1 rich Libsyn https://www.libsyn.com 90 600 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 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. 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. The Food, Drug, and Cosmetic (FD&amp;amp;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). 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&amp;amp;C Act. The recent ADA statement recommends against the use of compounded GLP-1s due to these concerns. References Karagiannis T, Malandris K, Avgerinos I, et al. Subcutaneously administered tirzepatide vs semaglutide for adults with type 2 diabetes: a systematic review and network meta-analysis of randomised controlled trials. Diabetologia. 2024;67(7):1206-1222. doi:10.1007/s00125-024-06144-1 Müllertz ALO, Sandsdal RM, Jensen SBK, Torekov SS. Potent incretin-based therapy for obesity: A systematic review and meta-analysis of the efficacy of semaglutide and tirzepatide on body weight and waist circumference, and safety. Obes Rev. 2024;25(5):e13717. doi:10.1111/obr.13717 Jastreboff AM, Le Roux CW, Stefanski A, et al. Tirzepatide for Obesity Treatment and Diabetes Prevention. New England Journal of Medicine. 2024. https://www.nejm.org/doi/full/10.1056/NEJMoa2410819 Contract Year 2026 Policy and Technical Changes to the Medicare Advantage Program, Medicare Prescription Drug Benefit Program, Medicare Cost Plan Program, and Programs of All-Inclusive Care for the Elderly (CMS-4208-P). https://www.cms.gov/newsroom/fact-sheets/contract-year-2026-policy-and-technical-changes-medicare-advantage-program-medicare-prescription Human Drug Compounding. https://www.fda.gov/drugs/guidance-compliance-regulatory-information/human-drug-compounding Compounded Drug Products That Are Essentially Copies of a Commercially Available Drug Product Under Section 503A of the Federal Food, Drug, and Cosmetic Act. https://www.fda.gov/media/98973/download FDA alerts health care providers, compounders and patients of dosing errors associated with compounded injectable semaglutide products. https://www.fda.gov/drugs/human-drug-compounding/fda-alerts-health-care-providers-compounders-and-patients-dosing-errors-associated-compounded FDA’s Concerns with Unapproved GLP-1 Drugs Used for Weight Loss. https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/fdas-concerns-unapproved-glp-1-drugs-used-weight-loss Nomination of Semaglutide Products to the Demonstrable Difficulties for Compounding Lists. https://www.regulations.gov/document/FDA-2017-N-2562-0029 Neumiller JJ, Bajaj M, Bannuru RR, et al. Compounded GLP 1 and dual GIP/GLP 1 receptor agonists: A statement from the American Diabetes Association. Diabetes Care. 2024 Dec 2:dci240091. doi: 10.2337/dci24-0091. HelixTalk - Rosalind Franklin University's College of Pharmacy Podcast http://helixtalk.com <iframe title="Libsyn Player" style="border: none" src="//html5-player.libsyn.com/embed/episode/id/34419220/height/90/theme/custom/thumbnail/yes/direction/forward/render-playlist/no/custom-color/88AA3C/" height="90" width="600" scrolling="no" allowfullscreen webkitallowfullscreen mozallowfullscreen oallowfullscreen msallowfullscreen></iframe> https://assets.libsyn.com/secure/item/34419220