Navigating the Complexities of DSCSA Compliance: What You Need to Know

Navigating the Complexities of DSCSA Compliance: What You Need to Know

The industry is approaching the culmination of DSCSA implementation. Although it’s been 10 years in the making, with significant milestones, the last effective date is on the horizon – November 27, 2023.

What is DSCSA?

The Drug Supply Chain Security Act (DSCSA) was enacted in 2013 to outline steps to introduce greater transparency into the distribution of prescription drugs in the U.S. Often, DSCSA is referred to as ‘track and trace’ as it best encompasses the overarching goals of the law. Law requirements have been implemented over a 10-year period and in three phases.  

Key provisions of the law require product serialization via 2D barcodes to be implemented by manufacturers and product verification by dispensers. The contents of the 2D barcode include the GTIN, unique serial number (SNI), lot number, and expiration date of the drug product. ScriptPro’s 2D barcode scanners allow dispensers to read the information within the 2D barcode and assist in visual verification.

What do I need to be doing right now?

Prior to the November deadline, pharmacies should incorporate several items into their processes. Pharmacies should ensure they’re only doing business with authorized trading partners (for example, wholesalers that are licensed and registered to ship into your state). Pharmacies should also be receiving, storing, and providing product transaction data when requested (by the FDA, state regulatory entity, or vendor partner). Lastly, pharmacies should establish procedures to investigate and handle suspect or illegitimate drugs.

How do I know if I’m ready for November 27, 2023?

The November 2023 deadline requires three key things from pharmacies. First, pharmacies should be ready to receive and exchange transaction data (Transaction Information and Transaction Statements only)electronically. Until November 2023, transaction data may be sent in hard copy form or by electronic medium (ex: log-in portals or email). Second, pharmacies should be ready to implement systems or processes for package-level verification as needed. And third, pharmacies should be prepared to adopt processes to produce serialized transaction information when requested by the FDA, state regulatory agency, or a trading partner in the event of an investigation.

Drug wholesalers and third-party logistics providers may offer services for some or all of the items detailed above. Getting in touch with these partners to explore available options is recommended. However, it’s also important to remember that vendors offering solutions may have additional requirements on top of what is legally required. 

Where can I learn more?

DSCSA requirements are complex, however, here are a variety of resources to learn more: