Under the interim policy, officials do not intend to take action against sites that produce the peptides.
The Department of Health and Human Services will support the production of six unapproved peptide products by compounding pharmacies.
Through the “enforcement discretion” policy published Wednesday, the HHS is lifting barriers to the production of peptides including BPC-157 and TB-500, products promoted in combination online as the “Wolverine stack” for muscle building and soft tissue repair. The FDA raised concerns about the safety of the peptides in 2023, noting the risk of immunogenicity.
However, the Trump administration has taken a different approach to peptides. In July, experts on the FDA’s Pharmacy Compounding Advisory Committee voted in favor of compounding the six peptides covered by the enforcement discretion policy. The experts voted against a seventh peptide, emideltide, also known as delta sleep-inducing peptide (DSIP) and advertised to promote slow-wave (delta) sleep among other benefits.
The HHS framed the enforcement discretion policy as a way to discourage consumers’ use of research-use-only peptides supplied by foreign manufacturers that pose safety risks. Allowing limited compounding under appropriate safeguards will give patients a more controlled alternative, HHS said. The policy is designed to “advance patient choice and freedom while appropriately protecting patient safety.”
Under the policy, state-licensed pharmacies, federal facilities and licensed physicians can compound the peptides without risking reprisals from the HHS. The policy is an interim measure to provide access to six peptides that are not on the list of bulk substances that can be compounded.
Responses to the enforcement policy split along the same lines as comments submitted to the Pharmacy Compounding Advisory Committee. The Alliance for Pharmacy Compounding welcomed the HHS’ action, calling it “an important step for patients.” The American Academy of Peptide Medicine hailed the policy as “a vital step toward eliminating the unsafe gray and black markets.”
Leaders at the Partnership for Safe Medicines (PSM) and PhRMA were among those to speak out against the policy. The policy “leaves Americans in a gray area as to whether peptides are safe or not,” PSM Executive Director Shabbir Imber Safdar said in a statement. Jim Stansel, general counsel and corporate secretary at PhRMA, also set out the concerns of branded drugmakers.
“It is deeply concerning that HHS is telling the FDA they should ignore the law and allow illegal compounding of unapproved peptides,” Stansel said in a statement. “Permitting access to peptides that have not been demonstrated to be safe or effective in clinical trials jeopardizes patient safety.”
