Compounded GLP-1s in 2026: what FDA says after the shortages ended
FDA declared the tirzepatide injection shortage resolved on December 19, 2024 and the semaglutide injection shortage resolved on February 21, 2025. Its grace periods for compounders have ended, and in an April 1, 2026 update FDA said neither drug is on the drug shortage list or the 503B bulks list. Compounding is still allowed only under narrow conditions.
When did FDA end the GLP-1 shortages?
| Date | FDA action |
|---|---|
| Oct 2, 2024 | Tirzepatide injection shortage determined resolved |
| Dec 19, 2024 | After re-evaluation, tirzepatide shortage again determined resolved |
| Feb 21, 2025 | Semaglutide injection shortage determined resolved |
| Mar 19, 2025 | End of tirzepatide enforcement discretion for 503B outsourcing facilities |
| Apr 24, 2025 | Court denied injunction in the semaglutide case; 503A discretion ended |
| May 22, 2025 | End of semaglutide enforcement discretion for 503B facilities |
| Apr 1, 2026 | FDA reminds compounders of 503A/503B conditions |
All dates from FDA[1].
Can pharmacies still compound semaglutide or tirzepatide?
Only under the statute’s conditions. A 503A pharmacy compounds for an individual patient on a prescription and may not compound "regularly or in inordinate amounts" drugs that are essentially copies of a commercially available product[1]. FDA treats a product as essentially a copy if it has the same active ingredient in the same, similar or easily substitutable strength and can be used by the same route, unless a prescriber documents a change that produces a significant difference for an identified patient[1]. FDA gives the example of semaglutide combined with vitamin B12 being considered a copy when strengths are within 10%[1]. FDA has said it does not intend to act against a compounder filling four or fewer prescriptions of such a copy in a calendar month[1].
503B outsourcing facilities may not compound from bulk substances unless the substance is on the 503B bulks list or the drug is on the shortage list; FDA states tirzepatide and semaglutide are on neither[1].
Why do telehealth programs still list compounded GLP-1s?
Several programs we track still list compounded options on their public pages: Mochi from $60 (semaglutide) and $90 (tirzepatide)[2], Ivím Health[3], OrderlyMeds[4], TrimRx[5], Fridays[6], Found[7] and Henry Meds[8]. We list their published prices on our compounded semaglutide and compounded tirzepatide pages. We don’t judge whether any particular program meets the FDA conditions above.
What FDA says about compounded drugs generally
"Compounded drugs are not approved by FDA," and FDA-approved drugs go through premarket review for safety, effectiveness and quality[1]. FDA may still act against compounders for other violations, including substandard quality[1].
What do compounded GLP-1s cost?
The price gap has narrowed. Brand-name semaglutide now starts at $149 a month for the Wegovy pill and $199 for the first two fills of the Wegovy pen[9]; Zepbound starts at $299[10]. Published compounded starting prices range from $60 to $297 a month for semaglutide, before any membership, depending on program and plan length.
Questions people ask
Is compounded semaglutide legal in 2026?
Compounding is legal only under the conditions of sections 503A and 503B. FDA says semaglutide is no longer on its shortage list, and its grace periods for compounders ended in 2025.
When did the tirzepatide shortage end?
FDA determined the tirzepatide injection shortage resolved on October 2, 2024, and confirmed that again on December 19, 2024 after re-evaluation.
Are compounded GLP-1s FDA-approved?
No. FDA says compounded drugs are not FDA-approved.
Sources
Every price above links to one of these pages. We loaded each one and saved a copy on the date shown.
- FDA clarifies policies for compounders as national GLP-1 supply begins to stabilize . U.S. Food and Drug Administration. Checked .https://www.fda.gov/drugs/drug-alerts-and-statements/fda-clarifies-policies-compounders-national-glp-1-supply-begins-stabilize
- Ivím Health: compounded GLP-1 prices and membership . Ivím Health. Checked .https://www.ivimhealth.com/
- Henry Meds programs (plan prices; page dated December 3, 2025) . Henry Meds. Checked .https://henrymeds.com/legal/programs
- Wegovy savings offer and self-pay prices (pen, HD pen and pill) . Novo Nordisk (NovoCare). Checked .https://www.novocare.com/obesity/products/wegovy/savings-offer.html
- Zepbound on LillyDirect (vial and KwikPen self-pay prices) . Eli Lilly and Company. Checked .https://www.lilly.com/lillydirect/zepbound