The Department of Health and Human Services is giving compounding pharmacies a temporary green light to manufacture six peptides while the agency continues to work on a formal rule change.
In a notice filed Wednesday, the agency said it would exercise its “enforcement discretion,” meaning it would not take legal action against pharmacies that manufacture the six unapproved peptides. In practice, that means these pharmacies can start carrying them now, even though peptides aren’t yet on the Food and Drug Administration’s list of ingredients that pharmacies are allowed to make.
The six peptides are BPC-157, epitalon, KPV, MOTS-c, semax and TB-500.
They have been promoted online as treatments for everything from faster healing to younger-looking skin and longer life. None are approved by the FDA, and the agency’s own scientists have concluded that there is not enough data to prove they are safe and effective.
The FDA has stated that compounding pharmacies must certify the identity and purity of compounds. They also now have to report side effects, which was not required before.
The move comes as a growing “gray market” has emerged around peptides, where retailers sell them labeled “for research purposes only,” a legal workaround that allows them to claim they are not intended for humans. Health Secretary Robert F. Kennedy Jr. and others have argued that allowing peptides to be compounded would move people away from this gray market and toward safer products.
“Under the leadership of President Trump, HHS is working to put prevention and patient safety at the center of health care, which includes combatting the risks associated with the peptide black market,” Emily Hilliard, an HHS spokesperson, said in a statement.
Dr. Peter Lurie, a former FDA official who now leads the Center for Science in the Public Interest watchdog group, said the FDA is “turning a blind eye” to expanding access to drugs that have not been proven effective.
Compounding pharmacies generally can only use ingredients that the FDA has added to an official list known as the Bulk Drug Substances List. Adding an ingredient requires the FDA to propose a rule, collect public comments, and issue a final rule, a process that can take several months.
The agency took a step forward in this process in July, when an FDA advisory committee narrowly voted to add six peptides to the overall list. The panel included six new people with ties to the peptide industry and another who is the son of a U.S. representative who pushed Kennedy to make peptides more available. (During that meeting, some committee members expressed concern that the recommendation could make it more difficult for the FDA to say no to other unapproved drugs in the future.)
On Tuesday and Wednesday, the FDA was scheduled to meet with outside groups, including Medivant Healthcare, a compounding pharmacy that offers peptides, according to Reginfo.gov, a federal website that tracks government regulations.
Shabbir Safdar, executive director of the Partnership for Safe Medicines, which studies the dangers of counterfeit drugs, said enforcement discretion and the upcoming rule change would expose Americans to “untested dangerous substances.”
“Imagine what it means for the nation’s top pharmaceutical regulator to announce that it will not enforce laws on people making completely untested compounds and distributing them to the public,” Safdar said.
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