DSCSA SOLUTION FOR DISPENSERS

UNDERSTANDING THE DRUG SUPPLY CHAIN SECURITY ACT (DSCSA) FOR PHARMACIST

Enacted by Congress in 2013 and overseen by the Food and Drug Administration, the Drug Supply Chain Security Act (DSCSA) outlines steps to safeguard the public from counterfeit and adulterated drugs. Under the DSCSA dispensers / pharmacists are required to electronically track and trace certain prescription drugs as they enter their pharmacy. This is achieved through tracking and tracing T3 data (transaction history, transaction information, and transaction statement) generated at each step of the supply chain from trading partners. By 2020, pharmacists must be able to electronically receive and accept only serialized products encoded with a 2D barcode, and by 2023 pharmacists must have a fully electronic and interoperable system in place to track and trace prescription drugs.

What Pharmacists Need to Know

The Drug Supply Chain and Security Act (DSCSA) requires the electronic tracking and tracing of all dispensed prescription products. Since November 2017, the FDA has required pharmacists to electronically track all products entering their pharmacies, and follow the FDA’s standards for receiving and maintaining drug product and purchasing data. Pharmacists have a unique set of requirements and milestones to meet under the DSCSA. Contact rfxcel to learn more about your obligations under the law and SNAP our solution to help you meet the DSCSA.

Important Dates to Meet DSCSA Deadlines:

• November 2017 – All lot level transactions should be electronic
• November 2020 –Pharmacies/dispensers can only receive and engage with products that are encoded with a serial number and 2D barcode
• November 2023 – All pharmacies/dispensers are required to have systems to support unit level traceability, enabling traceability back to point of origin

Under the DSCSA Dispensers Are Required To:

• Electronically receive T3 data from authorized trading partners
• Electronically store T3 data from all authorized trading partners for 6 years
• Have a system in place to investigate and quarantine suspicious products, and then notify trading partners and the FDA of illegitimate or suspicious products
• Generate T3 data for outgoing sales
• Receive only products with serialized data encoded in a 2D barcode, by the year 2020

Meet DSCSA Requirements with rfxcel SNAP

Electronically Connect with Trading Partners

• Electronically connect with your licensed and verified trading partners (primary wholesalers, secondary wholesalers, and manufacturers)
• Receive only products with serialized data encoded in a 2D barcode, by the year 2020

Receive, Store, and Provide Product Tracing Documentation

• Accept and verify T3 product information (transaction history, transaction information, and transaction statement)
• Store T3 data in an electronic format for 6 years or longer
• Generate T3 data for outgoing sales and transactions Director