Novo Nordisk filed a citizen petition with FDA, requesting that semaglutide be excluded from the 503B Bulks List, which allows outsourcing facilities to compound certain bulk drug substances.
The petition argues that there is no clinical need for semaglutide to be compounded, as FDA-approved alternatives, including Rybelsus, Ozempic, and Wegovy, already meet patient needs for the treatment of diabetes and weight management.
The petition further calls for the FDA to rescind the Interim Policy on Compounding Using Bulk Drug Substances under Section 503B, arguing that it facilitates the production of compounded semaglutide without the rigorous testing required for FDA-approved drugs.
Novo cited concerns about safety, pointing to reports of adverse events related to compounded semaglutide, including dosing errors and the presence of impurities in compounded versions of the drug.
Novo Nordisk also claims that compounded semaglutide poses significant risks, including potential immunogenicity and lack of efficacy due to inconsistent dosing. The company emphasizes that including semaglutide on the 503B Bulks List could undermine the integrity of FDA-approved drug development, discouraging pharmaceutical companies from investing in the research necessary to bring new treatments to market.
The FDA now has 180 days to respond to the petition.
This case is part of ongoing legal issues over the sale of non-FDA approved drug modifications. Recently, Novo filed legal complaints against compounding pharmacies for selling altered versions of semaglutide. Back in April, a Florida U.S. District Judge dismissed a lawsuit filed by Eli Lilly against compounding pharmacy RXCompoundStore.com, concluding the case with prejudice, which prevents Lilly from refiling the claim.
Eli Lilly had accused the pharmacy of violating Florida’s Drug and Cosmetic Act and the Florida Deceptive and Unfair Trade Practices Act by selling compounded versions of tirzepatide, a drug used in Lilly’s FDA-approved treatments for diabetes and weight management. The company argued that these compounded drugs were not FDA-approved and posed safety risks. However, Judge Altman ruled that Eli Lilly was attempting to enforce federal regulations through state laws, a responsibility that lies with the FDA, not private companies.