FDA proposes a rule on liposomal compounding aimed at GLP-1 copies

The Food and Drug Administration has proposed a rule that would add liposomal delivery to a list of compounding methods pharmacies are not allowed to use. The technology is the one behind the oral semaglutide pill sold by telehealth company Hims & Hers ^[1]. The proposal has already drawn comments questioning both how the rule is written and whether the FDA has the legal authority to issue it ^[1].

The timing matters. On February 9, 2026, Novo Nordisk sued Hims & Hers for patent infringement over its compounded semaglutide pill, days after Novo's own 25 mg high-dose Wegovy entered the market in January ^[1]. Novo is asking a court for a permanent injunction and argues the compounded product infringes U.S. Patent 8,129,343, which covers Novo's SNAC delivery technology used in its oral semaglutide tablet Rybelsus ^[1]. Hims & Hers first described its pill as personalized, then pulled the compounded semaglutide offering from sale ^[1]. Attorney Martha Rumore, writing for Health Law Alliance, called this the first patent infringement case ever brought against 503A compounded semaglutide ^[1].

Separately, the FDA referred Hims & Hers to the Department of Justice over possible violations of the Federal Food, Drug and Cosmetic Act, and said it plans "decisive steps" to restrict the raw ingredient, or API, that compounders use to make GLP-1 drugs ^[1]. One option under discussion is adding semaglutide to a not-yet-existing "Demonstrably Difficult to Compound" list, something the brand manufacturer petitioned for years ago ^[1]. The liposomal proposed rule is described as part of that broader DDC framework, and it has not been finalized ^[1].

Why it matters for patients

For patients currently using a compounded oral semaglutide product built on liposomal delivery, the proposed rule signals that this category of product could eventually become unavailable through compounding pharmacies, though nothing is final yet ^[1]. The rule is still in the comment period, and critics have challenged both its wording and whether the FDA even has the statutory authority to bar this compounding method ^[1].

The legal fight also touches on labeling and counseling. Rumore's analysis notes that oral semaglutide has specific administration requirements around timing and food intake that can affect how well the drug works and what side effects show up, which raises the bar for pharmacist counseling and documentation regardless of whether a product is brand-name or compounded ^[1]. Patients switching between a brand pill and a compounded one, or considering either, are in a market where the rules about what pharmacies can legally offer are actively being rewritten.

Insurance coverage is also shifting alongside this. The article notes that pharmacy benefit managers and payors are reassessing formulary placement and prior authorization for GLP-1 therapies as the branded oral option becomes available, which could affect what patients pay out of pocket or how easily they get a prescription filled ^[1].

What happens next

The proposed liposomal compounding rule remains open to public comment, and the FDA has not said when it will finalize it ^[1]. Novo Nordisk's patent lawsuit against Hims & Hers, filed February 9, 2026, is proceeding in court, with Novo seeking a permanent injunction against the compounded product ^[1]. The FDA's referral of Hims & Hers to the Department of Justice is also pending, and the agency has not detailed exactly what "decisive steps" it will take to restrict GLP-1 active ingredients used in compounding ^[1].