{"id":42406,"date":"2026-10-23T00:52:36","date_gmt":"2026-10-23T04:52:36","guid":{"rendered":"https:\/\/staging.systech.ssdev.ca\/?page_id=42406"},"modified":"2026-10-29T11:45:59","modified_gmt":"2026-10-29T15:45:59","slug":"preparing-for-ndc-12-a-practical-readiness-guide-for-pharmaceutical-organizations","status":"publish","type":"page","link":"https:\/\/www.systechone.com\/de\/preparing-for-ndc-12-a-practical-readiness-guide-for-pharmaceutical-organizations\/","title":{"rendered":"Preparing for NDC-12: A Practical Readiness Guide for Pharmaceutical Organizations"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"42406\" class=\"elementor elementor-42406\" data-elementor-post-type=\"page\">\n\t\t\t\t<div data-dce-background-color=\"#54585926\" class=\"elementor-element elementor-element-45b5cb0 e-flex e-con-boxed e-con e-parent\" data-id=\"45b5cb0\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-4441a25 e-con-full e-flex e-con e-child\" data-id=\"4441a25\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-824f290 elementor-absolute elementor-hidden-mobile elementor-hidden-desktop elementor-hidden-tablet elementor-widget elementor-widget-global elementor-global-19140 elementor-widget-breadcrumbs\" data-id=\"824f290\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;_position&quot;:&quot;absolute&quot;}\" data-widget_type=\"breadcrumbs.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<p id=\"breadcrumbs\"><span><span><a href=\"https:\/\/www.systechone.com\/\">Home<\/a><\/span><\/span><\/p>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-1820950 elementor-widget elementor-widget-heading\" data-id=\"1820950\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h1 class=\"elementor-heading-title elementor-size-default\">Preparing for NDC-12: A practical readiness guide for pharmaceutical organizations<\/h1>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-5136a07 elementor-widget elementor-widget-text-editor\" data-id=\"5136a07\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>What the transition means for your systems, data and operations\u2014and what to do now.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div data-dce-background-image-url=\"https:\/\/www.systechone.com\/wp-content\/uploads\/2024\/03\/line-element.svg\" class=\"elementor-element elementor-element-1feabd7 e-con-full elementor-hidden-tablet elementor-hidden-mobile e-flex e-con e-child\" data-id=\"1feabd7\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;,&quot;position&quot;:&quot;absolute&quot;}\">\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-a23becf e-flex e-con-boxed e-con e-parent\" data-id=\"a23becf\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-bad3b2d elementor-widget elementor-widget-html\" data-id=\"bad3b2d\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"html.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<a href=\"#toctoc\" class=\"scroll-top-button\">\n    \u2191\n<\/a>\n\n<style>\n\n\/* SMOOTH SCROLL *\/\nhtml{\n    scroll-behavior: smooth;\n}\n\n.scroll-top-button,\n.scroll-top-button:visited,\n.scroll-top-button:hover{\n\n    color: #ffffff !important;\n}\n\n\/* SCROLL BUTTON *\/\n.scroll-top-button{\n\n\n    color: #ffffff!important;\n    position: fixed;\n\n    right: 24px;\n    bottom: 24px;\n\n    width: 56px;\n    height: 56px;\n\n    display: flex;\n    align-items: center;\n    justify-content: center;\n\n    border-radius: 16px 0 0 16px;\n\n    background: #84BD00;\n    color: #fff;\n\n    font-size: 28px;\n    text-decoration: none;\n\n    z-index: 9999;\n\n    opacity: 0;\n    visibility: hidden;\n\n    transform: translateY(20px);\n\n    transition:\n        opacity .3s ease,\n        transform .3s ease,\n        visibility .3s ease,\n        background .25s ease;\n}\n\n\/* ACTIVE *\/\n.scroll-top-button.active{\n\n    opacity: 1;\n    visibility: visible;\n\n    transform: translateY(0);\n}\n\n\/* HOVER *\/\n.scroll-top-button:hover{\n\n    background: #6f9d00;\n}\n\n<\/style>\n\n<script>\n\ndocument.addEventListener('DOMContentLoaded', () => {\n\n    const button = document.querySelector('.scroll-top-button');\n\n    if(!button) return;\n\n    window.addEventListener('scroll', () => {\n\n        if(window.scrollY > 400){\n\n            button.classList.add('active');\n\n        }else{\n\n            button.classList.remove('active');\n        }\n    });\n});\n\n<\/script>\n\n\n<script>\ndocument.addEventListener('DOMContentLoaded', () => {\n\n    document.addEventListener('click', e => {\n\n        const link = e.target.closest('#toctoc-body a');\n\n        if(!link) return;\n\n        setTimeout(() => {\n\n            const tocBody = document.querySelector('#toctoc-body');\n            const tocHead = document.querySelector('#toctoc-head');\n\n            if(tocBody && tocBody.style.display !== 'none'){\n\n                tocHead.click();\n            }\n\n        }, 100);\n    });\n\n});\n<\/script>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-9c26324 toc-content elementor-widget elementor-widget-text-editor\" data-id=\"9c26324\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p><span class=\"TextRun SCXW255120649 BCX8\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW255120649 BCX8\" data-ccp-parastyle=\"Normal (Web)\">The move to a uniform <\/span><\/span><a class=\"Hyperlink SCXW255120649 BCX8\" href=\"https:\/\/www.federalregister.gov\/documents\/2026\/03\/05\/2026-04368\/revising-the-national-drug-code-format-and-drug-label-barcode-requirements\" target=\"_blank\" rel=\"noreferrer noopener\"><span class=\"TextRun Underlined SCXW255120649 BCX8\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"none\"><span class=\"NormalTextRun SCXW255120649 BCX8\" data-ccp-charstyle=\"Hyperlink\">12-digit National Drug Code (NDC)<\/span><\/span><\/a><span class=\"TextRun SCXW255120649 BCX8\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW255120649 BCX8\" data-ccp-parastyle=\"Normal (Web)\"> may look like <\/span><span class=\"NormalTextRun SCXW255120649 BCX8\" data-ccp-parastyle=\"Normal (Web)\">a small change<\/span><span class=\"NormalTextRun SCXW255120649 BCX8\" data-ccp-parastyle=\"Normal (Web)\"> on paper. It is not.<\/span><\/span><span class=\"EOP Selected SCXW255120649 BCX8\" data-ccp-props=\"{&quot;134233117&quot;:true,&quot;134233118&quot;:true,&quot;201341983&quot;:0,&quot;335559740&quot;:240}\">\u00a0<\/span><\/p><p><span class=\"TextRun SCXW241644191 BCX8\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW241644191 BCX8\" data-ccp-parastyle=\"Normal (Web)\">For pharmaceutical manufacturers, <\/span><\/span><a class=\"Hyperlink SCXW241644191 BCX8\" href=\"https:\/\/www.systechone.com\/industries\/pharma-track-and-trace\/cdmo\/\" target=\"_blank\" rel=\"noreferrer noopener\"><span class=\"TextRun Underlined SCXW241644191 BCX8\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"none\"><span class=\"NormalTextRun SCXW241644191 BCX8\" data-ccp-charstyle=\"Hyperlink\">CDMOs<\/span><\/span><\/a><span class=\"TextRun SCXW241644191 BCX8\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW241644191 BCX8\" data-ccp-parastyle=\"Normal (Web)\">, <\/span><span class=\"NormalTextRun SpellingErrorV2Themed SCXW241644191 BCX8\" data-ccp-parastyle=\"Normal (Web)\">repackagers<\/span><span class=\"NormalTextRun SCXW241644191 BCX8\" data-ccp-parastyle=\"Normal (Web)\"> and their trading partners, NDC-12 will reach well beyond the product label. It can affect packaging lines, artwork, master data, serialization, ERP, warehouse systems, financial processes, reporting <\/span><span class=\"NormalTextRun ContextualSpellingAndGrammarErrorV2Themed SCXW241644191 BCX8\" data-ccp-parastyle=\"Normal (Web)\">interfaces<\/span><span class=\"NormalTextRun SCXW241644191 BCX8\" data-ccp-parastyle=\"Normal (Web)\"> and the data exchanged across the supply chain.<\/span><\/span><\/p><p><span class=\"TextRun SCXW78016591 BCX8\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW78016591 BCX8\" data-ccp-parastyle=\"Normal (Web)\">The U.S. Food and Drug Administration <\/span><span class=\"NormalTextRun SCXW78016591 BCX8\" data-ccp-parastyle=\"Normal (Web)\">(FDA) <\/span><span class=\"NormalTextRun SCXW78016591 BCX8\" data-ccp-parastyle=\"Normal (Web)\">has given the industry until March 7, 2033, before it begins assigning <\/span><\/span><a class=\"Hyperlink SCXW78016591 BCX8\" href=\"https:\/\/www.systechone.com\/blog\/fda-finalizes-12-digit-ndc-format-what-it-means-for-the-pharma-supply-chain\/\" target=\"_blank\" rel=\"noreferrer noopener\"><span class=\"TextRun Underlined SCXW78016591 BCX8\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"none\"><span class=\"NormalTextRun SCXW78016591 BCX8\" data-ccp-charstyle=\"Hyperlink\">12-digit NDCs<\/span><\/span><\/a><span class=\"TextRun SCXW78016591 BCX8\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW78016591 BCX8\" data-ccp-parastyle=\"Normal (Web)\">. That sounds like plenty of time\u2014until you factor in product portfolios, <\/span><span class=\"NormalTextRun SCXW78016591 BCX8\" data-ccp-parastyle=\"Normal (Web)\">validated<\/span><span class=\"NormalTextRun SCXW78016591 BCX8\" data-ccp-parastyle=\"Normal (Web)\"> systems, label change cycles, competing IT priorities and the coordination <\/span><span class=\"NormalTextRun SCXW78016591 BCX8\" data-ccp-parastyle=\"Normal (Web)\">required<\/span><span class=\"NormalTextRun SCXW78016591 BCX8\" data-ccp-parastyle=\"Normal (Web)\"> across CMOs, 3PLs, wholesalers and other partners.<\/span><\/span><span class=\"EOP Selected SCXW78016591 BCX8\" data-ccp-props=\"{&quot;134233117&quot;:true,&quot;134233118&quot;:true,&quot;201341983&quot;:0,&quot;335559740&quot;:240}\">\u00a0<\/span><\/p><p><span class=\"TextRun SCXW59135859 BCX8\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW59135859 BCX8\" data-ccp-parastyle=\"Normal (Web)\">This is not a two-digit update. It is a multi-year operational transition.<\/span><\/span><span class=\"EOP Selected SCXW59135859 BCX8\" data-ccp-props=\"{&quot;134233117&quot;:true,&quot;134233118&quot;:true,&quot;201341983&quot;:0,&quot;335559740&quot;:240}\">\u00a0<\/span><\/p><p><span class=\"TextRun SCXW253226407 BCX8\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW253226407 BCX8\" data-ccp-parastyle=\"Normal (Web)\">The organizations that wait for NDC-12 to become an urgent compliance deadline may find themselves managing avoidable data mismatches, labeling constraints, <\/span><span class=\"NormalTextRun ContextualSpellingAndGrammarErrorV2Themed SCXW253226407 BCX8\" data-ccp-parastyle=\"Normal (Web)\">validation<\/span> <span class=\"NormalTextRun SCXW253226407 BCX8\" data-ccp-parastyle=\"Normal (Web)\">bottlenecks<\/span><span class=\"NormalTextRun SCXW253226407 BCX8\" data-ccp-parastyle=\"Normal (Web)\"> and partner-readiness issues under pressure.<\/span><\/span><span class=\"EOP Selected SCXW253226407 BCX8\" data-ccp-props=\"{&quot;134233117&quot;:true,&quot;134233118&quot;:true,&quot;201341983&quot;:0,&quot;335559740&quot;:240}\">\u00a0<\/span><\/p><p><span class=\"NormalTextRun SCXW5778063 BCX8\" data-ccp-parastyle=\"Normal (Web)\">Those<\/span><span class=\"NormalTextRun SCXW5778063 BCX8\" data-ccp-parastyle=\"Normal (Web)\"> that start now have time to map dependencies, make deliberate <\/span><span class=\"NormalTextRun ContextualSpellingAndGrammarErrorV2Themed SCXW5778063 BCX8\" data-ccp-parastyle=\"Normal (Web)\">decisions<\/span><span class=\"NormalTextRun SCXW5778063 BCX8\" data-ccp-parastyle=\"Normal (Web)\"> and test changes before product movement is at stake.<\/span><\/p><p><strong><span class=\"TextRun SCXW176421248 BCX8\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW176421248 BCX8\" data-ccp-charstyle=\"Strong\">This guide outlines where to begin.<\/span><\/span><span class=\"EOP Selected SCXW176421248 BCX8\" data-ccp-props=\"{&quot;134233117&quot;:true,&quot;134233118&quot;:true,&quot;201341983&quot;:0,&quot;335559740&quot;:240}\">\u00a0<\/span><\/strong><\/p><p><strong>1. <span class=\"NormalTextRun SCXW223003833 BCX8\">Know <\/span><span class=\"NormalTextRun SCXW223003833 BCX8\">everywhere your <\/span><span class=\"NormalTextRun SCXW223003833 BCX8\">NDC <\/span><span class=\"NormalTextRun SCXW223003833 BCX8\">g<\/span><span class=\"NormalTextRun SCXW223003833 BCX8\">oes<\/span><\/strong><\/p><p><span class=\"TextRun SCXW61516150 BCX8\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW61516150 BCX8\">The first step toward readiness is understanding the full lifecycle of the NDC within your organization<\/span><\/span>.<\/p><p><span class=\"TextRun SCXW56927338 BCX8\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW56927338 BCX8\">That means looking beyond where the NDC is stored.<\/span><\/span><span class=\"EOP Selected SCXW56927338 BCX8\" data-ccp-props=\"{}\">\u00a0<\/span><\/p><p><span class=\"TextRun SCXW28267136 BCX8\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW28267136 BCX8\">Ask<\/span><span class=\"NormalTextRun SCXW28267136 BCX8\"> these questions:<\/span><\/span><span class=\"EOP Selected SCXW28267136 BCX8\" data-ccp-props=\"{}\">\u00a0<\/span><\/p><ul style=\"padding-bottom: 20px;\"><li><span class=\"TextRun SCXW92522051 BCX8\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW92522051 BCX8\">Where is <\/span><span class=\"NormalTextRun SCXW92522051 BCX8\">the NDC <\/span><span class=\"NormalTextRun SCXW92522051 BCX8\">created or <\/span><span class=\"NormalTextRun SCXW92522051 BCX8\">maintained<\/span><span class=\"NormalTextRun SCXW92522051 BCX8\">? Consider product and material <\/span><\/span><a class=\"Hyperlink SCXW92522051 BCX8\" href=\"https:\/\/www.systechone.com\/products\/unitrace-traceability\/master-data-systech\/\" target=\"_blank\" rel=\"noreferrer noopener\"><span class=\"TextRun Underlined SCXW92522051 BCX8\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"none\"><span class=\"NormalTextRun SCXW92522051 BCX8\" data-ccp-charstyle=\"Hyperlink\">master data<\/span><\/span><\/a><span class=\"TextRun SCXW92522051 BCX8\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW92522051 BCX8\">.<\/span><\/span><\/li><li><span class=\"TextRun SCXW222894787 BCX8\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW222894787 BCX8\">Where is it consumed? <\/span><span class=\"NormalTextRun SCXW222894787 BCX8\">Identify<\/span><span class=\"NormalTextRun SCXW222894787 BCX8\"> systems and processes dependent on the identifier.<\/span><\/span><span class=\"EOP Selected SCXW222894787 BCX8\" data-ccp-props=\"{}\">\u00a0<\/span><\/li><li><span class=\"TextRun SCXW57172861 BCX8\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW57172861 BCX8\">Where is it displayed? Examine labels, packaging, <\/span><span class=\"NormalTextRun ContextualSpellingAndGrammarErrorV2Themed SCXW57172861 BCX8\">reports<\/span><span class=\"NormalTextRun SCXW57172861 BCX8\"> and user interfaces.<\/span><\/span><span class=\"EOP Selected SCXW57172861 BCX8\" data-ccp-props=\"{}\">\u00a0<\/span><\/li><li><span class=\"TextRun SCXW218472508 BCX8\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW218472508 BCX8\">Where is it shared? Map EDI, <\/span><span class=\"NormalTextRun ContextualSpellingAndGrammarErrorV2Themed SCXW218472508 BCX8\">EPCIS<\/span><span class=\"NormalTextRun SCXW218472508 BCX8\"> and other exchanges with trading partners.<\/span><\/span><span class=\"EOP Selected SCXW218472508 BCX8\" data-ccp-props=\"{}\">\u00a0<\/span><\/li><li><span class=\"TextRun SCXW196834363 BCX8\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW196834363 BCX8\">What business processes depend on it? Consider inventory, contracts, customer eligibility, financial <\/span><span class=\"NormalTextRun ContextualSpellingAndGrammarErrorV2Themed SCXW196834363 BCX8\">reporting<\/span><span class=\"NormalTextRun SCXW196834363 BCX8\"> and other downstream activities.<\/span><\/span><span class=\"EOP Selected SCXW196834363 BCX8\" data-ccp-props=\"{}\">\u00a0<\/span><\/li><\/ul><p><span class=\"TextRun SCXW200347522 BCX8\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW200347522 BCX8\">The goal is not simply a list of affected applications. It is a clear picture of how NDC data moves across the organization and where a change in format could create downstream consequences.<\/span><\/span><\/p><p><strong>2. <span class=\"TextRun SCXW67577361 BCX8\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW67577361 BCX8\" data-ccp-parastyle=\"heading 2\">Plan for a period when both <\/span><span class=\"NormalTextRun SCXW67577361 BCX8\" data-ccp-parastyle=\"heading 2\">10- and 12-Digit NDCs<\/span><span class=\"NormalTextRun SCXW67577361 BCX8\" data-ccp-parastyle=\"heading 2\"> may be in use<\/span><\/span><\/strong><\/p><p><span class=\"TextRun SCXW168928764 BCX8\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW168928764 BCX8\" data-ccp-parastyle=\"heading 2\">During the three-year transition period, organizations may <\/span><span class=\"NormalTextRun SCXW168928764 BCX8\" data-ccp-parastyle=\"heading 2\">encounter<\/span><span class=\"NormalTextRun SCXW168928764 BCX8\" data-ccp-parastyle=\"heading 2\"> both 10- and 12-digit NDCs. That creates a practical question: how will your systems, <\/span><span class=\"NormalTextRun ContextualSpellingAndGrammarErrorV2Themed SCXW168928764 BCX8\" data-ccp-parastyle=\"heading 2\">data<\/span><span class=\"NormalTextRun SCXW168928764 BCX8\" data-ccp-parastyle=\"heading 2\"> and workflows recognize and manage both formats?<\/span><\/span><span class=\"EOP Selected SCXW168928764 BCX8\" data-ccp-props=\"{&quot;134245418&quot;:true,&quot;134245529&quot;:true,&quot;335559738&quot;:160,&quot;335559739&quot;:80}\">\u00a0<\/span><\/p><p><span class=\"NormalTextRun SCXW31645158 BCX8\">This is not only a technical issue. It can affect how teams <\/span><span class=\"NormalTextRun SCXW31645158 BCX8\">represent<\/span><span class=\"NormalTextRun SCXW31645158 BCX8\"> products, manage item records, reconcile <\/span><span class=\"NormalTextRun ContextualSpellingAndGrammarErrorV2Themed SCXW31645158 BCX8\">transactions<\/span><span class=\"NormalTextRun SCXW31645158 BCX8\"> and coordinate with trading partners.<\/span><\/p><p><span class=\"TextRun SCXW217330999 BCX8\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW217330999 BCX8\">For instance, organizations may need to <\/span><span class=\"NormalTextRun SCXW217330999 BCX8\">determine<\/span><span class=\"NormalTextRun SCXW217330999 BCX8\"> whether a 12-digit NDC will be treated as an update to an existing product record or as <\/span><span class=\"NormalTextRun SCXW217330999 BCX8\">a new item<\/span><span class=\"NormalTextRun SCXW217330999 BCX8\"> configuration in certain systems. Those decisions can affect processes well beyond master data.<\/span><span class=\"NormalTextRun SCXW217330999 BCX8\">\u00a0<\/span><\/span><span class=\"EOP Selected SCXW217330999 BCX8\" data-ccp-props=\"{}\">\u00a0<\/span><\/p><p><span class=\"TextRun SCXW256926258 BCX8\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW256926258 BCX8\">A change in one place can cascade through the enterprise:<\/span><\/span><span class=\"EOP Selected SCXW256926258 BCX8\" data-ccp-props=\"{}\">\u00a0<\/span><\/p><p><strong><span class=\"TextRun SCXW156358054 BCX8\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW156358054 BCX8\">Master data \u2192 Inventory \u2192 Financial reporting \u2192 Trading partner setup \u2192 Transaction processing<\/span><\/span><span class=\"EOP Selected SCXW156358054 BCX8\" data-ccp-props=\"{}\">\u00a0<\/span><\/strong><\/p><p><span class=\"TextRun SCXW221944117 BCX8\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW221944117 BCX8\">This is why NDC-12 planning needs representation from more than <\/span><\/span><a class=\"Hyperlink SCXW221944117 BCX8\" href=\"https:\/\/www.systechone.com\/solutions\/regulatory-compliance\/pharmaceutical-compliance\/\" target=\"_blank\" rel=\"noreferrer noopener\"><span class=\"TextRun Underlined SCXW221944117 BCX8\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"none\"><span class=\"NormalTextRun SCXW221944117 BCX8\" data-ccp-charstyle=\"Hyperlink\">regulatory<\/span><\/span><\/a><span class=\"TextRun SCXW221944117 BCX8\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW221944117 BCX8\"> or serialization teams.<\/span><span class=\"NormalTextRun SCXW221944117 BCX8\"> It requires shared decisions across the functions that create, <\/span><span class=\"NormalTextRun ContextualSpellingAndGrammarErrorV2Themed SCXW221944117 BCX8\">use<\/span><span class=\"NormalTextRun SCXW221944117 BCX8\"> and exchange product information.<\/span><\/span><span class=\"EOP Selected SCXW221944117 BCX8\" data-ccp-props=\"{}\">\u00a0<\/span><\/p><p><strong>3.<span class=\"NormalTextRun SCXW153548322 BCX8\"> Look <\/span><span class=\"NormalTextRun SCXW153548322 BCX8\">from the packaging line through the enterprise<\/span><\/strong><\/p><p><span class=\"NormalTextRun SCXW83340286 BCX8\">NDC-12 r<\/span><span class=\"NormalTextRun SCXW83340286 BCX8\">eadiness should be <\/span><span class=\"NormalTextRun ContextualSpellingAndGrammarErrorV2Themed SCXW83340286 BCX8\">evaluated<\/span><span class=\"NormalTextRun SCXW83340286 BCX8\"> end to <\/span><span class=\"NormalTextRun SCXW83340286 BCX8\">end. A<\/span><span class=\"NormalTextRun SCXW83340286 BCX8\"> change that <\/span><span class=\"NormalTextRun ContextualSpellingAndGrammarErrorV2Themed SCXW83340286 BCX8\">begins on<\/span><span class=\"NormalTextRun SCXW83340286 BCX8\"> packaging can affect multiple layers of technology and operations before information <\/span><span class=\"NormalTextRun SCXW83340286 BCX8\">ultimately reaches<\/span><span class=\"NormalTextRun SCXW83340286 BCX8\"> a trading partner.<\/span><\/p><p><span class=\"TextRun SCXW249438704 BCX8\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW249438704 BCX8\">A practical assessment should consider dependencies across:<\/span><\/span><\/p><p><strong><span class=\"TextRun SCXW193317010 BCX8\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW193317010 BCX8\">Packaging &amp; labeling \u2192 Site systems \u2192 Enterprise serialization and traceability \u2192 ERP\/business systems \u2192 External transactions and trading partners<\/span><\/span><span class=\"EOP Selected SCXW193317010 BCX8\" data-ccp-props=\"{}\">\u00a0<\/span><\/strong><\/p><p><span class=\"TextRun SCXW68855725 BCX8\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW68855725 BCX8\">The <\/span><\/span><a class=\"Hyperlink SCXW68855725 BCX8\" href=\"https:\/\/www.federalregister.gov\/documents\/2026\/03\/05\/2026-04368\/revising-the-national-drug-code-format-and-drug-label-barcode-requirements\" target=\"_blank\" rel=\"noreferrer noopener\"><span class=\"TextRun Underlined SCXW68855725 BCX8\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"none\"><span class=\"NormalTextRun SCXW68855725 BCX8\" data-ccp-charstyle=\"Hyperlink\">FDA\u2019s rule<\/span><\/span><\/a><span class=\"TextRun SCXW68855725 BCX8\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW68855725 BCX8\"> also allows <\/span><span class=\"NormalTextRun SCXW68855725 BCX8\">also <\/span><span class=\"NormalTextRun SCXW68855725 BCX8\">permits<\/span><span class=\"NormalTextRun SCXW68855725 BCX8\"> qualifying 2D Data Matrix barcodes to encode the 12-digit NDC alongside the other <\/span><\/span><a class=\"Hyperlink SCXW68855725 BCX8\" href=\"https:\/\/www.systechone.com\/serialization\/dscsa-compliance\/\" target=\"_blank\" rel=\"noreferrer noopener\"><span class=\"TextRun Underlined SCXW68855725 BCX8\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"none\"><span class=\"NormalTextRun SCXW68855725 BCX8\" data-ccp-charstyle=\"Hyperlink\">Drug Supply Chain Security Act (DSCSA)<\/span><\/span><\/a><span class=\"TextRun SCXW68855725 BCX8\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW68855725 BCX8\"> product identifier elements beginning March 7, 2033<\/span><span class=\"NormalTextRun SCXW68855725 BCX8\">. That<\/span><span class=\"NormalTextRun SCXW68855725 BCX8\"> reinforc<\/span><span class=\"NormalTextRun SCXW68855725 BCX8\">es<\/span><span class=\"NormalTextRun SCXW68855725 BCX8\"> the connection between identification, <\/span><span class=\"NormalTextRun ContextualSpellingAndGrammarErrorV2Themed SCXW68855725 BCX8\">packaging<\/span><span class=\"NormalTextRun SCXW68855725 BCX8\"> and downstream traceability processes.<\/span><\/span><span class=\"EOP Selected SCXW68855725 BCX8\" data-ccp-props=\"{}\">\u00a0<\/span><\/p><p><span class=\"TextRun SCXW75022776 BCX8\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW75022776 BCX8\">Testing a single system in isolation may not reveal the problems that <\/span><span class=\"NormalTextRun SCXW75022776 BCX8\">emerge<\/span><span class=\"NormalTextRun SCXW75022776 BCX8\"> at the handoff between systems. The key question is whether the updated identifier can move accurately and consistently from the packaging line through the enterprise and across the supply chain.<\/span><\/span><span class=\"EOP Selected SCXW75022776 BCX8\" data-ccp-props=\"{}\">\u00a0<\/span><\/p><p><strong>4. <span class=\"NormalTextRun SCXW81587515 BCX8\"> Plan for the <\/span><span class=\"NormalTextRun SCXW81587515 BCX8\">exceptions, not just the happy path<\/span><\/strong><\/p><p><span class=\"NormalTextRun SCXW126127482 BCX8\" data-ccp-parastyle=\"Normal (Web)\">Most transition plans begin by confirming that the intended process works. That is necessary, but <\/span><span class=\"NormalTextRun SCXW126127482 BCX8\" data-ccp-parastyle=\"Normal (Web)\">it<\/span><span class=\"NormalTextRun SCXW126127482 BCX8\" data-ccp-parastyle=\"Normal (Web)\">\u2019<\/span><span class=\"NormalTextRun SCXW126127482 BCX8\" data-ccp-parastyle=\"Normal (Web)\">s<\/span><span class=\"NormalTextRun SCXW126127482 BCX8\" data-ccp-parastyle=\"Normal (Web)\"> not enough.<\/span><\/p><p><span class=\"TextRun SCXW146863820 BCX8\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW146863820 BCX8\" data-ccp-parastyle=\"Normal (Web)\">Large identifier changes can introduce <\/span><\/span><a class=\"Hyperlink SCXW146863820 BCX8\" href=\"https:\/\/www.systechone.com\/blog\/what-a-dscsa-exception-really-costs-you\/\" target=\"_blank\" rel=\"noreferrer noopener\"><span class=\"TextRun Underlined SCXW146863820 BCX8\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"none\"><span class=\"NormalTextRun SCXW146863820 BCX8\" data-ccp-charstyle=\"Hyperlink\">exceptions<\/span><\/span><\/a><span class=\"TextRun SCXW146863820 BCX8\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW146863820 BCX8\" data-ccp-parastyle=\"Normal (Web)\"> when systems interpret data differently, master data is incomplete or inconsistent, trading partners transition at <\/span><span class=\"NormalTextRun SCXW146863820 BCX8\" data-ccp-parastyle=\"Normal (Web)\">different times<\/span><span class=\"NormalTextRun SCXW146863820 BCX8\" data-ccp-parastyle=\"Normal (Web)\">, or barcode data does not align with electronic transactions.<\/span><\/span><\/p><p><span class=\"TextRun SCXW253089248 BCX8\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW253089248 BCX8\">Organizations should incorporate exception scenarios into their testing strategy\u2014not simply confirm that a correctly configured 12-digit NDC passes through the expected workflow.<\/span><\/span><\/p><p><span class=\"TextRun SCXW38128143 BCX8\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW38128143 BCX8\">That means asking:<\/span> <\/span><span class=\"TextRun SCXW38128143 BCX8\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW38128143 BCX8\">What happens when it <\/span><span class=\"NormalTextRun SCXW38128143 BCX8\">doesn\u2019t<\/span><span class=\"NormalTextRun SCXW38128143 BCX8\">?<\/span><\/span><span class=\"EOP Selected SCXW38128143 BCX8\" data-ccp-props=\"{}\">\u00a0<\/span><\/p><p><span class=\"TextRun SCXW90212530 BCX8\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW90212530 BCX8\">Teams should understand how quickly they can <\/span><span class=\"NormalTextRun SCXW90212530 BCX8\">identify<\/span><span class=\"NormalTextRun SCXW90212530 BCX8\"> an issue, <\/span><span class=\"NormalTextRun SCXW90212530 BCX8\">determine<\/span><span class=\"NormalTextRun SCXW90212530 BCX8\"> where it <\/span><span class=\"NormalTextRun ContextualSpellingAndGrammarErrorV2Themed SCXW90212530 BCX8\">originated<\/span><span class=\"NormalTextRun SCXW90212530 BCX8\"> and resolve it before it affects product movement.<\/span><\/span><span class=\"EOP Selected SCXW90212530 BCX8\" data-ccp-props=\"{}\">\u00a0<\/span><\/p><p><strong>5. <span class=\"NormalTextRun SCXW109867408 BCX8\">Build <\/span><span class=\"NormalTextRun SCXW109867408 BCX8\">the right<\/span><span class=\"NormalTextRun SCXW109867408 BCX8\"> NDC-12 <\/span><span class=\"NormalTextRun SCXW109867408 BCX8\">r<\/span><span class=\"NormalTextRun SCXW109867408 BCX8\">eadiness <\/span><span class=\"NormalTextRun SCXW109867408 BCX8\">t<\/span><span class=\"NormalTextRun SCXW109867408 BCX8\">eam <\/span><span class=\"NormalTextRun SCXW109867408 BCX8\">n<\/span><span class=\"NormalTextRun SCXW109867408 BCX8\">ow<\/span><\/strong><\/p><p><span class=\"TextRun SCXW217641145 BCX8\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW217641145 BCX8\">NDC-12 <\/span><span class=\"NormalTextRun SCXW217641145 BCX8\">shouldn\u2019t<\/span><span class=\"NormalTextRun SCXW217641145 BCX8\"> belong to a single <\/span><span class=\"NormalTextRun SCXW217641145 BCX8\">department. Depending<\/span><span class=\"NormalTextRun SCXW217641145 BCX8\"> on the organization, preparation may require participation from serialization and <\/span><\/span><a class=\"Hyperlink SCXW217641145 BCX8\" href=\"https:\/\/www.systechone.com\/products\/pharmaceutical-track-trace\/\" target=\"_blank\" rel=\"noreferrer noopener\"><span class=\"TextRun Underlined SCXW217641145 BCX8\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"none\"><span class=\"NormalTextRun SCXW217641145 BCX8\" data-ccp-charstyle=\"Hyperlink\">traceability<\/span><\/span><\/a><span class=\"TextRun SCXW217641145 BCX8\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW217641145 BCX8\">, packaging, supply chain, IT, regulatory, quality, master data, <\/span><span class=\"NormalTextRun SCXW217641145 BCX8\">finance<\/span><span class=\"NormalTextRun SCXW217641145 BCX8\"> and commercial operations<\/span><span class=\"NormalTextRun SCXW217641145 BCX8\">. Contract manufacturers, <\/span><span class=\"NormalTextRun SpellingErrorV2Themed SCXW217641145 BCX8\">repackagers<\/span><span class=\"NormalTextRun SCXW217641145 BCX8\">, 3PLs and other trading partners may also need to be part of the conversation.<\/span><span class=\"NormalTextRun SCXW217641145 BCX8\">\u00a0<\/span><\/span><\/p><p><span class=\"TextRun SCXW81527381 BCX8\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW81527381 BCX8\">A practical starting point is to <\/span><span class=\"NormalTextRun SCXW81527381 BCX8\">establish<\/span><span class=\"NormalTextRun SCXW81527381 BCX8\"> ownership <\/span><span class=\"NormalTextRun SCXW81527381 BCX8\">across<\/span><span class=\"NormalTextRun SCXW81527381 BCX8\"> four activities:<\/span><\/span><span class=\"EOP Selected SCXW81527381 BCX8\" data-ccp-props=\"{}\">\u00a0<\/span><\/p><p><strong><span class=\"TextRun SCXW13854486 BCX8\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW13854486 BCX8\" data-ccp-charstyle=\"Strong\">Map \u2192 Assess \u2192 Plan \u2192 Test<\/span><\/span><span class=\"EOP Selected SCXW13854486 BCX8\" data-ccp-props=\"{}\">\u00a0<\/span><\/strong><\/p><ul><li aria-setsize=\"-1\" data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"2\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\uf0b7&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}\" data-aria-posinset=\"6\" data-aria-level=\"1\"><b><span data-contrast=\"auto\">Map<\/span><\/b><span data-contrast=\"auto\"> every NDC touchpoint across systems, processes and partners.\u00a0<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:0,&quot;335559740&quot;:240}\">\u00a0<\/span><\/li><\/ul><ul><li aria-setsize=\"-1\" data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"2\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\uf0b7&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}\" data-aria-posinset=\"7\" data-aria-level=\"1\"><b><span data-contrast=\"auto\">Assess<\/span><\/b><span data-contrast=\"auto\"> the technology, data, labeling and operational impacts.\u00a0<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:0,&quot;335559740&quot;:240}\">\u00a0<\/span><\/li><\/ul><ul><li aria-setsize=\"-1\" data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"2\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\uf0b7&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}\" data-aria-posinset=\"8\" data-aria-level=\"1\"><b><span data-contrast=\"auto\">Plan<\/span><\/b><span data-contrast=\"auto\"> how your organization will manage the transition and coexistence period.\u00a0<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:0,&quot;335559740&quot;:240}\">\u00a0<\/span><\/li><\/ul><ul><li aria-setsize=\"-1\" data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"2\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\uf0b7&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}\" data-aria-posinset=\"9\" data-aria-level=\"1\"><b><span data-contrast=\"auto\">Test<\/span><\/b><span data-contrast=\"auto\"> across connected systems and trading partners\u2014not only within individual applications.<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/li><\/ul><p><span class=\"TextRun SCXW163963126 BCX8\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW163963126 BCX8\">Clear ownership and early cross-functional alignment can help prevent NDC-12 from becoming a last-minute compliance project.<\/span><\/span><\/p><p><strong><span class=\"TextRun SCXW45762381 BCX8\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW45762381 BCX8\">Start <\/span><span class=\"NormalTextRun SCXW45762381 BCX8\">preparing before <\/span><span class=\"NormalTextRun SCXW45762381 BCX8\">NDC-12 <\/span><span class=\"NormalTextRun SCXW45762381 BCX8\">b<\/span><span class=\"NormalTextRun SCXW45762381 BCX8\">ecomes an NDC-12 <\/span><span class=\"NormalTextRun SCXW45762381 BCX8\">p<\/span><span class=\"NormalTextRun SCXW45762381 BCX8\">roject<\/span><\/span><span class=\"EOP Selected SCXW45762381 BCX8\" data-ccp-props=\"{}\">\u00a0<\/span><\/strong><\/p><p><span class=\"NormalTextRun SCXW102300440 BCX8\">The FDA has provided the pharmaceutical ecosystem with time to prepare. Manufacturers, distributors, pharmacies, providers, <\/span><span class=\"NormalTextRun SCXW102300440 BCX8\">payors<\/span><span class=\"NormalTextRun SCXW102300440 BCX8\"> and other affected parties can use that time to update systems, <\/span><span class=\"NormalTextRun SCXW102300440 BCX8\">processes<\/span><span class=\"NormalTextRun SCXW102300440 BCX8\"> and infrastructure ahead of the <\/span><span class=\"NormalTextRun SCXW102300440 BCX8\">March <\/span><span class=\"NormalTextRun SCXW102300440 BCX8\">2033 transition.<\/span><\/p><p><span class=\"TextRun SCXW115489376 BCX8\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW115489376 BCX8\">Organizations should use that runway<\/span><\/span>.<\/p><p><span class=\"TextRun SCXW98325276 BCX8\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW98325276 BCX8\">Starting now creates more time to <\/span><span class=\"NormalTextRun SCXW98325276 BCX8\">identify<\/span><span class=\"NormalTextRun SCXW98325276 BCX8\"> system limitations, align internal teams, work with partners, <\/span><span class=\"NormalTextRun SCXW98325276 BCX8\">establish<\/span><span class=\"NormalTextRun SCXW98325276 BCX8\"> data <\/span><span class=\"NormalTextRun ContextualSpellingAndGrammarErrorV2Themed SCXW98325276 BCX8\">governance<\/span><span class=\"NormalTextRun SCXW98325276 BCX8\"> and test changes without the pressure of an imminent <\/span><span class=\"NormalTextRun SCXW98325276 BCX8\">compliance <\/span><span class=\"NormalTextRun SCXW98325276 BCX8\">deadline.<\/span><\/span><span class=\"EOP Selected SCXW98325276 BCX8\" data-ccp-props=\"{}\">\u00a0<\/span><\/p><p><span class=\"TextRun SCXW136617770 BCX8\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW136617770 BCX8\">At <\/span><span class=\"NormalTextRun SpellingErrorV2Themed SCXW136617770 BCX8\">Systech<\/span><span class=\"NormalTextRun SCXW136617770 BCX8\">, we help pharmaceutical organizations navigate evolving serialization and traceability requirements across the packaging line, site, <\/span><span class=\"NormalTextRun ContextualSpellingAndGrammarErrorV2Themed SCXW136617770 BCX8\">enterprise<\/span><span class=\"NormalTextRun SCXW136617770 BCX8\"> and supply chain<\/span><span class=\"NormalTextRun SCXW136617770 BCX8\">. <\/span><span class=\"NormalTextRun SCXW136617770 BCX8\">That means helping teams prepare not only for the next requirement, but for the operational realities that follow.<\/span><\/span><span class=\"EOP Selected SCXW136617770 BCX8\" data-ccp-props=\"{}\">\u00a0<\/span><\/p><p>\u00a0<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-1aecdc0 e-flex e-con-boxed e-con e-parent\" data-id=\"1aecdc0\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-44c3e34 e-con-full e-flex e-con e-child\" data-id=\"44c3e34\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-2ecdde1 elementor-widget__width-initial elementor-widget elementor-widget-heading\" data-id=\"2ecdde1\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Ready to assess your NDC-12 readiness?<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-5c563df e-con-full e-flex e-con e-child\" data-id=\"5c563df\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-ce7b49c elementor-widget elementor-widget-button\" data-id=\"ce7b49c\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"button.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-button-wrapper\">\n\t\t\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-sm\" href=\"\/contact-2\/\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">Talk to a Systech expert<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-e05a362 e-flex e-con-boxed e-con e-parent\" data-id=\"e05a362\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-43d0311 e-con-full e-flex e-con e-child\" data-id=\"43d0311\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-cefb937 elementor-widget elementor-widget-heading\" data-id=\"cefb937\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Frequently asked questions <\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-a6e7a4d e-con-full e-flex e-con e-child\" data-id=\"a6e7a4d\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-e466675 elementor-widget elementor-widget-n-accordion\" data-id=\"e466675\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;n_accordion_animation_duration&quot;:{&quot;unit&quot;:&quot;ms&quot;,&quot;size&quot;:300,&quot;sizes&quot;:[]},&quot;max_items_expended&quot;:&quot;multiple&quot;,&quot;default_state&quot;:&quot;expanded&quot;}\" data-widget_type=\"nested-accordion.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"e-n-accordion\" aria-label=\"Accordion. Open links with Enter or Space, close with Escape, and navigate with Arrow Keys\">\n\t\t\t\t\t\t<details id=\"e-n-accordion-item-2390\" class=\"e-n-accordion-item\" open>\n\t\t\t\t<summary class=\"e-n-accordion-item-title\" data-accordion-index=\"1\" tabindex=\"0\" aria-expanded=\"true\" aria-controls=\"e-n-accordion-item-2390\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><div class=\"e-n-accordion-item-title-text\"> What is changing with NDC-12?  <\/div><\/span>\n\t\t\t\t\t\t\t<span class='e-n-accordion-item-title-icon'>\n\t\t\t<span class='e-opened' ><i aria-hidden=\"true\" class=\"fas fa-chevron-up\"><\/i><\/span>\n\t\t\t<span class='e-closed'><i aria-hidden=\"true\" class=\"fas fa-chevron-down\"><\/i><\/span>\n\t\t<\/span>\n\n\t\t\t\t\t\t<\/summary>\n\t\t\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-2390\" class=\"elementor-element elementor-element-0d67e40 e-con-full e-flex e-con e-child\" data-id=\"0d67e40\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-768ddc4 elementor-widget elementor-widget-text-editor\" data-id=\"768ddc4\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p><span class=\"TextRun SCXW138777009 BCX8\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW138777009 BCX8\">The U.S. Food and Drug Administration is moving to a uniform 12-digit National Drug Code format for FDA-assigned NDCs. Beginning March 7, 2033, the agency will assign only 12-digit <\/span><span class=\"NormalTextRun ContextualSpellingAndGrammarErrorV2Themed SCXW138777009 BCX8\">NDCs, and<\/span><span class=\"NormalTextRun SCXW138777009 BCX8\"> previously assigned 10-digit NDCs will transition to the new format.<\/span><\/span><span class=\"EOP Selected SCXW138777009 BCX8\" data-ccp-props=\"{&quot;134233117&quot;:true,&quot;134233118&quot;:true,&quot;201341983&quot;:0,&quot;335559740&quot;:240}\">\u00a0<\/span><\/p><p><span class=\"TextRun SCXW133541810 BCX8\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW133541810 BCX8\">The change applies to human drugs, including biologics, and animal drugs. It does not apply to HIPAA-standard 11-digit reimbursement formats.<\/span><\/span><span class=\"EOP Selected SCXW133541810 BCX8\" data-ccp-props=\"{&quot;134233117&quot;:true,&quot;134233118&quot;:true,&quot;201341983&quot;:0,&quot;335559740&quot;:240}\">\u00a0<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/details>\n\t\t\t\t\t\t<details id=\"e-n-accordion-item-2391\" class=\"e-n-accordion-item\" >\n\t\t\t\t<summary class=\"e-n-accordion-item-title\" data-accordion-index=\"2\" tabindex=\"-1\" aria-expanded=\"false\" aria-controls=\"e-n-accordion-item-2391\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><div class=\"e-n-accordion-item-title-text\"> When do pharmaceutical organizations need to be ready for NDC-12?  <\/div><\/span>\n\t\t\t\t\t\t\t<span class='e-n-accordion-item-title-icon'>\n\t\t\t<span class='e-opened' ><i aria-hidden=\"true\" class=\"fas fa-chevron-up\"><\/i><\/span>\n\t\t\t<span class='e-closed'><i aria-hidden=\"true\" class=\"fas fa-chevron-down\"><\/i><\/span>\n\t\t<\/span>\n\n\t\t\t\t\t\t<\/summary>\n\t\t\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-2391\" class=\"elementor-element elementor-element-6ae9745 e-con-full e-flex e-con e-child\" data-id=\"6ae9745\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-de89963 elementor-widget elementor-widget-text-editor\" data-id=\"de89963\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p><span class=\"TextRun SCXW236516117 BCX8\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW236516117 BCX8\">The transition begins March 7, 2033, but readiness work should begin well before then. The FDA will continue assigning 10-digit NDCs until March 6, 2033, followed by a three-year labeling transition period through March 6, 2036.<\/span><\/span><\/p><p><span class=\"TextRun SCXW7336530 BCX8\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW7336530 BCX8\">That may sound like a long runway, but label updates, system changes, <\/span><span class=\"NormalTextRun SCXW7336530 BCX8\">validation<\/span><span class=\"NormalTextRun SCXW7336530 BCX8\"> and coordination with CMOs, 3PLs and trading partners can take years. Organizations that begin <\/span><span class=\"NormalTextRun SCXW7336530 BCX8\">now will have more time to <\/span><span class=\"NormalTextRun SCXW7336530 BCX8\">identify<\/span><span class=\"NormalTextRun SCXW7336530 BCX8\"> dependencies and test changes without creating unnecessary operational pressure.<\/span><\/span><span class=\"EOP SCXW7336530 BCX8\" data-ccp-props=\"{&quot;134233117&quot;:true,&quot;134233118&quot;:true,&quot;201341983&quot;:0,&quot;335559740&quot;:240}\">\u00a0<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/details>\n\t\t\t\t\t\t<details id=\"e-n-accordion-item-2392\" class=\"e-n-accordion-item\" >\n\t\t\t\t<summary class=\"e-n-accordion-item-title\" data-accordion-index=\"3\" tabindex=\"-1\" aria-expanded=\"false\" aria-controls=\"e-n-accordion-item-2392\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><div class=\"e-n-accordion-item-title-text\"> Is NDC-12 just a labeling or barcode change?  <\/div><\/span>\n\t\t\t\t\t\t\t<span class='e-n-accordion-item-title-icon'>\n\t\t\t<span class='e-opened' ><i aria-hidden=\"true\" class=\"fas fa-chevron-up\"><\/i><\/span>\n\t\t\t<span class='e-closed'><i aria-hidden=\"true\" class=\"fas fa-chevron-down\"><\/i><\/span>\n\t\t<\/span>\n\n\t\t\t\t\t\t<\/summary>\n\t\t\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-2392\" class=\"elementor-element elementor-element-8c3ab16 e-con-full e-flex e-con e-child\" data-id=\"8c3ab16\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-76656b0 elementor-widget elementor-widget-text-editor\" data-id=\"76656b0\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p><span class=\"NormalTextRun SCXW167281612 BCX8\">No. NDC-12 may begin with a product identifier, but its impact can extend across packaging, artwork, master data, serialization, ERP, warehouse systems, financial processes, <\/span><span class=\"NormalTextRun SCXW167281612 BCX8\">reporting<\/span><span class=\"NormalTextRun SCXW167281612 BCX8\"> and trading partner transactions.<\/span><\/p><p><span class=\"TextRun SCXW16116298 BCX8\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW16116298 BCX8\">The key issue is not simply whether individual systems can accept 12 digits. It is whether NDC data can move consistently from the packaging line through the enterprise and across the supply chain.<\/span><\/span><span class=\"EOP Selected SCXW16116298 BCX8\" data-ccp-props=\"{&quot;134233117&quot;:true,&quot;134233118&quot;:true,&quot;201341983&quot;:0,&quot;335559740&quot;:240}\">\u00a0<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/details>\n\t\t\t\t\t\t<details id=\"e-n-accordion-item-2393\" class=\"e-n-accordion-item\" >\n\t\t\t\t<summary class=\"e-n-accordion-item-title\" data-accordion-index=\"4\" tabindex=\"-1\" aria-expanded=\"false\" aria-controls=\"e-n-accordion-item-2393\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><div class=\"e-n-accordion-item-title-text\"> Can organizations use 10-digit and 12-digit NDCs at the same time?  <\/div><\/span>\n\t\t\t\t\t\t\t<span class='e-n-accordion-item-title-icon'>\n\t\t\t<span class='e-opened' ><i aria-hidden=\"true\" class=\"fas fa-chevron-up\"><\/i><\/span>\n\t\t\t<span class='e-closed'><i aria-hidden=\"true\" class=\"fas fa-chevron-down\"><\/i><\/span>\n\t\t<\/span>\n\n\t\t\t\t\t\t<\/summary>\n\t\t\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-2393\" class=\"elementor-element elementor-element-38dd196 e-con-full e-flex e-con e-child\" data-id=\"38dd196\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-27f64d7 elementor-widget elementor-widget-text-editor\" data-id=\"27f64d7\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p><span class=\"NormalTextRun SCXW117033059 BCX8\">During the three-year transition period for labeling, both formats may appear under certain circumstances. Organizations should <\/span><span class=\"NormalTextRun ContextualSpellingAndGrammarErrorV2Themed SCXW117033059 BCX8\">plan for<\/span><span class=\"NormalTextRun SCXW117033059 BCX8\"> how their systems, <\/span><span class=\"NormalTextRun ContextualSpellingAndGrammarErrorV2Themed SCXW117033059 BCX8\">workflows<\/span><span class=\"NormalTextRun SCXW117033059 BCX8\"> and trading-partner processes will recognize and manage both formats.<\/span><\/p><p><span class=\"NormalTextRun SCXW234662159 BCX8\">This includes deciding how the updated identifier will be represented in master data, inventory records, <\/span><span class=\"NormalTextRun ContextualSpellingAndGrammarErrorV2Themed SCXW234662159 BCX8\">transactions<\/span><span class=\"NormalTextRun SCXW234662159 BCX8\"> and reporting. Teams should also test exception scenarios, such as when a trading partner, <\/span><span class=\"NormalTextRun ContextualSpellingAndGrammarErrorV2Themed SCXW234662159 BCX8\">barcode<\/span><span class=\"NormalTextRun SCXW234662159 BCX8\"> and electronic transaction do not yet use the same format.<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/details>\n\t\t\t\t\t\t<details id=\"e-n-accordion-item-2394\" class=\"e-n-accordion-item\" >\n\t\t\t\t<summary class=\"e-n-accordion-item-title\" data-accordion-index=\"5\" tabindex=\"-1\" aria-expanded=\"false\" aria-controls=\"e-n-accordion-item-2394\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><div class=\"e-n-accordion-item-title-text\"> Who should be involved in NDC-12 readiness planning?  <\/div><\/span>\n\t\t\t\t\t\t\t<span class='e-n-accordion-item-title-icon'>\n\t\t\t<span class='e-opened' ><i aria-hidden=\"true\" class=\"fas fa-chevron-up\"><\/i><\/span>\n\t\t\t<span class='e-closed'><i aria-hidden=\"true\" class=\"fas fa-chevron-down\"><\/i><\/span>\n\t\t<\/span>\n\n\t\t\t\t\t\t<\/summary>\n\t\t\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-2394\" class=\"elementor-element elementor-element-c6dd942 e-con-full e-flex e-con e-child\" data-id=\"c6dd942\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-0bc537b elementor-widget elementor-widget-text-editor\" data-id=\"0bc537b\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p><span data-contrast=\"auto\">NDC-12 should be treated as a cross-functional business initiative, not a project owned by one department. Core stakeholders may include serialization and traceability, packaging, supply chain, IT, regulatory, quality, master data, finance and commercial operations.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:true,&quot;134233118&quot;:true,&quot;201341983&quot;:0,&quot;335559740&quot;:240}\">\u00a0<\/span><\/p><p><span data-contrast=\"auto\">Contract manufacturers, repackagers, 3PLs and other trading partners should also be part of the conversation. A practical first step is to assign ownership to <\/span><b><span data-contrast=\"auto\">map, assess, plan and test<\/span><\/b><span data-contrast=\"auto\"> every NDC touchpoint across systems, processes and partners.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:true,&quot;134233118&quot;:true,&quot;201341983&quot;:0,&quot;335559740&quot;:240}\">\u00a0<\/span><\/p><p><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/details>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>Preparing for NDC-12: A practical readiness guide for pharmaceutical organizations What the transition means for your systems, data and operations\u2014and what to do now. \u2191 The move to a uniform 12-digit National Drug Code (NDC) may look like a small change on paper. It is not.\u00a0 For pharmaceutical manufacturers, CDMOs, repackagers and their trading partners, [&hellip;]<\/p>\n","protected":false},"author":47,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"footnotes":""},"content-stage":[],"content-type":[],"conversation-track":[],"product-category":[],"class_list":["post-42406","page","type-page","status-publish","hentry"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.7 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Preparing for NDC-12: A Practical Readiness Guide for Pharmaceutical Organizations - Systech<\/title>\n<meta name=\"description\" content=\"Preparing for NDC-12: A practical readiness guide for pharmaceutical organizations What the transition means for your systems, data and operations\u2014and\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.systechone.com\/de\/preparing-for-ndc-12-a-practical-readiness-guide-for-pharmaceutical-organizations\/\" \/>\n<meta property=\"og:locale\" content=\"de_DE\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Preparing for NDC-12: A Practical Readiness Guide for Pharmaceutical Organizations - 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