Current through Register Vol. XLI, No. 25, June 21, 2024
Section 15-19-2 - DefinitionsThe 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.