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FDA Advisory Committee Voted Yes on Six Peptides. Now What? The Regulatory Road Ahead

The FDA’s Pharmacy Compounding Advisory Committee (PCAC) recently voted in favor of adding six peptides—BPC-157, KPV, TB-500, MOTS-c, Epitalon and Semax—to the list of bulk drug substances that may be used in compounding under Section 503A of the Federal Food, Drug, and Cosmetic Act (the 503A Bulks List).

The July 2026 votes represented a significant development for the compounding industry, particularly because FDA staff had recommended against inclusion of the peptides before PCAC reached a different conclusion.

Learn more about the next steps and implications for FDA following this vote, and considerations for compounding pharmacies.

Authors:

 

Dae Y. Lee
dae.lee@bipc.com

 

 

 


 
 

 

 

Barbara A. Binzak Blumenfeld
barbara.binzak@bipc.com

 
 
 


 
 

 

 

Tina Hu-Rodgers
tina.hu@bipc.com

 
 
 


 
 

 

 

Natalie P. Crow
natalie.crow@bipc.com