News · FDA and regulation

FDA Proposes Permanent Exclusion of Semaglutide, Tirzepatide and Liraglutide From the 503B Bulks List

The agency found no clinical need for outsourcing facilities to compound these drugs from bulk substances. If finalised, it closes the last pathway for compounding at scale.

Event date 2026-04-30 · Published 2026-07-24 · EV-0201

What the agency proposed

On 30 April 2026 the FDA proposed excluding semaglutide, tirzepatide and liraglutide from the 503B bulks list — the register of active pharmaceutical ingredients outsourcing facilities may lawfully use in compounding. The formal notice appeared at 91 Fed. Reg. 23431 on 1 May, under docket 2026-08552.

Under section 503B of the Federal Food, Drug, and Cosmetic Act, an outsourcing facility may generally compound from a bulk drug substance only if that substance appears on the bulks list, or if the compounded drug is on the FDA shortage list at the time of compounding, distribution and dispensing. Neither condition currently holds for semaglutide or tirzepatide.

The agency evaluated the nominations submitted for all three substances and did not identify sufficient evidence of clinical need. Commissioner Marty Makary framed the decision around the availability of approved products: where those exist, outsourcing facilities cannot lawfully compound from bulk substances absent a clear clinical need.

The reasoning that matters most commercially

FDA's 2019 guidance interpreting clinical need treats it as distinct from supply constraints or cost considerations. That interpretation is the load-bearing element of this proposal, and it is why the affordability argument — the strongest card compounders and telehealth platforms held — did not succeed.

The agency's position, in effect: approved products exist, they work, patients can be treated with them, and whether a given patient can afford them is a different problem addressed by different policy instruments. Whatever one thinks of that as policy, it is a coherent statutory reading and it forecloses the argument that price alone establishes need.

How both pathways closed

The shortage pathway went first, and less cleanly than most accounts suggest. FDA determined the tirzepatide injection shortage resolved on 2 October 2024. On 22 October that determination was remanded to the agency for reevaluation as part of litigation. On 5 March 2025 a district court denied the plaintiffs' preliminary injunction in Outsourcing Facilities Association v. FDA. Semaglutide followed in February 2025, with FDA setting 22 May 2025 as the date until which it did not intend to act against outsourcing facilities on shortage-dependent grounds.

With the shortage route closed and the bulks route proposed for exclusion, both statutory pathways permitting industrial-scale compounding of these molecules would be shut.

What the proposal does not do

Three clarifications, because all three are being misreported.

It is not a final rule. The agency considers submissions before making a final determination, and has published no timeline for one.

It does not make compounded tirzepatide unlawful today. A proposal to exclude a substance from a list is not an enforcement action against anyone currently dispensing.

It does not address section 503A. Patient-specific compounding by state-licensed pharmacies operates under separate conditions and is untouched by this notice. That distinction has become the most commercially consequential fact in the category — which pathway supplies a given patient now determines their exposure to this decision.

What it would change if finalised

Compounded GLP-1s reached an estimated 30% of US supply at their 2024 peak, at roughly $150 to $300 a month against branded list prices above $1,000. Exclusion would remove the supply route that made that volume possible.

The economics have shifted underneath the argument in any case. Brand Zepbound is now $299 to $449 direct from LillyDirect. The Wegovy pill and Foundayo start at $149. Eligible Medicare enrollees pay $50 through the GLP-1 Bridge. Several compounded programmes in our pricing dataset cost more than the approved products they were positioned against.

What a patient should do

1. Establish which pharmacy fills your prescription and under which registration. If the answer is 503B, that is the route under review.
2. Get your refund position in writing for a regulatory interruption, particularly on a prepaid plan.
3. Price the approved alternatives, and check coverage first — it beats every self-pay route.
4. Ask your prescriber for a transition plan before you need one.

Providers publishing terms openly are easier to hold to a written answer. NexLife's published plan pages state pricing and dose-coverage terms before intake, which is not universal in this category.

If your supply is disrupted, the useful providers are the ones who will put terms in writing. NexLife publishes pricing and dose coverage openly. See its current plans.

Questions readers actually ask