1. Track and Trace PSSNY 2015 Mid-Winter Conference Al Emmans
Dir/Marketing & IT Business Management
RDC

2. What is Track and Trace? FDA regulatory compliance program
Based on “Drug Quality and Security Act” (DQSA)
signed into law on November 27, 2013
10 year implementation plan
Goal:
“build an electronic, interoperable system to identify and trace certain prescription drugs as they are distributed in the United States”
Purpose:
Verify legitimacy of drugs down to individual package level
Detect and notify FDA regarding illegitimate drugs
Make recalls more efficient

3. Manufacturers JANUARY 1, 2015 Manufacturers provide the “3T’s”
TS Transaction Statement – statement of authenticity by FDA Authorized Trading Partner
TH Transaction History – chain of custody transfers
TI Transaction Information – product information including lot number
Single document, electronic (ePedigrees) or paper
Beginning November 2017, manufacturers are required to provide 3T’s based on individual package serialization

4. Authorized Trading Distributors
JANUARY 1, 2015
Download the 3T’s in ePedigrees or capture paper documents at point of Receiving
Cannot receive product unless the 3T’s are provided
Must set up quarantine system
Verify lot information
Append receipts to original 3T’s
Adds to ePedigree, or modifies paper documents
Must store 3T’s for 6 years
Electronic storage, scan paper-to-electronic, or physical
Provide appended 3T’s to next party
Distributors or Dispensers

5. Dispensers
JULY 1, 2015
Dispensers download 3T’s in ePedigrees or capture paper documents at point of Receiving
Dispensers verify lot numbers and product information against 3T’s
Dispensers cannot accept product unless 3T’s are provided
Must set up quarantine system
Dispensers must store 3T’s for 6 years

6. Reporting Based on FDA requests, audits, and investigations
Distributors have 24 hours to respond
Dispensers have 48 hours to respond
Both parties must provide final T3 documents
Options for voluntarily reporting suspected counterfeit, tampered or stolen product
Report to distributor
Return to distributor
Report to FDA

7. How Can Supply Chain Help?
1.) Outsource Storage
According to FDA, dispensers may outsource storage and retrieval of 3T ePedigrees to third party companies
Some distributors providing internally built solutions
Others contracting with “Traceability Vendors” such as Axway, TraceLink, Frequenz, rfXcel, & more
Systems must be confidential
Most likely to be web interface
Could be direct or “cloud” storage
Dispenser simply signs 3rd party agreement effectively outsourcing ePedigree storage and retrieval to outside vendor

8. How Can Supply Chain Help
2.) Reduce paper
Distributors can reduce paper by encouraging manufacturers to convert from paper receiving documents to ePedigrees
If manufacturers do not convert, distributors can also convert receiving documents to ePedigrees
The goal is to maximize the amount of true properly standardized T3 ePedigrees available for look-up by dispensers

9. How Can Supply Chain Help
3.) Buy direct from mfrs
For Authorized Distributors who buy directly from manufacturers, FDA does not require lot number and other specific item information to be sent to the dispenser in the Transaction Information (TI) segment (defined in section 582(26))
If Authorized Distributors are not required to send lot number information on items purchased directly from the manufacturer, then the dispenser simply needs to verify receipt of product using current inbound order processes
Conversely, Secondary Distributors ARE required to send lot number information on items purchased from other suppliers. In this case the dispenser DOES need to verify lot information at the point of receiving, and quarantine product if incorrect

10. Questions for your Trading Partners
Are you an Authorized Trading Partner, licensed with FDA?
Do you buy directly from manufacturers?
Do you provide the 3T’s in your pedigrees?
Do you provide an ePedigree storage and retrieval solution for dispensers?
If so, for how long?
If so, can I produce ePedigrees within 48 hours?

11. Awaiting Guidance Is old product grand-fathered?
Yes. Shipments received prior to January 1st , 2015 are not subject to Track and Trace
What about Returns?
Awaiting guidance from FDA
“Word on the street” is returns are not required for 6 years
However, Trading Partners may ask for T3’s on unknown product
Drop Ship Rx – specialty, etc?

12. Awaiting Guidance Store Transfers? Awaiting guidance from FDA
“In theory”, pharmacy is acting as a distributor role and should provide T3’s to receiving pharmacy
To err on the side of caution - both parties should document detailed transfer on original 3T’s statement as best as possible, and store for 6 years
What about syringes, kits, etc.?
Many are exempt from Track and Trace
Individual trading partners may provide item lists or notate on ordering systems

13. Is Product Serialization Coming?
Yes. A full system conversion begins in 2017
Manufacturers provide individual package ePedigree
Current plan is to use EPCIS 2-D scan codes standardized by GS-1 (international technology standards group)
2-D Scan code will include the 3T’s
Wholesalers must scan every package inbound and outbound
November 27, 2020 – pharmacies scan inbound
Scanning equipment linked to wholesaler ordering system and/or ePedigree storage?
Download day’s receipt, scan all packages, ePedigrees appended automatically

14. Summary
We are on the ground level of a sophisticated tracking system designed to protect consumers and eliminate counterfeits from healthcare distribution
Embrace FDA’s plan
Dispensers begin compliance on July 1, 2015
Embrace supply partner technologies for minimal disruption to your daily practice
Engage in conversations with your suppliers now
Watch for updates on continuing FDA guidance

15. Questions?

16. Sources FDA Track and Trace Website
FDA Presentation at NACDS, Aug 14, 2014 by Connie Jung, RPh, PhD
tse.nacds.org/presentations/2014/Sunday/Supply_Chain_Security_Act.pdf