FDA Removes Key Peptides from Category 2: What This Means for You 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 FDA Puts BPC 157, TB 500, and 5 Other Peptides Under the Microscope: What Prescribers Need to Know About the 503A Review Lengea The reason peptide access is changing comes down to two regulatory categories most patients don't know exist: 503A and 503B. 503A = traditional compounding pharmacies. State licensed, patient specific prescriptions. 503B = FDA registered outsourcing FDA mulls compounding for peptides previously flagged over safety risks BioSpace