What HHS announced
The Department of Health and Human Services said in a notice filed Wednesday that it will use "enforcement discretion" toward compounding pharmacies that prepare six peptides not approved by the Food and Drug Administration, NBC News reported. In effect, the government will not take legal action against those pharmacies, and they can begin offering the products immediately.
The arrangement is meant as a stopgap. The peptides are not yet on the FDA's list of ingredients that compounding pharmacies may use, and the agency is still working on a formal rule that would add them.
The substances are TB-500, semax, MOTS-c, KPV, epitalon and BPC-157. Online, they have been marketed for purposes ranging from quicker healing to younger-looking skin and a longer life. The FDA has not approved any of them, and, according to NBC News, the agency's own scientists concluded the available data are not enough to show they are safe and effective.
Conditions placed on pharmacies
The FDA said pharmacies making these products must certify what the compounds are and how pure they are. They will also be required to report side effects, a obligation that did not exist before.
Compounding pharmacies are generally limited to ingredients on the FDA's bulk drug substances list. Adding an item normally requires the agency to propose a rule, gather public comment and then issue a final rule, a sequence that can take several months. The enforcement-discretion approach lets the peptides reach customers while that process continues.
The gray market argument
The decision comes as a gray market for peptides has grown. Some retailers sell the compounds labeled "for research use only," a legal workaround that lets them say the products are not intended for human consumption.
Health Secretary Robert F. Kennedy Jr. and others have argued that allowing pharmacies to compound peptides would steer people away from that market and toward safer sources. HHS spokesperson Emily Hilliard said in a statement: "Under President Trump’s leadership, HHS is working to put prevention and patient safety at the center of health care—and that includes confronting the risks of black-market peptides."
Criticism and the road to the rule
Dr. Peter Lurie, a former FDA official who now heads the watchdog group Center for Science in the Public Interest, said the agency was essentially "turning a blind eye" in order to broaden access to drugs not shown to work. Shabbir Safdar, executive director of the Partnership for Safe Medicines, said both the enforcement discretion and the coming rule change would expose Americans to "untested dangerous substances."
The formal process took a step forward in July, when an FDA advisory panel narrowly voted to recommend adding the six peptides to the bulk list. According to NBC News, the panel included six new appointees with ties to the peptide industry, along with another member who is the son of a U.S. representative who has urged Kennedy to widen peptide access. During that meeting, some members worried the recommendation could make it harder for the FDA to turn down other unapproved drugs later.
NBC News also reported, citing Reginfo.gov, a federal site that tracks regulations, that the FDA was scheduled on Tuesday and Wednesday to meet outside groups. They included Medivant Healthcare, a compounding pharmacy that offers peptides.
