Compounded incretins in clinical practice: An opinion of the endocrine and metabolism practice and research network of the American College of Clinical Pharmacy.
Level 5 - mechanism / opinion, no new human data
Expert opinion and professional practice network committee statement without original human data or systematic review
PubMed 41176849 · doi:10.1016/j.dsx.2025.103314
What was done
An independent committee convened by the Endocrine and Metabolism Practice and Research Network of the American College of Clinical Pharmacy reviewed the clinical, safety, and legal considerations surrounding compounded incretin mimetics (such as semaglutide and tirzepatide) during drug shortages to establish clinical guidance.
What was found
The abstract reports no quantitative data. It notes limited evidence of positive clinical outcomes in small cohorts receiving compounded semaglutide and tirzepatide, counterbalanced by major safety and legal concerns stemming from a lack of FDA approval. The committee recommends prioritizing FDA-approved formulations and advising clinicians to ensure the use of reputable compounding pharmacies with routine monitoring if compounded alternatives are used.
Why it matters
Provides clinical guidance from clinical pharmacy specialists on the safety, efficacy, and regulatory risks of using unapproved compounded GLP-1 receptor agonists and dual agonists during widespread drug shortages.
Limits
This is an expert opinion piece rather than a systematic review or empirical study. The abstract provides no specific patient numbers, comparative risk metrics, or quantitative clinical outcomes.
Cited by
- supports Under US regulatory rules during an official drug shortage, compounding pharmacies are permitted to manufacture compounded versions of medications to meet the shortage.