U.S. Drug Supply Chain Security Act (DSCSA)
Signed into law in 2013, the DSCSA affects all pharma supply chain actors. It was designed to prevent counterfeit, stolen, contaminated, or otherwise harmful drugs from getting into the U.S. supply chain. It outlines steps to build an interoperable electronic system to identify and trace prescription drugs as they are distributed throughout the country.
Two Phases of the DSCSA Rollout
Phase I (2015–2023)
Lot-level traceability through the exchange of transaction information (“T3 information”) about every package of medication.
Phase II (2023)
Complete unit-level serialization of the U.S. drug supply chain.
DSCSA Milestones & Requirements
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2013
November 27: DSCSCA is enacted.
2014
November 27: 3PLs must report licensure information to FDA annually.
2015
All trading partners must be authorized.
Manufacturers must print lot numbers of packaging for all prescription drugs.
July 1: Dispensers must provide T3 information to trading partners.
2017
Manufacturers must serialize and verify products.
2018
Repackagers must serialize products — associate and verify serial numbers
2019
Wholesalers/Distributors can receive & distribute only serialized products.
Wholesalers must verify SNIs, including saleable returns
2020
Dispensers can receive & ship/dispense only serialized products and must verify SNIs.
2023
Full interoperable electronic unit-level traceability for all stakeholders.
2016-2019
- Confirm trading partners are licensed or registered.
- Receive, store, and provide T3 information: transaction information (TI), transaction history (TH), and a transaction statement (TS).
- Accept only prescription drugs with proper T3 information.
- Store T3 information for six years.
- Generate and provide all T3 information when selling a drug to a trading partner.
- Investigate and properly handle suspect and illegitimate drugs.
2023
- Complete serialization of the U.S. drug supply chain. Stakeholders must electronically track products at the individual package level.
Requirements for manufacturers
- Lot-level management: Share T3 information at the lot (or batch) level
- Serialize packages with a product identifier (GTIN or National Drug Code), serial number, lot number, and expiration date
- Use Verification Router Service (VRS) to meet FDA saleable returns verification requirement
- November 2023: Serialized item-level traceability with information to trace ownership back to the initial manufacturer or repackager
rfxcel products
- rfxcel Traceability System (rTS) with Serialization Processing (rSP) and Compliance Management (rCM)
Requirements for repackagers
- Lot-level management: Share T3 information at the lot (or batch) level
- Serialize packages of drug products using a product identifier (GTIN or National Drug Code), serial number, lot number, and expiration date
rfxcel products
- rfxcel Traceability System (rTS) with Serialization Processing (rSP) and Compliance Management (rCM)
- rfxcel Verification Router Services (rVRS)
Requirements for wholesale distributors
- Lot-level management: Share T3 information at the lot (or batch) level
- Verify every product’s serial number
- Must receive verified serial numbers from manufacturers
- Use Verification Router Service (VRS) to meet FDA saleable returns verification requirement
rfxcel products
- rfxcel Traceability System (rTS) with Serialization Processing (rSP) and Compliance Management (rCM)
- rfxcel Verification Router Services (rVRS)
Requirements for dispensers (pharmacies, hospitals, clinics)
- Lot-level management: Share T3 information (to be prepared for audits)
- Investigate and properly handle suspect and illegitimate drugs
- Buy and sell only serialized drugs, authenticate serialization at the package level
rfxcel products
- rfxcel Dispenser Compliance Solution (rDCS) for pharmacies, healthcare systems, and hospitals
How rfxcel can help
Traceability and serialization technology is the cornerstone of the DSCSA — it’s also the cornerstone of our business. We have been developing leading-edge track and trace and serialization solutions since 2003. Our supply chain experts know the DSCSA inside and out. They will design a solution to ensure you meet all DSCSA deadlines and remain compliant forever.
Why rfxcel is different
Founded in 2003, rfxcel is the longest-tenured compliance and track and trace solutions provider in the life sciences industry. A digital supply chain from rfxcel will ensure you’ll meet all DSCSA requirements — plus the requirements of all other global regulations, such as the EU Falsified Medicines Directive (FMD), Russia’s National Track and Trace Digital System (Chestny ZNAK), and Brazil’s Health Regulatory Agency (ANVISA).
rfxcel will also help you:
- Safeguard your products
- Ensure patients get the right drug at the right time
- Combat counterfeit drugs
- Secure your business investments
Take the worry out of DSCSA compliance with rfxcel Traceability System (rTS)
rTS is our award-winning track and trace platform that literally has DSCSA compliance built into it. It powers our rfxcel Compliance Management (rCM) and Serialization Processing (rSP) solutions, which work in tandem to automate every aspect of DSCSA compliance.
rTS simplifies and accelerates compliance and increases supply chain visibility no matter where you do business. It also integrates seamlessly with your existing systems and enhances scalability by letting you add new features quickly.
Find out more about our DSCSA compliance solutions today!
Your value beyond compliance with rfxcel
- Digitize and centralize your entire supply chain in one elegant, easy-to-use, intuitive platform
- Enhance performance and reduce processing time in multiple languages
- Leverage IoT technology to gain new real-time insight into and control of your supply chain
- Trace your products forward and backward
- Maintain historical information for a batch or individual product with continuous review and supply chain optimization
- Drive growth by lowering costs and risks, eliminating inefficiencies, and tracking all activity anywhere in your supply chain, including among suppliers, distributors, and 3PLs
- Integrate with any trading partner
