{"formats":[{"name":"JSON","format":"json","url":"\/downloads\/2025\/code-json\/54.1-3442.3.json"},{"name":"Plain Text","format":"text","url":"\/downloads\/2025\/code-text\/54.1-3442.3.txt"},{"name":"XML","format":"xml","url":"\/downloads\/2025\/code-xml\/54.1-3442.3.xml"},{"name":"HTML","format":"html","url":"\/downloads\/2025\/code-html\/54.1-3442.3.html"}],"law_id":80203,"edition_id":1,"section_id":80203,"structure_id":14934,"section_number":"54.1-3442.3","catch_line":"Expanded access to investigational drugs, biological products, or devices; cost; insurance coverage","history":"2015, cc. 655, 656.","full_text":"A\n\nA manufacturer of an investigational drug, biological product, or device may make such investigational drug, biological product, or device available to a person who meets the criteria set forth in subsection A of § 54.1-3442.2; however, nothing in this article shall require a manufacturer of an investigational drug, biological product, or device to make such investigational drug, biological product, or device available to such person.B\n\nA manufacturer that makes an investigational drug, biological product, or device available to a person who meets the criteria set forth in subsection A of § 54.1-3442.2 may provide the investigational drug, biological product, or device to the person free of charge or may require the person to pay the costs of, or the costs associated with, the manufacture of the investigational drug, biological product, or device.C\n\nAn insurer proposing to issue individual or group accident and sickness insurance policies providing hospital, medical and surgical, or major medical coverage on an expense-incurred basis, a corporation providing individual or group accident and sickness subscription contracts, or a health maintenance organization providing a health care plan for health care services may provide coverage for costs related to treatment of a person’s terminal condition with an investigational drug, biological product, or device; however, nothing in this article shall require an insurer proposing to issue individual or group accident and sickness insurance policies providing hospital, medical and surgical, or major medical coverage on an expense-incurred basis, a corporation providing individual or group accident and sickness subscription contracts, or a health maintenance organization providing a health care plan for health care services to provide coverage for costs related to treatment of a person’s terminal condition with an investigational drug, biological product, or device.","order_by":null,"text":{"0":{"id":287110,"text":"A manufacturer of an investigational drug, biological product, or device may make such investigational drug, biological product, or device available to a person who meets the criteria set forth in subsection A of § 54.1-3442.2; however, nothing in this article shall require a manufacturer of an investigational drug, biological product, or device to make such investigational drug, biological product, or device available to such person.","type":"section","prefixes":["A"],"prefix":"A","entire_prefix":"A","prefix_anchor":"A","level":1,"next_prefix":"B"},"1":{"id":287111,"text":"A manufacturer that makes an investigational drug, biological product, or device available to a person who meets the criteria set forth in subsection A of § 54.1-3442.2 may provide the investigational drug, biological product, or device to the person free of charge or may require the person to pay the costs of, or the costs associated with, the manufacture of the investigational drug, biological product, or device.","type":"section","prefixes":["B"],"prefix":"B","entire_prefix":"B","prefix_anchor":"B","level":1,"prior_prefix":"A","next_prefix":"C"},"2":{"id":287112,"text":"An insurer proposing to issue individual or group accident and sickness insurance policies providing hospital, medical and surgical, or major medical coverage on an expense-incurred basis, a corporation providing individual or group accident and sickness subscription contracts, or a health maintenance organization providing a health care plan for health care services may provide coverage for costs related to treatment of a person’s terminal condition with an investigational drug, biological product, or device; however, nothing in this article shall require an insurer proposing to issue individual or group accident and sickness insurance policies providing hospital, medical and surgical, or major medical coverage on an expense-incurred basis, a corporation providing individual or group accident and sickness subscription contracts, or a health maintenance organization providing a health care plan for health care services to provide coverage for costs related to treatment of a person’s terminal condition with an investigational drug, biological product, or device.","type":"section","prefixes":["C"],"prefix":"C","entire_prefix":"C","prefix_anchor":"C","level":1,"prior_prefix":"B"}},"ancestry":[{"id":14934,"edition_id":1,"name":"Expanded Access to Investigational Drugs, Biological Products, and Devices","identifier":"4.1","label":"article","depth":4,"order_by":1,"parent_id":13240,"metadata":{},"date_created":"2026-06-26 03:50:53","date_modified":"2026-06-26 03:50:53","permalink":{"id":243591,"object_type":"structure","relational_id":14934,"identifier":"4.1","token":"54.1\/III\/34\/4.1","url":"\/54.1\/III\/34\/4.1\/","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":73280,"structure_id":14934,"section_number":"54.1-3442.1","catch_line":"Definitions","url":"\/54.1-3442.1\/","token":"54.1\/III\/34\/4.1\/54.1-3442.1","metadata":false},{"id":76563,"structure_id":14934,"section_number":"54.1-3442.2","catch_line":"Eligibility for expanded access to investigational drugs, biological products, and devices; written, informed consent to treatment","url":"\/54.1-3442.2\/","token":"54.1\/III\/34\/4.1\/54.1-3442.2","metadata":false},{"id":80203,"structure_id":14934,"section_number":"54.1-3442.3","catch_line":"Expanded access to investigational drugs, biological products, or devices; cost; insurance coverage","url":"\/54.1-3442.3\/","token":"54.1\/III\/34\/4.1\/54.1-3442.3","metadata":false},{"id":56990,"structure_id":14934,"section_number":"54.1-3442.4","catch_line":"Limitation of liability","url":"\/54.1-3442.4\/","token":"54.1\/III\/34\/4.1\/54.1-3442.4","metadata":false}],"previous_section":{"id":76563,"structure_id":14934,"section_number":"54.1-3442.2","catch_line":"Eligibility for expanded access to investigational drugs, biological products, and devices; written, informed consent to treatment","url":"\/54.1-3442.2\/","token":"54.1\/III\/34\/4.1\/54.1-3442.2","metadata":false},"next_section":{"id":56990,"structure_id":14934,"section_number":"54.1-3442.4","catch_line":"Limitation of liability","url":"\/54.1-3442.4\/","token":"54.1\/III\/34\/4.1\/54.1-3442.4","metadata":false},"metadata":false,"official_url":"https:\/\/law.lis.virginia.gov\/vacode\/54.1-3442.3\/","history_text":"

This law was first created in 2015. The record of its establishment is cataloged in chapters 655<\/a> and 656<\/a> of that year\u2019s edition of \u201cActs of Assembly,\u201d the annual state publication listing all changes made to the Code of Virginia in that year.<\/p>","references":false,"refers_to":[{"id":76563,"section_number":"54.1-3442.2","catch_line":"Eligibility for expanded access to investigational drugs, biological products, and devices; written, informed consent to treatment","order_by":null,"url":"\/54.1-3442.2\/"}],"permalink":{"id":243601,"object_type":"law","relational_id":80203,"identifier":"54.1-3442.3","token":"54.1\/III\/34\/4.1\/54.1-3442.3","url":"\/54.1-3442.3\/","edition_id":1,"permalink":0,"preferred":1},"url":"\/54.1-3442.3\/","token":"54.1\/III\/34\/4.1\/54.1-3442.3","dublin_core":{"Title":"Expanded access to investigational drugs, biological products, or devices; cost; insurance coverage","Type":"Text","Format":"text\/html","Identifier":"\u00a7 54.1-3442.3","Relation":"Code of Virginia"},"html":"\n\t\t\t\t\t\t

A.<\/span> A manufacturer<\/span> of an investigational drug<\/span>, biological product<\/span>, or device<\/span> may make such investigational drug<\/span>, biological product<\/span>, or device<\/span> available to a person<\/span> who meets the criteria set forth in subsection A of § 54.1-3442.2<\/a>; however, nothing in this article shall require a manufacturer<\/span> of an investigational drug<\/span>, biological product<\/span>, or device<\/span> to make such investigational drug<\/span>, biological product<\/span>, or device<\/span> available to such person<\/span>. <\/i><\/a><\/p><\/section>\n\t\t\t\t\t\t

B.<\/span> A manufacturer<\/span> that makes an investigational drug<\/span>, biological product<\/span>, or device<\/span> available to a person<\/span> who meets the criteria set forth in subsection A of § 54.1-3442.2<\/a> may provide the investigational drug<\/span>, biological product<\/span>, or device<\/span> to the person<\/span> free of charge or may require the person<\/span> to pay the costs of, or the costs associated with, the manufacture<\/span> of the investigational drug<\/span>, biological product<\/span>, or device<\/span>. <\/i><\/a><\/p><\/section>\n\t\t\t\t\t\t

C.<\/span> An insurer proposing to issue<\/span> individual or group accident and sickness insurance policies providing hospital, medical and surgical, or major medical coverage on an expense-incurred basis, a corporation providing individual or group accident and sickness subscription contracts<\/span>, or a health maintenance organization providing a health care plan for health care services may provide coverage for costs related to treatment of a person<\/span>’s terminal condition<\/span> with an investigational drug<\/span>, biological product<\/span>, or device<\/span>; however, nothing in this article shall require an insurer proposing to issue<\/span> individual or group accident and sickness insurance policies providing hospital, medical and surgical, or major medical coverage on an expense-incurred basis, a corporation providing individual or group accident and sickness subscription contracts<\/span>, or a health maintenance organization providing a health care plan for health care services to provide coverage for costs related to treatment of a person<\/span>’s terminal condition<\/span> with an investigational drug<\/span>, biological product<\/span>, or device<\/span>. <\/i><\/a><\/p><\/section>","plain_text":" CODE OF VIRGINIA\n\nEXPANDED ACCESS TO INVESTIGATIONAL DRUGS, BIOLOGICAL PRODUCTS, OR DEVICES; COST;\nINSURANCE COVERAGE (\u00a7 54.1-3442.3)\n\nA. A manufacturer of an investigational drug, biological product, or device may\nmake such investigational drug, biological product, or device available to a\nperson who meets the criteria set forth in subsection A of § 54.1-3442.2;\nhowever, nothing in this article shall require a manufacturer of an\ninvestigational drug, biological product, or device to make such investigational\ndrug, biological product, or device available to such person.\n\nB. A manufacturer that makes an investigational drug, biological product, or\ndevice available to a person who meets the criteria set forth in subsection A of\n§ 54.1-3442.2 may provide the investigational drug, biological product, or\ndevice to the person free of charge or may require the person to pay the costs\nof, or the costs associated with, the manufacture of the investigational drug,\nbiological product, or device.\n\nC. An insurer proposing to issue individual or group accident and sickness\ninsurance policies providing hospital, medical and surgical, or major medical\ncoverage on an expense-incurred basis, a corporation providing individual or\ngroup accident and sickness subscription contracts, or a health maintenance\norganization providing a health care plan for health care services may provide\ncoverage for costs related to treatment of a person’s terminal condition\nwith an investigational drug, biological product, or device; however, nothing in\nthis article shall require an insurer proposing to issue individual or group\naccident and sickness insurance policies providing hospital, medical and\nsurgical, or major medical coverage on an expense-incurred basis, a corporation\nproviding individual or group accident and sickness subscription contracts, or a\nhealth maintenance organization providing a health care plan for health care\nservices to provide coverage for costs related to treatment of a person’s\nterminal condition with an investigational drug, biological product, or device.\n\nHISTORY: 2015, cc. 655, 656.","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}}