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 vs tirzepatide: which can still be compounded?
Semaglutide (compounded)Tirzepatide (compounded)
Approved originalsOzempic, Wegovy (Novo Nordisk)Mounjaro, Zepbound (Eli Lilly)
Shortage declared resolvedFebruary 2025Late 2024 (upheld by a federal court in 2025)
503A compounding endedApril 22, 2025February 18, 2025
503B compounding endedMay 22, 2025March 19, 2025
What survivesNarrow patient-specific 503A exceptionNarrow patient-specific 503A exception
Pending decisionProposed permanent 503B exclusion - comments closed Jul 30, 2026Same proposal, same docket, same pending decision
Sport (WADA)Not prohibited - on the Monitoring Program since 2024Not 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