18 Va. Admin. Code § 110-20-10
In addition to words and terms defined in §§ 54.1-3300 and 54.1-3401 of the Code of Virginia, the following words and terms when used in this chapter shall have the following meanings, unless the context clearly indicates otherwise:
"Acquisition" of an existing entity permitted, registered, or licensed by the board means
"Actively reports" means reporting all dispensing errors and analyses of such errors to a patient safety organization as soon as practical or at least within 30 days of identifying the error.
"Alternate delivery site" means a location authorized in 18VAC110-20-275 to receive dispensed prescriptions on behalf of and for further delivery or administration to a patient.
"Analysis" means a review of the findings collected and documented on each dispensing error, assessment of the cause and any factors contributing to the dispensing error, and any recommendation for remedial action to improve pharmacy systems and workflow processes to prevent or reduce future errors.
"Authorized collector" means a narcotic treatment program, hospital or clinic with an on-site pharmacy, or pharmacy that is authorized by the U.S. Drug Enforcement Administration to receive drugs for the purpose of destruction.
"Beyond-use date" means the date beyond which the integrity of a compounded, repackaged, or dispensed drug can no longer be ensured and as such is deemed to be adulterated or misbranded as defined in §§ 54.1-3461 and 54.1-3462 of the Code of Virginia.
"Board" means the Virginia Board of Pharmacy.
"Chart order" means a lawful order for a drug or device entered on the chart or in a medical record of a patient by a prescriber or the prescriber's designated agent.
"Compliance packaging" means packaging for dispensed drugs that is comprised of a series of containers for solid oral dosage forms and designed to assist the user in administering or self-administering the drugs in accordance with directions for use.
"Correctional facility" means any prison, penitentiary, penal facility, jail, detention unit, or other facility in which persons are incarcerated by government officials.
"DEA" means the U.S. Drug Enforcement Administration.
"Designated location" means a station, EMS agency substation or satellite location, or other location approved by the DEA, if applicable, and designated by an EMS agency or regional EMS council.
"Dispensing error" means one or more of the following discovered after the final verification by the pharmacist, regardless of whether the patient received the drug:
"Drug donation site" means a permitted pharmacy that specifically registers with the board for the purpose of receiving or redispensing eligible donated prescription drugs pursuant to § 54.1-3411.1 of the Code of Virginia.
"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 CFR Part 1300.
"Emergency medical services provider" or "EMS provider" means the same as defined in 12VAC5-31-10.
"Emergency medical services vehicle" or "EMS vehicle" has the same meaning prescribed in § 32.1-111.1 of the Code of Virginia.
"EMS agency" has the same meaning as prescribed in § 32.1-111.1 of the Code of Virginia.
"Expiration date" means that date placed on a drug package by the manufacturer or repacker beyond which the product may not be dispensed or used.
"Faxed prescription" means a written prescription or order that is transmitted by an electronic device that sends over telephone lines the exact image to the receiver (pharmacy) in a hard copy form.
"FDA" means the U.S. Food and Drug Administration.
"Floor stock" means a supply of drugs that have been distributed for the purpose of general administration by a prescriber or other authorized person pursuant to a valid order of a prescriber.
"Forgery" means a prescription that was falsely created, falsely signed, or altered.
"Generic drug name" means the nonproprietary name listed in the United States Pharmacopeia-National Formulary (USP-NF) or in the United States Adopted Names (USAN) and the USP Dictionary of Drug Names.
"Hospital" or "nursing home" means those facilities as defined in Title 32.1 of the Code of Virginia or as defined in regulations by the Virginia Department of Health.
"Hospital-owned" means, with respect to an EMS agency, owned by a hospital.
"Initials" means the first letters of a person's name or other unique personal identifier.
"Long-term care facility" means a nursing home, retirement care, mental care, or other facility or institution that provides extended health care to resident patients.
"NABP" means the National Association of Boards of Pharmacy.
"Nuclear pharmacy" means a pharmacy providing radiopharmaceutical services.
"On duty" means that a pharmacist is on the premises at the address of the permitted pharmacy and is available as needed.
"On-hold prescription" means a valid prescription that is received and maintained at the pharmacy for initial dispensing on a future date.
"Other EMS vehicle" means a vehicle used by the EMS agency or regional EMS council for the purpose of providing or facilitating emergency medical care or transporting controlled substances to and from the registered and designated locations. Such vehicles must be either owned by or registered to an EMS agency, regional EMS council, or jurisdiction and operated by an EMS agency or regional EMS council.
"Patient safety organization" means an organization that has as its primary mission continuous quality improvement under the Patient Safety and Quality Improvement Act of 2005 (P.L. 109-41) and is credentialed by the Agency for Healthcare Research and Quality.
"Permitted physician" means a physician who is licensed pursuant to § 54.1-3304 of the Code of Virginia to dispense drugs to persons to whom or for whom pharmacy services are not reasonably available.
"Perpetual inventory" means an ongoing system for recording quantities of drugs received, dispensed, or otherwise distributed by a pharmacy.
"Personal supervision" means the pharmacist must be physically present and render direct, personal control over the entire service being rendered or act being performed. Neither prior nor future instructions shall be sufficient nor shall supervision rendered by telephone, written instructions, or by any mechanical or electronic methods be sufficient.
"Pharmacy closing" means that the permitted pharmacy ceases pharmacy services or fails to provide for continuity of pharmacy services or lawful access to patient prescription records or other required patient records for the purpose of continued pharmacy services to patients.
"PIC" means the pharmacist-in-charge of a permitted pharmacy.
"Practice location" means any location in which a prescriber evaluates or treats a patient.
"Prescription department" means any contiguous or noncontiguous areas used for the compounding, dispensing, and storage of all Schedules II through VI drugs and devices and any Schedule I investigational drug.
"Quality assurance plan" means a plan approved by the board for ongoing monitoring, measuring, evaluating, and, if necessary, improving the performance of a pharmacy function or system.
"Radiopharmaceutical" means any drug that exhibits spontaneous disintegration of unstable nuclei with the emission of nuclear particles or photons and includes any nonradioactive 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. The term also includes any biological product that is labeled with a radionuclide or intended solely to be labeled with a radionuclide.
"Regional EMS council" means an organization designated by the State Board of Health pursuant to § 32.1-111.4:2 of the Code of Virginia.
"Registered EMS agency headquarters" means the principal office and primary business location of an EMS agency that maintains a controlled substances registration issued by the board or a hospital-owned EMS agency that is covered by the registration of a hospital.
"Registered location" means, for the purposes of emergency medical services, a location that appears on a DEA certificate of registration or controlled substances registration issued to an EMS agency or regional EMS council, which shall be the location at which the agency or council receives Schedules II through VI controlled substances from those entities authorized to distribute controlled substances.
"Repackaged drug" means any drug removed from the manufacturer's original package and placed in different packaging.
"Robotic pharmacy system" means a mechanical system controlled by a computer that performs operations or activities relative to the storage, packaging, compounding, labeling, dispensing, or distribution of medications and collects, controls, and maintains all transaction information.
"Safety closure container" means a container that meets the requirements of the federal Poison Prevention Packaging Act of 1970 (15 USC §§ 1471-1476), that is, in testing such containers, that 85% of a test group of 200 children of ages 41-52 months are unable to open the container in a five-minute period and that 80% fail in another five minutes after a demonstration of how to open it and that 90% of a test group of 100 adults must be able to open and close the container.
"Satellite pharmacy" means a pharmacy that is noncontiguous to the centrally permitted pharmacy of a hospital but at the location designated on the pharmacy permit.
"Special packaging" means packaging that is designed or constructed to be significantly difficult for children younger than five years of age to open to obtain a toxic or harmful amount of the drug contained therein within a reasonable time and not difficult for normal adults to use properly but does not mean packaging that all such children cannot open or obtain a toxic or harmful amount within a reasonable time.
"Special use permit" means a permit issued to conduct a pharmacy of a special scope of service that varies in any way from the provisions of any board regulation.
"Station" means an enclosed structure that houses one or more EMS vehicles or other EMS vehicles in the state in which the EMS agency is registered that is actively and primarily being used for emergency response by the EMS agency.
"Storage temperature" means those specific directions stated in some monographs with respect to the temperatures at which pharmaceutical articles shall be stored, where it is considered that storage at a lower or higher temperature may produce undesirable results. The conditions are defined by the following terms:
"Terminally ill" means a patient with a terminal condition as defined in § 54.1-2982 of the Code of Virginia.
"Ultimate user" means a person who has lawfully obtained, and who possesses, a controlled substance for that person's own use or for the use of a member of that person's household or for an animal owned by that person or a member of that person's household.
"Unit dose container" means a container that is a single-unit container, as defined in United States Pharmacopeia-National Formulary, for articles intended for administration by other than the parenteral route as a single dose, direct from the container.
"Unit dose package" means a container that contains a particular dose ordered for a patient.
"Unit dose system" means a system in which multiple drugs in unit dose packaging are dispensed in a single container, such as a medication drawer or bin, labeled only with patient name and location. Directions for administration are not provided by the pharmacy on the drug packaging or container but are obtained by the person administering directly from a prescriber's order or medication administration record.
"USP-NF" means the United States Pharmacopeia-National Formulary.
"Well-closed container" means a container that protects the contents from extraneous solids and from loss of the drug under the ordinary or customary conditions of handling, shipment, storage, and distribution.
18 Va. Admin. Code § 110-20-10
Statutory Authority: §§ 54.1-2400 and 54.1-3307 of the Code of Virginia.