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Office of Compliance | FDA

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class="lcds-section-nav__link">Office of Translational Sciences</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-1242ac4badea25f21a78bc93421d29beda9f45bd97dd49cf0f34e03315770234"> </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="/about-fda">About FDA</a> </li> <li > <a href="/about-fda/fda-organization">FDA Organization</a> </li> <li > <a href="/about-fda/fda-organization/center-drug-evaluation-and-research-cder">Center for Drug Evaluation and Research (CDER)</a> </li> <li > <a href="/about-fda/center-drug-evaluation-and-research-cder/cder-offices-and-divisions">CDER Offices and Divisions</a> </li> <li > <a class="current-link">Office of Compliance</a> </li> </ol> <ol class="lcds-breadcrumb visible-sm visible-xs"> <li> <a href="/about-fda/center-drug-evaluation-and-research-cder/cder-offices-and-divisions" title="CDER Offices and Divisions"> CDER Offices and Divisions </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-13" 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="text-center content-title">Office of Compliance </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%2Fabout-fda%2Fcder-offices-and-divisions%2Foffice-compliance" 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=Office%20of%20Compliance&amp;url=https://www.fda.gov%2Fabout-fda%2Fcder-offices-and-divisions%2Foffice-compliance" 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&amp;url=https://www.fda.gov%2Fabout-fda%2Fcder-offices-and-divisions%2Foffice-compliance&amp;title=Office%20of%20Compliance&amp;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=Office%20of%20Compliance&amp;body=https://www.fda.gov%2Fabout-fda%2Fcder-offices-and-divisions%2Foffice-compliance" 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"> <hr> <p><h2>Who We Are:</h2> <p>The Office of Compliance (OC) shields patients from poor quality, unsafe, and ineffective drugs through compliance strategies and risk-based enforcement actions. OC makes strategic and risk-based decisions that are guided by law and science to foster global collaboration, promote voluntary compliance and takes decisive and swift actions to protect patients.</p> <div class="aside aside-cu"> <div alt="Office of Compliance 2023 Annual Report Cover" data-embed-button="media_browser" data-entity-embed-display="media_image" data-entity-embed-display-settings="Array" data-entity-type="media" data-entity-uuid="17fa4078-f213-45c9-8704-e63481bf53f4" data-langcode="en" title="Office of Compliance 2023 Annual Report Cover" class="align-center embedded-entity"> <img loading="lazy" src="/files/cder-office-compliance-annual-report-2023.jpg" alt="Office of Compliance 2023 Annual Report Cover" title="Office of Compliance 2023 Annual Report Cover" class="img-responsive"> </div> <p style="text-align: center;"><a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="f1f47902-4cd1-48cb-8afe-349d2eec9715" href="/media/175379/download?attachment" title="Office of Compliance Annual Report FY 2023">Office of Compliance Annual Report FY 2023</a>&nbsp;(PDF - 8 MB)</p> </div> <h2>What We Do:</h2> <ul> <li>Address patient health risks that arise from violations of FDA regulations and law. Develop risk-based enforcement and communication strategies to reduce and prevent patient harm associated with these violations.</li> <li>Work to protect consumers from unsafe <a href="/compounding" target>compounded drugs</a>.</li> <li>Protect the integrity of the legitimate drug supply chain and minimize consumer exposure to dangerous products marketed outside the legitimate supply chain.</li> <li>Monitor the quality of human drugs through facility inspections, product testing, and other pre- and postmarket compliance activities.</li> <li>Ensure drugs in FDA approval system have reliable evidence of safety and effectiveness, human subjects in clinical trials are protected, and drugs meet postmarket safety requirements.</li> <li>Develop policies and compliance strategies to help ensure that over-the-counter and prescription drugs are properly labeled and meet drug approval requirements.</li> <li>Coordinate evaluation and classification of <a href="/drug-recalls" target>drug recalls</a>, and work with FDA offices globally to implement recalls.</li> <li>Monitor and assist with alleviation of drug shortages involving compliance issues.</li> <li>Provide support and guidance on developing potential investigations and regulatory actions to FDA offices around the world.</li> <li>Maintain the electronic drug registration and listing database and work to ensure the information in the database is up to date and accurate.</li> </ul> <h2>Organization:</h2> <ul> <li><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="b5d0c363-7085-4077-bc05-51019e53a98c" href="/about-fda/cder-offices-and-divisions/office-compliance-office-compounding-quality-and-compliance" title="Office of Compliance - Office of Compounding Quality and Compliance">Office of Compounding Quality and Compliance</a></li> <li><a href="/about-fda/about-center-drug-evaluation-and-research/office-drug-security-integrity-and-response" target>Office of Drug Security, Integrity, and Response</a></li> <li><a href="/about-fda/about-center-drug-evaluation-and-research/office-manufacturing-quality" target>Office of Manufacturing Quality</a></li> <li><a href="/about-fda/about-center-drug-evaluation-and-research/office-program-and-regulatory-operations-compliance" target>Office of Program and Regulatory Operations</a></li> <li><a href="/about-fda/about-center-drug-evaluation-and-research/office-scientific-investigations" target>Office of Scientific Investigations</a></li> <li><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="6c320987-0d89-4d1e-a894-fcc4a8932b14" href="/about-fda/cder-offices-and-divisions/office-unapproved-drugs-and-labeling-compliance" title="Office of Unapproved Drugs and Labeling Compliance">Office of Unapproved Drugs and Labeling Compliance</a></li> </ul> <h2>For More Information:</h2> <ul> <li><a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="f1f47902-4cd1-48cb-8afe-349d2eec9715" href="/media/175379/download?attachment" title="Office of Compliance Annual Report FY 2023">Office of Compliance Annual Report FY 2023</a>&nbsp;(PDF - 8&nbsp;MB)</li> <li><a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="8febbe3b-0ba2-4002-a88e-c023479584a1" href="/media/166289/download?attachment" title="CDER Office of Compliance Annual Report FY 2022">Office of Compliance Annual Report FY 2022</a> (PDF - 7&nbsp;MB)</li> <li><a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="5a48e4d8-ab65-43aa-8322-ed2ee1ab9e14" href="/media/157954/download?attachment" title="CDER Office of Compliance 2021 Annual Report">Office of Compliance Annual Report 2021</a> (PDF - 11&nbsp;MB)</li> <li><a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="f119596a-32d2-445e-b7d0-bd98f7c8fb3c" href="/media/146904/download?attachment" title="OC Annual Report 2020 final">Office of Compliance Annual Report 2020</a> (PDF - 6 MB)</li> <li><a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="c5ab9e36-527d-43ee-920a-c8d91b9fa0bf" href="/media/136576/download?attachment" title="Office of Compliance Annual Report 2019 (PDF - 4.89MB)">Office of Compliance Annual Report 2019</a> (PDF - 5 MB)</li> <li><a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="115029e1-4731-4fef-a2fd-28c00fcbfc88" href="/media/128429/download?attachment" title="Compliance Annual Report 062619">Office of Compliance Annual Report 2018</a> (PDF -&nbsp;1 MB)</li> </ul> <hr> <h3>Contact Us:</h3> <p>Email: <a href="mailto:CDERCompliance@fda.hhs.gov">CDERCompliance@fda.hhs.gov</a></p> <p>Phone: 301-796-3100<br> Fax: 301-847-8747</p> <p>Office of Compliance<br> 10903 New Hampshire Avenue<br> Bldg. 51, Rm 5271<br> Silver Spring, MD 20993-0002</p> <br/> <br></p> <hr> <!--BEGIN QUALTRICS WEBSITE FEEDBACK 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