HHS Eases Enforcement on Six Unapproved Peptides

The Department of Health and Human Services has directed the Food and Drug Administration not to enforce certain rules against pharmacies compounding six unapproved wellness peptides, easing access for patients with prescriptions while leaving the substances outside the FDA’s approval process for safe and effective medicines. The policy covers BPC-157, TB-500, Epitalon, KPV, MOTS-c and Semax. It applies to specialty pharmacies that make customized medications and permits the peptides to be compounded under specified safeguards, including patient-specific prescriptions and ingredients from registered manufacturers. Compounders are also directed to verify ingredient quality and collect information on side effects for safety analysis. HHS said the approach is intended to offer patients a more controlled alternative to online products made with unscreened ingredients. The agency has also cited public interest and the growth of gray and black markets as reasons for expanding access. Compounded drugs do not undergo the same FDA review as approved brand-name or generic medicines, and the policy acknowledges risks to their safety and effectiveness. Six people familiar with the...