Drug Supply Chain Security Act

Responsible and Compliant Pharmaceutical Handling and Traceability

DSCSA Overview

Ensure that your pharmaceutical inventory is FDA compliant

Humanitarian Software has invested following the FDA regulations for many years. With this, we have fully integrated and DSCSA compliant modules for EDI, Advance Shipment Notifications, Inventory Control and more. HELM is fully DSCSA compliant and gives organizations the tools to be DSCSA compliant for their pharmaceutical product handling and distribution needs.

DSCSA Details

The Drug Quality and Security Act (DQSA), was enacted by Congress on November 27, 2013. Title II of the DQSA, The Drug Supply Chain Security Act (DSCSA), outlines the procedure to build an electronic system to identify and monitor prescription drugs that are distributed in the US. This aids in protecting both traders and consumers from exposure to drugs that may be counterfeit, stolen, contaminated, or otherwise harmful.

Additionally, the DSCSC oversees the FDA in establishing national licensure standards for wholesale distributors and third-party logistics providers, and requires these entities report licensure and other information to FDA every year.

Dispensers must now exchange “product tracing information” with the FDA when a transaction takes place. Product tracing information consists of: Transaction information (TI), transaction history (TH), and transaction statement (TS).

For more information, read the Drug Supply Chain Security Act. Find a list of DCSCA policy documents and FDA’s implementation plan. Additionally, read the key provisions of the law and find out if you are ready for DSCSA’s requirements.

Major provisions of the DSCSA include:

  • Product tracing (by 2015 lot-level, by 2023 package-level)
  • Product verification
    • Quarantine and investigation (steps for detection and response)
    • Notification, recordkeeping
  • Product identification (applied to product beginning 2017)
  • Wholesale distributor and Third-party logistics provider standards for licensure
  • Enhanced system (electronic, interoperable system to trace products at the package-level by 2023)
  • Penalties for non-compliance
  • National uniform policy

What we do to Comply

  • Integrated EDI module to pull ASN 856 data from donors and vendors
  • ASN (Advance Shipment Notification) module to store inbound pharma data and pedigree.
  • Outbound distribution and ASN data for full shipment pedigrees.
  • Full handling of TI, TS, and TH information
  • Internal traceability from receipt to shipment with license plating to tie TI information like lot and expiration back to the original manufacturer/receipt.

Becoming DSCSA compliant is of great importance if your enterprise handles pharmaceutical aid. We have widespread experience working with VANs (value added networks) to provide secure communications and management reporting in order to help our clients become complaint with DSCSA standards so that they can work towards their mission.

We have also worked with Tracelink to track pharmaceutical shipments and set up EDI trading partners in an effort to provide integrated compliance and eliminate harmful drugs from ever reaching the field.

HELM comes with all the tools needed to help your company become DSCSA compliant, including full handling of TI, TS, and TH information and modules to store pharmaceutical data. You are also able to track shipments from the time the pharmaceuticals were manufactured to their final delivery point, making gathering critical information extremely convenient when it’s time to report.