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<law><site_title>Virginia Decoded</site_title><site_url>https://vacode.org</site_url><law_id>68796</law_id><section_number>54.1-3461</section_number><catch_line>Adulterated drug or device</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="6">Misbranded and Adulterated Drugs and Cosmetics</unit></structure><text>
						<section id="A"><p><span class="prefix-number">A.</span> A <span class="dictionary">drug</span> or <span class="dictionary">device</span> shall be deemed to be adulterated: <a id="paragraph-249043" class="section-permalink" href="https://vacode.org/54.1-3461/#A"><i class="fa fa-link"/></a></p></section>
						<section id="A1" class="indent-1"><p><span class="prefix-number">1.</span> If it consists in whole or in part of any filth, putrid or decomposed substance; <a id="paragraph-249044" class="section-permalink" href="https://vacode.org/54.1-3461/#A1"><i class="fa fa-link"/></a></p></section>
						<section id="A2" class="indent-1"><p><span class="prefix-number">2.</span> If it has been produced, prepared, packed, or held under insanitary conditions whereby it has been contaminated with filth, or whereby it has been rendered injurious to health; <a id="paragraph-249045" class="section-permalink" href="https://vacode.org/54.1-3461/#A2"><i class="fa fa-link"/></a></p></section>
						<section id="A3" class="indent-1"><p><span class="prefix-number">3.</span> If it is a <span class="dictionary">drug</span> and the methods used in, or the facilities or controls used for, its <span class="dictionary">manufacture</span>, processing, packing, or holding do not conform to or are not operated or administered in conformity with current good manufacturing practice to assure that such <span class="dictionary">drug</span> meets the requirements of this chapter; <a id="paragraph-249046" class="section-permalink" href="https://vacode.org/54.1-3461/#A3"><i class="fa fa-link"/></a></p></section>
						<section id="A4" class="indent-1"><p><span class="prefix-number">4.</span> If it is a <span class="dictionary">drug</span> and its container is composed, in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health; <a id="paragraph-249047" class="section-permalink" href="https://vacode.org/54.1-3461/#A4"><i class="fa fa-link"/></a></p></section>
						<section id="A5" class="indent-1"><p><span class="prefix-number">5.</span> If it is a <span class="dictionary">drug</span> and it bears or contains, for purposes of coloring only, a color additive which is unsafe within the meaning of the federal act or &#xA7; <a class="law" title="Poisonous or deleterious substance, or color additive" href="/54.1-3460/">54.1-3460</a>; or <a id="paragraph-249048" class="section-permalink" href="https://vacode.org/54.1-3461/#A5"><i class="fa fa-link"/></a></p></section>
						<section id="A6" class="indent-1"><p><span class="prefix-number">6.</span> It is a color additive, the intended use of which in or on <span class="dictionary">drugs</span> is for purposes of coloring only, and is unsafe within the meaning of the federal act or &#xA7; <a class="law" title="Poisonous or deleterious substance, or color additive" href="/54.1-3460/">54.1-3460</a>. <a id="paragraph-249049" class="section-permalink" href="https://vacode.org/54.1-3461/#A6"><i class="fa fa-link"/></a></p></section>
						<section id="B"><p><span class="prefix-number">B.</span> A <span class="dictionary">drug</span> or <span class="dictionary">device</span> shall be deemed to be adulterated if it purports to be or is represented as a <span class="dictionary">drug</span> the name of which is recognized in an <span class="dictionary">official compendium</span>, and its strength differs from, or its quality or purity falls below, the standard set forth in such compendium. Such determination of strength, quality, or purity shall be made in accordance with the tests or methods of assay set forth in such compendium, or in the absence of or inadequacy of such tests or methods of assay, those prescribed under authority of the federal act. No <span class="dictionary">drug</span> defined in an <span class="dictionary">official compendium</span> shall be deemed to be adulterated under this subsection because it differs from the standard of strength, quality, or purity set forth in such compendium, if the difference in strength, quality, or purity from such standard is plainly stated on its <span class="dictionary">label</span>.
			Whenever a <span class="dictionary">drug</span> is recognized in both the United States Pharmacopoeia National Formulary and the Homeopathic Pharmacopoeia of the United States it shall be subject to the requirements of the United States Pharmacopoeia National Formulary unless it is labeled and offered for <span class="dictionary">sale</span> as a homeopathic <span class="dictionary">drug</span>, in which case it shall be subject to the provisions of the Homeopathic Pharmacopoeia of the United States and not to those of the United States Pharmacopoeia National Formulary. <a id="paragraph-249050" class="section-permalink" href="https://vacode.org/54.1-3461/#B"><i class="fa fa-link"/></a></p></section>
						<section id="C"><p><span class="prefix-number">C.</span> A <span class="dictionary">drug</span> or <span class="dictionary">device</span> shall be deemed to be adulterated if it is not subject to the provisions of subsection B of this section and its strength differs from, or its purity or quality falls below, that which it purports or is represented to possess. <a id="paragraph-249051" class="section-permalink" href="https://vacode.org/54.1-3461/#C"><i class="fa fa-link"/></a></p></section>
						<section id="D"><p><span class="prefix-number">D.</span> A <span class="dictionary">drug</span> or <span class="dictionary">device</span> shall be deemed to be adulterated if it is a <span class="dictionary">drug</span> and any substance has been (i) mixed or packed with it so as to reduce its quality or strength or (ii) substituted wholly or in part for it. <a id="paragraph-249052" class="section-permalink" href="https://vacode.org/54.1-3461/#D"><i class="fa fa-link"/></a></p></section></text><history>Code 1950, &#xA7; 54-461; 1970, c. 650, &#xA7; 54-524.92; 1988, c. 765.</history><metadata></metadata></law>
