Federal Policy
Compounding Pharmacies Modify GLP-1 Formulations to Circumvent FDA Compounding Restrictions
A JAMA Health Forum study published July 17, 2026 finds that some compounding pharmacies are making minor compositional changes to semaglutide and tirzepatide products to evade FDA restrictions on compounding copies of approved drugs. The FDA previously added these GLP-1 medications to its drug shortage list due to surging demand, which legally permitted compounding. As shortages resolve and FDA moves to restrict compounding of these products, some pharmacies are altering formulations to maintain legal compounding status. This affects Medicaid managed care organizations that cover GLP-1s for diabetes and obesity, as it creates uncertainty around formulary management, prior authorization protocols, and pharmacy network oversight.
Why it mattersMedicaid MCOs covering GLP-1 medications face potential increased costs and quality concerns from proliferation of modified compounded formulations that may lack the safety and efficacy data of FDA-approved products, requiring enhanced pharmacy benefit management and utilization review protocols.