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# Add Semaglutide to DDC Lists: Novo Nordisk
- URL: https://www.fdaweb.com/add-semaglutide-to-ddc-lists-novo-nordisk/
- Published: 2024-10-23T12:00:00.000Z
- Updated: 2026-09-14T14:44:48.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5158042

Novo Nordisk is petitioning FDA to add its semaglutide products (Ozempic and Wegovy) to the Demonstrable Difficulties for Compounding (DDC) lists. The firm’s nominating [petition](https://downloads.regulations.gov/FDA-2017-N-2562-0029/attachment%5F1.pdf?ref=fdaweb.com) says the products belong on the lists “due to the complexities associated with their formulations, delivery mechanisms, dosage forms, achievement of bioavailability, compounding processes, and physiochemical and analytical testing.”

FDA permitted compounding of semaglutide products earlier this year when they were in shortage. The petition asks the agency to convene an advisory committee to consider whether semaglutide should be added to the DDC lists.

It gives these factors as reasons for its request:

- the complexity of semaglutide products’ formulation;
- the complexity of semaglutide products’ delivery mechanisms;
- semaglutide products dosage forms are complex;
- semaglutide products’ complexity in achieving and assessing bioavailability;
- the complexity of semaglutide products’ compounding process; and
- compounding semaglutide requires complex physiochemical or analytical testing.

“The risks with compounding semaglutide products are numerous and outweigh any actual or potential benefit of compounded semaglutide products,” Novo Nordisk says.