SB617 Sub1 eng
Senate Bill No. 617
(By Senators Prezioso, White, Jenkins, Minear, Unger and Hunter)
[Originating in the Committee on Health and Human Resources;
reported March 24, 2005.]
A BILL to amend and reenact §30-5-1b of the Code of West Virginia,
1931, as amended; and to amend said code by adding thereto a
new section, designated §30-5-6b, all relating to pharmacies
and pharmacists; defining terms; authorizing remote dispensing
and delivery of prescription drugs; and authorizing the Board
of Pharmacy to propose legislative rules.
Be it enacted by the Legislature of West Virginia:
That §30-5-1b of the Code of West Virginia, 1931, as amended,
be amended and reenacted; and that said code be amended by adding
thereto a new section, designated §30-5-6b, 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
(a) "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.
(b) "Board of Pharmacy" or "Board" means the West Virginia
State Board of Pharmacy.
(c) "Compounding" means:
(1) The preparation, mixing, assembling, packaging or labeling
of a drug or device:
(A) 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
(B) For the purpose of, or as an incident to, research,
teaching or chemical analysis and not for sale or dispensing;
(2) The preparation of drugs or devices in anticipation of
prescription drug orders based on routine, regularly observed
(d) "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 pharmacist's
professional judgment, the release is necessary to the patient's
health and well-being; 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.
(e) "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.
(f) "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."
(g) "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.
(h) "Distribute" means the delivery of a drug or device other
than by administering or dispensing.
(i) "Drug" means:
(1) Articles recognized as drugs in the USP-DI, facts and
comparisons, physicians desk reference or supplements thereto, for
use in the diagnosis, cure, mitigation, treatment or prevention of
disease in human or other animals;
(2) Articles, other than food, intended to affect the
structure or any function of the body of human or other animals;
(3) Articles intended for use as a component of any articles
specified in subsection (1) or (2) of this section.
(j) "Drug regimen review" includes, but is not limited to, the
(1) Evaluation of the prescription drug orders and patient
(A) Known allergies;
(B) Rational therapy-contraindications;
(C) Reasonable dose and route of administration; and
(D) Reasonable directions for use.
(2) Evaluation of the prescription drug orders and patient
records for duplication of therapy.
(3) Evaluation of the prescription drug for interactions
and/or adverse effects which may include, but are not limited to,
any of the following:
(C) Drug-disease; and
(D) Adverse drug reactions.
(4) Evaluation of the prescription drug orders and patient
records for proper use, including over use and under use and
optimum therapeutic outcomes.
(k) "Intern" means an individual who is:
(1) 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
(2) 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
(3) A qualified applicant awaiting examination for licensure;
(4) An individual participating in a residency or fellowship
(l) "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.
(m) "Mail-order pharmacy" means a pharmacy, regardless of its
location, which dispenses greater than ten percent prescription
drugs via the mail.
(n) "Manufacturer" means a person engaged in the manufacture
of drugs or devices.
(o) "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(s) 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
(p) "Medical home" means a federally qualified health center
clinic where a patient has established a relationship, has his or
her routine medical care or treatment and where his or her medical
records are maintained.
"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.
"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.
"Person" means an individual, corporation,
partnership, association or any other legal entity, including
"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.
"Pharmacist" or "registered pharmacist" means an
individual currently licensed by this state to engage in the
practice of pharmacy and pharmaceutical care.
"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.
"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.
"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
"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's assistants,
optometrists, veterinarians, podiatrists and nurse practitioners as allowed by law.
"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.
"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:
(1) "Caution: Federal law prohibits dispensing without
(2) "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.
"Prescription drug order" means a lawful order of a
practitioner for a drug or device for a specific patient.
"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.
(dd) "Remote delivery" means moving or transporting filled
pharmacist-verified prescription drugs from a fully licensed
pharmacy to a remote medical home in a satellite location for
dispensing of the filled prescription to patients.
"USP-DI" means the United States Pharmacopeia-Dispensing Information.
"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.
§30-5-6b. Remote delivery of prescriptions; rule-making authority.
To improve patient access to prescription drugs, the Board
shall propose legislative rules pursuant to article three, chapter
twenty-nine-a of this code, after consultation with the
Pharmaceutical Advocate established pursuant to article fifteen,
chapter five of this code, to permit remote delivery of
prescription drugs filled by a licensed pharmacist to a patient's
medical home for dispensing to the patient. The rule shall provide
for patient counseling by a licensed pharmacist via telephone or