Why a shortage changes the compounding rules
Under federal law a drug shortage is a period when demand, or projected demand, for a drug in the United States exceeds its supply [3]. Compounders may prepare versions of a drug on the FDA’s shortage list if they meet conditions set in law [4].
The FDA has spelled out what changes when the listing ends. State-licensed pharmacies compounding under section 503A may not regularly, or in inordinate amounts, make products that are essentially copies of a commercially available drug, and the FDA generally treats a drug as commercially available once its shortage is resolved. Outsourcing facilities under section 503B may not make essentially a copy of an approved drug unless that drug is on the shortage list [1]. That is why each shortage decision below came with a deadline for compounders.
The timeline
| Date | What the FDA announced | Source |
|---|---|---|
| 2022 | Tirzepatide and semaglutide injections enter shortage because of increased demand (the FDA gives the year only) | FDA [1] |
| 18 July 2023 | First posting of liraglutide injection entries in the FDA shortage data | openFDA [5] |
| 2 October 2024 | Tirzepatide injection shortage declared resolved; semaglutide, dulaglutide and liraglutide still listed | FDA [1] |
| 17 and 22 October 2024 | In litigation, the tirzepatide decision is sent back to the FDA for re-evaluation; the FDA writes to explain its approach meanwhile | FDA [1] |
| 19 December 2024 | After re-evaluation, a new decision: tirzepatide shortage resolved. Grace period to 18 February 2025 (503A) and 19 March 2025 (503B) | FDA [1] |
| 11 February 2025 | FDA restates the tirzepatide deadlines, or the date of a pending court ruling if later | FDA [1] |
| 21 February 2025 | Semaglutide injection shortage declared resolved. Grace period to 22 April 2025 (503A) and 22 May 2025 (503B) | FDA [1] |
| 5 March 2025 (FDA update 10 March) | Court denies an injunction on tirzepatide; pharmacy grace period ends, outsourcing facilities keep 19 March 2025 | FDA [1] |
| 24 April 2025 (FDA update 28 April) | Court denies an injunction on semaglutide; pharmacy grace period ends, outsourcing facilities keep 22 May 2025 | FDA [1] |
| 1 April 2026 | FDA restates the 503A and 503B conditions; neither drug is on the shortage list or the 503B bulks list | FDA [1] |
| Page current 1 October 2026 | Retatrutide and cagrilintide cannot be used in compounding; warnings to sellers of “research use” GLP-1 products | FDA [2] |
What the grace periods were
Each time a shortage ended, the FDA said it did not intend to take action, for a limited time, against compounders for violations that depended on the drug having been on the shortage list. The window was 60 calendar days for state-licensed pharmacies and physicians under 503A and 90 days for outsourcing facilities under 503B [1]. This is what the FDA calls enforcement discretion.
Two limits were attached each time. The discretion covered only the shortage-related conditions, and the FDA said it could still act on other violations, such as a product found to be of substandard quality or otherwise unsafe [1]. And after the court rulings of 5 March and 24 April 2025, the pharmacy windows closed on those dates, while the outsourcing facility deadlines of 19 March and 22 May 2025 stood [1].
What the April 2026 update added
On 1 April 2026 the FDA reminded compounders of the conditions in both sections of the law. For 503A pharmacies it described when a compounded product counts as essentially a copy: the same active ingredient in the same, similar or easily substitutable strength, usable by the same route, unless a prescriber documents a significant difference for an identified patient [1].
It applied this to combinations. A compounded injection pairing semaglutide with vitamin B12 may be considered essentially a copy of approved products if each ingredient is within 10% of the strength of a commercially available product given the same way [1]. The FDA also said it does not intend to act against a pharmacy that fills four or fewer prescriptions of such a product in a calendar month [1]. For 503B facilities, it repeated that tirzepatide and semaglutide were on neither the shortage list nor the bulks list [1].
Where things stood in October 2026
- Retatrutide and cagrilintide cannot be used in compounding under federal law, are not part of any approved drug, and have not been found safe and effective for any condition [2].
- The FDA has warned telehealth companies, ingredient distributors and outsourcing facilities over retatrutide, and companies selling GLP-1 products labelled “for research purposes” or “not for human consumption” [2].
- A green-list import alert (66-80) is meant to keep GLP-1 ingredients with possible quality problems out of the US supply chain [2].
- By 31 May 2026 the FDA had received 990 adverse event reports for compounded semaglutide and more than 730 for compounded tirzepatide, and it expects under-reporting because most pharmacies are not required to report [2].
- The FDA’s shortage data still listed liraglutide injection entries as current when queried on 20 October 2026 [5].
How to read these dates
A resolved shortage is a national determination: the FDA says patients may still meet short, local supply gaps as stock moves from manufacturers to pharmacies [1][3]. The dates also say nothing about whether any particular compounded product is safe or effective; compounded drugs are not FDA approved and are not reviewed by the FDA before they are sold [2]. Status can change again, so check the FDA pages themselves before relying on this list.
