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Guidelines for Bar Coding in the Pharmaceutical Supply Chain

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Guidelines for Bar Coding in the Pharmaceutical Supply Chain HEALTHCARE DISTRIBUTION ALLIANCE Guidelines for Bar Coding in the Pharmaceutical Supply Chain Distributed by AmerisourceBergen Corporation with permission from HDA HDA GUIDELINES FOR BAR CODING IN THE PHARMACEUTICAL SUPPLY CHAIN HDA would like to thank Excellis Health Solutions LLC for their barcoding and serialization expertise in supporting the Bar Code Task Force development of the HDA Guidelines for Bar Coding in the Pharmaceutical Supply Chain. Excellis Health Solutions is a global provider of strategy and implementation consulting services within the life sciences and healthcare industries. Excellis provides deep subject matter expertise in compliance with global product traceability regulations, GS1 Standards and pharmaceutical/medical device supply chain systems implementation. Services include strategy, project/program management, comprehensive validation, change management, quality and regulatory compliance, managed services administration, software release management, subject matter support, global GS1/serialization/track-and-trace support; as well as education and training and systems integration. As a GS1 Solution Partner, Excellis Health Solutions has certified subject matter experts with GS1 Standards Professional Designation and GS1 Standards for UDI. Excellis Health Solutions, LLC 4 E. Bridge Street, Suite 300 New Hope, PA 18938 https://Excellishealth.com Contact: Gordon Glass, VP Consulting, at +1-609-847-9921 or [email protected] Revised November 2017 Although HDA has prepared or compiled the information presented herein in an effort to inform its members and the general public about the healthcare distribution industry, HDA does not warrant, either expressly or implicitly, the accuracy or completeness of this information and assumes no responsibility for its use. © Copyright 2017 Healthcare Distribution Alliance All rights reserved. No part of this book may be reproduced or transmitted in any form or by any means, electronic or mechanical, including photocopying, recording or by an information storage and retrieval system, without permission in writing from the publisher. ISBN: 978-0-9743437-8-5 The Healthcare Distribution Alliance (HDA) represents primary pharmaceutical distributors — the vital link between the nation’s pharmaceutical manufacturers and more than 200,000 pharmacies, hospitals, long-term care facilities, clinics and others nationwide. Since 1876, HDA has helped members navigate regulations and innovations to get the right medicines to the right patients at the right time, safely and efficiently. The HDA Research Foundation, HDA’s non-profit charitable foundation, serves the healthcare industry by providing research and education focused on priority healthcare supply chain issues. For more information, visit www.hda.org. HDA GUIDELINES FOR BAR CODING IN THE PHARMACEUTICAL SUPPLY CHAIN | PAGE ii TABLE OF CONTENTS SUMMARY OF REVISIONS .................................................................................................................. v INTRODUCTION .................................................................................................................................. 1 FOOD AND DRUG ADMINISTRATION (FDA) REQUIREMENTS AND GUIDANCE IMPACTING BAR CODING OF PHARMACEUTICALS .............................................................................................. 2 The NDC ..................................................................................................................................................2 DSCSA .....................................................................................................................................................2 FDA Bar Code Rule ..................................................................................................................................3 FDA Final Guidance, “Standards for Securing the Drug Supply Chain – Standardized Numerical Identifier for Prescription Drug Packages” ...............................................................................................4 Linear and 2D Bar Codes for FDA-Regulated Products ..........................................................................5 CONFIGURING THE NDC IN BAR CODES ......................................................................................... 6 Decoding the 10-Digit NDC ....................................................................................................................6 Importance of NDC Format .....................................................................................................................8 UPCs, NDCs and GS1 Company Prefixes for Pharmaceuticals ...............................................................9 THE PRODUCT IDENTIFIER .............................................................................................................. 10 Building the GTIN ..................................................................................................................................11 Serializing the GTIN ...............................................................................................................................14 Expiration Date ......................................................................................................................................14 Lot Number ...........................................................................................................................................16 Recommendation to Cease Using AI(22) and AI(30) .............................................................................16 TWO DIMENSIONAL (2D) BAR CODE .............................................................................................. 17 Electronic Product Code Information Services (EPCIS) .........................................................................21 LINEAR BAR CODES ......................................................................................................................... 21 BAR CODES ON VERY SMALL PACKAGING CONFIGURATIONS .................................................... 22 Products Intended for Individual Resale .................................................................................................22 Linear Bar Codes for Products Not Intended for Individual Resale .......................................................23 Alternate Linear Bar Code Symbology for Very Small Packages ...........................................................23 HDA GUIDELINES FOR BAR CODING IN THE PHARMACEUTICAL SUPPLY CHAIN | PAGE iii BAR CODING ON PACKAGING CONFIGURATIONS LARGER THAN INDIVIDUAL SALEABLE UNITS .........24 Inner Packs (Bundles) .............................................................................................................................24 Homogenous Cases ..............................................................................................................................25 DSCSA Product Identifier ..........................................................................................................25 Homogenous Case: Product Identification Label ......................................................................26 Homogenous Case Label: Product Identification Label Placement and Corner Wrap Examples ....27 HDA Shipping Case Product Identification Label: Summary Specifications ..............................30 Product Identification Label Format 1 — Serialized Product .....................................................32 Product Identification Label Format 2 — Non-Serialized Product .............................................37 Case Marking and Labeling .......................................................................................................41 Partial Homogenous Case and Non-Homogenous Case ......................................................................41 Partial Homogenous Case, Internal Transfers ............................................................................41 Partial Homogenous Case Sold to a Trading Partner .................................................................42 Non-Homogenous/Mixed-Product Cases: Serialized Shipping Container Code (SSCC) Labeling ........43 Individual Shipping Cases and Pallets: Logistics/SSCC Label Placement ..............................................46 Multiple Data Carriers on Logistical Containers .........................................................................46 Pallets and Unit Loads: Logistics/SSCC Label Placement ......................................................................46 SPECIFYING SYMBOL SIZE: X-DIMENSION VS. MAGNIFICATION .................................................. 47 NON-PHARMACEUTICAL PRODUCTS: UPC NUMBERING SCHEME, UPC SYMBOLOGY ................ 48 TECHNOLOGY CONSIDERATIONS ................................................................................................... 49 Bar Code Scanners .................................................................................................................................49 APPLICATION SOFTWARE DESIGN ISSUES: ISO/IEC SYMBOLOGY IDENTIFIERS ........................... 49 SCANNER AND DATA–COLLECTION HARDWARE ISSUES .............................................................. 50 HDA BAR CODE TASK FORCE RECOMMENDATIONS ..................................................................... 51 HDA GUIDELINES FOR BAR CODING IN THE PHARMACEUTICAL SUPPLY CHAIN | PAGE iv SUMMARY OF REVISIONS Below is a list of significant changes from the 2011 HDMA Guidelines for Bar Coding in the Pharmaceutical Supply
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