§30-5-4

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WEST VIRGINIA CODE: §30-5-4

§30-5-4. Definitions.

As used in this article:

“Ambulatory health care facility” includes any facility defined in §16-5B-1 et seq. of this

code, that also has a pharmacy, offers pharmacist care, or is otherwise engaged in the

practice of pharmacist care.

“Active Ingredients” means chemicals, substances, or other components of articles intended

for use in the diagnosis, cure, mitigation, treatment, or prevention of diseases in humans or

animals or for use as nutritional supplements.

“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.

“Board” means the West Virginia Board of Pharmacy.

“Board authorization” means a license, registration, or permit issued under this article.

“Chain Pharmacy Warehouse” means a permanent physical location for drugs or devices that

acts as a central warehouse and performs intracompany sales and transfers of prescription

drugs or devices to chain pharmacies, which are members of the same affiliated group,

under common ownership and control.

“Charitable clinic pharmacy” means a clinic or facility organized as a not-for-profit

corporation that has a pharmacy, offers pharmacist care, or is otherwise engaged in the

practice of pharmacist care and dispenses its prescriptions free of charge to appropriately

screened and qualified indigent patients.

“Collaborative pharmacy practice” is that practice of pharmacist care where one or more

pharmacists have jointly agreed, on a voluntary basis, to work in conjunction with one or

more physicians under written protocol where the pharmacist or pharmacists may perform

certain patient care functions authorized by the physician or physicians under certain

specified conditions and limitations.

“Collaborative pharmacy practice agreement” is a written and signed agreement, which is a

physician directed approach, that is entered into between an individual physician or

physician group, or for a medical provider in training where the agreement is signed by the

supervising physician or chairperson of the medical department where the medical provider

in training is practicing, and an individual pharmacist or pharmacists that provides for

collaborative pharmacy practice for the purpose of drug therapy management of a patient.

“Common Carrier” means any person or entity who undertakes, whether directly or by any

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other arrangement, to transport property including prescription drugs for compensation.

“Component” means any active ingredient or added substance intended for use in the

compounding of a drug product, including those that may not appear in such product.

“Compounding” means:

(A) The preparation, mixing, assembling, packaging, or labeling of a drug or device:

(i) 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

(ii) For the purpose of, or as an incident to, research, teaching, or chemical analysis and not

for sale or dispensing; and

(B) The preparation of drugs or devices in anticipation of prescription drug orders based on

routine, regularly observed prescribing patterns.

“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.

“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.”

“Digital Signature” means an electronic signature based upon cryptographic methods of

originator authentication, and computed by using a set of rules and a set of parameters so

that the identity of the signer and the integrity of the data can be verified.

“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.

“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:

(A) To dispense or administer;

(B) (i) 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;

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(ii) 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;

(iii) Intracompany sales.

“Drop shipment” means the sale of a prescription drug to a wholesale distributor by the

manufacturer of the prescription drug or by that manufacturer’s colicensed product partner,

that manufacturer’s third-party logistics provider, that manufacturer’s exclusive distributor,

or by an authorized distributor of record that purchased the product directly from the

manufacturer or from one of these entities whereby:

(A) The wholesale distributor takes title to but not physical possession of such prescription

drug;

(B) The wholesale distributor invoices the pharmacy, pharmacy warehouse, or other person

authorized by law to dispense or administer such drug; and

administer such drug receives delivery of the prescription drug directly from the

manufacturer or from that manufacturer’s colicensed product partner, that manufacturer’s

third-party logistics provider, that manufacturer’s exclusive distributor, or from an

authorized distributor of record that purchased the product directly from the manufacturer

or from one of these entities.

“Drug” means:

(A) Articles recognized as drugs by the United States Food and Drug Administration, or in

any official compendium, or supplement;

(B) An article, designated by the board, for use in the diagnosis, cure, mitigation, treatment,

or prevention of disease in humans or other animals;

human or other animals; and

(D) Articles intended for use as a component of any articles specified in paragraph (A), (B),

or (C) of this subdivision.

“Drug regimen review” includes, but is not limited to, the following activities:

(A) Evaluation of the prescription drug orders and if available, patient records for:

(i) Known allergies;

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(ii) Rational therapy-contraindications;

(iii) Reasonable dose and route of administration; and

(iv) Reasonable directions for use.

(B) Evaluation of the prescription drug orders and patient records for duplication of therapy.

but are not limited to, any of the following:

(i) Drug-drug;

(ii) Drug-food;

(iii) Drug-disease; and

(iv) Adverse drug reactions.

(D) Evaluation of the prescription drug orders and if available, patient records for proper

use, including overuse and underuse and optimum therapeutic outcomes.

“Drug therapy management” means the review of drug therapy regimens of patients by a

pharmacist for the purpose of evaluating and rendering advice to a physician regarding

adjustment of the regimen in accordance with the collaborative pharmacy practice

agreement. Decisions involving drug therapy management shall be made in the best interest

of the patient. Drug therapy management is limited to:

(A) Implementing, modifying, and managing drug therapy according to the terms of the

collaborative pharmacy practice agreement;

(B) Collecting and reviewing patient histories;

agreement;

(D) Ordering screening laboratory tests that are dose related and specific to the patient’s

medication or are protocol driven and are also specifically set out in the collaborative

pharmacy practice agreement between the pharmacist and physician.

“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

pharmacy to facilitate the secure transmission of:

(A) An electronic prescription order;

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(B) A refill authorization request;

(D) Other patient care information.

“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”.

“Electronic Signature” means an electronic sound, symbol, or process attached to or

logically associated with a record and executed or adopted by a person with the intent to

sign the record.

“Electronic transmission” means transmission of information in electronic form or the

transmission of the exact visual image of a document by way of electronic equipment.

“Emergency medical reasons” include, but are not limited to, transfers of a prescription drug

by one pharmacy to another pharmacy to alleviate a temporary shortage of a prescription

drug; sales to nearby emergency medical services, i.e., ambulance companies and

firefighting organizations in the same state or same marketing or service area, or nearby

licensed practitioners of prescription drugs for use in the treatment of acutely ill or injured

persons; and provision of minimal emergency supplies of prescription drugs to nearby

nursing homes for use in emergencies or during hours of the day when necessary

prescription drugs cannot be obtained.

“Exclusive distributor” means an entity that:

(A) Contracts with a manufacturer to provide or coordinate warehousing, wholesale

distribution, or other services on behalf of a manufacturer and who takes title to that

manufacturer’s prescription drug, but who does not have general responsibility to direct the

sale or disposition of the manufacturer’s prescription drug; and

(B) Is licensed as a wholesale distributor under this article.

“FDA” means the Food and Drug Administration, a federal agency within the United States

Department of Health and Human Services.

“Health care entity” means a person that provides diagnostic, medical, pharmacist care,

surgical, dental treatment, or rehabilitative care but does not include a wholesale

distributor.

“Health information” means any information, whether oral or recorded in a form or medium,

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that:

(A) Is created or received by a health care provider, health plan, public health authority,

employer, life insurer, school or university, or health care clearinghouse, and

(B) Relates to the past, present, or future physical or mental health or condition of an

individual; or the past, present, or future payment for the provision of health care to an

individual.

“Heath care system” means an organization of people, institutions, and resources that

deliver health care services to meet the health needs of a target population.

“HIPAA” is the federal Health Insurance Portability and Accountability Act of 1996 (Public

Law 104-191).

“Immediate container” means a container and does not include package liners.

“Individually identifiable health information” is information that is a subset of health

information, including demographic information collected from an individual and is created

or received by a health care provider, health plan, employer, or health care clearinghouse;

and relates to the past, present, or future physical or mental health or condition of an

individual; the provision of health care to an individual; or the past, present, or future

payment for the provision of health care to an individual; and that identifies the individual;

or with respect to which there is a reasonable basis to believe the information can be used to

identify the individual.

“Intracompany sales” means any transaction between a division, subsidiary, parent, or

affiliated or related company under the common ownership and control of a corporate or

other legal business entity.

“Label” means a display of written, printed, or graphic matter upon the immediate container

of any drug or device.

“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.

“Long-Term care facility” means a nursing home, retirement care, mental care, or other

facility or institution that provides extended health care to resident patients.

“Mail-order pharmacy” means a pharmacy, regardless of its location, which dispenses

greater than 25 percent of its prescription drugs via the mail or other delivery services.

“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.

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“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.

“Medical order” means a lawful order of a practitioner that may or may not include a

prescription drug order.

“Medication therapy management” is a distinct service or group of services that optimize

medication therapeutic outcomes for individual patients. Medication therapy management

services are independent of, but can occur in conjunction with, the provision of a medication

or a medical device. Medication therapy management encompasses a broad range of

professional activities and responsibilities within the licensed pharmacist’s scope of practice.

These services may include the following, according to the individual needs of the patient:

(A) Performing or obtaining necessary assessments of the patient’s health status pertinent to

medication therapy management;

(B) Optimize medication use, performing medication therapy, and formulating

recommendations for patient medication care plans;

(D) Monitoring and evaluating the patient’s response to medication therapy, including safety

and effectiveness;

(E) Performing a comprehensive medication review to identify, resolve, and prevent

medication-related problems, including adverse drug events;

(F) Documenting the care delivered and communicating essential information to the

patient’s primary care providers;

(G) Providing verbal education and training designed to enhance patient understanding and

appropriate use of his or her medications;

(H) Providing information, support services, and resources designed to enhance patient

adherence with his or her medication therapeutic regimens;

(I) Coordinating and integrating medication therapy management services within the

broader health care management services being provided to the patient; and

(J) Such other patient care services as may be allowed by law.

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“Misbranded” means a drug or device that has a label that is false or misleading in any

particular manner; or the label does not bear the name and address of the manufacturer,

packer, or distributor and does not have an accurate statement of the quantities of the active

ingredients in the case of a drug; or the label does not show an accurate monograph for

prescription drugs.

“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.

“Normal distribution channel” means a chain of custody for a prescription drug that goes

directly or by drop shipment, from a manufacturer of the prescription drug, the

manufacturer’s third-party logistics provider, or the manufacturer’s exclusive distributor to:

(A) A wholesale distributor to a pharmacy to a patient or other designated persons

authorized by law to dispense or administer such prescription drug to a patient;

(B) A wholesale distributor to a chain pharmacy warehouse to that chain pharmacy

warehouse’s intracompany pharmacy to a patient or other designated persons authorized by

law to dispense or administer such prescription drug to a patient;

pharmacy to a patient or other designated persons authorized by law to dispense or

administer such prescription drug to a patient;

(D) A pharmacy or to other designated persons authorized by law to dispense or administer

such prescription drug to a patient; or

(E) As prescribed by the board’s legislative rules.

“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.

“Pedigree” means a statement or record in written form or electronic form, approved by the

board, that records each wholesale distribution of any given prescription drug (excluding

veterinary prescription drugs), which leaves the normal distribution channel.

“Person” means an individual, corporation, partnership, association, or any other legal

entity, including government.

“Pharmacist” means an individual currently licensed by this state to engage in the practice

of pharmacist care.

“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

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or prevention of a disease, elimination, or reduction of a patient’s symptoms, or arresting or

slowing of a disease process and as provided for in section ten.

“Pharmacist-in-charge” means a pharmacist currently licensed in this state who accepts

responsibility for the operation of a pharmacy in conformance with all laws and legislative

rules pertinent to the practice of pharmacist care and the distribution of drugs and who is

personally in full charge of the pharmacy and pharmacy personnel.

“Pharmacist’s scope of practice pursuant to the collaborative pharmacy practice agreement”

means those duties and limitations of duties placed upon the pharmacist by the collaborating

physician.

“Pharmacy” means any place within this state where drugs are dispensed and pharmacist

care is provided and any place outside of this state where drugs are dispensed and

pharmacist care is provided to residents of this state.

“Pharmacy Intern” or “Intern” means an individual who is currently licensed to engage in

the practice of pharmacist care while under the supervision of a pharmacist.

“Pharmacy related primary care” means the pharmacist’s activities in patient education,

health promotion, selection and use of over the counter drugs and appliances and referral or

assistance with the prevention and treatment of health related issues and diseases.

“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.

“Physician” means an individual currently licensed, in good standing and without

restrictions, as an allopathic physician by the West Virginia Board of Medicine or an

osteopathic physician by the West Virginia Board of Osteopathic Medicine.

“Practice notification” means a written notice to the appropriate licensing board that an

individual physician or physician group or a medical provider in training where the

agreement is signed by the supervising physician or chairperson of the medical department

where the medical provider in training is practicing, and an individual pharmacist or

pharmacists will practice in collaboration.

“Practice of telepharmacy” means the provision of pharmacist care by properly licensed

pharmacists located within United States jurisdictions through the use of

telecommunications or other technologies to patients or their agents at a different location

that are located within United States jurisdictions.

“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.

“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

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subject to section 503(b) of the federal Food, Drug and Cosmetic Act.

“Prescription or prescription drug 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.

“Product Labeling” means all labels and other written, printed, or graphic matter upon any

article or any of its containers or wrappers, or accompanying such article.

“Repackage” means changing the container, wrapper, quantity, or product labeling of a drug

or device to further the distribution of the drug or device.

“Repackager” means a person who repackages.

“Therapeutic equivalence” mean drug products classified as therapeutically equivalent can

be substituted with the full expectation that the substituted product will produce the same

clinical effect and safety profile as the prescribed product which contain the same active

ingredient(s); dosage form and route of administration; and strength.

“Third-party logistics provider” means a person who contracts with a prescription drug

manufacturer to provide or coordinate warehousing, distribution, or other services on behalf

of a manufacturer, but does not take title to the prescription drug or have general

responsibility to direct the prescription drug’s sale or disposition. A third-party logistics

provider shall be licensed as a wholesale distributor under this article and, in order to be

considered part of the normal distribution channel, shall also be an authorized distributor of

record.

“Valid patient-practitioner relationship” means the following have been established:

(A) A patient has a medical complaint;

(B) A medical history has been taken;

performed by the prescribing practitioner or in the instances of telemedicine through

telemedicine practice approved by the appropriate practitioner board; and

(D) Some logical connection exists between the medical complaint, the medical history, and

the physical examination and the drug prescribed.

“Wholesale distribution” and “wholesale distributions” mean distribution of prescription

drugs, including directly or through the use of a third-party logistics provider or any other

situation in which title, ownership, or control over the prescription drug remains with one

person or entity but the prescription drug is brought into this state by another person or

entity on his, her, or its behalf, to persons other than a consumer or patient, but does not

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include:

(A) Intracompany sales, as defined in this section;

(B) The purchase or other acquisition by a hospital or other health care entity that is a

member of a group purchasing organization of a drug for its own use from the group

purchasing organization or from other hospitals or health care entities that are members of

such organizations;

charitable organization described in section 501(c)(3) of the United States Internal Revenue

Code of 1986 to a nonprofit affiliate of the organization to the extent otherwise permitted by

law;

(D) The sale, purchase, or trade of a drug or an offer to sell, purchase, or trade a drug

among hospitals or other health care entities that are under common control. For purposes

of this article, “common control” means the power to direct or cause the direction of the

management and policies of a person or an organization, whether by ownership of stock,

voting rights, by contract, or otherwise;

(E) The sale, purchase, or trade of a drug or an offer to sell, purchase or trade a drug for

“emergency medical reasons” for purposes of this article includes transfers of prescription

drugs by a retail pharmacy to another retail pharmacy to alleviate a temporary shortage,

except that the gross dollar value of such transfers shall not exceed five percent of the total

prescription drug sales revenue of either the transferor or transferee pharmacy during any

12 consecutive month period;

(F) The sale, purchase, or trade of a drug, an offer to sell, purchase, or trade a drug or the

dispensing of a drug pursuant to a prescription;

(G) The distribution of drug samples by manufacturers’ representatives or distributors’

representatives, if the distribution is permitted under federal law [21 U. S. C. 353(d)];

(H) Drug returns by a pharmacy or chain drug warehouse to wholesale drug distributor or

the drug’s manufacturer; or

(J) The sale, purchase, or trade of blood and blood components intended for transfusion.

“Wholesale drug distributor” or “wholesale distributor” means any person or entity engaged

in wholesale distribution of prescription drugs, including, but not limited to, manufacturers,

repackers, own-label distributors, jobbers, private-label distributors, brokers, warehouses,

including manufacturers’ and distributors’ warehouses, chain drug warehouses and

wholesale drug warehouses, independent wholesale drug traders, prescription drug

repackagers, physicians, dentists, veterinarians, birth control and other clinics, individuals,

hospitals, nursing homes and/or their providers, health maintenance organizations and other

health care providers, and retail and hospital pharmacies that conduct wholesale

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distributions, including, but not limited to, any pharmacy distributor as defined in this

section. A wholesale drug distributor shall not include any for hire carrier or person or entity

hired solely to transport prescription drugs.

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