Track and Trace PSSNY - 2015 Mid-Winter Conference
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Track and Trace
PSSNY
2015 Mid-Winter Conference
Al Emmans
Dir/Marketing & IT Business Management
RDCWhat 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 efficientManufacturers
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 serializationAuthorized 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 DispensersDispensers
• 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 yearsReporting
• 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 FDAHow Can Supply Chain Help? • 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
How Can Supply Chain Help • 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
How Can Supply Chain Help • 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
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?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?
• Awaiting guidance from FDAAwaiting 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 systemsIs 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 automaticallySummary • 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
Questions?
Sources • FDA Track and Trace Website http://www.fda.gov/Drugs/DrugSafety/DrugIntegrityandSupplyChainSecurity/DrugS upplyChainSecurityAct/ • FDA Presentation at NACDS, Aug 14, 2014 by Connie Jung, RPh, PhD tse.nacds.org/presentations/2014/Sunday/Supply_Chain_Security_Act.pdf
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