FDA proposes rule to block liposomal compounded semaglutide copies
A proposed FDA rule would end liposomal compounding of semaglutide copies, a change that could affect patients who get their GLP-1 medication from a compounding pharmacy.
The FDA has issued a proposed rule that would prohibit compounding pharmacies from using liposomal delivery, the formulation approach behind the Hims & Hers oral semaglutide pill, according to a February 16, 2026 legal analysis of the action [1]. The proposal would place semaglutide on a federal list of drugs that are demonstrably difficult to compound. It has not been finalized, and it drew numerous comments questioning both the rule's language and the agency's statutory authority, the analysis says [1].
The FDA already has authority over compounding through section 503A of the federal food and drug law, and that is the pathway the current compounded semaglutide market relies on [1]. The rule in question would use the Demonstrably Difficult to Compound List, which does not yet exist as a final regulatory category. The manufacturer petitioned the FDA to add semaglutide to that list several years ago [1]. If finalized, the rule would bar compounding with liposomal delivery, a technique also used for other compounded drugs such as testosterone, and would significantly restrict mass compounding methods such as automated compounding, according to the analysis [1].
The proposed rule is one part of a broader enforcement push described in the analysis. On February 9, 2026, Novo Nordisk filed a patent infringement lawsuit against the telehealth company Hims & Hers over compounded semaglutide in pill form. The analysis describes it as the first patent infringement case against semaglutide 503A compounding [1]. Novo is seeking a permanent injunction and argues that mass compounding is occurring and that its patents are being infringed. The patent at issue is U.S. 8,129,343, which covers semaglutide compositions using SNAC delivery technology [1]. Hims & Hers initially said its compounded pill was personalized, then abruptly pulled the offering [1].
Separately, the FDA referred Hims & Hers to the Department of Justice for potential violations of the Federal Food, Drug and Cosmetic Act, and said it plans to take what it called decisive steps to restrict GLP-1 active pharmaceutical ingredient for compounding [1]. What those steps will involve has not been disclosed. The analysis notes the FDA could pursue more red-listing of foreign API manufacturers, inspections, warning letters or seizures [1]. Novo's 25 mg high-dose Wegovy product entered the U.S. market in January 2026, according to the analysis [1].
Why it matters for patients
A finalized rule would remove one specific kind of compounded semaglutide product from the market: oral versions that use liposomal delivery. The analysis says regulators and payers are already questioning whether compounded GLP-1 practices remain justified now that an FDA-approved oral semaglutide is commercially available, particularly where the earlier justification was tied to access or formulation limits [1].
The analysis also points to practical differences in how oral semaglutide is taken. It says improper timing, food intake or missed dosing can directly affect how well the drug works and the risk of side effects, and that pharmacies should expect closer scrutiny of counseling records, workflows and staff training [1]. It further warns that marketing which overstates weight loss results or blurs the difference between FDA-approved and compounded products creates legal exposure under consumer protection laws and state pharmacy rules [1].
On coverage, the analysis says pharmacy benefit managers and payers are reassessing formulary placement, prior authorization criteria and other controls for GLP-1 drugs, and that pharmacies should anticipate more audits and recoupment activity tied to medical necessity and dispensing patterns [1]. It does not report how any of this would change what patients pay, and no pricing figures are given.
What happens next
The proposed rule has yet to be finalized, and no timeline for a final version has been reported [1]. How the FDA responds to the comments on its language and legal authority is also not yet known [1]. Novo's lawsuit, filed February 9, 2026, is pending, and the analysis does not say when a ruling on the requested permanent injunction might come [1]. The outcome of the Justice Department referral and the specific restrictions the FDA intends to place on GLP-1 active pharmaceutical ingredients have not been disclosed [1].
Sources
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