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<law><site_title>Virginia Decoded</site_title><site_url>https://vacode.org</site_url><law_id>81842</law_id><section_number>54.1-3408.03</section_number><catch_line>Dispensing of therapeutically equivalent drug product permitted</catch_line><edition url="https://vacode.org/2025/" slug="2025" current="TRUE" last_updated="">2025</edition><referred_to_by><reference>38.2-3407.15:4</reference><reference>54.1-3457</reference><reference>65.2-603.1</reference></referred_to_by><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="1">General Provisions</unit></structure><text>
						<section id="A"><p><span class="prefix-number">A.</span> A pharmacist may <span class="dictionary">dispense</span> a therapeutically equivalent <span class="dictionary">drug product</span> for a <span class="dictionary">prescription</span> that is written for a brand-name <span class="dictionary">drug product</span> unless (i) the <span class="dictionary">prescriber</span> indicates such substitution is not authorized by specifying on the <span class="dictionary">prescription</span>, &#x201C;brand medically necessary&#x201D; or (ii) the patient insists on the <span class="dictionary">dispensing</span> of the brand-name <span class="dictionary">drug product</span>.
			In the case of an oral <span class="dictionary">prescription</span>, the <span class="dictionary">prescriber</span>&#x2019;s oral <span class="dictionary">dispensing</span> instructions regarding substitution shall be followed. <a id="paragraph-293200" class="section-permalink" href="https://vacode.org/54.1-3408.03/#A"><i class="fa fa-link"/></a></p></section>
						<section id="B"><p><span class="prefix-number">B.</span> <span class="dictionary">Prescribers</span> using <span class="dictionary">prescription</span> blanks printed in compliance with Virginia <span class="dictionary">law</span> in effect on June 30, 2003, having two check boxes and referencing the Virginia Voluntary Formulary, may indicate, until July 1, 2006, that substitution is not authorized by checking the &#x201C;<span class="dictionary">Dispense</span> as Written&#x201D; box. If the &#x201C;Voluntary Formulary Permitted&#x201D; box is checked on such <span class="dictionary">prescription</span> blanks or if neither box is checked, a pharmacist may <span class="dictionary">dispense</span> a therapeutically equivalent <span class="dictionary">drug product</span> pursuant to such <span class="dictionary">prescriptions</span>. <a id="paragraph-293201" class="section-permalink" href="https://vacode.org/54.1-3408.03/#B"><i class="fa fa-link"/></a></p></section>
						<section id="C"><p><span class="prefix-number">C.</span> If the pharmacist <span class="dictionary">dispenses</span> a <span class="dictionary">drug product</span> other than the brand name prescribed, he shall so inform the purchaser and shall indicate, unless otherwise directed by the <span class="dictionary">prescriber</span>, on both his permanent record and the <span class="dictionary">prescription</span> <span class="dictionary">label</span>, the brand name or, in the case of a therapeutically equivalent <span class="dictionary">drug product</span>, the name of the <span class="dictionary">manufacturer</span> or the <span class="dictionary">distributor</span>. Whenever a pharmacist <span class="dictionary">dispenses</span> a therapeutically equivalent <span class="dictionary">drug product</span> pursuant to a <span class="dictionary">prescription</span> written for a brand-name product, the pharmacist shall <span class="dictionary">label</span> the drug with the name of the therapeutically equivalent <span class="dictionary">drug product</span> followed by the words &#x201C;generic for&#x201D; and the brand name of the drug for which the <span class="dictionary">prescription</span> was written. <a id="paragraph-293202" class="section-permalink" href="https://vacode.org/54.1-3408.03/#C"><i class="fa fa-link"/></a></p></section>
						<section id="D"><p><span class="prefix-number">D.</span> When a pharmacist <span class="dictionary">dispenses</span> a <span class="dictionary">drug product</span> other than the <span class="dictionary">drug product</span> prescribed, the dispensed <span class="dictionary">drug product</span> shall be at a lower retail price than that of the <span class="dictionary">drug product</span> prescribed. Such retail price shall not exceed the usual and customary retail price charged by the pharmacist for the dispensed therapeutically equivalent <span class="dictionary">drug product</span>. <a id="paragraph-293203" class="section-permalink" href="https://vacode.org/54.1-3408.03/#D"><i class="fa fa-link"/></a></p></section>
						<section id="E"><p><span class="prefix-number">E.</span> A therapeutically equivalent drug shall be eligible for <span class="dictionary">dispensing</span> only if the <span class="dictionary">manufacturer</span> has established adequate provisions for the return of outdated <span class="dictionary">drugs</span>, through the <span class="dictionary">distributor</span> or otherwise, by pharmacies. Such provisions shall permit pharmacies to return <span class="dictionary">drugs</span> in both full and partial containers up to six months after the <span class="dictionary">label</span> expiration date for full credit or replacement. <a id="paragraph-293204" class="section-permalink" href="https://vacode.org/54.1-3408.03/#E"><i class="fa fa-link"/></a></p></section></text><history>2003, c. 639; 2025, c. 270.</history><metadata></metadata></law>
