The U.S. Department of Health and Human Services (HHS), under Secretary Robert F. Kennedy Jr., has introduced a new enforcement discretion policy allowing qualifying compounding pharmacies to prepare six previously restricted peptides, including BPC-157, TB-500, MOTS-c, Semax, KPV, and Epitalon. An article in GQ examines the administration’s efforts to expand access to these substances through licensed pharmacies while addressing concerns about their limited clinical research, potential safety risks, and widespread availability through unregulated online sellers. Although the policy creates a pathway for pharmacy compounding, the six peptides remain unapproved by the U.S. Food and Drug Administration (FDA) for human use.
Edgar J. Asebey provided insight into the regulatory implications of the policy and the distinction between enforcement discretion and FDA approval.
“Enforcement discretion means that the FDA will not enforce a certain regulation. And in this case, it’s the prohibition against compounding these six peptides. That’s what it boils down to”
Edgar noted that enforcement discretion has historically been used to expand access to certain medications under specific circumstances, including during GLP-1 drug shortages. Of importance, the government’s decision to exercise enforcement discretion does not constitute FDA approval or establish the safety and effectiveness of these peptides.
