HHS sends peptide compounding plan to White House for review

The Department of Health and Human Services has sent a peptide “interim access policy” to the White House Office of Management and Budget for review, according to a government website listing. The filing does not give details. Two people familiar with the plan told STAT it is intended to let pharmacies temporarily compound some popular peptides, including BPC-157.

The FDA previously listed BPC-157 and more than a dozen other injectable peptides as too risky for compounding. The FDA cites possible contamination, allergic reactions and tumor growth. MedPage Today reported that, in July, outside advisers recommended dropping restrictions on six of the seven peptides they reviewed. FDA staff scientists said none had been studied enough to establish safety and effectiveness.

The policy would use enforcement discretion, according to the people familiar with it, meaning the FDA could choose not to enforce some regulations against pharmacies producing certain peptides. Formally adding peptides to the FDA’s list of drugs safe for compounding would require federal rulemaking, which could take years. It was not clear whether the administration still plans that process.