FDA Ends the Semaglutide Shortage and Compounded Copies (2025)

On 21 February 2025 the U.S. Food and Drug Administration issued a declaratory order finding that the national shortage of semaglutide injection products — on the FDA drug shortage list since 2022 — was resolved. Because the law lets pharmacies and outsourcing facilities make copies of an approved drug mainly while that drug is in shortage, the decision ended the legal basis for most compounded semaglutide injections, after grace periods that closed in April and on 22 May 2025. Semaglutide itself, a GLP-1 receptor agonist, is described on the site’s GLP-1 Receptor Agonists page.

This page reports what the FDA documents say: what the order decided and on what evidence, what compounding under sections 503A and 503B of the law means, the grace periods and why the agency gave them, the court rulings that fixed the final dates, the “essentially a copy” rules the FDA restated, the earlier tirzepatide decision, what the order does not do, and its legal status as of 11 October 2026. Every statement below is attributed to an FDA document listed under Primary Documents.

Table of Contents

  1. 1. What the FDA Did
  2. 2. Compounding, 503A and 503B Explained
  3. 3. What the Order Changed, and When
  4. 4. How the FDA Decided the Shortage Was Over
  5. 5. Why the FDA Gave Grace Periods
  6. 6. The Court Rulings and the Final Dates
  7. 7. The “Essentially a Copy” Rules
  8. 8. The Tirzepatide Decision Before It
  9. 9. What the Order Does Not Do
  10. 10. Dates and Legal Status (as of 11 October 2026)
  11. 11. How the Order Fits Earlier and Later Actions
  12. 12. Primary Documents
  13. Key Research Papers
  14. Connections

1. What the FDA Did

The action is a declaratory order titled “Resolution of Shortages of Semaglutide Injection Products,” dated 21 February 2025, signed by the Acting Director of the FDA’s Center for Drug Evaluation and Research and addressed to the manufacturer of the approved semaglutide injections. Its central finding reads: “FDA has determined that the semaglutide injection product shortage is resolved.”

The order covers the only two FDA-approved semaglutide injections, both brand-name pens from the same manufacturer: one approved in December 2017 for type 2 diabetes (with later cardiovascular and kidney indications), and one approved in June 2021 for long-term weight management and cardiovascular risk reduction. According to the order, the weight-management product was added to the FDA drug shortage list on 31 March 2022 and the diabetes product on 23 August 2022. A footnote notes that the approved semaglutide tablets, taken by mouth, were not in shortage.

The same day, the FDA posted the decision on its statement page “FDA clarifies policies for compounders as national GLP-1 supply begins to stabilize,” which said that semaglutide injection products “have been in shortage since 2022 due to increased demand.”

A declaratory order is a formal, final agency decision made to “terminate a controversy or remove uncertainty” (the order quotes the Administrative Procedure Act, 5 U.S.C. § 554(e)). It is not a regulation, so it was not published in the Federal Register and has no Federal Register docket; the FDA released it as a public PDF and summarized it on its website.

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2. Compounding, 503A and 503B Explained

Compounding is the preparation of a medicine by mixing or altering ingredients outside the drug-approval process. The FDA’s statement page puts it plainly: “Compounded drugs are not approved by FDA.” Two sections of the Federal Food, Drug, and Cosmetic Act (FD&C Act) set the conditions for two kinds of compounders:

Both sections limit the making of copies. Under 503A, a compounder may not regularly, or in inordinate amounts, make drugs that are “essentially copies of a commercially available drug product.” Under 503B, an outsourcing facility may not make a drug that is essentially a copy of an FDA-approved drug, and may compound from a bulk drug substance (the raw active ingredient) only if that substance is on the “503B bulks list” of substances with a clinical need, or the drug made from it is on the FDA drug shortage list.

The drug shortage list is the key. The order quotes the statutory definition of a shortage as “a period of time when the demand or projected demand for the drug within the United States exceeds the supply of the drug.” The order states that for 503A purposes the FDA does not consider a drug on the shortage list to be “commercially available,” and the statement page says that “When a drug shortage is resolved, FDA generally considers the drug to be commercially available.” Taking semaglutide off the list therefore switched the copy restrictions back on.

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3. What the Order Changed, and When

The order states that the FDA would not take action against compounders for violations “arising from conditions that depend on semaglutide injection products’ inclusion on the FDA drug shortage list” for a limited time from the date of the order:

This kind of temporary hands-off policy is called enforcement discretion: the law has not changed, but the agency announces it will not act on certain violations for a stated time. The order adds that it “does not prevent FDA from taking action for violations of any other statutory or regulatory requirements, such as to address findings that a product may be of substandard quality or otherwise unsafe.”

After those dates, the shortage-based route for compounded semaglutide copies was closed. Section 6 explains how the court rulings set the exact end dates.

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4. How the FDA Decided the Shortage Was Over

According to the order, the FDA reviewed the manufacturer’s confidential data on production and inventory for all strengths, quantities supplied and demanded, projected supply and demand in future months, and wholesaler inventory. It also considered information from “telehealth companies, pharmacy compounders, associations representing pharmacy compounders and outsourcing facilities, and individuals.”

The order concludes that the manufacturer’s supply was “currently meeting or exceeding demand,” that the manufacturer had built reserves of finished product plus significant semi-finished product, and that, in the agency’s “best judgment,” supply would meet or exceed projected demand. It states that the information from other sources had “important limitations” and did not outweigh the manufacturer’s data.

The order acknowledges reports that some patients and pharmacists could not obtain the approved drugs and that “a substantial amount of semaglutide compounding is occurring.” It explains that the FDA judges a shortage at the national level, not the local level, and attributes local difficulties mostly to “the practical dynamics of the part of the supply chain” between the manufacturer, wholesale distributors and pharmacies. The statement page told patients and prescribers that they “may still see intermittent and limited localized supply disruptions.”

The order also explains why the FDA decided by order rather than by a rule open to public comment: much of the evidence is the manufacturer’s trade-secret data that the agency may not publish, the law requires an “up-to-date” shortage list, and the law lets the FDA withhold shortage information that could prompt hoarding. The FDA states that interested parties were heard by submitting information, and that it considered those submissions.

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5. Why the FDA Gave Grace Periods

The order gives the agency’s reasons on both sides. Against a long transition, it states that compounded drugs “have not undergone FDA premarket review for safety, effectiveness, and quality,” that 503A compounders are not held to CGMP standards, and that the copy restrictions also protect the drug-approval process. It concludes that “an indefinite or overly long period of enforcement discretion” would not be appropriate.

For some transition, the order says the 60- and 90-day periods would give patients “a reasonable amount of time to transfer their prescriptions, as needed, to different pharmacies to obtain the FDA-approved drug,” let local pharmacies adjust their stocking, and let compounders deal with products already made or awaiting sterility tests. It notes that the shortage had lasted a long time, that compounding was widespread, and that litigation over the earlier tirzepatide decision may have caused uncertainty. It records that compounding-pharmacy groups had asked for a 60-day transition.

The order states that these periods were longer than those in the FDA’s earlier guidance for outsourcing facilities, and that outsourcing facilities received 90 days rather than 60 because they are held to stricter quality requirements and need more time and investment to produce under CGMP.

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6. The Court Rulings and the Final Dates

The FDA’s statement page records that the decision was challenged in federal court by a trade association of outsourcing facilities (case 4:25-cv-00174, U.S. District Court for the Northern District of Texas). On 10 March 2025 the FDA updated its grace periods: the 503A period would run until 22 April 2025 “or until the date of the district court’s decision on the plaintiffs’ forthcoming preliminary injunction motion,” whichever was later, and the 503B period until 22 May 2025 on the same terms.

A preliminary injunction is a court order that would have paused the FDA’s decision while the case continued. According to the FDA’s update of 28 April 2025, the district court denied that motion on 24 April 2025. The update states that, as a result:

So in practice the 503A grace period ran until the court ruling of 24 April 2025, and the 503B period ended on 22 May 2025. The FDA documents used here do not report the later course of the lawsuit, and this page does not.

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7. The “Essentially a Copy” Rules

In an update dated 1 April 2026, the FDA’s statement page restated the conditions compounders must meet, citing its guidance documents. Under 503A, the agency says it intends to treat a compounded drug as “essentially a copy” of a commercially available drug when it has the same active ingredient in “the same, similar or an easily substitutable strength” and the approved drug can be used by the same route — unless a prescriber “determines and documents” that the compounded drug contains a change producing a significant difference for an identified individual patient.

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8. The Tirzepatide Decision Before It

The semaglutide order followed a similar decision on tirzepatide, another injected weight-loss and diabetes drug. According to the FDA’s statement page:

On 21 February 2025, the FDA listed two other GLP-1 drugs as still in shortage: dulaglutide injection (“Manufacturer has reported all presentations are available”) and liraglutide injection (two presentations available, three with limited availability). The FDA notes that “available” reflects the manufacturer’s report and “is not an FDA determination that the shortage has been resolved.”

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9. What the Order Does Not Do

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10. Dates and Legal Status (as of 11 October 2026)

Status as of 11 October 2026: the shortage determination is final and in effect, and both grace periods have ended. Semaglutide injection products are not on the FDA drug shortage list, according to the FDA’s most recent statement update (1 April 2026). The related 2026 bulks-list proposal remains open and is covered on its own page, FDA Proposal on Compounded Semaglutide and Tirzepatide (2026).

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11. How the Order Fits Earlier and Later Actions

The semaglutide shortage began in 2022 with rising demand, and the FDA’s statement page traces the agency’s public updates: on 2 October 2024 the manufacturer had reported all but one presentation available; on 19 December 2024, all presentations available, while the FDA kept the drug listed and kept “working to determine whether the demand or projected demand … exceeds the available supply.” The order cites both updates as the public notice that preceded its decision, and it followed the tirzepatide decision described in Section 8 by about two months.

After the order, the FDA’s attention moved from shortage status to the compounded market that had grown during the shortage:

Read together, the 2025 order removed the shortage route for compounded copies, and the 2026 proposal addresses the remaining “clinical need” route for outsourcing facilities.

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12. Primary Documents

  1. U.S. Food and Drug Administration, Center for Drug Evaluation and Research (2025). Declaratory Order: Resolution of Shortages of Semaglutide Injection Products. 21 February 2025 (issued as an order, not published in the Federal Register; no docket) — fda.gov declaratory order (PDF)
  2. U.S. Food and Drug Administration. FDA clarifies policies for compounders as national GLP-1 supply begins to stabilize. Drug Alerts and Statements, dated updates 2 October 2024, 22 October 2024, 19 December 2024, 11 February 2025, 21 February 2025, 10 March 2025, 28 April 2025 and 1 April 2026 — fda.gov statement
  3. U.S. Food and Drug Administration (2026). FDA Warns 30 Telehealth Companies Against Illegal Marketing of Compounded GLP-1s. Press release, 3 March 2026 — fda.gov press release

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Key Research Papers

  1. Wilding JPH, Batterham RL, Calanna S, Davies M, Van Gaal LF, Lingvay I, McGowan BM, Rosenstock J, Tran MTD, Wadden TA, Wharton S, Yokote K, Zeuthen N, Kushner RF; STEP 1 Study Group (2021). Once-Weekly Semaglutide in Adults with Overweight or Obesity. New England Journal of Medicine 384(11):989-1002 — PubMed PMID: 33567185
  2. Marso SP, Bain SC, Consoli A, Eliaschewitz FG, Jódar E, Leiter LA, Lingvay I, Rosenstock J, Seufert J, Warren ML, Woo V, Hansen O, Holst AG, Pettersson J, Vilsbøll T; SUSTAIN-6 Investigators (2016). Semaglutide and Cardiovascular Outcomes in Patients with Type 2 Diabetes. New England Journal of Medicine 375(19):1834-1844 — PubMed PMID: 27633186
  3. Lambson JE, Flegal SC, Johnson AR (2023). Administration errors of compounded semaglutide reported to a poison control center—Case series. Journal of the American Pharmacists Association 63(5):1643-1645 — PubMed PMID: 37392810
  4. Ho RY, Regelman H, Ma A, Lee SY, Sandhu S, Shapiro S, Lewis J, Tsutaoka B, Apollonio DE (2025). Changes in Glucagon-Like Peptide-1 Receptor Agonist (GLP-1 RA) Exposures Following Recent Demand for Weight Management: A Retrospective Review of California Poison Control System Data. Journal of Pharmacy Technology 41(4):165-173 — PubMed PMID: 40371098
  5. Liu G, Jarema M, Mo M, Stievater T (2025). Navigating compounded semaglutide: what health care providers need to know. American Journal of Managed Care 31(9):480-484 — PubMed PMID: 40966636
  6. DiStefano MJ, Tilley A, Paratane D, Gyimah Gyamfi H, Moore GD, Nair KV (2026). Postshortage Compounded GLP-1 RA Market in 2 States With Potentially High Demand. JAMA Health Forum 7(7):e262207 — PubMed PMID: 42467450

The first two papers are the large trials behind the approved semaglutide injections’ weight-management and cardiovascular uses. The next two describe dosing errors with compounded semaglutide reported to poison control centers, and the last examines which compounded GLP-1 products were still offered in two states after the semaglutide and tirzepatide shortages ended.

PubMed Topic Searches

  1. PubMed: compounded semaglutide
  2. PubMed: semaglutide shortage
  3. PubMed: compounded GLP-1 receptor agonists

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Connections

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