West Virginia Code of State Rules › Agency 15 - Pharmacy › Title 15 - LEGISLATIVE RULE WEST VIRGINIA BOARD OF PHARMACY › Series 15-19 - Inspections › Section 15-19-2 - Definitions

Current through Register Vol. XLI, No. 28, July 12, 2024
The following words and phrases as used in this Rule
				  mean:
2.1. "Board" means the
				West Virginia Board of Pharmacy.
2.2. "Charitable clinic pharmacy" means a
				clinic or facility organized as a not-for-profit corporation that offers
				pharmaceutical care and dispenses prescriptions free of charge to appropriately
				screened and qualified patients. A charitable clinic pharmacy shall meet the
				minimum standards for a pharmacy as set forth in W. Va. Code §
									30-5-1, et seq., and by this rule,
				but may not be charged any applicable licensing fees. A charitable clinic
				pharmacy may have pharmacists-in-charge, as that term is defined in this
				section, who volunteers his or her services. A charitable clinic may also
				receive donated drugs. It is not the intent of this rule to affect any
				organizations which are merely operating a prescribing practitioner's or
				clinic's free sample drug room.
2.3. "Controlled Substance Permit" means the
				permit require to be obtained by the Board, unless otherwise exempt, for every
				person who manufactures, distributes, including reverse distributing, or
				dispenses any controlled substances or who proposes to engage in the
				manufacture, distribution or dispensing of any controlled substance within this
				state.
2.4. "Inspection" means the
				process by which the Board verifies certain information of Board
				licenses.
2.5. "Inspector" means a
				person employed by the Board to perform inspections.
2.6. "Institutional pharmacy" means that
				physical portion of an institutional facility that is engaged in the
				compounding, dispensing, and distribution of drugs, devices, and other
				materials used in the diagnosis and treatment of injury, illness, and disease
				and which holds a pharmacy license from the Board.
2.7. "Non-compliance report" means a report
				created noting a deficiency discovered during an inspection.
2.8. "Non-sterile compounding" means the
				process of combining, admixing, diluting, pooling, reconstituting other than as
				provided in the manufacturer's labeling, or otherwise altering a drug or bulk
				drug substance to create a non-sterile preparation.
2.9. "Nuclear pharmacy" means a place where
				radioactive drugs are prepared and dispensed and which operates under
				specialized rules.
2.10. "Outpatient
				pharmacy" means any pharmacy, apothecary, or place within this state where
				drugs are dispensed and sold at retail or displayed for sale at retail and
				where the practice of pharmacy is conducted and pharmacist care is provided;
				and any place outside of this state where drugs are dispensed and the practice
				of pharmacy and pharmacist care is provided to residents of this
				state.
2.11. "Unscheduled
				inspection" means an unannounced inspection.
2.12. "Sterile compounding" means compounding
				or mixing prescription orders for sterile solutions or suspensions to be
				administered parenterally, enterally, by irrigation or ophthalmic
				drops.
2.13. "Wholesaler" means any
				person within this state or another state, other than a manufacturer, who
				sells, transfers or in any manner furnishes a drug product to any other person
				in this state for the purpose of being resold.