Peptide Access Policy Under White House Review

The U.S. Department of Health and Human Services and the Food and Drug Administration have submitted an interim policy on peptide access to the White House for review, a government filing shows. The proposal has not received final approval, and the filing does not describe its terms. Two people familiar with the deliberations told the Associated Press that the policy is intended to temporarily allow pharmacies to compound some popular peptides, including BPC-157. That account of the proposal’s scope comes from unnamed sources; the filing itself does not confirm which substances or safeguards might be included. Compounding pharmacies prepare customized medications by mixing ingredients. The reported approach would provide temporary enforcement discretion, meaning the FDA could choose not to enforce certain existing restrictions against pharmacies producing covered peptides. It would not, by itself, formally add the substances to the agency’s list of drugs considered safe for compounding. The FDA previously listed BPC-157 and more than a dozen other injectable peptides as too risky for pharmacy compounding. The agency cited potential contamination, allergic reactions and tumor...