FDA moves to restrict compounded versions of popular GLP-1 weight loss drugs
In a possible change from the 503B drug program, the U.S. Food and Drug Administration (FDA) said it’s looking to exclude popular drugs used to treat type 2 diabetes and obesity from the list of substances allowed for bulk compounding, citing a lack of medical evidence.
The FDA maintains a list of substances allowed to be compounded by outsourcing facilities as part of the 503B drug program, and it’s looking to exclude semaglutide, tirzepatide and liraglutide—popular weight loss drugs—as part of a crackdown on the online availability of these drugs, all part of the larger GLP-1 market.
In an announcement, the agency said that companies or providers that compound drugs must adhere to a list of approved substances. In most cases, bulk substances are now allowed unless “the compounded drug is on the FDA’s drug shortage list at the time of compounding, distribution and dispensing.”
The agency said, after evaluating the proposed clinical need for semaglutide, tirzepatide, and liraglutide to be added to the list, a review of the evidence did not support a medical need for most instances of the drugs being administered in bulk.
Compounding in bulk is typically something allowed with a significant public need or during drug shortages.
Removing the popular weight loss pharmaceuticals would mainly affect outsourcing facilities under the 503B program, which typically operate when demand outpaces supply.
The FDA said its change is aimed at improving safety and stopping widespread, unregulated versions of these high-demand weight-loss and diabetes drugs from being sold online by third-party distributors.
“When FDA-approved drugs are available, outsourcing facilities cannot lawfully compound using bulk drug substances unless there is a clear clinical need,” FDA Commissioner Marty Makary, MD, said in a statement. “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.”
Regulators are accepting public comments through June 29 to exclude semaglutide, tirzepatide and liraglutide, before any final change to the list of what’s approved under 503B is made.
Compound market a workaround to generics
Notably, these drugs are sold by large pharmaceutical companies under brand names such as Ozempic, Zepbound and Saxenda, among others depending on whether it’s for diabetes or weight loss.
The change by the FDA will not impact traditional prescriptions or direct distribution from these companies, such as through their own marketplaces or TrumpRx.gov. This would impact drugs that are custom-made by a pharmacy or facility, typically in response to a shortage—which acts in a manner similar to a generic drug, which is a copy made by a manufacturer.
The federal government stated that it is worried about compounded versions acting like unofficial generics, without the same oversight those manufacturers are subjected to.
The agency stated that it will consider submitted comments before making a final determination.
A form to submit public comment is available here.
Chad is an award-winning writer and editor with over 15 years of experience working in media. He has a decade-long professional background in healthcare, working as a writer and in public relations.