HHS issues interim policy allowing compounding of six unapproved peptides under set conditions

HHS announced an interim policy that will not take enforcement action against state-licensed pharmacies, federal facilities, or licensed physicians that compound six unapproved peptide bulk drug substances, as long as they meet the conditions set out in the guidance.

The policy applies only when the entities follow specific requirements detailed by HHS, which include documentation, quality controls, and reporting obligations.

The step gives the industry flexibility while formal rulemaking on these peptides is still pending, but the substances remain unapproved and could be subject to future regulatory action.