W. Va. Code R. § 15-1-2

Current through Register Vol. XLI, No. 24, June 14, 2024

Section 15-1-2 - Definitions

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.

W. Va. Code R. § 15-1-2