§ 54.1-3400 Citation
§ 54.1-3401 (Effective July 1, 2020) Definitions
§ 54.1-3401 v2 (Effective until July 1, 2020) Definitions
§ 54.1-3401.1 Repealed
§ 54.1-3402 Repealed
§ 54.1-3403 Chapter not applicable to economic poisons
§ 54.1-3404 Inventories of controlled substances required of certain persons; contents and form of record
§ 54.1-3405 Access to and copies of records; inspections
§ 54.1-3406 Records confidential; disclosure of information about violations of federal law
§ 54.1-3407 Analysis of controlled substances
§ 54.1-3408 Professional use by practitioners
§ 54.1-3408.01 Requirements for prescriptions
§ 54.1-3408.02 (Effective July 1, 2020) Transmission of prescriptions
§ 54.1-3408.02 v2 (Effective until July 1, 2020) Transmission of prescriptions
§ 54.1-3408.03 Dispensing of therapeutically equivalent drug product permitted
§ 54.1-3408.04 Dispensing of interchangeable biosimilars permitted
§ 54.1-3408.05 Use of FDA-approved substance upon publication of final rule
§ 54.1-3408.1 Prescription in excess of recommended dosage in certain cases
§ 54.1-3408.2 Failure to report administration or dispensing of or prescription for controlled substances; report required; penalty
§ 54.1-3408.3 Certification for use of cannabidiol oil or THC-A oil for treatment
§ 54.1-3408.4 (Expires July 1, 2022) Prescription of buprenorphine without naloxone; limitation
§ 54.1-3409 Professional use by veterinarians
§ 54.1-3410 When pharmacist may sell and dispense drugs
§ 54.1-3410.1 Requirements for radiopharmaceuticals
§ 54.1-3410.2 Compounding; pharmacists’ authority to compound under certain conditions; labeling and record maintenance requirements
§ 54.1-3411 When prescriptions may be refilled
§ 54.1-3411.1 Prohibition on returns, exchanges, or re-dispensing of drugs; exceptions
§ 54.1-3411.2 Prescription drug disposal programs
§ 54.1-3411.2:1 Guidelines for disposal of unused drugs
§ 54.1-3412 Date of dispensing; initials of pharmacist; automated data processing system
§ 54.1-3413 Manufacturing and administering Schedule I drugs
§ 54.1-3414 Official orders for Schedule II drugs
§ 54.1-3415 Distribution of drugs in Schedules II through VI by manufacturers and wholesalers
§ 54.1-3415.1 Delivery of medical devices on behalf of a medical equipment supplier
§ 54.1-3416 No prescription for preparations listed pursuant to Schedule V
§ 54.1-3417 Disposing of stocks of Schedules II through V drugs
§ 54.1-3418 Sale of aqueous or oleaginous solutions
§ 54.1-3419 Dispensing of insulin preparations
§ 54.1-3420 Distribution of certain drugs; written request or confirmation of receipt
§ 54.1-3420.1 Identification required for filling prescriptions
§ 54.1-3420.2 Delivery of prescription drug order
§ 54.1-3421 New drugs
§ 54.1-3422 Controlled substances registration certificate required in addition to other requirements; exemptions
§ 54.1-3423 Board to issue registration unless inconsistent with public interest; authorization to conduct research; application and fees
§ 54.1-3424 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
§ 54.1-3425 Repealed
§ 54.1-3426 Regulations for special packaging
§ 54.1-3427 Dispensing drugs without safety closure container
§ 54.1-3428 Dissemination of information
§ 54.1-3429 Revocation of permit issued to manufacturer, wholesaler or distributor
§ 54.1-3430 Display of permit; permits nontransferable; renewal
§ 54.1-3431 Admission into evidence of certain certificates of analysis

Terms Used In Virginia Code > Title 54.1 > Subtitle III > Chapter 34 > Article 1

  • 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. See Virginia Code 54.1-3401
  • Adult: means a person 18 years of age or more. See Virginia Code 1-203
  • Affidavit: A written statement of facts confirmed by the oath of the party making it, before a notary or officer having authority to administer oaths.
  • Agent: means an authorized person who acts on behalf of or at the direction of a manufacturer, distributor, or dispenser. See Virginia Code 54.1-3401
  • Animal: means any nonhuman animate being endowed with the power of voluntary action. See Virginia Code 54.1-3401
  • Appeal: A request made after a trial, asking another court (usually the court of appeals) to decide whether the trial was conducted properly. To make such a request is "to appeal" or "to take an appeal." One who appeals is called the appellant.
  • Appropriation: The provision of funds, through an annual appropriations act or a permanent law, for federal agencies to make payments out of the Treasury for specified purposes. The formal federal spending process consists of two sequential steps: authorization
  • Arrest: Taking physical custody of a person by lawful authority.
  • Assets: (1) The property comprising the estate of a deceased person, or (2) the property in a trust account.
  • Attachment: A procedure by which a person's property is seized to pay judgments levied by the court.
  • Beneficiary: A person who is entitled to receive the benefits or proceeds of a will, trust, insurance policy, retirement plan, annuity, or other contract. Source: OCC
  • Biological product: means a virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, protein other than a chemically synthesized polypeptide, or analogous product, or arsphenamine or any derivative of arsphenamine or any other trivalent organic arsenic compound, applicable to the prevention, treatment, or cure of a disease or condition of human beings. See Virginia Code 54.1-3401
  • Biosimilar: means a biological product that is highly similar to a specific reference biological product, notwithstanding minor differences in clinically inactive compounds, such that there are no clinically meaningful differences between the reference biological product and the biological product that has been licensed as a biosimilar pursuant to 42 U. See Virginia Code 54.1-3401
  • Board: means the Board of Pharmacy. See Virginia Code 54.1-3401
  • Bond with surety: includes the payment in cash of the full amount of the required bond and, in such case, no surety shall be required. See Virginia Code 1-205
  • bonds: as used in this chapter means obligations of the Authority for the payment of borrowed money. See Virginia Code 62.1-140
  • career and technical education: means an organized education program offering a sequence of courses that (i) may incorporate field, laboratory, and classroom instruction; (ii) emphasize career and technical occupational experiences; (iii) are designed to prepare individuals for further education and gainful employment; and (iv) are aligned with state or national program certification and accreditation standards, if such standards exist for the sequence of courses. See Virginia Code 22.1-227.01
  • City: means an independent incorporated community which became a city as provided by law before noon on July 1, 1971, or which has within defined boundaries a population of 5,000 or more and which has become a city as provided by law. See Virginia Code 1-208
  • 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. See Virginia Code 54.1-3401
  • Common law: The legal system that originated in England and is now in use in the United States. It is based on judicial decisions rather than legislative action.
  • Complaint: A written statement by the plaintiff stating the wrongs allegedly committed by the defendant.
  • 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. See Virginia Code 54.1-3401
  • Contract: A legal written agreement that becomes binding when signed.
  • 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 § Virginia Code 54.1-3401
  • Device: means instruments, apparatus, and contrivances, including their components, parts, and accessories, intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or animals or to affect the structure or any function of the body of man or animals. See Virginia Code 54.1-3401
  • dialysis patient care technician: means an individual who is certified by an organization approved by the Board of Health Professions pursuant to Chapter 27. See Virginia Code 54.1-3401
  • Discovery: Lawyers' examination, before trial, of facts and documents in possession of the opponents to help the lawyers prepare for trial.
  • Dispense: means to deliver a drug to an ultimate user or research subject by or pursuant to the lawful order of a practitioner, including the prescribing and administering, packaging, labeling, or compounding necessary to prepare the substance for that delivery. See Virginia Code 54.1-3401
  • Dispenser: means a practitioner who dispenses. See Virginia Code 54.1-3401
  • Distribute: means to deliver other than by administering or dispensing a controlled substance. See Virginia Code 54.1-3401
  • Distributor: means a person who distributes. See Virginia Code 54.1-3401
  • Division superintendent: means the division superintendent of schools of a school division. See Virginia Code 22.1-1
  • Drug: means (i) articles or substances recognized in the official United States Pharmacopoeia National Formulary or official Homeopathic Pharmacopoeia of the United States, or any supplement to any of them; (ii) articles or substances intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or animals; (iii) articles or substances, other than food, intended to affect the structure or any function of the body of man or animals; (iv) articles or substances intended for use as a component of any article specified in clause (i), (ii), or (iii); or (v) a biological product. See Virginia Code 54.1-3401
  • Drug product: means a specific drug in dosage form from a known source of manufacture, whether by brand or therapeutically equivalent drug product name. See Virginia Code 54.1-3401
  • Elementary: includes kindergarten. See Virginia Code 22.1-1
  • Equitable: Pertaining to civil suits in "equity" rather than in "law." In English legal history, the courts of "law" could order the payment of damages and could afford no other remedy. See damages. A separate court of "equity" could order someone to do something or to cease to do something. See, e.g., injunction. In American jurisprudence, the federal courts have both legal and equitable power, but the distinction is still an important one. For example, a trial by jury is normally available in "law" cases but not in "equity" cases. Source: U.S. Courts
  • Escrow: Money given to a third party to be held for payment until certain conditions are met.
  • Evidence: Information presented in testimony or in documents that is used to persuade the fact finder (judge or jury) to decide the case for one side or the other.
  • Fair market value: The price at which an asset would change hands in a transaction between a willing, informed buyer and a willing, informed seller.
  • FDA: means the U. See Virginia Code 54.1-3401
  • Fee simple: Absolute title to property with no limitations or restrictions regarding the person who may inherit it.
  • Felony: A crime carrying a penalty of more than a year in prison.
  • Fiscal year: The fiscal year is the accounting period for the government. For the federal government, this begins on October 1 and ends on September 30. The fiscal year is designated by the calendar year in which it ends; for example, fiscal year 2006 begins on October 1, 2005 and ends on September 30, 2006.
  • Fraud: Intentional deception resulting in injury to another.
  • Freedom of Information Act: A federal law that mandates that all the records created and kept by federal agencies in the executive branch of government must be open for public inspection and copying. The only exceptions are those records that fall into one of nine exempted categories listed in the statute. Source: OCC
  • Garnishment: Generally, garnishment is a court proceeding in which a creditor asks a court to order a third party who owes money to the debtor or otherwise holds assets belonging to the debtor to turn over to the creditor any of the debtor
  • Gift: A voluntary transfer or conveyance of property without consideration, or for less than full and adequate consideration based on fair market value.
  • Grantor: The person who establishes a trust and places property into it.
  • Guardian: A person legally empowered and charged with the duty of taking care of and managing the property of another person who because of age, intellect, or health, is incapable of managing his (her) own affairs.
  • 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. See Virginia Code 54.1-3401
  • in writing: include any representation of words, letters, symbols, numbers, or figures, whether (i) printed or inscribed on a tangible medium or (ii) stored in an electronic or other medium and retrievable in a perceivable form and whether an electronic signature authorized by Chapter 42. See Virginia Code 1-257
  • Includes: means includes, but not limited to. See Virginia Code 1-218
  • inhabitants: means with reference to any county, city, town, political subdivision of the Commonwealth or any combination thereof, the natural persons in such county, city, town, political subdivision or combination as shown by the unadjusted United States decennial census last preceding the time at which any provision dependent upon population is being applied or the time as of which it is being construed. See Virginia Code 1-235
  • Injunction: An order of the court prohibiting (or compelling) the performance of a specific act to prevent irreparable damage or injury.
  • Interchangeable: means a biosimilar that meets safety standards for determining interchangeability pursuant to 42 U. See Virginia Code 54.1-3401
  • Jurisdiction: (1) The legal authority of a court to hear and decide a case. Concurrent jurisdiction exists when two courts have simultaneous responsibility for the same case. (2) The geographic area over which the court has authority to decide cases.
  • Label: means a display of written, printed, or graphic matter upon the immediate container of any article. See Virginia Code 54.1-3401
  • Labeling: means all labels and other written, printed, or graphic matter on an article or any of its containers or wrappers, or accompanying such article. See Virginia Code 54.1-3401
  • Lease: A contract transferring the use of property or occupancy of land, space, structures, or equipment in consideration of a payment (e.g., rent). Source: OCC
  • Lien: A claim against real or personal property in satisfaction of a debt.
  • Locality: means a county, city, or town as the context may require. See Virginia Code 1-221
  • Manufacture: means the production, preparation, propagation, conversion, or processing of any item regulated by this chapter, either directly or indirectly by extraction from substances of natural origin, or independently by means of chemical synthesis, or by a combination of extraction and chemical synthesis, and includes any packaging or repackaging of the substance or labeling or relabeling of its container. See Virginia Code 54.1-3401
  • Manufacturer: means every person who manufactures, a manufacturer's co-licensed partner, or a repackager. See Virginia Code 54.1-3401
  • Marijuana: means any part of a plant of the genus Cannabis whether growing or not, its seeds, or its resin; and every compound, manufacture, salt, derivative, mixture, or preparation of such plant, its seeds, or its resin. See Virginia Code 54.1-3401
  • Medical equipment supplier: means any person, as defined in § 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. See Virginia Code 54.1-3401
  • Middle school: means separate schools for early adolescents and the middle school grades that might be housed at elementary or high schools. See Virginia Code 22.1-1
  • Misdemeanor: Usually a petty offense, a less serious crime than a felony, punishable by less than a year of confinement.
  • Month: means a calendar month and "year" means a calendar year. See Virginia Code 1-223
  • Mortgage: The written agreement pledging property to a creditor as collateral for a loan.
  • 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; (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. See Virginia Code 54.1-3401
  • New drug: means (i) any drug, except a new animal drug or an animal feed bearing or containing a new animal drug, the composition of which is such that such drug is not generally recognized, among experts qualified by scientific training and experience to evaluate the safety and effectiveness of drugs, as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling, except that such a drug not so recognized shall not be deemed to be a "new drug" if at any time prior to the enactment of this chapter it was subject to the Food and Drugs Act of June 30, 1906, as amended, and if at such time its labeling contained the same representations concerning the conditions of its use, or (ii) any drug, except a new animal drug or an animal feed bearing or containing a new animal drug, the composition of which is such that such drug, as a result of investigations to determine its safety and effectiveness for use under such conditions, has become so recognized, but which has not, otherwise than in such investigations, been used to a material extent or for a material time under such conditions. See Virginia Code 54.1-3401
  • 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. See Virginia Code 54.1-3401
  • Official compendium: means the official United States Pharmacopoeia National Formulary, official Homeopathic Pharmacopoeia of the United States, or any supplement to any of them. See Virginia Code 54.1-3401
  • Official written order: means an order written on a form provided for that purpose by the U. See Virginia Code 54.1-3401
  • Opium poppy: means the plant of the species Papaver somniferum L. See Virginia Code 54.1-3401
  • 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. See Virginia Code 54.1-3401
  • 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. See Virginia Code 54.1-3401
  • parents: means any parent, guardian, legal custodian, or other person having control or charge of a child. See Virginia Code 22.1-1
  • Partnership: A voluntary contract between two or more persons to pool some or all of their assets into a business, with the agreement that there will be a proportional sharing of profits and losses.
  • Person: means both the plural and singular, as the case demands, and includes an individual, partnership, corporation, association, governmental agency, trust, or other institution or entity. See Virginia Code 54.1-3401
  • Person: includes any individual, corporation, partnership, association, cooperative, limited liability company, trust, joint venture, government, political subdivision, or any other legal or commercial entity and any successor, representative, agent, agency, or instrumentality thereof. See Virginia Code 1-230
  • Personal property: All property that is not real property.
  • Personal representative: includes the executor of a will or the administrator of the estate of a decedent, the administrator of such estate with the will annexed, the administrator of such estate unadministered by a former representative, whether there is a will or not, any person who is under the order of a circuit court to take into his possession the estate of a decedent for administration, and every other curator of a decedent's estate, for or against whom suits may be brought for causes of action that accrued to or against the decedent. See Virginia Code 1-234
  • 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 § Source: OCC
  • practice of pharmacy: as used in this chapter shall be defined as provided in Chapter 33 (§ Virginia Code 54.1-3401
  • Prescriber: means a practitioner who is authorized pursuant to §§ Virginia Code 54.1-3401
  • 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 § Virginia Code 54.1-3401