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<law><site_title>Virginia Decoded</site_title><site_url>https://vacode.org</site_url><law_id>86023</law_id><section_number>54.1-3435</section_number><catch_line>License to act as wholesale distributor; renewal; fee</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="3">Wholesale Distributors and Medical Equipment Suppliers</unit></structure><text>
						<section id="A"><p><span class="prefix-number">A.</span> It shall be unlawful for any <span class="dictionary">person</span> to engage in the <span class="dictionary">wholesale distribution</span> of <span class="dictionary">prescription drugs</span> in the Commonwealth without a valid unrevoked license issued by the <span class="dictionary">Board</span>. The applicant for licensure as a <span class="dictionary">wholesale distributor</span>, as defined in &#xA7; <a class="law" title="Definitions" href="/54.1-3401/">54.1-3401</a>, in the Commonwealth shall apply to the <span class="dictionary">Board</span> for a license, using such forms as the <span class="dictionary">Board</span> may furnish; renew such license using such forms as the <span class="dictionary">Board</span> may furnish, if granted, annually on a date determined by the <span class="dictionary">Board</span> in regulation; notify the <span class="dictionary">Board</span> within 30 days of any substantive change in the information reported on the application form previously submitted to the <span class="dictionary">Board</span>; and remit a fee as determined by the <span class="dictionary">Board</span>. <a id="paragraph-308072" class="section-permalink" href="https://vacode.org/54.1-3435/#A"><i class="fa fa-link"/></a></p></section>
						<section id="B"><p><span class="prefix-number">B.</span> A <span class="dictionary">wholesale distributor</span> that ceases distribution of Schedule II through V drugs to a pharmacy, licensed physician <span class="dictionary">dispenser</span>, or licensed physician <span class="dictionary">dispensing</span> facility located in the Commonwealth due to suspicious <span class="dictionary">orders</span> of <span class="dictionary">controlled substances</span> shall notify the <span class="dictionary">Board</span> within five days of the cessation. For the purposes of this section, &#x201C;suspicious <span class="dictionary">orders</span> of <span class="dictionary">controlled substances</span>&#x201D; means, relative to the pharmacy&#x2019;s, licensed physician <span class="dictionary">dispenser</span>&#x2019;s, or licensed physician <span class="dictionary">dispensing</span> facility&#x2019;s <span class="dictionary">order</span> history and the <span class="dictionary">order</span> history of similarly situated pharmacies, licensed physician <span class="dictionary">dispensers</span>, or licensed physician <span class="dictionary">dispensing</span> facilities, (i) <span class="dictionary">orders</span> of unusual size, (ii) <span class="dictionary">orders</span> deviating substantially from a normal pattern, and (iii) <span class="dictionary">orders</span> of unusual frequency. <a id="paragraph-308073" class="section-permalink" href="https://vacode.org/54.1-3435/#B"><i class="fa fa-link"/></a></p></section>
						<section id="C"><p><span class="prefix-number">C.</span> A <span class="dictionary">wholesale distributor</span> shall be immune from civil liability for giving notice in accordance with subsection B unless the notice was given in bad faith or with <span class="dictionary">malicious</span> <span class="dictionary">intent</span>. <a id="paragraph-308074" class="section-permalink" href="https://vacode.org/54.1-3435/#C"><i class="fa fa-link"/></a></p></section>
						<section id="D"><p><span class="prefix-number">D.</span> The <span class="dictionary">Board</span> shall not impose any disciplinary or enforcement action against any licensee or permit holder solely on the basis of a notice received from a <span class="dictionary">wholesale distributor</span> pursuant to subsection B. <a id="paragraph-308075" class="section-permalink" href="https://vacode.org/54.1-3435/#D"><i class="fa fa-link"/></a></p></section>
						<section id="E"><p><span class="prefix-number">E.</span> The <span class="dictionary">Board</span> may promulgate such regulations relating to the storage, handling, and distribution of <span class="dictionary">prescription drugs</span> by <span class="dictionary">wholesale distributors</span> as it deems necessary to implement this section, to prevent <span class="dictionary">diversion</span> of <span class="dictionary">prescription drugs</span>, and to protect the public. <a id="paragraph-308076" class="section-permalink" href="https://vacode.org/54.1-3435/#E"><i class="fa fa-link"/></a></p></section>
						<section id="F"><p><span class="prefix-number">F.</span> Every <span class="dictionary">wholesale distributor</span> shall comply with federal requirements for an electronic, interoperable system to identify, trace, and verify <span class="dictionary">prescription drugs</span> as they are distributed. <a id="paragraph-308077" class="section-permalink" href="https://vacode.org/54.1-3435/#F"><i class="fa fa-link"/></a></p></section></text><history>1970, c. 650, &#xA7; 54-524.44; 1976, c. 614; 1980, c. 288; 1988, c. 765; 1992, c. 737; 2008, c. 320; 2015, c. 299; 2016, c. 221.</history><metadata></metadata></law>
