The United States Food and Drug Administration (FDA) has introduced new proposed restrictions aimed at limiting the ability of outsourcing facilities to produce compounded versions of widely used weight-loss and diabetes medications.
In a statement released on Thursday, April 30, the agency announced its intention to remove certain active ingredients found in these drugs from the bulk substances list that is available for compounding. This move is designed to tighten regulatory controls over the practice.
FDA Commissioner Marty Makary explained, “When FDA-approved drugs are available, outsourcing facilities cannot lawfully compound using bulk drug substances unless there is a clear clinical need. This action reflects our responsibility to protect patients and preserve the integrity of the drug approval process while continuing to provide a transparent, science-based pathway for public input.”
The FDA determined that there is no clinical justification for compounding key ingredients such as semaglutide, which is used in Novo Nordisk’s Ozempic and Wegovy, as well as tirzepatide, found in Eli Lilly’s Zepbound and Mounjaro. The proposal also covers liraglutide.
Compounding is distinct from the production of generic drugs. While generics are FDA-approved and must meet strict standards, compounded drugs are created using approved ingredients but are not themselves verified by the agency.
During periods of high demand and supply shortages, the practice of compounding weight-loss drugs had been temporarily tolerated. However, concerns have escalated over safety risks, including potential issues with dosage accuracy, product quality, and regulatory oversight.
If the proposal is finalized, compounding of these medications would only be permitted during periods of confirmed shortages. The FDA has opened the proposal for public comment, with submissions accepted until June 29. The announcement boosted pharmaceutical stocks, with Novo Nordisk rising more than six percent and Eli Lilly climbing over eight percent in early trading.
