Home / Health / FDA Moves to Limit Compounding of Weight-Loss Drugs
FDA Moves to Limit Compounding of Weight-Loss Drugs
30 Apr
Summary
- FDA proposed excluding key ingredients for popular weight-loss drugs.
- Semaglutide and tirzepatide active ingredients are targeted.
- Compounding will be limited unless drugs are on shortage list.
The U.S. Food and Drug Administration has taken steps to limit the compounding of certain weight-loss medications. A proposal was announced on April 30th, aiming to exclude active ingredients used in Novo Nordisk's Wegovy and Ozempic, as well as Eli Lilly's Zepbound and Mounjaro, from being compounded by outsourcing facilities.
The agency indicated there is no identified clinical need for these ingredients, semaglutide and tirzepatide, to be compounded from bulk drug substances when FDA-approved versions are readily available. The proposal also encompasses Novo Nordisk's liraglutide molecule. This action would restrict such compounding unless the drugs are officially listed as experiencing shortages.
FDA Commissioner Marty Makary emphasized that outsourcing facilities are legally prohibited from compounding with bulk drug substances if approved drugs are on the market and no clear clinical necessity exists. This move underscores the FDA's focus on ensuring patient access to regulated and approved medications.
