Law firm guidance says compounders must now justify every GLP-1 prescription individually

A client alert from the law firm Clark Hill says compounding pharmacies, telehealth companies, med spas, and weight-loss businesses can no longer rely on the old GLP-1 shortages to justify routine, large-scale production of compounded copies of Ozempic, Wegovy, Mounjaro, and Zepbound.^[1][2] The advice follows two Fifth Circuit Court of Appeals rulings that upheld the FDA's decisions to remove semaglutide and tirzepatide injection products from the federal drug shortage list.^[1][2]

The cases involved semaglutide products made by Novo Nordisk and tirzepatide products made by Eli Lilly. Compounding groups had argued the FDA acted improperly when it decided manufacturer supply could meet or exceed demand, and that the agency should have used formal notice-and-comment rulemaking first.^[1][2] The court disagreed, finding any procedural error was harmless because affected parties had actual notice and multiple chances to submit information to the FDA.^[1][2] The court also found the FDA reasonably relied on manufacturer production, inventory, and supply data over other evidence, including patient reports, screenshots, surveys, and news articles submitted by compounders and telehealth companies.^[1][2]

In the tirzepatide case, the FDA specifically discounted data collected through a Hims & Hers website because the submissions did not reliably show when an access problem happened, where the person lived, why the person could not get the drug, or whether the same person submitted more than one report.^[1][2] The Fifth Circuit agreed that manufacturer data was more reliable.^[1][2]

Federal law normally limits compounding of drugs that are essentially copies of approved products, but those limits loosen during an official shortage.^[1][2] With the shortage listings gone, that broader legal pathway has closed. Section 503A pharmacies and Section 503B outsourcing facilities operate under different rules, but both now face tighter restrictions.^[1][2] The alert says a valid patient-specific prescription is not enough on its own; the compounded product must also meet other statutory conditions, and programs built on standardized prescribing and broad marketing of essentially identical formulas may face more legal risk than compounding tailored to one patient's documented clinical need.^[1][2]

Why it matters for patients

Patients who currently get compounded semaglutide or tirzepatide through telehealth platforms, med spas, or online pharmacies may see changes in availability, pricing, or how prescriptions are issued as these businesses review their practices.^[1][2] The alert notes that legitimate patient-specific compounding remains legal, such as when a prescriber determines a compounded version is meaningfully different for a particular patient — for example, if someone cannot tolerate an ingredient in the approved drug.^[1][2] But a business that routinely directs many patients toward the same compounded formula, without individualized medical justification, may not meet the legal standard going forward.^[1][2] Patients considering compounded GLP-1 products may want to understand whether their prescription reflects an individualized medical need rather than a standardized offering, since that distinction is now central to whether a product can legally continue to be sold.^[1][2]

What happens next

The alert states that the FDA's shortage determinations for semaglutide and tirzepatide remain in place after the Fifth Circuit rulings, and the agency continues to scrutinize compounded GLP-1 products.^[1][2] Compounding pharmacies, telehealth companies, physicians, and other businesses are urged to review whether their prescribing, formulation, marketing, and distribution practices satisfy federal requirements before facing possible regulatory or enforcement action.^[1][2] No specific FDA enforcement dates are mentioned in the available sources, and it is not yet known how quickly individual companies will change their practices or how enforcement will unfold.^[1][2]