The Safeguard prescription drugs & protect consumers under the Drug Supply Chain Security Act (DSCSA) with rfxcel SNAP.
Enacted by Congress in 2013 and administered by the Food and Drug Administration (FDA), the DSCSA outlines steps to safeguard the public from counterfeit or 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 supply chain from trading partners. The goal of the DSCSA is to have a fully electronic and interoperable system in place to track and trace prescription drugs by 2023.
Responsibilities of Dispensers Under the Drug Supply Chain Security Act (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
- SNAP electronically connects with your licensed and verified trading partners (primary wholesalers, secondary wholesalers, and manufacturers)
- 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; in the event of an audit
- Generate T3 data for outgoing sales and transactions
- Investigate and properly handle suspect and illegitimate drugs
- Workflows that support the identification and quarantining of suspicious products
- Electronic notification to the FDA and trading partners of illegitimate or suspect products
Contact rfxcel to learn more about SNAP our DSCSA solution for pharmacies and your obligations as a dispenser under the DSCSA.
