According to the FDA’s announcement, the organization is asking for submitted comments for or against this decision by the end of June 2026 before making their final determination. Where do we submit our comments?
FDA proposes ban on bulk compounding of semaglutide and tirzepatide
**THIS IS THE TIME FOR ALL OF US TO SUBMIT OUR COMMENTS FOR OR AGAINST THIS DECISION. LET'S BAND TOGETHER AND LET OUR VOICES BE HEARD**
Based on the FDA’s announcement regarding the proposal to exclude compounded semaglutide, tirzepatide, and liraglutide from the 503B bulks list, public comments for or against this decision must be submitted by June 29, 2026. [1, 2]
Comments can be submitted either electronically or by mail:
• Electronic Submission: Use the Federal eRulemaking Portal at www.regulations.gov and search for the docket number FDA-2026-N-2431.
• Mail/Hand Delivery/Courier: Send written comments to:
Dockets Management Staff (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852
[4, 6, 7]
Important Tips for Submitting Comments:
• Include Docket Number: All submissions must include the docket number FDA-2026-N-2431 to ensure it is considered.
• Deadline: Comments must be received by 11:59 p.m. Eastern Time on June 29, 2026.
• Public Visibility: All comments are public and will be posted at www.regulations.gov. Do not include confidential or private information.
The FDA will review these comments to determine if there is a demonstrated "clinical need" to keep these drugs available from 503B outsourcing facilities before issuing a final decision. [1]
AI responses may include mistakes.
[8] https://www.regulations.gov/document/FDA-2026-N-1736-0001