What changed when the shortage ended?
The legal footing changed when the shortages ended. While semaglutide and tirzepatide were on the FDA’s shortage list, compounding pharmacies and outsourcing facilities were allowed to make copies to fill the gap. Once the FDA decided each shortage was resolved, it gave compounders a short wind-down period and then expected the copies to stop.
The FDA’s policy page for compounders, last updated April 1, 2026, sets out the dates:
| Drug | Shortage resolved | 503A pharmacies | 503B outsourcing facilities |
|---|---|---|---|
| Tirzepatide | December 19, 2024 | Grace period ended after a court denied an injunction on March 5, 2025 | March 19, 2025 |
| Semaglutide | February 21, 2025 | Grace period ended after a court denied an injunction on April 24, 2025 | May 22, 2025 |
Since then, mass production of these drugs as a stand-in for the brand products has had no shortage-based cover.
When can a pharmacy still compound semaglutide?
A 503A pharmacy can still compound semaglutide for an individual patient, but only if the product is not essentially a copy of an approved drug. The FDA treats a compounded drug as essentially a copy when it has the same active ingredient as a commercially available product, in the same, similar or easily substitutable strength, given by the same route.
The exception is clinical. A compounded version is not considered a copy when the clinician managing your care determines and documents a change that produces a significant difference for you as an identified patient. The FDA also says it does not intend to act against a 503A pharmacy that fills four or fewer orders of an essential copy in a calendar month, which is a narrow allowance, not a business model.
There is a second gate. Under the FDA’s rules for 503A bulk drug substances, a pharmacy may only compound from an ingredient that meets a USP or NF monograph, is a component of an FDA-approved drug, or appears on the FDA’s 503A bulks list. That last point is where salt forms fall down.
Why does the FDA single out salt forms?
Salt forms are a different ingredient from the semaglutide in approved products. The FDA’s page on unapproved GLP-1 drugs, current as of October 1, 2026, says semaglutide sodium and semaglutide acetate are different active ingredients, that it lacks information on whether they behave the same way, and that it knows of no lawful basis for compounding with them.
The same page describes what has gone wrong. As of May 31, 2026, the FDA had received 990 adverse event reports tied to compounded semaglutide and more than 730 tied to compounded tirzepatide, and it expects these are underreported. Some hospitalizations followed dosing errors, from patients measuring incorrectly and, in some cases, health care professionals miscalculating. The FDA has also warned companies selling GLP-1 products labeled “for research purposes” or “not for human consumption” directly to consumers.
How can you check what you are being offered?
Ask direct questions before your first injection, whoever is offering the medicine:
- What is the exact product? An FDA-approved brand, or a compounded preparation made for you.
- Which pharmacy made it, and is it licensed? You can look up a California pharmacy on the state license search.
- Is it a salt form? Semaglutide sodium or acetate is a red flag.
- What clinical difference was documented? If the only answer is price, the compounding rules are not being met.
- Is the dose written in milligrams? Clear units help prevent the measuring errors the FDA describes.
Never inject anything sold as “research use only.” Our article on the FDA warning about research-use semaglutide explains why, and the comparison of compounded semaglutide and Wegovy sets the two side by side. For what drives the numbers, see compounded semaglutide cost in 2026.
How Ultimate Male approaches compounded GLP-1s
At Ultimate Male, your provider names the exact product, its source and its dose schedule before you start, and FDA-approved semaglutide and tirzepatide are the starting point of the conversation. A compounded preparation is considered only when there is a documented clinical reason that applies to you, filled through a licensed U.S. compounding pharmacy. The clinic does not promise a low-cost compounded shortcut, because the rules no longer allow one.
The first step is an evaluation at our San Gabriel or Downey clinic: labs, body composition and a one-on-one consultation with a PA-C or MD, then a written plan you can review before committing. Learn how the medical weight loss program works or call 626-319-5261 for a free 10-minute phone call.
