U.S. Food and Drug Administration (FDA) Ends the Semaglutide Shortage and Compounded Copies (2025)

Table of Contents

1. 1. What the U.S. Food and Drug Administration Did
2. 2. Compounding, 503A and 503B Explained
3. 3. What the Order Changed, and When
4. 4. How the U.S. Food and Drug Administration Decided the Shortage Was Over
5. 5. Why the U.S. Food and Drug Administration 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
15. Featured Videos

1. What the U.S. Food and Drug Administration 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 U.S. Food and Drug Administration’s Center for Drug Evaluation and Research and addressed to the manufacturer of the approved semaglutide injections. Its central finding reads: “U.S. Food and Drug Administration has determined that the semaglutide injection product shortage is resolved.”

The order covers the only two U.S. Food and Drug Administration-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 U.S. Food and Drug Administration 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 U.S. Food and Drug Administration posted the decision on its statement page “U.S. Food and Drug Administration clarifies policies for compounders as national glucagon-like peptide-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 U.S. Food and Drug Administration 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 U.S. Food and Drug Administration’s statement page puts it plainly: “Compounded drugs are not approved by U.S. Food and Drug Administration.” Two sections of the Federal Food, Drug, and Cosmetic Act (FD&C Act) set the conditions for two kinds of compounders:

• Section 503A covers state-licensed pharmacies and physicians compounding for individual patients on a prescription. The order notes that these drugs are not subject to current good manufacturing practice (CGMP) requirements.
• Section 503B covers registered outsourcing facilities. The order describes them as subject to CGMP requirements, U.S. Food and Drug Administration inspections on a risk-based schedule and specific adverse-event reporting duties.

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 a U.S. Food and Drug Administration-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 U.S. Food and Drug Administration 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 U.S. Food and Drug Administration 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, U.S. Food and Drug Administration 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 U.S. Food and Drug Administration would not take action against compounders for violations “arising from conditions that depend on semaglutide injection products’ inclusion on the U.S. Food and Drug Administration drug shortage list” for a limited time from the date of the order:

• State-licensed pharmacies and physicians (503A): 60 calendar days, until 22 April 2025, for compounding, distributing or dispensing semaglutide injections that are essentially a copy of a commercially available drug.
• Outsourcing facilities (503B): 90 calendar days, until 22 May 2025, for using bulk semaglutide to compound a drug that had been on the shortage list, or for making semaglutide injections that are essentially a copy of a U.S. Food and Drug Administration-approved drug.

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 U.S. Food and Drug Administration 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 U.S. Food and Drug Administration Decided the Shortage Was Over

According to the order, the U.S. Food and Drug Administration 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 U.S. Food and Drug Administration 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 U.S. Food and Drug Administration 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 U.S. Food and Drug Administration withhold shortage information that could prompt hoarding. The U.S. Food and Drug Administration states that interested parties were heard by submitting information, and that it considered those submissions.

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5. Why the U.S. Food and Drug Administration 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 U.S. Food and Drug Administration 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 U.S. Food and Drug Administration-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 U.S. Food and Drug Administration’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 U.S. Food and Drug Administration’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 U.S. Food and Drug Administration 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 U.S. Food and Drug Administration’s decision while the case continued. According to the U.S. Food and Drug Administration’s update of 28 April 2025, the district court denied that motion on 24 April 2025. The update states that, as a result:

• for 503A pharmacies and physicians, “the period of enforcement discretion … has ended”; and
• for 503B outsourcing facilities, the U.S. Food and Drug Administration would not act on shortage-dependent violations until 22 May 2025.

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 U.S. Food and Drug Administration 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 U.S. Food and Drug Administration’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.

• Added vitamins. The U.S. Food and Drug Administration gives the example of a compounded injection combining semaglutide with vitamin B12 (cyanocobalamin): it may be considered essentially a copy if it is given the same way as approved products and the amounts of semaglutide and vitamin B12 are within 10% of the strengths of the respective commercially available products.
• Small numbers. The U.S. Food and Drug Administration states that, at this time, it does not intend to act against a 503A compounder for compounding such a copy if the compounder fills four or fewer prescriptions of it in a calendar month.
• Outsourcing facilities. They may compound from bulk ingredients only if the substance is on the 503B bulks list or the drug is on the shortage list. The update states: “Tirzepatide and semaglutide do not currently appear on the 503B bulks list or on U.S. Food and Drug Administration’s drug shortage list.”

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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 U.S. Food and Drug Administration’s statement page:

• 2 October 2024: the U.S. Food and Drug Administration determined that the tirzepatide injection shortage, in place since 2022, was resolved.
• 22 October 2024: as part of litigation, that decision was sent back to the agency for re-evaluation.
• 19 December 2024: after re-evaluating, the U.S. Food and Drug Administration again determined the tirzepatide shortage resolved, with grace periods until 18 February 2025 for 503A compounders and 19 March 2025 for outsourcing facilities.
• 5 March 2025: the district court denied a preliminary injunction in that case (4:24-cv-00953, N.D. Tex.); the U.S. Food and Drug Administration’s 10 March update stated that the 503A period had ended and the 503B period ran to 19 March 2025.

On 21 February 2025, the U.S. Food and Drug Administration listed two other glucagon-like peptide-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 U.S. Food and Drug Administration notes that “available” reflects the manufacturer’s report and “is not a U.S. Food and Drug Administration determination that the shortage has been resolved.”

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9. What the Order Does Not Do

• It does not ban compounding of semaglutide outright. Under the U.S. Food and Drug Administration’s stated policy, a compounded drug with a prescriber-documented change producing a significant difference for an identified patient is outside the “essentially a copy” bar, and the U.S. Food and Drug Administration describes a limit of four or fewer copy prescriptions a month below which it does not intend to act (Section 7).
• It does not change the U.S. Food and Drug Administration-approved products. The order concerns shortage status only; the approved semaglutide injections and tablets, their uses and their labeling are not altered by it.
• It does not guarantee supply at every pharmacy. The U.S. Food and Drug Administration states that intermittent, localized supply disruptions may still occur.
• It is not permanent. The order says the U.S. Food and Drug Administration “will continue to monitor supply and demand” and will consider whether semaglutide injections belong on the shortage list again in the future.
• It is not the 2026 bulks-list proposal. Whether semaglutide may be compounded from bulk ingredients because of a clinical need, regardless of shortage, is a separate question taken up in the U.S. Food and Drug Administration’s 2026 proposal (Section 11).
• It does not end U.S. Food and Drug Administration oversight of quality. The U.S. Food and Drug Administration states it may still act on any other violation, such as a product of substandard quality or one that is otherwise unsafe.

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

• 21 February 2025: declaratory order issued; semaglutide injection shortage declared resolved. Final agency action.
• 10 March 2025: U.S. Food and Drug Administration ties the grace periods to the pending court ruling.
• 24 April 2025: district court denies the preliminary injunction; the 503A grace period ends (U.S. Food and Drug Administration update of 28 April 2025).
• 22 May 2025: the 503B grace period ends.
• 1 April 2026: U.S. Food and Drug Administration restates the copy rules and states that semaglutide is on neither the drug shortage list nor the 503B bulks list.
• 30 April / 1 May 2026: U.S. Food and Drug Administration proposes not to place semaglutide, tirzepatide or liraglutide on the 503B bulks list — a proposal, not final, 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 U.S. Food and Drug Administration drug shortage list, according to the U.S. Food and Drug Administration’s most recent statement update (1 April 2026). The related 2026 bulks-list proposal remains open and is covered on its own page, U.S. Food and Drug Administration 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 U.S. Food and Drug Administration’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 U.S. Food and Drug Administration 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 U.S. Food and Drug Administration’s attention moved from shortage status to the compounded market that had grown during the shortage:

• September 2025: the U.S. Food and Drug Administration’s wider campaign against misleading drug advertising began; see U.S. Food and Drug Administration Crackdown on Misleading Drug Advertising (2025).
• 3 March 2026: the U.S. Food and Drug Administration announced warning letters to 30 telehealth firms over the marketing of compounded glucagon-like peptide-1 drugs, including claims that compounded products were the same as approved ones and obscuring who compounds the drug.
• 30 April / 1 May 2026: the U.S. Food and Drug Administration proposed to keep semaglutide, tirzepatide and liraglutide off the 503B bulks list, finding no clinical need for outsourcing facilities to compound them from bulk ingredients; see U.S. Food and Drug Administration Proposal on Compounded Semaglutide and Tirzepatide (2026).

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. U.S. Food and Drug Administration clarifies policies for compounders as national glucagon-like peptide-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). U.S. Food and Drug Administration Warns 30 Telehealth Companies Against Illegal Marketing of Compounded glucagon-like peptide-1 receptor agonists. 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 glucagon-like peptide-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

• U.S. Food and Drug Administration Actions of 2025
• U.S. Food and Drug Administration and Regulation
• U.S. Food and Drug Administration Proposal on Compounded Semaglutide and Tirzepatide (2026)
• U.S. Food and Drug Administration Review of Compounded Peptides (2026)
• U.S. Food and Drug Administration Crackdown on Misleading Drug Advertising (2025)
• Glucagon-Like Peptide-1 Receptor Agonists
• Glucagon-Like Peptide-1 Receptor Agonists: Side Effects and Cautions
• Glucagon-Like Peptide-1 Receptor Agonists: Weight Loss Studies
• Obesity
• Type 2 Diabetes

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