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
- Appropriation: The provision of funds, through an annual appropriations act or a permanent law, for federal agencies to make payments out of the Treasury for specified purposes. The formal federal spending process consists of two sequential steps: authorization
- Associate-degree-granting: means that an associate degree is the most advanced degree that is granted. See Virginia Code 23.1-100
- Associate-degree-granting public institution of higher education: includes Richard Bland College and each comprehensive community college. See Virginia Code 23.1-100
- Beneficiary: A person who is entitled to receive the benefits or proceeds of a will, trust, insurance policy, retirement plan, annuity, or other contract. Source: OCC
- 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 42 U. See Virginia Code 54.1-3401
- Board: means the board of visitors of Eastern Virginia Medical School. See Virginia Code 23.1-3000
- Board: means the Board of Pharmacy. See Virginia Code 54.1-3401
- Bonds: includes bonds, notes, revenue certificates, lease participation certificates, and other evidences of indebtedness, payment obligations, or deferred purchase financing arrangements. See Virginia Code 23.1-3000
- Chancellor: means the Chancellor of the Virginia Community College System. See Virginia Code 23.1-2900
- Comprehensive community college: means an associate-degree-granting public institution of higher education governed by the State Board that offers instruction in one or more of the following fields:
1. See Virginia Code 23.1-100
- Contract: A legal written agreement that becomes binding when signed.
- Costs: means (i) costs of construction, reconstruction, renovation, site work, and acquisition of lands, structures, rights-of-way, franchises, easements, and other property rights and interests; (ii) costs of demolition, removal, or relocation of buildings or structures; (iii) costs of labor; (iv) costs of materials, machinery, and all other kinds of equipment; (v) financing charges; (vi) costs of issuance of bonds, including printing, engraving, advertising, legal, and other similar expenses; (vii) credit enhancement and liquidity facility fees; (viii) fees for interest rate caps, collars, and swaps; (ix) interest on bonds and other borrowing in connection with a project prior to and during construction of the project and for a period not exceeding one year after the completion of such construction; (x) costs of engineering, inspection, financial, legal, and accounting services, plans, specifications, studies, surveys, estimates of costs and revenues, and feasibility studies; (xi) administrative expenses, including administrative expenses during the start-up of any project; (xii) working capital to be used in connection with any project; (xiii) reserve funds and other reserves for the payment of principal of and interest on bonds; and (xiv) all other expenses necessary, desirable, or incidental to the construction, reconstruction, renovation, acquisition, financing, refinancing, or placing in operation of projects. See Virginia Code 23.1-3000
- Council: means the State Council of Higher Education for Virginia. See Virginia Code 23.1-100
- Distributor: means a person who distributes. See Virginia Code 54.1-3401
- Donee: The recipient of a gift.
- 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
- Fiscal year: The fiscal year is the accounting period for the government. For the federal government, this begins on October 1 and ends on September 30. The fiscal year is designated by the calendar year in which it ends; for example, fiscal year 2006 begins on October 1, 2005 and ends on September 30, 2006.
- Includes: means includes, but not limited to. See Virginia Code 1-218
- Interest rate: The amount paid by a borrower to a lender in exchange for the use of the lender's money for a certain period of time. Interest is paid on loans or on debt instruments, such as notes or bonds, either at regular intervals or as part of a lump sum payment when the issue matures. Source: OCC
- Lease: A contract transferring the use of property or occupancy of land, space, structures, or equipment in consideration of a payment (e.g., rent). Source: OCC
- 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
- Medical School: means the Eastern Virginia Medical School. See Virginia Code 23.1-3000
- 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: 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
- 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 (21 U. See Virginia Code 54.1-3401
- Process: includes subpoenas, the summons and complaint in a civil action, and process in statutory actions. See Virginia Code 1-237
- Project: means any medical educational institution and medical facility, including colleges, schools, and divisions offering undergraduate and graduate programs for the health professions and sciences and such other courses of study as may be appropriate; medical and paramedical facilities; such other facilities deemed by the board as consistent with the powers and purposes of Eastern Virginia Medical School; all related and supporting facilities; and all necessary, desirable, or incidental lands, buildings, improvements, and other appurtenances and equipment. See Virginia Code 23.1-3000
- 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
- Public institution of higher education: includes the System as a whole and each associate-degree-granting and baccalaureate public institution of higher education in the Commonwealth. See Virginia Code 23.1-100
- 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
- State Board: means the State Board for Community Colleges. See Virginia Code 23.1-100
- System: means the Virginia Community College System. See Virginia Code 23.1-100
Virginia Code > Title 54.1 > Subtitle III > Chapter 34 > Article 4 – 1. Expanded Access to Investigational Drugs, Biological Products, and Devices
Current as of: 2023 | Check for updates
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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
- 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
- Board: means the board of visitors of Eastern Virginia Medical School. See Virginia Code 23.1-3000
- Chief executive officer: includes the Chancellor of the Virginia Community College System, the Chancellor of the University of Virginia's College at Wise, the Superintendent of Virginia Military Institute, and the president of each other public institution of higher education. See Virginia Code 23.1-100
- 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.
- 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.
- Council: means the State Council of Higher Education for Virginia. See Virginia Code 23.1-100
- 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
- Devise: To gift property by will.
- 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
- Gift: A voluntary transfer or conveyance of property without consideration, or for less than full and adequate consideration based on fair market value.
- 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
- Lease: A contract transferring the use of property or occupancy of land, space, structures, or equipment in consideration of a payment (e.g., rent). Source: OCC
- Liabilities: The aggregate of all debts and other legal obligations of a particular person or legal entity.
- Locality: means a county, city, or town as the context may require. See Virginia Code 1-221
- 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
- Medical School: means the Eastern Virginia Medical School. See Virginia Code 23.1-3000
- Mortgage: The written agreement pledging property to a creditor as collateral for a loan.
- Partnership: A voluntary contract between two or more persons to pool some or all of their assets into a business, with the agreement that there will be a proportional sharing of profits and losses.
- 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
- 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
- Project: means any medical educational institution and medical facility, including colleges, schools, and divisions offering undergraduate and graduate programs for the health professions and sciences and such other courses of study as may be appropriate; medical and paramedical facilities; such other facilities deemed by the board as consistent with the powers and purposes of Eastern Virginia Medical School; all related and supporting facilities; and all necessary, desirable, or incidental lands, buildings, improvements, and other appurtenances and equipment. See Virginia Code 23.1-3000
- Recess: A temporary interruption of the legislative business.
- 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.
- United States: includes 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 1-255
Virginia Code > Title 54.1 > Subtitle III > Chapter 34 > Article 4 – 2. Permitting of Pharmaceutical Processors to Produce and Dispense Cannabis Products
Current as of: 2023 | Check for updates
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Terms Used In Virginia Code > Title 54.1 > Subtitle III > Chapter 34 > Article 4 - 2. Permitting of Pharmaceutical Processors to Produce and Dispense Cannabis Products
- Adult: means a person 18 years of age or more. See Virginia Code 1-203
- 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
- Appropriation: The provision of funds, through an annual appropriations act or a permanent law, for federal agencies to make payments out of the Treasury for specified purposes. The formal federal spending process consists of two sequential steps: authorization
- Board: means the board of visitors of Eastern Virginia Medical School. See Virginia Code 23.1-3000
- Board: means the Board of Pharmacy. See Virginia Code 54.1-3401
- Bonds: includes bonds, notes, revenue certificates, lease participation certificates, and other evidences of indebtedness, payment obligations, or deferred purchase financing arrangements. See Virginia Code 23.1-3000
- Cannabis dispensing facility: means a facility that (i) has obtained a permit from the Board pursuant to § 54. See Virginia Code 54.1-3442.5
- Contract: A legal written agreement that becomes binding when signed.
- 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.
- Deed: The legal instrument used to transfer title in real property from one person to another.
- delivery: means the actual, constructive, or attempted transfer of any item regulated by this chapter, whether or not there exists an agency relationship, including delivery of a Schedule VI prescription device to an ultimate user or consumer on behalf of a medical equipment supplier by a manufacturer, nonresident manufacturer, wholesale distributor, nonresident wholesale distributor, warehouser, nonresident warehouser, third-party logistics provider, or nonresident third-party logistics provider at the direction of a medical equipment supplier in accordance with § 54. See Virginia Code 54.1-3401
- Dispense: means to deliver a drug to an ultimate user or research subject by or pursuant to the lawful order of a practitioner, including the prescribing and administering, packaging, labeling, or compounding necessary to prepare the substance for that delivery. 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
- Evidence: Information presented in testimony or in documents that is used to persuade the fact finder (judge or jury) to decide the case for one side or the other.
- 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.
- Includes: means includes, but not limited to. See Virginia Code 1-218
- Injunction: An order of the court prohibiting (or compelling) the performance of a specific act to prevent irreparable damage or injury.
- Jurisdiction: (1) The legal authority of a court to hear and decide a case. Concurrent jurisdiction exists when two courts have simultaneous responsibility for the same case. (2) The geographic area over which the court has authority to decide cases.
- Label: means a display of written, printed, or graphic matter upon the immediate container of any article. See Virginia Code 54.1-3401
- 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
- Lease: A contract transferring the use of property or occupancy of land, space, structures, or equipment in consideration of a payment (e.g., rent). Source: OCC
- Lien: A claim against real or personal property in satisfaction of a debt.
- Locality: means a county, city, or town as the context may require. See Virginia Code 1-221
- 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
- Marijuana: means any part of a plant of the genus Cannabis whether growing or not, its seeds, or its resin; and every compound, manufacture, salt, derivative, mixture, or preparation of such plant, its seeds, its resin, or any extract containing one or more cannabinoids. See Virginia Code 54.1-3401
- Medical School: means the Eastern Virginia Medical School. See Virginia Code 23.1-3000
- Mortgage: The written agreement pledging property to a creditor as collateral for a loan.
- National Bank: A bank that is subject to the supervision of the Comptroller of the Currency. The Office of the Comptroller of the Currency is a bureau of the U.S. Treasury Department. A national bank can be recognized because it must have "national" or "national association" in its name. Source: OCC
- Oversight: Committee review of the activities of a Federal agency or program.
- 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
- Pharmaceutical processor: means a facility that (i) has obtained a permit from the Board pursuant to § 54. See Virginia Code 54.1-3442.5
- Pharmacist-in-charge: means the person who, being licensed as a pharmacist, signs the application for a pharmacy permit and assumes full legal responsibility for the operation of the relevant pharmacy in a manner complying with the laws and regulations for the practice of pharmacy and the sale and dispensing of controlled substances; the "pharmacist-in-charge" shall personally supervise the pharmacy and the pharmacy's personnel as required by § 54. See Virginia Code 54.1-3401
- Practitioner: means a physician, dentist, licensed advanced practice registered nurse pursuant to § 54. See Virginia Code 54.1-3401
- Process: includes subpoenas, the summons and complaint in a civil action, and process in statutory actions. See Virginia Code 1-237
- Project: means any medical educational institution and medical facility, including colleges, schools, and divisions offering undergraduate and graduate programs for the health professions and sciences and such other courses of study as may be appropriate; medical and paramedical facilities; such other facilities deemed by the board as consistent with the powers and purposes of Eastern Virginia Medical School; all related and supporting facilities; and all necessary, desirable, or incidental lands, buildings, improvements, and other appurtenances and equipment. See Virginia Code 23.1-3000
- 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
- System: means the Virginia Community College System. See Virginia Code 23.1-100
- Tetrahydrocannabinol: means any naturally occurring or synthetic tetrahydrocannabinol, including its salts, isomers, and salts of isomers whenever the existence of such salts, isomers, and salts of isomers is possible within the specific chemical designation and any preparation, mixture, or substance containing, or mixed or infused with, any detectable amount of tetrahydrocannabinol. See Virginia Code 54.1-3401
- Tort: A civil wrong or breach of a duty to another person, as outlined by law. A very common tort is negligent operation of a motor vehicle that results in property damage and personal injury in an automobile accident.
- Total tetrahydrocannabinol: means the sum, after the application of any necessary conversion factor, of the percentage by weight of tetrahydrocannabinol and the percentage by weight of tetrahydrocannabinolic acid. See Virginia Code 54.1-3401
- Town: means any existing town or an incorporated community within one or more counties which became a town before noon, July 1, 1971, as provided by law or which has within defined boundaries a population of 1,000 or more and which has become a town as provided by law. See Virginia Code 1-254
- Trustee: A person or institution holding and administering property in trust.
- Wholesale distribution: means (i) distribution of prescription drugs to persons other than consumers or patients and (ii) delivery of Schedule VI prescription devices to the ultimate user or consumer pursuant to § 54. See Virginia Code 54.1-3401