One year after the semaglutide shortage ended, compounding enforcement narrows the market

An analysis published Aug. 16, 2026 takes stock roughly twelve months after the FDA determined that the national shortage of semaglutide — the active ingredient in Novo Nordisk's Ozempic and Wegovy — had been resolved ^[1]. That determination ended the shortage exception that had allowed compounding pharmacies and outsourcing facilities to produce copies of the drug at scale ^[1].

Under federal law, a compounded drug may not be "essentially a copy" of an FDA-approved product unless that product appears on the FDA's shortage list ^[1]. Once the exception lapsed for semaglutide, and separately for tirzepatide (Mounjaro and Zepbound), compounded versions again became unlawful to make outside narrow patient-specific exceptions, such as an allergy to an inactive ingredient or a documented clinical need for a different dosage form ^[1]. The FDA gave 503A pharmacies and 503B outsourcing facilities staggered wind-down periods, generally 60 to 90 days, to stop production and exhaust existing supply ^[1].

The two drugs' timelines are documented differently. Tirzepatide's shortage exemption closed on Dec. 19, 2024, when the FDA issued a declaratory order affirming the shortage was resolved ^[2]. For semaglutide, one account describes removal from the shortage database as happening in late 2024 while marking the anniversary in August 2026 ^[1]. A single, precise date for the semaglutide determination has not been reported in these accounts.

Enforcement has continued since. More than 135 warning letters have gone to GLP-1 compounders since September 2025, a count the FDA's inspectors continue to add to ^[2]. The agency has focused on formulations that add unapproved ingredients to tirzepatide without a documented, patient-specific rationale, and on marketing that describes mass-produced batches as personalized compounds ^[2]. Facilities have also received Form 483 inspection findings over inadequate stability testing and impurity profiling of compounded semaglutide salts, which differ from the FDA-approved base compound ^[1].

A proposed rule would tighten the 503B picture further. On April 30, 2026, the FDA proposed keeping tirzepatide, semaglutide and liraglutide off the 503B Bulks List permanently, finding no clinical basis for outsourcing facilities to compound them from bulk substances when approved versions are available ^[2]. The comment period closed July 30, 2026, after a 30-day extension, and no final rule has been issued ^[2]. Section 503A pharmacies are not directly governed by the Bulks List but remain bound by the patient-specific prescription requirement ^[2].

Manufacturer litigation is also still moving. Eli Lilly sued Strive Pharmacy in Delaware federal court and a second, Texas-based compounding pharmacy in New Jersey federal court in April 2025, and separately sued four telehealth platforms — Fella Health, Willow Health, Henry Meds and Mochi Health — in the Northern District of California ^[2]. Strive countersued Lilly and Novo Nordisk in January 2026, alleging antitrust conduct through exclusive agreements that kept telehealth platforms from working with compounding pharmacies ^[2]. None of the matters has reached final judgment ^[2]. The Outsourcing Facilities Association and individual compounders separately challenged the FDA's shortage determinations, arguing the process was not transparent enough and missed regional supply gaps; courts have generally deferred to the agency ^[1].

Why it matters for patients

Compounded semaglutide and tirzepatide are now generally available only with a valid, patient-specific prescription and a documented clinical reason the FDA-approved product will not work for that patient ^[2]. Neither pathway permits a standing protocol applied across a patient population ^[2].

Cost remains the backdrop. Brand-name GLP-1s were priced above $1,000 monthly without insurance coverage, and patient advocacy groups argue that affordability gaps — not manufacturing capacity alone — keep driving demand for compounded alternatives ^[1].

Patients who were receiving a compounded version may find that a pharmacy has stopped making it or changed how it can be supplied, though how many pharmacies exited this business, and how many patients were affected, has not been reported. The legal exposure created by the enforcement cycle also reaches documentation: as one law firm puts it, "the same documentation that satisfies a state inspector is the documentation a manufacturer's litigation team will request in discovery" ^[2].

What happens next

The FDA has not announced a date for a final rule on the 503B Bulks List exclusion, and the comment period on that proposal closed July 30, 2026 ^[2]. The agency's Pharmacy Compounding Advisory Committee continues to evaluate nominated peptides for the 503A bulk substances list, and additional exclusions are considered plausible given the FDA's stated concerns about immunogenicity and limited long-term safety data for popular research peptides such as BPC-157 and thymosin beta-4 ^[1]. Congress has shown renewed interest in tightening the "essentially a copy" exception and requiring more granular reporting on shortage determinations, though no legislation has been enacted ^[1]. Further guidance, litigation or legislative action within the coming year appears likely ^[1].