DSCSA Compliance

What is DSCSA?

The U.S. Drug Supply Chain Security Act (DSCSA) is included in Title II of The Drug Quality and Security Act (DQSA), which was enacted by Congress on November 27, 2013. This law outlines steps required for the pharmaceutical supply chain to electronically track and trace pharmaceutical products at the package level from manufacturing, through distribution, and to the dispenser. The goal of DSCSA is to ensure that counterfeit, adulterated, or otherwise unfit drugs do not enter the supply chain and result in serious adverse events or death in humans. The FDA launched a 10-year plan to implement these regulations and requires that dispensers have the systems in place to comply with DSCSA before November 27, 2023.

How will DSCSA affect my pharmacy?

Under DSCSA, all dispensers, large and small, must implement capabilities for the 100% interoperable, electronic exchange of compliance data with drug suppliers by November 27, 2023. Independent pharmacies must have the capabilities in place to:

• Onboard and integrate with all prescription drug suppliers, including suppliers that send drop shipments.
• Receive serialized compliance data electronically for all prescription drugs received prior to dispensing.
• Verify product serial numbers through the verification router service (VRS) as part of suspect or illegitimate product investigations.
• Execute a product tracing process to compile information about the chain of custody of an item as part of suspect or illegitimate product investigations.
• Ensure that each supplier is authorized, which means confirming that they have the required licensing from the state or federal government to sell drug products.
• Store serialized compliance data for all prescription drugs received for six years.

What’s the solution for my pharmacy?

PharmaLink has partnered with the global leader in track-and-trace solutions, TraceLink, to provide the dispenser community with a proven, turnkey solution backed by the best services and support teams in the industry. TraceLink enables healthcare dispensers and retail pharmacies to:

• Receive interoperable, serialized compliance data in the industry standard EPCIS format for every order through a single link to the TraceLink network.
• Onboard, authenticate, and integrate with all suppliers via a single connection to the TraceLink network, a process completed by TraceLink at no additional cost to the pharmacy.
• Store serialized compliance information and maintain that information for a minimum of six years.
• Initiate product verification of saleable returns and suspect and illegitimate product investigations through industry standard VRS.
• Utilize TraceLink services to manage and train all users (internal and external) and support DSCSA compliance audits.

Your PharmaLink sales representative can get you set up quickly and connect you to the powerful TraceLink network. Contact us now at (800) 257-3527 to sign up in time for the November 27, 2023 deadline.