Compounded semaglutide and tirzepatide: what the shortage rule allowed, and why it changed

Semaglutide and tirzepatide are not on the same regulatory path as most of this site

Most of the compounds this site covers — BPC-157, TB-500, KPV and the rest — have no FDA-approved product at all. Whether a pharmacy may use them is governed by the bulk-substances nomination process, covered in its own article on this site, which is still working through individual nominations one at a time.

Semaglutide and tirzepatide are a different case entirely. Both are approved drugs, sold under FDA-reviewed brand names, with their own evidence covered on this site's dedicated pages for each. Federal law treats a compounded copy of an approved drug far more restrictively than it treats a substance with no approved product at all. The reason is the whole point of compounding law. It exists to fill a gap the approved drug supply cannot fill, not to offer a cheaper or more convenient version of a product that already exists.

That restriction has exactly one built-in exception relevant here, and it is the subject of this article: a shortage.

The shortage exception, in plain terms

Under section 503A of the Federal Food, Drug, and Cosmetic Act, a state-licensed pharmacy generally may not compound a drug that is essentially a copy of a commercially available approved product. Under section 503B, an outsourcing facility generally may not compound using a bulk drug substance unless that substance is on the 503B bulks list.

Both restrictions have a shortage-based release valve. While a drug is officially listed on FDA's drug shortage list, a pharmacy or outsourcing facility may compound something that would otherwise be an impermissible copy of it. It may also use a bulk substance not on the applicable list. The exception exists so that patients are not cut off from a therapy entirely because the approved manufacturer cannot meet demand.

Both semaglutide injection products and tirzepatide injection had been on that shortage list since 2022, driven by demand that outpaced what the approved manufacturers could supply. For as long as that listing held, compounding a copy of either drug was not automatically unlawful the way it would otherwise be.

The exact dates the shortage ended

Tirzepatide moved first. FDA initially determined the tirzepatide injection shortage was resolved on October 2, 2024, reversed course amid ongoing litigation, and then issued a new determination on December 19, 2024 confirming the shortage resolved. To avoid disrupting patients already receiving compounded tirzepatide, FDA gave a limited grace period rather than an immediate cutoff. State-licensed 503A pharmacies had 60 days, ending February 18, 2025, and 503B outsourcing facilities had 90 days, ending March 19, 2025. A subsequent court ruling in early March 2025 left those dates in place.

Semaglutide followed roughly two months later. FDA determined the semaglutide injection shortage was resolved on February 21, 2025. The same grace-period structure applied: 60 days for 503A pharmacies, ending April 22, 2025, and 90 days for 503B outsourcing facilities, ending May 22, 2025. A district court denied a preliminary injunction sought by an outsourcing-facility trade association in April 2025, and FDA confirmed those dates stood.

Those dates are not this site's estimate. They are FDA's own dated determinations, stated on the same FDA page cited above as a running, dated log rather than a single announcement.

What compounding is still permitted after those dates

The shortage-based exception ending does not mean all compounding of these two molecules stopped. Section 503A's ordinary rule still applies: a pharmacy may compound for an individual patient based on a prescription. It may not do so regularly or in inordinate amounts for products that are essentially a copy of a commercially available drug.

FDA has published guidance on what counts as 'essentially a copy,' including for a compounded product that pairs semaglutide with a second ingredient such as vitamin B12. Its stated position is that a product can still count as a copy even with an added ingredient. That applies whenever it uses the same active ingredient by the same route at a similar strength to a commercially available product. The one exception is a prescriber who documents a specific, individualized reason the difference is clinically significant for that patient.

FDA has also described a narrow enforcement-discretion allowance, separate from any change in the underlying rule. It does not currently intend to act against a 503A compounder for filling four or fewer prescriptions of an otherwise-restricted copy in a calendar month. That covers genuinely individualized, low-volume compounding. It is not a continuation of the shortage-era exception at any scale.

For 503B outsourcing facilities, the picture is more closed. An outsourcing facility is restricted to bulk substances on the 503B list, or to drugs currently in shortage. With semaglutide and tirzepatide off the shortage list, it has no ordinary path to compound either one from bulk substance today.

The next door is closing too

On April 30, 2026, FDA announced it is proposing to exclude semaglutide, tirzepatide and liraglutide from the 503B bulks list entirely. It reviewed the nominations submitted for the three substances and stated it did not identify a clinical need for outsourcing facilities to compound them from bulk drug substances.

That announcement is a proposal, not a final rule. FDA opened a public comment period, later extended by Federal Register notice to July 30, 2026, and stated it will consider the comments received before making a final determination. As of the sources read on the date above, no final determination had been posted.

If finalized as proposed, the practical effect would be to close the second of the two legal pathways that ever let large-scale, industrial compounding of these two drugs happen. The 503A individual-prescription pathway, with its narrow, non-inordinate-amount and case-by-case-difference conditions, would remain the only lawful route for compounding either molecule, regardless of the bulks-list outcome.

What this means for reading a provider's claims today

A seller advertising 'compounded semaglutide' or 'compounded tirzepatide' as a current, ordinary offering is not describing the shortage-era exception, because that exception is over for both drugs. Whatever is being sold now is either genuinely individualized 503A compounding within the narrow conditions above, or it is happening outside them.

This site does not investigate any individual seller's compliance with those conditions, and nothing here should be read as a claim that a specific provider is or is not operating lawfully. The dated public record above is what any such claim can be checked against. The shortage ended on specific dates in 2025, the ordinary 503A rule is narrow and prescription-specific, the 503B route is effectively closed, and a further closure is proposed and not yet final.

A price, a promise of 'the same active ingredient' or a claim that a product is 'legally compounded' is a claim about the present. The dates above are what the present actually is.

Sources

Each document below is named as it names itself, with the date printed on that document rather than the day it was read.

1. FDA clarifies policies for compounders as national GLP-1 supply begins to stabilize — U.S. Food and Drug Administration, April 2026
2. FDA Proposes to Exclude Semaglutide, Tirzepatide, and Liraglutide on 503B Bulks List — U.S. Food and Drug Administration, April 2026
3. 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 — Federal Register, U.S. Government Publishing Office, June 2026