The news: The FDA is stepping up its enforcement on GLP-1 compounding with a new proposal to remove several key active ingredients from the bulk substances list that outsourcing manufacturers are allowed to use to make the copycat diabetes and obesity drugs. The change would remove semaglutide (the ingredient in Novo Nordisk’s Ozempic and Wegovy), tirzepatide (Eli Lilly’s Mounjaro and Zepbound), and liraglutide (Novo’s Victoza and Saxenda).

Catch up quick: Compounders are allowed to make prescription drugs during shortages. Lilly’s tirzepatide shortage ended in December 2024, and Novo’s semaglutide shortage ended in February 2025. But telehealth companies like Hims & Hers have continued to sell them under a regulatory exception that allows doctors to prescribe compounds at their discretion for individual patients.

Why it matters: The move threatens telehealth companies’ compounded GLP-1 weight loss drug sales and benefits brand drugmakers that have pushed against those sales.

Telehealth sellers of compounded drugs would have to move away from the bulk compounding that has fueled the compounded obesity drug market. Novo estimates 1.5 million US users of compounded GLP-1s. Hims recently pulled back on compounded drug sales, striking a deal with Novo in March to sell branded Wegovy and Ozempic and stop marketing compounds in exchange for Novo dropping a patent lawsuit. Novo and Lilly have asked the FDA to bar compounders from using their active ingredients and filed lawsuits against compounders and related manufacturers.

Implications for telehealth and pharma companies: While the proposal is still under review, it would reshape supply, access, and pricing if finalized.

Telehealth companies selling GLP-1 compounds would be forced to shift to brand-name prescribing and focus on obesity care support. They would also have to limit patient-specific prescriptions to documented clinical needs or potentially face FDA enforcement action.

GLP-1 brand drugmakers would gain greater influence over pricing, prescribing channels, and patient access. Although Lilly and Novo currently dominate the approved market, limiting compounding would make it easier for new entrants to compete without facing compounded competition.

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