Home › Compounded tirzepatide
Last reviewed 2026-09-30 · FDA and Federal Register text read 2026-09-30 · Compiled and edited by Darrel Donaghy
Compounded tirzepatide: what the FDA has published, as of September 2026
Compounded tirzepatide is made by a compounding pharmacy or outsourcing facility; it is not the FDA-approved product. The FDA ruled its shortage over twice, on October 2 and December 19, 2024, after litigation sent the first one back. Grace periods for compounders ran out by March 19, 2025. It is on neither the shortage list nor the 503B bulks list.
Status as reviewed 2026-09-30 · every line is the regulator's, with its date
- Is the FDA-approved tirzepatide product in shortage?
- No. On December 19, 2024 the FDA issued “a new decision determining the tirzepatide injection shortage is resolved”, replacing its October 2, 2024 decision after that decision was remanded in litigation. (FDA, FDA clarifies policies for compounders as national GLP-1 supply begins to stabilize, read 2026-09-30)
- Is tirzepatide on the 503B bulks list?
- No, and not on the shortage list either, per the FDA's April 1, 2026 entry (quoted in the timeline below). An outsourcing facility therefore may not compound from bulk tirzepatide. (FDA, FDA clarifies policies for compounders as national GLP-1 supply begins to stabilize, read 2026-09-30)
- Enforcement discretion for compounders after the shortage
- Ended. The FDA gave 503A pharmacies until February 18, 2025 or the court's ruling on the preliminary injunction, whichever was later, and 503B facilities until March 19, 2025. The court ruled on March 5, 2025; the FDA's March 10, 2025 entry says the 503A period “has ended”. (FDA, FDA clarifies policies for compounders as national GLP-1 supply begins to stabilize, read 2026-09-30)
- Proposal to keep it off the 503B bulks list
- On May 1, 2026 the FDA published a notice proposing not to include tirzepatide on the 503B bulks list (91 FR 23431); the comment period was extended to July 30, 2026 (91 FR 38719). (91 FR 23431 (May 1, 2026), docket FDA-2018-N-3240, read 2026-09-30)
- Adverse-event reports the FDA has received
- As of May 31, 2026, the FDA says it has received “more than 730 reports of adverse events associated with compounded tirzepatide”. It adds that such reports are likely underreported and that “it is not always possible to determine if the adverse event directly resulted from use of the drug or if other factors may have contributed to these adverse events”. (FDA, FDA's Concerns with Unapproved GLP-1 Drugs Used for Weight Loss, read 2026-09-30)
- Latest document on the 503B bulks-list docket (FDA-2018-N-3240)
- List of Bulk Drug Substances for Which There Is a Clinical Need Under Section 503B of the Federal Food, Drug, and Cosmetic Act; Extension of Comment Period, 91 FR 38719, published 2026-06-26. No final determination on tirzepatide had been published as of the build's docket check on 2026-10-15.
What this box does not say: whether any product is right for you, or what it costs. It says what the regulator has published, and when. The pharmacy on your label is the next thing to check: look it up.
What the FDA has said, in order
The FDA keeps a dated log of its compounding policy for GLP-1 drugs. These are its entries for tirzepatide, quoted with the FDA's own dates.
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.
As part of litigation, the decision to remove tirzepatide from the FDA drug shortage list has been remanded to the agency for reevaluation. FDA sent a letter on October 17, 2024, in response to a question regarding the agency's intended approach to the compounding of tirzepatide drug products during the reevaluation period.
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.
For a state-licensed pharmacy under section 503A of the FD&C Act compounding, distributing or dispensing tirzepatide injections within 60 calendar days from today's announcement, until February 18, 2025.
For outsourcing facilities under section 503B compounding, distributing or dispensing tirzepatide injections within 90 calendar days from today's announcement, until March 19, 2025.
For a state-licensed pharmacy or physician compounding under section 503A of the FD&C Act until February 18, 2025, or until the date of the district court's decision on the plaintiffs' preliminary injunction motion in Outsourcing Facilities Association (OFA) v. FDA (N.D. Tex.), whichever is longer.
Tirzepatide: On 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.).
For a state-licensed pharmacy or physician compounding under section 503A of the FD&C Act, the period of enforcement discretion described below has ended.
For outsourcing facilities under section 503B, FDA does not intend to take action against compounders for violations of the FD&C Act arising from conditions that depend on tirzepatide injection products' inclusion on FDA's drug shortage list until March 19, 2025.
Tirzepatide and semaglutide do not currently appear on the 503B bulks list or on FDA's drug shortage list.
Which pharmacy made your tirzepatide?
Type the name printed on the tirzepatide label. The statute's copy limits, in the FDA's words, are on 503A vs 503B.
Why the tirzepatide shortage was decided twice
Tirzepatide's shortage status went to court before semaglutide's. The FDA declared the shortage resolved on October 2, 2024. The decision was challenged in Outsourcing Facilities Association v. FDA, 4:24-cv-00953 in the Northern District of Texas, and on October 22 the FDA recorded that it had been remanded to the agency for reevaluation. On December 19, 2024 the FDA reached the same result again, this time as a declaratory order:
FDA determines that the tirzepatide injection product shortage is resolved.
This order revokes and replaces FDA's October 2, 2024 decision on the same subject.
The plaintiffs then asked the court to block the order while the case continued, and the FDA held its 503A grace period open until the court ruled. The court denied the motion on March 5, 2025. The 503A period ended with that ruling, and the 503B period ended on March 19, 2025. Semaglutide went through a separate case a few months later; its dates are on the compounded semaglutide page.
Common questions
Is compounded tirzepatide banned?
The FDA has not used that word, and this site does not make a legal call. What its log records: the shortage was declared resolved on December 19, 2024; the court denied the outsourcing facilities' preliminary injunction on March 5, 2025, which ended the FDA's grace period for 503A pharmacies; 503B facilities had until March 19, 2025. Since then a 503A pharmacy may not compound essentially a copy of the approved drug regularly or in inordinate amounts, and tirzepatide is on neither the shortage list nor the 503B bulks list. On May 1, 2026 the FDA proposed keeping it off that list; the proposal is not final.
Why did the FDA decide the tirzepatide shortage twice?
Because the first decision, on October 2, 2024, was challenged in court and remanded to the FDA for reevaluation on October 22, 2024. The FDA's December 19, 2024 declaratory order found the shortage resolved again and states that it revokes and replaces the October 2 decision.
Can a 503B outsourcing facility still make compounded tirzepatide?
Not from bulk tirzepatide under the conditions the FDA restated on April 1, 2026: an outsourcing facility may compound from a bulk drug substance only if the substance is on the 503B bulks list or the drug is on the FDA's shortage list, and tirzepatide is on neither. The FDA's register of outsourcing facilities lists inspections, not products, so it does not show which facilities made tirzepatide.
When did the grace period for compounded tirzepatide end?
For state-licensed 503A pharmacies, when the court denied the preliminary injunction on March 5, 2025 (the FDA's March 10, 2025 entry says the period has ended). For 503B outsourcing facilities, on March 19, 2025.
Each quotation links its source, read 2026-09-30; the proposal is also in the FDA press release, April 30, 2026 and its extension in 91 FR 38719 (June 26, 2026). The docket is re-queried from the Federal Register API at every build. Not medical advice; see methodology.