Senate Bill No. 722
(By Senators Prezioso and Unger)
[Introduced February 18, 2008; referred to the Committee on
Health and Human Resources.]
A BILL to amend and reenact §30-5-1b, §30-5-3, §30-5-14 and
§30-5-21 of the Code of West Virginia, 1931, as amended, all
relating to regulation by the Board of Pharmacy of ambulatory
health care facilities and free clinics who dispense
pharmaceuticals; and defining terms.
Be it enacted by the Legislature of West Virginia:
That §30-5-1b, §30-5-3, §30-5-14 and §30-5-21 of the Code of
West Virginia, 1931, as amended, be amended and reenacted, all to
read as follows:
ARTICLE 5. PHARMACISTS, PHARMACY TECHNICIANS, PHARMACY INTERNS
The following words and phrases, as used in this article, have
the following meanings, unless the context otherwise requires:
(1) "Administer" means the direct application of a drug to the body of a patient or research subject by injection, inhalation,
ingestion or any other means.
(2) "Board of Pharmacy" or "board" means the West Virginia
State Board of Pharmacy.
(3) "Charitable clinic pharmacy"
means a clinic or facility
organized as a not-for-profit corporation that offers
pharmaceutical care and dispenses prescriptions free of charge to
appropriately screened and qualified indigent patients. A
charitable clinic pharmacy shall meet the minimum standards for a
pharmacy as set forth in this article and by legislative rule
promulgated by the Board of Pharmacy, but may not be charged any
applicable licensing fees. A charitable clinic pharmacy may have
pharmacists in charge, as that term is defined in this section, who
volunteers his or her services. A charitable clinic may also
receive donated drugs.
(3) (4) "Collaborative pharmacy practice" is that practice of
pharmacy 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.
(4) (5) "Collaborative pharmacy practice agreement" is a
written and signed agreement between a pharmacist, a physician and
the individual patient, or the patient's authorized representative
who has granted his or her informed consent, that provides for collaborative pharmacy practice for the purpose of drug therapy
management of a patient, which has been approved by the Board of
Pharmacy, the Board of Medicine in the case of an allopathic
physician or the West Virginia Board of Osteopathy in the case of
an osteopathic physician.
(5) (6) "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
(6) (7) "Confidential information" means information
maintained by the pharmacist in the patient record or which is
communicated to the patient as part of patient counseling or which
is communicated by the patient to the pharmacist. This information
is privileged and may be released only to the patient or to other
members of the health care team and other pharmacists where, in the
pharmacists' professional judgment, the release is necessary to the
patient's health and well-being; to health plans, as that term is defined in 45 CFR §160.103, for payment; to other persons or
governmental agencies authorized by law to receive the privileged
information; as necessary for the limited purpose of peer review
and utilization review; as authorized by the patient or required by
court order. Appropriate disclosure, as permitted by this section,
may occur by the pharmacist either directly or through an
electronic data intermediary, as defined in subdivision (14) of
(7) (8) "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.
(8) (9) "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."
(9) (10) "Dispense" or "dispensing" means the preparation and
delivery of a drug or device in an appropriately labeled and
suitable container to a patient or patient's representative or
surrogate pursuant to a lawful order of a practitioner for
subsequent administration to, or use by, a patient.
(10) (11) "Distribute" means the delivery of a drug or device
other than by administering or dispensing.
(11) (12) "Drug" means:
(A) Articles recognized as drugs in the USP-DI, facts and comparisons, physician's desk reference or supplements thereto for
use in the diagnosis, cure, mitigation, treatment or prevention of
disease in human or other animals;
(B) Articles, other than food, intended to affect the
structure or any function of the body of human or other animals;
(C) Articles intended for use as a component of any articles
specified in paragraph (A) or (B) of this subdivision.
(12) (13) "Drug regimen review" includes, but is not limited
to, the following activities:
(A) Evaluation of the prescription drug orders and patient
(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 the following:
(iii) Drug-disease; and
(iv) Adverse drug reactions.
(D) Evaluation of the prescription drug orders and patient
records for proper use, including overuse and underuse and optimum
(13) (14) "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 shall be limited to:
(A) Implementing, modifying and managing drug therapy
according to the terms of the collaborative pharmacy practice
(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.
(14) (15) "Electronic data intermediary" means an entity that
provides the infrastructure to connect a computer system, hand-held
electronic device or other electronic device used by a prescribing
practitioner with a computer system or other electronic device used
by a pharmacist to facilitate the secure transmission of:
(A) An electronic prescription order;
(B) A refill authorization request;
(C) A communication; or
(D) Other patient care information.
(15) (16) "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
(16) (17) "Intern" means an individual who is:
(A) Currently registered by this state to engage in the
practice of pharmacy while under the supervision of a licensed
pharmacist and is satisfactorily progressing toward meeting the
requirements for licensure as a pharmacist; or
(B) A graduate of an approved college of pharmacy or a
graduate who has established educational equivalency by obtaining
a foreign pharmacy graduate examination committee (FPGEC)
certificate who is currently licensed by the board for the purpose
of obtaining practical experience as a requirement for licensure as
a pharmacist; or
(C) A qualified applicant awaiting examination for licensure; or
(D) An individual participating in a residency or fellowship
(17) (18) "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. Any label shall include all information required by
federal law or regulation and state law or rule.
(18) (19) "Mail-order pharmacy" means a pharmacy, regardless
of its location, which dispenses greater than ten percent
prescription drugs via the mail.
(19) (20) "Manufacturer" means a person engaged in the
manufacture of drugs or devices.
(20) (21) "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.
(21) (22) "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.
(22) (23) "Patient counseling" means the oral communication by
the pharmacist of information, as defined in the rules of the
board, to the patient to improve therapy by aiding in the proper
use of drugs and devices.
(23) (24) "Person" means an individual, corporation,
partnership, association or any other legal entity, including
(24) (25) "Pharmaceutical care" is the provision of drug
therapy and other pharmaceutical patient care services 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 as defined in the rules of the board.
(25) (26) "Pharmacist" or "registered pharmacist" means an
individual currently licensed by this state to engage in the
practice of pharmacy and pharmaceutical care.
(26) (27) "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 rules pertinent to
the practice of pharmacy and the distribution of drugs and who is
personally in full and actual charge of the pharmacy and personnel.
(27) (28) "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 of
Pharmacy and the Board of Medicine or the Board of Osteopathy.
(28) (29) "Pharmacy" means any drugstore, apothecary or place
within this state where drugs are dispensed and sold at retail or
displayed for sale at retail and pharmaceutical care is provided
and any place outside of this state where drugs are dispensed and
pharmaceutical care is provided to residents of this state.
(29) (30) "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 Osteopathy.
(30) (31) "Pharmacy technician" means registered supportive
personnel who work under the direct supervision of a pharmacist who
have passed an approved training program as described in this
(31) (32) "Practitioner" means an individual currently
licensed, registered or otherwise authorized by any state,
territory or district of the United States to prescribe and
administer drugs in the course of professional practices, including
allopathic and osteopathic physicians, dentists, physician
assistants, optometrists, veterinarians, podiatrists and nurse
practitioners as allowed by law.
(32) (33) "Preceptor" means an individual who is currently
licensed as a pharmacist by the board, meets the qualifications as a preceptor under the rules of the board and participates in the
instructional training of pharmacy interns.
(33) (34) "Prescription drug" or "legend drug" means a drug
which, under federal law, is required, prior to being dispensed or
delivered, to be labeled with either of the following statements:
(A) "Caution: Federal law prohibits dispensing without
(B) "Caution: Federal law restricts this drug to use by, or
on the order of, a licensed veterinarian"; or a drug which is
required by any applicable federal or state law or rule to be
dispensed pursuant only to a prescription drug order or is
restricted to use by practitioners only.
(34) (35) "Prescription drug order" means a lawful order of a
practitioner for a drug or device for a specific patient.
(35) (36) "Prospective drug use review" means a review of the
patient's drug therapy and prescription drug order, as defined in
the rules of the board, prior to dispensing the drug as part of a
drug regimen review.
(36) (37) "USP-DI" means the United States pharmacopeia-
(37) (38) "Wholesale distributor" means any person engaged in
wholesale distribution of drugs, including, but not limited to,
manufacturers' and distributors' warehouses, chain drug warehouses
and wholesale drug warehouses, independent wholesale drug trader
and retail pharmacies that conduct wholesale distributions.
§30-5-3. When licensed pharmacist required; person not licensed
pharmacist, pharmacy technician or licensed intern not to
compound prescriptions or dispense poisons or narcotics;
licensure of interns; prohibiting the dispensing of
prescription orders in absence of practitioner-patient
(a) It is unlawful for any person not a pharmacist, or who
does not employ a pharmacist, to conduct any pharmacy or store for
the purpose of retailing, compounding or dispensing prescription
drugs or prescription devices.
(b) It is unlawful for the proprietor of any store or
pharmacy, any ambulatory health care facility, as that term is
defined in section one, article five-b, chapter sixteen of this
code, that offers pharmaceutical care, or a facility operated to
provide health care or mental health care services free of charge
or at a reduced rate and that operates a charitable clinic pharmacy
to permit any person not a pharmacist to compound or dispense
prescriptions or prescription refills or to retail or dispense the
poisons and narcotic drugs named in sections two, three and six,
article eight, chapter sixteen of this code: Provided, That a
licensed intern may compound and dispense prescriptions or
prescription refills under the direct supervision of a pharmacist:
Provided, however, That registered pharmacy technicians may assist
in the preparation and dispensing of prescriptions or prescription refills, including, but not limited to, reconstitution of liquid
medications, typing and affixing labels under the direct
supervision of a licensed pharmacist.
(c) It is the duty of a pharmacist or employer who employs an
intern to license the intern with the board within ninety days
after employment. The board shall furnish proper forms for this
purpose and shall issue a certificate to the intern upon licensure.
(d) The experience requirement for licensure as a pharmacist
shall be computed from the date certified by the supervising
pharmacist as the date of entering the internship. If the
internship is not registered with the board of pharmacy, then the
intern shall receive no credit for such experience when he or she
makes application for examination for licensure as a pharmacist:
Provided, That credit may be given for such unregistered experience
if an appeal is made and evidence produced showing experience was
obtained but not registered and that failure to register the
internship experience was not the fault of the intern.
(e) An intern having served part or all of his or her
internship in a pharmacy in another state or foreign country shall
be given credit for the same when the affidavit of his or her
internship is signed by the pharmacist under whom he or she served,
and it shows the dates and number of hours served in the internship
and when the affidavit is attested by the secretary of the state
board of pharmacy of the state or country where the internship was
(f) Up to one third of the experience requirement for
licensure as a pharmacist may be fulfilled by an internship in a
(g) No pharmacist may compound or dispense any prescription
order when he or she has knowledge that the prescription was issued
by a practitioner without establishing an ongoing
practitioner-patient relationship. An online or telephonic
evaluation by questionnaire is inadequate to establish an
appropriate 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.
§30-5-14. Pharmacies to be registered; permit to operate; fees;
pharmacist to conduct business.
(a) The Board of Pharmacy shall require and provide for the
annual registration of every pharmacy doing business in this state,
including an ambulatory health care facility, as that term is
defined in section one, article five-b, chapter sixteen of this
code, who offers pharmaceutical care, and a facility operated to
provide health care or mental health care services free of charge
or at a reduced rate and who operates charitable clinic pharmacy. Any person, firm, corporation or partnership desiring to operate,
maintain, open or establish a pharmacy in this state shall apply to
the Board of Pharmacy for a permit to do so. The application for
such permit shall be made on a form prescribed and furnished by the
Board of Pharmacy, which, when properly executed, shall indicate
the owner, manager, trustee, lessee, receiver or other person or
persons desiring such permit, as well as the location of such
pharmacy, including street and number, and
other information as
the Board of Pharmacy may require. If it is desired to operate,
maintain, open or establish more than one pharmacy, separate
application shall be made and separate permits or licenses shall be
issued for each.
(b) Every initial application for a permit shall be
accompanied by the required fee of one hundred fifty dollars. The
fee for renewal of such permit or license shall be one hundred
(c) If an application is approved, the Secretary of the Board
of Pharmacy shall issue to the applicant a permit or license for
each pharmacy for which application is made. Permits or licenses
issued under this section shall not be transferable and shall
expire on the thirtieth day of June of each calendar year and if
application for renewal of permit or license is not made on or
before that date, or a new one granted on or before the first day
of August, following, the old permit or license shall lapse and
become null and void and shall require an inspection of the pharmacy and a fee of one hundred fifty dollars plus one hundred
fifty dollars for the inspection.
(d) Every place of business so registered shall employ a
pharmacist in charge and operate in compliance with the general
provisions governing the practice of pharmacy and the operation of
(e) The provisions of this section shall have no application
to the sale of nonprescription drugs which are not required to be
dispensed pursuant to a practitioner's prescription.
§30-5-21. Limitations of article.
(a) Nothing in this article shall 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 shall any 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 shall not be deemed to be
improperly engaging in the practice of pharmacy.
(b) Nothing in this article shall 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, as that term
is defined in section one, article five-b, chapter sixteen of this
code, that offers pharmaceutical care or a facility operated to
provide health care or mental health care services free of charge
or at a reduced rate that operates a charitable clinic pharmacy:
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.