The Department of Health and Human Services has sent an interim peptide-access policy to the White House Office of Management and Budget for review, according to an October 15 government posting described in a report published by CNBC. The submission does not amount to approval of the products involved.
The public filing gives no policy details. Two people familiar with the plan, speaking anonymously in the report, said it would temporarily allow specialty pharmacies to prepare certain peptides, including BPC-157, without being targeted for doing so.
The approach described is enforcement discretion: the Food and Drug Administration would choose not to enforce some restrictions. Formally adding the substances to the agency's compounding list would require federal rulemaking. The report said it was unclear whether the administration still planned to pursue that process.
In July, outside advisers recommended lifting restrictions on six of seven peptides they reviewed. FDA staff scientists disagreed, saying none of those peptides had been studied enough to establish safety and effectiveness.
The products at issue are distinct from peptide medicines already brought to market for diabetes and weight loss. The muscle-building, anti-aging and energy uses discussed in the report are not FDA-approved.
