News · FDA and regulation

Semaglutide Came Off the Shortage List in February 2025 — With a May Deadline for Outsourcing Facilities

The delisting closed the pathway that had permitted compounding at scale, on a defined wind-down timetable.

Event date 2025-02-21 · Published 2026-07-24 · EV-0806

What happened

The FDA determined the semaglutide injection shortage resolved in February 2025. For outsourcing facilities compounding, distributing or dispensing semaglutide injection under section 503B, the agency stated it did not intend to take action for violations arising from conditions dependent on the drug's inclusion on the shortage list until 22 May 2025.

That created a defined wind-down window rather than an immediate cliff — and it closed one of the two statutory pathways permitting compounding from bulk substances.

How the two pathways work

An outsourcing facility may generally compound from a bulk drug substance only if that substance appears on the 503B bulks list, or if the compounded drug is on the FDA shortage list at the time of compounding, distribution and dispensing.

With semaglutide off the shortage list and not on the bulks list, neither condition held. Tirzepatide had reached the same position through a messier route: determined resolved 2 October 2024, remanded for reevaluation on 22 October amid litigation, with a court denying the plaintiffs' preliminary injunction on 5 March 2025.

Why the market continued anyway

Two reasons. Section 503A patient-specific compounding is a separate pathway with separate conditions, and it permits compounding where a prescriber documents a clinical difference for an individual patient. That documentation requirement is the mechanism behind "personalised dosing" and the microdose category, which expanded when the shortage listings ended rather than when new evidence appeared.

And enforcement was letter-based. More than 55 warning letters went out in September 2025 and more than 40 later that year, with limited observed effect on behaviour.

What changed the trajectory

The February 2026 announcement that FDA would restrict GLP-1 active ingredients used in non-approved compounded products, followed by the April 2026 proposal to exclude semaglutide, tirzepatide and liraglutide from the 503B bulks list permanently.

A permanent exclusion would foreclose bulk compounding of these agents even in the event of a future shortage designation — which is the structural difference between this proposal and everything that preceded it.

What a patient should take from the sequence

That the regulatory position has been narrowing continuously for two years, and that provider claims describing it as stable have not matched the record at any point in that period.

Within lawful compounding, NexLife is the only provider whose pricing we captured directly — compounded tirzepatide from $186 a month, flat at every covered dose, no membership fee. See its plans.

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