W. Va. Code R. § 15-2-2 - [Effective 7/1/2025] Definitions

2.1. The following words and phrases as used in this Rule mean:

2.1.1. "Act" means the Uniform Controlled Substances Act as provided in W. Va. Code § 60A-1-101 et. seq.

2.1.2. "Acute care hospital" means a hospital licensed by the West Virginia Office of Health Facility Licensure and Certification that provides acute hospital care and treatment.

2.1.3. "Analogue" means a substance that, in relation to a controlled substance, has a substantially similar chemical structure.

2.1.4 "Commercial Container" means any bottle, jar, tube, ampule, or other receptacle in which a substance is held for distribution or dispensing to an ultimate user, and in addition, any box or package in which the receptacle is held for distribution or dispensing to an ultimate user. "Commercial Container" does not include any package liner, package insert or other material kept with or within a commercial container, nor any carton, crate, drug, or other package in which commercial containers are stored or are used for shipment of controlled substances.

2.1.5. "Immediate derivative" means a substance which is the principal compound or any analogue of the parent compound manufactured from a known controlled substance primarily for use and which has equal or similar pharmacologic activity as the parent compound which is necessary to prevent, curtail or limit manufacture.

2.1.6. "Immediate precursor" means a substance which is 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.

2.1.7. "Individual Practitioner" means a physician, dentist, veterinarian or other individual authorized by the jurisdiction in which he or she practices to dispense a controlled substance in the course of professional practice, but does not include a pharmacist, a pharmacy or an institutional practitioner.

2.1.8. "Institutional Practitioner" means a hospital or other person, not including an individual, authorized by the jurisdiction in which it practices, to dispense a controlled substance in the course of professional practice, but does not include a pharmacy.

2.1.9. "Label" means a display of written, printed, or graphic matter upon the immediate container of any drug or device.

2.1.10. "Labeling" means the process of preparing and affixing a label to a drug container exclusive, however, of a labeling by a manufacturer, packer or distributor of a nonprescription drug or commercially packaged prescription drug or device.

2.1.11. "Manufacture" means the producing, preparation, propagation, compounding, conversion or processing of a controlled substance, either directly or indirectly or 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 the labeling or relabeling of its container, except that this term does not include the preparation, compounding, packaging or labeling of a controlled substance:

2.1.11.a. By a practitioner as an incident to his or her administering or dispensing of a controlled substance in the course of his or her professional practice; or

2.1.11.b. By a practitioner, or by his or her authorized agent under his or her supervision, for the purpose of, or as an incident to, research, teaching or chemical analysis and not for sale.

2.1.12. "Manufacturer" means any person who is engaged in manufacturing, preparing, propagating, compounding, processing, packaging, repackaging or labeling of a prescription drug, whether within or outside this state.

2.1.13. "Perpetual inventory" means an ongoing system for recording quantities of drugs received, dispensed or otherwise distributed by a pharmacy.

2.1.14. "Pharmacist" or "registered pharmacist" means an individual currently licensed by the jurisdiction in which he or she practices to engage in the practice of pharmacist care.

2.1.15. "Pharmacist-in-charge" means a pharmacist currently licensed in this state who:

2.1.15.a. Accepts responsibility for the operation of a pharmacy in conformance with all state and federal laws and rules pertinent to the practice of pharmacist care and the distribution of drugs;

2.1.15.b. Has the responsibility for the practice of pharmacist care, as defined in this rule, at the pharmacy for which he or she is pharmacist-in-charge. The pharmacy permit holder has responsibility for all other functions, administrative and operational, of the pharmacy. The pharmacist-in-charge may advise the pharmacy permit holder in writing of administrative and operational matters. The pharmacist-in-charge is not legally responsible if the permit holder does not follow the written advice;

2.1.15.c. Work requirements as required in W.Va. §15 CSR 1.2.42.c-d.

2.1.16. "Pharmacy technician" means a person registered with the board to practice certain tasks related to the practice of pharmacist care as permitted by the board.

2.1.17. "Prescription" means an order for medication which is dispensed to or for an ultimate user but does not include the immediate administration to the ultimate user.

2.1.18. "Readily Retrievable" means that certain records are kept by automatic data processing systems or other electronic or mechanized record keeping systems in such a manner that they can be separated out from all other records in a reasonable time and/or records are kept on which certain items are asterisked, red-lined or in some other manner visually identifiable apart from other items appearing on the records.

2.1.19. "Registered nurse" means an individual granted this licensure by the West Virginia Board of Registered Nurses according to W.Va. Code § 30-7-6.

2.1.20. "Registrant" means a person who has obtained a controlled substance registration from the Board.

2.1.21. Any term not defined in this rule has the definition set forth in W. Va. Code § 60A-1-101 and 60A-8-5.

Notes

W. Va. Code R. § 15-2-2