Dispenser Direct
Dispenser Direct

FDA Enforcement of DSCSA Dispenser Requirements Is In Effect

Is your pharmacy operation compliant?

Learn more about TraceLink's Dispenser DSCSA Program. Book a direct appointment with one of our compliance experts within seconds by clicking here to find out about special pricing offers through our Preferred Partner program!


Learn More

What is the Drug Supply Chain Security Act (DSCSA)?

DSCSA is a federal law and stands for the Drug Supply Chain Security Act, which is Title II of the Drug Quality and Security Act (DQSA)

What is the purpose of the law?

DSCSA mandates a full supply chain traceability system from pharmaceutical manufacturer to pharmacy dispenser for prescription drugs being distributed in the United States. The law was signed by President Obama in November 2013, providing a national standard for drug security and replacing the patchwork of state-level Pedigree regulations that were previously being put into place. 

Why is this legislation important?

The World Health Organization estimates that between 1% and 10% of drugs sold around the world are counterfeit, with that number reaching as high as 50% in some countries. DSCSA will help protect patient safety by enabling verification of products, improving the detection of suspect ones, and facilitating product recalls. 

See How Product Track for Dispensers Works

Below are two short demos of how Product Track can be used to alleviate common pain points you're facing for DSCSA compliance. Specifically, we focus on the key capabilities of Product Track for you as a pharmacy dispenser: Finding & Viewing Transactions, Voiding Transactions and Managing your Receipts.  

How will DSCSA affect my pharmacy operation?

Which supply chain segments have a compliance requirement under DSCSA?

Drug manufacturers, wholesale distributors, repackagers, and dispensers that work with prescription products in the U.S. have a requirement under the law. 

Who qualifies as a dispenser in the eyes of the law?

Anyone who dispenses prescription products to patients – including but not limited to pharmacies, clinics, hospitals, physicians, and long-term care facilities – is considered a dispenser.

If your business dispenses to patients but also resells product to distributors or other dispensers, it falls under wholesale distributor requirements. 

What does DSCSA mean for my dispenser business?

The law has complex drug tracking, verification, and serialization regulations that impact DSCSA for Pharmacies our business and how you communicate with supply chain partners. 

What do I have to do to achieve compliance?

Step 1

Track & Receive Lot Level Compliance Data

Dispensers must be able to receive the lot-level Transaction History (TH), Transaction Information (TI), and Transaction Statement (TS) compliance documentation for every product they purchase. 

Step 2

Verify "T3"
Compliance Data

Dispensers should verify the "T3" Compliance Data against the product that was shipped to them by their suppliers, and must quarantine any product they determine to be suspect or questionable. 

Step 3

Store "T3"
Compliance Data

Dispensers must store the compliance information associated with every shipment they receive for a period of at least 6 years from the date of shipment receipt. 

Step 4

Retrieve & Respond to Request for Information

If the FDA or similar regulatory body issues a Request for Information (RFI), the dispenser in question must retrieve specific compliance data within 2 business days. 

What is Product Track?

What is Product Track, and how does it work?

  • Product Track is a transaction history management system that operates as a single, digital solution to handle all of your DSCSA compliance requirements.
  • One software platform that connects to all of your prescription drug suppliers, and does the heavy lifting of receiving any type of compliance data that they might send to your pharmacy.
  • Stores all compliance data for the 6-year retention requirement of DSCSA.
  • If you receive a Request for Information from the FDA, simply run a search of your electronic Transaction Histories based on receiving date, NDC, supplier name, or many other factors – and then respond to the inquiry within the 2-business day requirement.

Product Track NDC Verification Service

With support from major U.S. wholesalers, TraceLink offers an NDC Verification Service within its Product Track software that eases the burden of filtering large product volumes in shipments to determine what falls under DSCSA. When customers use Product Track, the NDC Verification Service will:

  • Exclude OTC and other non-prescription drug products from the T3 creation process – when receiving shipments from major U.S. wholesalers that use a "DSCSA exempt flag".
  • Utilize TraceLink’s Network Product Master Data Service to check for missing NDCs – against FDA and RED BOOKTM databases and the TraceLink Life Sciences Cloud network of products traded between more than 250,000 supply chain partners.
  • Generate T3 for all products with legitimate NDCs – using an "information icon" to identify any products that could not be verified through TraceLink’s Network Product Master Data Service and may require additional information before processing.
  • Allow dispensers to add missing NDC data and reprocess transaction records with a single click – at time of receipt or at a later date, based on SOPs defined by the dispenser.
  • Perform future verification checks against manufacturer GTINs—at no additional charge—to facilitate receipt of future serialized product.

What is TraceLink's DSCSA Dispenser Program?

What is the TraceLink Dispenser Program, and why was it created?

  • The TraceLink Dispenser DSCSA Program is a special compliance package that bundles a Product Track software license, on-demand education & training, and 24/7 support for any compliance questions that a pharmacy customer might face
  • After speaking directly with the dispenser community, we learned that pharmacy owners possess a strong desire to secure their supply chains and achieve DSCSA compliance -- but also want a solution that doesn't take time away from providing patient care
  • As a result, we created the TraceLink Dispenser Program to provide a world-class DSCSA compliance program, all at an affordable cost for pharmacy owners
  • Don't forget to check out the exclusive pricing offers available through our Preferred Partner Program--reach out to us today to find out if your GPO or Cooperative has a deal with TraceLink!

By taking advantage of the Dispenser Program, customers will:

  • Join the TraceLink Network and be directly connected to all of their suppliers
  • Secure a Product Track license for each pharmacy location from which they dispense Rx product, and have a single online location to store and search for all of their DSCSA compliance data
  • Be enrolled into TraceLink's DSCSA for Dispensers Training Course, where they will walk through the specific requirements of the law and learn how to use Product Track
  • Always be armed with an evolving software platform that gets updated as the compliance requirements for dispensers change
  • Have 24/7 email access to TraceLink's team of DSCSA compliance experts, who are ready to jump in and help if any questions or problems arise

 

Why is Product Track the best DSCSA solution for my dispensing operation?

  • Tracelink Product Track
  • Wholesaler Portal
  • Do-it-Yourself
  • Other Tech Solutions
Transaction History Management System, purpose-built for DSCSA dispenser compliance
A single connection to ALL of your vendors and suppliers--one location for accessing ALL of your compliance data
Leverage existing network of 160,000+ pharma trading partners to quickly connect and receive Transaction Histories
Accepts any of the more than 200 different data formats that a supplier might use to send an electronic Transaction History
Stores Transaction Histories from your primary wholesaler(s)
Stores Transaction Histories from your secondary trading partners
Stores any supplier's compliance documentation for the 6-year retention requirement
Instantly take your T3 data with you if you change wholesalers or suppliers
Receipt of Transaction Histories for manufacturer drop shipments
Electronic search of data for rapid response to any FDA inquiry within 2-business day requirement
Product verification support to meet DSCSA Verification & Request for Information (RFI) requirements
Seamless electronic connection between the compliance data at ALL of your owned pharmacies
Digital receipt of electronic Transaction Histories
Digital receipt of paper Transaction Histories through simple PDF scan or photo upload
Continuous product updates to meet changing compliance regulations, at no additional cost to you
24/7 email support for all of your compliance questions
Serialization capabilities available if a supplier sends serialized product