDA*, both argued 30 March 2026. ## Keep reading - [The glossary that will not do your math](https://peptyn.orlyn.ai/articles/peptide-glossary) Plain definitions from lyophilized to 503A, with sources. It defines every term and stops where the arithmetic starts. - [Retatrutide is not approved. What that means.](https://peptyn.orlyn.ai/articles/retatrutide-approval-status-2026) What investigational status is as a legal category, why a planned filing is not an approval date, and where the trials stand. - [Your lot number, and how to check it](https://peptyn.orlyn.ai/articles/glp1-recall-lot-number) Where the code lives on a pen, vial and carton, how to search FDA enforcement records, and which channel takes which report. This article is educational. It does not recommend doses, schedules, or products, and it is not medical advice. Every factual claim above is linked to its source. Questions about your own protocol belong with the prescriber who wrote it. --- Source: