The Murky Future of Compounded Weight-Loss Drugs

The uncertain future of GLP-1 compounding and what the pathway forward may look like for pharmacies and patients. | Viewpoints

by Ann Johnson, Pharm.D.

With tirzepatide and semaglutide facing shortages in 2022–2024, compounded GLP-1 medications proliferated, with television commercials and social media advertisements abounding. During the Food and Drug Administration (FDA) drug shortages, compounding pharmacies were legally allowed to compound these agents to meet market needs. However, now that the FDA has announced the resolution of tirzepatide and semaglutide shortages, the future of compounded GLP-1s is uncertain. For pharmacies and patients, what does the pathway forward look like?

HISTORY: Tirzepatide and Semaglutide Shortages

For those unfamiliar with the tirzepatide and semaglutide shortages, key dates associated with the GLP-1 shortages are as follows:

Tirzepatide:

• December 2022: Mounjaro (tirzepatide) placed on the FDA drug shortage list.

• Nov. 8, 2023: Zepbound (tirzepatide) was FDA approved.

• April 2024: Zepbound (tirzepatide) placed on the FDA drug shortage list.

• Oct. 2, 2024: The FDA announced that the tirzepatide shortage had been resolved.

• Oct. 7, 2024: The FDA was sued by a trade association and a compounder regarding tirzepatide’s removal from the drug shortage list.

• Oct. 11, 2024: A court order remanded the decision to the FDA for reevaluation.

• Dec. 19, 2024: The FDA reevaluated its Oct. 2 determination and again announced that the tirzepatide shortage had been resolved. For pharmacies compounding the product, the FDA stated that it would not take action against 503A pharmacies until Feb. 18, 2025, and would not take action against 503B outsourcing facilities until March 19, 2025.

• Feb. 11, 2025: The FDA clarified that it would not take action against 503A pharmacies until Feb. 18, 2025, or until the date of the district court’s decision on the plaintiff’s preliminary injunction motion in OFA v. FDA (4:24-cv-00953), whichever is later. For 503B outsourcing facilities, the FDA clarified that it would not take action until March 19, 2025, or until the date of the district court’s decision on the plaintiff’s preliminary injunction motion in OFA v. FDA (4:24-cv-00953), whichever is later.

• March 5, 2025: The FDA denied the plaintiff’s preliminary injunction motion in OFA v. FDA (4:24-cv-00953). For 503A pharmacies, the FDA’s period of enforcement discretion ended; for 503B outsourcing facilities, the action date against pharmacies remained March 19, 2025.

Semaglutide:

• March 2022: Wegovy (semaglutide) was placed on the FDA drug shortage list.

• August 2022: Ozempic (semaglutide) was placed on the FDA drug shortage list.

• Feb. 21, 2025: The FDA announced that the semaglutide shortage had been resolved. For those compounding the product, the FDA stated that it would not take action against 503A pharmacies until April 22, 2025, and would not take action against 503B outsourcing facilities until May 22, 2025.

• March 10, 2025: The FDA clarified that it would not take action against 503A pharmacies until April 22, 2025, or until the date of the district court’s decision on the plaintiff’s preliminary injunction motion in OFA v. FDA (4:25-cv-00174), whichever is later. For 503B outsourcing facilities, the FDA clarified that it would not take action until May 22, 2025 or until the date of the district court’s decision on the plaintiff’s preliminary injunction motion in OFA v. FDA (4:25-cv-00174), whichever is later.

• April 24, 2025: The FDA denied the plaintiff’s preliminary injunction motion in OFA v. FDA (4:25-cv-00174). For 503A pharmacies, the FDA’s period of enforcement discretion ended; for 503B outsourcing facilities, the action date against pharmacies remains May 22, 2025.

Read on to Learn More about:

• The FDA’s Stance on the enforcement discretion periods for 503A and 503B pharmacies following the official shortage resolutions and court decisions.

• Why Eli Lilly has sued major telehealth pharmacies and how your practice or patient care might be impacted by the ongoing legal battles.

• The Transition Plan for patients moving from compounded drugs back to branded medications, including valuable information on manufacturer direct-to-patient programs and co-pay cards.

• How some pharmacies are attempting to continue compounding with “unique” patient doses and added agents, and the serious legal ramifications of this strategy.