HB2577 H&HR AM 3-6
Delegates Perry and Perdue move to amend the bill, by striking
everything after the enacting clause and inserting in lieu thereof
"That §30-5-1a, §30-5-1b, §30-5-2a, §30-5-3a, §30-5-5a,
§30-5-5b, §30-5-6a, §30-5-7a, §30-5-7b, §30-5-7c, §30-5-9a,
§30-5-10a, §30-5-12c, §30-5-14a, §30-5-14b, §30-5-16a, §30-5-16b,
§30-5-16c and §30-5-22a of the Code of West Virginia, 1931, as
amended, be repealed; that §30-5-1, §30-5-2, §30-5-3, §30-5-4,
§30-5-5, §30-5-6, §30-5-7, §30-5-8, §30-5-9, §30-5-10, §30-5-11,
§30-5-12, §30-5-13, §30-5-14, §30-5-15, §30-5-16, §30-5-17,
§30-5-18, §30-5-19, §30-5-20, §30-5-21, §30-5-22, §30-5-23,
§30-5-24 §30-5-25, §30-5-26, §30-5-27, §30-5-28, §30-5-29 and
§30-5-30 of said code be amended and reenacted; that said code be
amended by adding thereto four new sections, designated §30-5-31,
§30-5-32, §30-5-33 and §30-5-34; and that §60A-10-3 of said code be
amended and reenacted; all to read as follows:
ARTICLE 5. PHARMACISTS, PHARMACY TECHNICIANS, PHARMACY INTERNS
§30-5-1. Short title.
_____This article shall be known as and may be cited as the "The
Larry W. Border Pharmacy Practice Act".
§30-5-2. Unlawful acts.
_____(a) It is unlawful for a person to practice or offer to
practice pharmacist care or practice or offer to assist in the practice of pharmacist care in this state without a license or
registration, issued under the provisions of this article, or
advertise or use any title or description tending to convey or give
the impression that he or she is a pharmacist or pharmacy
technician, unless the person is licensed or registered under the
provisions of this article.
_____(b) A business entity may not render any service or engage in
any activity which, if rendered or engaged in by an individual,
would constitute the practice of pharmacist care, except through a
_____(c) It is unlawful for the proprietor of a pharmacy or a
ambulatory health care facility to permit a person, not a licensed
pharmacist, to practice pharmacist care: Provided, That a
charitable clinic pharmacy may permit a licensed prescribing
practitioner to act in place of the pharmacist when no pharmacist
is present in the charitable clinic.
§30-5-3. Applicable law.
_____The practices authorized under the provisions of this article
and the Board of Pharmacy are subject to article one of this
chapter, the provisions of this article, and any rules promulgated
under this article.
_____The following words and phrases have the following meaning in
_____(1) "Ambulatory health care facility" as defined in section
one, article five-b, chapter sixteen of this code, that has a pharmacy, offers pharmacist care, or is otherwise engaged in the
practice of pharmacist care.
_____(2) "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.
_____(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.
_____(4) "Board" means the West Virginia Board of Pharmacy.
_____(5) "Board authorization" means a license, registration or
permit issued under this article.
_____(6) "Chain Pharmacy Warehouse" means a permanent physical
location for drugs and/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.
_____(7) "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.
_____(8) "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
_____(9) "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,
an individual pharmacist or pharmacists and an individual patient
or the patient's authorized representative who has given informed
that provides for collaborative pharmacy practice for the
purpose of drug therapy management of a patient, which has been
approved by the board, the Board of Medicine in the case of an
allopathic physician or the West Virginia Board of Osteopathic
Medicine in the case of an osteopathic physician.
_____(10) "Common Carrier" means any person or entity who
undertakes, whether directly or by any other arrangement, to
transport property including prescription drugs for compensation.
_____(11) "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.
_____ (12) "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
_____(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
_____(13) "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.
_____(14) "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."
_____(15) "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
_____(16) "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,
_____(17) "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;
_____(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.
_____(18) "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
_____(C) The pharmacy, pharmacy warehouse or other person authorized
by law to dispense or 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
_____(19) "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;
_____(C) Articles, other than food, intended to affect the structure
or any function of the body of 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.
_____(20) "Drug regimen review" includes, but is not limited to, the
_____(A) Evaluation of the prescription drug orders and if
available, patient records for:
_____(i) Known allergies;
_____(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.
_____(C) Evaluation of the prescription drug for interactions and/or
adverse effects which may include, but are not limited to, any of
_____(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.
_____(21) "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;
_____(C) Obtaining and checking vital signs, including pulse,
temperature, blood pressure and respiration;
_____(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.
_____(22) "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;
_____(B) A refill authorization request;
_____(C) A communication; or
_____(D) Other patient care information.
_____(23) "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".
_____(24) "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.
_____(25) "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.
_____(26) "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
_____(27) "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
_____(B) Is licensed as a wholesale distributor under this article.
_____(28) "FDA" means the Food and Drug Administration, a federal
agency within the United States Department of Health and Human
_____(29) "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.
_____(30) "Health information" means any information, whether oral
or recorded in a form or medium, 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.
_____(31) "HIPAA" is the federal Health Insurance Portability and
Accountability Act of 1996 (Public Law 104-191).
_____(32) "Immediate container" means a container and does not
include package liners.
_____(33) "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.
_____(34) "Intracompany sales" means any transaction between a
division, subsidiary, parent, and/or affiliated or related company
under the common ownership and control of a corporate or other legal
_____(35) "Label" means a display of written, printed, or graphic matter upon the immediate container of any drug or device.
_____(36) "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 legend drug or device.
_____(37) "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.
_____(38) "Mail-order pharmacy" means a pharmacy, regardless of its
location, which dispenses greater than twenty-five percent
prescription drugs via the mail or other delivery services.
_____(39) "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.
_____(40) "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
_____(41) "Medical order" means a lawful order of a practitioner that may or may not include a prescription drug order.
_____(42) "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;
_____(C) Developing therapeutic recommendations, to resolve
medication related problems;
_____(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
_____(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
_____(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.
_____(43) "Misbranded" means a drug or device that has a label that
is false or misleading in any particular; 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.
_____(44) "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.
_____(45) "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
_____(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;
_____(C) 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;
_____(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.
_____(46) "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.
_____(47) "Pedigree" means a statement or record in a 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
_____(48) "Person" means an individual, corporation, partnership,
association or any other legal entity, including government.
_____(49) "Pharmacist" means an individual currently licensed by
this state to engage in the practice of pharmacist care.
_____(50) "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, elimination or reduction of a patient's symptoms, or arresting or slowing of a disease process and as
provided for in section nine.
_____(51) "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
_____(52) "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, as jointly approved by the board and the
Board of Medicine or the West Virginia Board of Osteopathic
_____(53) "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.
_____(54) "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.
_____(55) "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
_____(56) "Pharmacy Technician" means s person registered with the
board to practice certain tasks related to the practice of
pharmacist care as permitted by the board.
_____(57) "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.
_____(58) "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.
_____(59) "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.
_____(60) "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.
_____(61) "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.
_____(62) "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.
_____(63) "Repackage" means changing the container, wrapper,
quantity, or product labeling of a drug or device to further the
distribution of the drug or device.
_____(64) "Repackager" means a person who repackages.
_____(65) "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.
_____(66) "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.
_____(67) "Valid patient-practitioner relationship" means the
following have been established:
_____(A) A patient has a medical complaint;
_____(B) A medical history has been taken;
_____(C) A face-to-face physical examination adequate to establish
the medical complaint has been performed by the prescribing practitioner or in the instances of telemedicine through
telemedicine practice approved by the appropriate practitioner
_____(D) Some logical connection exists between the medical
complaint, the medical history, and the physical examination and the
_____(68) "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
_____(1) Intracompany sales, being defined as any transaction,
transfer or delivery into or within this state between any division,
subsidiary, parent and/or affiliated or related company under the
common ownership and control of a corporate entity;
_____(2) 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;
_____(3) The sale, purchase or trade of a drug or an offer to sell,
purchase or trade a drug by a 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;
_____(4) 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;
_____(5) 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 twelve consecutive month period;
_____(6) 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
_____(7) 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)];
_____(8) Drug returns by a pharmacy or chain drug warehouse to
wholesale drug distributor or the drug's manufacturer; or
_____(9) The sale, purchase or trade of blood and blood components intended for transfusion.
_____(69) "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
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.
§30-5-5. West Virginia Board of Pharmacy.
_____(a) The West Virginia Board of Pharmacy is continued. The
members of the board in office on July 1, 2013, shall, unless sooner
removed, continue to serve until their respective terms expire and
until their successors have been appointed and qualified.
_____(b) The Governor, by and with the advice and consent of the
Senate, shall appoint:
_____(1) Five members who are licensed to practice pharmacist care
in this state; and
_____(2) Two citizen members, who are not licensed under the provisions of this article, and who do not perform any services
related to the practice of the pharmacist care regulated under the
provisions of this article.
_____(c) After the initial appointment term, the appointment term
is five years. A member may not serve more than two consecutive
terms. A member who has served two consecutive full terms may not
be reappointed for at least one year after completion of his or her
second full term. A member may continue to serve until his or her
successor has been appointed and qualified.
_____(d) Each licensed member of the board, at the time of his or
her appointment, shall have held a license in this state for a
period of not less than three years immediately preceding the
_____(e) Each member of the board shall be a resident of this state
during the appointment term.
_____(f) A vacancy on the board shall be filled by appointment by
the Governor for the unexpired term of the member whose office is
_____(g) The Governor may remove any member from the board for
neglect of duty, incompetency or official misconduct.
_____(h) A licensed member of the board immediately and
automatically forfeits membership to the board if his or her license
to practice is suspended or revoked in any jurisdiction.
_____(i) A member of the board immediately and automatically
forfeits membership to the board if he or she is convicted of a
felony under the laws of any jurisdiction or becomes a nonresident of this state.
_____(j) The board shall elect annually one of its members as
president, one member as vice president and one member as treasurer
who shall serve at the will and pleasure of the board.
_____(k) Each member of the board is entitled to receive
compensation and expense reimbursement in accordance with article
one of this chapter.
_____(l) A simple majority of the membership serving on the board
at a given time is a quorum for the transaction of business.
_____(m) The board shall hold at least two meetings annually. Other
meetings shall be held at the call of the chairperson or upon the
written request of three members, at the time and place as
designated in the call or request.
_____(n) Prior to commencing his or her duties as a member of the
board, each member shall take and subscribe to the oath required by
section five, article four of the Constitution of this state.
_____(o) The members of the board when acting in good faith and
without malice shall enjoy immunity from individual civil liability
while acting within the scope of their duties as board members.
§30-5-6. Powers and duties of the board.
_____The board has all the powers and duties set forth in this
article, by rule, in article one of this chapter and elsewhere in
_____(a) Hold meetings;
_____(b) Establish additional requirements for a license, permit and
_____(c) Establish procedures for submitting, approving and
rejecting applications for a license, permit and registration;
_____(d) Determine the qualifications of any applicant for a
license, permit and registration;
_____(e) Establish the fees charged under the provisions of this
_____(f) Issue, renew, deny, suspend, revoke or reinstate a license,
permit, and registration;_____
_____(g) Prepare, conduct, administer and grade written, oral or
written and oral examinations for a license and registration;
_____(h) Contract with third parties to administer the examinations
required under the provisions of this article;
_____(i) Maintain records of the examinations the board or a third
party administers, including the number of persons taking the
examination and the pass and fail rate;
_____(j) Maintain an office, and hire, discharge, establish the job
requirements and fix the compensation of employees and contract with
persons necessary to enforce the provisions of this article.
Inspectors shall be licensed pharmacists;
_____(k) Investigate alleged violations of the provisions of this
article, legislative rules, orders and final decisions of the board;
_____(l) Conduct disciplinary hearings of persons regulated by the
_____(m) Determine disciplinary action and issue orders;
_____(n) Institute appropriate legal action for the enforcement of
the provisions of this article;
_____(o) Maintain an accurate registry of names and addresses of all
persons regulated by the board;
_____(p) Keep accurate and complete records of its proceedings, and
certify the same as may be necessary and appropriate;
_____(q) Propose rules in accordance with the provisions of article
three, chapter twenty-nine-a of this code to implement the
provisions of this article;
_____(r) Sue and be sued in its official name as an agency of this
_____(s) Confer with the Attorney General or his or her assistant
in connection with legal matters and questions; and
_____(t) Take all other actions necessary and proper to effectuate
the purposes of this article._
§30-5-7. Rule-making authority.
_____(a) The board shall propose rules for legislative approval, in
accordance with the provisions of article three, chapter
twenty-nine-a of this code, to implement the provisions of this
article, and articles two, three, eight, nine and ten of chapter
_____(1) Standards and requirements for a license, permit and
_____(2) Educational and experience requirements;
_____(3) Procedures for examinations and reexaminations;
_____(4) Requirements for third parties to prepare, administer or
prepare and administer examinations and reexaminations;
_____(5) The passing grade on the examination;
_____(6) Procedures for the issuance and renewal of a license,
permit and registration;
_____(7) A fee schedule;
_____(8) Continuing education requirements;
_____(9) Set standards for professional conduct;
_____(10) Establish equipment and facility standards for pharmacies;
_____(11) Approve courses and standards for training pharmacist
_____(12) Regulation of charitable clinic pharmacies;
_____(13) Regulation of mail order pharmacies;
_____(14) Agreements with organizations to form pharmacist recovery
_____(15) Create an alcohol or chemical dependency treatment
_____(16) A ratio of pharmacy technicians to on-duty pharmacist
operating in any outpatient, mail order or institutional pharmacy;
_____(17) Regulation of telepharmacy;
_____(18) The minimum standards for a charitable clinic pharmacy and
rules regarding the applicable definition of a pharmacist-in-charge,
who may be a volunteer, at charitable clinic pharmacies: Provided,
That a charitable clinic pharmacy may not be charged any applicable
licensing fees and such clinics may receive donated drugs.
_____(19) Establish standards for substituted drug products;
_____(20) Establish the regulations for E-prescribing;
_____(21) Establish the proper use of the automated data processing
_____(22) Registration and control of the manufacture and
distribution of controlled substances within this state.
_____(23) Regulation of pharmacies;
_____(24) Sanitation and equipment requirements for wholesalers,
distributers and pharmacies.
_____(25) The procedures for denying, suspending, revoking,
reinstating or limiting the practice of a licensee, permittee or
_____(26) Regulations on prescription paper as provided in section
five, article five-w, chapter sixteen;
_____(27) Regulations on controlled substances as provided in
article two, chapter sixty-a;
_____(28) Regulations on manufacturing, distributing, or dispensing
any controlled substance as provided in article three, chapter
_____(29) Regulations on wholesale drug distribution as provided in
article eight, chapter sixty-a;____
_____(30) Regulations on controlled substances monitoring as
provided in article nine, chapter sixty-a;
_____(31) Regulations on Methamphetamine Laboratory Eradication Act
as provided in article ten, chapter sixty-a; and
_____(32) Any other rules necessary to effectuate the provisions of
_____(b) The board may provide an exemption to the
pharmacist-in-charge requirement for the opening of a new retail
pharmacy or during a declared emergency;
_____(c) The board, the Board of Medicine and the Board of
Osteopathic Medicine shall jointly agree and propose rules
concerning collaborative pharmacy practice for legislative approval
in accordance with the provisions of article three, chapter
twenty-nine-a of the code;
_____(d) The board with the advice of the Board of Medicine and the
Board of Osteopathic Medicine shall propose rules for legislative
approval in accordance with the provisions of article three, chapter
twenty-nine-a of this code to perform influenza and pneumonia
immunizations, on a person of eighteen years of age or older. These
rules shall provide, at a minimum, for the following:
_____(1) Establishment of a course, or provide a list of approved
courses, in immunization administration. The courses shall be based
on the standards established for such courses by the Centers for
Disease Control and Prevention in the public health service of the
United States Department of Health and Human Services;
_____(2) Definitive treatment guidelines which shall include, but
not be limited to, appropriate observation for an adverse reaction
of an individual following an immunization;
_____(3) Prior to administration of immunizations, a pharmacist
shall have completed a board approved immunization administration
course and completed an American Red Cross or American Heart
Association basic life-support training, and maintain certification
in the same.
_____(4) Continuing education requirements for this area of
_____(5) Reporting requirements for pharmacists administering
immunizations to report to the primary care physician or other
licensed health care provider as identified by the person receiving
_____(6) Reporting requirements for pharmacists administering
immunizations to report to the West Virginia Statewide Immunization
_____(7) That a pharmacist may not delegate the authority to
administer immunizations to any other person; unless administered
by a licensed pharmacy intern under the direct supervision of a
pharmacist of whom both pharmacist and intern have successfully
completed all board required training.
_____(8) Any other provisions necessary to implement the provisions
of this section.
_____(e) The board, the Board of Medicine and the Board of
Osteopathic Medicine shall propose joint rules for legislative
approval in accordance with the provisions of article three, chapter
twenty-nine-a of this code to permit licensed pharmacists to
administer other immunizations such as Hepatitis A, Hepatitis B,
Herpes Zoster and Tetanus. These rules shall provide, at a minimum,
the same provisions contained in subsection (d)(1) through (d)(8)
of this section.
All of the board's rules in effect and not in conflict with
these provisions, shall remain in effect until they are amended or
_____§30-5-8. Fees; special revenue account; administrative fines.
_____(a) All fees and other moneys, except fines, received by the
board shall be deposited in a separate special revenue fund in the
State Treasury designated the "Board of Pharmacy Fund", which fund
is continued. The fund is used by the board for the administration
of this article. Except as may be provided in article one of this
chapter, the board shall retain the amounts in the special revenue
account from year to year. Any compensation or expense incurred
under this article is not a charge against the General Revenue Fund.
_____(b) The board shall deposit any amounts received as
administrative fines imposed pursuant to this article into the
General Revenue Fund of the State Treasury.
§30-5-9. Qualifications for licensure as pharmacist;
_____(a) To be eligible for a license to practice pharmacist care
under the provisions of this article, the applicant shall:
_____(1) Submit a written application to the board;
_____(2) Be eighteen years of age or older;
_____(3) Pay all applicable fees;
_____(4) Graduate from an accredited school of pharmacy;
_____(5) Complete at least fifteen hundred hours of internship in
a pharmacy under the instruction and supervision of a pharmacist;
_____(6) Pass an examination or examinations approved by the board;
_____(7) Not be an alcohol or drug abuser, as these terms are
defined in section eleven, article one-a, chapter twenty-seven of
this code: Provided, That an applicant in an active recovery
process, which may, in the discretion of the board, be evidenced by
participation in a twelve-step program or other similar group or process, may be considered;
_____(8) Present to the board satisfactory evidence that he or she
is a person of good moral character, has not been convicted of a
felony involving controlled substances or violent crime;
_____(9) Not been convicted in any jurisdiction of a felony or any
crime which bears a rational nexus to the individual's ability to
practice pharmacist care; and
_____(10) Has fulfilled any other requirement specified by the board
_____(b) An applicant from another jurisdiction shall comply with
all the requirements of this article.
§30-5-10. Scope practice for licensed pharmacist;
_____(a) A licensed pharmacist may:
_____(1) Provide care related to the interpretation, evaluation, and
implementation of medical orders;
_____(2) Dispense of prescription drug orders; participate in drug
and device selection;
_____(3) Provide drug administration;
_____(4) Provide drug regimen review;
_____(5) Provide drug or drug-related research;
_____(6) Perform patient counseling;
_____(7) Provide pharmacy related primary care;
_____(8) Provide pharmacist care in all areas of patient care,
including collaborative pharmacy practice;
_____(9) Compound and label drugs and drug devices;
_____(10) Proper and safe storage of drugs and devices;
_____(11) Maintain proper records;
_____(12) Provide patient counseling concerning the therapeutic
value and proper use of drugs and devices;
_____(13) Order laboratory tests in accordance with drug therapy
_____(14) Provide medication therapy management.
_____(b) A licensee meeting the requirements as promulgated by
legislative rule may administer immunizations.
§30-5-11. Registration of pharmacy technicians;
_____(a) To be eligible for registration as a pharmacy technician
to assist in the practice of pharmacist care, the applicant shall:
_____(1) Submit a written application to the board;
_____(2) Pay the applicable fees;
_____(3) Have graduated from high school or obtained a Certificate
of General Educational Development (GED) or equivalent;
_____(A) Graduated from a competency-based pharmacy technician
education and training program as approved by legislative rule of
the board; or
_____(B)Completed a pharmacy provided, competency-based education
and training program approved by the board;
_____(5) Effective July 1, 2014, have successfully passed an
examination developed using nationally recognized and validated
psychometric and pharmacy practice standards approved by the board;
_____(6) Not be an alcohol or drug abuser, as these terms are
defined in section eleven, article one-a, chapter twenty-seven of this code: Provided, That an applicant in an active recovery
process, which may, in the discretion of the board, be evidenced by
participation in a twelve-step program or other similar group or
process, may be considered;
_____(8) Not have been convicted of a felony in any jurisdiction
within ten years preceding the date of application for license,
which conviction remains unreversed;
_____(9) Not have been convicted of a misdemeanor or felony in any
jurisdiction if the offense for which he or she was convicted
bearing a rational nexus to the practice of pharmacist care, which
conviction remains unreversed; and
_____(10) Have fulfilled any other requirement specified by the
board in rule._
_____(b) A person whose license to practice pharmacist care has been
denied, revoked, suspended, or restricted for disciplinary purposes
in any jurisdiction is not eligible to be registered as a pharmacy
_____(c) A person registered to assist in the practice pharmacist
care issued by the board prior to June 30, 2014, shall for all
purposes be considered registered under this article and may renew
pursuant to the provisions of this article.
§30-5-12. Scope practice for registered pharmacy technician.
_____(a) A registered pharmacy technician shall, under the direct
supervision of the licensed pharmacist, but is not limited to,
perform the following:
_____(1) Assist in the dispensing process;
_____(2) Receive new written or electronic prescription drug orders;
_____(3) Compound; and
_____(4) Stock of medications._____
_____(b) A registered pharmacy technician may perform the following
under indirect supervision:
_____(1) Process medical coverage claims; and
_____(c) A registered pharmacy technician may not perform the
_____(1) Drug regimen review;
_____(2) Clinical conflict resolution;
_____(3) Contact a prescriber concerning prescription drug order
clarification or therapy modification;
_____(4) Patient counseling;
_____(5) Dispense process validation;
_____(6) Prescription transfer; and
_____(7) Receive new oral prescription drug orders.
_____(d) Indirect supervision of a registered pharmacy technician
is permitted to allow a pharmacist to take one break of no more than
thirty minutes during any contiguous eight-hour period. The
pharmacist may leave the pharmacy area but may not leave the
building during the break. When a pharmacist is on break, a
pharmacy technician may continue to prepare prescriptions for the
pharmacist's verification. A prescription may not be delivered
until the pharmacist has verified the accuracy of the prescription,
and counseling, if required, has been provided to or refused by the patient.
_____(e) A pharmacy that permits indirect supervision of a pharmacy
technician during a pharmacist's break shall have either an
interactive voice response system or a voice mail system installed
on the pharmacy phone line in order to receive new prescription
orders and refill authorizations during the break.
_____(f) The pharmacy shall establish protocols that require a
registered pharmacy technician to interrupt the pharmacist's break
if an emergency arises.
§30-5-13. Pharmacist interns.
_____(a) To be eligible for a license to assist in the practice of
pharmacist care as a pharmacy intern, the applicant shall be:
_____(1) Enrolled and progressing to obtain a degree in a
professional degree program of a school or college of pharmacy that
has been approved by the board, and is satisfactorily progressing
toward meeting the requirements for licensure as a pharmacist; or
_____(2) A graduate of an approved professional degree program of
a school or college of pharmacy or a graduate who has established
educational equivalency by obtaining a Foreign Pharmacy Graduate
Examination Committee Certificate, who is currently licensed by the
board for the purpose of obtaining practical experience as a
requirement for licensure as a pharmacist; or
_____(3) A qualified applicant awaiting examination for licensure
or meeting board requirements for relicensure; or
_____(4) An individual participating in a pharmacy residency or
§30-5-14. Prohibiting the dispensing of prescription orders in _
_____absence of practitioner-patient relationship.
_____A pharmacist may not compound or dispense any prescription
order when he or she has knowledge that the prescription was issued
by a practitioner without establishing a valid practitioner-patient
relationship. An online or telephonic evaluation by questionnaire,
or an online or telephonic consultation, is inadequate to establish
a valid practitioner-patient relationship: Provided, That this
prohibition does not apply:
_____(1) In a documented emergency;
_____(2) In an on-call or cross-coverage situation; or
_____(3) Where patient care is rendered in consultation with another
practitioner who has an ongoing relationship with the patient and
who has agreed to supervise the patient's treatment, including the
use of any prescribed medications.
§30-5-15. Reciprocal licensure of pharmacists from other states or
_____(a) The board may by reciprocity license pharmacists in this
state who have been authorized to practice pharmacist care in
another state: Provided, That the applicant for licensure meets the
requirements of the rules for reciprocity promulgated by the board
in accordance with the provisions of chapter twenty-nine-a of this
code: Provided, however, That reciprocity is not authorized for
pharmacists from another state where that state does not permit
reciprocity to pharmacists licensed in West Virginia.
_____(b) The board may refuse reciprocity to pharmacists from
another country unless the applicant qualifies under the legislative
rules as may be promulgated by the board for licensure of foreign
§30-5-16. Renewal requirements.
_____(a) All persons regulated by this article shall annually or
biannually, renew his or her board authorization by completing a
form prescribed by the board and submitting any other information
required by the board.
_____(b) The board shall charge a fee for each renewal of an board
authorization and shall charge a late fee for any renewal not paid
by the due date.____
_____(c) The board shall require as a condition of renewal that each
licensee or registrant complete continuing education.
_____(d) The board may deny an application for renewal for any
reason which would justify the denial of an original application.
_____(e) After June 30, 2014, a previously registered pharmacist
technician may renew his or her current registration without having
successfully completed subdivision six, subsection (a), of section
ten. The previously registered pharmacist may continue to renew his
or her registration under this provision.
§30-5-17. Special volunteer pharmacist license; civil immunity for
voluntary services rendered to indigents.
_____(a) There is a special volunteer pharmacist license for
pharmacists retired or retiring from the active practice of pharmacist care who wish to donate their expertise for the
pharmacist care and treatment of indigent and needy patients in the
clinic setting of clinics organized, in whole or in part, for the
delivery of health care services without charge. The special
volunteer pharmacist license shall be issued by the board to
pharmacists licensed or otherwise eligible for licensure under this
article and the legislative rules promulgated hereunder without the
payment of an application fee, license fee or renewal fee, and the
initial license shall be issued for the remainder of the licensing
period, and renewed consistent with the boards other licensing
requirements. The board shall develop application forms for the
special license provided in this subsection which shall contain the
pharmacist's acknowledgment that:
_____(1) The pharmacist's practice under the special volunteer
pharmacist license shall be exclusively devoted to providing
pharmacist care to needy and indigent persons in West Virginia;
_____(2) The pharmacist may not receive any payment or compensation,
either direct or indirect, or have the expectation of any payment
or compensation, for any pharmacist care rendered under the special
volunteer pharmacist license;
_____(3) The pharmacist will supply any supporting documentation
that the board may reasonably require; and
_____(4) The pharmacist agrees to continue to participate in
continuing professional education as required by the board for the
special volunteer pharmacist license.
_____(b) Any pharmacist who renders any pharmacist care to indigent and needy patients of a clinic organized, in whole or in part, for
the delivery of health care services without charge under a special
volunteer pharmacist license authorized under subsection (a) of this
section without payment or compensation or the expectation or
promise of payment or compensation is immune from liability for any
civil action arising out of any act or omission resulting from the
rendering of the pharmacist care at the clinic unless the act or
omission was the result of the pharmacist's gross negligence or
willful misconduct. In order for the immunity under this subsection
to apply, there shall be a written agreement between the pharmacist
and the clinic pursuant to which the pharmacist provides voluntary
uncompensated pharmacist care under the control of the clinic to
patients of the clinic before the rendering of any services by the
pharmacist at the clinic: Provided, That any clinic entering into
such written agreement is required to maintain liability coverage
of not less than $1 million per occurrence.
_____(c) Notwithstanding the provisions of subsection (b) of this
section, a clinic organized, in whole or in part, for the delivery
of health care services without charge is not relieved from imputed
liability for the negligent acts of a pharmacist rendering voluntary
pharmacist care at or for the clinic under a special volunteer
pharmacist license authorized under subsection (a) of this section.
_____(d) For purposes of this section, "otherwise eligible for
licensure" means the satisfaction of all the requirements for
licensure as listed in section eight of this article and in the
legislative rules promulgated thereunder, except the fee requirements of that section and of the legislative rules
promulgated by the board relating to fees.
_____(e) Nothing in this section may be construed as requiring the
board to issue a special volunteer pharmacist license to any
pharmacist whose license is or has been subject to any disciplinary
action or to any pharmacist who has surrendered a license or caused
such license to lapse, expire and become invalid in lieu of having
a complaint initiated or other action taken against his or her
license, or who has elected to place a pharmacist license in
inactive status in lieu of having a complaint initiated or other
action taken against his or her license, or who has been denied a
_____(f) Any policy or contract of liability insurance providing
coverage for liability sold, issued or delivered in this state to
any pharmacist covered under the provisions of this article shall
be read so as to contain a provision or endorsement whereby the
company issuing such policy waives or agrees not to assert as a
defense on behalf of the policyholder or any beneficiary thereof,
to any claim covered by the terms of such policy within the policy
limits, the immunity from liability of the insured by reason of the
care and treatment of needy and indigent patients by a pharmacist
who holds a special volunteer pharmacist license.
§30-5-18. Pharmacist requirements to participate in a
collaborative pharmacy practice agreement.
_____For a pharmacist to participate in a collaborative pharmacy
practice agreement, the pharmacist shall:
_____(a) Have an unrestricted and current license to practice as a
pharmacist in West Virginia;
_____(b) Personally have or have employer coverage of at least $1
million of professional liability insurance coverage;
_____(c) Meet one of the following qualifications, at a minimum:
_____(1) Earned a Certification from the Board of Pharmaceutical
Specialties, is a Certified Geriatric Practitioner, or has completed
an American Society of Health System Pharmacists(ASHP) accredited
residency program, which includes two years of clinical experience
approved by the board; or
_____(2) Successfully completed the course of study and holds the
academic degree of Doctor of Pharmacy and has three years of
clinical experience approved by th board and has completed an
Accreditation Council for Pharmacy Education (ACPE) approved
practice based continuing pharmacy education activity in the area
of practice covered by the collaborative pharmacy practice
_____(3) Successfully completed the course of study and hold the
academic degree of Bachelor of Science in Pharmacy and has five
years of clinical experience approved by the board and has completed
two ACPE approved practice based continuing pharmacy education
with at least one program in the area of practice covered
by a collaborative pharmacy practice agreement.
§30-5-19. Collaborative pharmacy practice agreement.
_____(a) A pharmacist engaging in collaborative pharmacy practice
shall have on file at his or her place of practice the collaborative pharmacy practice agreement. The existence and subsequent
termination of the agreement and any additional information the
rules may require concerning the agreement, including the agreement
itself, shall be made available to the appropriate licensing board
for review upon request. The agreement may allow the pharmacist,
within the pharmacist's scope of practice pursuant to the
collaborative pharmacy practice agreement, to conduct drug therapy
management activities approved by the collaborating physician. The
collaborative pharmacy practice agreement shall be a voluntary
process, which is a physician directed approach, that is entered
into between an individual physician or physician group, an
individual pharmacist or pharmacists and an individual patient or
the patient's authorized representative who has given informed
consent as per subsection (c).
_____(b) A collaborative pharmacy practice agreement may authorize
a pharmacist to provide drug therapy management. In instances where
drug therapy is discontinued, the pharmacist shall notify the
treating physician of the discontinuance in the time frame and in
the manner established by joint legislative rules. Each protocol
developed, pursuant to the collaborative pharmacy practice
agreement, shall contain detailed direction concerning the services
that the pharmacists may perform for that patient. The protocol
shall include, but need not be limited to:
_____(1) The specific drug or drugs to be managed by the pharmacist;
_____(2) The terms and conditions under which drug therapy may be
implemented, modified or discontinued;
_____(3) The conditions and events upon which the pharmacist is
required to notify the physician; and
_____(4) The laboratory tests that may be ordered in accordance with
drug therapy management.
_____(c) All activities performed by the pharmacist in conjunction
with the protocol shall be documented in the patient's medical
record. The pharmacists shall report at least every thirty days to
the physician regarding the patient's drug therapy management. The
collaborative pharmacy practice agreement and protocols shall be
available for inspection by the board, the West Virginia Board of
Medicine, or the West Virginia Board of Osteopathic Medicine,
depending on the licensing board of the participating physician.
A copy of the protocol shall be filed in the patient's medical
_____(d) Collaborative pharmacy agreements may not include the
management of controlled substances.
_____(e) A collaborative pharmacy practice agreement, meeting the
requirements herein established and in accordance with joint rules,
shall be allowed in the hospital setting, the nursing home setting,
the medical school setting and the hospital, community-based
pharmacy setting and ambulatory care clinics. The pharmacist shall
be employed by or under contract to provide services to the
hospital, pharmacy, nursing home or medical school, or hold a
faculty appointment with one of the schools of pharmacy or medicine
in this state.
_____(f) Nothing pertaining to collaborative pharmacy practice shall be interpreted to permit a pharmacist to accept delegation of a
physician's authority outside the limits included in the appropriate
board's statute and rules.
§30-5-20. Board authorizations shall be displayed.
_____(a) The board shall prescribe the form for an board
authorization, and may issue a duplicate upon payment of a fee.
_____(b) Any person regulated by the article shall conspicuously
display his or her board authorization at his or her principal
§30-5-21. Responsibility for quality of drugs dispensed;
exception; falsification of labels; deviation from
_____(a) All persons, whether licensed pharmacists or not, shall be
responsible for the quality of all drugs, chemicals and medicines
they may sell or dispense, with the exception of those sold in or
dispensed unchanged from the original retail package of the
manufacturer, in which event the manufacturer shall be responsible.
_____(b) Except as provided in section twenty-one of this article,
the following acts shall be prohibited:
_____(1) The falsification of any label upon the immediate
container, box and/or package containing a drug;
_____(2) The substitution or the dispensing of a different drug in
lieu of any drug prescribed in a prescription without the approval
of the practitioner authorizing the original prescription:
Provided, That this may not be construed to interfere with the art of prescription compounding which does not alter the therapeutic
properties of the prescription or appropriate generic substitute;
_____(3) The filling or refilling of any prescription for a greater
quantity of any drug or drug product than that prescribed in the
original prescription without a written or electronic order or an
oral order reduced to writing, or the refilling of a prescription
without the verbal, written or electronic consent of the
practitioner authorizing the original prescription.
§30-5-22. Pharmacies to be registered.
_____(a) A pharmacy, an ambulatory health care facility, and a
charitable clinic pharmacy shall register with the board.
_____(b) A person desiring to operate, maintain, open or establish
a pharmacy shall register with the board.
_____(c) To be eligible for a registration to operate, maintain,
open or establish a pharmacy the applicant shall:
_____(1) Submit a written application to the board;
_____(2) Pay all applicable fees;
_____(3) Designate a pharmacist-in-charge;
_____(4) Successfully complete an inspection by the board.
_____(d) A separate application shall be made and separate permits
issued for each location.
_____(e) Permits are not transferable.
_____(f) Permits expire and shall be renewed annually.
_____(g) If a permit expires, the pharmacy shall be reinspected and
an inspection fee is required.
_____(h) A registrant shall employ a pharmacist-in-charge and operate in compliance with the legislative rules governing the
practice of pharmacist care and the operation of a pharmacy.
_____(i) The provisions of this section do not apply to the sale of
nonprescription drugs which are not required to be dispensed
pursuant to a practitioner's prescription.
_____(a) A pharmacy shall be under the direction and supervision of
a licensed pharmacist who shall be designated by the owner of the
pharmacy as the pharmacist-in-charge: Provided that, the Board may
permit by rule for a charitable clinic pharmacy to be supervised by
a committee of pharmacists-in-charge who accept as a group the
responsibilities of the required pharmacist-in-charge. This
designation shall be filed with the board within thirty days of the
_____(b) The pharmacist-in-charge is responsible for the pharmacy's
compliance with state and federal pharmacy laws and regulations and
for maintaining records and inventory.
_____(c) A pharmacist-in-charge may not hold such designated
position at more than one pharmacy, whether within or outside the
State of West Virginia: Provided that, the Board may permit by rule
that he or she may volunteer as the pharmacist-in-charge at a
charitable clinic pharmacy while serving as a pharmacist-in-charge
in another pharmacy.
_____(d) An interim pharmacist-in-charge may be designated for a
period not to exceed sixty days. The request for an interim
pharmacist-in-charge shall detail the circumstances which warrant the change. This change in designation shall be filed with the
board within thirty days of the designation.
§30-5-24. Permits for mail-order pharmacy.
_____(a) A mail-order pharmacy which dispenses drugs shall register
with the board.
_____(b) A mail-order pharmacy shall submit an application for a
permit to the board. The application shall require the following
_____(1) The owner of the mail-order pharmacy, whether an
individual, a partnership, or a corporation.
_____(2) The names and titles of all individual owners, partners or
_____(3) The pharmacy manager.
_____(4) The pharmacist-in-charge.
_____(5) The complete address, telephone number and fax number of
the mail-order pharmacy.
_____(c) This section does not apply to any mail-order pharmacy
which operates solely as a wholesale distributor.
§30-5-25. Permit for manufacture and packaging of drugs,
medicines, distribution of prescription drugs.
_____(a) Drugs may not be manufactured, made, produced, packed,
packaged or prepared within the state, except under the personal
supervision of a pharmacist or other qualified person as may be
approved by the board;
_____(b) A person may not manufacture, package or prepare a drug without obtaining a permit from the board.
_____(c) A person, who offers for sale, sells, offers for sale
through the method of distribution any legend drugs is subject to
_____(d) The application for a permit shall be made on a form to be
prescribed and furnished by the board and shall be accompanied by
an application fee.
_____(e) The board shall promulgate rules on permit requirements and
_____(f) Separate applications shall be made and separate permits
issued for each place of manufacture, distribution, making,
producing, packing, packaging or preparation.
§30-5-26. Filling of prescriptions more than one year after ____
_____A prescription order may not be dispensed after twelve months
from the date of issuance by the practitioner. A pharmacist may
fill the prescription after twelve months if the prescriber confirms
to the pharmacist that he or she still wants the prescription filled
and the pharmacist documents upon the prescription that the
confirmation was obtained.
§30-5-27. Partial filling of prescriptions.
_____(a) The partial filling of a prescription is permissible for
any prescription if the pharmacist is unable to supply, or the
patient requests less than the full quantity called for in a
written, electronic, or oral prescription, provided the pharmacist makes a notation of the quantity supplied on either the written
prescription or in the electronic record.
_____(b) The partial filling of a prescription for a controlled
substance listed in Schedule II is permissible if the pharmacist is
unable to supply or the patient requests less than the full quantity
called for in the prescription. The remaining portion of the
prescription may be filled within seventy-two hours of the first
partial filling: Provided, That if the remaining portion is not or
cannot be filled within the seventy-two hour period, the pharmacist
shall notify the prescribing individual practitioner. Further
quantity may not be supplied beyond seventy-two hours without a new
§30-5-28. Partial filling of prescriptions for long-term care __
facility or terminally ill patients; requirements; records; _____
_____(a) As used in this section, "long-term care facility" or
"LTCF" means any nursing home, personal care home, or residential
board and care home as defined in section two, article five-c,
chapter sixteen of this code which provides extended health care to
resident patients: Provided, That the care or treatment in a
household, whether for compensation or not, of any person related
by blood or marriage, within the degree of consanguinity of second
cousin to the head of the household, or his or her spouse, may not
be deemed to constitute a nursing home, personal care home or
residential board and care home within the meaning of this article. This section does not apply to:
_____(1) Hospitals, as defined under section one, article five-b,
chapter sixteen of this code or to extended care facilities operated
in conjunction with a hospital;
_____(2) State institutions as defined in section six, article one,
chapter twenty-seven or in section three, article one, chapter
twenty-five, all of this code;
_____(3) Nursing homes operated by the federal government;
_____(4) Facilities owned or operated by the state government;
_____(5) Institutions operated for the treatment and care of
_____(6) Offices of physicians; or
_____(7) Hotels, boarding homes or other similar places that furnish
to their guests only a room and board.
_____(b) As used in this section, "terminally ill" means that an
individual has a medical prognosis that his or her life expectancy
is six months or less.
_____(c) Schedule II prescriptions for patients in a LTCF and for
terminally ill patients shall be valid for a period of sixty days
from the date of issue unless terminated within a shorter period by
the discontinuance of the medication.
_____(d) A prescription for a Schedule II controlled substance
written for a patient in a LTCF or for a terminally ill patient may
be filled in partial quantities, including, but not limited to,
individual dosage units. The total quantity of Schedule II
controlled substances dispensed in all partial filling may not exceed the total quantity prescribed.
_____(1) If there is any question whether a patient may be
classified as having a terminal illness, the pharmacist shall
contact the prescribing practitioner prior to partially filling the
_____(2) Both the pharmacist and the prescribing practitioner have
a corresponding responsibility to assure that the controlled
substance is for a terminally ill patient.
_____(e) The pharmacist shall record on the prescription that the
patient is "terminally ill" or a "LTCF patient". A prescription
that is partially filled and does not contain the notation
"terminally ill" or "LTCF patient" shall be deemed to have been
filled in violation of section three hundred eight, article three,
chapter sixty-a of this code.
_____(f) For each partial filling, the dispensing pharmacist shall
record on the back of the prescription, or on another appropriate
record which is readily retrievable, the following information:
_____(1) The date of the partial filling;
_____(2) The quantity dispensed;
_____(3) The remaining quantity authorized to be dispensed; and
_____(4) The identification of the dispensing pharmacist.
_____(g) Information pertaining to current Schedule II prescriptions
for terminally ill and LTCF patients may be maintained in a
computerized system if such a system has the capability to permit
either by display or printout, for each patient and each medication,
all of the information required by this section as well as the patient's name and address, the name of each medication, original
prescription number, date of issue, and prescribing practitioner
information. The system shall also allow immediate updating of the
prescription record each time a partial filling of the prescription
is performed and immediate retrieval of all information required
under this section.
§30-5-29. Limitations of article.
_____(a) This article may not be construed to prevent, restrict or
in any manner interfere with the sale of nonnarcotic nonprescription
drugs which may be lawfully sold without a prescription in
accordance with the United States Food, Drug and Cosmetic Act or the
laws of this state, nor may any legislative rule be adopted by the
board which shall require the sale of nonprescription drugs by a
licensed pharmacist or in a pharmacy or which shall prevent,
restrict or otherwise interfere with the sale or distribution of
such drugs by any retail merchant. The sale or distribution of
nonprescription drugs may not be deemed to be improperly engaging
in the practice of pharmacist care.
_____(b) This article may not be construed to interfere with any
legally qualified practitioner of medicine, dentistry or veterinary
medicine, who is not the proprietor of the store for the dispensing
or retailing of drugs and who is not in the employ of such
proprietor, in the compounding of his or her own prescriptions or
to prevent him or her from supplying to his or her patients such
medicines as he or she may deem proper, if such supply is not made
as a sale.
_____(c) The exception provided in subsection (b) of this section
does not apply to an ambulatory health care facility: Provided,
That a legally licensed and qualified practitioner of medicine or
dentistry may supply medicines to patients that he or she treats in
a free clinic and that he or she deems appropriate.
§30-5-30. Actions to enjoin violations.
_____(a) If the board obtains information that any person has
engaged in, is engaging in or is about to engage in any act which
constitutes or will constitute a violation of the provisions of this
article, the rules promulgated pursuant to this article, or a final
order or decision of the board, it may issue a notice to the person
to cease and desist in engaging in the act and/or apply to the
circuit court in the county of the alleged violation for an order
enjoining the act.
_____(b) The circuit court may issue a temporary injunction pending
a decision on the merits, and may issue a permanent injunction based
on its findings in the case.
_____(c) The judgment of the circuit court on an application
permitted by the provisions of this section is final unless
reversed, vacated or modified on appeal to the West Virginia Supreme
Court of Appeals.
§30-5-31. Complaints; investigations; due process procedure;____
_____grounds for disciplinary action.
_____(a) The board may initiate a complaint upon receipt of credible
information, and shall upon the receipt of a written complaint of any person, cause an investigation to be made to determine whether
grounds exist for disciplinary action under this article or the
legislative rules promulgated pursuant to this article.
_____(b) After reviewing any information obtained through an
investigation, the board shall determine if probable cause exists
that the licensee, registrant or permittee has violated subsection
(g) of this section or rules promulgated pursuant to this article.
_____(c) Upon a finding of probable cause to go forward with a
complaint, the board shall provide a copy of the complaint to the
licensee, registrant or permittee.
_____(d) Upon a finding that probable cause exists that the
licensee, registrant or permittee has violated subsection (g) of
this section or rules promulgated pursuant to this article, the
board may enter into a consent decree or hold a hearing for
disciplinary action against the licensee, registrant or permittee.
Any hearing shall be held in accordance with the provisions of this
article, and shall require a violation to be proven by a
preponderance of the evidence.
_____(e) Any member of the board or the executive director of the
board may issue subpoenas and subpoenas duces tecum to obtain
testimony and documents to aid in the investigation of allegations
against any person regulated by the article.
_____(f) Any member of the board or its executive director may sign
a consent decree or other legal document on behalf of the board.
_____(g) The board may, after notice and opportunity for hearing,
deny or refuse to renew, suspend, restrict or revoke the license, registration or permit of, or impose probationary conditions upon
or take disciplinary action against, any licensee, registrant or
permittee for any of the following reasons:
_____(1) Obtaining a board authorization by fraud, misrepresentation
or concealment of material facts;
_____(2) Being convicted of a felony or other crime involving drugs,
violent crime, or moral turpitude, or engaging in any act involving
moral turpitude or gross immorality;
_____(3) Being guilty of unprofessional conduct which placed the
public at risk, as defined by legislative rule of the board;
_____(4) Intentional violation of a lawful order or legislative rule
of the board;
_____(5) Having had a board authorization revoked or suspended,
other disciplinary action taken, or an application for a board
authorization revoked or suspended by the proper authorities of
_____(6) Aiding or abetting unlicensed practice;
_____(7) Engaging in an act while acting in a professional capacity
which has endangered or is likely to endanger the health, welfare
or safety of the public;
_____(8) Incapacity that prevents a licensee or registrant from
engaging in the practice of pharmacist care or assisting in the
practice of pharmacist care, with reasonable skill, competence, and
safety to the public;
_____(9) Violation of any laws, including rules pertaining thereto,
of this or any other jurisdiction, relating to the practice of pharmacist care, drug samples, drug manufacturing, wholesale or
retail drug or device distribution, or controlled substances;
_____(10) Committing fraud in connection with the practice of
_____(11) Disciplinary action taken by another state or jurisdiction
against a board authorization to practice pharmacist care based upon
conduct by the licensee, registrant or permittee similar to conduct
that would constitute grounds for actions as defined in this
_____(12) Failure to report to the board any adverse action taken
by another licensing jurisdiction, government agency, law-
enforcement agency, or court for conduct that would constitute
grounds for action as defined in this section;
_____(13) Failure to report to the board one's surrender of a
license or authorization to practice pharmacist care in another
jurisdiction while under disciplinary investigation by any of those
authorities or bodies for conduct that would constitute grounds for
action as defined in this section;
_____(14) Failure to report to the board any adverse judgment,
settlement, or award arising from a malpractice claim arising
related to conduct that would constitute grounds for action as
defined in this section;
_____(15) Knowing or suspecting that a licensee or registrant is
incapable of engaging in the practice of pharmacist care or
assisting in the practice of pharmacist care, with reasonable skill,
competence, and safety to the public, and failing to report any relevant information to the board;
_____(16) Illegal use or disclosure of protected health information;
_____(17) Engaging in any conduct that subverts or attempts to
subvert any licensing examination or the administration of any
_____(18) Failure to furnish to the board or its representatives any
information legally requested by the board, or failure to cooperate
with or engaging in any conduct which obstructs an investigation
being conducted by the board;
_____(19) Agree to participate in a prescription drug product
conversion program promoted or offered by a manufacturer, wholesaler
or distributor of such product for which the pharmacist or pharmacy
received any form of financial remuneration, or agreed to
participate in a prescription drug program in which the pharmacist
or pharmacy is promoted or offered as the exclusive provider of
prescription drug products or whereby in any way the public is
denied, limited or influenced in selecting pharmacist care or
_____(20) Violation of any of the terms or conditions of any order
entered in any disciplinary action.
_____(h) For the purposes of subsection (g) of this section,
effective July 1, 2013, disciplinary action may include:
_____(6) Administrative fine, not to exceed $1,000 per day per
_____(7) Mandatory attendance at continuing education seminars or
_____(8) Practicing under supervision or other restriction; or
_____(9) Requiring the licensee, registrant or permittee to report
to the board for periodic interviews for a specified period of time.
_____(i) In addition to any other sanction imposed, the board may
require a licensee, registrant or permittee to pay the costs of the
_____(j) The board may defer disciplinary action with regard to an
impaired licensee or registrant who voluntarily signs an agreement,
in a form satisfactory to the board, agreeing not to practice
pharmacist care and to enter an approved treatment and monitoring
program in accordance with the board's legislative rule. This
subsection, provided that this section should not apply to a
licensee or registrant who has been convicted of, pleads guilty to,
or enters a plea of nolo contendere or a conviction relating to a
controlled substance in any jurisdiction.
_____(k) Nothing shall be construed as barring criminal prosecutions
for violations of this article.
_____(l) A person authorized to practice under this article, who
reports or otherwise provides evidence of the negligence, impairment
or incompetence of another member of this profession to the board
or to any peer review organization, is not liable to any person for making such a report if such report is made without actual malice
and in the reasonable belief that such report is warranted by the
facts known to him or her at the time.
§30-5-32. Procedures for hearing; right of appeal.
_____(a) Hearings are governed by the provisions of section eight,
article one of this chapter.
_____(b) The board may conduct the hearing or elect to have an
administrative law judge conduct the hearing.
_____(c) If the hearing is conducted by an administrative law judge,
at the conclusion of a hearing he or she shall prepare a proposed
written order containing findings of fact and conclusions of law.
The proposed order may contain proposed disciplinary actions if the
board so directs. The board may accept, reject or modify the
decision of the administrative law judge.
_____(d) Any member or the executive director of the board has the
authority to administer oaths, examine any person under oath and
issue subpoenas and subpoenas duces tecum.
_____(e) If, after a hearing, the board determines the licensee,
registrant or permittee has violated provisions of this article or
the board's rules, a formal written decision shall be prepared which
contains findings of fact, conclusions of law and a specific
description of the disciplinary actions imposed.
§30-5-33. Judicial review.
_____Any person adversely affected by a decision of the board
entered after a hearing may obtain judicial review of the decision
in accordance with section four, article five, chapter twenty-nine-a of this code, and may appeal any ruling resulting from judicial
review in accordance with article six, chapter twenty-nine-a of this
§30-5-34. Criminal proceedings; penalties.
_____(a) When, as a result of an investigation under this article
or otherwise, the board has reason to believe that a person
authorized under this article has committed a criminal offense under
this article, the board may bring its information to the attention
of an appropriate law-enforcement official.
_____(b) Any person, who violates any of the provisions of this
article is guilty of a misdemeanor, and, upon conviction, shall be
fined not to exceed $50 for the first offense, and upon conviction
of a second offense shall be fined not less than $50 nor more than
$500, or shall be imprisoned in the county jail not to exceed thirty
days, or both fined and imprisoned. Each and every day that the
violation continues shall constitute a separate offense.____
CHAPTER 60A. UNIFORM CONTROLLED SUBSTANCES ACT.
ARTICLE 10. METHAMPHETAMINE LABORATORY ERADICATION ACT.
In this article:
(a) "Board of Pharmacy" or "board" means the West Virginia
Board of Pharmacy established by the provisions of article five,
chapter thirty of this code.
(b) "Designated precursor" means any drug product made subject
to the requirements of this article by the provisions of section seven of this article.
(c) "Distributor" means any person within this state or another
state, other than a manufacturer or wholesaler, who sells, delivers,
transfers or in any manner furnishes a drug product to any person
who is not the ultimate user or consumer of the product.
(d) "Drug product" means a pharmaceutical product that contains
ephedrine, pseudoephedrine or phenylpropanolamine or a substance
identified on the supplemental list provided in section seven of
this article which may be sold without a prescription and which is
labeled for use by a consumer in accordance with the requirements
of the laws and rules of this state and the federal government.
(e) "Ephedrine " means ephedrine, its salts or optical isomers
or salts of optical isomers.
(f) "Manufacturer" means any person within this state who
produces, compounds, packages or in any manner initially prepares
for sale or use any drug product or any such person in another state
if they cause the products to be compounded, packaged or transported
into this state.
(g) "National Association of Drug Diversion Investigators" or
"NADDI" means the non-profit 501(c)(3) organization established in
1989, made up of members who are responsible for investigating and
prosecuting pharmaceutical drug diversion, and that facilitates
cooperation between law enforcement, health care professionals,
state regulatory agencies and pharmaceutical manufacturers in the
investigation and prevention of prescription drug abuse and
(h) "Multi-State Real-Time Tracking System" or "MSRTTS" means
the real-time electronic logging system provided by NADDI at no cost
to states that have legislation requiring real-time electronic
monitoring of precursor purchases, and agree to use the system.
MSRTTS is used by pharmacies and law enforcement to track sales of
over-the-counter (OTC) cold and allergy medications containing
precursors to the illegal drug, methamphetamine.
(i) "Phenylpropanolamine" means phenylpropanolamine, its salts,
optical isomers and salts of optical isomers.
(j) "Pseudoephedrine" means pseudoephedrine, its salts, optical
isomers and salts of optical isomers.
(k) "Precursor" means any substance which may be used along
with other substances as a component in the production and
distribution of illegal methamphetamine.
(l) "Pharmacist" means an individual currently licensed by this
state to engage in the practice of
pharmacy and pharmaceutical care
pharmacist care as defined in subsection (t), section one-b, article
five, chapter thirty of this code.
(m) "Pharmacy intern" has the same meaning as the term "intern"
as set forth in section one-b, article five, chapter thirty of this
(n) "Pharmacy" means any drugstore, apothecary or place within
this state where drugs are dispensed and sold at retail or display
for sale at retail and
pharmaceutical pharmacist care is provided
outside of this state where drugs are dispensed and pharmaceutical
pharmacist care is provided to residents of this state.
(o) "Pharmacy counter" means an area in the pharmacy restricted
to the public where controlled substances are stored and housed and
where controlled substances may only be sold, transferred or
dispensed by a pharmacist, pharmacy intern or pharmacy technician.
(p) "Pharmacy technician" means a registered technician who
meets the requirements for registration as set forth in article
five, chapter thirty of this code.
(q) "Retail establishment" means any entity or person within
this state who sells, transfers or distributes goods, including
over-the-counter drug products, to an ultimate consumer.
(r) "Schedule V" means the schedule of controlled substances
set out in section two hundred twelve, section two of this chapter.
(s) "Superintendent of the State Police" or "Superintendent"
means the Superintendent of the West Virginia State Police as set
forth in section five, article two, chapter fifteen of this code.
(t) "Wholesaler" means any person within this state or another
state, other than a manufacturer, who sells, transfers or in any
manner furnishes a drug product to any other person in this state
for the purpose of being resold.