Drug Supply Chain Security Act (DSCSA)

<!DOCTYPE html> <html lang="en" dir="ltr" prefix="og: https://ogp.me/ns#"> <head> <meta charset="utf-8" /> <script async src="https://www.googletagmanager.com/gtag/js?id=G-273DTKB5QW"></script> <meta name="description" content="The Drug Quality and Security Act (DQSA) of 2013 -- Law outlines critical steps to build a system to identify and trace certain prescription drugs as they are distributed in the United States. Ten years after enactment, the electronic, interoperable system will facilitate the exchange of information" /> <meta name="dcterms.title" content="Drug Supply Chain Security Act (DSCSA)" /> <meta name="dcterms.creator" content="Center for Drug Evaluation and Research" /> <meta name="dcterms.description" content="The Drug Quality and Security Act (DQSA) of 2013 -- Law outlines critical steps to build a system to identify and trace certain prescription drugs as they are distributed in the United States. Ten years after enactment, the electronic, interoperable system will facilitate the exchange of information" /> <meta name="dcterms.publisher" content="FDA" /> <meta name="dcterms.source" content="FDA" /> <meta property="og:site_name" content="U.S. Food and Drug Administration" /> <meta property="og:type" content="Article" /> <meta property="og:url" content="https://www.fda.gov/drugs/drug-supply-chain-integrity/drug-supply-chain-security-act-dscsa" /> <meta property="og:title" content="Drug Supply Chain Security Act (DSCSA)" /> <meta property="og:description" content="DQSA of 2013 -- Law outlines critical steps to build a system to identify and trace certain prescription drugs as they are distributed in the United States" /> <meta property="og:updated_time" content="Thu, 07/18/2024 - 00:00" /> <meta property="article:published_time" content="Fri, 08/09/2024 - 22:45" /> <meta property="article:modified_time" content="Thu, 07/18/2024 - 00:00" /> <meta name="google-site-verification" content="tWxlDhm4ANdksJZPj7TBmHgNoMqZCnecPp0Aa2vC9XA" /> <meta name="twitter:card" content="summary_large_image" /> <meta name="twitter:site" content="@US_FDA" /> <meta property="twitter:description" content="DQSA of 2013 -- Law outlines critical steps to build a system to identify and trace certain prescription drugs as they are distributed in the United States" /> <meta name="twitter:title" content="Drug Supply Chain Security Act (DSCSA)" /> <meta name="twitter:creator" content="@US_FDA" /> <meta name="MobileOptimized" content="width" /> <meta name="HandheldFriendly" content="true" /> <meta name="viewport" content="width=device-width, initial-scale=1.0" /> <script type="application/ld+json">{ "@context": "https://schema.org", "@graph": [ { "@type": "Article", "headline": "Drug Supply Chain Security Act (DSCSA)", "name": "Drug Supply Chain Security Act (DSCSA)", "description": "The Drug Quality and Security Act (DQSA) of 2013 -- Law outlines critical steps to build a system to identify and trace certain prescription drugs as they are distributed in the United States. Ten years after enactment, the electronic, interoperable system will facilitate the exchange of information", "datePublished": "Fri, 08/09/2024 - 22:45", "dateModified": "Thu, 07/18/2024 - 00:00", "author": { "@type": "Organization", "name": "Center for Drug Evaluation and Research" }, "publisher": { "@type": "Organization", "name": "FDA" } } ] }</script> <meta property="og:image" content="https://www.fda.gov/themes/custom/preview/img/FDA-Social-Graphic.png" /> <meta name="twitter:image" content="https://www.fda.gov/themes/custom/preview/img/FDA-Social-Graphic.png" /> <link rel="icon" href="/themes/custom/preview/favicon.ico" type="image/vnd.microsoft.icon" /> <link rel="alternate" hreflang="en" href="https://www.fda.gov/drugs/drug-supply-chain-integrity/drug-supply-chain-security-act-dscsa" /> <link rel="canonical" href="https://www.fda.gov/drugs/drug-supply-chain-integrity/drug-supply-chain-security-act-dscsa" /> <link rel="shortlink" href="https://www.fda.gov/node/359976" /> <script src="/files/google_tag/production/google_tag.script.js?smgeuw" defer></script> <title>Drug Supply Chain Security Act (DSCSA) | FDA</title> <link rel="stylesheet" media="all" href="/files/css/css_pF_-QtQgT8ZN3eoadzEfql-KALI0XgOcCRIPM_0eEtw.css?delta=0&language=en&theme=preview&include=eJxlj1GOwjAMRC8UGn6Q9jaRm7hpRBJbtgvqnn4paFsEP9Z4LI3fTNQN7qjU0E-HHlwmyhUDdKirlaj-03C6qmHzIyg6FrwVvPtcaYR6Ultr6fnLjlLY1I1EpibAnonphuKmBCFeMRUjCdhn6BEbdlMPMZKkQj0Y5Q1AZxKLlNBt0eqfc2iUloqvHGpcy5bwuoXL-efNdAwC-fF8Vp9kYajD4QxL52WsRWdMbnpgdjJUv6u9URT4XTEfFRPwE-p_3zFPe4M_uG6P1A" /> <link rel="stylesheet" media="all" href="/files/css/css_xLeUZALg1CD0YmiSIzZnqkwKfNF_g3TkAjkxBt_uccA.css?delta=1&language=en&theme=preview&include=eJxlj1GOwjAMRC8UGn6Q9jaRm7hpRBJbtgvqnn4paFsEP9Z4LI3fTNQN7qjU0E-HHlwmyhUDdKirlaj-03C6qmHzIyg6FrwVvPtcaYR6Ultr6fnLjlLY1I1EpibAnonphuKmBCFeMRUjCdhn6BEbdlMPMZKkQj0Y5Q1AZxKLlNBt0eqfc2iUloqvHGpcy5bwuoXL-efNdAwC-fF8Vp9kYajD4QxL52WsRWdMbnpgdjJUv6u9URT4XTEfFRPwE-p_3zFPe4M_uG6P1A" /> <script src="https://script.crazyegg.com/pages/scripts/0024/3700.js" async></script> <script src="https://dap.digitalgov.gov/Universal-Federated-Analytics-Min.js?agency=HHS&subagency=FDA&sdor=fda.gov&dclink=true" language="javascript" id="_fed_an_ua_tag"></script> <script>window.dataLayer = window.dataLayer || [];function gtag(){dataLayer.push(arguments)};gtag("js", new Date());gtag("set", "developer_id.dMDhkMT", true);gtag("config", "G-273DTKB5QW", {"groups":"default","page_placeholder":"PLACEHOLDER_page_location","allow_ad_personalization_signals":false});</script> </head> <body class="role-anonymous path-node page-node-type-sub-section has-glyphicons"> <div id="quicklinks" class="sr-only"> <ul> <li><a href="#main-content" class="sr-only sr-only-focusable" tabindex="1">Skip to main content</a></li> <li><a href="#search-form" class="sr-only sr-only-focusable" tabindex="1">Skip to FDA Search</a></li> <li><a href="#section-nav" class="sr-only sr-only-focusable" tabindex="1">Skip to in this section menu</a></li> <li><a href="#footer-heading" class="sr-only sr-only-focusable" tabindex="1">Skip to footer links</a></li> </ul> </div> <noscript><iframe src="https://www.googletagmanager.com/ns.html?id=GTM-M95XGZW" height="0" width="0" style="display:none;visibility:hidden"></iframe></noscript> <div class="dialog-off-canvas-main-canvas" data-off-canvas-main-canvas> <div class="main-container container-fluid"> <div class="row"> <header class="lcds-header container-fluid" role="heading" aria-level="1"> <div class="row us-masthead"> <div class="usa-banner col-xs-12"> <img class="usa-banner__us-flag" src="/themes/custom/preview/assets/images/US_Flag.png" alt="U.S. flag" /> <span>An official website of the United States government</span> <a id="USMenuButton" class="collapsed" data-toggle="collapse" data-target="#USABannerMenu" aria-controls="USABannerMenu">Here’s how you know <span class="toggle-indicator"> </span></a> <div class="col-xs-12 collapse usa-banner__menu" id="USABannerMenu" aria-labelledby="USMenuButton"> <div id="gov-banner" class="row usa-banner-content usa-grid usa-accordion-content" aria-hidden="true"> <div class="col-xs-12 col-sm-6 col-md-3"> <img class="usa-banner-icon usa-media_block-img" src="/themes/custom/preview/assets/images/icon-dot-gov.svg" alt="Dot gov" style="width:3em;"> <div class="usa-media_block-body"> <p><strong>The .gov means it’s official.</strong><br>Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.</p> </div> </div> <div class="col-xs-12 col-sm-6 col-md-3"> <img class="usa-banner-icon usa-media_block-img" src="/themes/custom/preview/assets/images/icon-https.svg" alt="SSL" style="width:3em;"> <div class="usa-media_block-body"> <p><strong>The site is secure.</strong><br> The <strong>https://</strong> ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.</p> </div> </div> </div> </div> </div> </div> <div class="alert alert-warning margin-left-neg-2 margin-right-neg-2 margin-top-3 margin-bottom-1"> <p>On Oct. 1, 2024, the FDA began implementing a <a href="/about-fda/fda-organization/fda-modernization-efforts-establishing-unified-human-foods-program-new-model-field-operations-and" title="FDA Modernization Efforts for Establishing a Unified Human Foods Program, New Model for Field Operations and More">reorganization</a> impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.</p> </div> <div class="row fda-masthead"> <div class="col-xs-4 col-md-8"> <a href="/" title="FDA Homepage"> <h1 class="fda-masthead__fda-logo">U.S. Food and Drug Administration</h1> </a> </div> <div class="col-xs-8 col-md-4"> <ul class='fda-masthead__item-list'> <li><a title="" id="btn-search" class="btn btn-default btn-sm fda-masthead__btn-search"> <span class="fa fa-search" aria-hidden="true"> </span> <span class="fda-masthead__btn-label">Search</span> </a></li> <li><a id="menu-btn" class="btn btn-default btn-sm fda-masthead__btn-menu collapsed" href="#primary-nav" data-toggle="collapse" aria-expanded="true"> <span class="fa fa-bars" aria-hidden="true"> </span> <span class='fda-masthead__btn-label'>Menu</span> </a></li> </ul> </div> <form class="fda-masthead__search sr-only" role="search" action="/search" method="GET" name="searchForm" id="search-form" accept-charset="UTF-8" > <div class="search-popover" id="search-popover"> <div class="input-group pull-right" id="search-group"> <label class="sr-only" for="search-query">Search FDA</label> <input class="form-control search-input" id="search-query" name="s" aria-autocomplete="list" aria-haspopup="true" title="Enter the terms you wish to search for." placeholder="Search FDA" type="text" /> <span class="input-group-btn" id="input-group-btn"> <button type="submit" class="btn btn-danger search-btn" id="search-btn" title="Search"><span class="fa fa-search" aria-hidden="true"><span class="sr-only">Submit search</span></span></button> </span> </div> </div> </form> </div> <nav id="primary-nav" class="lcds-primary-nav row collapse"> <div class="col-md-5 col-lg-4"> <section class="lcds-primary-nav__group lcds-primary-nav__group--bordered"> <h2 class="lcds-primary-nav__group-heading">Featured</h2> <ul class="lcds-primary-nav__list lcds-primary-nav__list--featured"> <li class="lcds-primary-nav__list-item"><a href="https://www.safetyreporting.hhs.gov/smarthub#/" title="Report a Problem with an FDA Regulated Product">Report a Product Problem</a></li> <li class="lcds-primary-nav__list-item"><a href="/about-fda/contact-fda">Contact FDA</a></li> <li class="lcds-primary-nav__list-item"><a href="/regulatory-information/search-fda-guidance-documents">FDA Guidance Documents</a></li> <li class="lcds-primary-nav__list-item"><a href="/safety/recalls-market-withdrawals-safety-alerts">Recalls, Market Withdrawals and Safety Alerts</a></li> <li class="lcds-primary-nav__list-item"><a href="/news-events/newsroom/press-announcements">Press Announcements</a></li> <li class="lcds-primary-nav__list-item"><a href="/inspections-compliance-enforcement-and-criminal-investigations/compliance-actions-and-activities/warning-letters">Warning Letters</a></li> <li class="lcds-primary-nav__list-item"><a href="/advisory-committees">Advisory Committees</a></li> <li class="lcds-primary-nav__list-item"><a href="/fda-en-espanol">En Espa&#241ol</a></li> </ul> </section> </div> <div class="col-md-7 col-lg-8"> <section class="lcds-primary-nav__group lcds-primary-nav__group--bordered"> <h2 class="lcds-primary-nav__group-heading">Products</h2> <ul class="lcds-primary-nav__list"> <li class="lcds-primary-nav__list-item"><a href="/food">Food</a></li> <li class="lcds-primary-nav__list-item"><a href="/drugs">Drugs</a></li> <li class="lcds-primary-nav__list-item"><a href="/medical-devices">Medical Devices</a></li> <li class="lcds-primary-nav__list-item"><a href="/radiation-emitting-products">Radiation-Emitting Products</a></li> <li class="lcds-primary-nav__list-item"><a href="/vaccines-blood-biologics">Vaccines, Blood, and Biologics</a></li> <li class="lcds-primary-nav__list-item"><a href="/animal-veterinary">Animal and Veterinary</a></li> <li class="lcds-primary-nav__list-item"><a href="/cosmetics">Cosmetics</a></li> <li class="lcds-primary-nav__list-item"><a href="/tobacco-products">Tobacco Products</a></li> </ul> </section> <section class="lcds-primary-nav__group lcds-primary-nav__group--bordered"> <h2 class="lcds-primary-nav__group-heading">Topics</h2> <ul class="lcds-primary-nav__list"> <li class="lcds-primary-nav__list-item"><a href="/about-fda">About FDA</a></li> <li class="lcds-primary-nav__list-item"><a href="/combination-products">Combination Products</a></li> <li class="lcds-primary-nav__list-item"><a href="/regulatory-information">Regulatory Information</a></li> <li class="lcds-primary-nav__list-item"><a href="/safety">Safety</a></li> <li class="lcds-primary-nav__list-item"><a href="/emergency-preparedness-and-response">Emergency Preparedness</a></li> <li class="lcds-primary-nav__list-item"><a href="/international-programs">International Programs</a></li> <li class="lcds-primary-nav__list-item"><a href="/news-events">News and Events</a></li> <li class="lcds-primary-nav__list-item"><a href="/training-and-continuing-education">Training and Continuing Education</a></li> <li class="lcds-primary-nav__list-item"><a href="/inspections-compliance-enforcement-and-criminal-investigations">Inspections and Compliance</a></li> <li class="lcds-primary-nav__list-item"><a href="/science-research">Science and Research</a></li> </ul> </section> <section class="lcds-primary-nav__group lcds-primary-nav__group--bordered"> <h2 class="lcds-primary-nav__group-heading">Information For</h2> <ul class="lcds-primary-nav__list"> <li class="lcds-primary-nav__list-item"><a href="/consumers">Consumers</a></li> <li class="lcds-primary-nav__list-item"><a href="/patients">Patients</a></li> <li class="lcds-primary-nav__list-item"><a href="/industry">Industry</a></li> <li class="lcds-primary-nav__list-item"><a href="/health-professionals">Health Professionals</a></li> <li class="lcds-primary-nav__list-item"><a href="/federal-state-local-tribal-and-territorial-officials">Federal, State and Local Officials</a></li> </ul> </section> </div> </nav> </header> <div class="col-xs-12"> <div data-drupal-messages-fallback class="hidden"></div> </div> <section id="block-entityviewcontent" data-block-plugin-id="entity_view:node" class="block block-ctools block-entity-viewnode clearfix"> <a class="lcds-button--expandable collapsed hidden-md hidden-lg" data-toggle="collapse" href="#section-nav">In this section<span class="visible-sm-inline-block">: Drug Supply Chain Integrity </span> </a> <nav id="section-nav" class="lcds-card lcds-section-nav lcds-section-nav hidden-md hidden-lg collapse"> <ul class="lcds-section-nav__list"> <li> <a href="/drugs/drug-supply-chain-integrity/drug-supply-chain-security-act-dscsa" class="lcds-section-nav__section-link lcds-section-nav__link lcds-section-nav__parent-link">Drug Supply Chain Security Act (DSCSA)</a> <div class="views-element-container form-group"><div class="view view-in-this-section view-id-in_this_section view-display-id-block_5 js-view-dom-id-122ba9ac959d15d54813f5f0af2a14eb87dc65de91fc7a541aeff470d4d8e6f6"> <div> <ul class="lcds-section-nav__section-link__active lcds-section-nav__list"> <li><a href="/drugs/drug-supply-chain-security-act-dscsa/drug-supply-chain-security-act-law-and-policies" class="lcds-section-nav__link">Drug Supply Chain Security Act Law and Policies</a></li> <li><a href="/drugs/drug-supply-chain-security-act-dscsa/drug-supply-chain-security-act-dscsa-portal-cder-nextgen" class="lcds-section-nav__link">Drug Supply Chain Security Act (DSCSA) Portal in CDER NextGen</a></li> <li><a href="/drugs/drug-supply-chain-security-act-dscsa/drug-supply-chain-security-act-dscsa-waivers-exceptions-and-exemptions" class="lcds-section-nav__link">The Drug Supply Chain Security Act (DSCSA) Waivers, Exceptions, and Exemptions</a></li> <li><a href="/drugs/drug-supply-chain-security-act-dscsa/notify-fda-illegitimate-products" class="lcds-section-nav__link">Notify FDA of Illegitimate Products</a></li> <li><a href="/drugs/drug-supply-chain-security-act-dscsa/pharmacists-utilize-dscsa-requirements-protect-your-patients" class="lcds-section-nav__link">Pharmacists: Utilize DSCSA Requirements to Protect Your Patients</a></li> <li><a href="/drugs/drug-supply-chain-security-act-dscsa/drug-supply-chain-security-act-dscsa-assessment-small-dispensers" class="lcds-section-nav__link">Drug Supply Chain Security Act (DSCSA) Assessment of Small Dispensers</a></li> <li><a href="/drugs/drug-supply-chain-security-act-dscsa/engage-fda" class="lcds-section-nav__link">Engage with FDA</a></li> <li><a href="/drugs/drug-supply-chain-security-act-dscsa/drug-supply-chain-security-act-public-private-partnership" class="lcds-section-nav__link">Drug Supply Chain Security Act Public-Private Partnership</a></li> <li><a href="/drugs/drug-supply-chain-security-act-dscsa/annual-licensure-reporting-wholesale-drug-distributors-and-third-party-logistics-providers" class="lcds-section-nav__link">Annual Licensure Reporting by Wholesale Drug Distributors and Third-Party Logistics Providers</a></li> </ul> </div> </div> </div> <div class="views-element-container form-group"><div class="view view-in-this-section-sub view-id-in_this_section_sub view-display-id-block_2 js-view-dom-id-acf2739643e52687cc7d1bf7b1c6d4cb2b9be59176fc5e5151616c563e2d6063"> </div> </div> </li> </ul> </nav> </section> <section id="block-entityviewcontent-15" data-block-plugin-id="entity_view:node" class="block block-ctools block-entity-viewnode clearfix"> <ol class="lcds-breadcrumb visible-md visible-lg"> <li > <a href="/">Home</a> </li> <li > <a href="/drugs">Drugs</a> </li> <li > <a href="/drugs/drug-safety-and-availability">Drug Safety and Availability</a> </li> <li > <a href="/drugs/drug-safety-and-availability/drug-supply-chain-integrity">Drug Supply Chain Integrity</a> </li> <li > <a class="current-link">Drug Supply Chain Security Act (DSCSA)</a> </li> </ol> <ol class="lcds-breadcrumb visible-sm visible-xs"> <li> <a href="/drugs/drug-safety-and-availability/drug-supply-chain-integrity" title="Drug Supply Chain Integrity"> Drug Supply Chain Integrity </a> </li> </ol> </section> <main> <article id="main-content" class="article main-content container-fluid" role="article"> <header class="row content-header" role="heading" aria-level="1"> <section id="block-entityviewcontent-14" data-block-plugin-id="entity_view:node" class="block block-ctools block-entity-viewnode clearfix"> <div class="col-sm-12 col-md-8 col-md-offset-2"> <h1 class="content-title text-center">Drug Supply Chain Security Act (DSCSA)</h1> <div class="lcds-toolbar lcds-toolbar--social"> <ul class="lcds-share lcds-share--default"> <li class="lcds-share__item"> <a href="https://www.facebook.com/sharer/sharer.php?u=https://www.fda.gov%2Fdrugs%2Fdrug-supply-chain-integrity%2Fdrug-supply-chain-security-act-dscsa" class="lcds-share__btn lcds-share--default__btn-facebook js-share" id="fb-share" target="_blank"><span class="fa icon-facebook" aria-hidden="true"></span>Share</a> </li> <li class="lcds-share__item"> <a href="https://x.com/intent/tweet/?text=Drug%20Supply%20Chain%20Security%20Act%20%28DSCSA%29&url=https://www.fda.gov%2Fdrugs%2Fdrug-supply-chain-integrity%2Fdrug-supply-chain-security-act-dscsa" target="_blank" class="lcds-share__btn lcds-share--default__btn-x-twitter js-share" id="twitter-share"> <svg class="icon-svg-inline" aria-hidden="true"> <use href="/themes/custom/preview/assets/images/fa-icons.svg#icon-x-twitter"> </svg> Post </a> </li> <li class="lcds-share__item hidden-xs"> <a href="https://www.linkedin.com/shareArticle?mini=true&url=https://www.fda.gov%2Fdrugs%2Fdrug-supply-chain-integrity%2Fdrug-supply-chain-security-act-dscsa&title=Drug%20Supply%20Chain%20Security%20Act%20%28DSCSA%29&source=FDA" class="lcds-share__btn lcds-share--default__btn-linkedin js-share" id="linkedin-share" target="_blank"><span class="fa icon-linkedin" aria-hidden="true"></span>Linkedin</a> </li> <li class="lcds-share__item"> <a href="mailto:?subject=Drug%20Supply%20Chain%20Security%20Act%20%28DSCSA%29&body=https://www.fda.gov%2Fdrugs%2Fdrug-supply-chain-integrity%2Fdrug-supply-chain-security-act-dscsa" class="lcds-share__btn lcds-share--default__btn-mail"><span class="fa icon-envelope" aria-hidden="true"></span>Email</a> </li> <li class=" lcds-share__item hidden-xs"> <a href="javascript:window.print();" title="Print this page" class="lcds-share__btn lcds-share--default__btn-print"><span class="fa icon-print" aria-hidden="true"></span>Print</a> </li> </ul> <div class="form-group"> </div> </div> </div> </section> </header> <div class="col-md-8 col-md-push-2" role="main"> <p class="text-align-center"><a class="btn btn-primary" href="https://public.govdelivery.com/accounts/USFDA/subscriber/new?topic_id=USFDA_661" target="_blank"><span class="text">Sign up for Drug Supply Chain Security Act email updates</span></a></p> <p>The <a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="c10d944c-8cb1-41a2-ab64-bd9723748867" href="/drugs/drug-supply-chain-security-act-dscsa/title-ii-drug-quality-and-security-act" title="Title II of the Drug Quality and Security Act">Drug Supply Chain Security Act (DSCSA)</a> outlines steps to achieve an interoperable and electronic way to identify and trace certain prescription drugs at the package level as they move through the supply chain. This helps prevent harmful drugs from entering the U.S. drug supply chain, detect harmful drugs if they do enter the supply chain and enable rapid response to remove harmful drugs from the supply chain to protect patients.</p> <p>Visit <a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="29090898-d1f8-4935-96a8-f4d794c07185" href="/drugs/drug-supply-chain-security-act-dscsa/fdas-implementation-drug-supply-chain-security-act-dscsa-requirements" title="FDA’s Implementation of Drug Supply Chain Security Act (DSCSA) Requirements">FDA’s implementation of DSCSA requirements</a> and <a href="/drugs/drug-supply-chain-security-act-dscsa/drug-supply-chain-security-act-product-tracing-requirements-frequently-asked-questions" title="Drug Supply Chain Security Act Product Tracing Requirements | Frequently Asked Questions">product tracing</a> for more information.</p> <div class="inset-column"> <div type="info"> <div class="alert alert-info"> <h5>Latest Activity</h5> <ul> <li>FDA reopened a <a href="https://lnks.gd/l/eyJhbGciOiJIUzI1NiJ9.eyJidWxsZXRpbl9saW5rX2lkIjoxMDMsInVyaSI6ImJwMjpjbGljayIsInVybCI6Imh0dHBzOi8vd3d3LmZlZGVyYWxyZWdpc3Rlci5nb3YvcHVibGljLWluc3BlY3Rpb24vMjAyNC0xMjg1Ny9pbnRlcm9wZXJhYmxlLXN5c3RlbXMtYW5kLXByb2Nlc3Nlcy1mb3ItZW5oYW5jZWQtZHJ1Zy1kaXN0cmlidXRpb24tc2VjdXJpdHktcmVxdWlyZW1lbnRzLXVuZGVyLXRoZT91dG1fbWVkaXVtPWVtYWlsJnV0bV9zb3VyY2U9Z292ZGVsaXZlcnkiLCJidWxsZXRpbl9pZCI6IjIwMjQwNjEzLjk2MjAyNzMxIn0.varom9pvEKZgZC62LK69LPku30E2cGHVrxHFg6Aw21M/s/1255905117/br/244119972230-l">request for information</a> to better understand the status of trading partners’ interoperable systems and processes for enhanced drug distribution security (June 12, 2024).</li> <li><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="cb33bdff-551f-4fe5-a649-a9177b0987ef" href="/drugs/drug-supply-chain-security-act-dscsa/waivers-and-exemptions-beyond-stabilization-period" title="Waivers and Exemptions Beyond the Stabilization Period">DSCSA waivers and exemptions beyond the stabilization period, June 12, 2024</a></li> </ul> </div> </div> </div> <br> <div class="field field--name-field-sub-topic-paragraphs field--type-entity-reference-revisions field--label-above"> <div class="field--label">Sub-Topic Paragraphs</div> <div class="field--items"> <div class="field--item"> <section class="lcds-card-deck--promoted lcds-card-deck bg-lightest-gray"> <header class="lcds-card-deck__header"> <h2 class="lcds-card-deck__heading sr-only" >Learn more about the Drug Supply Chain Security Act (DSCSA)</h2> </header> <div class="lcds-card-deck__body"> <a href="/drugs/drug-supply-chain-security-act-dscsa/drug-supply-chain-security-act-law-and-policies" title="Review DSCSA and FDA policies"> <article class="lcds-card lcds-card--promoted lcds-card--promoted-subtopic bg-white"> <div> <div class="field field--name-image field--type-image field--label-hidden field--item"> <picture> <source srcset="/files/styles/thunbnail_3/public/dscsa-policy.png?itok=vXAcfiUC 380w" media="all and (max-width: 320px)" type="image/png" sizes="100vw" width="380" height="200"/> <source srcset="/files/styles/thunbnail_3/public/dscsa-policy.png?itok=vXAcfiUC 380w" media="all and (min-width: 321px) and (max-width: 480px)" type="image/png" sizes="100vw" width="380" height="200"/> <source srcset="/files/styles/medium_3/public/dscsa-policy.png?itok=kL8Ptw8c 420w" media="all and (min-width: 481px) and (max-width: 767px)" type="image/png" sizes="100vw" width="420" height="220"/> <source srcset="/files/styles/medium_3/public/dscsa-policy.png?itok=kL8Ptw8c 420w" media="all and (min-width: 768px) and (max-width: 992px)" type="image/png" sizes="100vw" width="420" height="220"/> <source srcset="/files/styles/medium_3/public/dscsa-policy.png?itok=kL8Ptw8c 420w" media="all and (min-width: 993px) and (max-width: 1200px)" type="image/png" sizes="100vw" width="420" height="220"/> <source srcset="/files/styles/medium_3/public/dscsa-policy.png?itok=kL8Ptw8c 420w" media="all and (min-width: 1201px)" type="image/png" sizes="100vw" width="420" height="220"/> <img loading="eager" src="/files/styles/medium_3/public/dscsa-policy.png?itok=kL8Ptw8c" width="420" height="220" alt="Review DSCSA and FDA Policies" class="img-responsive" /> </picture> </div> </div> <div class="lcds-card__body"> <h3 class="lcds-card__title">Review DSCSA and FDA policies</h3> <p class="lcds-card__text"></p> </div> </article> </a> <a href="/drugs/drug-supply-chain-security-act-dscsa/pharmacists-utilize-dscsa-requirements-protect-your-patients" title="Find information for pharmacists"> <article class="lcds-card lcds-card--promoted lcds-card--promoted-subtopic bg-white"> <div> <div class="field field--name-image field--type-image field--label-hidden field--item"> <picture> <source srcset="/files/styles/thunbnail_3/public/dscsa-pharmacists.png?itok=VtVMCV5l 380w" media="all and (max-width: 320px)" type="image/png" sizes="100vw" width="380" height="200"/> <source srcset="/files/styles/thunbnail_3/public/dscsa-pharmacists.png?itok=VtVMCV5l 380w" media="all and (min-width: 321px) and (max-width: 480px)" type="image/png" sizes="100vw" width="380" height="200"/> <source srcset="/files/styles/medium_3/public/dscsa-pharmacists.png?itok=-mfUBcEK 420w" media="all and (min-width: 481px) and (max-width: 767px)" type="image/png" sizes="100vw" width="420" height="220"/> <source srcset="/files/styles/medium_3/public/dscsa-pharmacists.png?itok=-mfUBcEK 420w" media="all and (min-width: 768px) and (max-width: 992px)" type="image/png" sizes="100vw" width="420" height="220"/> <source srcset="/files/styles/medium_3/public/dscsa-pharmacists.png?itok=-mfUBcEK 420w" media="all and (min-width: 993px) and (max-width: 1200px)" type="image/png" sizes="100vw" width="420" height="220"/> <source srcset="/files/styles/medium_3/public/dscsa-pharmacists.png?itok=-mfUBcEK 420w" media="all and (min-width: 1201px)" type="image/png" sizes="100vw" width="420" height="220"/> <img loading="eager" src="/files/styles/medium_3/public/dscsa-pharmacists.png?itok=-mfUBcEK" width="420" height="220" alt="pharmacist speaking to a patient" class="img-responsive" /> </picture> </div> </div> <div class="lcds-card__body"> <h3 class="lcds-card__title">Find information for pharmacists</h3> <p class="lcds-card__text"></p> </div> </article> </a> <a href="/drugs/drug-supply-chain-security-act-dscsa/drug-supply-chain-security-act-public-private-partnership" title="Learn about our private-public partnership "> <article class="lcds-card lcds-card--promoted lcds-card--promoted-subtopic bg-white"> <div> <div class="field field--name-image field--type-image field--label-hidden field--item"> <picture> <source srcset="/files/styles/thunbnail_3/public/dscsa-public-private-partnership.png?itok=fVzrmteL 380w" media="all and (max-width: 320px)" type="image/png" sizes="100vw" width="380" height="200"/> <source srcset="/files/styles/thunbnail_3/public/dscsa-public-private-partnership.png?itok=fVzrmteL 380w" media="all and (min-width: 321px) and (max-width: 480px)" type="image/png" sizes="100vw" width="380" height="200"/> <source srcset="/files/styles/medium_3/public/dscsa-public-private-partnership.png?itok=kzfJZAP3 420w" media="all and (min-width: 481px) and (max-width: 767px)" type="image/png" sizes="100vw" width="420" height="220"/> <source srcset="/files/styles/medium_3/public/dscsa-public-private-partnership.png?itok=kzfJZAP3 420w" media="all and (min-width: 768px) and (max-width: 992px)" type="image/png" sizes="100vw" width="420" height="220"/> <source srcset="/files/styles/medium_3/public/dscsa-public-private-partnership.png?itok=kzfJZAP3 420w" media="all and (min-width: 993px) and (max-width: 1200px)" type="image/png" sizes="100vw" width="420" height="220"/> <source srcset="/files/styles/medium_3/public/dscsa-public-private-partnership.png?itok=kzfJZAP3 420w" media="all and (min-width: 1201px)" type="image/png" sizes="100vw" width="420" height="220"/> <img loading="eager" src="/files/styles/medium_3/public/dscsa-public-private-partnership.png?itok=kzfJZAP3" width="420" height="220" alt="public private partnership drug supply chain security act" class="img-responsive" /> </picture> </div> </div> <div class="lcds-card__body"> <h3 class="lcds-card__title">Learn about our private-public partnership </h3> <p class="lcds-card__text"></p> </div> </article> </a> <a href="/drugs/drug-supply-chain-security-act-dscsa/engage-fda" title="Engage with FDA"> <article class="lcds-card lcds-card--promoted lcds-card--promoted-subtopic bg-white"> <div> <div class="field field--name-image field--type-image field--label-hidden field--item"> <picture> <source srcset="/files/styles/thunbnail_3/public/dscsa-engage.png?itok=KhUP1Eco 380w" media="all and (max-width: 320px)" type="image/png" sizes="100vw" width="380" height="200"/> <source srcset="/files/styles/thunbnail_3/public/dscsa-engage.png?itok=KhUP1Eco 380w" media="all and (min-width: 321px) and (max-width: 480px)" type="image/png" sizes="100vw" width="380" height="200"/> <source srcset="/files/styles/medium_3/public/dscsa-engage.png?itok=QCcHuJCL 420w" media="all and (min-width: 481px) and (max-width: 767px)" type="image/png" sizes="100vw" width="420" height="220"/> <source srcset="/files/styles/medium_3/public/dscsa-engage.png?itok=QCcHuJCL 420w" media="all and (min-width: 768px) and (max-width: 992px)" type="image/png" sizes="100vw" width="420" height="220"/> <source srcset="/files/styles/medium_3/public/dscsa-engage.png?itok=QCcHuJCL 420w" media="all and (min-width: 993px) and (max-width: 1200px)" type="image/png" sizes="100vw" width="420" height="220"/> <source srcset="/files/styles/medium_3/public/dscsa-engage.png?itok=QCcHuJCL 420w" media="all and (min-width: 1201px)" type="image/png" sizes="100vw" width="420" height="220"/> <img loading="eager" src="/files/styles/medium_3/public/dscsa-engage.png?itok=QCcHuJCL" width="420" height="220" alt="Engage with FDA on Drug Supply Chain Security Act" class="img-responsive" /> </picture> </div> </div> <div class="lcds-card__body"> <h3 class="lcds-card__title">Engage with FDA</h3> <p class="lcds-card__text"></p> </div> </article> </a> </div> </section></div> <div class="field--item"> <section class="lcds-card-deck--teaser lcds-card-deck txt-dark"> <header class="lcds-card-deck__header"> <h2 class="lcds-card-deck__heading" >Submit Information to FDA</h2> </header> <div class="lcds-card-deck__body"> <article class="lcds-card lcds-card--border-top lcds-card--teaser lcds-card--teaser-subtopic"> <h3 class="lcds-card__title"><a href="/drugs/drug-supply-chain-security-act-dscsa/drug-supply-chain-security-act-dscsa-portal-cder-nextgen">DSCSA Portal</a></h3> <p class="lcds-card__text">Use the DSCSA portal to exchange information with FDA and other trading partners.</p> </article> <article class="lcds-card lcds-card--border-top lcds-card--teaser lcds-card--teaser-subtopic"> <h3 class="lcds-card__title"><a href="/drugs/drug-supply-chain-security-act-dscsa/drug-supply-chain-security-act-dscsa-waivers-exceptions-and-exemptions">Waiver, Exceptions and Exemptions</a></h3> <p class="lcds-card__text">Request a waiver, exception and exemption from certain DSCSA requirements.</p> </article> <article class="lcds-card lcds-card--border-top lcds-card--teaser lcds-card--teaser-subtopic"> <h3 class="lcds-card__title"><a href="/drugs/drug-supply-chain-security-act-dscsa/notify-fda-illegitimate-products">Illegitimate Product Notification</a></h3> <p class="lcds-card__text">Notify FDA within 24-hours after determining a product is illegitimate. </p> </article> <article class="lcds-card lcds-card--border-top lcds-card--teaser lcds-card--teaser-subtopic"> <h3 class="lcds-card__title"><a href="/drugs/drug-supply-chain-security-act-dscsa/annual-licensure-reporting-wholesale-drug-distributors-and-third-party-logistics-providers">Annual Reports for Licensure</a></h3> <p class="lcds-card__text">Wholesale distributors and third-party logistics providers to report licensure and other information annually to FDA.</p> </article> </div> </section> </div> </div> </div> <br> </div> <aside class="col-md-2 col-md-push-2" role="complementary"> <section id="block-entityviewcontent-4" data-block-plugin-id="entity_view:node" class="block block-ctools block-entity-viewnode clearfix"> <div class="region region-"> <aside class="lcds-card lcds-card--border-top" > <ul role="menu" class="lcds-description-list"> <li role="menuitem" class="node-current-date lcds-description-list__item"> <div> <h2 class="lcds-description-list__item-heading">Content current as of:</h2> <p class="lcds-description-list__item-text"><time datetime="2024-07-18T00:00:00Z">07/18/2024</time> </p> </div> </li> <li role="menuitem" class="lcds-description-list__item"> <div> <h2 class="lcds-description-list__item-heading">Regulated Product(s)</h2> <ul role="menu" class="lcds-metadata-list"> <li role="menuitem">Drugs</li> </ul> </div> </li> </ul> </aside> </div> </section> </aside> <aside class="col-md-2 col-md-pull-10" role="complementary"> <section id="block-entityviewcontent-3" data-block-plugin-id="entity_view:node" class="block block-ctools block-entity-viewnode clearfix"> <div class="region region-"> <nav id="section-nav" class="lcds-card lcds-section-nav lcds-section-nav--side hidden-xs hidden-sm"> <ul class="lcds-section-nav__list lcds-section-nav--side__list"> <li> <a href="/drugs/drug-supply-chain-integrity/drug-supply-chain-security-act-dscsa" class="lcds-section-nav__link lcds-section-nav--side__link lcds-section-nav__parent-link lcds-section-nav--side__parent-link">Drug Supply Chain Security Act (DSCSA)</a> <div class="views-element-container form-group"><div class="view view-in-this-section view-id-in_this_section view-display-id-block_4 js-view-dom-id-280ced368b3d9a229e2edf117d41f405eb29ac7f26d6441ceb5d5f552f385209"> <div class="item-list"> <ul class="lcds-section-nav__active lcds-section-nav__list lcds-section-nav--side__list"> <li><a href="/drugs/drug-supply-chain-security-act-dscsa/drug-supply-chain-security-act-law-and-policies" class="lcds-section-nav__link lcds-section-nav--side__link">Drug Supply Chain Security Act Law and Policies</a></li> <li><a href="/drugs/drug-supply-chain-security-act-dscsa/drug-supply-chain-security-act-dscsa-portal-cder-nextgen" class="lcds-section-nav__link lcds-section-nav--side__link">Drug Supply Chain Security Act (DSCSA) Portal in CDER NextGen</a></li> <li><a href="/drugs/drug-supply-chain-security-act-dscsa/drug-supply-chain-security-act-dscsa-waivers-exceptions-and-exemptions" class="lcds-section-nav__link lcds-section-nav--side__link">The Drug Supply Chain Security Act (DSCSA) Waivers, Exceptions, and Exemptions</a></li> <li><a href="/drugs/drug-supply-chain-security-act-dscsa/notify-fda-illegitimate-products" class="lcds-section-nav__link lcds-section-nav--side__link">Notify FDA of Illegitimate Products</a></li> <li><a href="/drugs/drug-supply-chain-security-act-dscsa/pharmacists-utilize-dscsa-requirements-protect-your-patients" class="lcds-section-nav__link lcds-section-nav--side__link">Pharmacists: Utilize DSCSA Requirements to Protect Your Patients</a></li> <li><a href="/drugs/drug-supply-chain-security-act-dscsa/drug-supply-chain-security-act-dscsa-assessment-small-dispensers" class="lcds-section-nav__link lcds-section-nav--side__link">Drug Supply Chain Security Act (DSCSA) Assessment of Small Dispensers</a></li> <li><a href="/drugs/drug-supply-chain-security-act-dscsa/engage-fda" class="lcds-section-nav__link lcds-section-nav--side__link">Engage with FDA</a></li> <li><a href="/drugs/drug-supply-chain-security-act-dscsa/drug-supply-chain-security-act-public-private-partnership" class="lcds-section-nav__link lcds-section-nav--side__link">Drug Supply Chain Security Act Public-Private Partnership</a></li> <li><a href="/drugs/drug-supply-chain-security-act-dscsa/annual-licensure-reporting-wholesale-drug-distributors-and-third-party-logistics-providers" class="lcds-section-nav__link lcds-section-nav--side__link">Annual Licensure Reporting by Wholesale Drug Distributors and Third-Party Logistics Providers</a></li> </ul> </div> </div> </div> <div class="views-element-container form-group"><div class="view view-in-this-section-sub view-id-in_this_section_sub view-display-id-block_1 js-view-dom-id-11c83331ba49604d3c455c0690a1a837bc2ae60ef908ed858baf85d351c47271"> </div> </div> </li> </ul> </nav> </div> </section> </aside> </article> </main> </div> </div> <div class="region region-subscribe"> <section id="block-entityviewcontent-5" data-block-plugin-id="entity_view:node" class="block block-ctools block-entity-viewnode clearfix"> </section> </div> <footer class="lcds-footer container-fluid"> <div class="row lcds-footer__primary"> <h2 id="footer-heading" class="sr-only">Footer Links</h2> <nav class="text-center"> <div class="col-sm-4"> <ul class="nav"> <li><a href="/about-fda/about-website/fdagov-archive" >FDA Archive</a></li> <li><a href="/about-fda" >About FDA</a></li> <li><a href="/about-fda/about-website/internet-accessibility" >Accessibility</a></li> </ul> </div> <div class="col-sm-4"> <ul class="nav"> <li><a href="/about-fda/visitor-information" >Visitor Information</a> </li> <li><a href="/about-fda/about-website/website-policies" >Website Policies / Privacy</a></li> <li><a href="/about-fda/jobs-and-training-fda/no-fear-act" >No FEAR Act</a></li> <li><a href="https://www.hhs.gov/vulnerability-disclosure-policy/index.html" >Vulnerability Disclosure Policy</a></li> </ul> </div> <div class="col-sm-4"> <ul class="nav"> <li><a href="/regulatory-information/freedom-information" title="Freedom of Information Act">FOIA</a></li> <li><a href="https://www.hhs.gov/" title="Health and Human Services" target="_blank">HHS.gov</a></li> <li><a href="https://www.usa.gov/" target="_blank">USA.gov</a></li> </ul> </div> </nav> </div> <div class="row lcds-footer__secondary"> <div class="col-sm-12 col-md-6 col-lg-4 lcds-footer__social-links"> <a href="/about-fda/contact-fda" class="btn btn-default btn-md">Contact FDA</a> <a href="https://www.facebook.com/FDA" title="Follow FDA on Facebook" class="no-disclaimer"> <span class="fa fa-facebook fa-2x" aria-hidden="true"> <span class="sr-only">Follow FDA on Facebook</span> </span> </a> <a href="https://x.com/US_FDA" title="Follow FDA on X" class="no-disclaimer"> <svg class="icon-svg-inline fa-2x" aria-hidden="true"> <use href="/themes/custom/preview/assets/images/fa-icons.svg#icon-x-twitter"> </svg> <span class="sr-only">Follow FDA on X</span> </a> <a href="https://instagram.com/FDA" title="Follow FDA on Instagram" class="no-disclaimer"> <span class="fa fa-instagram fa-2x" aria-hidden="true"> <span class="sr-only">Follow FDA on Instagram</span> </span> </a> <br class='visible-xs-inline'/> <a href="https://www.linkedin.com/company/fda/" title="Follow FDA on LinkedIn" class="no-disclaimer"> <span class="fa fa-linkedin fa-2x" aria-hidden="true"> <span class="sr-only">Follow FDA on LinkedIn</span> </span> </a> <a href="https://youtube.com/@US_FDA" title="View FDA videos on YouTube" class="no-disclaimer"> <span class="fa fa-youtube fa-2x" aria-hidden="true"> <span class="sr-only">View FDA videos on YouTube</span> </span> </a> <a href="/about-fda/contact-fda/subscribe-podcasts-and-news-feeds" title="Subscribe to FDA RSS feeds"> <span class="fa fa-rss fa-2x" aria-hidden="true"> <span class="sr-only">Subscribe to FDA RSS feeds</span> </span> </a> </div> <a href="/" title="FDA Homepage"> <div class="visible-lg-block col-lg-4 text-center lcds-footer__logo"> <span class="sr-only">FDA Homepage</span> </div> </a> <div class="col-sm-12 col-md-6 col-lg-4 text-center lcds-footer__contact-number"> <span class="fa fa-phone" aria-hidden="true"> </span> <span class="sr-only">Contact Number</span> 1-888-INFO-FDA (1-888-463-6332) </div> </div>  </footer> <a href="" id="btn-top" class="btn btn-primary btn-top"><span class="sr-only">Back to </span>Top</a> </div> <script type="application/json" data-drupal-selector="drupal-settings-json">{"path":{"baseUrl":"\/","pathPrefix":"","currentPath":"node\/359976","currentPathIsAdmin":false,"isFront":false,"currentLanguage":"en"},"pluralDelimiter":"\u0003","suppressDeprecationErrors":true,"fda_ckeditor_enhancements":{"basePath":"modules\/custom\/fda_ckeditor_enhancements"},"google_analytics":{"account":"G-273DTKB5QW","trackOutbound":true,"trackMailto":true,"trackTel":true,"trackDownload":true,"trackDownloadExtensions":"7z|aac|arc|arj|asf|asx|avi|bin|csv|doc(x|m)?|dot(x|m)?|exe|flv|gif|gz|gzip|hqx|jar|jpe?g|js|mp(2|3|4|e?g)|mov(ie)?|msi|msp|pdf|phps|png|ppt(x|m)?|pot(x|m)?|pps(x|m)?|ppam|sld(x|m)?|thmx|qtm?|ra(m|r)?|sea|sit|tar|tgz|torrent|txt|wav|wma|wmv|wpd|xls(x|m|b)?|xlt(x|m)|xlam|xml|z|zip"},"bootstrap":{"forms_has_error_value_toggle":1,"modal_animation":1,"modal_backdrop":"true","modal_focus_input":1,"modal_keyboard":1,"modal_select_text":1,"modal_show":1,"modal_size":"","popover_enabled":1,"popover_animation":1,"popover_auto_close":1,"popover_container":"body","popover_content":"","popover_delay":"0","popover_html":0,"popover_placement":"right","popover_selector":"","popover_title":"","popover_trigger":"click"},"ajax":[],"user":{"uid":0,"permissionsHash":"3aef67b4ac7d861d8624bf1f7ab2bc9cfc56d3c25b7d709dc15466dfa996dfb0"}}</script> <script src="/files/js/js_jmx6639WuKcEs1DgFSmm8g__5ByGF4YtLnPWvZO-XrM.js?scope=footer&delta=0&language=en&theme=preview&include=eJxlj1GOwjAMRC8UGn6Q9jaRm7hpRBJbtgvqnn4paFsEP9Z4LI3fTNQN7qjU0E-HHlwmyhUDdKirlaj-03C6qmHzIyg6FrwVvPtcaYR6Ultr6fnLjlLY1I1EpibAnonphuKmBCFeMRUjCdhn6BEbdlMPMZKkQj0Y5Q1AZxKLlNBt0eqfc2iUloqvHGpcy5bwuoXL-efNdAwC-fF8Vp9kYajD4QxL52WsRWdMbnpgdjJUv6u9URT4XTEfFRPwE-p_3zFPe4M_uG6P1A"></script> <script type="text/javascript" src="/gq99Y_V0q5/KuhV/sZod41/hYVOwczLtmJfOi/QwpAMw/IAVea3/RqCSA"></script></body> </html>

CINXE.COM

Drug Supply Chain Security Act (DSCSA) | FDA