In October 2024, we reported that Novo Nordisk requested the US FDA to include semaglutide in the FDA’s Demonstrable Difficulties for Compounding (DDC) list, citing safety concerns.
In a response made available on 26 November 2024, the US Alliance for Pharmacy Compounding (APC) has provided a lengthy rebuttal to Novo Nordisk’s assertions arguing that synthetic semaglutide APIs are safe and rigorously regulated, often showing comparable or better impurity profiles than Novo Nordisk’s recombinant APIs.
The association highlights that compounded semaglutide has been successfully dispensed in large quantities during the ongoing shortage, meeting patient needs without safety concerns. The APC challenges Novo Nordisk’s attempt to list semaglutide on the FDA’s DDC list, arguing it would unjustly restrict patient access.