Research · 10 min read
What FDA's Shortage Decisions Changed for GLP-1 Compounders
A shortage listing is what let compounders make versions of these drugs at scale. When FDA declared the shortages resolved, that basis went away on a published clock, and the rules that were always underneath became the rules again.
Key takeaways
- A drug on FDA's shortage list is not treated as commercially available, which is what let compounders make copies of it.
- FDA determined the tirzepatide shortage resolved in December 2024 and the semaglutide shortage resolved in February 2025.
- The wind-down ran 60 calendar days for 503A compounders and 90 days for 503B outsourcing facilities from each announcement.
- FDA states that tirzepatide and semaglutide do not currently appear on the 503B bulks list or on its drug shortage list.
- Retatrutide and cagrilintide cannot be used in compounding under federal law, and FDA has warned sellers on that point.
- Ask a program on what basis it compounds today, and confirm the status yourself in FDA's shortage database.
The mechanism, in one paragraph
Federal law restricts compounding a drug that is essentially a copy of a commercially available one. A drug on FDA's drug shortage list is not treated as commercially available, so the restriction does not bite while the shortage lasts. That single exception is what opened the compounded GLP-1 market.
Outsourcing facilities work under a parallel version of the same idea. A facility registered under section 503B may use a bulk drug substance in only two situations. Either that substance is on FDA's 503B bulks list, or the drug compounded from it is on FDA's shortage list at the time of compounding, distribution and dispensing.
So the shortage list was not a technicality. It was the legal footing under a large part of what was being sold, and everything that followed is a consequence of that footing moving.
What FDA actually decided, and when
FDA determined in October 2024 that the tirzepatide injection shortage was resolved. That decision was remanded to the agency for reevaluation as part of litigation, and in December 2024 FDA issued a new decision reaching the same conclusion.
FDA determined in February 2025 that the semaglutide injection shortage was resolved. The agency said semaglutide injection products had been in shortage since 2022 because of increased demand. It added that it had confirmed with the manufacturer that stated availability and manufacturing capacity could meet present and projected national demand.
FDA added a caution to both decisions that matters to patients. Even after a shortage is resolved, people may still see intermittent and localized supply disruptions as products move from manufacturers and distributors to local pharmacies. Resolved describes the national picture, not every counter.
The wind-down was a clock, and the clock had two hands
FDA did not switch the market off on the day of each decision. It said it did not intend to take action against compounders for violations arising from conditions that depend on the product's presence on the shortage list, for a stated period.
The period differed by category. For a state-licensed pharmacy or physician compounding under section 503A, FDA gave 60 calendar days from the announcement. For outsourcing facilities under section 503B, it gave 90 calendar days.
Applied to tirzepatide, that ran to February 2025 for 503A compounders and March 2025 for 503B facilities. Applied to semaglutide, it ran to April 2025 for 503A and May 2025 for 503B.
Litigation extended the semaglutide dates conditionally, tying them to a court decision if that came later. A federal district court in Texas denied the plaintiffs' preliminary injunction motion in March 2025 for tirzepatide and in April 2025 for semaglutide. FDA then confirmed the 503A enforcement discretion period had ended.
FDA attached the same caveat to every one of those windows. It could still act on violations of other requirements, including a finding that a product was of substandard quality or otherwise unsafe. The clock only ever covered the shortage-dependent conditions.
Where the rules stand now
FDA's most recent update on that page states that tirzepatide and semaglutide do not currently appear on the 503B bulks list or on FDA's drug shortage list. Both routes that made large-scale copying lawful are therefore closed for those two ingredients.
The agency also restated what an essential copy means, in unusually concrete terms. It applies where the compounded product has the same active ingredient as a commercially available product, in the same, similar or easily substitutable strength. The second condition is that the commercially available product can be used by the same route of administration. A prescriber may determine and document that a change produces a significant difference for a specific patient.
Adding an ingredient does not automatically escape that. FDA gave the example of semaglutide combined with vitamin B12. Such a product may be treated as an essential copy where the route of administration matches. The other condition is that the amount of each ingredient falls within 10 percent of the strength of the respective commercially available product.
FDA also stated a volume threshold for its own enforcement posture. It said it does not intend to act on the regularly or inordinate amounts condition where a compounder fills four or fewer prescriptions of that product in a calendar month.
Two ingredients FDA has singled out
Retatrutide and cagrilintide cannot be used in compounding under federal law. FDA has said so directly, and has added that neither is a component of an FDA-approved drug and neither has been found safe and effective for any condition.
FDA has issued warnings on that point in three directions. It has warned telehealth companies for marketing unapproved drugs such as retatrutide, including direct marketing to consumers. It has warned distributors of active pharmaceutical ingredients for selling retatrutide and other GLP-1 drugs to compounders. And it has warned outsourcing facilities for repackaging retatrutide.
Those warnings concern how products were sold and promoted. Read them for what they say rather than as a character judgment, and weigh a specific letter's actual subject rather than its existence.
Salt forms sit in the same territory. FDA has said some semaglutide products sold by compounders may be salt forms, such as semaglutide sodium or semaglutide acetate. These are different active ingredients from the one used in the approved drugs, and the agency has identified no lawful basis for their use in compounding.
What this means when you are shopping
A program still offering a compounded version of one of these drugs is not automatically operating outside the rules. Compounding to meet an individual patient's documented need is a real and lawful category, and a prescriber-documented significant difference is a real pathway.
What changed is that the easy, blanket answer disappeared. Before the shortage decisions, a program could point at the shortage list. Now the basis has to be specific to a patient, which means a program should be able to state what its basis is.
So ask it as a plain question: on what basis is this being compounded for me today, and which pharmacy or outsourcing facility is preparing it? A clear answer is checkable against FDA's own registration table and the current shortage database. A vague answer is itself useful.
No status is printed here for you to rely on months from now, because that kind of claim goes stale silently. FDA's drug shortage database carries the current position, and it is the source worth checking on the day you order.
Frequently asked questions
Are compounded GLP-1s illegal now?
Compounding itself remains lawful under sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act, subject to conditions. What ended is the shortage-based basis that let compounders make what FDA calls essential copies at scale. FDA has stated that tirzepatide and semaglutide do not currently appear on the 503B bulks list or on its drug shortage list. A program offering one of these products should be able to say plainly on what basis it is compounding it, and FDA's shortage database is where the current listing status can be checked.
What is an essentially a copy drug, in practice?
FDA has described the test concretely. The compounded product has the same active ingredient as a commercially available product, in the same, similar or easily substitutable strength. And that commercially available product can be used by the same route of administration prescribed for the compounded one. The exception is where a prescriber determines and documents a change producing a significant difference for an identified individual patient. FDA has also said it does not intend to act on the regularly or inordinate amounts condition where a compounder fills four or fewer prescriptions of that product in a calendar month.
Does adding vitamin B12 make a compounded product something different?
Not on its own. FDA gave that exact example and said a product combining semaglutide with another ingredient such as vitamin B12 may still be treated as an essential copy of a commercially available drug. It described two conditions. The products are used by the same route of administration, and the amounts of each ingredient fall within 10 percent of the strengths of the respective commercially available products. Combination formulations are not FDA-approved, and no regulator has reviewed the specific mixture being offered.
Why did the deadlines differ for different pharmacies?
Because FDA set the wind-down by category. For a state-licensed pharmacy or physician compounding under section 503A, the agency gave 60 calendar days from each shortage-resolution announcement. For outsourcing facilities under section 503B, it gave 90 calendar days. Litigation then extended the semaglutide windows conditionally, tying them to a district court decision if that came later. FDA said throughout that it could still act on other violations, including findings that a product was of substandard quality or otherwise unsafe.
Does a resolved shortage mean my pharmacy will have the drug?
Not necessarily, and FDA said as much in both decisions. The agency noted that patients and prescribers may still see intermittent and limited localized supply disruptions as products move through the supply chain from the manufacturer and distributors to local pharmacies. A resolution is a national determination based on the manufacturer's stated availability and capacity against present and projected demand. It is not a guarantee about any particular counter on any particular day.