{"formats":[{"name":"JSON","format":"json","url":"\/downloads\/2025\/code-json\/54.1-3401.json"},{"name":"Plain Text","format":"text","url":"\/downloads\/2025\/code-text\/54.1-3401.txt"},{"name":"XML","format":"xml","url":"\/downloads\/2025\/code-xml\/54.1-3401.xml"},{"name":"HTML","format":"html","url":"\/downloads\/2025\/code-html\/54.1-3401.html"}],"law_id":59669,"edition_id":1,"section_id":59669,"structure_id":13871,"section_number":"54.1-3401","catch_line":"Definitions","history":"Code 1950, \u00a7\u00a7 54-399, 54-487; 1952, c. 451; 1958, c. 551, \u00a7 54-524.2; 1966, c. 193; 1968, c. 582; 1970, c. 650; 1971, Ex. Sess., c. 94; 1972, c. 798; 1975, c. 425; 1976, c. 14; 1977, c. 193; 1978, c. 833; 1979, c. 435; 1980, c. 150; 1988, c. 765; 1991, cc. 519, 524; 1992, cc. 737, 793; 1996, cc. 37, 152, 158, 407, 408; 1997, cc. 20, 677, 806; 1998, c. 470; 1999, cc. 661, 750; 2000, cc. 861, 878, 935; 2003, cc. 509, 639, 995; 2005, cc. 475, 839; 2006, c. 346; 2012, c. 213; 2013, cc. 412, 504, 544, 765; 2014, cc. 674, 719; 2015, cc. 158, 180, 300; 2016, cc. 221, 495; 2017, cc. 115, 429; 2018, cc. 241, 242, 689, 690; 2019, cc. 653, 654; 2020, cc. 831, 1285, 1286; 2021, Sp. Sess. I, c. 110; 2023, cc. 183, 744, 794; 2024, cc. 63, 513; 2025, c. 341.","full_text":"As used in this chapter, unless the context requires a different meaning:\n\t\t“Administer” means the direct application of a controlled substance, whether by injection, inhalation, ingestion, or any other means, to the body of a patient or research subject by (i) a practitioner or by his authorized agent and under his direction or (ii) the patient or research subject at the direction and in the presence of the practitioner.\n\t\t“Advertisement” means all representations disseminated in any manner or by any means, other than by labeling, for the purpose of inducing, or which are likely to induce, directly or indirectly, the purchase of drugs or devices.\n\t\t“Agent” means an authorized person who acts on behalf of or at the direction of a manufacturer, distributor, or dispenser. “Agent” does not include a common or contract carrier, public warehouseman, or employee of the carrier or warehouseman.\n\t\t“Anabolic steroid” means any drug or hormonal substance, chemically and pharmacologically related to testosterone, other than estrogens, progestins, corticosteroids, and dehydroepiandrosterone.\n\t\t“Animal” means any nonhuman animate being endowed with the power of voluntary action.\n\t\t“Automated drug dispensing system” means a mechanical or electronic system that performs operations or activities, other than compounding or administration, relating to pharmacy services, including the storage, dispensing, or distribution of drugs and the collection, control, and maintenance of all transaction information, to provide security and accountability for such drugs.\n\t\t“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.\n\t\t“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.S.C. \u00a7 262(k) in terms of safety, purity, and potency of the product.\n\t\t“Board” means the Board of Pharmacy.\n\t\t“Bulk drug substance” means any substance that is represented for use, and that, when used in the compounding, manufacturing, processing, or packaging of a drug, becomes an active ingredient or a finished dosage form of the drug; however, “bulk drug substance” does not include intermediates that are used in the synthesis of such substances.\n\t\t“Change of ownership” of an existing entity permitted, registered, or licensed by the Board means (i) the sale or transfer of all or substantially all of the assets of the entity or of any corporation that owns or controls the entity; (ii) the creation of a partnership by a sole proprietor, the dissolution of a partnership, or a change in partnership composition; (iii) the acquisition or disposal of 50 percent or more of the outstanding shares of voting stock of a corporation owning the entity or of the parent corporation of a wholly owned subsidiary owning the entity, except that this shall not apply to any corporation the voting stock of which is actively traded on any securities exchange or in any over-the-counter market; (iv) the merger of a corporation owning the entity or of the parent corporation of a wholly owned subsidiary owning the entity with another business or corporation; or (v) the expiration or forfeiture of a corporation’s charter.\n\t\t“Co-licensed partner” means a person who, with at least one other person, has the right to engage in the manufacturing or marketing of a prescription drug, consistent with state and federal law.\n\t\t“Compounding” means the combining of two or more ingredients to fabricate such ingredients into a single preparation and includes the mixing, assembling, packaging, or labeling of a drug or device (i) by a pharmacist, or within a permitted pharmacy, pursuant to a valid prescription issued for a medicinal or therapeutic purpose in the context of a bona fide practitioner-patient-pharmacist relationship, or in expectation of receiving a valid prescription based on observed historical patterns of prescribing and dispensing; (ii) by a practitioner of medicine, osteopathy, podiatry, dentistry, or veterinary medicine as an incident to his administering or dispensing, if authorized to dispense, a controlled substance in the course of his professional practice; or (iii) for the purpose of, or as incident to, research, teaching, or chemical analysis and not for sale or for dispensing. The mixing, diluting, or reconstituting of a manufacturer’s product drugs for the purpose of administration to a patient, when performed by a practitioner of medicine or osteopathy licensed under Chapter 29 (\u00a7 54.1-2900 et seq.), a person supervised by such practitioner pursuant to subdivision A 6 or 19 of \u00a7 54.1-2901, or a person supervised by such practitioner or a licensed advanced practice registered nurse or physician assistant pursuant to subdivision A 4 of \u00a7 54.1-2901 shall not be considered compounding.\n\t\t“Controlled substance” means a drug, substance, or immediate precursor in Schedules I through VI of this chapter. “Controlled substance” does not include distilled spirits, wine, malt beverages, or tobacco as those terms are defined or used in Title 3.2 or Title 4.1. The term “controlled substance” includes a controlled substance analog that has been placed into Schedule I or II by the Board pursuant to the regulatory authority in subsection D of \u00a7 54.1-3443.\n\t\t“Controlled substance analog” means a substance the chemical structure of which is substantially similar to the chemical structure of a controlled substance in Schedule I or II and either (i) which has a stimulant, depressant, or hallucinogenic effect on the central nervous system that is substantially similar to or greater than the stimulant, depressant, or hallucinogenic effect on the central nervous system of a controlled substance in Schedule I or II or (ii) with respect to a particular person, which such person represents or intends to have a stimulant, depressant, or hallucinogenic effect on the central nervous system that is substantially similar to or greater than the stimulant, depressant, or hallucinogenic effect on the central nervous system of a controlled substance in Schedule I or II. “Controlled substance analog” does not include (a) any substance for which there is an approved new drug application as defined under \u00a7 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. \u00a7 355) or that is generally recognized as safe and effective pursuant to \u00a7\u00a7 501, 502, and 503 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. \u00a7\u00a7 351, 352, and 353) and 21 C.F.R. Part 330; (b) with respect to a particular person, any substance for which an exemption is in effect for investigational use for that person under \u00a7 505 of the Federal Food, Drug, and Cosmetic Act to the extent that the conduct with respect to that substance is pursuant to such exemption; or (c) any substance to the extent not intended for human consumption before such an exemption takes effect with respect to that substance.\n\t\t“DEA” means the Drug Enforcement Administration, U.S. Department of Justice, or its successor agency.\n\t\t“Deliver” or “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 \u00a7 54.1-3415.1.\n\t\t“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.\n\t\t“Dialysis care technician” or “dialysis patient care technician” means an individual who is certified by an organization approved by the Department of Health Professions pursuant to Chapter 27.01 (\u00a7 54.1-2729.1 et seq.) and who, under the supervision of a licensed physician, an advanced practice registered nurse, a physician assistant, or a registered nurse, assists in the care of patients undergoing renal dialysis treatments in a Medicare-certified renal dialysis facility.\n\t\t“Dialysis solution” means either the commercially available, unopened, sterile solutions whose purpose is to be instilled into the peritoneal cavity during the medical procedure known as peritoneal dialysis, or commercially available solutions whose purpose is to be used in the performance of hemodialysis not to include any solutions administered to the patient intravenously.\n\t\t“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. However, “dispensing” does not include the transportation of drugs mixed, diluted, or reconstituted in accordance with this chapter to other sites operated by such practitioner or that practitioner’s medical practice for the purpose of administration of such drugs to patients of the practitioner or that practitioner’s medical practice at such other sites. For practitioners of medicine or osteopathy, “dispense” includes only the provision of drugs by a practitioner to patients to take with them away from the practitioner’s place of practice.\n\t\t“Dispenser” means a practitioner who dispenses.\n\t\t“Distribute” means to deliver other than by administering or dispensing a controlled substance.\n\t\t“Distributor” means a person who distributes.\n\t\t“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. “Drug” does not include devices or their components, parts, or accessories.\n\t\t“Drug product” means a specific drug in dosage form from a known source of manufacture, whether by brand or therapeutically equivalent drug product name.\n\t\t“Electronic prescription” means a written prescription that is generated on an electronic application and is transmitted to a pharmacy as an electronic data file; Schedules II through V prescriptions shall be transmitted in accordance with 21 C.F.R. Part 1300.\n\t\t“Facsimile (FAX) prescription” means a written prescription or order that is transmitted by an electronic device over telephone lines that sends the exact image to the receiving pharmacy in hard copy form.\n\t\t“FDA” means the U.S. Food and Drug Administration.\n\t\t“Immediate precursor” means a substance which the Board of Pharmacy has found to be and by regulation designates as being the principal compound commonly used or produced primarily for use, and which is an immediate chemical intermediary used or likely to be used in the manufacture of a controlled substance, the control of which is necessary to prevent, curtail, or limit manufacture.\n\t\t“Interchangeable” means a biosimilar that meets safety standards for determining interchangeability pursuant to 42 U.S.C. \u00a7 262(k)(4).\n\t\t“Label” means a display of written, printed, or graphic matter upon the immediate container of any article. A requirement made by or under authority of this chapter that any word, statement, or other information appear on the label shall not be considered to be complied with unless such word, statement, or other information also appears on the outside container or wrapper, if any, of the retail package of such article or is easily legible through the outside container or wrapper.\n\t\t“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.\n\t\t“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. “Manufacture” does not include compounding.\n\t\t“Manufacturer” means every person who manufactures, a manufacturer’s co-licensed partner, or a repackager.\n\t\t“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. “Marijuana” does not include (i) the mature stalks of such plant, fiber produced from such stalk, or oil or cake made from the seeds of such plant, unless such stalks, fiber, oil, or cake is combined with other parts of plants of the genus Cannabis; (ii) industrial hemp, as defined in \u00a7 3.2-4112, that is possessed by a person registered pursuant to subsection A of \u00a7 3.2-4115 or his agent; (iii) industrial hemp, as defined in \u00a7 3.2-4112, that is possessed by a person who holds a hemp producer license issued by the U.S. Department of Agriculture pursuant to 7 C.F.R. Part 990; (iv) a hemp product, as defined in \u00a7 3.2-4112; (v) an industrial hemp extract, as defined in \u00a7 3.2-5145.1; or (vi) any substance containing a tetrahydrocannabinol isomer, ester, ether, salt, or salts of such isomer, ester, or ether that has been placed by the Board of Pharmacy into one of the schedules set forth in the Drug Control Act (\u00a7 54.1-3400 et seq.) pursuant to \u00a7 54.1-3443.\n\t\t“Medical equipment supplier” means any person, as defined in \u00a7 1-230, engaged in the delivery to the ultimate consumer, pursuant to the lawful order of a practitioner, of hypodermic syringes and needles, medicinal oxygen, Schedule VI controlled devices, those Schedule VI controlled substances with no medicinal properties that are used for the operation and cleaning of medical equipment, solutions for peritoneal dialysis, and sterile water or saline for irrigation.\n\t\t“Narcotic drug” means any of the following, whether produced directly or indirectly by extraction from substances of vegetable origin, or independently by means of chemical synthesis, or by a combination of extraction and chemical synthesis: (i) opium, opiates, and any salt, compound, derivative, or preparation of opium or opiates; (ii) any salt, compound, isomer, derivative, or preparation thereof which is chemically equivalent or identical with any of the substances referred to in clause (i), but not including the isoquinoline alkaloids of opium; (iii) opium poppy and poppy straw; or (iv) coca leaves and any salt, compound, derivative, or preparation of coca leaves, and any salt, compound, isomer, derivative, or preparation thereof which is chemically equivalent or identical with any of these substances, but not including decocainized coca leaves or extraction of coca leaves which do not contain cocaine or ecgonine.\n\t\t“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.\n\t\t“Nuclear medicine technologist” means an individual who holds a current certification with the American Registry of Radiological Technologists or the Nuclear Medicine Technology Certification Board.\n\t\t“Official compendium” means the official United States Pharmacopoeia National Formulary, official Homeopathic Pharmacopoeia of the United States, or any supplement to any of them.\n\t\t“Official written order” means an order written on a form provided for that purpose by the U.S. Drug Enforcement Administration, under any laws of the United States making provision therefor, if such order forms are authorized and required by federal law, and if no such order form is provided then on an official form provided for that purpose by the Board of Pharmacy.\n\t\t“Opiate” means any substance having an addiction-forming or addiction-sustaining liability similar to morphine or being capable of conversion into a drug having such addiction-forming or addiction-sustaining liability. “Opiate” does not include, unless specifically designated as controlled under Article 4 (\u00a7 54.1-3437 et seq.), the dextrorotatory isomer of 3-methoxy-n-methylmorphinan and its salts (dextromethorphan). “Opiate” does include its racemic and levorotatory forms.\n\t\t“Opium poppy” means the plant of the species Papaver somniferum L., except the seeds thereof.\n\t\t“Original package” means the unbroken container or wrapping in which any drug or medicine is enclosed together with label and labeling, put up by or for the manufacturer, wholesaler, or distributor for use in the delivery or display of such article.\n\t\t“Outsourcing facility” means a facility that is engaged in the compounding of sterile drugs and is currently registered as an outsourcing facility with the U.S. Secretary of Health and Human Services and that complies with all applicable requirements of federal and state law, including the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. \u00a7 301 et seq.\n\t\t“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.\n\t\t“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 \u00a7 54.1-3432.\n\t\t“Poppy straw” means all parts, except the seeds, of the opium poppy, after mowing.\n\t\t“Practitioner” means a physician, dentist, licensed advanced practice registered nurse pursuant to \u00a7 54.1-2957.01, licensed physician assistant pursuant to \u00a7 54.1-2952.1, pharmacist pursuant to \u00a7 54.1-3300, TPA-certified optometrist pursuant to Article 5 (\u00a7 54.1-3222 et seq.) of Chapter 32, veterinarian, scientific investigator, or other person licensed, registered, or otherwise permitted to distribute, dispense, prescribe and administer, or conduct research with respect to a controlled substance in the course of professional practice or research in the Commonwealth.\n\t\t“Prescriber” means a practitioner who is authorized pursuant to \u00a7\u00a7 54.1-3303 and 54.1-3408 to issue a prescription.\n\t\t“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.\n\t\t“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 \u00a7 503(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. \u00a7 353(b)).\n\t\t“Production” or “produce” includes the manufacture, planting, cultivation, growing, or harvesting of a controlled substance or marijuana.\n\t\t“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. However, “proprietary medicine” does not include a drug that is only advertised or promoted professionally to licensed practitioners, a narcotic or drug containing a narcotic, a drug that may be dispensed only upon prescription or the label of which bears substantially the statement “Warning may be habit-forming,” or a drug intended for injection.\n\t\t“Radiopharmaceutical” means any drug that exhibits spontaneous disintegration of unstable nuclei with the emission of nuclear particles or photons and includes any non-radioactive reagent kit or radionuclide generator that is intended to be used in the preparation of any such substance, but does not include drugs such as carbon-containing compounds or potassium-containing salts that include trace quantities of naturally occurring radionuclides. “Radiopharmaceutical” also includes any biological product that is labeled with a radionuclide or intended solely to be labeled with a radionuclide.\n\t\t“Reference biological product” means the single biological product licensed pursuant to 42 U.S.C. \u00a7 262(a) against which a biological product is evaluated in an application submitted to the U.S. Food and Drug Administration for licensure of biological products as biosimilar or interchangeable pursuant to 42 U.S.C. \u00a7 262(k).\n\t\t“Remote dispensing system” means a profile-driven automated drug dispensing system that performs operations or activities relative to the storage, packaging, labeling, or dispensing of medications employing bidirectional audio-visual technology to facilitate pharmacist communication with a patient, authorized agent of the patient, or person licensed to administer drugs, and collects, controls, and maintains all information online. Drugs intended to be administered by the patient or a person not licensed to administer drugs must fully comply with the labeling requirements in \u00a7\u00a7 54.1-3410 and 54.1-3463 and Board regulations. Directions for use may only be abbreviated when drugs are administered exclusively by persons licensed to administer drugs.\n\t\t“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.\n\t\t“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. For the purposes of this definition, “isomer” means the optical, position, and geometric isomers.\n\t\t“Therapeutically equivalent drug products” means drug products that contain the same active ingredients and are identical in strength or concentration, dosage form, and route of administration and that are classified as being therapeutically equivalent by the U.S. Food and Drug Administration pursuant to the definition of “therapeutically equivalent drug products” set forth in the most recent edition of the Approved Drug Products with Therapeutic Equivalence Evaluations, otherwise known as the “Orange Book.”\n\t\t“Third-party logistics provider” means a person that provides or coordinates warehousing of or other logistics services for a drug or device in interstate commerce on behalf of a manufacturer, wholesale distributor, or dispenser of the drug or device but does not take ownership of the product or have responsibility for directing the sale or disposition of the product.\n\t\t“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.\n\t\t“USP-NF” means the current edition of the United States Pharmacopeia-National Formulary.\n\t\t“Warehouser” means any person, other than a wholesale distributor, manufacturer, or third-party logistics provider, engaged in the business of (i) selling or otherwise distributing prescription drugs or devices to any person who is not the ultimate user or consumer and (ii) delivering Schedule VI prescription devices to the ultimate user or consumer pursuant to \u00a7 54.1-3415.1. No person shall be subject to any state or local tax by reason of this definition.\n\t\t“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 \u00a7 54.1-3415.1, subject to the exemptions set forth in the federal Drug Supply Chain Security Act.\n\t\t“Wholesale distributor” means any person other than a manufacturer, a manufacturer’s co-licensed partner, a third-party logistics provider, or a repackager that engages in wholesale distribution.\n\t\tThe words “drugs” and “devices” as used in Chapter 33 (\u00a7 54.1-3300 et seq.) and in this chapter do not include surgical or dental instruments, physical therapy equipment, X-ray apparatus, or glasses or lenses for the eyes.\n\t\tThe terms “pharmacist,” “pharmacy,” and “practice of pharmacy” as used in this chapter have the same meanings as provided in Chapter 33 (\u00a7 54.1-3300 et seq.) unless the context requires a different meaning.","order_by":null,"text":{"0":{"id":218533,"text":"As used in this chapter, unless the context requires a different meaning:\n\t\t“Administer” means the direct application of a controlled substance, whether by injection, inhalation, ingestion, or any other means, to the body of a patient or research subject by (i) a practitioner or by his authorized agent and under his direction or (ii) the patient or research subject at the direction and in the presence of the practitioner.\n\t\t“Advertisement” means all representations disseminated in any manner or by any means, other than by labeling, for the purpose of inducing, or which are likely to induce, directly or indirectly, the purchase of drugs or devices.\n\t\t“Agent” means an authorized person who acts on behalf of or at the direction of a manufacturer, distributor, or dispenser. “Agent” does not include a common or contract carrier, public warehouseman, or employee of the carrier or warehouseman.\n\t\t“Anabolic steroid” means any drug or hormonal substance, chemically and pharmacologically related to testosterone, other than estrogens, progestins, corticosteroids, and dehydroepiandrosterone.\n\t\t“Animal” means any nonhuman animate being endowed with the power of voluntary action.\n\t\t“Automated drug dispensing system” means a mechanical or electronic system that performs operations or activities, other than compounding or administration, relating to pharmacy services, including the storage, dispensing, or distribution of drugs and the collection, control, and maintenance of all transaction information, to provide security and accountability for such drugs.\n\t\t“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.\n\t\t“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.S.C. \u00a7 262(k) in terms of safety, purity, and potency of the product.\n\t\t“Board” means the Board of Pharmacy.\n\t\t“Bulk drug substance” means any substance that is represented for use, and that, when used in the compounding, manufacturing, processing, or packaging of a drug, becomes an active ingredient or a finished dosage form of the drug; however, “bulk drug substance” does not include intermediates that are used in the synthesis of such substances.\n\t\t“Change of ownership” of an existing entity permitted, registered, or licensed by the Board means (i) the sale or transfer of all or substantially all of the assets of the entity or of any corporation that owns or controls the entity; (ii) the creation of a partnership by a sole proprietor, the dissolution of a partnership, or a change in partnership composition; (iii) the acquisition or disposal of 50 percent or more of the outstanding shares of voting stock of a corporation owning the entity or of the parent corporation of a wholly owned subsidiary owning the entity, except that this shall not apply to any corporation the voting stock of which is actively traded on any securities exchange or in any over-the-counter market; (iv) the merger of a corporation owning the entity or of the parent corporation of a wholly owned subsidiary owning the entity with another business or corporation; or (v) the expiration or forfeiture of a corporation’s charter.\n\t\t“Co-licensed partner” means a person who, with at least one other person, has the right to engage in the manufacturing or marketing of a prescription drug, consistent with state and federal law.\n\t\t“Compounding” means the combining of two or more ingredients to fabricate such ingredients into a single preparation and includes the mixing, assembling, packaging, or labeling of a drug or device (i) by a pharmacist, or within a permitted pharmacy, pursuant to a valid prescription issued for a medicinal or therapeutic purpose in the context of a bona fide practitioner-patient-pharmacist relationship, or in expectation of receiving a valid prescription based on observed historical patterns of prescribing and dispensing; (ii) by a practitioner of medicine, osteopathy, podiatry, dentistry, or veterinary medicine as an incident to his administering or dispensing, if authorized to dispense, a controlled substance in the course of his professional practice; or (iii) for the purpose of, or as incident to, research, teaching, or chemical analysis and not for sale or for dispensing. The mixing, diluting, or reconstituting of a manufacturer’s product drugs for the purpose of administration to a patient, when performed by a practitioner of medicine or osteopathy licensed under Chapter 29 (\u00a7 54.1-2900 et seq.), a person supervised by such practitioner pursuant to subdivision A 6 or 19 of \u00a7 54.1-2901, or a person supervised by such practitioner or a licensed advanced practice registered nurse or physician assistant pursuant to subdivision A 4 of \u00a7 54.1-2901 shall not be considered compounding.\n\t\t“Controlled substance” means a drug, substance, or immediate precursor in Schedules I through VI of this chapter. “Controlled substance” does not include distilled spirits, wine, malt beverages, or tobacco as those terms are defined or used in Title 3.2 or Title 4.1. The term “controlled substance” includes a controlled substance analog that has been placed into Schedule I or II by the Board pursuant to the regulatory authority in subsection D of \u00a7 54.1-3443.\n\t\t“Controlled substance analog” means a substance the chemical structure of which is substantially similar to the chemical structure of a controlled substance in Schedule I or II and either (i) which has a stimulant, depressant, or hallucinogenic effect on the central nervous system that is substantially similar to or greater than the stimulant, depressant, or hallucinogenic effect on the central nervous system of a controlled substance in Schedule I or II or (ii) with respect to a particular person, which such person represents or intends to have a stimulant, depressant, or hallucinogenic effect on the central nervous system that is substantially similar to or greater than the stimulant, depressant, or hallucinogenic effect on the central nervous system of a controlled substance in Schedule I or II. “Controlled substance analog” does not include (a) any substance for which there is an approved new drug application as defined under \u00a7 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. \u00a7 355) or that is generally recognized as safe and effective pursuant to \u00a7\u00a7 501, 502, and 503 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. \u00a7\u00a7 351, 352, and 353) and 21 C.F.R. Part 330; (b) with respect to a particular person, any substance for which an exemption is in effect for investigational use for that person under \u00a7 505 of the Federal Food, Drug, and Cosmetic Act to the extent that the conduct with respect to that substance is pursuant to such exemption; or (c) any substance to the extent not intended for human consumption before such an exemption takes effect with respect to that substance.\n\t\t“DEA” means the Drug Enforcement Administration, U.S. Department of Justice, or its successor agency.\n\t\t“Deliver” or “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 \u00a7 54.1-3415.1.\n\t\t“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.\n\t\t“Dialysis care technician” or “dialysis patient care technician” means an individual who is certified by an organization approved by the Department of Health Professions pursuant to Chapter 27.01 (\u00a7 54.1-2729.1 et seq.) and who, under the supervision of a licensed physician, an advanced practice registered nurse, a physician assistant, or a registered nurse, assists in the care of patients undergoing renal dialysis treatments in a Medicare-certified renal dialysis facility.\n\t\t“Dialysis solution” means either the commercially available, unopened, sterile solutions whose purpose is to be instilled into the peritoneal cavity during the medical procedure known as peritoneal dialysis, or commercially available solutions whose purpose is to be used in the performance of hemodialysis not to include any solutions administered to the patient intravenously.\n\t\t“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. However, “dispensing” does not include the transportation of drugs mixed, diluted, or reconstituted in accordance with this chapter to other sites operated by such practitioner or that practitioner’s medical practice for the purpose of administration of such drugs to patients of the practitioner or that practitioner’s medical practice at such other sites. For practitioners of medicine or osteopathy, “dispense” includes only the provision of drugs by a practitioner to patients to take with them away from the practitioner’s place of practice.\n\t\t“Dispenser” means a practitioner who dispenses.\n\t\t“Distribute” means to deliver other than by administering or dispensing a controlled substance.\n\t\t“Distributor” means a person who distributes.\n\t\t“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. “Drug” does not include devices or their components, parts, or accessories.\n\t\t“Drug product” means a specific drug in dosage form from a known source of manufacture, whether by brand or therapeutically equivalent drug product name.\n\t\t“Electronic prescription” means a written prescription that is generated on an electronic application and is transmitted to a pharmacy as an electronic data file; Schedules II through V prescriptions shall be transmitted in accordance with 21 C.F.R. Part 1300.\n\t\t“Facsimile (FAX) prescription” means a written prescription or order that is transmitted by an electronic device over telephone lines that sends the exact image to the receiving pharmacy in hard copy form.\n\t\t“FDA” means the U.S. Food and Drug Administration.\n\t\t“Immediate precursor” means a substance which the Board of Pharmacy has found to be and by regulation designates as being the principal compound commonly used or produced primarily for use, and which is an immediate chemical intermediary used or likely to be used in the manufacture of a controlled substance, the control of which is necessary to prevent, curtail, or limit manufacture.\n\t\t“Interchangeable” means a biosimilar that meets safety standards for determining interchangeability pursuant to 42 U.S.C. \u00a7 262(k)(4).\n\t\t“Label” means a display of written, printed, or graphic matter upon the immediate container of any article. A requirement made by or under authority of this chapter that any word, statement, or other information appear on the label shall not be considered to be complied with unless such word, statement, or other information also appears on the outside container or wrapper, if any, of the retail package of such article or is easily legible through the outside container or wrapper.\n\t\t“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.\n\t\t“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. “Manufacture” does not include compounding.\n\t\t“Manufacturer” means every person who manufactures, a manufacturer’s co-licensed partner, or a repackager.\n\t\t“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. “Marijuana” does not include (i) the mature stalks of such plant, fiber produced from such stalk, or oil or cake made from the seeds of such plant, unless such stalks, fiber, oil, or cake is combined with other parts of plants of the genus Cannabis; (ii) industrial hemp, as defined in \u00a7 3.2-4112, that is possessed by a person registered pursuant to subsection A of \u00a7 3.2-4115 or his agent; (iii) industrial hemp, as defined in \u00a7 3.2-4112, that is possessed by a person who holds a hemp producer license issued by the U.S. Department of Agriculture pursuant to 7 C.F.R. Part 990; (iv) a hemp product, as defined in \u00a7 3.2-4112; (v) an industrial hemp extract, as defined in \u00a7 3.2-5145.1; or (vi) any substance containing a tetrahydrocannabinol isomer, ester, ether, salt, or salts of such isomer, ester, or ether that has been placed by the Board of Pharmacy into one of the schedules set forth in the Drug Control Act (\u00a7 54.1-3400 et seq.) pursuant to \u00a7 54.1-3443.\n\t\t“Medical equipment supplier” means any person, as defined in \u00a7 1-230, engaged in the delivery to the ultimate consumer, pursuant to the lawful order of a practitioner, of hypodermic syringes and needles, medicinal oxygen, Schedule VI controlled devices, those Schedule VI controlled substances with no medicinal properties that are used for the operation and cleaning of medical equipment, solutions for peritoneal dialysis, and sterile water or saline for irrigation.\n\t\t“Narcotic drug” means any of the following, whether produced directly or indirectly by extraction from substances of vegetable origin, or independently by means of chemical synthesis, or by a combination of extraction and chemical synthesis: (i) opium, opiates, and any salt, compound, derivative, or preparation of opium or opiates; (ii) any salt, compound, isomer, derivative, or preparation thereof which is chemically equivalent or identical with any of the substances referred to in clause (i), but not including the isoquinoline alkaloids of opium; (iii) opium poppy and poppy straw; or (iv) coca leaves and any salt, compound, derivative, or preparation of coca leaves, and any salt, compound, isomer, derivative, or preparation thereof which is chemically equivalent or identical with any of these substances, but not including decocainized coca leaves or extraction of coca leaves which do not contain cocaine or ecgonine.\n\t\t“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.\n\t\t“Nuclear medicine technologist” means an individual who holds a current certification with the American Registry of Radiological Technologists or the Nuclear Medicine Technology Certification Board.\n\t\t“Official compendium” means the official United States Pharmacopoeia National Formulary, official Homeopathic Pharmacopoeia of the United States, or any supplement to any of them.\n\t\t“Official written order” means an order written on a form provided for that purpose by the U.S. Drug Enforcement Administration, under any laws of the United States making provision therefor, if such order forms are authorized and required by federal law, and if no such order form is provided then on an official form provided for that purpose by the Board of Pharmacy.\n\t\t“Opiate” means any substance having an addiction-forming or addiction-sustaining liability similar to morphine or being capable of conversion into a drug having such addiction-forming or addiction-sustaining liability. “Opiate” does not include, unless specifically designated as controlled under Article 4 (\u00a7 54.1-3437 et seq.), the dextrorotatory isomer of 3-methoxy-n-methylmorphinan and its salts (dextromethorphan). “Opiate” does include its racemic and levorotatory forms.\n\t\t“Opium poppy” means the plant of the species Papaver somniferum L., except the seeds thereof.\n\t\t“Original package” means the unbroken container or wrapping in which any drug or medicine is enclosed together with label and labeling, put up by or for the manufacturer, wholesaler, or distributor for use in the delivery or display of such article.\n\t\t“Outsourcing facility” means a facility that is engaged in the compounding of sterile drugs and is currently registered as an outsourcing facility with the U.S. Secretary of Health and Human Services and that complies with all applicable requirements of federal and state law, including the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. \u00a7 301 et seq.\n\t\t“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.\n\t\t“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 \u00a7 54.1-3432.\n\t\t“Poppy straw” means all parts, except the seeds, of the opium poppy, after mowing.\n\t\t“Practitioner” means a physician, dentist, licensed advanced practice registered nurse pursuant to \u00a7 54.1-2957.01, licensed physician assistant pursuant to \u00a7 54.1-2952.1, pharmacist pursuant to \u00a7 54.1-3300, TPA-certified optometrist pursuant to Article 5 (\u00a7 54.1-3222 et seq.) of Chapter 32, veterinarian, scientific investigator, or other person licensed, registered, or otherwise permitted to distribute, dispense, prescribe and administer, or conduct research with respect to a controlled substance in the course of professional practice or research in the Commonwealth.\n\t\t“Prescriber” means a practitioner who is authorized pursuant to \u00a7\u00a7 54.1-3303 and 54.1-3408 to issue a prescription.\n\t\t“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.\n\t\t“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 \u00a7 503(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. \u00a7 353(b)).\n\t\t“Production” or “produce” includes the manufacture, planting, cultivation, growing, or harvesting of a controlled substance or marijuana.\n\t\t“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. However, “proprietary medicine” does not include a drug that is only advertised or promoted professionally to licensed practitioners, a narcotic or drug containing a narcotic, a drug that may be dispensed only upon prescription or the label of which bears substantially the statement “Warning may be habit-forming,” or a drug intended for injection.\n\t\t“Radiopharmaceutical” means any drug that exhibits spontaneous disintegration of unstable nuclei with the emission of nuclear particles or photons and includes any non-radioactive reagent kit or radionuclide generator that is intended to be used in the preparation of any such substance, but does not include drugs such as carbon-containing compounds or potassium-containing salts that include trace quantities of naturally occurring radionuclides. “Radiopharmaceutical” also includes any biological product that is labeled with a radionuclide or intended solely to be labeled with a radionuclide.\n\t\t“Reference biological product” means the single biological product licensed pursuant to 42 U.S.C. \u00a7 262(a) against which a biological product is evaluated in an application submitted to the U.S. Food and Drug Administration for licensure of biological products as biosimilar or interchangeable pursuant to 42 U.S.C. \u00a7 262(k).\n\t\t“Remote dispensing system” means a profile-driven automated drug dispensing system that performs operations or activities relative to the storage, packaging, labeling, or dispensing of medications employing bidirectional audio-visual technology to facilitate pharmacist communication with a patient, authorized agent of the patient, or person licensed to administer drugs, and collects, controls, and maintains all information online. Drugs intended to be administered by the patient or a person not licensed to administer drugs must fully comply with the labeling requirements in \u00a7\u00a7 54.1-3410 and 54.1-3463 and Board regulations. Directions for use may only be abbreviated when drugs are administered exclusively by persons licensed to administer drugs.\n\t\t“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.\n\t\t“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. For the purposes of this definition, “isomer” means the optical, position, and geometric isomers.\n\t\t“Therapeutically equivalent drug products” means drug products that contain the same active ingredients and are identical in strength or concentration, dosage form, and route of administration and that are classified as being therapeutically equivalent by the U.S. Food and Drug Administration pursuant to the definition of “therapeutically equivalent drug products” set forth in the most recent edition of the Approved Drug Products with Therapeutic Equivalence Evaluations, otherwise known as the “Orange Book.”\n\t\t“Third-party logistics provider” means a person that provides or coordinates warehousing of or other logistics services for a drug or device in interstate commerce on behalf of a manufacturer, wholesale distributor, or dispenser of the drug or device but does not take ownership of the product or have responsibility for directing the sale or disposition of the product.\n\t\t“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.\n\t\t“USP-NF” means the current edition of the United States Pharmacopeia-National Formulary.\n\t\t“Warehouser” means any person, other than a wholesale distributor, manufacturer, or third-party logistics provider, engaged in the business of (i) selling or otherwise distributing prescription drugs or devices to any person who is not the ultimate user or consumer and (ii) delivering Schedule VI prescription devices to the ultimate user or consumer pursuant to \u00a7 54.1-3415.1. No person shall be subject to any state or local tax by reason of this definition.\n\t\t“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 \u00a7 54.1-3415.1, subject to the exemptions set forth in the federal Drug Supply Chain Security Act.\n\t\t“Wholesale distributor” means any person other than a manufacturer, a manufacturer’s co-licensed partner, a third-party logistics provider, or a repackager that engages in wholesale distribution.\n\t\tThe words “drugs” and “devices” as used in Chapter 33 (\u00a7 54.1-3300 et seq.) and in this chapter do not include surgical or dental instruments, physical therapy equipment, X-ray apparatus, or glasses or lenses for the eyes.\n\t\tThe terms “pharmacist,” “pharmacy,” and “practice of pharmacy” as used in this chapter have the same meanings as provided in Chapter 33 (\u00a7 54.1-3300 et seq.) unless the context requires a different meaning.","type":"section","prefixes":[""],"prefix":"","entire_prefix":"","prefix_anchor":"","level":1}},"ancestry":[{"id":13871,"edition_id":1,"name":"General Provisions","identifier":"1","label":"article","depth":4,"order_by":1,"parent_id":13240,"metadata":{},"date_created":"2026-06-26 03:46:08","date_modified":"2026-06-26 03:46:08","permalink":{"id":243225,"object_type":"structure","relational_id":13871,"identifier":"1","token":"54.1\/III\/34\/1","url":"\/54.1\/III\/34\/1\/","edition_id":1,"permalink":0,"preferred":1}},{"id":13240,"edition_id":1,"name":"Drug Control Act","identifier":"34","label":"chapter","depth":3,"order_by":1,"parent_id":12758,"metadata":{},"date_created":"2026-06-26 03:44:30","date_modified":"2026-06-26 03:44:30","permalink":{"id":243223,"object_type":"structure","relational_id":13240,"identifier":"34","token":"54.1\/III\/34","url":"\/54.1\/III\/34\/","edition_id":1,"permalink":0,"preferred":1}},{"id":12758,"edition_id":1,"name":"Professions and Occupations Regulated by Boards Within the Department of Health Professions","identifier":"III","label":"subtitle","depth":2,"order_by":1,"parent_id":12754,"metadata":{},"date_created":"2026-06-26 03:43:51","date_modified":"2026-06-26 03:43:51","permalink":{"id":241105,"object_type":"structure","relational_id":12758,"identifier":"III","token":"54.1\/III","url":"\/54.1\/III\/","edition_id":1,"permalink":0,"preferred":1}},{"id":12754,"edition_id":1,"name":"Professions and Occupations","identifier":"54.1","label":"title","depth":1,"order_by":1,"parent_id":null,"metadata":{},"date_created":"2026-06-26 03:43:51","date_modified":"2026-06-26 03:43:51","permalink":{"id":239313,"object_type":"structure","relational_id":12754,"identifier":"54.1","token":"54.1","url":"\/54.1\/","edition_id":1,"permalink":0,"preferred":1}}],"structure_contents":[{"id":77846,"structure_id":13871,"section_number":"54.1-3400","catch_line":"Citation","url":"\/54.1-3400\/","token":"54.1\/III\/34\/1\/54.1-3400","metadata":false},{"id":59669,"structure_id":13871,"section_number":"54.1-3401","catch_line":"Definitions","url":"\/54.1-3401\/","token":"54.1\/III\/34\/1\/54.1-3401","metadata":false},{"id":73061,"structure_id":13871,"section_number":"54.1-3401.1","catch_line":"Repealed","url":"\/54.1-3401.1\/","token":"54.1\/III\/34\/1\/54.1-3401.1","metadata":false},{"id":67762,"structure_id":13871,"section_number":"54.1-3402","catch_line":"Repealed","url":"\/54.1-3402\/","token":"54.1\/III\/34\/1\/54.1-3402","metadata":false},{"id":66637,"structure_id":13871,"section_number":"54.1-3403","catch_line":"Chapter not applicable to economic poisons","url":"\/54.1-3403\/","token":"54.1\/III\/34\/1\/54.1-3403","metadata":false},{"id":64371,"structure_id":13871,"section_number":"54.1-3404","catch_line":"Inventories of controlled substances required of certain persons; 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initials of pharmacist; automated data processing system","url":"\/54.1-3412\/","token":"54.1\/III\/34\/1\/54.1-3412","metadata":false},{"id":84967,"structure_id":13871,"section_number":"54.1-3413","catch_line":"Manufacturing and administering Schedule I drugs","url":"\/54.1-3413\/","token":"54.1\/III\/34\/1\/54.1-3413","metadata":false},{"id":72920,"structure_id":13871,"section_number":"54.1-3414","catch_line":"Official orders for Schedule II drugs","url":"\/54.1-3414\/","token":"54.1\/III\/34\/1\/54.1-3414","metadata":false},{"id":75448,"structure_id":13871,"section_number":"54.1-3415","catch_line":"Distribution of drugs in Schedules II through VI by manufacturers and wholesalers","url":"\/54.1-3415\/","token":"54.1\/III\/34\/1\/54.1-3415","metadata":false},{"id":65722,"structure_id":13871,"section_number":"54.1-3415.1","catch_line":"Delivery of medical devices on behalf of a medical equipment supplier","url":"\/54.1-3415.1\/","token":"54.1\/III\/34\/1\/54.1-3415.1","metadata":false},{"id":81317,"structure_id":13871,"section_number":"54.1-3416","catch_line":"No prescription for preparations listed pursuant to Schedule V","url":"\/54.1-3416\/","token":"54.1\/III\/34\/1\/54.1-3416","metadata":false},{"id":85551,"structure_id":13871,"section_number":"54.1-3417","catch_line":"Disposing of stocks of Schedules II through V drugs","url":"\/54.1-3417\/","token":"54.1\/III\/34\/1\/54.1-3417","metadata":false},{"id":57515,"structure_id":13871,"section_number":"54.1-3418","catch_line":"Sale of aqueous or oleaginous solutions","url":"\/54.1-3418\/","token":"54.1\/III\/34\/1\/54.1-3418","metadata":false},{"id":72600,"structure_id":13871,"section_number":"54.1-3419","catch_line":"Dispensing of insulin preparations","url":"\/54.1-3419\/","token":"54.1\/III\/34\/1\/54.1-3419","metadata":false},{"id":83366,"structure_id":13871,"section_number":"54.1-3420","catch_line":"Distribution of certain drugs; written request or confirmation of receipt","url":"\/54.1-3420\/","token":"54.1\/III\/34\/1\/54.1-3420","metadata":false},{"id":79253,"structure_id":13871,"section_number":"54.1-3420.1","catch_line":"Identification required for filling prescriptions","url":"\/54.1-3420.1\/","token":"54.1\/III\/34\/1\/54.1-3420.1","metadata":false},{"id":56483,"structure_id":13871,"section_number":"54.1-3420.2","catch_line":"Delivery of prescription drug order","url":"\/54.1-3420.2\/","token":"54.1\/III\/34\/1\/54.1-3420.2","metadata":false},{"id":55265,"structure_id":13871,"section_number":"54.1-3420.3","catch_line":"Prohibition on refusing to fill prescription from telemedicine provider","url":"\/54.1-3420.3\/","token":"54.1\/III\/34\/1\/54.1-3420.3","metadata":false},{"id":55995,"structure_id":13871,"section_number":"54.1-3421","catch_line":"New drugs","url":"\/54.1-3421\/","token":"54.1\/III\/34\/1\/54.1-3421","metadata":false},{"id":73818,"structure_id":13871,"section_number":"54.1-3422","catch_line":"Controlled substances registration certificate required in addition to other requirements; exemptions","url":"\/54.1-3422\/","token":"54.1\/III\/34\/1\/54.1-3422","metadata":false},{"id":87135,"structure_id":13871,"section_number":"54.1-3423","catch_line":"Board to issue registration unless inconsistent with public interest; authorization to conduct research; application and fees","url":"\/54.1-3423\/","token":"54.1\/III\/34\/1\/54.1-3423","metadata":false},{"id":59124,"structure_id":13871,"section_number":"54.1-3424","catch_line":"Suspension or revocation of registration, license or permit; limitation to particular controlled substance; controlled substances placed under seal; sale of perishables and forfeiture; notification to DEA","url":"\/54.1-3424\/","token":"54.1\/III\/34\/1\/54.1-3424","metadata":false},{"id":83858,"structure_id":13871,"section_number":"54.1-3425","catch_line":"Repealed","url":"\/54.1-3425\/","token":"54.1\/III\/34\/1\/54.1-3425","metadata":false},{"id":86762,"structure_id":13871,"section_number":"54.1-3426","catch_line":"Regulations for special packaging","url":"\/54.1-3426\/","token":"54.1\/III\/34\/1\/54.1-3426","metadata":false},{"id":85278,"structure_id":13871,"section_number":"54.1-3427","catch_line":"Dispensing drugs without safety closure container","url":"\/54.1-3427\/","token":"54.1\/III\/34\/1\/54.1-3427","metadata":false},{"id":68396,"structure_id":13871,"section_number":"54.1-3428","catch_line":"Dissemination of information","url":"\/54.1-3428\/","token":"54.1\/III\/34\/1\/54.1-3428","metadata":false},{"id":74207,"structure_id":13871,"section_number":"54.1-3429","catch_line":"Revocation of permit issued to manufacturer, wholesaler or distributor","url":"\/54.1-3429\/","token":"54.1\/III\/34\/1\/54.1-3429","metadata":false},{"id":73141,"structure_id":13871,"section_number":"54.1-3430","catch_line":"Display of permit; permits nontransferable; renewal","url":"\/54.1-3430\/","token":"54.1\/III\/34\/1\/54.1-3430","metadata":false},{"id":76001,"structure_id":13871,"section_number":"54.1-3431","catch_line":"Admission into evidence of certain certificates of analysis","url":"\/54.1-3431\/","token":"54.1\/III\/34\/1\/54.1-3431","metadata":false}],"previous_section":{"id":77846,"structure_id":13871,"section_number":"54.1-3400","catch_line":"Citation","url":"\/54.1-3400\/","token":"54.1\/III\/34\/1\/54.1-3400","metadata":false},"next_section":{"id":73061,"structure_id":13871,"section_number":"54.1-3401.1","catch_line":"Repealed","url":"\/54.1-3401.1\/","token":"54.1\/III\/34\/1\/54.1-3401.1","metadata":false},"metadata":false,"official_url":"https:\/\/law.lis.virginia.gov\/vacode\/54.1-3401\/","history_text":"

The record of this law\u2019s original creation isn\u2019t available online. It has been modified 35 times. Those modifications are cataloged by \u201cThe Acts of Assembly,\u201d a state publication, by year and chapter. Those modifications that can be read on the General Assembly\u2019s website will be linked accordingly. Those modifications are as follows: in 1952, chapter 451; in 1958, chapter 551; in 1966, chapter 193; in 1968, chapter 582; in 1970, chapter 650; in 1972, chapter 798; in 1975, chapter 425; in 1976, chapter 14; in 1977, chapter 193; in 1978, chapter 833; in 1979, chapter 435; in 1980, chapter 150; in 1988, chapter 765; in 1991, chapters 519 and 524; in 1992, chapters 737 and 793; in 1996, chapters 37<\/a>, 152<\/a>, 158<\/a>, 407<\/a>, and 408<\/a>; in 1997, chapters 20<\/a>, 677<\/a>, and 806<\/a>; in 1998, chapter 470<\/a>; in 1999, chapters 661<\/a> and 750<\/a>; in 2000, chapters 861<\/a>, 878<\/a>, and 935<\/a>; in 2003, chapters 509<\/a>, 639<\/a>, and 995<\/a>; in 2005, chapters 475<\/a> and 839<\/a>; in 2006, chapter 346<\/a>; in 2012, chapter 213<\/a>; in 2013, chapters 412<\/a>, 504<\/a>, 544<\/a>, and 765<\/a>; in 2014, chapters 674<\/a> and 719<\/a>; in 2015, chapters 158<\/a>, 180<\/a>, and 300<\/a>; in 2016, chapters 221<\/a> and 495<\/a>; in 2017, chapters 115<\/a> and 429<\/a>; in 2018, chapters 241<\/a>, 242<\/a>, 689<\/a>, and 690<\/a>; in 2019, chapters 653<\/a> and 654<\/a>; in 2020, chapters 831<\/a>, 1285<\/a>, and 1286<\/a>; in 2023, chapters 183<\/a>, 744<\/a>, and 794<\/a>; in 2024, chapters 63<\/a> and 513<\/a>; in 2025, chapter 341<\/a>.<\/p>","references":[{"id":60256,"section_number":"15.2-1724","catch_line":"Police and other officers may be sent beyond territorial limits","order_by":null,"url":"\/15.2-1724\/"},{"id":61177,"section_number":"15.2-2291","catch_line":"Assisted living facilities and group homes of eight or fewer; single-family residence","order_by":null,"url":"\/15.2-2291\/"},{"id":85083,"section_number":"15.2-907","catch_line":"Authority to require removal, repair, etc., of buildings and other structures harboring illegal drug use or other criminal activity","order_by":null,"url":"\/15.2-907\/"},{"id":84070,"section_number":"18.2-247","catch_line":"Use of terms \"controlled substances,\" \"marijuana,\" \"Schedules I, II, III, IV, V, and VI,\" \"imitation controlled substance,\" and \"counterfeit controlled substance\" in Title 18.2","order_by":null,"url":"\/18.2-247\/"},{"id":57190,"section_number":"18.2-258","catch_line":"Certain premises deemed common nuisance; penalty","order_by":null,"url":"\/18.2-258\/"},{"id":86559,"section_number":"18.2-264","catch_line":"Inhaling drugs or other noxious chemical substances or causing, etc., others to do so; distribution of nitrous oxide to persons under 18 prohibited; penalties","order_by":null,"url":"\/18.2-264\/"},{"id":59050,"section_number":"18.2-265.19","catch_line":"Definitions","order_by":null,"url":"\/18.2-265.19\/"},{"id":63617,"section_number":"22.1-212.2:4","catch_line":"Interscholastic athletics; student-athletes; compensation and representation for name, image, or likeness","order_by":null,"url":"\/22.1-212.2_4\/"},{"id":62165,"section_number":"22.1-274.01:1","catch_line":"Students who are diagnosed with diabetes; self-care; insertion and reinsertion of insulin pump","order_by":null,"url":"\/22.1-274.01_1\/"},{"id":78246,"section_number":"22.1-274.2","catch_line":"Possession and administration of inhaled asthma medications, epinephrine, glucagon, and seizure rescue medications by certain students or school board employees","order_by":null,"url":"\/22.1-274.2\/"},{"id":54486,"section_number":"23.1-408.1","catch_line":"Intercollegiate athletics; student-athletes; compensation and representation for name, image, or likeness","order_by":null,"url":"\/23.1-408.1\/"},{"id":81195,"section_number":"3.2-5145.1","catch_line":"Definitions","order_by":null,"url":"\/3.2-5145.1\/"},{"id":57301,"section_number":"32.1-126.02","catch_line":"Hospital pharmacy employees; criminal records check required","order_by":null,"url":"\/32.1-126.02\/"},{"id":66908,"section_number":"32.1-42.1","catch_line":"Administration and dispensing of necessary drugs, devices and vaccines during a declared disaster or emergency","order_by":null,"url":"\/32.1-42.1\/"},{"id":80337,"section_number":"38.2-3407.15:6","catch_line":"Prescription drug price transparency","order_by":null,"url":"\/38.2-3407.15_6\/"},{"id":70057,"section_number":"54.1-2952.1","catch_line":"Prescription of certain controlled substances and devices by licensed physician assistants","order_by":null,"url":"\/54.1-2952.1\/"},{"id":71447,"section_number":"54.1-2957.01","catch_line":"Prescription of certain controlled substances and devices by licensed advanced practice registered nurses","order_by":null,"url":"\/54.1-2957.01\/"},{"id":65541,"section_number":"54.1-2957.9","catch_line":"Regulation of the practice of midwifery","order_by":null,"url":"\/54.1-2957.9\/"},{"id":55719,"section_number":"54.1-3301","catch_line":"Exceptions","order_by":null,"url":"\/54.1-3301\/"},{"id":86967,"section_number":"54.1-3303.1","catch_line":"Initiating of treatment with and dispensing and administering of controlled substances by pharmacists","order_by":null,"url":"\/54.1-3303.1\/"},{"id":57997,"section_number":"54.1-3434.02","catch_line":"Automated drug dispensing systems and remote dispensing systems","order_by":null,"url":"\/54.1-3434.02\/"},{"id":86023,"section_number":"54.1-3435","catch_line":"License to act as wholesale distributor; renewal; fee","order_by":null,"url":"\/54.1-3435\/"},{"id":69203,"section_number":"54.1-3435.2","catch_line":"Permit to act as medical equipment supplier; storage; limitation; regulations","order_by":null,"url":"\/54.1-3435.2\/"},{"id":78752,"section_number":"54.1-3435.4","catch_line":"Permit to act as warehouser; regulations","order_by":null,"url":"\/54.1-3435.4\/"},{"id":66818,"section_number":"54.1-3443","catch_line":"Board to administer article","order_by":null,"url":"\/54.1-3443\/"},{"id":63550,"section_number":"59.1-365","catch_line":"Definitions","order_by":null,"url":"\/59.1-365\/"}],"refers_to":[{"id":56662,"section_number":"1-230","catch_line":"Person","order_by":null,"url":"\/1-230\/"},{"id":79195,"section_number":"3.2-4112","catch_line":"Definitions","order_by":null,"url":"\/3.2-4112\/"},{"id":87044,"section_number":"3.2-4115","catch_line":"Issuance of registrations; exemption","order_by":null,"url":"\/3.2-4115\/"},{"id":81195,"section_number":"3.2-5145.1","catch_line":"Definitions","order_by":null,"url":"\/3.2-5145.1\/"},{"id":70746,"section_number":"54.1-2729.1","catch_line":"Scope of chapter","order_by":null,"url":"\/54.1-2729.1\/"},{"id":63078,"section_number":"54.1-2900","catch_line":"Definitions","order_by":null,"url":"\/54.1-2900\/"},{"id":83528,"section_number":"54.1-2901","catch_line":"Exceptions and exemptions generally","order_by":null,"url":"\/54.1-2901\/"},{"id":70057,"section_number":"54.1-2952.1","catch_line":"Prescription of certain controlled substances and devices by licensed physician assistants","order_by":null,"url":"\/54.1-2952.1\/"},{"id":71447,"section_number":"54.1-2957.01","catch_line":"Prescription of certain controlled substances and devices by licensed advanced practice registered nurses","order_by":null,"url":"\/54.1-2957.01\/"},{"id":54127,"section_number":"54.1-3222","catch_line":"TPA certification; certification for treatment of diseases or abnormal conditions with therapeutic pharmaceutical agents (TPAs)","order_by":null,"url":"\/54.1-3222\/"},{"id":72064,"section_number":"54.1-3300","catch_line":"Definitions","order_by":null,"url":"\/54.1-3300\/"},{"id":85347,"section_number":"54.1-3303","catch_line":"Prescriptions to be issued and drugs to be dispensed for medical or therapeutic purposes only","order_by":null,"url":"\/54.1-3303\/"},{"id":77846,"section_number":"54.1-3400","catch_line":"Citation","order_by":null,"url":"\/54.1-3400\/"},{"id":77665,"section_number":"54.1-3408","catch_line":"Professional use by practitioners","order_by":null,"url":"\/54.1-3408\/"},{"id":83740,"section_number":"54.1-3410","catch_line":"When pharmacist may sell and dispense drugs","order_by":null,"url":"\/54.1-3410\/"},{"id":65722,"section_number":"54.1-3415.1","catch_line":"Delivery of medical devices on behalf of a medical equipment supplier","order_by":null,"url":"\/54.1-3415.1\/"},{"id":76730,"section_number":"54.1-3432","catch_line":"Supervision by pharmacist","order_by":null,"url":"\/54.1-3432\/"},{"id":55332,"section_number":"54.1-3437","catch_line":"Permit to manufacture drugs","order_by":null,"url":"\/54.1-3437\/"},{"id":66818,"section_number":"54.1-3443","catch_line":"Board to administer article","order_by":null,"url":"\/54.1-3443\/"},{"id":55895,"section_number":"54.1-3463","catch_line":"Exemption of drugs dispensed by filling or refilling prescription","order_by":null,"url":"\/54.1-3463\/"}],"permalink":{"id":243231,"object_type":"law","relational_id":59669,"identifier":"54.1-3401","token":"54.1\/III\/34\/1\/54.1-3401","url":"\/54.1-3401\/","edition_id":1,"permalink":0,"preferred":1},"url":"\/54.1-3401\/","token":"54.1\/III\/34\/1\/54.1-3401","dublin_core":{"Title":"Definitions","Type":"Text","Format":"text\/html","Identifier":"\u00a7 54.1-3401","Relation":"Code of Virginia"},"html":"\n\t\t\t\t\t\t

As used in this chapter, unless the context requires a different meaning:\n\t\t“Administer<\/span>” means the direct application of a controlled substance, whether by injection, inhalation, ingestion, or any other means, to the body of a patient or research subject by (i) a practitioner<\/span> or by his authorized agent<\/span> and under his direction or (ii) the patient or research subject at the direction and in the presence of the practitioner<\/span>.\n\t\t“Advertisement<\/span>” means all representations disseminated in any manner or by any means, other than by labeling<\/span>, for the purpose of inducing, or which are likely to induce, directly or indirectly, the purchase of drugs or devices<\/span>.\n\t\t“Agent<\/span>” means an authorized person<\/span> who acts on behalf of or at the direction of a manufacturer<\/span>, distributor, or dispenser<\/span>. “Agent<\/span>” does not include a common or contract<\/span> carrier, public warehouseman, or employee of the carrier or warehouseman.\n\t\t“Anabolic steroid<\/span>” means any drug or hormonal substance, chemically and pharmacologically related to testosterone, other than estrogens, progestins, corticosteroids, and dehydroepiandrosterone.\n\t\t“Animal<\/span>” means any nonhuman animate being endowed with the power of voluntary action.\n\t\t“Automated drug dispensing system<\/span>” means a mechanical or electronic system that performs operations or activities, other than compounding<\/span> or administration, relating to pharmacy services, including the storage, dispensing, or distribution of drugs and the collection, control, and maintenance of all transaction information, to provide security and accountability for such drugs.\n\t\t“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.\n\t\t“Biosimilar<\/span>” means a biological product that is highly similar to a specific reference biological product<\/span>, notwithstanding minor<\/span> differences in clinically inactive compounds, such that there are no clinically meaningful differences between the reference biological product<\/span> and the biological product that has been licensed as a biosimilar<\/span> pursuant to 42 U.S.C. \u00a7 262(k) in terms of safety, purity, and potency of the product.\n\t\t“Board<\/span>” means the Board<\/span> of Pharmacy.\n\t\t“Bulk drug substance<\/span>” means any substance that is represented for use, and that, when used in the compounding<\/span>, manufacturing, processing, or packaging of a drug, becomes an active ingredient or a finished dosage form of the drug; however, “bulk drug substance<\/span>” does not include intermediates that are used in the synthesis of such substances.\n\t\t“Change of ownership<\/span>” of an existing entity permitted, registered, or licensed by the Board<\/span> means (i) the sale<\/span> or transfer of all or substantially all of the assets<\/span> of the entity or of any corporation that owns or controls the entity; (ii) the creation of a partnership by a sole proprietor, the dissolution of a partnership, or a change in partnership composition; (iii) the acquisition or disposal of 50 percent or more of the outstanding shares of voting stock of a corporation owning the entity or of the parent corporation of a wholly owned subsidiary owning the entity, except that this shall not apply to any corporation the voting stock of which is actively traded on any securities exchange or in any over-the-counter market; (iv) the merger of a corporation owning the entity or of the parent corporation of a wholly owned subsidiary owning the entity with another business or corporation; or (v) the expiration or forfeiture of a corporation’s charter.\n\t\t“Co-licensed partner<\/span>” means a person<\/span> who, with at least one other person<\/span>, has the right to engage in the manufacturing or marketing of a prescription drug<\/span>, consistent with state and federal law<\/span>.\n\t\t“Compounding<\/span>” means the combining of two or more ingredients to fabricate such ingredients into a single preparation and includes the mixing, assembling, packaging, or labeling<\/span> of a drug or device<\/span> (i) by a pharmacist, or within a permitted pharmacy, pursuant to a valid prescription issued for a medicinal or therapeutic purpose in the context of a bona fide practitioner<\/span>-patient-pharmacist relationship, or in expectation of receiving a valid prescription based on observed historical patterns of prescribing and dispensing; (ii) by a practitioner<\/span> of medicine, osteopathy, podiatry, dentistry, or veterinary medicine as an incident to his administering or dispensing, if authorized to dispense<\/span>, a controlled substance in the course of his professional practice; or (iii) for the purpose of, or as incident to, research, teaching, or chemical analysis and not for sale<\/span> or for dispensing. The mixing, diluting, or reconstituting of a manufacturer<\/span>’s product drugs for the purpose of administration to a patient, when performed by a practitioner<\/span> of medicine or osteopathy licensed under Chapter 29 (\u00a7 54.1-2900<\/a> et seq.), a person<\/span> supervised by such practitioner<\/span> pursuant to subdivision A 6 or 19 of \u00a7 54.1-2901<\/a>, or a person<\/span> supervised by such practitioner<\/span> or a licensed advanced practice registered nurse or physician assistant pursuant to subdivision A 4 of \u00a7 54.1-2901<\/a> shall not be considered compounding<\/span>.\n\t\t“Controlled substance” means a drug, substance, or immediate precursor<\/span> in Schedules<\/span> I through VI of this chapter. “Controlled substance” does not include distilled spirits, wine, malt beverages, or tobacco as those terms are defined or used in Title 3.2 or Title 4.1. The term “controlled substance” includes a controlled substance analog<\/span> that has been placed into Schedule I or II by the Board<\/span> pursuant to the regulatory authority in subsection D of \u00a7 54.1-3443<\/a>.\n\t\t“Controlled substance analog<\/span>” means a substance the chemical structure of which is substantially similar to the chemical structure of a controlled substance in Schedule I or II and either (i) which has a stimulant, depressant, or hallucinogenic effect on the central nervous system that is substantially similar to or greater than the stimulant, depressant, or hallucinogenic effect on the central nervous system of a controlled substance in Schedule I or II or (ii) with respect to a particular person<\/span>, which such person<\/span> represents or intends to have a stimulant, depressant, or hallucinogenic effect on the central nervous system that is substantially similar to or greater than the stimulant, depressant, or hallucinogenic effect on the central nervous system of a controlled substance in Schedule I or II. “Controlled substance analog<\/span>” does not include (a) any substance for which there is an approved new drug<\/span> application as defined under \u00a7 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. \u00a7 355) or that is generally recognized as safe and effective pursuant to \u00a7\u00a7 501, 502, and 503 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. \u00a7\u00a7 351, 352, and 353) and 21 C.F.R. Part 330; (b) with respect to a particular person<\/span>, any substance for which an exemption is in effect for investigational use for that person<\/span> under \u00a7 505 of the Federal Food, Drug, and Cosmetic Act to the extent that the conduct with respect to that substance is pursuant to such exemption; or (c) any substance to the extent not intended for human consumption before such an exemption takes effect with respect to that substance.\n\t\t“DEA<\/span>” means the Drug Enforcement Administration, U.S. Department of Justice, or its successor agency.\n\t\t“Deliver<\/span>” or “delivery<\/span>” means the actual, constructive, or attempted transfer of any item regulated by this chapter, whether or not there exists an agency relationship, including delivery<\/span> of a Schedule VI prescription device<\/span> to an ultimate user or consumer on behalf of a medical equipment supplier<\/span> by a manufacturer<\/span>, nonresident manufacturer<\/span>, wholesale distributor<\/span>, nonresident wholesale distributor<\/span>, warehouser<\/span>, nonresident warehouser<\/span>, third-party<\/span> logistics provider<\/span>, or nonresident third-party<\/span> logistics provider<\/span> at the direction of a medical equipment supplier<\/span> in accordance with \u00a7 54.1-3415.1<\/a>.\n\t\t“Device<\/span>” 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<\/span> or to affect the structure or any function of the body of man or animals<\/span>.\n\t\t“Dialysis care technician<\/span>” or “dialysis patient care technician<\/span>” means an individual who is certified by an organization approved by the Department of Health Professions pursuant to Chapter 27.01 (\u00a7 54.1-2729.1<\/a> et seq.) and who, under the supervision of a licensed physician, an advanced practice registered nurse, a physician assistant, or a registered nurse, assists in the care of patients undergoing renal dialysis treatments in a Medicare-certified renal dialysis facility.\n\t\t“Dialysis solution<\/span>” means either the commercially available, unopened, sterile solutions whose purpose is to be instilled into the peritoneal cavity during the medical procedure known as peritoneal dialysis, or commercially available solutions whose purpose is to be used in the performance of hemodialysis not to include any solutions administered to the patient intravenously.\n\t\t“Dispense<\/span>” means to deliver<\/span> a drug to an ultimate user or research subject by or pursuant to the lawful order of a practitioner<\/span>, including the prescribing and administering, packaging, labeling<\/span>, or compounding<\/span> necessary to prepare the substance for that delivery<\/span>. However, “dispensing” does not include the transportation of drugs mixed, diluted, or reconstituted in accordance with this chapter to other sites operated by such practitioner<\/span> or that practitioner<\/span>’s medical practice for the purpose of administration of such drugs to patients of the practitioner<\/span> or that practitioner<\/span>’s medical practice at such other sites. For practitioners<\/span> of medicine or osteopathy, “dispense<\/span>” includes only the provision of drugs by a practitioner<\/span> to patients to take with them away from the practitioner<\/span>’s place of practice.\n\t\t“Dispenser<\/span>” means a practitioner<\/span> who dispenses<\/span>.\n\t\t“Distribute<\/span>” means to deliver<\/span> other than by administering or dispensing a controlled substance.\n\t\t“Distributor” means a person<\/span> who distributes<\/span>.\n\t\t“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<\/span>; (iii) articles or substances, other than food, intended to affect the structure or any function of the body of man or animals<\/span>; (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. “Drug” does not include devices<\/span> or their components, parts, or accessories.\n\t\t“Drug product<\/span>” means a specific drug in dosage form from a known source of manufacture<\/span>, whether by brand or therapeutically equivalent drug product<\/span> name.\n\t\t“Electronic prescription<\/span>” means a written prescription that is generated on an electronic application and is transmitted to a pharmacy as an electronic data file; Schedules<\/span> II through V prescriptions<\/span> shall be transmitted in accordance with 21 C.F.R. Part 1300.\n\t\t“Facsimile (FAX) prescription” means a written prescription or order that is transmitted by an electronic device<\/span> over telephone lines that sends the exact image to the receiving pharmacy in hard copy form.\n\t\t“FDA<\/span>” means the U.S. Food and Drug Administration.\n\t\t“Immediate precursor<\/span>” means a substance which the Board<\/span> of Pharmacy has found to be and by regulation designates as being the principal compound commonly used or produced primarily for use, and which is an immediate chemical intermediary used or likely to be used in the manufacture<\/span> of a controlled substance, the control of which is necessary to prevent, curtail, or limit manufacture<\/span>.\n\t\t“Interchangeable<\/span>” means a biosimilar<\/span> that meets safety standards for determining interchangeability pursuant to 42 U.S.C. \u00a7 262(k)(4).\n\t\t“Label<\/span>” means a display of written, printed, or graphic matter upon the immediate container of any article. A requirement made by or under authority of this chapter that any word, statement, or other information appear on the label<\/span> shall not be considered to be complied with unless such word, statement, or other information also appears on the outside container or wrapper, if any, of the retail package of such article or is easily legible through the outside container or wrapper.\n\t\t“Labeling<\/span>” means all labels<\/span> and other written, printed, or graphic matter on an article or any of its containers or wrappers, or accompanying such article.\n\t\t“Manufacture<\/span>” means the production<\/span>, 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<\/span> or relabeling of its container. “Manufacture<\/span>” does not include compounding<\/span>.\n\t\t“Manufacturer<\/span>” means every person<\/span> who manufactures<\/span>, a manufacturer<\/span>’s co-licensed partner<\/span>, or a repackager.\n\t\t“Marijuana<\/span>” means any part of a plant of the genus Cannabis whether growing or not, its seeds, or its resin; and every compound, manufacture<\/span>, salt, derivative, mixture, or preparation of such plant, its seeds, its resin, or any extract containing one or more cannabinoids. “Marijuana<\/span>” does not include (i) the mature stalks of such plant, fiber produced from such stalk, or oil or cake made from the seeds of such plant, unless such stalks, fiber, oil, or cake is combined with other parts of plants of the genus Cannabis; (ii) industrial hemp, as defined in \u00a7 3.2-4112<\/a>, that is possessed by a person<\/span> registered pursuant to subsection A of \u00a7 3.2-4115<\/a> or his agent<\/span>; (iii) industrial hemp, as defined in \u00a7 3.2-4112<\/a>, that is possessed by a person<\/span> who holds a hemp producer license issued by the U.S. Department of Agriculture pursuant to 7 C.F.R. Part 990; (iv) a hemp product, as defined in \u00a7 3.2-4112<\/a>; (v) an industrial hemp extract, as defined in \u00a7 3.2-5145.1<\/a>; or (vi) any substance containing a tetrahydrocannabinol isomer<\/span>, ester, ether, salt, or salts of such isomer<\/span>, ester, or ether that has been placed by the Board<\/span> of Pharmacy into one of the schedules<\/span> set forth in the Drug Control Act (\u00a7 54.1-3400<\/a> et seq.) pursuant to \u00a7 54.1-3443<\/a>.\n\t\t“Medical equipment supplier<\/span>” means any person<\/span>, as defined in \u00a7 1-230<\/a>, engaged in the delivery<\/span> to the ultimate consumer, pursuant to the lawful order of a practitioner<\/span>, of hypodermic syringes and needles, medicinal oxygen, Schedule VI controlled devices<\/span>, those Schedule VI controlled substances<\/span> with no medicinal properties that are used for the operation and cleaning of medical equipment, solutions for peritoneal dialysis, and sterile water or saline for irrigation.\n\t\t“Narcotic drug<\/span>” means any of the following, whether produced directly or indirectly by extraction from substances of vegetable origin, or independently by means of chemical synthesis, or by a combination of extraction and chemical synthesis: (i) opium, opiates<\/span>, and any salt, compound, derivative, or preparation of opium or opiates<\/span>; (ii) any salt, compound, isomer<\/span>, derivative, or preparation thereof which is chemically equivalent or identical with any of the substances referred to in clause (i), but not including the isoquinoline alkaloids of opium; (iii) opium poppy<\/span> and poppy straw<\/span>; or (iv) coca leaves and any salt, compound, derivative, or preparation of coca leaves, and any salt, compound, isomer<\/span>, derivative, or preparation thereof which is chemically equivalent or identical with any of these substances, but not including decocainized coca leaves or extraction of coca leaves which do not contain cocaine or ecgonine.\n\t\t“New drug<\/span>” means (i) any drug, except a new animal<\/span> drug or an animal<\/span> feed bearing or containing a new animal<\/span> 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<\/span>, except that such a drug not so recognized shall not be deemed to be a “new drug<\/span>” 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<\/span> contained the same representations concerning the conditions of its use, or (ii) any drug, except a new animal<\/span> drug or an animal<\/span> feed bearing or containing a new animal<\/span> 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<\/span> extent or for a material<\/span> time under such conditions.\n\t\t“Nuclear medicine technologist<\/span>” means an individual who holds a current certification with the American Registry of Radiological Technologists or the Nuclear Medicine Technology Certification Board<\/span>.\n\t\t“Official compendium<\/span>” means the official United States Pharmacopoeia National Formulary, official Homeopathic Pharmacopoeia of the United States, or any supplement to any of them.\n\t\t“Official written order<\/span>” means an order written on a form provided for that purpose by the U.S. Drug Enforcement Administration, under any laws<\/span> of the United States making provision therefor, if such order forms are authorized and required by federal law<\/span>, and if no such order form is provided then on an official form provided for that purpose by the Board<\/span> of Pharmacy.\n\t\t“Opiate<\/span>” means any substance having an addiction-forming or addiction-sustaining liability similar to morphine or being capable of conversion into a drug having such addiction-forming or addiction-sustaining liability. “Opiate<\/span>” does not include, unless specifically designated as controlled under Article 4 (\u00a7 54.1-3437<\/a> et seq.), the dextrorotatory isomer<\/span> of 3-methoxy-n-methylmorphinan and its salts (dextromethorphan). “Opiate<\/span>” does include its racemic and levorotatory forms.\n\t\t“Opium poppy<\/span>” means the plant of the species Papaver somniferum L., except the seeds thereof.\n\t\t“Original package<\/span>” means the unbroken container or wrapping in which any drug or medicine is enclosed together with label<\/span> and labeling<\/span>, put up by or for the manufacturer<\/span>, wholesaler, or distributor for use in the delivery<\/span> or display of such article.\n\t\t“Outsourcing facility<\/span>” means a facility that is engaged in the compounding<\/span> of sterile drugs and is currently registered as an outsourcing facility<\/span> with the U.S. Secretary of Health and Human Services and that complies with all applicable requirements of federal and state law<\/span>, including the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. \u00a7 301 et seq.\n\t\t“Person<\/span>” 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.\n\t\t“Pharmacist-in-charge<\/span>” means the person<\/span> 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<\/span> and regulations for the practice of pharmacy and the sale<\/span> and dispensing of controlled substances<\/span>; the “pharmacist-in-charge<\/span>” shall personally supervise the pharmacy and the pharmacy’s personnel as required by \u00a7 54.1-3432<\/a>.\n\t\t“Poppy straw<\/span>” means all parts, except the seeds, of the opium poppy<\/span>, after mowing.\n\t\t“Practitioner<\/span>” means a physician, dentist, licensed advanced practice registered nurse pursuant to \u00a7 54.1-2957.01<\/a>, licensed physician assistant pursuant to \u00a7 54.1-2952.1<\/a>, pharmacist pursuant to \u00a7 54.1-3300<\/a>, TPA-certified optometrist pursuant to Article 5 (\u00a7 54.1-3222<\/a> et seq.) of Chapter 32, veterinarian, scientific investigator, or other person<\/span> licensed, registered, or otherwise permitted to distribute<\/span>, dispense<\/span>, prescribe and administer<\/span>, or conduct research with respect to a controlled substance in the course of professional practice or research in the Commonwealth.\n\t\t“Prescriber<\/span>” means a practitioner<\/span> who is authorized pursuant to \u00a7\u00a7 54.1-3303<\/a> and 54.1-3408<\/a> to issue<\/span> a prescription.\n\t\t“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<\/span> authorized by law<\/span> to prescribe and administer<\/span> such drugs or medical supplies.\n\t\t“Prescription drug<\/span>” means any drug required by federal law<\/span> or regulation to be dispensed only pursuant to a prescription, including finished dosage forms and active ingredients subject to \u00a7 503(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. \u00a7 353(b)).\n\t\t“Production<\/span>” or “produce<\/span>” includes the manufacture<\/span>, planting, cultivation, growing, or harvesting of a controlled substance or marijuana<\/span>.\n\t\t“Proprietary medicine<\/span>” means a completely compounded nonprescription drug in its unbroken, original package<\/span> which does not contain any controlled substance or marijuana<\/span> 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<\/span> or primary distributor, under a trademark, trade name, or other trade symbol privately owned, and the labeling<\/span> of which conforms to the requirements of this chapter and applicable federal law<\/span>. However, “proprietary medicine<\/span>” does not include a drug that is only advertised or promoted professionally to licensed practitioners<\/span>, a narcotic or drug containing a narcotic, a drug that may be dispensed only upon prescription or the label<\/span> of which bears substantially the statement “Warning may be habit-forming,” or a drug intended for injection.\n\t\t“Radiopharmaceutical<\/span>” means any drug that exhibits spontaneous disintegration of unstable nuclei with the emission of nuclear particles or photons and includes any non-radioactive reagent kit or radionuclide generator that is intended to be used in the preparation of any such substance, but does not include drugs such as carbon-containing compounds or potassium-containing salts that include trace quantities of naturally occurring radionuclides. “Radiopharmaceutical<\/span>” also includes any biological product that is labeled with a radionuclide or intended solely to be labeled with a radionuclide.\n\t\t“Reference biological product<\/span>” means the single biological product licensed pursuant to 42 U.S.C. \u00a7 262(a) against which a biological product is evaluated in an application submitted to the U.S. Food and Drug Administration for licensure of biological products<\/span> as biosimilar<\/span> or interchangeable<\/span> pursuant to 42 U.S.C. \u00a7 262(k).\n\t\t“Remote dispensing system<\/span>” means a profile-driven automated drug dispensing system<\/span> that performs operations or activities relative to the storage, packaging, labeling<\/span>, or dispensing of medications employing bidirectional audio-visual technology to facilitate pharmacist communication with a patient, authorized agent<\/span> of the patient, or person<\/span> licensed to administer<\/span> drugs, and collects, controls, and maintains all information online. Drugs intended to be administered by the patient or a person<\/span> not licensed to administer<\/span> drugs must fully comply with the labeling<\/span> requirements in \u00a7\u00a7 54.1-3410<\/a> and 54.1-3463<\/a> and Board<\/span> regulations. Directions for use may only be abbreviated when drugs are administered exclusively by persons<\/span> licensed to administer<\/span> drugs.\n\t\t“Sale<\/span>” includes barter, exchange, or gift, or offer therefor, and each such transaction made by any person<\/span>, whether as an individual, proprietor, agent<\/span>, servant, or employee.\n\t\t“Tetrahydrocannabinol” means any naturally occurring or synthetic tetrahydrocannabinol, including its salts, isomers<\/span>, and salts of isomers<\/span> whenever the existence of such salts, isomers<\/span>, and salts of isomers<\/span> is possible within the specific chemical designation and any preparation, mixture, or substance containing, or mixed or infused with, any detectable amount of tetrahydrocannabinol. For the purposes of this definition, “isomer<\/span>” means the optical, position, and geometric isomers<\/span>.\n\t\t“Therapeutically equivalent drug products<\/span>” means drug products that contain the same active ingredients and are identical in strength or concentration, dosage form, and route of administration and that are classified as being therapeutically equivalent by the U.S. Food and Drug Administration pursuant to the definition of “therapeutically equivalent drug products<\/span>” set forth in the most recent edition of the Approved Drug Products with Therapeutic Equivalence Evaluations, otherwise known as the “Orange Book.”\n\t\t“Third-party<\/span> logistics provider<\/span>” means a person<\/span> that provides or coordinates warehousing of or other logistics services for a drug or device<\/span> in interstate commerce on behalf of a manufacturer<\/span>, wholesale distributor<\/span>, or dispenser<\/span> of the drug or device<\/span> but does not take ownership of the product or have responsibility for directing the sale<\/span> or disposition<\/span> of the product.\n\t\t“Total tetrahydrocannabinol<\/span>” 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.\n\t\t“USP-NF<\/span>” means the current edition of the United States Pharmacopeia-National Formulary.\n\t\t“Warehouser<\/span>” means any person<\/span>, other than a wholesale distributor<\/span>, manufacturer<\/span>, or third-party<\/span> logistics provider<\/span>, engaged in the business of (i) selling or otherwise distributing prescription drugs<\/span> or devices<\/span> to any person<\/span> who is not the ultimate user or consumer and (ii) delivering Schedule VI prescription devices<\/span> to the ultimate user or consumer pursuant to \u00a7 54.1-3415.1<\/a>. No person<\/span> shall be subject to any state or local tax by reason of this definition.\n\t\t“Wholesale distribution<\/span>” means (i) distribution of prescription drugs<\/span> to persons<\/span> other than consumers or patients and (ii) delivery<\/span> of Schedule VI prescription devices<\/span> to the ultimate user or consumer pursuant to \u00a7 54.1-3415.1<\/a>, subject to the exemptions set forth in the federal Drug Supply Chain Security Act.\n\t\t“Wholesale distributor<\/span>” means any person<\/span> other than a manufacturer<\/span>, a manufacturer<\/span>’s co-licensed partner<\/span>, a third-party<\/span> logistics provider<\/span>, or a repackager that engages in wholesale distribution<\/span>.\n\t\tThe words “drugs” and “devices<\/span>” as used in Chapter 33 (\u00a7 54.1-3300<\/a> et seq.) and in this chapter do not include surgical or dental instruments, physical therapy equipment, X-ray apparatus, or glasses or lenses for the eyes.\n\t\tThe terms “pharmacist,” “pharmacy,” and “practice of pharmacy” as used in this chapter have the same meanings as provided in Chapter 33 (\u00a7 54.1-3300<\/a> et seq.) unless the context requires a different meaning.<\/p><\/section>","plain_text":" CODE OF VIRGINIA\n\nDEFINITIONS (\u00a7 54.1-3401)\n\nAs used in this chapter, unless the context requires a different meaning:\n\t\t“Administer” means the direct application of a controlled\nsubstance, whether by injection, inhalation, ingestion, or any other means, to\nthe body of a patient or research subject by (i) a practitioner or by his\nauthorized agent and under his direction or (ii) the patient or research subject\nat the direction and in the presence of the practitioner.\n\t\t“Advertisement” means all representations disseminated in any\nmanner or by any means, other than by labeling, for the purpose of inducing, or\nwhich are likely to induce, directly or indirectly, the purchase of drugs or\ndevices.\n\t\t“Agent” means an authorized person who acts on behalf of or at the\ndirection of a manufacturer, distributor, or dispenser. “Agent” does\nnot include a common or contract carrier, public warehouseman, or employee of\nthe carrier or warehouseman.\n\t\t“Anabolic steroid” means any drug or hormonal substance,\nchemically and pharmacologically related to testosterone, other than estrogens,\nprogestins, corticosteroids, and dehydroepiandrosterone.\n\t\t“Animal” means any nonhuman animate being endowed with the power\nof voluntary action.\n\t\t“Automated drug dispensing system” means a mechanical or\nelectronic system that performs operations or activities, other than compounding\nor administration, relating to pharmacy services, including the storage,\ndispensing, or distribution of drugs and the collection, control, and\nmaintenance of all transaction information, to provide security and\naccountability for such drugs.\n\t\t“Biological product” means a virus, therapeutic serum, toxin,\nantitoxin, vaccine, blood, blood component or derivative, allergenic product,\nprotein other than a chemically synthesized polypeptide, or analogous product,\nor arsphenamine or any derivative of arsphenamine or any other trivalent organic\narsenic compound, applicable to the prevention, treatment, or cure of a disease\nor condition of human beings.\n\t\t“Biosimilar” means a biological product that is highly similar to\na specific reference biological product, notwithstanding minor differences in\nclinically inactive compounds, such that there are no clinically meaningful\ndifferences between the reference biological product and the biological product\nthat has been licensed as a biosimilar pursuant to 42 U.S.C. \u00a7 262(k) in terms\nof safety, purity, and potency of the product.\n\t\t“Board” means the Board of Pharmacy.\n\t\t“Bulk drug substance” means any substance that is represented for\nuse, and that, when used in the compounding, manufacturing, processing, or\npackaging of a drug, becomes an active ingredient or a finished dosage form of\nthe drug; however, “bulk drug substance” does not include\nintermediates that are used in the synthesis of such substances.\n\t\t“Change of ownership” of an existing entity permitted, registered,\nor licensed by the Board means (i) the sale or transfer of all or substantially\nall of the assets of the entity or of any corporation that owns or controls the\nentity; (ii) the creation of a partnership by a sole proprietor, the dissolution\nof a partnership, or a change in partnership composition; (iii) the acquisition\nor disposal of 50 percent or more of the outstanding shares of voting stock of a\ncorporation owning the entity or of the parent corporation of a wholly owned\nsubsidiary owning the entity, except that this shall not apply to any\ncorporation the voting stock of which is actively traded on any securities\nexchange or in any over-the-counter market; (iv) the merger of a corporation\nowning the entity or of the parent corporation of a wholly owned subsidiary\nowning the entity with another business or corporation; or (v) the expiration or\nforfeiture of a corporation’s charter.\n\t\t“Co-licensed partner” means a person who, with at least one other\nperson, has the right to engage in the manufacturing or marketing of a\nprescription drug, consistent with state and federal law.\n\t\t“Compounding” means the combining of two or more ingredients to\nfabricate such ingredients into a single preparation and includes the mixing,\nassembling, packaging, or labeling of a drug or device (i) by a pharmacist, or\nwithin a permitted pharmacy, pursuant to a valid prescription issued for a\nmedicinal or therapeutic purpose in the context of a bona fide\npractitioner-patient-pharmacist relationship, or in expectation of receiving a\nvalid prescription based on observed historical patterns of prescribing and\ndispensing; (ii) by a practitioner of medicine, osteopathy, podiatry, dentistry,\nor veterinary medicine as an incident to his administering or dispensing, if\nauthorized to dispense, a controlled substance in the course of his professional\npractice; or (iii) for the purpose of, or as incident to, research, teaching, or\nchemical analysis and not for sale or for dispensing. The mixing, diluting, or\nreconstituting of a manufacturer’s product drugs for the purpose of\nadministration to a patient, when performed by a practitioner of medicine or\nosteopathy licensed under Chapter 29 (\u00a7 54.1-2900 et seq.), a person supervised\nby such practitioner pursuant to subdivision A 6 or 19 of \u00a7 54.1-2901, or a\nperson supervised by such practitioner or a licensed advanced practice\nregistered nurse or physician assistant pursuant to subdivision A 4 of \u00a7\n54.1-2901 shall not be considered compounding.\n\t\t“Controlled substance” means a drug, substance, or immediate\nprecursor in Schedules I through VI of this chapter. “Controlled\nsubstance” does not include distilled spirits, wine, malt beverages, or\ntobacco as those terms are defined or used in Title 3.2 or Title 4.1. The term\n“controlled substance” includes a controlled substance analog that\nhas been placed into Schedule I or II by the Board pursuant to the regulatory\nauthority in subsection D of \u00a7 54.1-3443.\n\t\t“Controlled substance analog” means a substance the chemical\nstructure of which is substantially similar to the chemical structure of a\ncontrolled substance in Schedule I or II and either (i) which has a stimulant,\ndepressant, or hallucinogenic effect on the central nervous system that is\nsubstantially similar to or greater than the stimulant, depressant, or\nhallucinogenic effect on the central nervous system of a controlled substance in\nSchedule I or II or (ii) with respect to a particular person, which such person\nrepresents or intends to have a stimulant, depressant, or hallucinogenic effect\non the central nervous system that is substantially similar to or greater than\nthe stimulant, depressant, or hallucinogenic effect on the central nervous\nsystem of a controlled substance in Schedule I or II. “Controlled\nsubstance analog” does not include (a) any substance for which there is an\napproved new drug application as defined under \u00a7 505 of the Federal Food, Drug,\nand Cosmetic Act (21 U.S.C. \u00a7 355) or that is generally recognized as safe and\neffective pursuant to \u00a7\u00a7 501, 502, and 503 of the Federal Food, Drug, and\nCosmetic Act (21 U.S.C. \u00a7\u00a7 351, 352, and 353) and 21 C.F.R. Part 330; (b) with\nrespect to a particular person, any substance for which an exemption is in\neffect for investigational use for that person under \u00a7 505 of the Federal Food,\nDrug, and Cosmetic Act to the extent that the conduct with respect to that\nsubstance is pursuant to such exemption; or (c) any substance to the extent not\nintended for human consumption before such an exemption takes effect with\nrespect to that substance.\n\t\t“DEA” means the Drug Enforcement Administration, U.S. Department\nof Justice, or its successor agency.\n\t\t“Deliver” or “delivery” means the actual,\nconstructive, or attempted transfer of any item regulated by this chapter,\nwhether or not there exists an agency relationship, including delivery of a\nSchedule VI prescription device to an ultimate user or consumer on behalf of a\nmedical equipment supplier by a manufacturer, nonresident manufacturer,\nwholesale distributor, nonresident wholesale distributor, warehouser,\nnonresident warehouser, third-party logistics provider, or nonresident\nthird-party logistics provider at the direction of a medical equipment supplier\nin accordance with \u00a7 54.1-3415.1.\n\t\t“Device” means instruments, apparatus, and contrivances, including\ntheir components, parts, and accessories, intended for use in the diagnosis,\ncure, mitigation, treatment, or prevention of disease in man or animals or to\naffect the structure or any function of the body of man or animals.\n\t\t“Dialysis care technician” or “dialysis patient care\ntechnician” means an individual who is certified by an organization\napproved by the Department of Health Professions pursuant to Chapter 27.01 (\u00a7\n54.1-2729.1 et seq.) and who, under the supervision of a licensed physician, an\nadvanced practice registered nurse, a physician assistant, or a registered\nnurse, assists in the care of patients undergoing renal dialysis treatments in a\nMedicare-certified renal dialysis facility.\n\t\t“Dialysis solution” means either the commercially available,\nunopened, sterile solutions whose purpose is to be instilled into the peritoneal\ncavity during the medical procedure known as peritoneal dialysis, or\ncommercially available solutions whose purpose is to be used in the performance\nof hemodialysis not to include any solutions administered to the patient\nintravenously.\n\t\t“Dispense” means to deliver a drug to an ultimate user or research\nsubject by or pursuant to the lawful order of a practitioner, including the\nprescribing and administering, packaging, labeling, or compounding necessary to\nprepare the substance for that delivery. However, “dispensing” does\nnot include the transportation of drugs mixed, diluted, or reconstituted in\naccordance with this chapter to other sites operated by such practitioner or\nthat practitioner’s medical practice for the purpose of administration of\nsuch drugs to patients of the practitioner or that practitioner’s medical\npractice at such other sites. For practitioners of medicine or osteopathy,\n“dispense” includes only the provision of drugs by a practitioner to\npatients to take with them away from the practitioner’s place of practice.\n\t\t“Dispenser” means a practitioner who dispenses.\n\t\t“Distribute” means to deliver other than by administering or\ndispensing a controlled substance.\n\t\t“Distributor” means a person who distributes.\n\t\t“Drug” means (i) articles or substances recognized in the official\nUnited States Pharmacopoeia National Formulary or official Homeopathic\nPharmacopoeia of the United States, or any supplement to any of them; (ii)\narticles or substances intended for use in the diagnosis, cure, mitigation,\ntreatment, or prevention of disease in man or animals; (iii) articles or\nsubstances, other than food, intended to affect the structure or any function of\nthe body of man or animals; (iv) articles or substances intended for use as a\ncomponent of any article specified in clause (i), (ii), or (iii); or (v) a\nbiological product. “Drug” does not include devices or their\ncomponents, parts, or accessories.\n\t\t“Drug product” means a specific drug in dosage form from a known\nsource of manufacture, whether by brand or therapeutically equivalent drug\nproduct name.\n\t\t“Electronic prescription” means a written prescription that is\ngenerated on an electronic application and is transmitted to a pharmacy as an\nelectronic data file; Schedules II through V prescriptions shall be transmitted\nin accordance with 21 C.F.R. Part 1300.\n\t\t“Facsimile (FAX) prescription” means a written prescription or\norder that is transmitted by an electronic device over telephone lines that\nsends the exact image to the receiving pharmacy in hard copy form.\n\t\t“FDA” means the U.S. Food and Drug Administration.\n\t\t“Immediate precursor” means a substance which the Board of\nPharmacy has found to be and by regulation designates as being the principal\ncompound commonly used or produced primarily for use, and which is an immediate\nchemical intermediary used or likely to be used in the manufacture of a\ncontrolled substance, the control of which is necessary to prevent, curtail, or\nlimit manufacture.\n\t\t“Interchangeable” means a biosimilar that meets safety standards\nfor determining interchangeability pursuant to 42 U.S.C. \u00a7 262(k)(4).\n\t\t“Label” means a display of written, printed, or graphic matter\nupon the immediate container of any article. A requirement made by or under\nauthority of this chapter that any word, statement, or other information appear\non the label shall not be considered to be complied with unless such word,\nstatement, or other information also appears on the outside container or\nwrapper, if any, of the retail package of such article or is easily legible\nthrough the outside container or wrapper.\n\t\t“Labeling” means all labels and other written, printed, or graphic\nmatter on an article or any of its containers or wrappers, or accompanying such\narticle.\n\t\t“Manufacture” means the production, preparation, propagation,\nconversion, or processing of any item regulated by this chapter, either directly\nor indirectly by extraction from substances of natural origin, or independently\nby means of chemical synthesis, or by a combination of extraction and chemical\nsynthesis, and includes any packaging or repackaging of the substance or\nlabeling or relabeling of its container. “Manufacture” does not\ninclude compounding.\n\t\t“Manufacturer” means every person who manufactures, a\nmanufacturer’s co-licensed partner, or a repackager.\n\t\t“Marijuana” means any part of a plant of the genus Cannabis\nwhether growing or not, its seeds, or its resin; and every compound,\nmanufacture, salt, derivative, mixture, or preparation of such plant, its seeds,\nits resin, or any extract containing one or more cannabinoids.\n“Marijuana” does not include (i) the mature stalks of such plant,\nfiber produced from such stalk, or oil or cake made from the seeds of such\nplant, unless such stalks, fiber, oil, or cake is combined with other parts of\nplants of the genus Cannabis; (ii) industrial hemp, as defined in \u00a7 3.2-4112,\nthat is possessed by a person registered pursuant to subsection A of \u00a7 3.2-4115\nor his agent; (iii) industrial hemp, as defined in \u00a7 3.2-4112, that is\npossessed by a person who holds a hemp producer license issued by the U.S.\nDepartment of Agriculture pursuant to 7 C.F.R. Part 990; (iv) a hemp product, as\ndefined in \u00a7 3.2-4112; (v) an industrial hemp extract, as defined in \u00a7\n3.2-5145.1; or (vi) any substance containing a tetrahydrocannabinol isomer,\nester, ether, salt, or salts of such isomer, ester, or ether that has been\nplaced by the Board of Pharmacy into one of the schedules set forth in the Drug\nControl Act (\u00a7 54.1-3400 et seq.) pursuant to \u00a7 54.1-3443.\n\t\t“Medical equipment supplier” means any person, as defined in \u00a7\n1-230, engaged in the delivery to the ultimate consumer, pursuant to the lawful\norder of a practitioner, of hypodermic syringes and needles, medicinal oxygen,\nSchedule VI controlled devices, those Schedule VI controlled substances with no\nmedicinal properties that are used for the operation and cleaning of medical\nequipment, solutions for peritoneal dialysis, and sterile water or saline for\nirrigation.\n\t\t“Narcotic drug” means any of the following, whether produced\ndirectly or indirectly by extraction from substances of vegetable origin, or\nindependently by means of chemical synthesis, or by a combination of extraction\nand chemical synthesis: (i) opium, opiates, and any salt, compound, derivative,\nor preparation of opium or opiates; (ii) any salt, compound, isomer, derivative,\nor preparation thereof which is chemically equivalent or identical with any of\nthe substances referred to in clause (i), but not including the isoquinoline\nalkaloids of opium; (iii) opium poppy and poppy straw; or (iv) coca leaves and\nany salt, compound, derivative, or preparation of coca leaves, and any salt,\ncompound, isomer, derivative, or preparation thereof which is chemically\nequivalent or identical with any of these substances, but not including\ndecocainized coca leaves or extraction of coca leaves which do not contain\ncocaine or ecgonine.\n\t\t“New drug” means (i) any drug, except a new animal drug or an\nanimal feed bearing or containing a new animal drug, the composition of which is\nsuch that such drug is not generally recognized, among experts qualified by\nscientific training and experience to evaluate the safety and effectiveness of\ndrugs, as safe and effective for use under the conditions prescribed,\nrecommended, or suggested in the labeling, except that such a drug not so\nrecognized shall not be deemed to be a “new drug” if at any time\nprior to the enactment of this chapter it was subject to the Food and Drugs Act\nof June 30, 1906, as amended, and if at such time its labeling contained the\nsame representations concerning the conditions of its use, or (ii) any drug,\nexcept a new animal drug or an animal feed bearing or containing a new animal\ndrug, the composition of which is such that such drug, as a result of\ninvestigations to determine its safety and effectiveness for use under such\nconditions, has become so recognized, but which has not, otherwise than in such\ninvestigations, been used to a material extent or for a material time under such\nconditions.\n\t\t“Nuclear medicine technologist” means an individual who holds a\ncurrent certification with the American Registry of Radiological Technologists\nor the Nuclear Medicine Technology Certification Board.\n\t\t“Official compendium” means the official United States\nPharmacopoeia National Formulary, official Homeopathic Pharmacopoeia of the\nUnited States, or any supplement to any of them.\n\t\t“Official written order” means an order written on a form provided\nfor that purpose by the U.S. Drug Enforcement Administration, under any laws of\nthe United States making provision therefor, if such order forms are authorized\nand required by federal law, and if no such order form is provided then on an\nofficial form provided for that purpose by the Board of Pharmacy.\n\t\t“Opiate” means any substance having an addiction-forming or\naddiction-sustaining liability similar to morphine or being capable of\nconversion into a drug having such addiction-forming or addiction-sustaining\nliability. “Opiate” does not include, unless specifically designated\nas controlled under Article 4 (\u00a7 54.1-3437 et seq.), the dextrorotatory isomer\nof 3-methoxy-n-methylmorphinan and its salts (dextromethorphan).\n“Opiate” does include its racemic and levorotatory forms.\n\t\t“Opium poppy” means the plant of the species Papaver somniferum\nL., except the seeds thereof.\n\t\t“Original package” means the unbroken container or wrapping in\nwhich any drug or medicine is enclosed together with label and labeling, put up\nby or for the manufacturer, wholesaler, or distributor for use in the delivery\nor display of such article.\n\t\t“Outsourcing facility” means a facility that is engaged in the\ncompounding of sterile drugs and is currently registered as an outsourcing\nfacility with the U.S. Secretary of Health and Human Services and that complies\nwith all applicable requirements of federal and state law, including the Federal\nFood, Drug, and Cosmetic Act, 21 U.S.C. \u00a7 301 et seq.\n\t\t“Person” means both the plural and singular, as the case demands,\nand includes an individual, partnership, corporation, association, governmental\nagency, trust, or other institution or entity.\n\t\t“Pharmacist-in-charge” means the person who, being licensed as a\npharmacist, signs the application for a pharmacy permit and assumes full legal\nresponsibility for the operation of the relevant pharmacy in a manner complying\nwith the laws and regulations for the practice of pharmacy and the sale and\ndispensing of controlled substances; the “pharmacist-in-charge”\nshall personally supervise the pharmacy and the pharmacy’s personnel as\nrequired by \u00a7 54.1-3432.\n\t\t“Poppy straw” means all parts, except the seeds, of the opium\npoppy, after mowing.\n\t\t“Practitioner” means a physician, dentist, licensed advanced\npractice registered nurse pursuant to \u00a7 54.1-2957.01, licensed physician\nassistant pursuant to \u00a7 54.1-2952.1, pharmacist pursuant to \u00a7 54.1-3300,\nTPA-certified optometrist pursuant to Article 5 (\u00a7 54.1-3222 et seq.) of\nChapter 32, veterinarian, scientific investigator, or other person licensed,\nregistered, or otherwise permitted to distribute, dispense, prescribe and\nadminister, or conduct research with respect to a controlled substance in the\ncourse of professional practice or research in the Commonwealth.\n\t\t“Prescriber” means a practitioner who is authorized pursuant to\n\u00a7\u00a7 54.1-3303 and 54.1-3408 to issue a prescription.\n\t\t“Prescription” means an order for drugs or medical supplies,\nwritten or signed or transmitted by word of mouth, telephone, telegraph, or\nother means of communication to a pharmacist by a duly licensed physician,\ndentist, veterinarian, or other practitioner authorized by law to prescribe and\nadminister such drugs or medical supplies.\n\t\t“Prescription drug” means any drug required by federal law or\nregulation to be dispensed only pursuant to a prescription, including finished\ndosage forms and active ingredients subject to \u00a7 503(b) of the Federal Food,\nDrug, and Cosmetic Act (21 U.S.C. \u00a7 353(b)).\n\t\t“Production” or “produce” includes the manufacture,\nplanting, cultivation, growing, or harvesting of a controlled substance or\nmarijuana.\n\t\t“Proprietary medicine” means a completely compounded\nnonprescription drug in its unbroken, original package which does not contain\nany controlled substance or marijuana as defined in this chapter and is not in\nitself poisonous, and which is sold, offered, promoted, or advertised directly\nto the general public by or under the authority of the manufacturer or primary\ndistributor, under a trademark, trade name, or other trade symbol privately\nowned, and the labeling of which conforms to the requirements of this chapter\nand applicable federal law. However, “proprietary medicine” does not\ninclude a drug that is only advertised or promoted professionally to licensed\npractitioners, a narcotic or drug containing a narcotic, a drug that may be\ndispensed only upon prescription or the label of which bears substantially the\nstatement “Warning may be habit-forming,” or a drug intended for\ninjection.\n\t\t“Radiopharmaceutical” means any drug that exhibits spontaneous\ndisintegration of unstable nuclei with the emission of nuclear particles or\nphotons and includes any non-radioactive reagent kit or radionuclide generator\nthat is intended to be used in the preparation of any such substance, but does\nnot include drugs such as carbon-containing compounds or potassium-containing\nsalts that include trace quantities of naturally occurring radionuclides.\n“Radiopharmaceutical” also includes any biological product that is\nlabeled with a radionuclide or intended solely to be labeled with a\nradionuclide.\n\t\t“Reference biological product” means the single biological product\nlicensed pursuant to 42 U.S.C. \u00a7 262(a) against which a biological product is\nevaluated in an application submitted to the U.S. Food and Drug Administration\nfor licensure of biological products as biosimilar or interchangeable pursuant\nto 42 U.S.C. \u00a7 262(k).\n\t\t“Remote dispensing system” means a profile-driven automated drug\ndispensing system that performs operations or activities relative to the\nstorage, packaging, labeling, or dispensing of medications employing\nbidirectional audio-visual technology to facilitate pharmacist communication\nwith a patient, authorized agent of the patient, or person licensed to\nadminister drugs, and collects, controls, and maintains all information online.\nDrugs intended to be administered by the patient or a person not licensed to\nadminister drugs must fully comply with the labeling requirements in \u00a7\u00a7\n54.1-3410 and 54.1-3463 and Board regulations. Directions for use may only be\nabbreviated when drugs are administered exclusively by persons licensed to\nadminister drugs.\n\t\t“Sale” includes barter, exchange, or gift, or offer therefor, and\neach such transaction made by any person, whether as an individual, proprietor,\nagent, servant, or employee.\n\t\t“Tetrahydrocannabinol” means any naturally occurring or synthetic\ntetrahydrocannabinol, including its salts, isomers, and salts of isomers\nwhenever the existence of such salts, isomers, and salts of isomers is possible\nwithin the specific chemical designation and any preparation, mixture, or\nsubstance containing, or mixed or infused with, any detectable amount of\ntetrahydrocannabinol. For the purposes of this definition, “isomer”\nmeans the optical, position, and geometric isomers.\n\t\t“Therapeutically equivalent drug products” means drug products\nthat contain the same active ingredients and are identical in strength or\nconcentration, dosage form, and route of administration and that are classified\nas being therapeutically equivalent by the U.S. Food and Drug Administration\npursuant to the definition of “therapeutically equivalent drug\nproducts” set forth in the most recent edition of the Approved Drug\nProducts with Therapeutic Equivalence Evaluations, otherwise known as the\n“Orange Book.”\n\t\t“Third-party logistics provider” means a person that provides or\ncoordinates warehousing of or other logistics services for a drug or device in\ninterstate commerce on behalf of a manufacturer, wholesale distributor, or\ndispenser of the drug or device but does not take ownership of the product or\nhave responsibility for directing the sale or disposition of the product.\n\t\t“Total tetrahydrocannabinol” means the sum, after the application\nof any necessary conversion factor, of the percentage by weight of\ntetrahydrocannabinol and the percentage by weight of tetrahydrocannabinolic\nacid.\n\t\t“USP-NF” means the current edition of the United States\nPharmacopeia-National Formulary.\n\t\t“Warehouser” means any person, other than a wholesale distributor,\nmanufacturer, or third-party logistics provider, engaged in the business of (i)\nselling or otherwise distributing prescription drugs or devices to any person\nwho is not the ultimate user or consumer and (ii) delivering Schedule VI\nprescription devices to the ultimate user or consumer pursuant to \u00a7\n54.1-3415.1. No person shall be subject to any state or local tax by reason of\nthis definition.\n\t\t“Wholesale distribution” means (i) distribution of prescription\ndrugs to persons other than consumers or patients and (ii) delivery of Schedule\nVI prescription devices to the ultimate user or consumer pursuant to \u00a7\n54.1-3415.1, subject to the exemptions set forth in the federal Drug Supply\nChain Security Act.\n\t\t“Wholesale distributor” means any person other than a\nmanufacturer, a manufacturer’s co-licensed partner, a third-party\nlogistics provider, or a repackager that engages in wholesale distribution.\n\t\tThe words “drugs” and “devices” as used in Chapter 33\n(\u00a7 54.1-3300 et seq.) and in this chapter do not include surgical or dental\ninstruments, physical therapy equipment, X-ray apparatus, or glasses or lenses\nfor the eyes.\n\t\tThe terms “pharmacist,” “pharmacy,” and\n“practice of pharmacy” as used in this chapter have the same\nmeanings as provided in Chapter 33 (\u00a7 54.1-3300 et seq.) unless the context\nrequires a different meaning.\n\nHISTORY: Code 1950, \u00a7\u00a7 54-399, 54-487; 1952, c. 451; 1958, c. 551, \u00a7\n54-524.2; 1966, c. 193; 1968, c. 582; 1970, c. 650; 1971, Ex. Sess., c. 94;\n1972, c. 798; 1975, c. 425; 1976, c. 14; 1977, c. 193; 1978, c. 833; 1979, c.\n435; 1980, c. 150; 1988, c. 765; 1991, cc. 519, 524; 1992, cc. 737, 793; 1996,\ncc. 37, 152, 158, 407, 408; 1997, cc. 20, 677, 806; 1998, c. 470; 1999, cc. 661,\n750; 2000, cc. 861, 878, 935; 2003, cc. 509, 639, 995; 2005, cc. 475, 839; 2006,\nc. 346; 2012, c. 213; 2013, cc. 412, 504, 544, 765; 2014, cc. 674, 719; 2015,\ncc. 158, 180, 300; 2016, cc. 221, 495; 2017, cc. 115, 429; 2018, cc. 241, 242,\n689, 690; 2019, cc. 653, 654; 2020, cc. 831, 1285, 1286; 2021, Sp. Sess. I, c.\n110; 2023, cc. 183, 744, 794; 2024, cc. 63, 513; 2025, c. 341.","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}}