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<law><site_title>Virginia Decoded</site_title><site_url>https://vacode.org</site_url><law_id>56049</law_id><section_number>4.1-1603.2</section_number><catch_line>Cannabis product registration; approval, deviation, and modification</catch_line><edition url="https://vacode.org/2025/" slug="2025" current="TRUE" last_updated="">2025</edition><referred_to_by><reference>4.1-1602</reference></referred_to_by><structure><unit label="title" level="1" order_by="1" identifier="4.1">Alcoholic Beverage and Cannabis Control</unit><unit label="subtitle" level="2" order_by="1" identifier="II">Cannabis Control Act</unit><unit label="chapter" level="3" order_by="1" identifier="16">Medical Cannabis Program</unit></structure><text>
						<section id="A"><p><span class="prefix-number">A.</span> A <span class="dictionary">pharmaceutical processor</span> shall register with the <span class="dictionary">Board</span> each <span class="dictionary">cannabis product</span> it <span class="dictionary">manufactures</span>. Applications for <span class="dictionary">cannabis product</span> registration shall be submitted to the <span class="dictionary">Board</span> on a form prescribed by the <span class="dictionary">Board</span>. <a id="paragraph-205454" class="section-permalink" href="https://vacode.org/4.1-1603.2/#A"><i class="fa fa-link"/></a></p></section>
						<section id="B"><p><span class="prefix-number">B.</span> An application for <span class="dictionary">cannabis product</span> registration shall include: <a id="paragraph-205455" class="section-permalink" href="https://vacode.org/4.1-1603.2/#B"><i class="fa fa-link"/></a></p></section>
						<section id="B1" class="indent-1"><p><span class="prefix-number">1.</span> The <span class="dictionary">total tetrahydrocannabinol</span> and total cannabidiol in such <span class="dictionary">cannabis product</span>, based on laboratory <span class="dictionary">testing</span> results for the <span class="dictionary">cannabis product</span> formulation; <a id="paragraph-205456" class="section-permalink" href="https://vacode.org/4.1-1603.2/#B1"><i class="fa fa-link"/></a></p></section>
						<section id="B2" class="indent-1"><p><span class="prefix-number">2.</span> A product name; <a id="paragraph-205457" class="section-permalink" href="https://vacode.org/4.1-1603.2/#B2"><i class="fa fa-link"/></a></p></section>
						<section id="B3" class="indent-1"><p><span class="prefix-number">3.</span> A proposed product package; and <a id="paragraph-205458" class="section-permalink" href="https://vacode.org/4.1-1603.2/#B3"><i class="fa fa-link"/></a></p></section>
						<section id="B4" class="indent-1"><p><span class="prefix-number">4.</span> A proposed product label, which shall not be required to contain an expiration date at the time of application. <a id="paragraph-205459" class="section-permalink" href="https://vacode.org/4.1-1603.2/#B4"><i class="fa fa-link"/></a></p></section>
						<section id="C"><p><span class="prefix-number">C.</span> The <span class="dictionary">Board</span> shall register all <span class="dictionary">cannabis products</span> that meet <span class="dictionary">testing</span>, labeling, and packaging standards after an application for registration is submitted. If the <span class="dictionary">cannabis product</span> fails to meet such standards or the application was deficient, the <span class="dictionary">Board</span> shall notify the applicant of the specific reasons for such failure or deficiency. <a id="paragraph-205460" class="section-permalink" href="https://vacode.org/4.1-1603.2/#C"><i class="fa fa-link"/></a></p></section>
						<section id="D"><p><span class="prefix-number">D.</span> Within two business days of the <span class="dictionary">Board</span>&#x2019;s approval or deemed approval, the <span class="dictionary">Board</span> shall enter the <span class="dictionary">cannabis product</span>&#x2019;s national drug code number into the Prescription Monitoring Program. <a id="paragraph-205461" class="section-permalink" href="https://vacode.org/4.1-1603.2/#D"><i class="fa fa-link"/></a></p></section>
						<section id="E"><p><span class="prefix-number">E.</span> The following <span class="dictionary">cannabis product</span> deviations from an approved <span class="dictionary">cannabis product</span> registration shall be permitted without any requirement for a new <span class="dictionary">cannabis product</span> registration or notice to the <span class="dictionary">Board</span>: <a id="paragraph-205462" class="section-permalink" href="https://vacode.org/4.1-1603.2/#E"><i class="fa fa-link"/></a></p></section>
						<section id="E1" class="indent-1"><p><span class="prefix-number">1.</span> A deviation in the concentration of <span class="dictionary">total tetrahydrocannabinol</span> (THC) or total cannabidiol (CBD) in a <span class="dictionary">cannabis product</span> or dose thereof of up to 15 percent greater than or less than the concentration of <span class="dictionary">total tetrahydrocannabinol</span> or total cannabidiol, either or both, listed in the approved <span class="dictionary">cannabis product</span> registration; however, for a <span class="dictionary">cannabis product</span> with five milligrams or less of total THC or total CBD per dose, the total THC or total CBD concentration shall be within 0.5 milligrams of the single dose total THC or total CBD concentrations approved for that <span class="dictionary">cannabis product</span>; <a id="paragraph-205463" class="section-permalink" href="https://vacode.org/4.1-1603.2/#E1"><i class="fa fa-link"/></a></p></section>
						<section id="E2" class="indent-1"><p><span class="prefix-number">2.</span> A variation in packaging, provided that the packaging is substantially similar to the approved packaging and otherwise complies with applicable packaging requirements; <a id="paragraph-205464" class="section-permalink" href="https://vacode.org/4.1-1603.2/#E2"><i class="fa fa-link"/></a></p></section>
						<section id="E3" class="indent-1"><p><span class="prefix-number">3.</span> A deviation in labeling, including a variation made in accordance with &#xA7; <a class="law" title="Expired" href="/54.1-3442.7_1/">54.1-3442.7:1</a>, that reflects allowable deviations in total THC or total CBD or that makes a <span class="dictionary">minor</span> text, font, design, or similar modification, provided that the labeling is substantially similar to the approved labeling and otherwise complies with applicable labeling requirements; and <a id="paragraph-205465" class="section-permalink" href="https://vacode.org/4.1-1603.2/#E3"><i class="fa fa-link"/></a></p></section>
						<section id="E4" class="indent-1"><p><span class="prefix-number">4.</span> Any other insignificant changes. <a id="paragraph-205466" class="section-permalink" href="https://vacode.org/4.1-1603.2/#E4"><i class="fa fa-link"/></a></p></section>
						<section id="F"><p><span class="prefix-number">F.</span> A <span class="dictionary">pharmaceutical processor</span> may submit a request to modify an existing <span class="dictionary">cannabis product</span> registration in the event of a <span class="dictionary">cannabis product</span> deviation that is not set forth in subsection E. Upon receipt, the <span class="dictionary">Board</span> shall respond to such request. The <span class="dictionary">Board</span> may grant or deny the request, propose a reasonable revision, or require the <span class="dictionary">pharmaceutical processor</span> to provide additional information. <a id="paragraph-205467" class="section-permalink" href="https://vacode.org/4.1-1603.2/#F"><i class="fa fa-link"/></a></p></section></text><history>2023, cc. 760, 780, &#xA7; 54.1-3442.7:2.</history><metadata></metadata></law>
