Are compounded GLP-1s still legal?
What providers need to know about compounded semaglutide, tirzepatide, and retatrutide.

The compounded semaglutide or compounded tirzepatide prescription you could write in 2024 can put you at risk in 2026. While both drugs were on the FDA drug shortage list, federal law let pharmacies compound copies. However, the FDA declared both shortages over in 2025. Since then, the FDA, state boards, state attorneys general, and drugmakers have all moved against compounded as well as unapproved GLP-1s. Here is where the law stands in 2026 for the NPs, PAs, and physicians who prescribe GLP-1s, and what the latest enforcement means for your practice.

Are compounded GLP-1s still legal to prescribe?

Only in narrow cases, and never simply to offer a cheaper version of a branded GLP-1 such as Wegovy (semaglutide) or Zepbound (tirzepatide). Federal law (section 503A of the Food, Drug, and Cosmetic Act) bars a pharmacy from compounding drugs that are “essentially copies” of a commercially available drug “regularly or in inordinate amounts.” Now that both shortages are resolved, the FDA treats Wegovy, Zepbound, and other approved GLP-1s as commercially available.

The exception is a change made for a specific, named patient that produces a “significant difference,” as determined by the prescriber (21 U.S.C. § 353a(b)(2)). A classic example is a documented allergy to an inactive ingredient in the approved product. This is viewed as a justifiable or “medically necessary” reason to create a compound medication using a patented active ingredient. Under the FDA’s 2018 guidance, a compounded drug is a copy if it has the same active ingredient, the same route, and the same or a similar strength. In the FDA’s case, “similar” means “within 10 percent” of the commercial product’s strength.

Can providers still prescribe compounded tirzepatide or compounded semaglutide?

The tirzepatide shortage ended in December 2024, the pharmacy grace period ended March 5, 2025, and the Fifth Circuit upheld the FDA’s decision in August 2026. Search results saying compounding “can resume” date from October 2024 and are out of date.

Similarly, the semaglutide shortage ended in February 2025, and the pharmacy grace period ended April 24, 2025.

Notably, adding an ingredient doesn’t necessarily make a compound compliant. For example, the FDA says a semaglutide and B12 injection still counts as a copy when each ingredient is within 10 percent of commercial strength. In another recent example, the FDA said the same about tirzepatide with niacinamide in its 2026 letter to Empower Pharmacy. State medical and nursing boards may also question whether an add-in was clinically justified.

When did the FDA end compounding for semaglutide and tirzepatide?

Tirzepatide on March 5, 2025, and semaglutide on April 24, 2025, for 503A pharmacies. Each shortage decision came with a short grace period, and each grace period was tied to court rulings in lawsuits brought by the Outsourcing Facilities Association.

The FDA originally set the 503A deadlines at February 18 and April 22, 2025, then extended each until a federal court ruled on a preliminary injunction. The court denied both injunctions, on March 5 and April 24. As of the FDA’s April 1, 2026 update, neither drug is on the shortage list or on the 503B bulks list, and on May 1, 2026, the FDA proposed keeping semaglutide, tirzepatide, and liraglutide off the 503B bulks list entirely.

What has the FDA done since the GLP-1 shortage ended?

It has restricted GLP-1 ingredients, banned specific marketing claims, and sent several rounds of warning letters.

In September 2025, the FDA sent warning letters to telehealth companies and compounders over GLP-1 marketing as part of a broader push on deceptive drug advertising. On February 6, 2026, the FDA announced it would restrict GLP-1 active ingredients intended for non-approved compounded drugs that are mass-marketed as alternatives to approved products. The statement says companies can’t call compounded products generic versions, can’t say they contain the same active ingredient, and can’t say they are clinically proven, and it warns that violations may lead to seizure and injunction without further notice. On March 3, 2026, the FDA sent 30 more warning letters to telehealth companies over compounded GLP-1 marketing.

Does a “significant difference” note protect the prescriber?

Not if it’s standard or templated, meaning the same reason pasted over and over again for many patients. For example, on September 18, 2026, the FDA issued a warning letter to Empower Pharmacy, a large Houston 503A compounder, over compounded tirzepatide with niacinamide and semaglutide with vitamin B12. The FDA said the volume of orders suggested the differences from the approved products were “pretextual,” meaning an excuse to compound rather than a real clinical need.

The FDA cited three kinds of evidence: prescriptions with no significant-difference determination at all, prescriptions whose significant-difference statements were repeated word for word across many records, which suggested they were “pre-generated for selection by the prescriber,” and the sheer number of orders. The FDA also said that third-party technology platforms that give prescribers pre-selected menu options for a significant-difference statement call into question whether those determinations were individualized. For example, ordering compounded GLP-1s through a pharmacy or telehealth portal that offers a dropdown of reasons.

The warning letter went to the pharmacy. However, the prescriptions behind it were written by prescribers, and those prescriptions are now part of an FDA record.

Can providers prescribe retatrutide before FDA approval?

No. Retatrutide, Eli Lilly’s investigational GLP-1, GIP, and glucagon receptor agonist, is not approved for any use, and the FDA says it cannot be used in compounding under federal law. The FDA told the Federation of State Medical Boards and the National Council of State Boards of Nursing this in a March 31, 2025 letter. It has since warned telehealth companies, ingredient distributors, outsourcing facilities, and “research use only” sellers over retatrutide.

Retatrutide has extremely promising clinical trial data: in Lilly’s TRIUMPH-1 trial, the 12 mg dose produced 28.3 percent average weight loss over 80 weeks, and Lilly plans to submit it to the FDA in early 2027. However, until approval, patients can get it only through a clinical trial.

Who is at risk for compounded GLP-1s, the prescriber or the pharmacy?

Both. While FDA letters have mostly gone to pharmacies and telehealth companies, prescribers face additional risks.

• State boards. A board of nursing or medicine judges whether a prescription met the standard of care, and a compounded copy without a documented, patient-specific reason is hard to defend.

• State attorneys general. Ohio warned 14 med spas in April 2025, and Connecticut sent letters to clinics, med spas, and practices in May 2025 over compounded GLP-1 claims.

• Drugmakers. Novo Nordisk sued Hims & Hers in February 2026, and law firms report that Novo and Lilly have sent cease-and-desist letters to clinics and prescribers.

• Payment and ad partners. Stripe must approve telehealth and online pharmacy businesses before processing their payments. LegitScript, which certifies health businesses for card networks and ad platforms like Google, treats any claim that a compounded GLP-1 is FDA-approved as a violation.

Advertising is where most practices get caught. “Same active ingredient as Wegovy” and “generic Zepbound” are phrases the FDA named in February 2026.

What should providers prescribe instead?

FDA-approved GLP-1s, which now cost far less than they did when compounding took off. For a patient whose commercial plan covers weight loss drugs, a manufacturer savings card can bring Zepbound, Wegovy, or Foundayo down to $25 a month, which is the cheapest path by far. Self-pay prices through LillyDirect and NovoCare Pharmacy start at $149 a month, and eligible Medicare patients can get Wegovy, Foundayo, or the Zepbound KwikPen for $50 a month through the CMS GLP-1 Bridge.

Our guide to making GLP-1s affordable for your patients covers each payment path step by step. For any patient who truly needs a compounded formulation, document in the chart the “change, made for an identified individual patient, which produces for that patient a significant difference” from the approved product (21 U.S.C. § 353a(b)(2)).

We love talking through the nuances of how providers grow their practices compliantly and sustainably. A free call with the Prax team can help you plan your practice and keep you on the right side of regulations.

This guide is for general information only and isn’t legal, tax, or medical advice. Federal and state rules on compounded drugs change. Talk with a qualified professional about your situation.

Last reviewed: October 27, 2026. Reviewed by: Prax Health Research Team.