FDA proposes excluding semaglutide, tirzepatide and liraglutide from the 503B compounding list

The Food and Drug Administration proposed on April 30, 2026 to keep semaglutide, tirzepatide and liraglutide off the 503B bulks list, saying large outsourcing facilities have no clinical need to compound the three molecules from bulk ingredients ^[1].

Semaglutide is the active ingredient in Novo Nordisk's Ozempic and Wegovy; tirzepatide is the active ingredient in Eli Lilly's Mounjaro and Zepbound ^[5]. Liraglutide was named alongside them ^[1].

The proposal carries docket number FDA-2018-N-3240 and ran 14 pages in the Federal Register of May 1, 2026, at 91 FR 23431 ^[2].

What the list controls

Under section 503B of the Federal Food, Drug, and Cosmetic Act, an outsourcing facility generally cannot make a drug from a bulk drug substance unless that substance appears on the bulks list — or unless the compounded product is on the FDA's shortage list at the moment it is compounded, distributed and dispensed ^[1].

After reviewing nominations for all three ingredients, the agency said it "did not identify sufficient evidence to include" them ^[1]. Clinical need, the FDA said, is judged on patient safety and medical necessity under the law ^[1].

"When FDA-approved drugs are available, outsourcing facilities cannot lawfully compound using bulk drug substances unless there is a clear clinical need," FDA Commissioner Marty Makary said in the announcement ^[1].

STAT reported the proposal is a victory for Novo Nordisk and Eli Lilly and would rework the choices available to consumers ^[5].

Pressure on compounding predates the proposal

A comparison site that earns commissions from the telehealth providers it lists says the FDA ended enforcement discretion on April 1, 2026 for 503A pharmacies making what regulators treat as "essentially a copy" of tirzepatide or semaglutide at telehealth scale; those pharmacies are now limited to compounding justified for an individual patient ^[3]. A clinic that prescribes branded GLP-1 drugs says the branded shortage was declared resolved in October 2024 and that decision affirmed that December ^[4].

That clinic's review cites FDA safety figures: more than 480 adverse event reports tied to compounded tirzepatide and more than 520 tied to compounded semaglutide as of April 2025; reports of patients receiving 10 to 20 times the prescribed dose from multidose vials; and an inspection that found a product labeled 1.25 mg containing 1.75 mg ^[4]. It also cites a peer-reviewed 2026 study reporting that compounding tirzepatide with vitamin B12 can form a molecule absent from the approved drug, at levels up to 10% of total polypeptide content, with unknown effects in people ^[4]. The same review says the FDA sent 55 warning letters to telehealth companies during 2026 — 30 in March and 25 in June — over false or misleading claims about compounded GLP-1 products ^[4].

Why it matters for patients

Compounded semaglutide and tirzepatide are not FDA-approved drugs ^[3]. Outsourcing facilities that make larger batches under 503B face stricter oversight and testing than 503A pharmacies filling single prescriptions, which are not held to the same checks on potency, sterility and consistency ^[4]. Even 503B sites have drawn serious inspection findings, that review notes ^[4].

Which channel supplies a given patient therefore matters. If the exclusion is finalized, 503B facilities would no longer be able to compound these three molecules from bulk substances ^[3]. No final ruling has been issued ^[4].

Pricing figures for the branded versions differ between accounts. The clinic review lists LillyDirect self-pay Zepbound at $299 for the 2.5 mg starting dose and $449 for maintenance doses of 7.5 mg to 15 mg, with a savings card that can bring eligible commercial-insurance costs to as little as $25 per fill and up to $1,300 in annual savings ^[4]. The comparison site lists the starter dose at the same $299 but maintenance at $399 to $699, plus a list price of $499 to $1,086 per fill ^[3]. The difference has not been explained. The clinic review also says a Medicare GLP-1 Bridge Program started July 1, 2026, giving eligible Part D enrollees access to Zepbound, Wegovy and Foundayo for $50 a month ^[4].

What happens next

Comment deadlines are stated differently. The FDA announcement gives June 29, 2026 ^[1]; the Federal Register notice says June 30, 2026 ^[2]. The docket shows a separate notice, dated June 26, 2026, extending the comment period ^[2]. The clinic review says comments closed July 30, 2026, with a final ruling still pending ^[4]. The FDA has said it will consider submitted comments before deciding ^[1].

Separately, the Centers for Medicare & Medicaid Services said on April 21, 2026 that it is delaying the Medicare Part D portion of its BALANCE model for 2027 pending further evaluation and data collection; the model is intended to widen access to GLP-1 medications and other healthy lifestyle interventions ^[6].