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<law><site_title>Virginia Decoded</site_title><site_url>https://vacode.org</site_url><law_id>56990</law_id><section_number>54.1-3442.4</section_number><catch_line>Limitation of liability</catch_line><edition url="https://vacode.org/2025/" slug="2025" current="TRUE" last_updated="">2025</edition><structure><unit label="title" level="1" order_by="1" identifier="54.1">Professions and Occupations</unit><unit label="subtitle" level="2" order_by="1" identifier="III">Professions and Occupations Regulated by Boards Within the Department of Health Professions</unit><unit label="chapter" level="3" order_by="1" identifier="34">Drug Control Act</unit><unit label="article" level="4" order_by="1" identifier="4.1">Expanded Access to Investigational Drugs, Biological Products, and Devices</unit></structure><text>
						<section id="A"><p><span class="prefix-number">A.</span> Notwithstanding any other provision of <span class="dictionary">law</span> to the contrary, a health care provider as defined in &#xA7; <a class="law" title="Definitions" href="/8.01-581.1/">8.01-581.1</a> who recommends an <span class="dictionary">investigational <span class="dictionary">drug</span>, <span class="dictionary">biological product</span>, or device</span> to a <span class="dictionary">person</span> who meets the criteria set forth in subsection A of &#xA7; <a class="law" title="Eligibility for expanded access to investigational drugs, biological products, and devices; written, informed consent to treatment" href="/54.1-3442.2/">54.1-3442.2</a> shall be immune from civil liability for any adverse action, condition, or other outcome resulting from the <span class="dictionary">person</span>&#x2019;s use of the <span class="dictionary">investigational <span class="dictionary">drug</span>, <span class="dictionary">biological product</span>, or device</span>. <a id="paragraph-208738" class="section-permalink" href="https://vacode.org/54.1-3442.4/#A"><i class="fa fa-link"/></a></p></section>
						<section id="B"><p><span class="prefix-number">B.</span> Notwithstanding any other provision of <span class="dictionary">law</span> to the contrary, a <span class="dictionary">manufacturer</span>, <span class="dictionary">distributor</span>, administrator, health care provider as defined in &#xA7; <a class="law" title="Definitions" href="/8.01-581.1/">8.01-581.1</a>, sponsor, or physician who <span class="dictionary">manufactures</span>, supplies, <span class="dictionary">distributes</span>, <span class="dictionary">administers</span>, prescribes, or recommends an <span class="dictionary">investigational <span class="dictionary">drug</span>, <span class="dictionary">biological product</span>, or device</span> to a <span class="dictionary">person</span> who meets the criteria set forth in &#xA7; <a class="law" title="Eligibility for expanded access to investigational drugs, biological products, and devices; written, informed consent to treatment" href="/54.1-3442.2/">54.1-3442.2</a> shall be immune from suit and liability caused by, arising out of, or relating to the design, development, clinical testing and investigation, <span class="dictionary">manufacture</span>, <span class="dictionary">labeling</span>, distribution, <span class="dictionary">sale</span>, purchase, donation, <span class="dictionary">dispensing</span>, <span class="dictionary">prescription</span>, recommendation, administration, efficacy, or use of such <span class="dictionary">investigational <span class="dictionary">drug</span>, <span class="dictionary">biological product</span>, or device</span> made available to such <span class="dictionary">person</span>. <a id="paragraph-208739" class="section-permalink" href="https://vacode.org/54.1-3442.4/#B"><i class="fa fa-link"/></a></p></section>
						<section id="C"><p><span class="prefix-number">C.</span> No claim or <span class="dictionary">cause of action</span> against a <span class="dictionary">manufacturer</span>, <span class="dictionary">distributor</span>, administrator, health care provider as defined in &#xA7; <a class="law" title="Definitions" href="/8.01-581.1/">8.01-581.1</a>, sponsor, or physician who <span class="dictionary">manufactures</span>, supplies, <span class="dictionary">distributes</span>, <span class="dictionary">administers</span>, prescribes, or recommends an <span class="dictionary">investigational <span class="dictionary">drug</span>, <span class="dictionary">biological product</span>, or device</span> to a <span class="dictionary">person</span> who meets the criteria set forth in &#xA7; <a class="law" title="Eligibility for expanded access to investigational drugs, biological products, and devices; written, informed consent to treatment" href="/54.1-3442.2/">54.1-3442.2</a> shall exist in any state <span class="dictionary">court</span> for claims of property, personal injury, or death caused by, arising out of, or relating to the design, development, clinical testing and investigation, <span class="dictionary">manufacture</span>, <span class="dictionary">labeling</span>, distribution, <span class="dictionary">sale</span>, purchase, donation, <span class="dictionary">dispensing</span>, <span class="dictionary">prescription</span>, recommendation, administration, efficacy, or use of such <span class="dictionary">investigational <span class="dictionary">drug</span>, <span class="dictionary">biological product</span>, or device</span> made available to such <span class="dictionary">person</span>. <a id="paragraph-208740" class="section-permalink" href="https://vacode.org/54.1-3442.4/#C"><i class="fa fa-link"/></a></p></section>
						<section id="D"><p><span class="prefix-number">D.</span> No health care provider as defined in &#xA7; <a class="law" title="Definitions" href="/8.01-581.1/">8.01-581.1</a> who recommends, prescribes, <span class="dictionary">administers</span>, <span class="dictionary">distributes</span>, or supplies an <span class="dictionary">investigational <span class="dictionary">drug</span>, <span class="dictionary">biological product</span>, or device</span> to a <span class="dictionary">person</span> who meets the criteria set forth in &#xA7; <a class="law" title="Eligibility for expanded access to investigational drugs, biological products, and devices; written, informed consent to treatment" href="/54.1-3442.2/">54.1-3442.2</a> shall be deemed to have engaged in unprofessional conduct, or shall be adversely affected in any decision relating to licensure, on such grounds. <a id="paragraph-208741" class="section-permalink" href="https://vacode.org/54.1-3442.4/#D"><i class="fa fa-link"/></a></p></section>
						<section id="E"><p><span class="prefix-number">E.</span> Nothing in this article shall require a <span class="dictionary">person</span> to violate or act in contravention of any federal or state <span class="dictionary">law</span> as such <span class="dictionary">law</span> relates to the prescribing, <span class="dictionary">dispensing</span>, administration, or use of an <span class="dictionary">investigational <span class="dictionary">drug</span>, <span class="dictionary">biological product</span>, or device</span>. <a id="paragraph-208742" class="section-permalink" href="https://vacode.org/54.1-3442.4/#E"><i class="fa fa-link"/></a></p></section></text><history>2015, cc. 655, 656.</history><metadata></metadata></law>
