FDA Puts BPC 157, TB 500, and 5 Other Peptides Under the Microscope: What Prescribers Need to Know About the 503A Review Lengea BPC 157 has a decades long safety record with zero deaths or hospitalizations. Yet, it's unapproved because the FDA process is too expensive and the business model doesn't allow for profit. Approved drugs with FDA Removes 12 Peptides from 503A Category 2 Newtropin BPC 157 FDA Approval Status 2026: RFK Jr, Advisory Committee & Reclassification