FDA panel backs compounding pharmacies to make two peptides, rejects third

The U.S. Food and Drug Administration’s advisory committee met on Friday and issued recommendations on the manufacturing of certain peptide drugs by compounding pharmacies.

Committee members voted in favor of allowing pharmacies to compound the peptides epitalon and semax, citing potential benefits for patient access.

Conversely, the panel narrowly voted against extending compounding privileges to the peptide emideltide, expressing concerns that outweighed perceived advantages.

The split decision highlights ongoing regulatory scrutiny of peptide therapies and may shape how specialty pharmacies handle these products moving forward.