CBER-Regulated Products: Shortages and Discontinuations

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data-entity-uuid="c2e5370b-72e2-4f8e-a1f3-1f1c3e631ffe" href="/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/office-compliance-and-biologics-quality-ocbq" title="Office of Compliance and Biologics Quality (OCBQ)">Office of Compliance and Biologics Quality</a> (OCBQ) directs the CBER-regulated product shortage program, which includes product discontinuations.</p> <p>The Food and Drug Administration Safety and Innovation Act (FDASIA) (Public Law 112-144) made substantial changes to section 506C of the FD&C Act related to reporting and addressing interruptions in manufacturing or permanent discontinuances of certain drug products. For example, FDASIA requires manufacturers of certain drug products to notify FDA at least 6 months prior to the date of the permanent discontinuance in the manufacture of the drug or an interruption in the manufacturing of the drug that is likely to lead to a meaningful disruption in the supply of that drug in the United States, or, if that is not possible, as soon as practicable. Such drug products include those that are life-supporting, life-sustaining, or intended for use in the prevention or treatment of a debilitating disease or condition, including any such drug used in emergency medical care or during surgery. FDASIA excludes radiopharmaceutical products. More information on FDASIA is provided on FDA’s <a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="2f8b73de-fc20-48e7-9d5e-d8528bd16348" href="/regulatory-information/food-and-drug-administration-safety-and-innovation-act-fdasia/fact-sheet-drug-products-shortage-united-states" title="Fact Sheet: Drug Products in Shortage in the United States">FDASIA Fact Sheet</a> Page.</p> <p>Shortages of drugs and biologics pose a significant public health threat, delaying, and in some cases even denying, critically needed care for patients. Preventing shortages remains a top priority for FDA. For more information please see <a href="http://wayback.archive-it.org/7993/20170111094016/http://www.fda.gov/downloads/NewsEvents/Newsroom/FactSheets/UCM373078.pdf">FDA Facts: Drug Shortages in the United States</a>.</p> <p>Additional information regarding possible causes of CBER-regulated product shortages is provided on the <a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="523cebf2-7688-4dfe-aacf-4dcc145e09a0" href="/vaccines-blood-biologics/safety-availability-biologics/cber-regulated-products-possible-causes-shortages" title="CBER-Regulated Products: Possible Causes of Shortages">CBER-Regulated Products: Possible Causes of Shortages</a> page.</p> <div class="callout"> <h2>Spotlight</h2> <ul> <li><a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="ec68e790-f20a-4a50-8037-afa3e5927aac" href="/media/83301/download?attachment" title="SOPP 8506: Management of Shortages of CBER-Regulated Products">SOPP 8506: Management of Shortages of CBER-Regulated Products</a></li> <li>Guidance - <a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="768958d2-f64c-4ed2-b290-bf499646dce7" href="/regulatory-information/search-fda-guidance-documents/notifying-fda-discontinuance-or-interruption-manufacturing-finished-products-or-active" title="Notifying FDA of a Discontinuance or Interruption in Manufacturing of Finished Products or Active Pharmaceutical Ingredients Under Section 506C of the FD&C Act">Notifying FDA of a Discontinuance or Interruption in Manufacturing of Finished Products or Active Pharmaceutical Ingredients Under Section 506C of the FD&C Act</a></li> <li>Guidance - <a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="93815f62-78ea-4688-83e8-55ffaff35627" href="/regulatory-information/search-fda-guidance-documents/notifying-fda-permanent-discontinuance-or-interruption-manufacturing-device-under-section-506j-fdc" title="Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act">Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act</a></li> <li><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="607877f4-9d91-4fb6-8e17-712eda7b35ec" href="/drugs/drug-shortages/report-drug-shortages-root-causes-and-potential-solutions" title="Report | Drug Shortages: Root Causes and Potential Solutions">Report | Drug Shortages: Root Causes and Potential Solutions</a><br> Examines the underlying factors responsible for drug shortages and recommends enduring solutions</li> <li><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="3b35534b-4c68-47a6-ad94-b75680e3eae7" href="/news-events/press-announcements/statement-fdas-new-report-regarding-root-causes-and-potential-solutions-drug-shortages" title="Statement on FDA’s new report regarding root causes and potential solutions to drug shortages">Statement on FDA’s new report regarding root causes and potential solutions to drug shortages</a></li> <li><a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="fab11471-3791-412d-94a7-47539a79e78a" href="/media/179156/download?attachment" title="00524342 drug_shortages_cy_2023_rtc_final">Annual Report on Drug Shortages for Calendar Year 2023</a></li> </ul> </div> <p> </p> <hr> <h2>Related Information</h2> <ul> <li><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="18a8cefc-081c-471a-a1c4-082d5ceceb63" href="/vaccines-blood-biologics/safety-availability-biologics/cber-regulated-products-current-shortages" title="CBER-Regulated Products: Current Shortages">CBER-Regulated Products: Current Shortages</a></li> <li><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="82b17cfb-76ce-43b4-b850-0667ae6e75dc" href="/vaccines-blood-biologics/safety-availability-biologics/cber-regulated-products-resolved-shortages" title="CBER-Regulated Products: Resolved Shortages">CBER-Regulated Products: Resolved Shortages</a></li> <li><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="661af5cb-0f8c-4a58-97a0-3ee70de82c9d" href="/vaccines-blood-biologics/safety-availability-biologics/cber-regulated-products-permanent-discontinuations" title="CBER-Regulated Products: Permanent Discontinuations">CBER-Regulated Products: Permanent Discontinuations</a></li> <li><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="e6e4cc90-ae11-45f3-a871-7a17e299683b" href="/vaccines-blood-biologics/safety-availability-biologics/how-report-product-shortage-or-supply-issue-fda" title="How to Report a Product Shortage or Supply Issue to FDA">How to Report a Product Shortage or Supply Issue to FDA</a></li> <li><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="4f296f43-5ed8-4555-b785-faf2584dcfed" href="/drugs/drug-safety-and-availability/drug-shortages" title="Drug Shortages">Drug Shortages</a> </li> <li><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="f981f0c0-7591-4448-8a7a-a81cd16a1230" href="/animal-veterinary/product-safety-information/animal-drug-shortage-information" title="Animal Drug Shortage Information">CVM Animal Drug Shortage Information </a></li> <li><a href="https://www.cdc.gov/vaccines/hcp/imz-schedules/?CDC_AAref_Val=https://www.cdc.gov/vaccines/schedules/hcp/index.html" target="_blank">CDC's Recommended Immunization Schedules for Adults and Children</a></li> </ul>   </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="2024-06-07T13:36:00Z">06/07/2024</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">Biologics</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 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