Current Peptide Compliance

The Drug Supply Chain Security Act (DSCSA) is now fully enforceable, and peptide distributors face significant obligations around product tracing, verification, and reporting. Non-compliance can result in product holds, import refusals, and FDA enforcement actions that disrupt your entire supply chain.

Core DSCSA Requirements

Every entity in the pharmaceutical distribution chain — from manufacturer to dispenser — must be able to trace products at the package level using standardized transaction data. For peptide distributors, this means maintaining transaction information (TI), transaction history (TH), and transaction statements (TS) for every product you handle. You must also verify product identifiers when investigating suspect or illegitimate products and report confirmed illegitimate products to the FDA and trading partners within 24 hours.

Serialization Requirements

All prescription drug packages must carry a unique product identifier encoded in a 2D barcode that includes the NDC, serial number, lot number, and expiration date. Distributors must verify this identifier during product receipt and before further distribution. Systems must be in place to scan, record, and transmit serialization data to downstream trading partners.

Your Compliance Checklist

Key items to address immediately: verify your FDA establishment registration is current, confirm all trading partners hold valid state and federal licenses, implement barcode scanning for serialized product verification, establish suspect product investigation procedures, create an illegitimate product notification workflow, maintain six years of transaction documentation, and train all personnel handling distribution records on DSCSA requirements.

Need a DSCSA compliance assessment? Current Peptide Compliance builds distribution SOPs and traceability systems that satisfy DSCSA requirements from day one. Get in touch.