The U.S. Food and Drug Administration has proposed removing key active ingredients used in popular obesity and diabetes treatments from its bulk drug substances list, a move that would further limit the ability of outsourcing facilities to produce compounded versions of such medications.
In a statement, FDA Commissioner Marty Makary said the proposal aligns with regulatory standards that prohibit compounding when approved drugs are readily available, except where a clear clinical need exists.
The agency said it found no such need for outsourcing facilities to compound semaglutide—used in Ozempic and Wegovy produced by Novo Nordisk—or tirzepatide, the active ingredient in Zepbound and Mounjaro developed by Eli Lilly. The proposal also includes liraglutide.
Compounding involves producing customised medications using approved ingredients but does not equate to manufacturing generic drugs, which must undergo FDA approval and demonstrate therapeutic equivalence to branded versions.
The regulator had previously allowed some level of compounding for weight-loss drugs due to supply shortages and surging demand. However, concerns have since emerged over safety, dosage accuracy, and regulatory compliance, alongside revenue impacts on pharmaceutical manufacturers.
If finalised, the rule would restrict compounding of the affected drugs except in cases of verified shortages.
Following the announcement, shares of Novo Nordisk rose by more than six per cent in early trading, while Eli Lilly gained over eight per cent, supported by both the regulatory development and strong quarterly earnings.
