Drug Supply Chain Integrity

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class="lcds-section-nav__section-link__active lcds-section-nav__list"> <li><a href="/drugs/drug-supply-chain-integrity/fda-leads-effort-create-supply-chain-security-toolkit-medical-products" class="lcds-section-nav__link">FDA Leads Effort to Create a Supply Chain Security Toolkit for Medical Products</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-5a09aa98f4b2e48a287dfca16dc5d038a4999507cbd00e4563fd4936e3472dce"> <div class="view-content"> <div> <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">Drug Supply Chain Security Act (DSCSA)</a></li> </ul> </div> </div> </div> </div> </li> </ul> </nav> </section> <section id="block-entityviewcontent-15" data-block-plugin-id="entity_view:node" class="block block-ctools 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consumers from unsafe drugs that can enter the U.S. drug supply chain</h2> <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-safety-and-availability%2Fdrug-supply-chain-integrity" 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%20Integrity&url=https://www.fda.gov%2Fdrugs%2Fdrug-safety-and-availability%2Fdrug-supply-chain-integrity" 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 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</header> <div class="col-md-8 col-md-push-2" role="main"> <div class="callout"> <h2>On this page</h2> <ul> <li><a href="#consumers">Protecting Consumers from Unsafe Drugs</a></li> <li><a href="#professionals">Information for Health Care Professionals</a></li> <li><a href="#industry">Information for Industry</a></li> <li><a href="#domestic">Domestic and International Engagement</a></li> <li><a href="#email">Report Issues by Email</a></li> <li><a href="#reporting">Reporting Issues to FDA</a></li> </ul> </div> <h2>U.S Drug Supply Chain is Among the Safest in the World</h2> <p>The U.S. drug supply chain remains one of the safest in the world. However, the <a href="/drugs/drug-shortages/graphic-drug-supply-chain-example">drug supply chain</a> has become increasingly complex as it reaches <a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="1c05d04f-107b-49bf-8211-2ff964eaebfa" href="/international-programs/fda-globalization" title="FDA Globalization">beyond U.S. borders</a>. Threats to the supply chain such as counterfeiting, diversion, theft and imports of falsified, unapproved or otherwise unsafe drugs, could result in unsafe, ineffective drugs in U.S. distribution.</p> <p>FDA has safeguards in place to protect the integrity of the drug supply chain to help ensure safe, effective and high-quality drugs reach U.S. consumers. Our system of federal and state laws create a “closed” drug distribution system to help ensure the U.S. drug supply remains secure. The agency remains vigilant in protecting the integrity of the U.S. drug supply chain.</p> <p class="text-align-center"><a class="btn btn-primary btn-lg" href="#reporting"><span class="text">Report a Problem to FDA</span></a></p> <ul> </ul> <hr> <h2><a id="consumers" name="consumers"></a>Protecting Consumers from Unsafe Drugs</h2> <p>FDA works to prevent unsafe drugs from reaching and harming U.S. consumers, including:  </p> <ul> <li>informing consumers about the risks of purchasing prescription medicine from unsafe online pharmacies through FDA’s <a href="/drugs/quick-tips-buying-medicines-over-internet/besaferx-your-source-online-pharmacy-information">BeSafeRx</a> campaign. BeSafeRx helps educate consumers about <a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="fc57660b-4ca9-4b92-9e39-22ba3f909aea" href="/consumers/consumer-updates/how-buy-medicines-safely-online-pharmacy" title="How to Buy Medicines Safely From an Online Pharmacy">how to safely buy medicines online</a>.</li> <li>ensuring medicines <a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="5329802b-88ab-43cd-8385-0daaf6aa448e" href="/drugs/guidance-compliance-regulatory-information/human-drug-imports" title="Human Drug Imports">imported</a> into the U.S. comply with all legal and regulatory requirements. All imported drugs must meet FDA’s standards for quality, safety and effectiveness.</li> <li>protecting the U.S. drug supply from <a href="/drugs/buying-using-medicine-safely/counterfeit-medicine">counterfeit medicine</a>, which may be passed off as authentic but may contain the wrong ingredients, contain too much, too little or no active ingredient at all or contain other harmful ingredients.</li> <li>issuing <a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="e19f13b1-a062-4e19-a913-9b71c8f9b54d" href="/drugs/drug-supply-chain-integrity/internet-pharmacy-warning-letters" title="Internet Pharmacy Warning Letters">warning letters</a> to inform website operators they are engaged in illegal activity in violation of the Federal Food, Drug and Cosmetic Act. Additionally, FDA, in partnership with international regulatory and law enforcement agencies, protects American consumers from harm by <a>taking action against </a>websites that illegally sell potentially dangerous, unapproved versions of prescription medicines, including opioids.</li> <li>coordinating with drug manufacturers to <a href="/drugs/guidance-compliance-regulatory-information/human-drug-exports">recall</a> drugs that may be unsafe, ineffective or poor-quality.</li> <li><a>helping to ensure drugs </a><a href="/drugs/guidance-compliance-regulatory-information/human-drug-exports">exported</a> from the U.S. meet quality, safety and effectiveness standards.</li> </ul> <h2><a id="professionals" name="professionals"></a>Information for Health Care Professionals</h2> <p>FDA’s <a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="c204fc0e-7c4b-4c67-97a5-4bd092ce4a56" href="/drugs/information-health-care-professionals-drugs/know-your-source-protecting-patients-unsafe-drugs" title="Know Your Source: Protecting Patients from Unsafe Drugs">Know Your Source</a> program educates health care professionals about buying the medicines from licensed sources, including safe purchasing practices, to help prevent unsafe or ineffective drugs from harming patients.</p> <h2><a id="industry" name="industry"></a>Information for Industry</h2> <ul> <li>The <a href="/drugs/drug-supply-chain-integrity/drug-supply-chain-security-act-dscsa">Drug Supply Chain Security Act (DSCSA)</a><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="e9feccfc-a3ec-4491-83ca-3f8c0d8606ec" href="/drugs/drug-supply-chain-integrity/drug-supply-chain-security-act-dscsa" title="Drug Supply Chain Security Act (DSCSA)"> </a>outlines steps to achieve interoperable, electronic product tracing at the package level to identify and trace certain prescription drugs as they are distributed in the U.S. This will enhance FDA’s ability to help protect consumers from exposure to counterfeit, stolen, contaminated or otherwise harmful drugs.</li> <li><a>FDA issued a </a><a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="2e3cb9e4-50e0-42db-aae5-9980f07f3868" href="/media/116720/download?attachment" title="Incorporation of Physical-Chemical Identifiers into Solid Oral Dosage Form Drug Products for Anticounterfeiting">guidance for industry</a> on anti-counterfeiting for drug manufacturers who want to use physical-chemical identifiers in solid oral dosage forms. A physical-chemical identifier is a substance or combination of substances that possesses a unique physical or chemical property that unequivocally identifies and authenticates a drug or dosage form.</li> <li><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="7ef7eaa8-5e64-4a41-8e50-c59cfb8a699b" href="/regulatory-information/selected-amendments-fdc-act/prescription-drug-marketing-act-1987" title="Prescription Drug Marketing Act of 1987">Prescription Drug Marketing Act of 1987</a>: Report significant losses, theft and falsified prescription drug samples to FDA.</li> </ul> <h2><a id="domestic" name="domestic"></a>Domestic and International Engagement</h2> <p>Securing the U.S. drug supply chain reaches beyond the U.S. border. FDA works with domestic and international stakeholders to help ensure the integrity of the supply chain.</p> <div alt="Image of vials of drugs in the background with a circle -shaped graphic with spokes representing the 10 Centers of Excellence in the toolkit" data-embed-button="media_browser" data-entity-embed-display="media_image" data-entity-embed-display-settings="Array" data-entity-type="media" data-entity-uuid="ea1ec8d6-1678-45d9-b541-c3d829ac8023" data-langcode="en" title="Supply Chain Security Toolkit for Medical Products" class="align-right embedded-entity"> <img loading="lazy" src="/files/supply-chain-toolkit.png" alt="Image of vials of drugs in the background with a circle -shaped graphic with spokes representing the 10 Centers of Excellence in the toolkit" title="Supply Chain Security Toolkit for Medical Products" class="img-responsive"> </div> <ul> <li>FDA collaborates with Asia Pacific Economic Cooperation to maintain the <a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="d4321952-ee6c-4a73-bb60-ff4d3d830357" href="/drugs/drug-supply-chain-integrity/fda-leads-effort-create-supply-chain-security-toolkit-medical-products" title="FDA Leads Effort to Create a Supply Chain Security Toolkit for Medical Products">Supply Chain Security Toolkit for Medical Products</a>. The toolkit is a resource for member and non-member economies to further protect consumers in the global marketplace by covering supply chain and lifecycle and medical products.</li> <li>Visit <a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="36ed1a2e-1571-4790-9f99-d9227769e8a7" href="/international-programs/partnerships-and-collaboration/fdas-role-who-member-state-mechanism-substandard-and-falsified-medical-products" title="FDA's Role in the WHO Member State Mechanism on Substandard and Falsified Medical Products">FDA’s role in the WHO’s Member State Mechanism on Substandard and Falsified Medical Products</a> for more information on our international partnership with the World Health Organization.</li> <li>FDA hosts <a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="ea29ca8c-5490-42ad-8dcc-ae877ddf6f37" href="/drugs/news-events-human-drugs/online-controlled-substances-summits" title="Online Controlled Substances Summits">Online Controlled Substances Summits</a> to collaborate with stakeholders in the internet ecosystem, government, academia and other important partners to reduce the illegal availability of opioids and other controlled substances online.</li> </ul> <h2><a id="email" name="email"></a>Report Issues by Email</h2> <p>Notify FDA about specific issues through the following contacts:</p> <ul> <li>Supply chain issues related to drugs and components: <a href="mailto:DrugSupplyChainIntegrity@fda.hhs.gov">DrugSupplyChainIntegrity@fda.hhs.gov</a></li> <li>Wholesale distributor or third-party logistics provider requirements: <a href="mailto:WDD3PLRequirements@fda.hhs.gov">WDD3PLRequirements@fda.hhs.gov</a></li> <li>Drug imports: <a href="mailto:CDERImportsExports@fda.hhs.gov?subject=">CDERImports@fda.hhs.gov</a> </li> <li>Drug recalls: <a href="/safety/industry-guidance-recalls/ora-recall-coordinators">Recall coordinator contact information</a></li> <li>Drug exports: <a href="mailto:CDERexports@fda.hhs.gov" target="_blank">CDERexports@fda.hhs.gov</a>  ot later than 30 days after the date of the initial notification in paragraph (b)(1) of this section</li> </ul> <h2><a id="reporting" name="reporting"></a>Reporting Issues to FDA</h2> <p>Product problems should be reported to the FDA when there is a concern about the quality, authenticity, performance or safety of any medication or device. Learn how to <a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="73a337e5-ef3e-4826-8e37-bf689a3a808e" href="/safety/reporting-serious-problems-fda/product-problems" title="Product Problems">identify</a> these problems. The following links provide information on how to report these problems to FDA:</p> <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" >How to Report Issues to FDA</h2> </header> <div class="lcds-card-deck__body"> <a href="https://www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=reporting.home" title="Use FDA’s MedWatch to Report Product Problems"> <article class="lcds-card lcds-card--promoted lcds-card--promoted-subtopic bg-white"> <div class="lcds-card__body"> <h3 class="lcds-card__title">Use FDA’s MedWatch to Report Product Problems</h3> <p class="lcds-card__text">Health professionals, consumers and patients can voluntarily report observed or suspected adverse events for human medical products to FDA.</p> </div> </article> </a> <a href="/safety/report-problem-fda/reporting-unlawful-sales-medical-products-internet" title="Report Potentially Unsafe Online Pharmacies to FDA"> <article class="lcds-card lcds-card--promoted lcds-card--promoted-subtopic bg-white"> <div class="lcds-card__body"> <h3 class="lcds-card__title">Report Potentially Unsafe Online Pharmacies to FDA</h3> <p class="lcds-card__text">Report a website that you think is illegally selling human drugs, animal drugs, medical devices, biological products, foods, dietary supplements or cosmetics.</p> </div> </article> </a> <a href="https://www.accessdata.fda.gov/scripts/email/oc/oci/contact.cfm" title="Report Suspected Criminal Activity"> <article class="lcds-card lcds-card--promoted lcds-card--promoted-subtopic bg-white"> <div class="lcds-card__body"> <h3 class="lcds-card__title">Report Suspected Criminal Activity</h3> <p class="lcds-card__text">If you wish to report suspected criminal activity relating to FDA regulated products, describe the suspected criminal activity.</p> </div> </article> </a> <a href="/drugs/drug-supply-chain-security-act-dscsa/notify-fda-illegitimate-products" title="Notify FDA of Illegitimate Products"> <article class="lcds-card lcds-card--promoted lcds-card--promoted-subtopic bg-white"> <div class="lcds-card__body"> <h3 class="lcds-card__title">Notify FDA of Illegitimate Products</h3> <p class="lcds-card__text">Companies must notify FDA within 24 hours of illegitimate products under the Drug Supply Chain Security Act (DSCSA) </p> </div> </article> </a> <a href="mailto: PDMAreports@fda.hhs.gov" title="Prescription Drug Marketing Act (PDMA) Reporting"> <article class="lcds-card lcds-card--promoted lcds-card--promoted-subtopic bg-white"> <div class="lcds-card__body"> <h3 class="lcds-card__title">Prescription Drug Marketing Act (PDMA) Reporting</h3> <p class="lcds-card__text">Companies should report theft, significant losses and falsified prescription drug samples via email.</p> </div> </article> </a> <a href="/drugs/buying-using-medicine-safely/counterfeit-medicine" title="Report a Counterfeit Drug to FDA"> <article class="lcds-card lcds-card--promoted lcds-card--promoted-subtopic bg-white"> <div class="lcds-card__body"> <h3 class="lcds-card__title">Report a Counterfeit Drug to FDA</h3> <p class="lcds-card__text">Counterfeit medicine may be harmful. Report suspected unsafe products to FDA.<br /> <br /> </p> </div> </article> </a> </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="2024-07-18T06:43:00Z">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> <h2 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js-view-dom-id-6bea7c573f5f86cee84fc6de5e8963dcc0400bac668cb7e64385dcb1e32f7894"> <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-integrity/fda-leads-effort-create-supply-chain-security-toolkit-medical-products" class="lcds-section-nav__link lcds-section-nav--side__link">FDA Leads Effort to Create a Supply Chain Security Toolkit for Medical Products</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-cad570fe1054f706ba6ed8edbff1202ecbe976b413a70c84f2619849944c9575"> <div class="view-content"> <div> <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--side__link">Drug Supply Chain Security Act 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