{"formats":[{"name":"JSON","format":"json","url":"\/downloads\/2025\/code-json\/54.1-3442.4.json"},{"name":"Plain Text","format":"text","url":"\/downloads\/2025\/code-text\/54.1-3442.4.txt"},{"name":"XML","format":"xml","url":"\/downloads\/2025\/code-xml\/54.1-3442.4.xml"},{"name":"HTML","format":"html","url":"\/downloads\/2025\/code-html\/54.1-3442.4.html"}],"law_id":56990,"edition_id":1,"section_id":56990,"structure_id":14934,"section_number":"54.1-3442.4","catch_line":"Limitation of liability","history":"2015, cc. 655, 656.","full_text":"A\n\nNotwithstanding any other provision of law to the contrary, a health care provider as defined in § 8.01-581.1 who recommends an investigational drug, biological product, or device to a person who meets the criteria set forth in subsection A of § 54.1-3442.2 shall be immune from civil liability for any adverse action, condition, or other outcome resulting from the person’s use of the investigational drug, biological product, or device.B\n\nNotwithstanding any other provision of law to the contrary, a manufacturer, distributor, administrator, health care provider as defined in § 8.01-581.1, sponsor, or physician who manufactures, supplies, distributes, administers, prescribes, or recommends an investigational drug, biological product, or device to a person who meets the criteria set forth in § 54.1-3442.2 shall be immune from suit and liability caused by, arising out of, or relating to the design, development, clinical testing and investigation, manufacture, labeling, distribution, sale, purchase, donation, dispensing, prescription, recommendation, administration, efficacy, or use of such investigational drug, biological product, or device made available to such person.C\n\nNo claim or cause of action against a manufacturer, distributor, administrator, health care provider as defined in § 8.01-581.1, sponsor, or physician who manufactures, supplies, distributes, administers, prescribes, or recommends an investigational drug, biological product, or device to a person who meets the criteria set forth in § 54.1-3442.2 shall exist in any state court for claims of property, personal injury, or death caused by, arising out of, or relating to the design, development, clinical testing and investigation, manufacture, labeling, distribution, sale, purchase, donation, dispensing, prescription, recommendation, administration, efficacy, or use of such investigational drug, biological product, or device made available to such person.D\n\nNo health care provider as defined in § 8.01-581.1 who recommends, prescribes, administers, distributes, or supplies an investigational drug, biological product, or device to a person who meets the criteria set forth in § 54.1-3442.2 shall be deemed to have engaged in unprofessional conduct, or shall be adversely affected in any decision relating to licensure, on such grounds.E\n\nNothing in this article shall require a person to violate or act in contravention of any federal or state law as such law relates to the prescribing, dispensing, administration, or use of an investigational drug, biological product, or device.","order_by":null,"text":{"0":{"id":208738,"text":"Notwithstanding any other provision of law to the contrary, a health care provider as defined in § 8.01-581.1 who recommends an investigational drug, biological product, or device to a person who meets the criteria set forth in subsection A of § 54.1-3442.2 shall be immune from civil liability for any adverse action, condition, or other outcome resulting from the person’s use of the investigational drug, biological product, or device.","type":"section","prefixes":["A"],"prefix":"A","entire_prefix":"A","prefix_anchor":"A","level":1,"next_prefix":"B"},"1":{"id":208739,"text":"Notwithstanding any other provision of law to the contrary, a manufacturer, distributor, administrator, health care provider as defined in § 8.01-581.1, sponsor, or physician who manufactures, supplies, distributes, administers, prescribes, or recommends an investigational drug, biological product, or device to a person who meets the criteria set forth in § 54.1-3442.2 shall be immune from suit and liability caused by, arising out of, or relating to the design, development, clinical testing and investigation, manufacture, labeling, distribution, sale, purchase, donation, dispensing, prescription, recommendation, administration, efficacy, or use of such investigational drug, biological product, or device made available to such person.","type":"section","prefixes":["B"],"prefix":"B","entire_prefix":"B","prefix_anchor":"B","level":1,"prior_prefix":"A","next_prefix":"C"},"2":{"id":208740,"text":"No claim or cause of action against a manufacturer, distributor, administrator, health care provider as defined in § 8.01-581.1, sponsor, or physician who manufactures, supplies, distributes, administers, prescribes, or recommends an investigational drug, biological product, or device to a person who meets the criteria set forth in § 54.1-3442.2 shall exist in any state court for claims of property, personal injury, or death caused by, arising out of, or relating to the design, development, clinical testing and investigation, manufacture, labeling, distribution, sale, purchase, donation, dispensing, prescription, recommendation, administration, efficacy, or use of such investigational drug, biological product, or device made available to such person.","type":"section","prefixes":["C"],"prefix":"C","entire_prefix":"C","prefix_anchor":"C","level":1,"prior_prefix":"B","next_prefix":"D"},"3":{"id":208741,"text":"No health care provider as defined in § 8.01-581.1 who recommends, prescribes, administers, distributes, or supplies an investigational drug, biological product, or device to a person who meets the criteria set forth in § 54.1-3442.2 shall be deemed to have engaged in unprofessional conduct, or shall be adversely affected in any decision relating to licensure, on such grounds.","type":"section","prefixes":["D"],"prefix":"D","entire_prefix":"D","prefix_anchor":"D","level":1,"prior_prefix":"C","next_prefix":"E"},"4":{"id":208742,"text":"Nothing in this article shall require a person to violate or act in contravention of any federal or state law as such law relates to the prescribing, dispensing, administration, or use of an investigational drug, biological product, or device.","type":"section","prefixes":["E"],"prefix":"E","entire_prefix":"E","prefix_anchor":"E","level":1,"prior_prefix":"D"}},"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 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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\/"},{"id":79489,"section_number":"8.01-581.1","catch_line":"Definitions","order_by":null,"url":"\/8.01-581.1\/"}],"permalink":{"id":243605,"object_type":"law","relational_id":56990,"identifier":"54.1-3442.4","token":"54.1\/III\/34\/4.1\/54.1-3442.4","url":"\/54.1-3442.4\/","edition_id":1,"permalink":0,"preferred":1},"url":"\/54.1-3442.4\/","token":"54.1\/III\/34\/4.1\/54.1-3442.4","dublin_core":{"Title":"Limitation of liability","Type":"Text","Format":"text\/html","Identifier":"\u00a7 54.1-3442.4","Relation":"Code of Virginia"},"html":"\n\t\t\t\t\t\t

A.<\/span> Notwithstanding any other provision of law<\/span> to the contrary, a health care provider as defined in § 8.01-581.1<\/a> who recommends an investigational drug<\/span>, biological product<\/span>, or device<\/span> to a person<\/span> who meets the criteria set forth in subsection A of § 54.1-3442.2<\/a> shall be immune from civil liability for any adverse action, condition, or other outcome resulting from the person<\/span>’s use of the investigational drug<\/span>, biological product<\/span>, or device<\/span>. <\/i><\/a><\/p><\/section>\n\t\t\t\t\t\t

B.<\/span> Notwithstanding any other provision of law<\/span> to the contrary, a manufacturer<\/span>, distributor<\/span>, administrator, health care provider as defined in § 8.01-581.1<\/a>, sponsor, or physician who manufactures<\/span>, supplies, distributes<\/span>, administers<\/span>, prescribes, or recommends an investigational drug<\/span>, biological product<\/span>, or device<\/span> to a person<\/span> who meets the criteria set forth in § 54.1-3442.2<\/a> shall be immune from suit and liability caused by, arising out of, or relating to the design, development, clinical testing and investigation, manufacture<\/span>, labeling<\/span>, distribution, sale<\/span>, purchase, donation, dispensing<\/span>, prescription<\/span>, recommendation, administration, efficacy, or use of such investigational drug<\/span>, biological product<\/span>, or device<\/span> made available to such person<\/span>. <\/i><\/a><\/p><\/section>\n\t\t\t\t\t\t

C.<\/span> No claim or cause of action<\/span> against a manufacturer<\/span>, distributor<\/span>, administrator, health care provider as defined in § 8.01-581.1<\/a>, sponsor, or physician who manufactures<\/span>, supplies, distributes<\/span>, administers<\/span>, prescribes, or recommends an investigational drug<\/span>, biological product<\/span>, or device<\/span> to a person<\/span> who meets the criteria set forth in § 54.1-3442.2<\/a> shall exist in any state court<\/span> for claims of property, personal injury, or death caused by, arising out of, or relating to the design, development, clinical testing and investigation, manufacture<\/span>, labeling<\/span>, distribution, sale<\/span>, purchase, donation, dispensing<\/span>, prescription<\/span>, recommendation, administration, efficacy, or use of such investigational drug<\/span>, biological product<\/span>, or device<\/span> made available to such person<\/span>. <\/i><\/a><\/p><\/section>\n\t\t\t\t\t\t

D.<\/span> No health care provider as defined in § 8.01-581.1<\/a> who recommends, prescribes, administers<\/span>, distributes<\/span>, or supplies an investigational drug<\/span>, biological product<\/span>, or device<\/span> to a person<\/span> who meets the criteria set forth in § 54.1-3442.2<\/a> shall be deemed to have engaged in unprofessional conduct, or shall be adversely affected in any decision relating to licensure, on such grounds. <\/i><\/a><\/p><\/section>\n\t\t\t\t\t\t

E.<\/span> Nothing in this article shall require a person<\/span> to violate or act in contravention of any federal or state law<\/span> as such law<\/span> relates to the prescribing, dispensing<\/span>, administration, or use of an investigational drug<\/span>, biological product<\/span>, or device<\/span>. <\/i><\/a><\/p><\/section>","plain_text":" CODE OF VIRGINIA\n\nLIMITATION OF LIABILITY (\u00a7 54.1-3442.4)\n\nA. Notwithstanding any other provision of law to the contrary, a health care\nprovider as defined in § 8.01-581.1 who recommends an investigational drug,\nbiological product, or device to a person who meets the criteria set forth in\nsubsection A of § 54.1-3442.2 shall be immune from civil liability for any\nadverse action, condition, or other outcome resulting from the person’s\nuse of the investigational drug, biological product, or device.\n\nB. Notwithstanding any other provision of law to the contrary, a manufacturer,\ndistributor, administrator, health care provider as defined in §\n8.01-581.1, sponsor, or physician who manufactures, supplies, distributes,\nadministers, prescribes, or recommends an investigational drug, biological\nproduct, or device to a person who meets the criteria set forth in §\n54.1-3442.2 shall be immune from suit and liability caused by, arising out of,\nor relating to the design, development, clinical testing and investigation,\nmanufacture, labeling, distribution, sale, purchase, donation, dispensing,\nprescription, recommendation, administration, efficacy, or use of such\ninvestigational drug, biological product, or device made available to such\nperson.\n\nC. No claim or cause of action against a manufacturer, distributor,\nadministrator, health care provider as defined in § 8.01-581.1, sponsor, or\nphysician who manufactures, supplies, distributes, administers, prescribes, or\nrecommends an investigational drug, biological product, or device to a person\nwho meets the criteria set forth in § 54.1-3442.2 shall exist in any state\ncourt for claims of property, personal injury, or death caused by, arising out\nof, or relating to the design, development, clinical testing and investigation,\nmanufacture, labeling, distribution, sale, purchase, donation, dispensing,\nprescription, recommendation, administration, efficacy, or use of such\ninvestigational drug, biological product, or device made available to such\nperson.\n\nD. No health care provider as defined in § 8.01-581.1 who recommends,\nprescribes, administers, distributes, or supplies an investigational drug,\nbiological product, or device to a person who meets the criteria set forth in\n§ 54.1-3442.2 shall be deemed to have engaged in unprofessional conduct, or\nshall be adversely affected in any decision relating to licensure, on such\ngrounds.\n\nE. Nothing in this article shall require a person to violate or act in\ncontravention of any federal or state law as such law relates to the\nprescribing, dispensing, administration, or use of an investigational drug,\nbiological 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}}