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Welcome Justine Freisleben Senior Director, Industry Relations Healthcare Distribution Alliance (HDA)

Before we get started… • Today’s webinar is being recorded. • All participant lines are muted.

• Presentation and audio-replay will be made available by Tuesday, October 18.

Speaker Disclaimer This webinar is for information and educational purposes only. HDA offers a wide range of quality programming and speakers at its webinars. Please note that the statements and speaking materials presented by speakers who are not members of HDA staff are speaking on their own behalf and not on behalf of HDA. The presentations here are made to inform and stimulate discussion, and the information herein does not constitute legal advice. HDA disclaims any or all liability arising from any speaker's statements or materials.

Q&A: Submit Your Questions Type your question into the Q&A box located on the right-hand side of your screen.

Click the SEND button to submit your question.

Sponsored by

Panelists Adrian Bailey, Healthcare Industry Engagement Consultant, GS1 US

Scott Mooney, Vice President, Distribution Operations – Supply Chain Assurance, McKesson Pharmaceutical

Healthcare

GS1 US ® – HDA Present GTIN 101 An Introduction to GTINs

Adrian Bailey – HC Industry Engagement Consultant October 13, 2016

Antitrust Caution

GS1 US® is committed to complying fully with antitrust laws. We ask and expect everyone to refrain from discussing prices, margins, discounts, suppliers, the timing of price changes, marketing or product plans, or other competitively sensitive topics. If anyone has concerns about the propriety of a discussion, please inform a GS1 US representative as soon as possible. Please remember to make your own business decisions and that all GS1 standards are voluntary and not mandatory. Please review the complete GS1 US antitrust policy at: http://www.gs1us.org/gs1-us-antitrust-compliance-policy.

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Legal Disclosure

GS1 US, Inc. is providing this presentation, as is, as a service to interested parties. GS1 US MAKES NO REPRESENTATIONS IN THIS REGARD AND DISCLAIMS ALL WARRANTIES, EITHER EXPRESS OR IMPLIED, INCLUDING BUT NOT LIMITED TO, ANY WARRANTY OF ACCURACY OR RELIABILITY OF ANY CONTENT, NONINFRINGEMENT, MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE. GS1 US shall not be liable for any consequential, special, indirect, incidental, liquidated, exemplary or punitive damages of any kind or nature whatsoever, or any lost income or profits, under any theory of liability, arising out of the use of this presentation or any content herein, even if advised of the possibility of such loss or damage or if such loss or damage could have been reasonably foreseen. GS1 US employees are not representatives or agents of the FDA, and the content of this presentation has not been reviewed, approved or authorized by the FDA.

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Today’s Agenda

• • • • • • • • • •

GS1 Overview How to License a GS1 Company Prefix GTIN Overview Assigning Indicator Digits Product Hierarchy GTIN Allocation Rules McKesson Overview Role of Distributors Importance of GS1 Standards for DSCSA Resources

© 2016 GS1 US All Rights Reserved

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110+ Member Organizations Serving Business Around the World

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The Global Language of Business

GS1 Standards make it possible to identify, capture, and share information automatically and accurately about products, business locations, and more.

© 2016 GS1 US All Rights Reserved

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How to License a GS1 Company Prefix • A GS1 Company Prefix is a unique identification number licensed just to your company—and it is part of every barcode and identification number you create.

• Step 1: Estimate Your Barcode and Product Identification Needs • Step 2: Decide Which GS1 Company Prefix is Right for you • Step 3: Fill Out Our Online Application – http://www.gs1us.org/get-started

© 2016 GS1 US All Rights Reserved

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CREATING A GTIN-14 WITH NDC



Although the length of the GS1 Company Prefix and the length of the Item Reference vary, they will always be a combined total of 12 digits in a GTIN-14. The Indicator Digit and the Check Digit comprise the remaining 2 digits of the GTIN-14. The figure below provides a color-coded example of a hypothetical GTIN-14 that embeds an NDC, and a key explaining how each digit is populated.

Example of a GTIN-14 with an NDC embedded GTIN

2

0

3

6

1

4

1

4

5

6

7

8

9

8

Digit/Position

1

2

3

4

5

6

7

8

9

10

11

12

13

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How to Populate Each Digit

(color-coded to coordinate with the GTIN-14 shown above)

Position 1

Indicator Digit (numeric value from 0 to 8)

Position 2 and 3

GS1 Prefix “03”

Positions 4 through 13

NDC Labeler Code as assigned by FDA plus NDC Product/Package Code created by the manufacturer (Although the length of the Labeler Code and the Product/Package Code vary, they will always be a combined total of 10 digits.)

Position 14

Check Digit

© 2016 GS1 US All Rights Reserved

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Identify: GS1 Identification Numbers

GS1 Standards begin with GS1 Identification Numbers used to uniquely distinguish all products (trade items), logistic units, locations, assets and relationships across the supply chain from manufacturer to patient.

© 2016 GS1 US All Rights Reserved

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What is a Global Trade Item Number ? 

• A Global Trade Item Number® (or GTIN®) is a number that uniquely identifies trade items as they move through the global supply chain to the ultimate enduser. • GTIN Formats: GTIN-8, GTIN-12, GTIN-13 or GTIN-14 - A GTIN 14 can provide up to 8 separate GTINs to identify trade item grouping - Is used in ITF-14, GS1-128, GS1 DataBar™ and Data Matrix symbols as well as EPCs - Creates higher levels of packaging (e.g., inner-packs, cases, pallets) - Currently, not used for point-of-sale items

Example: Trade Item Grouping

© 2016 GS1 US All Rights Reserved

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Constructing a GTIN® in 14-digit format

Step 1

Step 2

Step 3

Step 4

Set Indicator Digit or a Zero

Use GS1 or U.P.C. Company Prefix

Use Assigned Item Reference Number

Calculate the Check Digit

© 2016 GS1 US All Rights Reserved

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The Indicator Digit • Left most digit

1

2

3

4

• For use in EAN/UPC Barcode - Will not be used - Must be “zero” in databases

• For 14-digit barcodes - Numbers 1-8 are used to indicate a packaging level - The number 9 indicates a variable measure item FORMAT OF THE ELEMENT STRING ®

Global Trade Item Number (in 14-digit format)

In this presentation, the letters “U.P.C.” are used solely as an abbreviation for the “Universal Product Code” which is a product identification system. They do not refer to the UPC, which is a federally registered certification mark of the International Association of Plumbing and Mechanical Officials (IAPMO) to certify compliance with a Uniform Plumbing Code as authorized by IAPMO.

© 2016 GS1 US All Rights Reserved

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GTIN in a 14-Digit Structure

1

U.P.C. Company Prefix

Item Reference Number

Indicator digit

GS1 Company Prefix

2

3

4

Same Item Reference Number from GTIN-12

© 2016 GS1 US All Rights Reserved

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Trade Item Hierarchy and GTIN® Assignment Methods

© 2016 GS1 US All Rights Reserved

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Example: 2 Level Hierarchy

- Example: A case containing 12 bottles of Rx Product

Item (Lowest Saleable Unit)

Case

© 2016 GS1 US All Rights Reserved

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GTIN® Hierarchy

There are several different options for assignment of GTINs in a hierarchy Indicator digit for higher levels of packaging Case* Inner Pack Lowest Sellable Unit* Each

*packaging levels required by DSCSA Regulation

© 2016 GS1 US All Rights Reserved

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GTIN® Allocation Rules for Healthcare

© 2016 GS1 US All Rights Reserved

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GTIN® Allocation Rules • Rules exist for when GS1 member companies assign new GTINs based on product changes • The GS1 Website has an interactive version of the rules: http://www.gs1.org/1/gtinrules/

• Voluntary standards developed by GS1 Healthcare tailored for the Global Healthcare sector • Products in scope: -

Pharmaceuticals

-

Medical devices

• Local regulations may apply and take precedence over guideline: http://www.gs1.org/docs/gsmp/healthcare/GS1_Healthcare_GTIN_Allocation_Rules.pdf

© 2016 GS1 US All Rights Reserved

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Pre-defined Characteristics • Basic pre-defined information of a trade item are: - Product Name, Brand and Description - Formulation (active ingredients)

- Strength - Dosage (or usage) - Net quantity (weight, volume) - Packaging configuration

- For groupings, the number of elementary items, example: (case, tote, and pallet) • A modification to any of the basic elements that characterize a trade item will usually lead to a change in the GTIN®.

© 2016 GS1 US All Rights Reserved

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Questions about GTINs Implementation Guide at: www.gs1us.org/GTIN

© 2016 GS1 US All Rights Reserved

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Introduction of McKesson and Scott Mooney • McKesson is primarily known as a full service distributor in the U.S. of pharmaceuticals, medical/surgical and specialty products. • McKesson also is a repackager, a 3PL and a software company. • McKesson carries over 23,000 pharmaceuticals products. • Scott Mooney from McKesson participates in GS1 US and GS1 Global Healthcare Leadership teams, GSMP standards workgroups and the HDA Traceability Implementation Workgroup.

© 2016 GS1 US All Rights Reserved

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Role of Distributors in U.S. Supply Chain • Over 90% of pharmaceutical supply chain flows through distributors in the U.S. • Distributors provide not only product logistical services to dispensers but also supporting systems as well. - Many dispensers rely on distributors to manage the DSCSA data for them. • Distributors have a dual requirement for DSCSA in receiving DSCSA data with suppliers and also having to create/provide DSCSA data to dispensers.

© 2016 GS1 US All Rights Reserved

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Why are GS1 Standards Important for DSCSA? • GS1 2D Data Matrix - FDA requires an “internationally recognized” standard for the DSCSA transaction - FDA has recognized GS1 2D data matrix for some time • Vaccines, UDI, Blood • GS1 EPCIS - At the November 2015 HDMA Traceability Conference, most distributors’ presentation included expectations: • GS1 EPCIS is for the exchange of serialized DSCSA data • McKesson, Cardinal, ABC, H. D. Smith and (J. M.) Smith Brothers ...

© 2016 GS1 US All Rights Reserved

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Are you prepared for 2017 and 2018? • Understand the GS1 standards as it relates to the use of a 2D data matrix for Rx product - FDA expects NDC to be embedded in the GTIN - Most common issues seen to date in terms of the PNI have been: • GTIN not including the NDC • Date encoded in PNI not using standard format - MMDDYY or DDMMYY used instead of YYMMDD • End of field indicator not present on lot/batch field

© 2016 GS1 US All Rights Reserved

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DSCSA Education available through GS1 US®

• Free Implementation documents available on our website: http://www.gs1us.org/industries/healthcare/tools-and-resources/implementation-resources

• Training Videos available on our website: http://www.gs1us.org/resources/education-and-training

• Live Workshop: Using the GS1 System of Standards for DSCSA/EPCIS – November 2nd in Chicago, IL. https://resources.gs1us.org/GS1-US-Store/Product-Viewer/GS1-Healthcare-US-DSCSA-Group-Workshop-Nov2016-Chicago

• GS1 US Advisory Services: A one-on-one private GS1 Standards and DSCSA/EPCIS engagement with your company organization. http://www.gs1us.org/industries/healthcare/tools-and-resources/advisory-services

• Live support though our GS1 US DSCSA Help Desk: Please feel free to contact us at 937-435-3870, option 5; or email us at: [email protected].

© 2016 GS1 US All Rights Reserved

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Adrian Bailey HC Industry Engagement Consultant

GS1 US Corporate Headquarters Princeton Pike Corporate Center

1009 Lenox Drive, Suite 202 Lawrenceville, NJ 08648 USA

T +1 937-428-3743 E [email protected] www.gs1us.org

© 2016 GS1 US All Rights Reserved

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Q&A: Submit Your Questions Type your question into the Q&A box located on the right-hand side of your screen.

Click the SEND button to submit your question.

Save the Date

Traceability Seminar November 9 – 11, 2016 | Washington, DC http://www.hda.org/events

Contact HDA Justine Freisleben [email protected] (703) 885-0277

Thank you

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