Obesity medications – particularly glucagon-like peptide 1 (GLP-1) agonist – have seen a tremendous increase in utilization, with the potential to impact pharmacy management in workers’ comp, as obesity is a common comorbidity in the U.S. population.
With many of these drugs experiencing shortages, compounders in the last few years have created their own formulations of these medications to meet demands. However, in early October the FDA determined that the shortage of tirzepatide injections (a GLP-1 agonist) had been resolved, meaning compounders can no longer create their own formulations of this drug.
The FDA reminded compounders of legal restrictions on making copies of FDA-approved drugs. There are exemptions to this rule during a drug shortage, and since 2022 tirzepatide injections have been recognized to be in shortage due to increased demand, allowing compounders to formulate the drug.
When the FDA declared the shortage over, compounders were restricted from creating this medication. But now the FDA has remanded this decision in light of litigation that came weeks after their original decision. The FDA is currently reevaluating their decision on whether or not tirzepatide is in shortage. At this time, compounders can continue to formulate the drug, until a further update is made.
Other GLP-1 drugs are still considered in shortage and compounders can still formulate these medications, including semaglutide, liraglutide, and dulaglutide.
For ongoing coverage of the latest drug approvals and alerts impacting workers’ comp, visit Med Monitor online.
