{"formats":[{"name":"JSON","format":"json","url":"\/downloads\/2025\/code-json\/54.1-3442.1.json"},{"name":"Plain Text","format":"text","url":"\/downloads\/2025\/code-text\/54.1-3442.1.txt"},{"name":"XML","format":"xml","url":"\/downloads\/2025\/code-xml\/54.1-3442.1.xml"},{"name":"HTML","format":"html","url":"\/downloads\/2025\/code-html\/54.1-3442.1.html"}],"law_id":73280,"edition_id":1,"section_id":73280,"structure_id":14934,"section_number":"54.1-3442.1","catch_line":"Definitions","history":"2015, cc. 655, 656.","full_text":"As used in this article, unless the context requires a different meaning:\n\t\t“Investigational drug, biological product, or device” means a drug, biological product, or device that has successfully completed Phase I of a clinical trial but has not been approved for general use by the U.S. Food and Drug Administration and remains under investigation in a clinical trial.\n\t\t“Terminal condition” means a condition caused by injury, disease, or illness from which, to a reasonable degree of medical probability, a patient cannot recover and (i) the patient’s death is imminent or (ii) the patient is in a persistent vegetative state.\n\t\t“Treating physician” means a physician who is providing or has previously provided medical treatment or evaluation to and has or previously had an ongoing treatment relationship with the person.","order_by":null,"text":{"0":{"id":263722,"text":"As used in this article, unless the context requires a different meaning:\n\t\t“Investigational drug, biological product, or device” means a drug, biological product, or device that has successfully completed Phase I of a clinical trial but has not been approved for general use by the U.S. Food and Drug Administration and remains under investigation in a clinical trial.\n\t\t“Terminal condition” means a condition caused by injury, disease, or illness from which, to a reasonable degree of medical probability, a patient cannot recover and (i) the patient’s death is imminent or (ii) the patient is in a persistent vegetative state.\n\t\t“Treating physician” means a physician who is providing or has previously provided medical treatment or evaluation to and has or previously had an ongoing treatment relationship with the person.","type":"section","prefixes":[""],"prefix":"","entire_prefix":"","prefix_anchor":"","level":1}},"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}],"next_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},"metadata":false,"official_url":"https:\/\/law.lis.virginia.gov\/vacode\/54.1-3442.1\/","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":false,"permalink":{"id":243593,"object_type":"law","relational_id":73280,"identifier":"54.1-3442.1","token":"54.1\/III\/34\/4.1\/54.1-3442.1","url":"\/54.1-3442.1\/","edition_id":1,"permalink":0,"preferred":1},"url":"\/54.1-3442.1\/","token":"54.1\/III\/34\/4.1\/54.1-3442.1","dublin_core":{"Title":"Definitions","Type":"Text","Format":"text\/html","Identifier":"\u00a7 54.1-3442.1","Relation":"Code of Virginia"},"html":"\n\t\t\t\t\t\t

As used in this article, unless the context requires a different meaning:\n\t\t“Investigational drug<\/span>, biological product<\/span>, or device<\/span>” means a drug<\/span>, biological product<\/span>, or device that has successfully completed Phase I of a clinical trial<\/span> but has not been approved for general use by the U.S. Food and Drug<\/span> Administration and remains under investigation in a clinical trial<\/span>.\n\t\t“Terminal condition<\/span>” means a condition caused by injury, disease, or illness from which, to a reasonable degree of medical probability, a patient cannot recover and (i) the patient’s death is imminent or (ii) the patient is in a persistent vegetative state.\n\t\t“Treating physician<\/span>” means a physician who is providing or has previously provided medical treatment or evaluation to and has or previously had an ongoing treatment relationship with the person<\/span>.<\/p><\/section>","plain_text":" CODE OF VIRGINIA\n\nDEFINITIONS (\u00a7 54.1-3442.1)\n\nAs used in this article, unless the context requires a different meaning:\n\t\t“Investigational drug, biological product, or device” means a\ndrug, biological product, or device that has successfully completed Phase I of a\nclinical trial but has not been approved for general use by the U.S. Food and\nDrug Administration and remains under investigation in a clinical trial.\n\t\t“Terminal condition” means a condition caused by injury, disease,\nor illness from which, to a reasonable degree of medical probability, a patient\ncannot recover and (i) the patient’s death is imminent or (ii) the patient\nis in a persistent vegetative state.\n\t\t“Treating physician” means a physician who is providing or has\npreviously provided medical treatment or evaluation to and has or previously had\nan ongoing treatment relationship with the person.\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}}