The Department of Health and Human Services is giving compounding pharmacies a temporary green light to make six peptides while the agency continues to work on a formal rule change. <\/p>\n
In a notice filed Wednesday, the agency said it would exercise \u201cenforcement discretion,\u201d meaning it will not take legal action against compounding pharmacies that make the six unapproved peptides. In practice, that means these pharmacies can start offering them now, even though the peptides aren\u2019t yet on the Food and Drug Administration\u2019s list of ingredients compounding pharmacies are allowed to make.<\/p>\n
The six peptides are BPC-157, epitalon, KPV, MOTS-c, semax and TB-500.<\/p>\n
They\u2019ve been promoted online as treatments<\/a> for everything from faster healing to younger-looking skin and a longer lifespan. None are approved by the FDA, and the agency\u2019s own scientists concluded there is insufficient data<\/a> to prove they are safe and effective.<\/p>\n The FDA said compounding pharmacies must certify the identity and purity of the compounds. They must also now report side effects, which was not previously mandated.<\/p>\n The move comes as a growing \u201cgray market\u201d has sprung up around peptides, where retailers sell them labeled \u201cfor research use only,\u201d a legal workaround that lets them claim they aren\u2019t meant 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.<\/p>\n \u201cUnder President Trump\u2019s leadership, HHS is working to put prevention and patient safety at the center of health care\u2014and that includes confronting the risks of black-market peptides,\u201d Emily Hilliard, an HHS spokesperson, said in a statement. <\/p>\n Dr. Peter Lurie, a former FDA official who now leads the Center for Science in the Public Interest watchdog group, said the FDA was essentially \u201cturning a blind eye\u201d to widen access to drugs that have not been proven to work.<\/p>\n Compounding pharmacies generally may use only ingredients the FDA has added to an official list known as the bulk drugs substances list. Adding an ingredient requires the FDA to propose a rule, take public comment and issue a final rule, a process that can take several months.<\/p>\n The agency took a step toward that process in July, when an FDA advisory panel narrowly voted in favor<\/a> of adding six peptides to the bulk list. The panel included six new appointees with ties to the peptide industry and another who is the son of a U.S. representative who has pushed<\/a> Kennedy to make peptides more available. (During that meeting, some committee members expressed concerns that the recommendation could make it harder for the FDA to say no to other unapproved drugs in the future.)<\/p>\n