Compare · regulatory status only
Semaglutide vs tirzepatide: which can still be compounded?
The short answer
Neither, in the routine sense. Both are FDA-approved drugs whose compounded copies were permitted only during their shortages, and both permissions have ended - tirzepatide's on February 18 / March 19, 2025, semaglutide's on April 22 / May 22, 2025 (503A pharmacies / 503B facilities respectively). Only a narrow patient-specific 503A exception survives for either. One decision now covers both: the FDA's proposed permanent 503B exclusion, with comments closed July 30, 2026 and a determination pending.
Status comparison, not advice - Peptlas compares legality and oversight, never effects. Published Aug 27, 2026 (ET) · sources below
Side by side
| Semaglutide (compounded) | Tirzepatide (compounded) | |
|---|---|---|
| Approved originals | Ozempic, Wegovy (Novo Nordisk) | Mounjaro, Zepbound (Eli Lilly) |
| Shortage declared resolved | February 2025 | Late 2024 (upheld by a federal court in 2025) |
| 503A compounding ended | April 22, 2025 | February 18, 2025 |
| 503B compounding ended | May 22, 2025 | March 19, 2025 |
| What survives | Narrow patient-specific 503A exception | Narrow patient-specific 503A exception |
| Pending decision | Proposed permanent 503B exclusion - comments closed Jul 30, 2026 | Same proposal, same docket, same pending decision |
| Sport (WADA) | Not prohibited - on the Monitoring Program since 2024 | Not prohibited - on the Monitoring Program since Jan 1, 2026 |
Two timelines, one destination
The two molecules ran the same regulatory arc a few weeks apart: shortage declared, compounded copies permitted, shortage resolved, permission wound down. Tirzepatide got there first - and its wind-down survived a court challenge, which settled the template semaglutide's then followed. Since spring 2025 the practical answer for both is the same: routine compounded copies are over, and what remains is the narrow patient-specific exception plus the enforcement posture around everything else.
The still-open question is shared too. In May 2026 the FDA proposed to leave semaglutide, tirzepatide, and liraglutide off the 503B bulks list permanently - which would close the outsourcing-facility route for good, shortage or no shortage. Comments closed July 30, 2026. Both the semaglutide and tirzepatide entries change status the day the FDA decides.
Asked and answered
- Can any pharmacy still compound semaglutide or tirzepatide?
- Only under the narrow 503A exception: a patient-specific product that is not essentially a copy of the approved drug, for a documented clinical need. Routine copies of either molecule have not been permitted since the 2025 wind-down dates.
- What is the 503B exclusion proposal that covers both?
- A May 2026 FDA proposal to determine there is no clinical need for outsourcing facilities to compound semaglutide, tirzepatide, or liraglutide from bulk - which would permanently exclude them from the 503B bulks list. The comment period closed July 30, 2026; the final determination is pending with no announced date.
- Are semaglutide and tirzepatide banned in sport?
- No. Neither is prohibited by WADA. Both sit on the WADA Monitoring Program - semaglutide since 2024, tirzepatide effective January 1, 2026 - meaning use is tracked, not sanctioned.
Sources
Keep going
Get alerted when any status changes
One short, human-verified email whenever an official status changes. No spam, no selling.