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College of Pharmacy

HelixTalk #186 - Breaking the Bank or Breaking the Scale: Controversies Surrounding Compounded GLP-1s RAs for Weight Loss

Date posted: December 12, 2024, 2:43 pm

In this episode, we discuss the efficacy and safety of semaglutide and tirzepatide for weight loss with a particular focus on the legal, regulatory, and safety aspects of these “compounded” GLP-1 receptor agonist medications.

Key Concepts

  1. Semaglutide and tirzepatide have growing evidence that their clinical benefits extend beyond the treatment of diabetes. Evidence now shows benefit in a variety of obesity-related disease states regardless of a patient’s diabetes status.
  2. Insurance coverage and drug cost is a major barrier to these medications, with cash prices exceeding $1000 per month in the US. There are many companies that are combining telemedicine visits with “compounded” GLP-1s to provide these medications at a reduced cost.
  3. The Food, Drug, and Cosmetic (FD&C) Act regulates compounded drugs. These regulations provide the legal context for pharmacies to compound GLP-1 medications. These regulations describe who can compound, what drugs can be compounded, and other unique circumstances (e.g. compounding in the context of a drug shortage).
  4. The FDA has released warnings regarding safety risks of compounded GLP-1s. The main safety concern is dosing errors; however, the warnings also include concerns of patients accessing drug products that are outside of the legal scope of the FD&C Act. The recent ADA statement recommends against the use of compounded GLP-1s due to these concerns.

References