West Virginia Code of State Rules › Agency 15 - Pharmacy › Title 15 - LEGISLATIVE RULE WEST VIRGINIA BOARD OF PHARMACY › Series 15-02 - Rules of the Board of Pharmacy for the Uniform Controlled Substances Act › Section 15-2-2 - Definitions

Current through Register Vol. XLI, No. 28, July 12, 2024
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. "Analogue" means a substance that, in
				relation to a controlled substance, has a substantially similar chemical
				structure.
2.1.3. "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.
2.1.4. "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.
2.1.5. "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.
2.1.6. "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.
2.1.7 "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.
2.1.8. "Label" means a display of written,
				printed, or graphic matter upon the immediate container of any drug or
				device.
2.1.9. "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.
2.1.10. "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:
2.1.10.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
2.1.10.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.
2.1.11.
				"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.
2.1.12. "Perpetual inventory" means an
				ongoing system for recording quantities of drugs received, dispensed or
				otherwise distributed by a pharmacy.
2.1.13. "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.
2.1.14. "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.
2.1.15. "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.
2.1.16. "Registrant" means
				a person who has obtained a controlled substance registration from the
				Board.
2.1.17. Any term not defined
				in this rule has the definition set forth in W. Va. Code §
										60A-1-101 and
				60A-8-5.