FDA Ends the Tirzepatide Shortage, Limiting Compounded Copies (2024)

On 2 October 2024 the U.S. Food and Drug Administration determined that the national shortage of tirzepatide injection, on the FDA drug shortage list since December 2022, was resolved. A lawsuit sent that decision back to the agency for a second look, and on 19 December 2024 the FDA issued a new declaratory order reaching the same conclusion, with grace periods for compounders that ran to 18 February 2025 for pharmacies and 19 March 2025 for outsourcing facilities. Because the law lets compounders make copies of an approved drug mainly while that drug is in shortage, the decision ended the legal basis for most compounded tirzepatide injections. Tirzepatide itself, a medicine that acts on both the GIP and GLP-1 hormone receptors, is described on the site’s GLP-1 Receptor Agonists page.

This page reports what the FDA documents say: what the agency decided in October and again in December 2024, what compounding under sections 503A and 503B of the law means, the court case and the re-evaluation, the evidence the FDA weighed, the grace periods and the reasons given for them, the status of the other GLP-1 drugs at the time, what the decision does not do, and its legal status as of 11 October 2026. It is the first of two such decisions; the semaglutide decision that followed in February 2025 has its own page, FDA Ends the Semaglutide Shortage and Compounded Copies (2025).

Table of Contents

  1. What the FDA Did on 2 October 2024
  2. Compounding, 503A and 503B Explained
  3. What the Decision Changed for Compounders
  4. The Lawsuit and the Re-Evaluation
  5. The 19 December 2024 Order
  6. How the FDA Judged the Shortage Over
  7. The Grace Periods and the Reasons Given
  8. What the Decision Does Not Do
  9. Dates and Legal Status (as of 11 October 2026)
  10. How the Decision Fits Earlier and Later Actions
  11. Primary Documents
  12. Key Research Papers
  13. Connections

1. What the FDA Did on 2 October 2024

The FDA announced the decision on its statement page “FDA clarifies policies for compounders as national GLP-1 supply begins to stabilize.” The entry dated 2 October 2024 reads: “The U.S. Food and Drug Administration has determined the shortage of tirzepatide injection, a glucagon-like peptide 1 (GLP-1) medication, has been resolved. Tirzepatide injection has been in shortage since 2022 due to increased demand.”

The FDA stated that it had “confirmed with the drug’s manufacturer that their stated product availability and manufacturing capacity can meet the present and projected national demand,” and that “patients and prescribers may still see intermittent localized supply disruptions as the products move through the supply chain from the manufacturer and distributors to local pharmacies.”

The same entry lists the factors the FDA says it considers before declaring any shortage over: the company’s ability to meet current and historical demand, the amount in the manufacturer’s stock, affected market share, the ability of other manufacturers to cover demand, and confirmed market stabilization.

According to the later declaratory order, two approved tirzepatide products existed, both from one manufacturer: pens for blood-sugar control in adults with type 2 diabetes, approved in May 2022 and added to the shortage list in December 2022 “due to high demand,” and pens for long-term weight reduction in adults with obesity, or overweight with at least one weight-related condition, approved in November 2023 and added to the shortage list in April 2024. Single-dose vials of the weight-reduction product, approved in March 2024, were never on the shortage list.

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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 puts it plainly: “Compounded drugs are not approved by FDA. FDA-approved drugs go through FDA’s rigorous review for safety, effectiveness, and quality as part of the premarket approval process.” 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. In the FDA’s words on 2 October 2024, section 503A “includes restrictions on compounding drugs that are essentially copies of a commercially available drug,” although “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 making compounded drugs that are essentially a copy of one or more FDA-approved drugs,” meaning 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.”

The drug shortage list is therefore the switch. The order quotes the legal definition of a shortage, “a period of time when the demand or projected demand for the drug within the United States exceeds the supply of the drug,” and states that for 503A purposes the FDA does not consider a drug on the shortage list to be “commercially available.” The October statement adds: “When a drug shortage is resolved, FDA generally considers the drug to be commercially available.”

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3. What the Decision Changed for Compounders

The December order names the three legal limits that depend on tirzepatide being on the shortage list: the 503A bar on compounding drugs that are essentially a copy of a commercially available drug product; the 503B limit on compounding from a bulk drug substance (the raw active ingredient) unless the substance is on the “503B bulks list” or the finished drug is on the shortage list; and the 503B bar on drugs that are essentially a copy of an FDA-approved drug product.

While tirzepatide was listed in shortage, those limits did not stop compounded copies. Once the shortage was declared resolved and any transition period had passed, they applied again. The FDA’s temporary promise not to act on these particular violations is called enforcement discretion: the law itself does not change, but the agency announces that it will not take action on certain violations for a stated time.

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4. The Lawsuit and the Re-Evaluation

According to the FDA’s December order and its letter of 17 October 2024, the agency was sued on 7 October 2024 in the U.S. District Court for the Northern District of Texas by a trade association of outsourcing facilities and a compounding pharmacy over the removal of tirzepatide from the shortage list (case 4:24-cv-00953). On 11 October 2024, on the FDA’s own motion, the court remanded the decision to the agency for re-evaluation. A remand sends a decision back to the agency that made it, to be reconsidered.

In its motion, the FDA said that during the re-evaluation, and until two weeks after its new decision (or, if the plaintiffs moved for a preliminary injunction, until the court ruled on that motion), it did not intend to act against the plaintiffs for the shortage-dependent violations described in Section 3. On 17 October 2024 the Director of the Office of Compounding Quality and Compliance in the FDA’s Center for Drug Evaluation and Research wrote to a trade association of compounding pharmacies that the FDA “intends to treat compounders consistently at this time,” extending the same approach to all compounders, “for the same duration of time and subject to all the same limitations.” The letter adds that neither the FDA’s statement nor the court’s order prevented action on other violations, “such as to address findings that the product may be of substandard quality or otherwise unsafe.”

The FDA’s statement page recorded the step on 22 October 2024: “As part of litigation, the decision to remove tirzepatide from the FDA drug shortage list has been remanded to the agency for reevaluation.”

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5. The 19 December 2024 Order

On 19 December 2024 the FDA issued “Declaratory Order: Resolution of Shortages of Tirzepatide Injection Products,” signed by the Director of the Center for Drug Evaluation and Research and addressed to the manufacturer. Its determination reads: “FDA determines that the tirzepatide injection product shortage is resolved.” The order states that it “revokes and replaces FDA’s October 2, 2024 decision on the same subject,” and that it rests on an internal decision memorandum of the same date, “Resolution of Tirzepatide Injection Product Shortage and Supply Status.” It covers the pens of both approved products in all six strengths, 2.5 mg to 15 mg.

The statement page summarized it the same day: “FDA re-evaluated its determination from October 2, 2024, on the status of the tirzepatide shortage. Today, FDA has issued a new decision determining the tirzepatide injection shortage is resolved. FDA’s determination is based on its analysis of all the information before the agency.”

A declaratory order is a final agency decision issued to “terminate a controversy or remove uncertainty” (the order quotes the Administrative Procedure Act, 5 U.S.C. 554(e)). The order explains why the FDA decided this way rather than by a regulation open to public comment: much of the evidence is the manufacturer’s trade-secret and confidential data that the agency may not publish; the law requires the shortage list to be kept “up-to-date”; and the law lets the FDA withhold shortage information when disclosure could cause hoarding. It was therefore not published in the Federal Register and has no Federal Register docket (a docket is the public file in which a rule, its supporting papers and public comments are collected). The order states that the manufacturer, individual patients, pharmacy compounders, outsourcing facilities, associations representing them and telehealth companies submitted information before the October decision and during the re-evaluation, and that the FDA considered those submissions.

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6. How the FDA Judged the Shortage Over

According to the order, the manufacturer gave the FDA stock reports for all strengths showing quantities supplied and demanded and inventory held, cumulative quantities supplied to and demanded by customers in 2024, projected demand and supply in future months, and wholesaler inventory data. The FDA concluded that supply was “currently meeting or exceeding demand,” that the manufacturer had built reserves of finished product “plus significant units of semi-finished product,” and that it had “scheduled substantial additional production over the coming months, such that supply will meet or exceed projected demand.”

The FDA also weighed information from patients, healthcare providers, compounders and sources it identified itself, and found that this information “has 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 tirzepatide compounding is occurring.” It explains that the FDA judges a shortage nationwide, not locally, and attributes intermittent local difficulties mostly to “the practical dynamics of the portion of the supply chain” between the manufacturer and individual customers, including wholesale distributors and retailers. It also recognizes that some patients using compounded products could be expected to seek the approved products once compounding was curtailed, and concludes that the information submitted did not show the manufacturer would be unable to meet that projected demand.

The order states that the FDA “will continue to monitor supply and demand for these products,” and whether any tirzepatide injection products belong on the shortage list again in the future.

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7. The Grace Periods and the Reasons Given

On top of the approach it had described during the litigation, the FDA stated that “to avoid unnecessary disruption to patient treatment” it did not intend to act on the shortage-dependent violations:

The order gives 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 drugs are subject to “less robust production standards,” and that the copy limits also protect the drug-approval process; “an indefinite or overly long period of enforcement discretion” would not be appropriate. For some transition, it says the 60/90-day period 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 ordering, and let compounders deal with products already made, for example batches awaiting sterility tests. It notes that the shortage had lasted since 15 December 2022, that much compounding was occurring, and that the re-evaluation in the litigation “may have caused some uncertainty.” It records that a pharmacy-compounding association, in letters of October 2024, had asked for a 60-day transition.

The order states that these periods were longer than those in the FDA’s earlier guidance documents, and that outsourcing facilities received 90 days rather than 60 because their products, made under FDA registration, inspection and CGMP, “provide more assurances of quality,” and because those facilities need more time and resources before they can produce.

On 11 February 2025 the FDA clarified the periods: until 18 February 2025 for 503A and 19 March 2025 for 503B, “or until the date of the district court’s decision on the plaintiffs’ preliminary injunction motion” (a request to pause the decision while the case continued), “whichever is longer.” Its update of 10 March 2025 records that on 5 March 2025 the district court denied that motion, so that for 503A pharmacies and physicians “the period of enforcement discretion … has ended,” while for outsourcing facilities it continued until 19 March 2025.

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8. What the Decision Does Not Do

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9. 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 are over. A check of the Federal Register through its public API on 11 October 2026 found no FDA document that changes the tirzepatide shortage decision; the FDA documents there that name tirzepatide in this area are the 2026 bulks-list proposal and its comment-period extension, and that proposal remains open (see FDA Proposal on Compounded Semaglutide and Tirzepatide (2026)). The FDA documents used here do not report the later course of the lawsuit, and this page does not.

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10. How the Decision Fits Earlier and Later Actions

The FDA’s statement page tracked the other GLP-1 drugs alongside tirzepatide. On 2 October 2024 it listed dulaglutide injection as in shortage; semaglutide injection as in shortage, with the manufacturer reporting all but one presentation available; and liraglutide injection as in shortage, with two presentations available and three of limited availability. On 19 December 2024 all three were still listed in shortage, with semaglutide’s manufacturer now reporting all presentations available. The FDA notes that “available” reflects the manufacturer’s report and “is not an FDA determination that the shortage has been resolved.”

The tirzepatide order set the pattern for what followed:

Read together, the 2024 tirzepatide order closed the shortage route for compounded tirzepatide copies, the 2025 order did the same for semaglutide, and the 2026 proposal addresses the remaining “clinical need” route for outsourcing facilities.

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11. Primary Documents

  1. 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
  2. U.S. Food and Drug Administration, Center for Drug Evaluation and Research (2024). Declaratory Order: Resolution of Shortages of Tirzepatide Injection Products. 19 December 2024 (issued as an order, not published in the Federal Register; no docket) — fda.gov declaratory order (PDF)
  3. U.S. Food and Drug Administration, CDER Office of Compounding Quality and Compliance (2024). Letter on the agency’s approach to compounding of tirzepatide during the re-evaluation. 17 October 2024 — fda.gov letter (PDF)

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Key Research Papers

  1. Frías JP, Davies MJ, Rosenstock J, Pérez Manghi FC, Fernández Landó L, Bergman BK, Liu B, Cui X, Brown K; SURPASS-2 Investigators (2021). Tirzepatide versus Semaglutide Once Weekly in Patients with Type 2 Diabetes. New England Journal of Medicine 385(6):503-515 — PubMed PMID: 34170647
  2. Jastreboff AM, Aronne LJ, Ahmad NN, Wharton S, Connery L, Alves B, Kiyosue A, Zhang S, Liu B, Bunck MC, Stefanski A; SURMOUNT-1 Investigators (2022). Tirzepatide Once Weekly for the Treatment of Obesity. New England Journal of Medicine 387(3):205-216 — PubMed PMID: 35658024
  3. McCall KL, Mastro Dwyer KA, Casey RT, Samana TN, Sulicz EK, Tso SY, Yalanzhi ER, Piper BJ (2026). Safety analysis of compounded GLP-1 receptor agonists: a pharmacovigilance study using the FDA adverse event reporting system. Expert Opinion on Drug Safety 25(3):581-588 — PubMed PMID: 40285721
  4. Belcourt J, Sapowadia A, White CM (2026). Compounded Semaglutide and Tirzepatide Products Use Unique Formulations but Efficacy and Safety Largely Unknown. Annals of Pharmacotherapy 60(9):902-906 — PubMed PMID: 41689811
  5. 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 large randomized trials of tirzepatide in type 2 diabetes and in obesity. The third compares adverse-event and product-quality reports for compounded and non-compounded GLP-1 drugs in the FDA Adverse Event Reporting System from 2018 to 2024; its authors note it was not designed to show cause and effect. The last two describe the compounded semaglutide and tirzepatide products offered after the shortages ended, including sublingual forms and products combined with B vitamins.

PubMed Topic Searches

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

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Connections

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