Slide 1 - GS1

					EPCglobal HLS Industry Adoption
           Roadmap
      Final Version v13.2
Prepared by the EPCglobal HLS Industry Adoption
                  Task Force

              For General Release

              Published ___, 2008
               A Message from the Co-Chairs
 •   We are proud to have served on this important initiative, and honored to have been
     chosen as leads for the effort.
 •   Many people gave selflessly of their time and talent to create this document.
 •   We wish to express heartfelt thanks to the EPCglobal HLS Tri-Chairs, Ron Bone, Mike
     Rose, and Ramesh Murthy for their unwavering support, advice, counsel, and friendship
     during the course of this project!
 •   We owe a debt of gratitude to the EPCglobal staff, particularly Chuck Schramek for his
     leadership in guiding us through the entire process, providing his excellent facilitation
     skills, and bringing humor and fellowship to the project.
 •   A special thank you to Bob Celeste as well, for his untiring efforts in promoting our efforts,
     helping us through the tough times, and generally just ‗being there‘ for us.
 •   And finally, a big thank you to our good friends at GS1: Ulrike Kreysa, Michel van der
     Heijden, Bernie Hogan, John Terwilliger and John Roberts for always making time to
     provide expert advice on GS1 standards and philosophy. Their contributions are evident
     throughout the document.
 •   We hope that you will find this information enlightening and useful in your efforts to design
     Serialization and Pedigree solutions for your companies.

 Best Regards and Happy Reading!
  Ted Ng, McKesson Corporation
  Grant Hodgkins, Alcon Laboratories


Slide 2
EPCglobal Confidential and Proprietary
            IATF Companies / Organizations
 The following organizations participated in creation of this deliverable.
 Supply Chain Partners                   Supply Chain Partners             Trade / Regulatory
 •Abbott Laboratories                    •Kimberly-Clark                   •Auto-ID Labs (MIT)
 •Ahold N.V.                             •Matsushita Electric              •CPhA
 •Albertsons                             •McKesson Corporation             •EPCglobal HLS Community
 •Alcon Laboratories                     •Merck & Co.                      •FDA
 •Allergan                               •MetaBiz
 •AmerisourceBergen Corp.                •Motorola Inc.                    •GS1 HUG Community
 •AstraZeneca                            •NEC Corporation                  •HDMA
 •Baxter Healthcare Corp.                •Nestle S.A.                      •NACDS
 •Bristol Meyers Squibb                  •Pfizer Inc.                      •NCPA
 •Cardinal Health                        •Proctor & Gamble
 •CVS                                    •Royal Philips Electronics N.V.
 •Dai Nippon Printing                    •Target
 •Genzyme Corporation                    •The Dow Chemical Company
 •GlaxoSmithKline                        •Unisys
 •Johnson & Johnson                      •Upsher-Smith Labs
 •Ken Traub Consulting LLC               •Walgreens Company


Slide 3
EPCglobal Confidential and Proprietary
          Table of Contents—HLS Roadmap
      Executive Summary

 1. Purpose
 2. Scope
 3. Capabilities and Suggestions
       a. Unique Identification
       b. Pedigree
 4. Action Steps
 5. Summary and Recommendations
 6. Appendices

     Communications Plan (Separate Deliverable)

Slide 4
EPCglobal Confidential and Proprietary
                                  Notes to Reader
 • Although this is an EPCglobal chartered team, this document
   provides flexibility in selecting an appropriate data carrier. Barcodes
   and RFID are both represented within the document.
 • This document is a point-in-time snapshot of the current thinking of
   the EPCglobal HLS Industry Adoption Task Force.
 • It is intended as a starting point for the various industry trade
   associations. See Appendix 5 for a list of associations who
   commented on the document.
 • Once the document is handed-off these industry trade associations,
   this document may no longer be kept current.
 • Work through your industry trade association to obtain the latest
   information regarding industry adoption activities and materials for
   your market segment.



Slide 5
EPCglobal Confidential and Proprietary
                                         Disclaimer
 • Supply chain participants should rely upon their
   companies‘ legal interpretations of regulatory
   requirements.
       – The Industry Adoption Task Force does not interpret legislation
         nor recommend compliance postures.
       – Suggestions presented in the Roadmap and associated
         documents are designed to provide a starting point for industry
         collaboration towards common solutions.
       – Suggestions and/or other team deliverables are not to be
         considered as legal advice and are not intended to substitute for
         competent legal counsel.




Slide 6
EPCglobal Confidential and Proprietary
                              Executive Summary
 • Mission:
       – Define a ‗starting set‘ of suggestions for industry trade
         associations to discuss with their members to facilitate their
         efforts in addressing current and emerging regulatory
         requirements for improving supply chain safety and security.
       – Work closely with EPCglobal and GS1 HUG (Healthcare User
         Group) to develop consensus-based suggestions.
       – Educate and hand-off the Roadmap and other deliverables to
         industry trade associations.

 • NOTE: Not intended to be the „final answer‟ for the industry—
   the Roadmap is only a starting point for more widespread
   debate and discussion within the various industry trade
   associations.

Slide 7
EPCglobal Confidential and Proprietary
                              Executive Summary
 • Deliverables:
       – HLS Industry Adoption Roadmap
             •   Capabilities
             •   Suggestions
             •   Action Steps
             •   Issues / Barriers / Assumptions
             •   Rationale / Pro and Con Assessment

       – Communications Plan / Strategy
             •   Outreach Message
             •   Groups to target for feedback
             •   Feedback mechanism and process
             •   Process to hand-off to industry trade associations



Slide 8
EPCglobal Confidential and Proprietary
                       Purpose of the Roadmap




Slide 9
EPCglobal Confidential and Proprietary
                      Purpose of The Roadmap
 • The Roadmap provides suggestions in meeting current and
   emerging regulatory expectations, including the direction
   outlined by the FDA‘s “Counterfeit Drug Task Force Report:
   2006 Update”, the California Pedigree Law (SB1476), and
   Federal PDMA law.
       – Pedigree and Unique Identification, deployed in a coordinated manner, are two
         Key Capabilities which can advance the industry towards improvements in the
         safety and security of the supply chain.
 • Serves as a starting point for broader discussions within the
   context of industry trade associations.
 • Documents the best ideas from the Industry Adoption Task
   Force, composed of a cross-section of knowledgeable
   industry representatives.
 • Describes the thought process and rationale of the Industry
   Adoption Task Force in arriving at the various suggested
   elements.
Slide 10
EPCglobal Confidential and Proprietary
                      Purpose of The Roadmap
 • The Health and Life Sciences (HLS) industry shares the
   vision of a ‗safe and secure drug supply chain‘ premised on
   transparency and accountability by all persons who handle
   the prescription drug, starting with the manufacturer and
   ending with the pharmacy or other healthcare points of
   dispense, including both forward- and reverse-logistics
   transactions.
       – Simply issuing a Pedigree or Uniquely Identifying a product alone does
         not improve safety nor security. The ―coordinated exchange‖ of
         uniquely identified products using the concept of pedigree transactions
         can result in improved supply chain safety and security.
       – The Roadmap is constructed to balance the perceived risks and
         benefits. This balancing is needed to lessen the impact of incremental
         costs on the continued availability of affordable healthcare while still
         achieving the goal of ‗a safe and secure supply chain‘.


Slide 11
EPCglobal Confidential and Proprietary
                         Scope of the Roadmap




Slide 12
EPCglobal Confidential and Proprietary
                        Scope of The Roadmap
 • Addresses two Key Capabilities:
       – Unique Identification, including,
             • Serialization
             • Data Carriers for Serialization
                   – RFID
                   – Barcodes
       – Pedigree, which includes the secure exchange of product
         transactional information between trading partners using an
         interoperable electronic system.

 • Presents Suggestions, Action Steps, and
   Issues/Barriers and Assumptions as a starting point for
   industry trade associations.


Slide 13
EPCglobal Confidential and Proprietary
                        Scope of The Roadmap
 • Applies to HLS supply chains and participants.
       – Focus on US Rx drug supply chains and products:
             • Most urgent compliance requirements and dates.
             • California represents the most stringent set of requirements.
       – Designed with flexibility to address other HLS products and
         geographic regions as future requirements arise.
       – Adapts and leverages existing GS1 and EPCglobal standards
         and guidance from HDMA publications.
       – A comprehensive list of key sources is included in the Appendix.




Slide 14
EPCglobal Confidential and Proprietary
         Assess Impact on Trading Partners
  Introduction to This Section

  • As choices of data carrier, serialization scheme, pedigree
    and other decisions are made, those choices will necessarily
    impact your trading partners.
  • The following slides highlight some of the concerns,
    organized by industry segment, that should be considered as
    you develop strategy and plans.
  • This section provides only a basic awareness and a starting
    point for trading partner discussions.
  • Benefits can be more easily captured by all supply chain
    participants if all segments work closely together to
    understand and address each others‘ concerns.


Slide 15
EPCglobal Confidential and Proprietary
         Assess Impact on Trading Partners
  Manufacturer Concerns with Options and Choices

  • Cost and time to implement serialization, regardless of data
    carrier, presents challenges to wide-scale deployment on all
    products and all packaging levels.
  • Variety of special-situation supply chains present unique
    challenges (cold chain, reverse logistics, vaccines, liquids,
    biologics, contract manufacturing, etc.)
  • Difficult to justify expenditures for serialization and pedigree
    unless it is clear that most or all trading partners will utilize
    this new technology.
  • Contract manufacturing supply chains may introduce some of
    the same concerns from the following Wholesaler and
    Retailer slides into the Manufacturer‘s operations.


Slide 16
EPCglobal Confidential and Proprietary
         Assess Impact on Trading Partners
  Wholesaler Concerns with Options and Choices

  • Supporting multiple data carriers will multiply the costs and
    complexities for the wholesalers.
  • In the absence of Serialized Inference, data carriers requiring line-
    of-sight used at lower packaging levels will significantly decrease
    productivity.
  • Mixture of pedigreed/serialized products and non-pedigreed/non-
    serialized products complicates operations.
  • Must have knowledge of the serialized hierarchy prior to receipt, for
    instance via an Rx ASN.
  • Trading partners may choose to build the serialized hierarchy
    and/or the pedigree in different formats, complicating operations.
  • Potential for throughput and inventory issues based on the
    combination of the above factors.

Slide 17
EPCglobal Confidential and Proprietary
         Assess Impact on Trading Partners
  Retailer Concerns with Options and Choices
  •   Each choice of data carrier has its own cost-benefit implications not only for a
      specific company, but also for those trading partners further down the supply
      chain.
  •   Supporting multiple data carriers will multiply the costs and complexities for the
      retail pharmacies in particular.
  •   In the absence of Serialized Inference, data carriers requiring line-of-sight used
      at lower packaging levels will significantly decrease the productivity of retail
      distribution centers and pharmacies.
  •   Must have knowledge of the serialized hierarchy prior to receipt, for instance
      via an Rx ASN.
  •   Trading partners may choose to build the serialized hierarchy and/or the
      pedigree in different formats, complicating operations.
  •   Potential for throughput and inventory issues based on the combination of the
      above factors.
  •   There is a compelling need for a total supply chain impact assessment
      comparing the costs and benefits of the current options for choice of data
      carrier, particularly at the item level.

Slide 18
EPCglobal Confidential and Proprietary
                 Capabilities and Suggestions




Slide 19
EPCglobal Confidential and Proprietary
                    Capability and Suggestions
 Capability and Suggestion slides formatted as:
     Capability
       – Identifies the capabilities needed by trading partners to address
         regulatory or other requirements.

     Suggestion
       – Designed to address known US regulatory requirements.
       – Identifies key dependencies of Standards-based activities.
       – Ability to extend to other HLS Supply Chains and jurisdictions.

     Other Suggestions
       – Supplemental information.

     Rationale
       – Supporting information to understand the Team‘s thought process.

Slide 20
EPCglobal Confidential and Proprietary
                               Unique Identification:

                        Capability and Suggestions




Slide 21
EPCglobal Confidential and Proprietary
                   Capability: Unique Identification
                                  (excerpted from SB1476)
 Note: California law defines „dangerous drug‟ as a “drug that by federal or state law can be lawfully
     dispensed only on prescription or furnished pursuant to Section 4006”. [Section 4022]

 •                 ―A pedigree shall track each dangerous drug at the smallest
     [Section 4034(d)]
     package or immediate container distributed by the manufacturer,
     received and distributed by the wholesaler, and received by the pharmacy
     or another person furnishing, administering, or dispensing the dangerous
     drug.‖
       – Capability needed: identify the prescription drug at the Item level as defined in
         California law.
 •                ―…uses a unique identification number, established at the
     [Section 4034(i)]
     point of manufacture…that is uniformly used by manufacturers,
     wholesalers, and pharmacies for the pedigree of a dangerous drug.‖
       – Capabilities needed: assign a unique identification number at point of
         manufacture; uniformly use that unique identification number throughout the
         supply chain.

 Ref: http://www.leginfo.ca.gov/pub/05-06/bill/sen/sb_1451-1500/sb_1476_bill_20060929_chaptered.pdf
  or http://www.pharmacy.ca.gov/laws_regs/lawbook.pdf


Slide 22
EPCglobal Confidential and Proprietary
                     Suggestions: Unique Identification
                                              Serialization
      • Uniquely Identify – Pallets, Totes, Cases, Items.

      • Unique Identification should be based on Serialization.
            – Use current GS1 and EPCglobal serialization schemes appropriate for
              the chosen data carrier.
            – Synchronize serial numbers when using two or more data carriers:
                  • SSCC: serial number ranges are the same for both Barcode and RFID.
                  • SGTIN: serial number range for AI(21) when used as backup for SGTIN-96
                           should be limited to same range as SGTIN-96.
Answers
one
specific    – Avoid encoding of Lot Code and/or Expiry Date as an integral part of
issue;        the serial number; instead, encode this data into RFID User Memory
now           and/or into barcode Application Identifiers designed for this purpose.
resolved
      • Include backup human-readable text per GS1 standards.

      • Continue to partner with GS1 Serialization Team to define
        global solutions to meet varying serialization challenges.
     Slide 23
     EPCglobal Confidential and Proprietary
                Suggestions: Unique Identification
                                         Serialization
 • Use EPCglobal, GS1, HDMA standards and
   guidelines.
       – Follow current GS1 and EPCglobal standards for use and/or re-use of serial
         numbers (standards for SSCC, SGTIN, AI(21) Serial Numbers).
       – Companies choosing to use other standards should be prepared to work with
         their trading partners to assure interoperability.

 • See Appendices for additional suggestions on special-
   interest serialization topics:
       – Serialized Inference
         Inferring reads when less than 100% of data carriers are read.

       – NDC Masking This is NOT recommended and does not meet GS1 Stds
         Optional, interim practice to mask the Item Reference portion of the 10-digit
         NDC in RFID tags to avoid divulging product number for products with patient
         privacy concerns.
       – Barcode and RFID Co-Existence
         Synchronizing serial numbers when using two or more data carriers.
Slide 24
EPCglobal Confidential and Proprietary
                Suggestions: Unique Identification
                         Data Carriers for Serialization




Slide 25
EPCglobal Confidential and Proprietary
                   Rationale: Unique Identification

 • Unique Identification Based on Serialization
       – Serialization is the most compatible mechanism to achieve unique
         identification using existing standards and data carriers.

 • Avoid encoding of Lot and/or Expiry as an integral part of the Serial
   Number:
       – GS1 and EPCglobal standards support encoding of Lot and Expiry into
         Application Identifiers, User Memory, or other appropriate data
         structures. Current standards do not support combining these elements
         into a single string.
       – SGTIN-96 serial numbers allow only numeric values. Lot information is
         alphanumeric.
       – GS1 and EPCglobal standards require a serial number to be transacted
         as a single string and disallow parsing of data.
       – Lot and Expiry data format and data values are not standardized
         across trading partners; it would be a logistical complication for every
         trading partner to know every other trading partner‘s decode scheme.
       – Difficult to interpret a single data stream containing up to three
         separate data elements in the absence of enabling standards.

Slide 26
EPCglobal Confidential and Proprietary
                   Rationale: Unique Identification

 • Uniquely Identify – Pallets, Totes, Cases, Items
       – California legislation requires unique identification at the Item level.
       – All packaging levels transacted through the supply chain must be
         serialized (in order to maintain the linkage between the serial numbers
         and the packaging level hierarchy within the pedigree systems).

 • Suggestion to use two data carriers
       – Flexibility in data carrier selection allows building of infrastructure that
         is data carrier agnostic.
       – Mirrors the path that Consumer Goods followed for adoption;
         compatible with Consumer Goods supply chain.
       – On many products in HLS, there is insufficient space to print human-
         readable data as a backup for the RFID tag
       – A barcode used in this situation can provide redundancy.
       – Redundancy is important to:
             • Provide machine-readable backup in case of failure of the RFID tag.
             • Provide those companies without RFID capabilities a means to capture the serialized
               information via machine-readable methods.


Slide 27
EPCglobal Confidential and Proprietary
                   Rationale: Unique Identification

 • No Solid Suggestion of HF or UHF RFID for Item-Level
       – UHF Gen2 standard is available now.
       – HF Version 2 standard scheduled for 3Q2007 with tags available later.
       – Until HF standard is completed and tags can be evaluated, premature
         to make suggestion.

 • 2-D Data Matrix barcode for Item-Level
       – Provides an alternative for RFID-challenged products (e.g., liquids,
         biologics).
       – Current uncertainty in RFID Item-Level direction.
       – Effective use of available label space for small packaging.
       – Potential for compatibility with European (EFPIA) 2-D Data Matrix
         barcoding initiatives.




Slide 28
EPCglobal Confidential and Proprietary
                   Rationale: Unique Identification

 • Include human-readable text per GS1 standards and per
   recommendations on Slide 23.
       – If a Barcode data carrier is present as the sole data carrier, then human
         readable text is highly recommended as a backup.
             • If possible, include the entire human-readable text string.
             • If that is not possible, then at minimum include the serial number portion of the string
               (AI 21 or AI 00)—the GTIN can be derived from the packaging.
       – If neither of the above are possible, then omit the human-readable text.




Slide 29
EPCglobal Confidential and Proprietary
                   Rationale: Unique Identification

 • SSCC-18 barcode usage for Pallet, Tote, Case
       – Serial number portions of SSCC-18 and SSCC-96 are equivalent and
         can be easily synchronized to the same value.
       – SSCC-18 has been used in many industries for many years, including
         within HLS, to serialize various logistics units.

 • 2-D Data Matrix barcode usage for Case level
     (Use Cases #3 and #5, exception-based)
       – Necessary due to the lack of label space on some smaller cases—the
         GS1 Code 128 equivalent barcode would be below minimum GS1
         specifications or physically would not fit.
       – Usage of 2-D Data Matrix barcodes encoding on Cases should be
         minimized in Healthcare supply chain
             • There are few image scanners to read these barcodes
             • There are no GS1 standards to support SSCC data encoded into Data Matrix at this
               time.




Slide 30
EPCglobal Confidential and Proprietary
                                         Pedigree:

                        Capability and Suggestions




Slide 31
EPCglobal Confidential and Proprietary
                                Capability: Pedigree
                               (paraphrased from SB1476)
 Summary of key language; NOT to be used as a substitute for the actual legislation.

 •   Means a Record, in Electronic Form,
       –   Containing information regarding each transaction
       –   Resulting in a change in ownership
       –   From sale by manufacturer until final sale to a pharmacy or other dispense point.
       –   Includes all information required by law

 •   Created / Maintained in an Interoperable Electronic System
       –   Contained within a standardized non-proprietary data format and architecture
       –   Uniformly used by manufacturers, wholesalers, pharmacies for the pedigree
       –   Ensuring compatibility throughout all stages of distribution

 •   Tracked at the Smallest Packaging Level (see Serialization Suggestions)
 •   Certifying that the Pedigree Information is True and Correct
       – From a Responsible Party of the source
       – Under penalty of perjury

 •   Returns documented on same Pedigree as the receipt transaction
 Ref: http://www.leginfo.ca.gov/pub/05-06/bill/sen/sb_1451-1500/sb_1476_bill_20060929_chaptered.pdf
  or http://www.pharmacy.ca.gov/laws_regs/lawbook.pdf
Slide 32
EPCglobal Confidential and Proprietary
                             Suggestions: Pedigree

 • There are two Options to provide a Pedigree:
       – Option 1 – Drug Pedigree Messaging Standard
       – Option 2 –Track and Trace

 • Drug Pedigree Messaging Standard available now.
       – Software available today with EPCglobal certifications.
                                                              Update:
 • Track and Trace in Requirements phase now.                 Global Traceability
                                                              Standard entering
       – Standards will follow at a later date.
                                                              standards approval
       – Then software will be available.
                                                              process
 • Further suggestions for choosing an Option cannot be
   provided until the following is completed for Track and Trace:
       – Requirements
       – Standards
       – Software designed and available which meets Standards
Slide 33
EPCglobal Confidential and Proprietary
                                  Rationale: Pedigree
          At this time, the California Board of Pharmacy has no preference for either Option presented
          below, and the use of the terms ‗track and trace‘ in the California SB1476 legislation is not
          intended to emphasize or endorse any particular option or technology.
          [Feedback from EPCglobal Pedigree Meeting with California Board of Pharmacy, Mar. 8, 2007]

 • Drug Pedigree Messaging Standard
       – The California Board of Pharmacy believes the standard meets
         California‘s electronic pedigree requirements.
       – However, additional work and amplification by the California
         BOP and Industry may be needed.
       – In some cases, California regulations may be necessary to
         provide the necessary amplification.

 • Track and Trace
       – Being designed with flexibility to accommodate known
         requirements from California and other jurisdictions.
       – As with Option 1, additional work and amplification may need to
         be done by the California BOP, other jurisdictions, and Industry.
         In some cases regulations may be necessary to provide the
         necessary amplification.
Slide 34
EPCglobal Confidential and Proprietary
                                 Rationale: Pedigree

 • Interoperability between systems based on Pedigree
   Messaging Standard or Track and Trace must be
   addressed to prevent supply chain and pedigree
   disruptions.
       – It is likely that both Pedigree Messaging Standard and Track /
         Trace will co-exist within the supply chain.
       – Therefore, any pedigree initiated under either approach must be
         interoperable with both approaches for forward- and reverse-
         logistics.
       – The following groups are tasked with documenting these
          requirements for inclusion into their work products / deliverables.
             • EPCglobal Track and Trace Interest Group
             • EPCglobal Supply Chain Integrity Joint Requirements Group
             • GS1 Traceability in Healthcare Work Group



Slide 35
EPCglobal Confidential and Proprietary
                                 Rationale: Pedigree

 • Trading Partner coordination when a pedigree solution
   is implemented or changed will be necessary.
       – It is likely that trading partners will have some level of effort to complete
         in order to use the information from a new pedigree solution.
       – Sufficient leadtime for trading partners to react should be planned and
         built into the implementation timelines.
       – Closely coordinating these types of changes should minimize problems
         for all parties.
       – Hierarchical shipment data including serial numbers and shipping
         information must be communicated in advance to the customer (e.g.,
         via pedigree, Rx ASN, Track and Trace or EPCIS transaction).




Slide 36
EPCglobal Confidential and Proprietary
                                 Rationale: Pedigree

 • Rx ASN (modified EDI Transaction Set 856, Advance Ship Notice)
   does not meet California requirements for pedigree.
       – Cannot support ‗certification under penalty of perjury‘.
       – Does not exist in an ‗interoperable electronic system widely used…‘
       – Does not meet requirement for ‗manufacturer-initiated pedigree‘.

 • Rx ASN‘s could be used to facilitate supply chain transactions
   (receipts, shipments, etc.).
       – ASN‘s support efficient receiving practices.
       – Use of ASN‘s will not meet pedigree obligations for jurisdictions
         requiring the pedigree in an ‗interoperable electronic system‘.




Slide 37
EPCglobal Confidential and Proprietary
                                         Action Steps




Slide 38
EPCglobal Confidential and Proprietary
                          Action Steps Overview
 • This section expands upon the ‗Begin Vendor & Industry
   Adoption‘ activity (see Slide 41).
 • The reader will find resources available to facilitate
   implementation and adoption activities.
 • Additional details can be found in the EPCglobal
   Cookbook (referenced in a following slide).




Slide 39
EPCglobal Confidential and Proprietary
               Status of Standards and Related Work
                                                                                                                 Requirements Dev.                                                                                                                                          Standards Development
                                              6                             6   0                                            4                5                          10                            1                                 4                     16                     12                                                     6                                                  4                                         4
    Updated: July 13, 2007                   wks                           wks wks                                          wks              wks                         wks                          wks                               wks                    wks                    wks                                                   wks                                                wks                                       wks




                                                                                                                                                                                                                                                                                                                                                                                               BSC/TSC Review of Recommended
                                                                                                                                                                                                                                                                                      Prototype Test of Proposed Spec.
6




                                                                                                                                                                                                                                                                                                                                            WG Review & Approve Candidate
        Tag Data Standards




                                                                                                                                                                                                      BSC/TSC Approval of EU Rqmts




                                                                                                                                                                                                                                                                                                                                                                                                                               Board Ratification of Standard
                                                                                                Collect Business Requests


                                                                                                                                           Define Technical Rgmts w/EU

                                                                                                                                                                         Develop EU Technical Rqmts




                                                                                                                                                                                                                                                                                                                                                                                                                                                                Vendor & Industry Adoption
                                                                                                                                                                                                                                     Technical WG Formation

                                                                                                                                                                                                                                                              Standards Development
                                             IAG Business Case Dev.
                                                                      IAG Business Rqmts Dev.
5




                                                                                                                                                                                                                                                                                                                                                                            30 DAY IP Review
          Track & Trace




                                                                                                                                                                                                                                                                                                                         30 DAY IP Review
                                                                                                                            Form WG/ JRG
4
                                  Security

      Supply Chain Integrity
                                  Privacy



3          Serialization


2       Item Level Tagging


1   Drug Pedigree Messaging Std


                                             IAG WG                                                                         IAG WG/JRG                                                                                                                                                                         TAG WG
    Legend:                              3 Months                                                                              5 Months                                                                                                                                                                 10 Months
         Previous Progress
         Since March 2007
     Slide 40
     EPCglobal Confidential and Proprietary
              Begin Vendor and Industry Adoption
                   (Activities may or may not be in parallel)
             EPCglobal Post-Ratification Activities

Ratified                                                        Test and         Certified
Standard                             Create         Create                       Software or
              Create Test                                        Certify
~~~~~                                 Test           Test       Software
                                                                                 Hardware
                Scripts
~~~~~                                Platform      Guidelines or Hardware        ~~~~~
                                                                                 ~~~~~



     Vendor and Industry Adoption Activities


                               Process                                          Scale up
            Capital                              System       Infrastructure
                                 Re-                                               &
           Planning                             Integration   Build-Out
                             Engineering                                       Implement


    Slide 41
    EPCglobal Confidential and Proprietary
            Key Standards and Other Resources

 • EPCglobal
       –   Standards are available at: http://www.epcglobalinc.org/standards/
       –   Drug Pedigree Messaging Standard
       –   Tag Data Standard
       –   Item Level Tagging Requirements Document
       –   Gen2 Standard
       –   EPCIS Standard
       –   Track and Trace Interest Group Requirements (opt-in required)
           http://www.epcglobalinc.org/apps/org/workgroup/hls_t_t_ig/index.php
       – EPCglobal Cookbook
             • Provides information on how to phase implementations, activities required,
               sequencing of activities, development of KPI‘s and metrics, among other
               useful topics.
                http://www.epcglobalinc.org/what/cookbook


Slide 42
EPCglobal Confidential and Proprietary
            Key Standards and Other Resources

 • GS1
       – GS1 General Specifications (via your GS1 Member Organization)
          http://www.gs1.org/productssolutions/barcodes/technical/genspecs/

       – GS1 Serialization Team Requirements
         (work in progress; join at http://www.gs1.org/hug/Membership/ )

       – GS1 GTIN Allocation Rules for Healthcare
          (http://www.gs1.org/docs/gsmp/HUG/HUG_GTIN_Allocation_i4.6.pdf )

 • FDA
       – FDA Compliance Policy Guide, ―Radiofrequency Identification
         Feasibility Studies and Pilot Programs for Drugs‖, Nov. 2004
          http://www.fda.gov/oc/initiatives/counterfeit/rfid_cpg.html

       – FDA Counterfeit Drug Task Force Report: 2006 Update, Jun. 2006
          http://www.fda.gov/oc/initiatives/counterfeit/report6_06.pdf




Slide 43
EPCglobal Confidential and Proprietary
            Key Standards and Other Resources

 • HDMA
       – ―Guidelines for Barcoding in the Pharmaceutical Supply Chain‖,
         December 2005 edition (available for purchase only)
          http://web1.hdma.net/shop/cgi-bin/shopper.exe?preadd=action&key=PUBS261




Slide 44
EPCglobal Confidential and Proprietary
                                         Action Steps
  Typical Activities For All Trading Partners
  • Engage with your Industry Trade Associations to ensure you have
    the most current information regarding policy and positions.
  • Work with EPCglobal and GS1 groups to obtain standards,
    education, and to learn from others.
  • Choose Serialization data carriers for every packaging level. (see
    Slide 23)
  • Choose Pedigree Option and software. (see Slide 31)
  • Develop scale-up and rollout-plans for Serialization and Pedigree
    (e.g., based on SKU counts or geographical rollout).
  • Work with all affected trading partners with sufficient leadtime on
    Serialization and Pedigree choices and options to facilitate efficient
    supply chain operations.
        – See EPCglobal Public Policy Guidelines for Healthcare Industry.
  • Convert operations to apply, commission and aggregate serial
    numbers.
Slide 45
EPCglobal Confidential and Proprietary
                                         Action Steps
  Typical Activities For All Trading Partners
  • Develop, implement, and adhere to effective Privacy standards to
    ensure appropriate use of these technologies.
  • Install capability to transact serial numbers and serialized
    pedigrees—based on specific local regulatory requirements.
  • Test serialized pedigree + serialized product final configurations
    with trading partners.
  • Start shipping serialized and pedigreed products.
        – Pallet, Tote, Case, Item Serialization.
        – Transact a manufacturer-initiated pedigree.
        – With sufficient lead time to load the supply chain with serialized products
          supported by a pedigree.
  • Execute your Scale-Up / Rollout Plans.
  • Retain Pedigree data according to regulatory data retention
    requirements.
  • Respond to requests for verification of Pedigree data.

Slide 46
EPCglobal Confidential and Proprietary
                                  Summary
                                    and
                               Recommendations




Slide 47
EPCglobal Confidential and Proprietary
                                         Summary
 • The Industry Adoption Task Force has taken the lead in
   synthesizing available material into a coherent, forward-looking
   Roadmap which can be used by industry trade associations as a
   starting point in their discussions with their members.

 • The Roadmap describes suggestions to meet the two Key
   Capabilities in a balanced yet effective manner.
       – Pedigree
       – Unique Identification

 • The Roadmap provides direction to help reconcile the varied
   interests of the diverse set of stakeholders toward common
   solutions.

 • Providing trading partners with agreed-upon standards and
   suggestions for actions reduces complexity, barriers to adoption,
   and lowers overall costs for all participants.

Slide 48
EPCglobal Confidential and Proprietary
                               Recommendations
• EPCglobal Work Teams
      – Work with US Drug Enforcement Agency to resolve remaining
        questions. [HLS Tri-Chairs / Co-Chairs]
      – Ensure that the EPCglobal HLS Track and Trace and Supply Chain
        Integrity JRG groups address interoperability of Pedigree Options 1
        and 2. [HLS Tri-Chairs / Co-Chairs and the two work groups]
      – Work with industry to finalize User Memory requirements for HLS. [HLS
        Tri-Chairs / Co-Chairs and all HLS work groups]




Slide 49
EPCglobal Confidential and Proprietary
                               Recommendations
• GS1 Global Office
      – Enable interoperability of GS1 and EPCglobal data carriers to
        common URN (Universal Resource Name) or equivalent.
            • Common software translation is required to ensure consistency of data captured
              and stored within EPCIS network architectures
            • Interoperability between trading partners accessing shared data bases
            • Handling of GS1 Company Prefix in EPCIS when using a barcode—there is no
              ‗dot‘ separator character as with an RFID data structure to delimit the variable-
              length GS1 Company Prefix

      – Work with the various regulatory jurisdictions to resolve conflicting
        requirements for serialization and item identification (EFPIA, Japan,
        Belgium, Italy, California, France, others). Focus on EFPIA and US
        harmonization as a first priority.
      – GS1 and EPCglobal to address remaining privacy concerns which will
        mitigate the need for NDC Masking practices for RFID data carriers.
      – Continue support of the GDSN Healthcare Work Team to adapt and/or
        extend GDSN to support serialization and/or pedigree suggestions
        presented in the Roadmap.
Slide 50
EPCglobal Confidential and Proprietary
                               Recommendations
• GS1 Global Office
      – Work with industry and EDI standards groups to include flags in
        the ASN (or Rx ASN) structure indicating which data carrier
        contains the serialized information (e.g., RFID or Barcode).
      – Work with industry and EDI standards groups to prepare a
        standard for Rx ASN transaction set, including that Rx ASN
        should be considered as the means to exchange the serialized
        numbers and the serialized hierarchy between trading partners.
      – Commission a study comparing UHF, HF, 2-D Data Matrix
        solutions (with and without Serialized Inference), to determine
        potential cost-effectiveness for each supply chain partner type.
            • Supporting data needed for trading partners to decide on unique
              identification.
            • Suggest study by Academic University, MIT Auto-ID, or independent
              group.
            • Initial work by MIT can be found at:
               http://autoidlabs.org/single-view/dir/article/6/221/page.html
Slide 51
EPCglobal Confidential and Proprietary
                               Recommendations
• FDA
      – Provide test results to industry regarding impact of RF energy
        on Biologics, at minimum on UHF and HF frequency ranges.
         -Initial testing for worst-case heating induced electric fields found at
            (http://www.rfidjournal.com/whitepapers/download/77)

           -PQRI Paper describing test protocol and initial results:
            (http://www.pqri.org/pdfs/RFID_Report_to_FDA_23Mar2006.pdf)

      – Determine next steps for Compliance Policy Guide,
        ―Radiofrequency Identification Feasibility Studies and Pilot
        Programs for Drugs‖, Nov. 2004.
        Document expires on 31-Dec-2007.




Slide 52
EPCglobal Confidential and Proprietary
                               Recommendations
• FDA
      – Work with industry to establish an on-going forum for discussion
        and joint resolution of questions.
      – Need FDA guidance on what prevailing controls apply to
        serialization (for example, is this GMP-related or subject to other
        controls).
      – Need FDA guidance on standardized language or symbology
        indicating the presence of an RFID tag on a pharmaceutical
        product.
      – Assess impacts of Proposed Rule to change NDC numbering
        scheme and process to allocate the NDC‘s on SGTIN, GTIN,
        Pedigree, Track and Trace, and other key elements of this
        Roadmap.
      – Need FDA guidance on regulatory filings required to apply RFID
        at item-level over the long-term (current CPG addresses pilot
        activities only, and does not include liquids or biologics).

Slide 53
EPCglobal Confidential and Proprietary
                               Recommendations
•     FDA
      – Need FDA guidance on protecting Biologic products from
        exposure to RF energy in RFID-enabled supply chains.
        Example: re-directing those products to avoid RFID tunnels,
        turning off RFID reader when Biologic products present in a
        reader field, etc.
      – FDA Barcode Regulation may need to be updated to allow:
            •   2-D Data Matrix as alternative to linear barcode.
            •   FDA did confirm with the IATF that there is no barrier to encoding a serial
                number into the existing linear barcode, or applying an additional 2-D Data
                Matrix barcode for serialization, so long as:
                  –    It does not affect readability of the NDC number encoded in the barcode.
                  –    It does not cause the product to be misbranded.




Slide 54
EPCglobal Confidential and Proprietary
                               Recommendations
 • HDMA
       – Update the HDMA Barcode Guidelines document with the
         following suggestions; provides consistency to a widely-used
         industry based document:
             • To reflect the RFID and barcode recommendations in this Roadmap.
             • To harmonize requirements with current GS1 and EPCglobal
               standards, where there are meaningful differences.




Slide 55
EPCglobal Confidential and Proprietary
                               Recommendations
 • Industry Trade Associations
       – Educate membership on standards and available resources.
       – Work with membership to develop positions and policy regarding
         adoption.
       – Work with other Trade Associations to review policy, positions,
         regulatory issues and/or guidance to minimize supply chain disruptions.
       – Engage additional participation from Generic, Biological, Secondary
         Wholesaler industry trade associations and their members.
       – Work with key regulatory bodies on education and outreach;
         communicate adoption policy and positions; identify areas for
         regulatory clarification and/or guidance.
       – Work with GS1 and EPCglobal to globally harmonize requirements.
       – Actively engage with EPCglobal regarding standards.
       – Provide guidance to members on methods for prioritizing efforts.




Slide 56
EPCglobal Confidential and Proprietary
Appendices
                                         Appendix 1
                     Suggestions: Serialized Inference
 Business Problem:
 • California SB1476 at Section 4034(b)(3) requires the ―name and address of
   each person certifying delivery or receipt‖.
 • This ‗certification‘ of item-level serial numbers presents new challenges:
       –   Line of sight technology would result in opening every case and scanning every item within,
           since the item serial numbers are not visible.
       –   Non-line of sight technology, if less than 100% of the items were read, would result in
           opening every case and scanning every item within.
       –   Opening cases at time of receipt introduces new risks, is time-consuming, and adds costs
           into supply chain operations.

 One Potential Suggestion:
 • Inference is one of many mechanisms to enable trading partners to
   leverage strong supply chain practices to meet these challenges.
 • Adoption of any solution to these challenges remains an individual
   company decision.
 • The California BOP has scheduled working sessions with industry to better
   understand these challenges. Regulatory guidance may result from these
   working sessions.

Slide 58
EPCglobal Confidential and Proprietary
                                         Appendix 1
          Suggestions: Serialized Inference Definitions
 • Infer (Inference): Conclude from evidence (Webster‘s Dictionary).

 • Working Definition: To infer the serialized number based on
   information provided by the upstream supply chain, reasonable
   inspection of the product, and application of the Serialized
   Inference Rule by the Shipping and Receiving partners.

 • Serialized Inference Rule: The process a supply chain partner
   uses to ensure there is enough evidence to infer the serialized
   number without physically reading ALL serialized numbers. A
   Serialized Inference Rule should be defined for each packaging
   unit (e.g., pallet, case, item, etc.) for the key process steps of
   Commission/Aggregation, Ship, and Receipt.
      Enhance Patient Safety in the supply chain by allowing supply chain partners
      to leverage the good business practices initiated by manufacturers which are
      then continued through the supply chain by downstream trading partners.

Slide 59
EPCglobal Confidential and Proprietary
                                         Appendix 1
                Suggestions: Serialized Inference
  Assumes that each Trading Partner follows good business
    practices, such as:
  • Good manufacturing and good distribution practices.
  • Documented controls and Standard Operating Procedures.
  • Captures quality metrics to minimize ―defects‖ of inbound
    and outbound product.
  • When process errors are detected, implements changes to
    those processes to prevent future errors.
  • Processes are periodically reviewed for improvement
    opportunities.




Slide 60
EPCglobal Confidential and Proprietary
                                         Appendix 1
                Suggestions: Serialized Inference
 To summarize, Serialized Inference is possible when the following conditions
    have been achieved:

 •   A collection (item, full or mixed case, tote, pallet, etc.) is present.
 •   The collection is identified with a unique serial number, and each member
     of the collection (item, case, tote, pallet) is also identified with a unique
     serial number.
 •   The receiving trading partner receives an electronic communication
     containing the serialized numbers and the hierarchical relationship of those
     serialized numbers within the collection.
 •   The receiving trading partner must have assurance that the collection has
     remained intact since leaving the last trading partner.
       –   If the receiving trading partner has reason to believe that the collection has not remained
           intact since leaving the last trading partner, then inference should not be used.


        These inference suggestions are intended to provide each trading partner with an
        understanding of how inference can be used by all the various supply chain
        participants. The application of inference remains an individual business decision.

Slide 61
EPCglobal Confidential and Proprietary
                                         Appendix 1
                Suggestions: Serialized Inference
                                             Designed for transactions between trading
  Serialized Inference Scenarios:            partners, however can be applied to intra-
  •   Single Item Commission                 company transactions as well.
       – Apply serial number to one single Item.
  •   Item into Case Commission/Aggregation
        – Apply serial number to Case and build item-to-case hierarchy.
  •   Case to Pallet Commission/Aggregation
       – Apply serial number to a homogenous pallet comprised of Cases of all one
         product and build case-to-pallet hierarchy.
       – May be a full pallet or a partial pallet.
  •   Tote or Mixed Case Commission/Aggregation
       – Apply serial number to Case or Tote containing either a mixture of SKU‘s or
          1 or more items of a single SKU, and build item-to-case hierarchy. Typically
          conducted as part of a pick/pack/ship operation.
  •   Mixed Pallet Commission/Aggregation
       – Apply serial number to Pallet of mixed Cases or Totes, and build case-to-
          pallet or tote-to-pallet hierarchy. Pallet could contain mixed cases and/or full
          cases. The full cases could be from one product or from multiple products.
Slide 62
EPCglobal Confidential and Proprietary
                                         Appendix 1
                Suggestions: Serialized Inference
                                                 Designed for transactions between trading
  Serialized Inference Scenarios:                partners, however can be applied to intra-
                                                 company transactions as well.
  •    Shipments
        – Single Item Shipment (one single item shipped)
        – Case Shipment (all one item)
        – Tote or Mixed Case Shipment (One or more items or mixed items,
             typically part of a pick/pack/ship operation)
        – Pallet Shipment (all one item on a pallet)
        – Mixed Pallet Shipment (mixed items on a pallet)

  •    Receipts
        – Single Item Receipt (one single item received)
        – Case Receipt (all one item)
        – Tote or Mixed Case Receipt (One or more items or mixed items,
              typically conducted as part of a pick/pack/ship operation)
        – Pallet Receipt (all one item on a pallet)
        – Mixed Pallet Receipt (mixed items on a pallet)

      Shipments and Receipts of pallet, case, mixed case, and tote assumes the hierarchy
      and packaging integrity remained intact from the Commission/Aggregation process.

Slide 63
EPCglobal Confidential and Proprietary
                                             Appendix 1
                               Serialized Inference Rules:
                                Commission/Aggregation
Use Case Scenario                    Manufacturer      Wholesaler      Retailer DC   Pharmacy
                                      Inference        Inference        Inference    Inference
Single Item Commission                    Read - I        NA               NA             NA

Item into Case                            Read - I        NA               NA             NA
Commission/Aggregation
Case to Pallet                            Read - C        NA               NA             NA
Commission/Aggregation                     Infer - I

Tote or Mixed Case                        Read - I      Read -I            NA             NA
Commission/Aggregation
Mixed Pallet                          Read – C,T       Read - C,T          NA             NA
Commission/Aggregation                 Infer - I        Infer - I
                                                                                  Assumes
Key: ―P‖ Pallet      ―C‖ Case ―T‖ Tote or Mixed Case       ―I‖- Item             Aggregation
                                                                                has Occurred




 Slide 64
 EPCglobal Confidential and Proprietary
                                            Appendix 1
                  Serialized Inference Rules: Shipments
Use Case Scenario                    Manufacturer        Wholesaler         Retailer DC   Pharmacy
                                      Inference          Inference           Inference    Inference
Single Item Shipment                       Read - I         Read - I            NA             NA

Case Shipment                             Read - C         Read - C             NA             NA
                                           Infer - I        Infer - I
Tote or Mixed Case Shipment               Read - C,T      Read - C,T            NA             NA
                                           Infer - I       Infer - I
Pallet Shipment                            Read - P        Read - P             NA             NA
                                          Infer - C, I     Infer -C, I

Mixed Pallet Shipment                   Read - P           Read - P             NA             NA
                                      Infer - C, T, I    Infer - C, T, I,

Key: ―P‖ Pallet      ―C‖ Case ―T‖ Tote or Mixed Case            ―I‖- Item               Assumes
                                                                                       Aggregation
                                                                                      has Occurred




 Slide 65
 EPCglobal Confidential and Proprietary
                                            Appendix 1
                    Serialized Inference Rules: Receipts
Use Case Scenario                     Manufacturer        Wholesaler       Retailer DC        Pharmacy
                                       Inference          Inference         Inference         Inference
Single Item Receipt                         Read - I        Read - I         Read - I           Read - I

Case Receipt                               Read - C        Read - C         Read - C           Read - C
                                            Infer - I       Infer - I        Infer - I          Infer - I
Tote or Mixed Case Receipt                Read - C,T      Read - C,T       Read - C,T         Read - C,T
                                           Infer - I       Infer - I        Infer - I          Infer - I

Pallet Receipt                             Read – P        Read - P         Read - P               NA
                                           Infer - C,I     Infer - C,I      Infer - C,I
Mixed Pallet Receipt                       Read – P         Read - P         Read - P              NA
                                          Infer – C,T,I   Infer – C,T,I    Infer – C,T,I
                                                                                            Assumes
Key: ―P‖ Pallet      ―C‖ Case ―T‖ Tote or Mixed Case           ―I‖- Item                   Aggregation
                                                                                          has Occurred




 Slide 66
 EPCglobal Confidential and Proprietary
                                             Appendix 1
                         Serialized Inference Rules:
                     Recalls, Returns, Reverse Logistics
Use Case Scenario                     Manufacturer        Wholesaler       Retailer DC        Pharmacy
                                       Inference          Inference         Inference         Inference
Single Item Receipt/Shipment               Read - I        Read - I         Read - I            Read - I


Case Receipt/Shipment                      Read - C        Read - C         Read - C           Read - C
                                            Infer - I       Infer - I        Infer - I          Infer - I

Tote or Mixed Case                        Read - C,T      Read - C,T       Read - C,T         Read - C,T
  Receipt/Shipment                         Infer - I       Infer - I        Infer - I          Infer - I

Pallet Receipt/Shipment                    Read - P        Read - P         Read - P               NA
                                           Infer - C,I     Infer - C,I      Infer - C,I
Mixed Pallet Receipt/Shipment              Read - P        Read - P         Read - P               NA
                                          Infer - C,T,I   Infer - C,T,I    Infer - C,T,I

Key: ―P‖ Pallet      ―C‖ Case ―T‖ Tote or Mixed Case           ―I‖- Item                    Assumes
                                                                                           Aggregation
                                                                                          has Occurred



 Slide 67
 EPCglobal Confidential and Proprietary
                                            Appendix 1
                  Serialized Inference Rules: Repacking
Use Case Scenario                         Aggregation     Shipping          Receiving
                                           Inference      Inference         Inference
Single Item                                 Read - I          NA                NA

Case                                        Read - I      Read – C          Read – C
                                                           Infer – I         Infer - I

Tote or Mixed Case                          Read - I     Read – C,T         Read – C,T
                                                          Infer - I          Infer - I
Pallet                                     Read - C       Read - P           Read - P
                                            Infer - I     Infer - C,I        Infer - C,I
Mixed Pallet                              Read - C,T      Read - P           Read - P
                                           Infer - I     Infer - C,T,I      Infer - C,T,I

Key: ―P‖ Pallet       ―C‖ Case ―T‖ Tote or Mixed Case           ―I‖- Item                    Assumes
                                                                                            Aggregation
                                                                                           has Occurred
            Assumes repackers will receive serialized product, then serialize
            outbound product, and retain the linkage between inbound and
            outbound serial numbers (if different or changed).
 Slide 68
 EPCglobal Confidential and Proprietary
                                         Appendix 2
                        Suggestions: NDC Masking
 • NDC Masking is an optional, interim method to address privacy
   concerns until a fully ratified GS1 and/or EPCglobal numbering and
   serialization standard or guideline is available.
 • This method applies only to RFID and other technologies that do
   not rely on line-of-sight scanning.
       – NDC Masking does not apply to barcodes.
 • Also consider that NDC Masking may alert others that this product
   is ‗sensitive‘ and therefore may draw unwanted additional attention.
 • Process to mask an NDC in the SGTIN format:
       – Set the Item Reference equal to all zeros.
       – Ensure for all items using a masked NDC that the serial numbers are unique
         across all of those product SKU‘s within a single GS1 Company Prefix (the Item
         Reference is no longer part of the key since it equals all zeros for those
         products).
       – All other elements of the SGTIN remain unchanged.
       – An example is shown on the following slide.
NOTE:
NDC Masking is NOT recommended practice and does not comply with GS1
standards. This slide recognizes that the practice does occur and seeks to
avoid multiple methods in deploying the practice
Slide 69
EPCglobal Confidential and Proprietary
                                         Appendix 2
                        Suggestions: NDC Masking
 Illustration of NDC Masking at the Item Level
                                         GS1 Company
                                         Prefix
  Data Format                Indicator   Country Labeler   Item Reference
                             Digit
                                         Code    Code
  NDC                        ------      -------- 0001       1234 98
  GTIN                       0           03      0001        1234 98 3
  SGTIN                      ------      03      0001      0 1234 98 _
                                                                                    Check
                                                                                 Digit Omitted
  mSGTIN                     ------      03      0001      0 0000 00 _
  (masked NDC)                                             (Item Reference = zeros)
                                        This is NOT recommended and does not meet GS1 Stds
         Notes:
         a. Packaging Level Indicator changes position in SGTIN.
         b. Check Digit is omitted in SGTIN.
Slide 70
EPCglobal Confidential and Proprietary
                                         Appendix 3
         Suggestions: RFID and Barcode Co-Existence
 Why Suggestions are Needed:
 • To avoid the assignment of more than one unique serial number on
   a single packaging level, when multiple data carriers are used.
 • Tracking more than one unique serial number on a single
   packaging level creates unnecessary complications and increases
   the chances for errors by all trading partners.
 • There are differences in the serialization schema in the various
   standards which must be understood to ensure that the serial
   numbers are synchronized across the data carriers.
 • Emphasize that information systems must be capable of handling
   the entire 20-digit alphanumeric AI(21) serial number range.
       – This range will be encountered in AI(21) barcode applications today.
       – When SGTIN-198 is adopted, will encounter this range for RFID as
         well.
 • Shows placement of AI(21) barcode in similar location as SSCC-18
   barcode would have been placed to facilitate physical handling.
                                         Update:
Slide 71                                 Parsing is the main barrier to coexistence and is being
EPCglobal Confidential and Proprietary   resolved
                                                      Appendix 3
              Suggestions: RFID and Barcode Co-Existence
               Note: Data is for illustration only; see GS1 Standards for usage
                          SSCC-96                                                 SGTIN-96
                  030001.5 1234567890                             030001. 2 123498. 123456789012
   RFID




               EPC Mgr ID           Extension Digit (5)          EPC Mgr ID                           Serial Number
                                    +Serial Number                              Indicator Digit (2)
                                                                                +Item Reference

                          SSCC-18                                       AI(01)                           AI(21)
   Barcodes




              (00)5 030001 1234567890 3                     (01) 2 030001 123498 7 (21)123456789012
              Extension Digit (5)       Serial Number         Indicator Digit (2)                          Serial Number
              +EPC Mgr ID               + Check Digit (3)     +EPC Mgr ID         Item Reference
                                                                                  + Check Digit (7)



                      This table is intended to illustrate synchronizing serial
                      numbers between RFID and Barcode data carriers. It is
                      NOT intended as guidance on choosing data carriers.


Slide 72
EPCglobal Confidential and Proprietary
                                         Appendix 3
         Suggestions: RFID and Barcode Co-Existence
      Single-SKU Case with AI(21)                     Mixed Case/Tote/Pallet with SSCC




                                         Std. Placement

       RFID Tags shown are for illustration and do not imply an endorsement of any particular supplier.
Slide 73
EPCglobal Confidential and Proprietary
                                         Appendix 3
         Suggestions: RFID and Barcode Co-Existence

      Item-Level Label with SGTIN-96 RFID Tag + Data Matrix Barcode




  RFID Tags shown are for illustration and do not imply an endorsement of any particular supplier.



Slide 74
EPCglobal Confidential and Proprietary
                                         Appendix 3
         Suggestions: RFID and Barcode Co-Existence
 • AI(00) SSCC (Serialized Shipping Container Code)
       – The RFID and Barcode SSCC serial number ranges are
         compatible in current GS1 and EPCglobal standards.
       – Suggestion: When both RFID and Barcodes are used for SSCC
         serialization on a single packaging level, synchronize the SSCC
         serial numbers (both serial numbers equal).




Slide 75
EPCglobal Confidential and Proprietary
                                         Appendix 3
         Suggestions: RFID and Barcode Co-Existence
 • AI(21) Serial Number as Backup for RFID SGTIN
       – AI(21) serial number range is 20 digits alphanumeric.
       – SGTIN-96 serial number range is limited to:
             • 0 through 274,877,906,943 (inclusive), numeric-only, no leading zeros
               allowed (unless the entire serial number consists of a single zero).
             • This limitation is resolved with SGTIN-198, which encodes the full range of
               AI(21) values.
       – Suggestion: When AI(21) is used as a backup for SGTIN-96
         serial numbers:
             • Synchronize the RFID and Barcode serial numbers (both serial numbers
               equal).
             • This is accomplished by limiting the range of the AI(21) serial numbers to
               correspond with the SGTIN-96 range in this particular situation.
       – Suggestion: When AI(21) is used without RFID tag, the full
         range of 20-digit alphanumeric values may be used.


Slide 76
EPCglobal Confidential and Proprietary
                                         Appendix 4
                                         Definitions
 • AI (Application Identifier)
       – The field of two or more characters at the beginning of an Element
         String that uniquely defines its format and meaning. (adopted from GS1
         General Specifications, v7.1)
       – Commonly used AI‘s in healthcare include:
             •   AI(00) SSCC
             •   AI(01) GTIN
             •   AI(10) Lot/Batch
             •   AI(17) Expiry
             •   AI(21) Serial Number
             •   AI(30) Quantity




Slide 77
EPCglobal Confidential and Proprietary
                                         Appendix 4
                                         Definitions
 • ASN (Advance Ship Notice)
       – Advanced Shipping Notice. This is a type of EDI transaction
         (transaction code 856). The ASN contains information regarding a
         specific shipment of product from a seller to a buyer and is transmitted
         prior to the arrival of the shipment. The fields, data and level of
         granularity (shipment, pallet, case, etc.) is determined by the trading
         partners. (adopted from Drug Pedigree Messaging Ratified Standard,
         V1.0)
 • Data Matrix Barcode (for serialization)
       – A standalone, two-dimensional matrix symbology that is made up of
         square modules arranged within a perimeter finder pattern. Data Matrix
         ISO version ECC 200 is the only version that supports GS1 System
         identification numbers, including Function Code 1. Data Matrix Symbols
         are read by two-dimensional imaging scanners or vision systems.
         (adopted from GS1 US Glossary, v6.0)




Slide 78
EPCglobal Confidential and Proprietary
                                         Appendix 4
                                         Definitions
 • Drug Pedigree
       – A record of each distribution of a prescription drug from the sale by a
         Manufacturer through acquisition and sale by any Wholesale Distributor
         until final sale to a Pharmacy or other authorized person administering
         or dispensing the Prescription Drug. (adopted from Drug Pedigree
         Messaging Ratified Standard, V1.0)
 • ECC200
       – Data Matrix ISO version ECC 200. See Data Matrix Barcode definition.
 • EDI
       – Electronic Data Interchange
 • Electronic Pedigree
       – An electronic record containing all data and information required by one
         or more pedigree laws including the necessary certifications. (adopted
         from Drug Pedigree Messaging Ratified Standard, V1.0)


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                                         Appendix 4
                                         Definitions
 • EPC (Electronic Product Code)
       – An identification scheme for universally identifying physical objects
         (e.g. trade items, assets, and locations) via RFID tags and other
         means. The standardized EPC data consists of an EPC (or EPC
         Identifier) that uniquely identifies an individual object, as well as an
         optional Filter Value when judged to be necessary to enable effective
         and efficient reading of the EPC tags. (adopted from GS1 General
         Specifications, v7.1)
 • Gen2 (Generation 2)
       – Refers to EPCglobal Class 1 (base class) passive-backscatter, radio-
         frequency identification (RFID) system operating in the UHF 860 MHz –
         960 MHz frequency range. (adopted from EPCglobal Gen2 Standard,
         Version 1.0.9).
 • GTIN (Global Trade Item Number)
       – The GS1 Identification Key used to identify trade items. The key is
         comprised of a GS1 or U.P.C. Company Prefix followed by an Item
         Reference Number and a Check Digit. (adopted from GS1 General
         Specifications, v7.1)

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                                         Appendix 4
                                         Definitions
 • HF (High Frequency)
       – Refers to current ISO or future EPCglobal radio-frequency identification
         (RFID) system operating in the HF 3 MHz – 30 MHz frequency range,
         typically at 13.56 MHz for HLS applications. (IATF Definition).
 • HLS
       – Health and Life Sciences industry. (IATF Definition)
 • IATF
       – EPCglobal HLS Industry Adoption Task Force. (IATF Definition)




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                                         Appendix 4
                                         Definitions
 • (Serialized) Inference Rule
       – The process a supply chain partner uses to ensure there is enough
         evidence to infer the serialized number without physically reading ALL
         serialized numbers. A Serialized Inference Rule should be defined for
         each packaging unit (e.g., pallet, case, item, etc.) for Aggregation,
         Shipping and Receiving processes. (IATF Definition)
 • Item Reference
       – The part of the Global Trade Item Number (GTIN) allocated by the user
         to identify a trade item for a given GS1 Company Prefix. (adopted from
         GS1 US Glossary, v6.0)
 • NDC (National Drug Code, US)
       – A 10-digit number that must be assigned to pharmaceuticals sold in the
         USA per federal law. The number comprises a Food and Drug
         Administration (FDA) assigned Labeler Code and manufacturer
         assigned Product ID and SKU/Trade Pack Size number. An NDC may
         be represented within a Global Trade Item Number (GTIN). (adopted
         from GS1 US Glossary, v6.0)


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                                         Appendix 4
                                         Definitions
 • NDC Masking
       – The process of replacing the Item Reference portion of the SGTIN with
         zeros to avoid divulging the underlying NDC number. (IATF Definition)
 • RFID
       – A data carrier technology that transmits information via signals in the
         radio frequency portion of the electromagnetic spectrum. A Radio
         Frequency Identification system consists of an antenna and a
         transceiver, which read the radio frequency and transfer the information
         to a processing device, and a transponder, or tag, which is an
         integrated circuit containing the radio frequency circuitry and
         information to be transmitted. (GS1 US Glossary, Version 6.0)
 • Rx ASN (Prescription Advance Ship Notice)
       – A non-standard, trading partner-specific EDI ASN transaction set
         (based on EDI 856 transaction set) incorporating additional information
         (such as Lot, Expiry, Rx Drug Serial Number, License Numbers) helpful
         in facilitating receiving, shipping, and other logistics processes for Rx
         drug products. The Rx ASN is one of the means to exchange the Rx
         Drug serialized numbers and the serialized hierarchy between trading
         partners. (IATF Definition)
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                                         Appendix 4
                                         Definitions
 • Serialization
       – Schema, processes, and controls for assignment of serial numbers to
         items. (IATF Definition)
 • Serialized Inference
       – To infer the serialized number based on information provided by the
         up-stream supply chain, reasonable inspection of the product, and
         application of the Serialized Inference Rule by the Shipping and
         Receiving partners. (IATF Definition)
 • Serial Number
       – A code, numeric or alphanumeric, assigned to an individual instance of
         an entity for its lifetime.
             • Example: Microscope model AC-2 with serial number 1234568 and
               microscope model AC-2 with serial number 1234569.
       – A unique individual item may be identified with the combined Global
         Trade Item Number (GTIN) and serial number.
       – Specific instance of the Object Class being tagged.
       – (Adopted from GS1 General Specifications, v7.1)

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                                         Appendix 4
                                         Definitions
 • SGTIN (Serialized Global Trade Item Number)
       – To create a unique identifier for individual objects, the GTIN is
         augmented with a serial number, which the managing entity is
         responsible for assigning uniquely to individual object classes.
         The combination of GTIN and a unique serial number is called a
         Serialized GTIN (SGTIN).
       – The SGTIN consists of the following information elements:
             • The Company Prefix, assigned by GS1 to a managing entity. The Company
               Prefix is the same as the Company Prefix digits within a GS1 GTIN decimal
               code.
             • The Item Reference + Indicator Digit, consisting of the GTIN‘s Item
               Reference prepended by GTIN Indicator Digit. The Item Reference and
               Indicator Digits are assigned by the managing entity to a particular object
               class.
             • The Serial Number, assigned by the managing entity to an individual object.
               The serial number is not part of the GTIN code, but is formally a part of the
               SGTIN.
       – (Adapted from EPCglobal Tag Data Standards Version 1.3,
         Ratified Specification).
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                                         Appendix 4
                                         Definitions
 • SKU (Stock Keeping Unit)
       – An individual color, flavor, size, or pack of a product that requires a
         separate identification number to distinguish it from other items (a
         measure of an item of merchandise for inventory management). In
         inventory control and identification systems, it represents the smallest
         unit for which sales and stock records are maintained. (adopted from
         GS1 US Glossary, v6.0)
 • SSCC (Serial Shipping Container Code)
       – The GS1 Identification Key used to identify logistics units. The key is
         comprised of GS1 Company Prefix, Extension Digit, Serial Reference,
         and Check Digit. (adopted from GS1 General Specifications, v7.1)




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                                         Appendix 4
                                         Definitions
 • Trace
       – The capability to identify the historical locations, the records of
         ownership, and the packaging hierarchy for a particular traceable item.
         “Trace” answers questions such as “where has the item been”, “who
         has previously owned the item”, and “in what packaging hierarchy did
         the product exist at various locations”. The EPCglobal Pedigree
         Messaging Standard v1.0 is one example of a Trace mechanism.
         (IATF Working Definition)
 • Track
       – The capability to identify the current (and at time of shipment the
         intended future) location, ownership, and packaging hierarchy of a
         traceable item through the supply chain as it moves between parties.
         (based on GS1 Traceability Standard).
       – “Track” addresses both forward- and reverse-logistics operations.
         “Track” answers questions such as “where is the item currently”, “who
         is the next intended recipient”, and “what is the current packaging
         hierarchy of this item”. (explanatory information added by IATF)

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                                         Appendix 4
                                         Definitions
 • Track and Trace
       – The combined capabilities of “Track” and “Trace” as previously defined.
         Addresses both forward- and reverse-logistics operations.
         (IATF Working Definition)
 • UHF (Ultra High Frequency)
       – See Gen2 definition.
 • Unique Identification
       – See definitions for Serial Number and Serialization.




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                                         Appendix 5
            Industry Associations Providing Comments
 •   NACDS: National Association of Chain Drug Stores
 •   HDMA: Healthcare Distribution Management Association
 •   PhRMA: Pharmaceutical Research and Manufacturers of America
 •   GPhA: Generic Pharmaceutical Association
 •   BIO: Biotechnology Industry Organization
 •   NCPA: National Community Pharmacists Association
 •   CPhA: California Pharmacists Association
 •   GS1
 •   EPCglobal
 •   On-Track (Accenture-led cross-functional industry pilot)




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