{"formats":[{"name":"JSON","format":"json","url":"\/downloads\/2026\/code-json\/54.1-3442.1.json"},{"name":"Plain Text","format":"text","url":"\/downloads\/2026\/code-text\/54.1-3442.1.txt"},{"name":"XML","format":"xml","url":"\/downloads\/2026\/code-xml\/54.1-3442.1.xml"},{"name":"HTML","format":"html","url":"\/downloads\/2026\/code-html\/54.1-3442.1.html"}],"law_id":368765,"edition_id":2,"section_id":368765,"structure_id":52543,"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\n&#8220;Investigational drug, biological product, or device&#8221; 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\n&#8220;Terminal condition&#8221; 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&#8217;s death is imminent or (ii) the patient is in a persistent vegetative state.\n\n&#8220;Treating physician&#8221; 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.\n\n","order_by":null,"text":{"0":{"id":1374311,"text":"As used in this article, unless the context requires a different meaning:","type":"section","prefixes":[""],"prefix":"","entire_prefix":"","prefix_anchor":"","level":1,"next_prefix":""},"1":{"id":1374312,"text":"&#8220;Investigational drug, biological product, or device&#8221; 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.","type":"section","prefixes":[""],"prefix":"","entire_prefix":"","prefix_anchor":"","level":1,"prior_prefix":"","next_prefix":""},"2":{"id":1374313,"text":"&#8220;Terminal condition&#8221; 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&#8217;s death is imminent or (ii) the patient is in a persistent vegetative state.","type":"section","prefixes":[""],"prefix":"","entire_prefix":"","prefix_anchor":"","level":1,"prior_prefix":"","next_prefix":""},"3":{"id":1374314,"text":"&#8220;Treating physician&#8221; 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,"prior_prefix":""}},"ancestry":[{"id":52543,"edition_id":2,"name":"Expanded Access to Investigational Drugs, Biological Products, and Devices","identifier":"4.1","label":"article","depth":4,"order_by":6,"parent_id":52537,"metadata":{"child_laws":4,"child_structures":0},"date_created":"2026-08-02 03:00:46","date_modified":"2026-08-02 12:35:15","permalink":{"id":1470593,"object_type":"structure","relational_id":52543,"identifier":"4.1","token":"54.1\/III\/34\/4.1","url":"\/54.1\/III\/34\/4.1\/","edition_id":2,"permalink":0,"preferred":1}},{"id":52537,"edition_id":2,"name":"Drug Control Act","identifier":"34","label":"chapter","depth":3,"order_by":16,"parent_id":52479,"metadata":{"child_laws":127,"child_structures":10},"date_created":"2026-08-02 03:00:37","date_modified":"2026-08-02 12:35:13","permalink":{"id":1470225,"object_type":"structure","relational_id":52537,"identifier":"34","token":"54.1\/III\/34","url":"\/54.1\/III\/34\/","edition_id":2,"permalink":0,"preferred":1}},{"id":52479,"edition_id":2,"name":"Professions and Occupations Regulated by Boards Within the Department of Health Professions","identifier":"III","label":"subtitle","depth":2,"order_by":3,"parent_id":52436,"metadata":{"child_laws":738,"child_structures":83},"date_created":"2026-08-02 02:59:23","date_modified":"2026-08-02 12:35:00","permalink":{"id":1468107,"object_type":"structure","relational_id":52479,"identifier":"III","token":"54.1\/III","url":"\/54.1\/III\/","edition_id":2,"permalink":0,"preferred":1}},{"id":52436,"edition_id":2,"name":"Professions and Occupations","identifier":"54.1","label":"title","depth":1,"order_by":118,"parent_id":null,"metadata":{"child_laws":1282,"child_structures":163},"date_created":"2026-08-02 02:58:52","date_modified":"2026-08-02 12:34:51","permalink":{"id":1466315,"object_type":"structure","relational_id":52436,"identifier":"54.1","token":"54.1","url":"\/54.1\/","edition_id":2,"permalink":0,"preferred":1}}],"structure_contents":[{"id":368765,"structure_id":52543,"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":368766,"structure_id":52543,"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":368767,"structure_id":52543,"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":368768,"structure_id":52543,"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":368766,"structure_id":52543,"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":"<p>This law was first created in 2015. The record of its establishment is cataloged in chapters <a href=\"https:\/\/legacylis.virginia.gov\/cgi-bin\/legp604.exe?151+ful+CHAP0655\">655<\/a> and <a href=\"https:\/\/legacylis.virginia.gov\/cgi-bin\/legp604.exe?151+ful+CHAP0656\">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":1470595,"object_type":"law","relational_id":368765,"identifier":"54.1-3442.1","token":"54.1\/III\/34\/4.1\/54.1-3442.1","url":"\/54.1-3442.1\/","edition_id":2,"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<section><p>As used in this article, unless the context requires a different meaning:<\/p><p>&#8220;<span class=\"dictionary\">Investigational <span class=\"dictionary\">drug<\/span>, <span class=\"dictionary\">biological product<\/span>, or device<\/span>&#8221; means a <span class=\"dictionary\">drug<\/span>, <span class=\"dictionary\">biological product<\/span>, or device that has successfully completed Phase I of a clinical <span class=\"dictionary\">trial<\/span> but has not been approved for general use by the U.S. Food and <span class=\"dictionary\">Drug<\/span> Administration and remains under investigation in a clinical <span class=\"dictionary\">trial<\/span>.<\/p><p>&#8220;<span class=\"dictionary\">Terminal condition<\/span>&#8221; 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&#8217;s death is imminent or (ii) the patient is in a persistent vegetative state.<\/p><p>&#8220;<span class=\"dictionary\">Treating physician<\/span>&#8221; 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 <span class=\"dictionary\">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\n&#8220;Investigational drug, biological product, or device&#8221; means a drug,\nbiological 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\n&#8220;Terminal condition&#8221; means a condition caused by injury, disease, or\nillness from which, to a reasonable degree of medical probability, a patient\ncannot recover and (i) the patient&#8217;s death is imminent or (ii) the patient\nis in a persistent vegetative state.\n\n&#8220;Treating physician&#8221; 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":2,"name":"2026","slug":"2026","date_created":"2026-07-16 18:40:23","date_modified":"2026-08-02 15:14:36","current":1,"order_by":2,"last_import":"2026-08-02 12:37:30"}}