Compounded incretins in clinical practice: An opinion of the endocrine and metabolism practice and research network of the American College of Clinical Pharmacy.
Courtney. Lindsay A LA; Clements. Jennifer N JN; Isaacs. Diana D; Pitlick. Jamie M JM; Reece. Sara Mandy SM; Whitley. Heather P HP
Key Findings
- Small patient groups have shown some positive results with compounded tirzepatide, but data are limited.
- Compounded tirzepatide is not FDA‑approved, creating legal and safety concerns.
- Healthcare providers should prioritize approved medications, and if compounding is used, ensure reputable compounding sources and monitor safety and efficacy.
Practical Outcomes
- Be cautious with compounded tirzepatide. Aim to obtain the FDA‑approved drug whenever possible. If you must use a compounded version, choose a reputable pharmacy and regularly check for side effects and effectiveness.
Summary
This article says that while a few small studies suggest compounded tirzepatide might help, the drug isn’t FDA‑approved, so there are legal and safety worries. Doctors should try to get patients the approved version, but if someone uses a compounded version, they need to pick a trustworthy pharmacy and watch for any problems.
Abstract
This article aims to summarize the role of compounded incretin mimetics in clinical practice and in the context of drug shortages. The Endocrine and Metabolism Practice and Research Network, a focused group of the American College of Clinical Pharmacy members, convened an independent committee to evaluate the role of compounded incretin mimetics. There is limited data demonstrating positive clinical outcomes in small cohorts of patients receiving compounded semaglutide and tirzepatide. However, there remain significant legal and safety concerns since compounded incretins do not undergo approval by the Food and Drug Administration. Whenever possible, healthcare providers should make every effort to assist patients with obtaining approved medications. If patients choose to obtain compounded incretins, providers can encourage safety by ensuring use of reputable compounding pharmacies and routinely monitoring patients for safety and efficacy of the compounded product.
Study Information
pubmed
2025
2025-10-21T00:00:00.000Z
10.1016/j.dsx.2025.103314
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