US FDA considers policy change to expand peptide compounding access

The US Food and Drug Administration (FDA) and the Department of Health and Human Services have submitted an interim access policy to the White House regarding the compounding of certain peptides. This proposal could allow pharmacies to more easily mix these substances, which are used for purposes ranging from muscle recovery to weight control.

An advisory panel previously recommended loosening restrictions on six peptides, including BPC-157, KPV, TB-500, MOTS-c, Semax, and Epitalon. While these substances are popular on social media, FDA scientists have noted a lack of evidence regarding their safety and effectiveness, raising concerns about potential liver damage and allergic reactions.

Reports of adverse events have emerged during the regulatory deliberation. Investigations have highlighted instances of migraines, eye pain, and fatigue, as well as hospitalizations involving life-threatening conditions and skin issues. Currently, many consumers purchase these products online, often labeled ‘for research use only,’ and administer them at home.