Presentation on theme: "EPCglobal HLS Industry Adoption Roadmap Final Version v13"— Presentation transcript:
1 EPCglobal HLS Industry Adoption Roadmap Final Version v13 EPCglobal HLS Industry Adoption Roadmap Final Version v13.2 Prepared by the EPCglobal HLS Industry Adoption Task Force For General Release Published ___, 2008
2 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 CorporationGrant Hodgkins, Alcon Laboratories
4 Table of Contents—HLS Roadmap Executive SummaryPurposeScopeCapabilities and SuggestionsUnique IdentificationPedigreeAction StepsSummary and RecommendationsAppendicesCommunications Plan (Separate Deliverable)
5 Notes to ReaderAlthough 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.
6 DisclaimerSupply 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.
7 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.
8 Executive Summary Deliverables: HLS Industry Adoption Roadmap CapabilitiesSuggestionsAction StepsIssues / Barriers / AssumptionsRationale / Pro and Con AssessmentCommunications Plan / StrategyOutreach MessageGroups to target for feedbackFeedback mechanism and processProcess to hand-off to industry trade associations
10 Purpose of The RoadmapThe 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.
11 Purpose of The RoadmapThe 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’.
13 Scope of The Roadmap Addresses two Key Capabilities: Unique Identification, including,SerializationData Carriers for SerializationRFIDBarcodesPedigree, 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.
14 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.
15 Assess Impact on Trading Partners Introduction to This SectionAs 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.
16 Assess Impact on Trading Partners Manufacturer Concerns with Options and ChoicesCost 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.
17 Assess Impact on Trading Partners Wholesaler Concerns with Options and ChoicesSupporting 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.
18 Assess Impact on Trading Partners Retailer Concerns with Options and ChoicesEach 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.
20 Capability and Suggestions Capability and Suggestion slides formatted as:CapabilityIdentifies the capabilities needed by trading partners to address regulatory or other requirements.SuggestionDesigned to address known US regulatory requirements.Identifies key dependencies of Standards-based activities.Ability to extend to other HLS Supply Chains and jurisdictions.Other SuggestionsSupplemental information.RationaleSupporting information to understand the Team’s thought process.
21 Unique Identification: Capability and Suggestions
22 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][Section 4034(d)] “A pedigree shall track each dangerous drug at the smallest 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.[Section 4034(i)] “…uses a unique identification number, established at the 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:or
23 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 should be limited to same range as SGTIN-96.Avoid encoding of Lot Code and/or Expiry Date as an integral part of the serial number; instead, encode this data into RFID User Memory and/or into barcode Application Identifiers designed for this purpose.Include backup human-readable text per GS1 standards.Continue to partner with GS1 Serialization Team to define global solutions to meet varying serialization challenges.Answers one specific issue; now resolved
24 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 InferenceInferring reads when less than 100% of data carriers are read.NDC MaskingOptional, 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-ExistenceSynchronizing serial numbers when using two or more data carriers.This is NOT recommended and does not meet GS1 Stds
25 Suggestions: Unique Identification Data Carriers for Serialization
26 Rationale: Unique Identification Unique Identification Based on SerializationSerialization 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.
27 Rationale: Unique Identification Uniquely Identify – Pallets, Totes, Cases, ItemsCalifornia 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 carriersFlexibility 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 tagA 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.
28 Rationale: Unique Identification No Solid Suggestion of HF or UHF RFID for Item-LevelUHF 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-LevelProvides 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.
29 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.
30 Rationale: Unique Identification SSCC-18 barcode usage for Pallet, Tote, CaseSerial 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 chainThere are few image scanners to read these barcodesThere are no GS1 standards to support SSCC data encoded into Data Matrix at this time.
32 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 transactionResulting in a change in ownershipFrom sale by manufacturer until final sale to a pharmacy or other dispense point.Includes all information required by lawCreated / Maintained in an Interoperable Electronic SystemContained within a standardized non-proprietary data format and architectureUniformly used by manufacturers, wholesalers, pharmacies for the pedigreeEnsuring compatibility throughout all stages of distributionTracked at the Smallest Packaging Level (see Serialization Suggestions)Certifying that the Pedigree Information is True and CorrectFrom a Responsible Party of the sourceUnder penalty of perjuryReturns documented on same Pedigree as the receipt transactionRef:or
33 Suggestions: Pedigree There are two Options to provide a Pedigree:Option 1 – Drug Pedigree Messaging StandardOption 2 –Track and TraceDrug Pedigree Messaging Standard available now.Software available today with EPCglobal certifications.Track and Trace in Requirements phase now.Standards will follow at a later date.Then software will be available.Further suggestions for choosing an Option cannot be provided until the following is completed for Track and Trace:RequirementsStandardsSoftware designed and available which meets StandardsUpdate:Global Traceability Standard entering standards approval process
34 Rationale: Pedigree Drug Pedigree Messaging Standard Track and Trace 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 StandardThe 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 TraceBeing 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.
35 Rationale: PedigreeInteroperability 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 GroupEPCglobal Supply Chain Integrity Joint Requirements GroupGS1 Traceability in Healthcare Work Group
36 Rationale: PedigreeTrading 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).
37 Rationale: PedigreeRx 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’.
39 Action Steps OverviewThis 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).
40 Status of Standards and Related Work Requirements Dev.Standards DevelopmentUpdated: July 13, 20076wks6wkswks4wks5wks10wks1wks4wks16wks12wks6wks4wks4wks6Tag Data Standards5Track & Trace30 DAY IP Review30 DAY IP Review4Supply Chain IntegrityCollect Business RequestsSecurityPrivacyTechnical WG FormationPrototype Test of Proposed Spec.Standards DevelopmentWG Review & Approve CandidateVendor & Industry AdoptionIAG Business Case Dev.Define Technical Rgmts w/EUDevelop EU Technical RqmtsBSC/TSC Approval of EU RqmtsBSC/TSC Review of RecommendedBoard Ratification of Standard3SerializationIAG Business Rqmts Dev.Form WG/ JRG2Item Level Tagging1Drug Pedigree Messaging StdIAG WGIAG WG/JRGTAG WGLegend:Previous ProgressSince March 20073 Months5 Months10 Months
41 Begin Vendor and Industry Adoption (Activities may or may not be in parallel) EPCglobal Post-Ratification ActivitiesRatifiedStandard~~~~~CertifiedSoftware orHardware~~~~~Create TestScriptsCreateTestPlatformCreateTestGuidelinesTest andCertifySoftwareor HardwareVendor and Industry Adoption ActivitiesCapitalPlanningProcessRe-EngineeringSystemIntegrationInfrastructureBuild-OutScale up&Implement
42 Key Standards and Other Resources EPCglobalStandards are available at:Drug Pedigree Messaging StandardTag Data StandardItem Level Tagging Requirements DocumentGen2 StandardEPCIS StandardTrack and Trace Interest Group Requirements (opt-in required)EPCglobal CookbookProvides information on how to phase implementations, activities required, sequencing of activities, development of KPI’s and metrics, among other useful topics.
43 Key Standards and Other Resources GS1GS1 General Specifications (via your GS1 Member Organization)GS1 Serialization Team Requirements (work in progress; join at )GS1 GTIN Allocation Rules for Healthcare (http://www.gs1.org/docs/gsmp/HUG/HUG_GTIN_Allocation_i4.6.pdf )FDAFDA Compliance Policy Guide, “Radiofrequency Identification Feasibility Studies and Pilot Programs for Drugs”, NovFDA Counterfeit Drug Task Force Report: 2006 Update, Jun
44 Key Standards and Other Resources HDMA“Guidelines for Barcoding in the Pharmaceutical Supply Chain”, December 2005 edition (available for purchase only)
45 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.
46 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.
48 SummaryThe 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.PedigreeUnique IdentificationThe 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.
49 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]
50 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 architecturesInteroperability between trading partners accessing shared data basesHandling 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 PrefixWork 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.
51 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:
52 RecommendationsFDAProvide 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 Document expires on 31-Dec-2007.
53 RecommendationsFDAWork 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).
54 RecommendationsFDANeed 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.
55 RecommendationsHDMAUpdate 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.
56 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.
58 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.
59 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.
60 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.
61 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.
62 Appendix 1 Suggestions: Serialized Inference Designed for transactions between trading partners, however can be applied to intra-company transactions as well.Serialized Inference Scenarios:Single Item CommissionApply serial number to one single Item.Item into Case Commission/AggregationApply serial number to Case and build item-to-case hierarchy.Case to Pallet Commission/AggregationApply 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/AggregationApply 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/AggregationApply 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.
63 Appendix 1 Suggestions: Serialized Inference Designed for transactions between trading partners, however can be applied to intra-company transactions as well.Serialized Inference Scenarios:ShipmentsSingle 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)ReceiptsSingle 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.
64 Appendix 1 Serialized Inference Rules: Commission/Aggregation Use Case ScenarioManufacturerInferenceWholesalerRetailer DCPharmacySingle Item CommissionRead - INAItem into Case Commission/AggregationCase to Pallet Commission/AggregationRead - CInfer - ITote or Mixed Case Commission/AggregationRead -IMixed Pallet Commission/AggregationRead – C,TRead - C,TAssumesAggregationhas OccurredKey: “P” Pallet “C” Case “T” Tote or Mixed Case “I”- Item
65 Appendix 1 Serialized Inference Rules: Shipments Use Case ScenarioManufacturerInferenceWholesalerRetailer DCPharmacySingle Item ShipmentRead - INACase ShipmentRead - CInfer - ITote or Mixed Case ShipmentRead - C,TPallet ShipmentRead - PInfer - C, IInfer -C, IMixed Pallet ShipmentInfer - C, T, IInfer - C, T, I,AssumesAggregationhas OccurredKey: “P” Pallet “C” Case “T” Tote or Mixed Case “I”- Item
66 Appendix 1 Serialized Inference Rules: Receipts Use Case ScenarioManufacturerInferenceWholesalerRetailer DCPharmacySingle Item ReceiptRead - ICase ReceiptRead - CInfer - ITote or Mixed Case ReceiptRead - C,TPallet ReceiptRead – PInfer - C,IRead - P Infer - C,INAMixed Pallet ReceiptInfer – C,T,IRead - P Infer – C,T,IAssumesAggregationhas OccurredKey: “P” Pallet “C” Case “T” Tote or Mixed Case “I”- Item
67 Appendix 1 Serialized Inference Rules: Recalls, Returns, Reverse Logistics Use Case ScenarioManufacturerInferenceWholesalerRetailer DCPharmacySingle Item Receipt/ShipmentRead - ICase Receipt/ShipmentRead - CInfer - ITote or Mixed CaseReceipt/ShipmentRead - C,TPallet Receipt/ShipmentRead - PInfer - C,INAMixed Pallet Receipt/ShipmentInfer - C,T,IAssumesAggregationhas OccurredKey: “P” Pallet “C” Case “T” Tote or Mixed Case “I”- Item
68 Appendix 1 Serialized Inference Rules: Repacking Use Case ScenarioAggregationInferenceShippingReceivingSingle ItemRead - INACaseRead – CInfer – IInfer - ITote or Mixed CaseRead – C,TPalletRead - CRead - P Infer - C,IMixed PalletRead - C,TRead - P Infer - C,T,IAssumesAggregationhas OccurredKey: “P” Pallet “C” Case “T” Tote or Mixed Case “I”- ItemAssumes repackers will receive serialized product, then serialize outbound product, and retain the linkage between inbound and outbound serial numbers (if different or changed).
69 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
70 Appendix 2 Suggestions: NDC Masking Illustration of NDC Masking at the Item LevelGS1 Company PrefixItem ReferenceData FormatIndicator DigitCountry CodeLabeler CodeNDC------0001GTIN03SGTIN_mSGTIN(masked NDC)_(Item Reference = zeros)CheckDigit OmittedThis is NOT recommended and does not meet GS1 StdsNotes:a. Packaging Level Indicator changes position in SGTIN.b. Check Digit is omitted in SGTIN.
71 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:Parsing is the main barrier to coexistence and is being resolved
72 Appendix 3 Suggestions: RFID and Barcode Co-Existence Note: Data is for illustration only; see GS1 Standards for usageSSCC-96SGTIN-96SSCC-18(00)AI(01) AI(21)(01) (21)RFIDEPC Mgr IDExtension Digit (5) +Serial NumberEPC Mgr IDSerial NumberIndicator Digit (2) +Item ReferenceBarcodesSerial Number + Check Digit (3)Extension Digit (5) +EPC Mgr IDSerial NumberIndicator Digit (2) +EPC Mgr IDItem 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.
73 Appendix 3 Suggestions: RFID and Barcode Co-Existence Single-SKU Case with AI(21)Mixed Case/Tote/Pallet with SSCCExamples only. See GS1 General Specifications for guidance.Std. PlacementRFID Tags shown are for illustration and do not imply an endorsement of any particular supplier.
74 Appendix 3 Suggestions: RFID and Barcode Co-Existence Item-Level Label with SGTIN-96 RFID Tag + Data Matrix BarcodeExample only. See GS1 General Specifications for guidance.RFID Tags shown are for illustration and do not imply an endorsement of any particular supplier.
75 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).
76 Appendix 3 Suggestions: RFID and Barcode Co-Existence AI(21) Serial Number as Backup for RFID SGTINAI(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.
77 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) SSCCAI(01) GTINAI(10) Lot/BatchAI(17) ExpiryAI(21) Serial NumberAI(30) Quantity
78 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)
79 Appendix 4 Definitions Drug Pedigree ECC200 EDI Electronic 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)ECC200Data Matrix ISO version ECC 200. See Data Matrix Barcode definition.EDIElectronic Data InterchangeElectronic PedigreeAn 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)
80 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)
81 Appendix 4 Definitions HF (High Frequency) HLS IATF Refers to current ISO or future EPCglobal radio-frequency identification (RFID) system operating in the HF 3 MHz – 30 MHz frequency range, typically at MHz for HLS applications. (IATF Definition).HLSHealth and Life Sciences industry. (IATF Definition)IATFEPCglobal HLS Industry Adoption Task Force. (IATF Definition)
82 Appendix 4 Definitions (Serialized) Inference Rule Item Reference 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 ReferenceThe 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)
83 Appendix 4 Definitions NDC Masking RFID The process of replacing the Item Reference portion of the SGTIN with zeros to avoid divulging the underlying NDC number. (IATF Definition)RFIDA 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)
84 Appendix 4 Definitions Serialization Serialized Inference Schema, processes, and controls for assignment of serial numbers to items. (IATF Definition)Serialized InferenceTo 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 NumberA code, numeric or alphanumeric, assigned to an individual instance of an entity for its lifetime.Example: Microscope model AC-2 with serial number and microscope model AC-2 with serial numberA 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)
85 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).
86 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)
87 Appendix 4 Definitions Trace Track 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)TrackThe 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)
88 Appendix 4 Definitions Track and Trace UHF (Ultra High Frequency) 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 IdentificationSee definitions for Serial Number and Serialization.
89 Appendix 5 Industry Associations Providing Comments NACDS: National Association of Chain Drug StoresHDMA: Healthcare Distribution Management AssociationPhRMA: Pharmaceutical Research and Manufacturers of AmericaGPhA: Generic Pharmaceutical AssociationBIO: Biotechnology Industry OrganizationNCPA: National Community Pharmacists AssociationCPhA: California Pharmacists AssociationGS1EPCglobalOn-Track (Accenture-led cross-functional industry pilot)