2006 Code of Virginia § 54.1-3401 - Definitions

54.1-3401. Definitions.

As used in this chapter, unless the context requires a different meaning:

"Administer" means the direct application of a controlled substance,whether by injection, inhalation, ingestion or any other means, to the bodyof a patient or research subject by (i) a practitioner or by his authorizedagent and under his direction or (ii) the patient or research subject at thedirection and in the presence of the practitioner.

"Advertisement" means all representations disseminated in any manner or byany means, other than by labeling, for the purpose of inducing, or which arelikely to induce, directly or indirectly, the purchase of drugs or devices.

"Agent" means an authorized person who acts on behalf of or at thedirection of a manufacturer, distributor, or dispenser. It does not include acommon or contract carrier, public warehouseman, or employee of the carrieror warehouseman.

"Anabolic steroid" means any drug or hormonal substance, chemically andpharmacologically related to testosterone, other than estrogens, progestins,corticosteroids, and dehydroepiandrosterone.

"Animal" means any nonhuman animate being endowed with the power ofvoluntary action.

"Automated drug dispensing system" means a mechanical or electronic systemthat performs operations or activities, other than compounding oradministration, relating to pharmacy services, including the storage,dispensing, or distribution of drugs and the collection, control, andmaintenance of all transaction information, to provide security andaccountability for such drugs.

"Board" means the Board of Pharmacy.

"Bulk drug substance" means any substance that is represented for use, andthat, when used in the compounding, manufacturing, processing, or packagingof a drug, becomes an active ingredient or a finished dosage form of thedrug; however, "bulk drug substance" shall not include intermediates thatare used in the synthesis of such substances.

"Change of ownership" of an existing entity permitted, registered orlicensed by the Board means (i) the sale or transfer of all or substantiallyall of the assets of the entity or of any corporation that owns or controlsthe entity; (ii) the creation of a partnership by a sole proprietor, thedissolution of a partnership, or change in partnership composition; (iii) theacquisition or disposal of 50 percent or more of the outstanding shares ofvoting stock of a corporation owning the entity or of the parent corporationof a wholly owned subsidiary owning the entity, except that this shall notapply to any corporation the voting stock of which is actively traded on anysecurities exchange or in any over-the-counter market; (iv) the merger of acorporation owning the entity or of the parent corporation of a wholly-ownedsubsidiary owning the entity with another business or corporation; or (v) theexpiration or forfeiture of a corporation's charter.

"Compounding" means the combining of two or more ingredients to fabricatesuch 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 amedicinal or therapeutic purpose in the context of a bona fidepractitioner-patient-pharmacist relationship, or in expectation of receivinga valid prescription based on observed prescribing patterns; (ii) by or for apractitioner of medicine, osteopathy, podiatry, dentistry, or veterinarymedicine as an incident to his administering or dispensing, if authorized todispense, a controlled substance in the course of his professional practice;or (iii) for the purpose of, or as incident to, research, teaching, orchemical analysis and not for sale or for dispensing. The mixing, diluting,or reconstituting of a manufacturer's product drugs for the purpose ofadministration to a patient, when performed by a practitioner of medicine orosteopathy licensed under Chapter 29 ( 54.1-2900 et seq.) or a personsupervised by such practitioner pursuant to subdivisions 4, 6, or 19 of 54.1-2901, shall not be considered compounding.

"Controlled substance" means a drug, substance or immediate precursor inSchedules I through VI of this chapter. The term shall not include distilledspirits, wine, malt beverages, or tobacco as those terms are defined or usedin Title 3.1 or Title 4.1.

"DEA" means the Drug Enforcement Administration, United States Departmentof Justice, or its successor agency.

"Deliver" or "delivery" means the actual, constructive, or attemptedtransfer of any item regulated by this chapter, whether or not there existsan agency relationship.

"Device" means instruments, apparatus, and contrivances, including theircomponents, parts and accessories, intended for use in the diagnosis, cure,mitigation, treatment, or prevention of disease in man or animals or toaffect the structure or any function of the body of man or animals.

"Dialysis care technician" or "dialysis patient care technician" means anindividual who is certified by an organization approved by the Board ofHealth Professions pursuant to Chapter 27.01 ( 54.1-2729.1 et seq.) and who,under the supervision of a licensed physician, nurse practitioner, physicianassistant or a registered nurse, assists in the care of patients undergoingrenal dialysis treatments in a Medicare-certified renal dialysis facility.

"Dialysis solution" means either the commercially available, unopened,sterile solutions whose purpose is to be instilled into the peritoneal cavityduring the medical procedure known as peritoneal dialysis, or commerciallyavailable solutions whose purpose is to be used in the performance ofhemodialysis not to include any solutions administered to the patientintravenously.

"Dispense" means to deliver a drug to an ultimate user or research subjectby or pursuant to the lawful order of a practitioner, including theprescribing and administering, packaging, labeling or compounding necessaryto prepare the substance for that delivery. However, dispensing shall notinclude the transportation of drugs mixed, diluted, or reconstituted inaccordance with this chapter to other sites operated by such practitioner orthat practitioner's medical practice for the purpose of administration ofsuch drugs to patients of the practitioner or that practitioner's medicalpractice at such other sites. For practitioners of medicine or osteopathy,"dispense" shall only include the provision of drugs by a practitioner topatients to take with them away from the practitioner's place of practice.

"Dispenser" means a practitioner who dispenses.

"Distribute" means to deliver other than by administering or dispensing acontrolled substance.

"Distributor" means a person who distributes.

"Drug" means (i) articles or substances recognized in the official UnitedStates Pharmacopoeia National Formulary or official Homeopathic Pharmacopoeiaof the United States, or any supplement to any of them; (ii) articles orsubstances intended for use in the diagnosis, cure, mitigation, treatment orprevention of disease in man or animals; (iii) articles or substances, otherthan food, intended to affect the structure or any function of the body ofman or animals; or (iv) articles or substances intended for use as acomponent of any article specified in clause (i), (ii) or (iii). "Drug"does not include devices or their components, parts or accessories.

"Drug product" means a specific drug in dosage form from a known source ofmanufacture, whether by brand or therapeutically equivalent drug product name.

"Electronic transmission prescription" means any prescription, other thanan oral or written prescription or a prescription transmitted by facsimilemachine, that is electronically transmitted directly to a pharmacy withoutinterception or intervention from a third party from a practitionerauthorized to prescribe or from one pharmacy to another pharmacy.

"Facsimile (FAX) prescription" means a written prescription or order, whichis transmitted by an electronic device over telephone lines that sends theexact image to the receiving pharmacy in hard copy form.

"FDA" means the United States Food and Drug Administration.

"Hashish oil" means any oily extract containing one or more cannabinoids,but shall not include any such extract with a tetrahydrocannabinol content ofless than 12 percent by weight.

"Immediate precursor" means a substance which the Board of Pharmacy hasfound to be and by regulation designates as being the principal compoundcommonly used or produced primarily for use, and which is an immediatechemical intermediary used or likely to be used in the manufacture of acontrolled substance, the control of which is necessary to prevent, curtail,or limit manufacture.

"Label" means a display of written, printed or graphic matter upon theimmediate container of any article. A requirement made by or under authorityof this chapter that any word, statement or other information appear on thelabel shall not be considered to be complied with unless such word, statementor other information also appears on the outside container or wrapper, ifany, of the retail package of such article, or is easily legible through theoutside container or wrapper.

"Labeling" means all labels and other written, printed or graphic matter onan article or any of its containers or wrappers, or accompanying such article.

"Manufacture" means the production, preparation, propagation, conversion orprocessing of any item regulated by this chapter, either directly orindirectly by extraction from substances of natural origin, or independentlyby means of chemical synthesis, or by a combination of extraction andchemical synthesis, and includes any packaging or repackaging of thesubstance or labeling or relabeling of its container. This term does notinclude compounding.

"Manufacturer" means every person who manufactures.

"Marijuana" means any part of a plant of the genus Cannabis whether growingor not, its seeds or resin; and every compound, manufacture, salt,derivative, mixture, or preparation of such plant, its seeds, or its resin.Marijuana shall not include any oily extract containing one or morecannabinoids unless such extract contains less than 12 percent oftetrahydrocannabinol by weight, nor shall marijuana include the mature stalksof such plant, fiber produced from such stalk, oil or cake made from theseeds of such plant, unless such stalks, fiber, oil or cake is combined withother parts of plants of the genus Cannabis.

"Medical equipment supplier" means any person, as defined in 1-230,engaged in the delivery to the ultimate consumer, pursuant to the lawfulorder of a practitioner, of hypodermic syringes and needles, medicinaloxygen, Schedule VI controlled devices, those Schedule VI controlledsubstances with no medicinal properties which are used for the operation andcleaning of medical equipment and solutions for peritoneal dialysis.

"Narcotic drug" means any of the following, whether produced directly orindirectly by extraction from substances of vegetable origin, orindependently by means of chemical synthesis, or by a combination ofextraction 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 chemicallyequivalent or identical with any of the substances referred to in clause (i),but not including the isoquinoline alkaloids of opium; (iii) opium poppy andpoppy straw; (iv) coca leaves and any salt, compound, derivative, orpreparation of coca leaves, and any salt, compound, isomer, derivative, orpreparation thereof which is chemically equivalent or identical with any ofthese substances, but not including decocainized coca leaves or extraction ofcoca leaves which do not contain cocaine or ecgonine.

"New drug" means: (i) any drug, except a new animal drug or an animal feedbearing or containing a new animal drug, the composition of which is suchthat such drug is not generally recognized, among experts qualified byscientific training and experience to evaluate the safety and effectivenessof drugs, as safe and effective for use under the conditions prescribed,recommended, or suggested in the labeling, except that such a drug not sorecognized shall not be deemed to be a "new drug" if at any time prior tothe enactment of this chapter it was subject to the Food and Drugs Act ofJune 30, 1906, as amended, and if at such time its labeling contained thesame 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 animaldrug, the composition of which is such that such drug, as a result ofinvestigations to determine its safety and effectiveness for use under suchconditions, has become so recognized, but which has not, otherwise than insuch investigations, been used to a material extent or for a material timeunder such conditions.

"Nuclear medicine technologist" means an individual who holds a currentcertification with the American Registry of Radiological Technologists or theNuclear Medicine Technology Certification Board.

"Official compendium" means the official United States PharmacopoeiaNational Formulary, official Homeopathic Pharmacopoeia of the United States,or any supplement to any of them.

"Official written order" means an order written on a form provided for thatpurpose by the United States Drug Enforcement Administration, under any lawsof the United States making provision therefor, if such order forms areauthorized and required by federal law, and if no such order form is providedthen on an official form provided for that purpose by the Board of Pharmacy.

"Opiate" means any substance having an addiction-forming oraddiction-sustaining liability similar to morphine or being capable ofconversion into a drug having such addiction-forming or addiction-sustainingliability. It does not include, unless specifically designated as controlledunder Article 4 ( 54.1-3437 et seq.) of this chapter, the dextrorotatoryisomer of 3-methoxy-n-methylmorphinan and its salts (dextromethorphan). Itdoes include its racemic and levorotatory forms.

"Opium poppy" means the plant of the species Papaver somniferum L., exceptthe seeds thereof.

"Original package" means the unbroken container or wrapping in which anydrug or medicine is enclosed together with label and labeling, put up by orfor the manufacturer, wholesaler, or distributor for use in the delivery ordisplay of such article.

"Person" means both the plural and singular, as the case demands, andincludes an individual, partnership, corporation, association, governmentalagency, trust, or other institution or entity.

"Pharmacist-in-charge" means the person who, being licensed as apharmacist, signs the application for a pharmacy permit and assumes fulllegal responsibility for the operation of the relevant pharmacy in a mannercomplying with the laws and regulations for the practice of pharmacy and thesale and dispensing of controlled substances; the "pharmacist-in-charge"shall personally supervise the pharmacy and the pharmacy's personnel asrequired by 54.1-3432.

"Poppy straw" means all parts, except the seeds, of the opium poppy, aftermowing.

"Practitioner" means a physician, dentist, licensed nurse practitionerpursuant to 54.1-2957.01, licensed physician assistant pursuant to 54.1-2952.1, pharmacist pursuant to 54.1-3300, TPA-certified optometristpursuant to Article 5 ( 54.1-3222 et seq.) of Chapter 32, veterinarian,scientific investigator, or other person licensed, registered or otherwisepermitted to distribute, dispense, prescribe and administer, or conductresearch with respect to, a controlled substance in the course ofprofessional practice or research in the Commonwealth.

"Prescriber" means a practitioner who is authorized pursuant to 54.1-3303 and 54.1-3408 to issue a prescription.

"Prescription" means an order for drugs or medical supplies, written orsigned or transmitted by word of mouth, telephone, telegraph or other meansof communication to a pharmacist by a duly licensed physician, dentist,veterinarian or other practitioner, authorized by law to prescribe andadminister such drugs or medical supplies.

"Prescription drug" means any drug required by federal law or regulation tobe dispensed only pursuant to a prescription, including finished dosage formsand active ingredients subject to 503 (b) of the Federal Food, Drug, andCosmetic Act (21 U.S.C. 353 (b)).

"Production" or "produce" includes the manufacture, planting,cultivation, growing or harvesting of a controlled substance or marijuana.

"Proprietary medicine" means a completely compounded nonprescription drugin its unbroken, original package which does not contain any controlledsubstance or marijuana as defined in this chapter and is not in itselfpoisonous, and which is sold, offered, promoted or advertised directly to thegeneral public by or under the authority of the manufacturer or primarydistributor, under a trademark, trade name or other trade symbol privatelyowned, and the labeling of which conforms to the requirements of this chapterand applicable federal law. However, this definition shall not include a drugwhich is only advertised or promoted professionally to licensedpractitioners, a narcotic or drug containing a narcotic, a drug which may bedispensed only upon prescription or the label of which bears substantiallythe statement "Warning - may be habit-forming," or a drug intended forinjection.

"Radiopharmaceutical" means any drug that exhibits spontaneousdisintegration of unstable nuclei with the emission of nuclear particles orphotons and includes any non-radioactive reagent kit or radionuclidegenerator that is intended to be used in the preparation of any suchsubstance, but does not include drugs such as carbon-containing compounds orpotassium-containing salts that include trace quantities of naturallyoccurring radionuclides. The term also includes any biological product thatis labeled with a radionuclide or intended solely to be labeled with aradionuclide.

"Sale" includes barter, exchange, or gift, or offer therefor, and each suchtransaction made by any person, whether as an individual, proprietor, agent,servant or employee.

"Therapeutically equivalent drug products" means drug products that containthe same active ingredients and are identical in strength or concentration,dosage form, and route of administration and that are classified as beingtherapeutically equivalent by the United States Food and Drug Administrationpursuant to the definition of "therapeutically equivalent drug products"set forth in the most recent edition of the Approved Drug Products withTherapeutic Equivalence Evaluations, otherwise known as the "Orange Book."

"USP-NF" means the current edition of the United StatesPharmacopeia-National Formulary.

"Warehouser" means any person, other than a wholesale distributor, engagedin the business of selling or otherwise distributing prescription drugs ordevices to any person who is not the ultimate user or consumer. No personshall be subject to any state or local tax by reason of this definition.

"Wholesale distribution" means distribution of prescription drugs topersons other than consumers or patients, subject to the exceptions set forthin 54.1-3401.1.

"Wholesale distributor" means any person engaged in wholesale distributionof prescription drugs including, but not limited to, manufacturers;repackers; own-label distributors; private-label distributors; jobbers;brokers; warehouses, including manufacturers' and distributors' warehouses,chain drug warehouses conducting wholesale distributions, and wholesale drugwarehouses; independent wholesale drug traders; and retail pharmaciesconducting wholesale distributions. No person shall be subject to any stateor local tax as a wholesale merchant by reason of this definition.

The words "drugs" and "devices" as used in Chapter 33 ( 54.1-3300 etseq.) and in this chapter shall not include surgical or dental instruments,physical therapy equipment, X-ray apparatus or glasses or lenses for the eyes.

The terms "pharmacist," "pharmacy" and "practice of pharmacy" as usedin this chapter shall be defined as provided in Chapter 33 unless the contextrequires a different meaning.

(Code 1950, 54-399, 54-487; 1952, c. 451; 1958, c. 551, 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.)