{"formats":[{"name":"JSON","format":"json","url":"\/downloads\/2025\/code-json\/54.1-3442.02.json"},{"name":"Plain Text","format":"text","url":"\/downloads\/2025\/code-text\/54.1-3442.02.txt"},{"name":"XML","format":"xml","url":"\/downloads\/2025\/code-xml\/54.1-3442.02.xml"},{"name":"HTML","format":"html","url":"\/downloads\/2025\/code-html\/54.1-3442.02.html"}],"law_id":75222,"edition_id":1,"section_id":75222,"structure_id":14166,"section_number":"54.1-3442.02","catch_line":"Prescription drug price transparency","history":"2021, Sp. Sess. I, c. 304.","full_text":"A\n\nAs used in this section:\n\t\t\t“Biosimilar” means a drug that is produced or distributed pursuant to a biologics license application approved under 42 U.S.C. § 262(k)(3).\n\t\t\t“Brand-name drug” means a prescription drug approved under 21 U.S.C. § 355(b) or 42 U.S.C. § 262.\n\t\t\t“Generic drug” means a prescription drug approved under 21 U.S.C. § 355(j) or 42 U.S.C. 262(k).\n\t\t\t“New prescription drug” means a drug or biological product receiving initial approval under an original new drug application pursuant to 21 U.S.C. § 355(b) or under a biologics license application under 42 U.S.C. § 262.\n\t\t\t“Nonprofit data services organization” has the same meaning as set forth in § 32.1-23.4.\n\t\t\t“Pharmacy benefits manager” has the same meaning as set forth in § 38.2-3407.15:4.\n\t\t\t“Wholesale acquisition cost” has the same meaning as set forth in 42 U.S.C. § 1395w-3a(c)(6)(B).B\n\nEvery manufacturer shall report annually by April 1 to the nonprofit organization with which the Department of Health has entered into a contract or agreement pursuant to \u00a7 32.1-23.4, for each (i) brand-name drug and biologic other than a biosimilar with a wholesale acquisition cost of $100 or more for a 30-day supply or a single course of treatment and any increase of 15 percent or more in the wholesale acquisition cost of such brand-name drug or biologic over the preceding calendar year; (ii) biosimilar with an initial wholesale acquisition cost that is not at least 15 percent less than the wholesale acquisition cost of the referenced brand biologic at the time the biosimilar is launched; and (iii) generic drug with a price increase that results in an increase in the wholesale acquisition cost of such generic drug that is equal to 200 percent or more during the preceding 12-month period, when the wholesale acquisition cost of such generic drug is equal to or greater than $100, annually adjusted by the Consumer Price Index for All Urban Consumers, for a 30-day supply, with such increase defined as the difference between the wholesale acquisition cost of the generic drug after such increase and the average wholesale acquisition cost of such generic drug during the previous 12 months, the following information:1\n\nThe name of the prescription drug;2\n\nWhether the drug is a brand name or generic;3\n\nThe effective date of the change in wholesale acquisition cost;4\n\nAggregate, company-level research and development costs for the most recent year for which final audit data is available;5\n\nThe name of each of the manufacturer’s new prescription drugs approved by the U.S. Food and Drug Administration within the previous three calendar years;6\n\nThe name of each of the manufacturer’s prescription drugs that, within the previous three calendar years, became subject to generic competition and for which there is a therapeutically equivalent generic version; and7\n\nA concise statement regarding the factor or factors that caused the increase in wholesale acquisition cost.C\n\nA manufacturer’s obligations pursuant to this section shall be fully satisfied by the submission to the nonprofit data services organization with which the Department of Health has entered into a contract pursuant to § 32.1-23.4 of information and data that a manufacturer includes in the manufacturer’s annual consolidation report on Securities and Exchange Commission Form 10-K or any other public disclosure.","order_by":null,"text":{"0":{"id":270109,"text":"As used in this section:\n\t\t\t“Biosimilar” means a drug that is produced or distributed pursuant to a biologics license application approved under 42 U.S.C. § 262(k)(3).\n\t\t\t“Brand-name drug” means a prescription drug approved under 21 U.S.C. § 355(b) or 42 U.S.C. § 262.\n\t\t\t“Generic drug” means a prescription drug approved under 21 U.S.C. § 355(j) or 42 U.S.C. 262(k).\n\t\t\t“New prescription drug” means a drug or biological product receiving initial approval under an original new drug application pursuant to 21 U.S.C. § 355(b) or under a biologics license application under 42 U.S.C. § 262.\n\t\t\t“Nonprofit data services organization” has the same meaning as set forth in § 32.1-23.4.\n\t\t\t“Pharmacy benefits manager” has the same meaning as set forth in § 38.2-3407.15:4.\n\t\t\t“Wholesale acquisition cost” has the same meaning as set forth in 42 U.S.C. § 1395w-3a(c)(6)(B).","type":"section","prefixes":["A"],"prefix":"A","entire_prefix":"A","prefix_anchor":"A","level":1,"next_prefix":"B"},"1":{"id":270110,"text":"Every manufacturer shall report annually by April 1 to the nonprofit organization with which the Department of Health has entered into a contract or agreement pursuant to \u00a7 32.1-23.4, for each (i) brand-name drug and biologic other than a biosimilar with a wholesale acquisition cost of $100 or more for a 30-day supply or a single course of treatment and any increase of 15 percent or more in the wholesale acquisition cost of such brand-name drug or biologic over the preceding calendar year; (ii) biosimilar with an initial wholesale acquisition cost that is not at least 15 percent less than the wholesale acquisition cost of the referenced brand biologic at the time the biosimilar is launched; and (iii) generic drug with a price increase that results in an increase in the wholesale acquisition cost of such generic drug that is equal to 200 percent or more during the preceding 12-month period, when the wholesale acquisition cost of such generic drug is equal to or greater than $100, annually adjusted by the Consumer Price Index for All Urban Consumers, for a 30-day supply, with such increase defined as the difference between the wholesale acquisition cost of the generic drug after such increase and the average wholesale acquisition cost of such generic drug during the previous 12 months, the following information:","type":"section","prefixes":["B"],"prefix":"B","entire_prefix":"B","prefix_anchor":"B","level":1,"prior_prefix":"A","next_prefix":"B1"},"2":{"id":270111,"text":"The name of the prescription drug;","type":"section","prefixes":["B","1"],"prefix":"1","entire_prefix":"B1","prefix_anchor":"B1","level":2,"prior_prefix":"B","next_prefix":"B2"},"3":{"id":270112,"text":"Whether the drug is a brand name or generic;","type":"section","prefixes":["B","2"],"prefix":"2","entire_prefix":"B2","prefix_anchor":"B2","level":2,"prior_prefix":"B1","next_prefix":"B3"},"4":{"id":270113,"text":"The effective date of the change in wholesale acquisition cost;","type":"section","prefixes":["B","3"],"prefix":"3","entire_prefix":"B3","prefix_anchor":"B3","level":2,"prior_prefix":"B2","next_prefix":"B4"},"5":{"id":270114,"text":"Aggregate, company-level research and development costs for the most recent year for which final audit data is available;","type":"section","prefixes":["B","4"],"prefix":"4","entire_prefix":"B4","prefix_anchor":"B4","level":2,"prior_prefix":"B3","next_prefix":"B5"},"6":{"id":270115,"text":"The name of each of the manufacturer’s new prescription drugs approved by the U.S. Food and Drug Administration within the previous three calendar years;","type":"section","prefixes":["B","5"],"prefix":"5","entire_prefix":"B5","prefix_anchor":"B5","level":2,"prior_prefix":"B4","next_prefix":"B6"},"7":{"id":270116,"text":"The name of each of the manufacturer’s prescription drugs that, within the previous three calendar years, became subject to generic competition and for which there is a therapeutically equivalent generic version; and","type":"section","prefixes":["B","6"],"prefix":"6","entire_prefix":"B6","prefix_anchor":"B6","level":2,"prior_prefix":"B5","next_prefix":"B7"},"8":{"id":270117,"text":"A concise statement regarding the factor or factors that caused the increase in wholesale acquisition cost.","type":"section","prefixes":["B","7"],"prefix":"7","entire_prefix":"B7","prefix_anchor":"B7","level":2,"prior_prefix":"B6","next_prefix":"C"},"9":{"id":270118,"text":"A manufacturer’s obligations pursuant to this section shall be fully satisfied by the submission to the nonprofit data services organization with which the Department of Health has entered into a contract pursuant to § 32.1-23.4 of information and data that a manufacturer includes in the manufacturer’s annual consolidation report on Securities and Exchange Commission Form 10-K or any other public disclosure.","type":"section","prefixes":["C"],"prefix":"C","entire_prefix":"C","prefix_anchor":"C","level":1,"prior_prefix":"B7"}},"ancestry":[{"id":14166,"edition_id":1,"name":"Permitting of Manufacturers","identifier":"4","label":"article","depth":4,"order_by":1,"parent_id":13240,"metadata":{},"date_created":"2026-06-26 03:47:06","date_modified":"2026-06-26 03:47:06","permalink":{"id":243553,"object_type":"structure","relational_id":14166,"identifier":"4","token":"54.1\/III\/34\/4","url":"\/54.1\/III\/34\/4\/","edition_id":1,"permalink":0,"preferred":1}},{"id":13240,"edition_id":1,"name":"Drug Control Act","identifier":"34","label":"chapter","depth":3,"order_by":1,"parent_id":12758,"metadata":{},"date_created":"2026-06-26 03:44:30","date_modified":"2026-06-26 03:44:30","permalink":{"id":243223,"object_type":"structure","relational_id":13240,"identifier":"34","token":"54.1\/III\/34","url":"\/54.1\/III\/34\/","edition_id":1,"permalink":0,"preferred":1}},{"id":12758,"edition_id":1,"name":"Professions and Occupations Regulated by Boards Within the Department of Health Professions","identifier":"III","label":"subtitle","depth":2,"order_by":1,"parent_id":12754,"metadata":{},"date_created":"2026-06-26 03:43:51","date_modified":"2026-06-26 03:43:51","permalink":{"id":241105,"object_type":"structure","relational_id":12758,"identifier":"III","token":"54.1\/III","url":"\/54.1\/III\/","edition_id":1,"permalink":0,"preferred":1}},{"id":12754,"edition_id":1,"name":"Professions and Occupations","identifier":"54.1","label":"title","depth":1,"order_by":1,"parent_id":null,"metadata":{},"date_created":"2026-06-26 03:43:51","date_modified":"2026-06-26 03:43:51","permalink":{"id":239313,"object_type":"structure","relational_id":12754,"identifier":"54.1","token":"54.1","url":"\/54.1\/","edition_id":1,"permalink":0,"preferred":1}}],"structure_contents":[{"id":55332,"structure_id":14166,"section_number":"54.1-3437","catch_line":"Permit to manufacture drugs","url":"\/54.1-3437\/","token":"54.1\/III\/34\/4\/54.1-3437","metadata":false},{"id":84440,"structure_id":14166,"section_number":"54.1-3437.1","catch_line":"Limited permit for repackaging drugs","url":"\/54.1-3437.1\/","token":"54.1\/III\/34\/4\/54.1-3437.1","metadata":false},{"id":68991,"structure_id":14166,"section_number":"54.1-3438","catch_line":"Manufacturing, etc., of drugs or proprietary medicines, to be supervised by pharmacist","url":"\/54.1-3438\/","token":"54.1\/III\/34\/4\/54.1-3438","metadata":false},{"id":82036,"structure_id":14166,"section_number":"54.1-3439","catch_line":"Application for nonrestricted manufacturing permit; 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A.<\/span> As used in this section:\n\t\t\t“Biosimilar<\/span>” means a drug that is produced or distributed pursuant to a biologics license application approved under 42 U.S.C. § 262(k)(3).\n\t\t\t“Brand-name drug<\/span>” means a prescription drug approved under 21 U.S.C. § 355(b) or 42 U.S.C. § 262.\n\t\t\t“Generic drug<\/span>” means a prescription drug approved under 21 U.S.C. § 355(j) or 42 U.S.C. 262(k).\n\t\t\t“New prescription drug<\/span>” means a drug or biological product<\/span> receiving initial approval under an original new drug<\/span> application pursuant to 21 U.S.C. § 355(b) or under a biologics license application under 42 U.S.C. § 262.\n\t\t\t“Nonprofit data services organization<\/span>” has the same meaning as set forth in § 32.1-23.4<\/a>.\n\t\t\t“Pharmacy benefits manager<\/span>” has the same meaning as set forth in § 38.2-3407.15:4<\/a>.\n\t\t\t“Wholesale acquisition cost<\/span>” has the same meaning as set forth in 42 U.S.C. § 1395w-3a(c)(6)(B). <\/i><\/a><\/p><\/section>\n\t\t\t\t\t\t

B.<\/span> Every manufacturer<\/span> shall report annually by April 1 to the nonprofit organization with which the Department of Health has entered into a contract<\/span> or agreement pursuant to \u00a7 32.1-23.4<\/a>, for each (i) brand-name drug<\/span> and biologic other than a biosimilar<\/span> with a wholesale acquisition cost<\/span> of $100 or more for a 30-day supply or a single course of treatment and any increase of 15 percent or more in the wholesale acquisition cost<\/span> of such brand-name drug<\/span> or biologic over the preceding calendar year; (ii) biosimilar<\/span> with an initial wholesale acquisition cost<\/span> that is not at least 15 percent less than the wholesale acquisition cost<\/span> of the referenced brand biologic at the time the biosimilar<\/span> is launched; and (iii) generic drug<\/span> with a price increase that results in an increase in the wholesale acquisition cost<\/span> of such generic drug<\/span> that is equal to 200 percent or more during the preceding 12-month period, when the wholesale acquisition cost<\/span> of such generic drug<\/span> is equal to or greater than $100, annually adjusted by the Consumer Price Index for All Urban Consumers, for a 30-day supply, with such increase defined as the difference between the wholesale acquisition cost<\/span> of the generic drug<\/span> after such increase and the average wholesale acquisition cost<\/span> of such generic drug<\/span> during the previous 12 months, the following information: <\/i><\/a><\/p><\/section>\n\t\t\t\t\t\t

1.<\/span> The name of the prescription drug; <\/i><\/a><\/p><\/section>\n\t\t\t\t\t\t

2.<\/span> Whether the drug is a brand name or generic; <\/i><\/a><\/p><\/section>\n\t\t\t\t\t\t

3.<\/span> The effective date of the change in wholesale acquisition cost<\/span>; <\/i><\/a><\/p><\/section>\n\t\t\t\t\t\t

4.<\/span> Aggregate, company-level research and development costs for the most recent year for which final audit data is available; <\/i><\/a><\/p><\/section>\n\t\t\t\t\t\t

5.<\/span> The name of each of the manufacturer<\/span>’s new prescription drugs<\/span> approved by the U.S. Food and Drug Administration within the previous three calendar years; <\/i><\/a><\/p><\/section>\n\t\t\t\t\t\t

6.<\/span> The name of each of the manufacturer<\/span>’s prescription drugs that, within the previous three calendar years, became subject to generic competition and for which there is a therapeutically equivalent generic version; and <\/i><\/a><\/p><\/section>\n\t\t\t\t\t\t

7.<\/span> A concise statement regarding the factor or factors that caused the increase in wholesale acquisition cost<\/span>. <\/i><\/a><\/p><\/section>\n\t\t\t\t\t\t

C.<\/span> A manufacturer<\/span>’s obligations pursuant to this section shall be fully satisfied by the submission to the nonprofit data services organization<\/span> with which the Department of Health has entered into a contract<\/span> pursuant to § 32.1-23.4<\/a> of information and data that a manufacturer<\/span> includes in the manufacturer<\/span>’s annual consolidation<\/span> report on Securities and Exchange Commission Form 10-K or any other public disclosure. <\/i><\/a><\/p><\/section>","plain_text":" CODE OF VIRGINIA\n\nPRESCRIPTION DRUG PRICE TRANSPARENCY (\u00a7 54.1-3442.02)\n\nA. As used in this section:\n\t\t\t“Biosimilar” means a drug that is produced or distributed\npursuant to a biologics license application approved under 42 U.S.C. §\n262(k)(3).\n\t\t\t“Brand-name drug” means a prescription drug approved under 21\nU.S.C. § 355(b) or 42 U.S.C. § 262.\n\t\t\t“Generic drug” means a prescription drug approved under 21 U.S.C.\n§ 355(j) or 42 U.S.C. 262(k).\n\t\t\t“New prescription drug” means a drug or biological product\nreceiving initial approval under an original new drug application pursuant to 21\nU.S.C. § 355(b) or under a biologics license application under 42 U.S.C.\n§ 262.\n\t\t\t“Nonprofit data services organization” has the same meaning as\nset forth in § 32.1-23.4.\n\t\t\t“Pharmacy benefits manager” has the same meaning as set forth in\n§ 38.2-3407.15:4.\n\t\t\t“Wholesale acquisition cost” has the same meaning as set forth in\n42 U.S.C. § 1395w-3a(c)(6)(B).\n\nB. Every manufacturer shall report annually by April 1 to the nonprofit\norganization with which the Department of Health has entered into a contract or\nagreement pursuant to \u00a7 32.1-23.4, for each (i) brand-name drug and biologic\nother than a biosimilar with a wholesale acquisition cost of $100 or more for a\n30-day supply or a single course of treatment and any increase of 15 percent or\nmore in the wholesale acquisition cost of such brand-name drug or biologic over\nthe preceding calendar year; (ii) biosimilar with an initial wholesale\nacquisition cost that is not at least 15 percent less than the wholesale\nacquisition cost of the referenced brand biologic at the time the biosimilar is\nlaunched; and (iii) generic drug with a price increase that results in an\nincrease in the wholesale acquisition cost of such generic drug that is equal to\n200 percent or more during the preceding 12-month period, when the wholesale\nacquisition cost of such generic drug is equal to or greater than $100, annually\nadjusted by the Consumer Price Index for All Urban Consumers, for a 30-day\nsupply, with such increase defined as the difference between the wholesale\nacquisition cost of the generic drug after such increase and the average\nwholesale acquisition cost of such generic drug during the previous 12 months,\nthe following information:\n\n 1. The name of the prescription drug;\n\n 2. Whether the drug is a brand name or generic;\n\n 3. The effective date of the change in wholesale acquisition cost;\n\n 4. Aggregate, company-level research and development costs for the most recent\n year for which final audit data is available;\n\n 5. The name of each of the manufacturer’s new prescription drugs\n approved by the U.S. Food and Drug Administration within the previous three\n calendar years;\n\n 6. The name of each of the manufacturer’s prescription drugs that,\n within the previous three calendar years, became subject to generic\n competition and for which there is a therapeutically equivalent generic\n version; and\n\n 7. A concise statement regarding the factor or factors that caused the\n increase in wholesale acquisition cost.\n\nC. A manufacturer’s obligations pursuant to this section shall be fully\nsatisfied by the submission to the nonprofit data services organization with\nwhich the Department of Health has entered into a contract pursuant to §\n32.1-23.4 of information and data that a manufacturer includes in the\nmanufacturer’s annual consolidation report on Securities and Exchange\nCommission Form 10-K or any other public disclosure.\n\nHISTORY: 2021, Sp. Sess. I, c. 304.","edition":{"id":1,"name":"2025","slug":"2025","date_created":"2026-06-21 22:39:22","date_modified":"2026-06-21 22:39:22","current":1,"order_by":1,"last_import":null}}