Track and Trace Compliance Guidance for the Pharmaceutical Industry

The FDA’s November 27, 2023 compliance deadline for interoperable electronic exchange, verification & tracing of drug supply products at the package level is right around the corner!

The DSCSA Conference will provide a platform for industry stakeholders – Manufacturers, Repackagers, Distributors, Wholesalers/3PLs and Dispensers – impacted by this requirement to gather in a roll-up-your-sleeves, collaborative environment with leading industry associations to discuss progress to date, issues to be resolved, technical challenges, and cohesive forward momentum to collectively improve the integrity of the drug supply chain.

Beginning in 2013, The Drug Quality and Security Act (DQSA) was enacted by Congress to create a uniform national standard for tracking and tracing pharmaceuticals through the entire supply chain. The law ensures the safety of drugs, protecting consumers from exposure to drugs that may be counterfeit, stolen, contaminated, or otherwise harmful, as well as substantiating supply chain integrity.

Title II of DQSA, the Drug Supply Chain Security Act (DSCSA), outlines steps to achieve interoperable, electronic tracing of products at the package level to identify and trace certain prescription drugs as they are distributed in the United States.

Additionally, the DSCSA directs FDA to establish national licensure standards for wholesale distributors and third-party logistics providers, and requires these entities to report licensure and other information to FDA annually.

Who will attend the DSCSA Conference?

• Manufacturers of pharmaceuticals who are required to comply with the DSCSA regulation
• Repackagers who are involved in packaging and labeling and shipping products
• Wholesale distributors and the pharmaceutical supply chain partners who warehouse and move products
• Dispensers including retail, hospital, chain pharmacies, and others authorized to dispense or administer prescription drugs, and the affiliated warehouses or distribution centers of such entities
• Solutions Providers to stay engaged with the latest developments and user needs in order to provide technical support and products

You can also explore the technology behind DSCSA in the exhibits area where you can learn about the solutions for your needs

DSCSA requires organizations to acquire new or improved technology to meet the requirements to efficiently mark products, scan product information at various points in its lifecycle, and transmit to an interoperable exchange and verify chain of custody. The DSCSA Conference offers a solution Showcase of the enabling technologies.

• Bar code printing
• Laser engraving
• Inkjet equipment
• Bar code scanners/imagers/verifiers
• 3D bar code printing etching equipment
• Portable data collection terminals
• Application software oriented around DSCSA

DSCSA Conference Sponsoring Organizations:

Leading industry organizations engaged in DSCSA have partnered with the Conference to help deliver educational guidance and pave the way for ongoing DSCSA momentum as we move towards the November 27, 2023 deadline:

Industry Organizations

Media

FDA Official Site for DSCSA

View the DSCSA Conference Agenda