Food and Drug Administration staffers said in newly released documents that they do not support letting compound pharmacies manufacture seven popular peptides.
FDA personnel said in documents posted online on June 29 that there are safety concerns with the peptides, including the possibility of triggering immune responses that could lead to “life-threatening and catastrophic reactions.”
They do not favor classifying BPC-157, KPV, TB-500, MOTS-c, Emideltide, Epitalon, or Semax in a way that would let pharmacies use them in compounded medicines.
Peptides are short chains of amino acids that act as building blocks of proteins and perform essential biological functions in the body. If permitted, compounding pharmacies can manufacture them for personalized medications tailored to patients’ unique needs….