Is compounded semaglutide still legal? GLP-1 compounding rules after the shortages

Yes, but under narrower conditions than in 2023 and 2024. While semaglutide and tirzepatide injections were in national shortage, FDA allowed pharmacies to make copies of them. Both shortages are over, and that temporary flexibility has ended. A compounded GLP-1 can still be prescribed today when a prescriber documents a clinical reason specific to the patient and the pharmacy meets the law’s other conditions. This guide explains the rules as of October 2026. It is general information, not legal advice. FDA policy update.

When did the GLP-1 shortages end?

Medicine	Shortage resolved	Flexibility ended for pharmacies (503A)	Flexibility ended for outsourcing facilities (503B)
Tirzepatide injection	October 2, 2024, confirmed December 19, 2024	March 2025	March 19, 2025
Semaglutide injection	February 21, 2025	April 2025	May 22, 2025

FDA first set the 503A dates as February 18, 2025 for tirzepatide and April 22, 2025 for semaglutide. The periods ended after related court decisions in March and April 2025. Neither injection is on FDA’s current shortage list. FDA drug shortage database.

What are 503A pharmacies and 503B outsourcing facilities?

Federal law has two paths for compounding. Section 503A covers state-licensed pharmacies and physicians that compound for individual patients based on a prescription. Section 503B covers outsourcing facilities that register with FDA, follow manufacturing quality standards and are inspected by FDA. Neither path produces an FDA-approved drug. FDA compounding questions and answers.

What is “essentially a copy”?

A 503A pharmacy may not regularly or in large amounts compound a product that is essentially a copy of a commercially available approved drug. FDA looks at whether the compounded product has the same active ingredient, a similar strength and the same route of administration. FDA’s policy says it generally does not intend to enforce this copying restriction when a pharmacy fills four or fewer prescriptions of such a copy in a calendar month, counting each refill separately. That policy does not waive any other requirement. FDA guidance on 503A copies.

The main exception is a change that a prescriber determines and documents as producing a significant difference for an identified individual patient. Examples could include a needed change in dose form or the removal of an ingredient the patient cannot tolerate.

Do added ingredients or a lower price create an exception?

Not by themselves. FDA’s policy gives an example: semaglutide combined with vitamin B12 can still be essentially a copy of the approved drug. In a September 18, 2026 warning letter, FDA questioned high volumes of GLP-1 products made with added niacinamide or vitamin B12, and “significant difference” statements that appeared to be repeated word for word across many prescriptions. Price, convenience and an added ingredient do not replace an individual clinical decision. FDA warning letter, September 2026.

What changed for outsourcing facilities?

503B facilities may only use bulk ingredients that are on FDA’s clinical need list or that are for drugs in shortage. Semaglutide and tirzepatide are on neither list. On April 30, 2026, FDA proposed formally excluding semaglutide, tirzepatide and liraglutide from the 503B bulks list. That was a proposal with public comments due by June 29, 2026, not a final rule. FDA announcement, April 2026.

What is FDA doing about online marketing?

In March 2026, FDA announced warning letters to 30 telehealth companies over claims about compounded GLP-1 drugs. The main problems were wording that implied the compounded product was the same as an approved drug and branding that suggested the telehealth company made the medicine. FDA’s guidance says compounded drugs should not be called generic, FDA-approved, clinically proven to match an approved drug, or made by an “FDA-approved pharmacy”. FDA warns 30 telehealth companies; FDA guidance for telehealth companies.

Those rules are also a useful test for patients. A website that calls a compounded drug “generic Ozempic” or promises Wegovy results is telling you something about how carefully it works.

What should patients check now?

1. Ask why compounded. Your provider should be able to explain why a compounded formulation fits you instead of an approved medicine.
2. Know the pharmacy. The label should name a state-licensed pharmacy that prepares your medicine.
3. Read the ingredients. Know the active ingredient, its form and anything added.
4. Compare with approved options. Ask about FDA-approved medicines such as Wegovy or Zepbound, including their price, before deciding.
5. Watch for red flags. Avoid sellers that skip the prescription, call the product generic or FDA-approved, or use trial results from brand-name drugs.

For safety details on each medicine, read is compounded semaglutide safe and is compounded tirzepatide safe.

How US Quick Health handles compounded GLP-1s

US Quick Health offers compounded semaglutide and compounded tirzepatide, so this guide is published by a telehealth platform with a commercial interest in arranging access to them. A licensed U.S. provider reviews each consultation and decides whether the requested medicine is appropriate. The provider can also discuss FDA-approved options. A licensed U.S. compounding pharmacy prepares compounded prescriptions. These medicines are not FDA-approved and are not generic versions of any brand-name medicine.