Authored by Zachary Stieber via The Epoch Times,
Food and Drug Administration staffers said in newly released documents that they do not support letting compound pharmacies manufacture seven popular peptides.
The Food and Drug Administration in White Oak, Md., on June 5, 2023. Madalina Vasiliu/The Epoch TimesFDA 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.
They have become popular among some fitness influencers and have received endorsement from Health Secretary Robert F. Kennedy Jr.
Compounding refers to doctors and pharmacists creating customized medicine by combining, mixing, or altering ingredients.
The documents were posed ahead of a scheduled meeting of the FDA's Pharmacy Compounding Advisory Committee, which will consider whether to support or oppose loosening restrictions on the peptides.
The FDA in April said it would not take action against compounding pharmacies that use some of the peptides, and is now consider
