West Virginia Code of State Rules › Agency 15 - Pharmacy › Title 15 - LEGISLATIVE RULE WEST VIRGINIA BOARD OF PHARMACY › Series 15-01 - Licensure and Practice of Pharmacy › Section 15-1-2 - 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. "Accredited School of Pharmacy" means
				a school of pharmacy accredited by the American Council on Pharmaceutical
				Education (ACPE), or a recognized school of pharmacy located outside of the
				United States or its territories (a foreign school of pharmacy) which pharmacy
				education is found by the Board to be equivalent to an ACPE accredited school
				by a graduate from the foreign school of pharmacy obtaining a Foreign Pharmacy
				Graduate Examination Committee Certificate (FPGEC) from the National
				Association of Boards of Pharmacy (NABP).
2.1.2. "Act" or "Uniform Controlled Substance
				Act" means West Virginia Code § 60A-1-1, et seq.
2.1.3. "Administer" means the direct
				application of a drug to the body of a patient or research subject by
				injection, inhalation, ingestion or any other means.
2.1.4. "Automated pharmacy system" means
				mechanical systems which perform operations or activities, other than
				compounding or administration, relative to the storage, packaging, dispensing,
				or distribution of medications, and which collect, control, and maintain all
				transaction information.
2.1.5.
				"Board" means the West Virginia Board of Pharmacy.
2.1.6. "Board authorization" means a license,
				registration or permit issued under West Virginia Code Chapter 30, Article 5,
				and this rule.
2.1.7. "Compounding"
				means:
2.1.7.a. The preparation, mixing,
				assembling, packaging, or labeling of a drug or device:
2.1.7.a.1. as the result of a practitioner's
				prescription drug order or initiative based on the practitioner/patient/
				pharmacist relationship in the course of professional practice for sale or
				dispensing, or
2.1.7.a.2. for the
				purpose of, or as an incident to, research, teaching or chemical analysis and
				not for sale or dispensing, and
2.1.7.b. The preparation of drugs or devices
				in anticipation of prescription drug orders based on routine, regularly
				observed prescribing patterns.
2.1.7.c. The following are not "compounding"
				and are exempt from USP 795 Compounding Standards:
2.1.7.c.1. the reconstitution of a drug
				pursuant to a manufacturer's directions;
2.1.7.c.2. the act of tablet splitting,
				crushing, or capsule opening; except those prohibited by USP General Chapter
				800 Hazardous Drugs;
2.1.7.c.3.
				upon the request of the prescribing practitioner and/or the patient for whom
				the prescription is ordered or such patient's agent, the addition of
				therapeutically inert, nonallergenic flavoring agents to a commercially
				manufactured product, not in excess of five percent (5%) of the preparation's
				total volume;
2.1.7.c.4. the
				combining of commercially manufactured ready to use products under the
				following conditions:
2.1.7.c.4.A. no more
				than four (4) commercially manufactured ready-to-use products are
				combined;
2.1.7.c.4.B. all products
				combined are FDA approved;
2.1.7.c.4.C. combining is not done in
				anticipation of medication orders;
2.1.7.c.4.D. USP 795 beyond use dating (BUDs)
				is followed;
2.1.7.c.4.E. combining
				with hazardous drugs from final dosage forms, listed in NIOSH List Tables 2 and
				3 requires assessment of risk, the pharmacist or pharmacy technician should
				wear personal protective equipment as described in USP Chapter 800 and must use
				compounding equipment dedicated solely for hazardous drugs;
2.1.7.c.4.F. a valid prescription shall serve
				as the combining record, including the name and amount or concentration, lot
				number, and expiration date of each ingredient; and
2.1.7.c.4.G. the prescription label shall
				comply with the labeling requirements as set forth in West Virginia CSR §
													15-1-18.
2.1.8. "Confidential
				information" means patient-identifiable information maintained by any person in
				connection with the practice of pharmacist care in the patient record or which
				is communicated to the patient as part of patient counseling, or which is
				communicated by the patient to the person providing pharmacist care.
2.1.9. "Controlled Substance" means a drug,
				substance, or immediate precursor in Schedule I through Schedule V of either
				the Federal Controlled Substances Act,
				21 USC Section
				801, et seq., or the West Virginia Uniform
				Controlled Substances Act, W. Va. Code § 60A-1-1, et seq.
2.1.10. "Cosmetic" means:
2.1.10.a. articles intended to be rubbed,
				poured, sprinkled or sprayed on, introduced into, or otherwise applied to the
				human body, or any part of the human body for cleansing, beautifying, promoting
				attractiveness or temporarily altering the appearance;
2.1.10.b. articles intended for use as a
				component of those articles, except that the term shall not include soap;
				and
2.1.10.c. shall be held to
				include "dentifrice" and "toilet articles"
2.1.11. "Deliver" or "delivery" means the
				actual, constructive or attempted transfer of a drug or device from one person
				to another, whether or not for a consideration.
2.1.12. "Device" means an instrument,
				apparatus, implement or machine, contrivance, implant or other similar or
				related article, including any component part or accessory, which is required
				under federal law to bear the label, "Caution: Federal or state law requires
				dispensing by or on the order of a physician" or the language or symbol as
				determined by the U. S. Food and Drug Administration.
2.1.13. "Direct supervision" means that a
				licensed pharmacist is physically present in the pharmacy and is available to
				verify the accuracy of a prescription before it is dispensed.
2.1.14. "Dispense" or "dispensing" means the
				interpretation, evaluation, and implementation of a prescription drug order,
				including the preparation, verification and delivery of a drug or device to a
				patient or patient's agent in a suitable container appropriately labeled for
				subsequent administration to, or use by, a patient.
2.1.15. "Distribute" or "Distribution" means
				to sell, offer to sell, deliver, offer to deliver, broker, give away, or
				transfer a drug, whether by passage of title, physical movement, or both. The
				term does not include:
2.1.15.a. To dispense
				or administer;
2.1.15.b. Delivering
				or offering to deliver a drug by a common carrier in the usual course of
				business as a common carrier; or providing a drug sample to a patient by a
				practitioner licensed to prescribe such drug;
2.1.15.b.1. A health care professional acting
				at the direction and under the supervision of a practitioner; or the pharmacy
				of a hospital or of another health care entity that is acting at the direction
				of such a practitioner and that received such sample in accordance with the
				Prescription Drug Marketing Act and regulations to administer or
				dispense;
2.1.15.b.2. Intracompany
				sales.
2.1.16.
				"Distributor" means a person licensed as a wholesaler or third-party logistics
				provider.
2.1.17. "Drug" means:
2.1.17.a. Articles recognized as drugs by the
				United States Food and Drug Administration, or in any official compendium, or
				supplement;
2.1.17.b. An article,
				designated by the board, for use in the diagnosis, cure, mitigation, treatment,
				or prevention of disease in humans or other animals;
2.1.17.c. Articles, other than food, intended
				to affect the structure or any function of the body of human or other animals;
				and
2.1.17.d. Articles intended for
				use as a component of any articles specified in paragraph 2.1.17.a., 2.1.17.b.
				or 2.1.17.c. of this subdivision.
2.1.18. "Drug regimen review" includes, but
				is not limited to, the following activities:
2.1.18.a. Evaluation of the prescription drug
				orders and, if available, patient records for:
2.1.18.a.1. Known allergies;
2.1.18.a.2. Rational
				therapy-contraindications;
2.1.18.a.3. Reasonable dose and route of
				administration; and
2.1.18.a.4.
				Reasonable directions for use.
2.1.18.b. Evaluation of the prescription drug
				orders and patient records for duplication of therapy.
2.1.18.c. Evaluation of the prescription drug
				for interactions and/or adverse effects which may include, but are not limited
				to, any of the following:
2.1.18.c.1.
				Drug-drug;
2.1.18.c.2.
				Drug-food;
2.1.18.c.3.
				Drug-disease; and
2.1.18.c.4.
				Adverse drug reactions.
2.1.18.d. Evaluation of the prescription drug
				orders and if available, patient records for proper use, including overuse and
				underuse and optimum therapeutic outcomes.
2.1.19. "Electronic data intermediary" means
				an entity that provides the infrastructure to connect a computer system,
				hand-held electronic device or other electronic device used by a prescribing
				practitioner with a computer system or other electronic device used by a
				pharmacist to facilitate the secure transmission of:
2.1.19.a. An electronic prescription
				order;
2.1.19.b. A refill
				authorization request;
2.1.19.c. A
				communication; or
2.1.19.d. Other
				patient care information.
2.1.20. "E-prescribing" means the
				transmission, using electronic media, of prescription or prescription-related
				information between a practitioner, pharmacist, pharmacy benefit manager or
				health plan as defined in 45
				CFR §
											160.103, either directly or
				through an electronic data intermediary. E-prescribing includes, but is not
				limited to, two-way transmissions between the point of care and the pharmacist.
				E-prescribing may also be referenced by the terms "electronic prescription" or
				"electronic order".
2.1.21.
				"Electronic supervision" means that a licensed pharmacist provides supervision
				of the pharmacy through the utilization of audio and visual technology, which
				may be used with both direct and indirect supervision tasks of a pharmacy
				technician or pharmacy technician trainee.
2.1.22. "Inpatient pharmacy" means the area
				within a licensed institution; i.e., a hospital, or other place where patients
				stay at least one night, where drugs are stored and dispensed to other areas of
				the institution for administration to the patients by other licensed health
				care providers.
2.1.23. "Inspector"
				means an agent of the Board, who is a licensed pharmacist, appointed by the
				Board to conduct periodic inspections of board authorization holders and
				perform other duties as designated by the Board.
2.1.24. "Institutional facility" means any
				organization whose primary purpose is to provide a physical environment for
				patients to obtain health care services, including but not limited to a
				hospital, convalescent home, nursing home, extended care facility, mental
				health facility, rehabilitation center, psychiatric center, developmental
				disability center, drug abuse treatment center, family planning clinic,
				correctional facility, hospice, public health facility, or athletic
				facility.
2.1.25. "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.
2.1.26. "Intern" or "pharmacy intern" means
				an individual who is currently licensed by the board to engage in the practice
				of pharmacist care while under the supervision of a pharmacist.
2.1.27. "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.
2.1.28. "Mail order pharmacy" means a
				pharmacy, regardless of its location, which dispenses greater than twenty-five
				percent (25%) prescription drugs via the mail or other delivery
				services.
2.1.29. "Manufacturer"
				means any person who is engaged in manufacturing, preparing, propagating,
				processing, packaging, repackaging or labeling of a prescription drug, whether
				within or outside this state.
2.1.30. "Manufacturing" means the production,
				preparation, propagation or processing of a drug or device, either directly or
				indirectly, by extraction from substances of natural origin or independently by
				means of chemical or biological synthesis and includes any packaging or
				repackaging of the substance or substances or labeling or relabeling of its
				contents and the promotion and marketing of the drugs or devices. Manufacturing
				also includes the preparation and promotion of commercially available products
				from bulk compounds for resale by pharmacies, practitioners, or other
				persons.
2.1.31. "Nonprescription
				drug" means a drug which may be sold without a prescription and which is
				labeled for use by the consumer in accordance with the requirements of the laws
				and rules of this state and the federal government.
2.1.32. "Nuclear pharmacist" means a
				pharmacist who has been certified in the specialty of nuclear
				pharmacy.
2.1.33. "Nuclear
				pharmacy" means a place where radioactive drugs are prepared and dispensed and
				which operates under specialized rules.
2.1.34. "Original License" means a license
				issued by the Board to an applicant when:
2.1.34.a. the applicant is a new
				business;
2.1.34.b. the applicant
				is an established business that is transferred to a successor;
2.1.34.c. the applicant is an established
				business in which fifty percent (50%) ownership or more is transferred to a new
				owner;
2.1.34.d. the applicant is
				an established business in which control of pharmaceutical services is
				transferred; not including a change in pharmacist-in-charge; or
2.1.34.e. the applicant is an established
				business which moves to a new location.
2.1.35. "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.
2.1.36. "Over-the counter drug" or "OTC drug"
				means any drug that is not a prescription drug or prescription drug.
2.1.37. "Patient counseling" means the
				communication by the pharmacist of information, as prescribed further in the
				rules of the board, to the patient to improve therapy by aiding in the proper
				use of drugs and devices.
2.1.38.
				"Person" means an individual, corporation, partnership, association or any
				other legal entity, including government.
2.1.39. "Person Addicted" means one who has
				acquired the habit of using alcoholic beverages or controlled substances or
				other agents to such an extent as to deprive him or her of reasonable
				self-control.
2.1.40. "Pharmacist
				care" means the provision by a pharmacist of patient care activities, with or
				without the dispensing of drugs or devices, intended to achieve outcomes
				related to the cure or prevention of a disease, the elimination or reduction of
				a patient's symptoms, or the arresting or slowing of a disease process, and as
				provided in West Virginia Code §
										30-5-10.
2.1.41. "Pharmacist" means an individual
				currently licensed by this state to engage in the practice of pharmacist
				care.
2.1.42.
				"Pharmacist-in-charge" means a pharmacist currently licensed in this state who:
2.1.42.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;
2.1.42.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;
2.1.42.c. works at least 30 hours a week,
				with the pharmacist-in-charge working at least three days per week, in that
				pharmacy, including the use of any accrued annual or sick leave; Provided That,
				in any pharmacy which is open on average less than 40 hours per week in a
				calendar year, he or she must work in the pharmacy a majority of the hours that
				the pharmacy is open (e.g., if open 20 hours per week, the pharmacist-in-charge
				must work 11 hours per week within the pharmacy); and
2.1.42.d. with regard to a
				pharmacist-in-charge in a Charitable Clinic Pharmacy, this position may be
				filled by a committee of up to three (3) pharmacists who accept as a group the
				responsibilities of the required pharmacist-in-charge. Further notwithstanding
				the requirements of subsection c, above, with regard to a Charitable Clinic
				Pharmacy, if the pharmacy is open an average of more than 40 hours per week,
				the pharmacist-in-charge or pharmacist-in-charge committee must work at least 8
				hours per calendar month; if the pharmacy is open on average at least 30 and up
				to 40 hours per week, the pharmacist-in-charge or pharmacist-in-charge
				committee must work in the charitable clinic pharmacy at least 6 hours per
				calendar month; if the pharmacy is open on average at least 15 and up to 30
				hours per week, the pharmacist-in-charge or pharmacist-in-charge committee must
				work in the charitable clinic pharmacy at least 4 hours per calendar month; if
				the charitable clinic pharmacy is open on average at least 5 and up to 15 hours
				per week, the pharmacist-in-charge or pharmacist-in-charge committee must work
				in the charitable clinic pharmacy at least 2 hours per calendar month; and, if
				the charitable clinic pharmacy is open less than 5 hours per week, the
				pharmacist-in-charge or pharmacist-in-charge committee must work in the
				charitable clinic pharmacy the lesser of 2 hours per month or 50% of the hours
				the charitable clinic pharmacy is open.
2.1.42.d.1.
Charitable Clinic Pharmacy hours per
							 week
Hours required by PIC per month
More than 40:
8
30 to 40:
6
15 to 30:
4
5 to 15:
2
Less than 5:
The lesser of 2 or 50% of hours open
2.1.43. "Pharmacy technician" means
				registered supportive personnel who work under the direct or electronic
				supervision of a pharmacist, and who have passed an approved training program;
				Provided That, in a Charitable Clinic Pharmacy, when no pharmacist is on-site,
				a pharmacy technician may work under the direct supervision of a prescribing
				practitioner who is licensed as a prescribing practitioner who is licensed as
				such in the State of West Virginia.
2.1.44. "Pharmacy technician trainee" means
				registered supportive personnel currently engaged in a pharmacy technician
				training program which has been approved by the Board and who is under the
				direct supervision of a pharmacist.
2.1.45. "Practitioner" or "prescribing
				practitioner" means an individual authorized by a jurisdiction of the United
				States to prescribe drugs in the course of professional practices, as allowed
				by law.
2.1.46. "Preceptor" means
				an individual who is currently licensed as a pharmacist by the board, meets the
				qualifications as a preceptor under the rules of the board, and participates in
				the instructional training of pharmacy interns.
2.1.47. "Prescription drug" means any human
				drug required by federal law or regulation to be dispensed only by
				prescription, including finished dosage forms and active ingredients subject to
				section 503(b) of the federal food, drug and cosmetic act.
2.1.48. "Prescription" or "Prescription
				order" means a lawful order from a practitioner for a drug or device for a
				specific patient, including orders derived from collaborative pharmacy
				practice, where a valid patient-practitioner relationship exists, that is
				communicated to a pharmacist in a pharmacy.
2.1.49. "President" means the President of
				the West Virginia Board.
2.1.50.
				"Refill" means a subsequent dispensing of the medicine ordered by the
				practitioner in the original prescription order, based upon the practitioner's
				authorization for the subsequent dispensing in that original prescription
				order.
2.1.51. "Renewal" means a
				new prescription drug order for the same medication previously prescribed for a
				patient, authorized by the practitioner without change or modification from the
				original prescription order after the authorized number of refills of the
				original prescription order has been exhausted.
2.1.52. "Sample" means a package of a
				prescription drug provided by a manufacturer on the request of a practitioner
				or charitable clinic to be given to a patient without charge in accordance with
				federal law.
2.1.53. "Secretary"
				means the Secretary of the West Virginia Board.
2.1.54. "Vendor" means a private vendor which
				produces or supplies official state prescription paper.
2.1.55. "Vice-President" means the
				Vice-President of the West Virginia Board.
2.1.56. "West Virginia Official Prescription
				Paper" means prescription paper which meets the following criteria:
2.1.56.a. Prevention of unauthorized
				copying;
2.1.56.b. Prevention of
				erasure or modification; and
2.1.56.c. An ability to prevent counterfeit
				prescriptions or prescription pads.
2.1.57. "Wholesaler" is a person or entity
				licensed by the Board to distribute, by sales or otherwise, prescription drugs
				to persons other than a consumer or patient.