The U.S. Department of Health and Human Services (HHS) announced a new policy that will permit licensed pharmacies to dispense certain unapproved peptides, a decision that has drawn both praise from industry advocates and sharp criticism from public health professionals.
The policy, published in the Federal Register on October 28, states that HHS will not take enforcement action against state-licensed pharmacies, federal facilities, or licensed physicians compounding drug products using six specific peptide bulk substances.
These peptides, listed in Appendix A of the policy, include BPC-157, Epitalon, KPV, MOTS-c, Semax, and TB-500. The decision follows a July meeting of an FDA committee that reviewed evidence on peptides. Despite advice from FDA staff against the move, the committee recommended allowing specialty pharmacies to dispense these six peptides.
HHS Secretary Robert F. Kennedy Jr., who signed the policy, cited "significant interest" in obtaining these peptides from compounding pharmacies and stated that the policy "advances patient choice and freedom while appropriately protecting patient safety."
Peptides are short chains of amino acids that are injected into the body. The FDA had previously moved to ban peptides in 2023 due to safety concerns. However, the new policy aims to expand patient access by allowing compounding pharmacies to provide them.
The decision is seen as a significant development for companies like Hims & Hers, which had reportedly been preparing to offer peptides. Analysts suggest the market for peptides could reach $3.3 billion, and Hims stock saw a 5% increase following the announcement.
Advocates argue that the policy will help eliminate unsafe gray and black markets, restoring safe patient access through legitimate, physician-supervised care. Lee Rosebush, chair of the American Academy of Peptide Medicine, called it a "vital step."
However, public health professionals have voiced strong opposition, arguing that the decision allows pharmacies to dispense medications without rigorous scientific evidence and potentially exposes consumers to risks. Fred Mills, chief policy officer for Americans for Safe and Effective Medicines, stated, "American consumers should not be treated like guinea pigs."
Consumer advocacy groups and physicians have raised concerns about the untested nature of these experimental drugs. Dr. Adriane Fugh-Berman, a professor at Georgetown University Medical Center, noted at the July meeting that the peptides are "untested and poorly characterized." She also recalled instances where individuals required emergency treatment after receiving peptides.
Critics also worry about the increasing reliance on compounding pharmacies for untested drugs. While compounding pharmacies traditionally fill specific prescriptions, they have recently been mass-producing drugs like GLP-1s. Pharmacists have warned that the peptide boom could pressure compounding pharmacies to expedite drug production for telehealth sites, potentially compromising safety standards.
Shortly after the policy's publication, telehealth websites began marketing the six peptides, with monthly prices ranging from $199 to $249.