§ 54.1-3442.1 Definitions.
§ 54.1-3442.2 Eligibility for expanded access to investigational drugs, biological products, and devices; written, informed consent to treatment.
§ 54.1-3442.3 Expanded access to investigational drugs, biological products, or devices; cost; insurance coverage.
§ 54.1-3442.4 Limitation of liability.

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Terms Used In Virginia Code > Title 54.1 > Subtitle III > Chapter 34 > Article 4.1 - . Expanded Access to Investigational Drugs, Biological Products, and Devices.

  • Attachment: A procedure by which a person's property is seized to pay judgments levied by the court.
  • Biological product: means a virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, protein other than a chemically synthesized polypeptide, or analogous product, or arsphenamine or any derivative of arsphenamine or any other trivalent organic arsenic compound, applicable to the prevention, treatment, or cure of a disease or condition of human beings. See Virginia Code 54.1-3401
  • City: means an independent incorporated community which became a city as provided by law before noon on July 1, 1971, or which has within defined boundaries a population of 5,000 or more and which has become a city as provided by law. See Virginia Code 1-208
  • Corporation: A legal entity owned by the holders of shares of stock that have been issued, and that can own, receive, and transfer property, and carry on business in its own name.
  • Device: means instruments, apparatus, and contrivances, including their components, parts, and accessories, intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or animals or to affect the structure or any function of the body of man or animals. See Virginia Code 54.1-3401
  • Distributor: means a person who distributes. See Virginia Code 54.1-3401
  • Drug: means (i) articles or substances recognized in the official United States Pharmacopoeia National Formulary or official Homeopathic Pharmacopoeia of the United States, or any supplement to any of them; (ii) articles or substances intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or animals; (iii) articles or substances, other than food, intended to affect the structure or any function of the body of man or animals; (iv) articles or substances intended for use as a component of any article specified in clause (i), (ii), or (iii); or (v) a biological product. See Virginia Code 54.1-3401
  • Guardian: A person legally empowered and charged with the duty of taking care of and managing the property of another person who because of age, intellect, or health, is incapable of managing his (her) own affairs.
  • Labeling: means all labels and other written, printed, or graphic matter on an article or any of its containers or wrappers, or accompanying such article. See Virginia Code 54.1-3401
  • Manufacture: means the production, preparation, propagation, conversion, or processing of any item regulated by this chapter, either directly or indirectly by extraction from substances of natural origin, or independently by means of chemical synthesis, or by a combination of extraction and chemical synthesis, and includes any packaging or repackaging of the substance or labeling or relabeling of its container. See Virginia Code 54.1-3401
  • Manufacturer: means every person who manufactures, a manufacturer's co-licensed partner, or a repackager. See Virginia Code 54.1-3401
  • Person: means both the plural and singular, as the case demands, and includes an individual, partnership, corporation, association, governmental agency, trust, or other institution or entity. See Virginia Code 54.1-3401
  • Personal property: All property that is not real property.
  • Prescription: means an order for drugs or medical supplies, written or signed or transmitted by word of mouth, telephone, telegraph, or other means of communication to a pharmacist by a duly licensed physician, dentist, veterinarian, or other practitioner authorized by law to prescribe and administer such drugs or medical supplies. See Virginia Code 54.1-3401
  • Sale: includes barter, exchange, or gift, or offer therefor, and each such transaction made by any person, whether as an individual, proprietor, agent, servant, or employee. See Virginia Code 54.1-3401
  • State: when applied to a part of the United States, includes any of the 50 states, the District of Columbia, the Commonwealth of Puerto Rico, Guam, the Northern Mariana Islands, and the United States Virgin Islands. See Virginia Code 1-245
  • 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. See Virginia Code 54.1-3442.1
  • 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. See Virginia Code 54.1-3442.1
  • Trial: A hearing that takes place when the defendant pleads "not guilty" and witnesses are required to come to court to give evidence.
  • Writ: A formal written command, issued from the court, requiring the performance of a specific act.