DSCSA Compliance

Drug Supply Chain Security Act (DSCSA) and how Safecor Health handles EPCIS data is a two-part answer that covers both our current practices and the role of our customers:

  1. Repackager Responsibilities and Customer Support Measures
    As a repackager, Safecor is not required under DSCSA to perform EPCIS based verification. That responsibility ultimately falls on the product owner—our customer. However, as part of our commitment to quality and transparency, we have implemented measures to support our customers in meeting their DSCSA obligations:
  • Upon receipt, we inspect all product packaging for any signs of damage or tampering.
  • Every unit is scanned for its Rx 2D barcode and we will make all received serial numbers and product details available in the Customer Portal for your review and reconciliation.
  • This service is offered to assist with traceability and to provide peace of mind regarding product integrity.
  1. EPCIS Data Integration and Verification
    We are also enhancing our systems to support direct EPCIS data matching. Safecor is capable of receiving EPCIS files from wholesalers. To activate this process, you may request your wholesaler to send a duplicate EPCIS file directly to Safecor. Once received, our system will match the EPCIS data against the scanned serial numbers.
  • If a mismatch or missing serial is identified, we will immediately notify both the wholesaler and the customer.
  • The affected product will be placed on hold until the issue is resolved, ensuring DSCSA compliance and supply chain security.

If you would like to move forward with EPCIS integration, we recommend authorizing your wholesaler to share the EPCIS data directly with us. We’re happy to assist with any technical coordination that is needed.

Please reach out to service@safecorhealth.com with any additional questions or if you’d like help initiating the EPCIS data sharing request.