AI Nav

The demand for weight loss medications like Ozempic, Rybelsus, Wegovy, and Mounjaro has skyrocketed, driven largely by social media. These drugs have shown unprecedented success in weight management, leading to supply shortages. The recent approval of Eli Lilly’s Zepbound—essentially Mounjaro rebranded for weight loss—is expected to further increase demand. To manage supply, Novo Nordisk, the manufacturer of Ozempic, Wegovy, and Rybelsus, has deliberately restricted new starter doses of Wegovy to ensure that current users can maintain their treatment despite ongoing production limitations.

The Role of Compounding Pharmacies

Compounding pharmacies, regulated by state pharmacy boards, create customized versions of medications to meet individual patient needs. They can modify drugs by altering ingredients to avoid allergens, improving taste, adjusting dosage forms (e.g., from tablets to liquids), or producing strengths unavailable in brand-name options.

Under Section 503A of the Federal Food, Drug, and Cosmetic Act, compounding pharmacies can legally formulate alternatives to branded medications. However, unlike drug manufacturers, they are not required to seek FDA approval or oversight for safety and efficacy.

Compounded Drugs and Shortages

When a drug appears on the FDA’s shortage list, compounding pharmacies are permitted to produce similar formulations to help bridge supply gaps. Currently, semaglutide—the active ingredient in Ozempic and Wegovy—remains in short supply due to overwhelming demand, impacting both the medication and its auto-injector pen. While tirzepatide, found in Mounjaro and Zepbound, has also faced shortages for diabetes patients, Eli Lilly reports that supply is improving. However, the FDA must still confirm whether availability meets demand before removing it from the shortage list.

Leave a Reply