One year after the semaglutide shortage ended, compliance analysts take stock

A widely circulated legal-industry commentary marks roughly one year since the FDA determined the national semaglutide shortage had ended, the event that started the clock on enforcement against compounding pharmacies that had been making versions of Ozempic and Wegovy under a shortage exception.^[1] The tirzepatide shortage affecting Mounjaro and Zepbound closed earlier, with FDA issuing a declaratory order on December 19, 2024, confirming that shortage was resolved.^[2] Once a drug leaves the FDA shortage list, compounded versions once again count as "essentially a copy" of the approved product and become unlawful outside narrow, patient-specific exceptions, such as a documented allergy to an inactive ingredient.^[1]

FDA gave pharmacies staggered wind-down periods, generally 60 to 90 days, to stop production and use up existing supply once the shortage exceptions lapsed.^[1] Since September 2025, the agency has issued more than 135 warning letters to GLP-1 compounders, with inspectors focused on formulations that add unapproved ingredients without a documented clinical rationale, and on marketing that describes mass-produced batches as personalized medicine.^[2] Separately, FDA has proposed permanently excluding tirzepatide, semaglutide, and liraglutide from the 503B Bulks List that governs large-scale outsourcing facilities; the proposal was issued April 30, 2026, its comment period closed July 30, 2026, and no final rule has been issued.^[2]

Eli Lilly has pursued its own litigation campaign, suing Strive Pharmacy and a second Texas-based compounding pharmacy, plus four telehealth platforms — Fella Health, Willow Health, Henry Meds, and Mochi Health — over marketing of compounded tirzepatide as personalized medicine.^[2] Strive countersued Lilly and Novo Nordisk in January 2026, alleging antitrust conduct through exclusive agreements that barred telehealth platforms from working with compounding pharmacies.^[2] None of these cases has reached final judgment.^[2] Meanwhile, FDA has also flagged quality issues distinct from the shortage question, issuing Form 483 observations to some outsourcing facilities for inadequate stability testing and impurity profiling of compounded semaglutide salts that differ chemically from the FDA-approved base compound.^[1]

Why it matters for patients

For patients who had turned to compounded semaglutide or tirzepatide because brand-name GLP-1 drugs cost more than $1,000 a month without insurance, this year's enforcement means fewer legal options to obtain a compounded version outside a genuine, documented individual medical need.^[1] A pharmacy that has not been sued or hasn't received a warning letter isn't necessarily operating lawfully; the absence of a case is not proof of compliance, according to the legal analysis.^[2] Patients relying on any compounded product should understand that its legal status can shift quickly if the underlying documentation or marketing doesn't meet the patient-specific standard regulators are now enforcing.^[1][2] The commentary also notes that affordability, not manufacturing capacity, is what continues to drive demand for compounded alternatives, a gap this year's enforcement does not resolve.^[1]

What happens next

FDA's Pharmacy Compounding Advisory Committee continues to evaluate whether various peptides belong on the 503A bulk substances list, and further exclusions are considered plausible given the agency's stated concerns about insufficient long-term safety data.^[1] The proposed 503B Bulks List exclusion for tirzepatide, semaglutide, and liraglutide remains pending, with no final rule yet issued after the July 30, 2026 comment deadline.^[2] Congress has also shown renewed interest in tightening the "essentially a copy" exception and requiring more detailed FDA reporting on shortage determinations, though no legislation has passed.^[1] The Eli Lilly lawsuits against compounding pharmacies and telehealth platforms, along with Strive's antitrust countersuit, remain unresolved.^[2]