Virginia § 54.1-3442.3 Expanded access to investigational drugs, biological products, or devices; cost; insurance coverage

Virginia Statutes

§ 54.1-3442.3 — Expanded access to investigational drugs, biological products, or devices; cost; insurance coverage

Virginia § 54.1-3442.3

JurisdictionVirginia

Title 54.1PROFESSIONS AND OCCUPATIONS

Subtitle IIIPROFESSIONS AND OCCUPATIONS REGULATED BY BOARDS WITHIN THE DEPARTMENT OF HEALTH PROFESSIONS

Ch. 34DRUG CONTROL ACT

Art. 4.1EXPANDED ACCESS TO INVESTIGATIONAL DRUGS, BIOLOGICAL PRODUCTS, AND DEVICES

This text of Virginia § 54.1-3442.3 (Expanded access to investigational drugs, biological products, or devices; cost; insurance coverage) is published on Counsel Stack Legal Research, covering Virginia primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook

Va. Code Ann. § 54.1-3442.3 (2026).

Text

A.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.

B.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 manufac

Free access — add to your briefcase to read the full text and ask questions with AI

A. 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.

B. 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.

C. 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.