Virginia Code > Title 54.1 > Subtitle III > Chapter 34 > Article 4 – Permitting of Manufacturers.
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Terms Used In Virginia Code > Title 54.1 > Subtitle III > Chapter 34 > Article 4 - Permitting of Manufacturers.
- Agent: means an authorized person who acts on behalf of or at the direction of a manufacturer, distributor, or dispenser. See Virginia Code 54.1-3401
- 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
- Biosimilar: means a biological product that is highly similar to a specific reference biological product, notwithstanding minor differences in clinically inactive compounds, such that there are no clinically meaningful differences between the reference biological product and the biological product that has been licensed as a biosimilar pursuant to Virginia Code 54.1-3401
- Board: means the Board of Pharmacy. 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
- Contract: A legal written agreement that becomes binding when signed.
- Defendant: In a civil suit, the person complained against; in a criminal case, the person accused of the crime.
- 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
- Includes: means includes, but not limited to. See Virginia Code 1-218
- Legal tender: coins, dollar bills, or other currency issued by a government as official money. Source: U.S. Mint
- Lien: A claim against real or personal property in satisfaction of a debt.
- 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
- New drug: means (i) any drug, except a new animal drug or an animal feed bearing or containing a new animal drug, the composition of which is such that such drug is not generally recognized, among experts qualified by scientific training and experience to evaluate the safety and effectiveness of drugs, as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling, except that such a drug not so recognized shall not be deemed to be a "new drug" if at any time prior to the enactment of this chapter it was subject to the Food and Drugs Act of June 30, 1906, as amended, and if at such time its labeling contained the same representations concerning the conditions of its use, or (ii) any drug, except a new animal drug or an animal feed bearing or containing a new animal drug, the composition of which is such that such drug, as a result of investigations to determine its safety and effectiveness for use under such conditions, has become so recognized, but which has not, otherwise than in such investigations, been used to a material extent or for a material time under such conditions. See Virginia Code 54.1-3401
- Person: shall include individuals, a trust, an estate, a partnership, an association, an order, a corporation, or any other legal or commercial entity;
6. See Virginia Code 8.01-2
- 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
- Prescription drug: means any drug required by federal law or regulation to be dispensed only pursuant to a prescription, including finished dosage forms and active ingredients subject to § 503(b) of the Federal Food, Drug, and Cosmetic Act (Virginia Code 54.1-3401
- produce: includes the manufacture, planting, cultivation, growing, or harvesting of a controlled substance or marijuana. See Virginia Code 54.1-3401
- Proprietary medicine: means a completely compounded nonprescription drug in its unbroken, original package which does not contain any controlled substance or marijuana as defined in this chapter and is not in itself poisonous, and which is sold, offered, promoted, or advertised directly to the general public by or under the authority of the manufacturer or primary distributor, under a trademark, trade name, or other trade symbol privately owned, and the labeling of which conforms to the requirements of this chapter and applicable federal law. See Virginia Code 54.1-3401
- Sheriff: shall include deputy sheriffs and such other persons designated in § Virginia Code 8.01-2
- 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
- Writ: A formal written command, issued from the court, requiring the performance of a specific act.