Novo to FDA: Our semaglutide API is the best API

Back in late 2024, Novo Nordisk petitioned the FDA to add semaglutide to the Demonstrably Difficult to Compound List, which would prevent the drug from being legally compounded by either 503A or 503B compounding facilities. 

This week the company took it a step further, submitting a supplement to its original petition that claims to provide additional evidence that compounding with what it asserts is inferior semaglutide API is “likely to lead to an adverse effect on the safety or effectiveness of semaglutide drugs.” 

What is this new “evidence”? Novo’s own testing. Not public data, not peer-reviewed research, and not even based on drugs from state-licensed compounding pharmacies. Just the company’s private research.

If anyone is going to ask the FDA to make such a drastic move — calling semaglutide “demonstrably difficult to compound” after years of it being done by thousands of compounding pharmacists across the country — there needs to be solid, incontrovertible evidence. Novo has none.

The reality is that semaglutide is not difficult to compound with. This entire process isn’t about patient safety; it’s about Novo trying to protect its bottom line.

For us, it’s frustrating. Frustrating to have to listen to false comments about pharmacy compounding, frustrating to have to educate policymakers, and frustrating to have to fight these kinds of blatant money-grabs … again and again. If you get tired of hearing us ask you to invest in the Compounding Defense Fund or OneFund or CompPAC, well, you know who to blame. (But please do invest.)