Senate Bill No. 702
(By Senators Prezioso and Love)
[Introduced February 19, 2007; referred to the Committee on
Health and Human Resources; and then to the Committee on the
A BILL to amend and reenact §30-5-1b and §30-5-3 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 out-of-state sales of pharmaceuticals; defining
terms; providing for licensure and permits of pharmacies, mail
order pharmacies and out-of-state pharmacies; and setting
forth the authority of the West Virginia Board of Pharmacy.
Be it enacted by the Legislature of West Virginia:
That §30-5-1b and §30-5-3 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
ARTICLE 5. PHARMACISTS, PHARMACY TECHNICIANS, PHARMACY INTERNS
§30-5-1b. Definitions.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) "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) "Collaborative pharmacy practice agreement" is a written
and signed agreement between a pharmacist, a physician, and the
individual patient or the patients' 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) "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) "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 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.
(7) "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) "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) "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) "Distribute" means the delivery of a drug or device other
than by administering or dispensing.
(11) "Drug" means:
(A) 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;
(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 paragraphs (A) or (B) of this subdivision.
(12) "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 over use and under use and
optimum therapeutic outcomes.
(13) "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) "Good faith prior examination" means an in-person medical
examination of the patient, arising from a complaint by the
patient, without regard to whether portions of the examination are
conducted by other practitioners, when the patient is physically
examined and a medical history of the patient is obtained.
(14)(15) "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;
(D) An individual participating in a residency or fellowship
(15)(16) "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.
(17)"Legitimate medical purpose" means any medical purpose
that arises from a documented practitioner-patient relationship.
(16)(18) "Mail-order pharmacy" means a pharmacy, regardless of
its location, which dispenses greater than ten percent prescription
drugs via the mail.
(17)(19)"Manufacturer" means a person engaged in the
manufacture of drugs or devices.
(18)(20)"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.
(19)(21)"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)"Out-of-state pharmacy" means any pharmacy which dispenses
drugs or medicines or conducts business using internet, electronic
communications, facsimile, or telephone, or otherwise from any
point outside the state of West Virginia to any point within the
state of West Virginia.
(20)(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.
(21)(24)"Person" means an individual, corporation,
partnership, association or any other legal entity, including
(22)(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.
(23)(26)"Pharmacist" or "registered pharmacist" means an
individual currently licensed by this state to engage in the
practice of pharmacy and pharmaceutical care.
(24)(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.
(25)(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.
(26)(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.
(27)(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.
(28)(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
(29)(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's assistants,
optometrists, veterinarians, podiatrists and nurse practitioners as
allowed by law.
(33)"Practitioner-patient relationship" means a medical
relationship that exists between a patient, a practitioner or
practitioner's designee, after the practitioner, or his or her
designee, has conducted at least one prior examination.
(30)(34)"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.
(31)(35)"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 prescription"; or
(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.
(32)(36)"Prescription drug order" means a lawful order of a
practitioner for a drug or device for a specific patient.
(33)(37)"Prospective drug use review" means a review of the
patients' 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.
(34)(38)"USP-DI" means the United States pharmacopeia-
(35)(39)"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 relationship.
(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
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, while practicing at any pharmacy licensed
by the board, in-state or out-of-state, may compound or dispense to
a resident of West Virginia any prescription order when he or she
has knowledge that the prescription was issued by a practitioner
without establishing an ongoing or legitimate 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 as an ongoing relationship with the
patient and who has agreed to supervise the patient's treatment,
including the use of any prescribed medications.
(h)An indication ongoing or legitimate practitioner-patient
relationship has been established when:
(1) A patient has a medical complaint;
(2) A medical history has been taken;
(3) A physical examination has been performed; and
(4) Some logical connection exists between the medical
complaint, the medical history, the physical examination and the
A patient completing a questionnaire that is reviewed by a
physician hired or working on behalf of an internet pharmacy shall
not establish an ongoing or legitimate practitioner-patient
relationship. This provision is not intended to limit the ability
of practitioners to engage in legitimate telemedicine where health
care is provided using telecommunication networks to transmit and
receive information including voice communications, images, and
(i) No person shall obtain or attempt to obtain a prescription
for a controlled substance without having formed a legitimate
practitioner-patient relationship with the practitioner from whom
the person seeks the prescription.
(j) No person shall assist a person to obtain a prescription
in violation of this chapter by any means, including but not
limited to, electronic communications, facsimile, internet, or
telephone, by facilitating the communication between a person and
the pharmacy or practitioner, or both, to complete any drug
Permits for out-of-state pharmacies; requests for
information by consumer; information disclosure by out-of-
state pharmacies, internet and electronic communications
related to out-of-state pharmacies.
(a) Every out-of-state pharmacy which dispenses drugs or
medicines or conducts business using internet, electronic
communications, facsimile, or telephone, or otherwise from any
point within the state of West Virginia to any point outside of the
state of West Virginia shall be registered as a pharmacy or
drugstore pursuant to the provisions of section fourteen of this
article. Prior to being qualified and authorized to transact
business in the state of West Virginia, every out-of-state pharmacy
shall register annually with the Board of Pharmacy to conduct such
business in this state. Such registration shall include fees for licensing and meeting all renewal and licensing qualifications.
(b) Every out-of-state pharmacy granted an permit by the board
shall disclose to the board the location, names, and titles of all
principal corporate officers and all pharmacists who are dispensing
prescription drugs to residents of the state. A report containing
this information shall be made to the board on an annual basis and
within thirty (30) days of any change of office, corporate officer,
(c) Every out-of-state pharmacy granted an permit shall comply
with all statutorily authorized directions and requests for
information from any regulatory agency of the state and from the
board in accordance with the provisions of this section. The out-
of-state pharmacy shall maintain at all times a valid unexpired
permit, license, or regular registration to conduct the pharmacy in
compliance with the laws of the jurisdiction in which it is a
resident. The out-of-state pharmacy shall also submit a copy of the
most recent inspection report resulting from an inspection
conducted by the regulatory or licensing agency of the jurisdiction
in which it is located: Provided, that the out-of-state pharmacy
granted a permit shall submit to the West Virginia Board of
Pharmacy a copy of any subsequent inspection report on the pharmacy
conducted by the regulatory or licensing body of the jurisdiction
in which it is located.
(d) Every out-of-state pharmacy granted an permit by the board shall maintain complete and accurate records of any prescription
drugs dispensed to patients in West Virginia. These records are to
be readily retrievable from the records of other drugs dispensed.
(e) Records for all prescriptions delivered into West Virginia
shall be readily retrievable from the other prescription records of
the out-of-state pharmacy.
(f) Every out-of-state pharmacy shall have a pharmacist in
charge who is licensed to engage in the practice of pharmacy by
West Virginia that shall be responsible for compliance by the
pharmacy with the provisions of this section.
(g) Every out-of-state pharmacy shall during its regular hours
of operation, but not less than six (6) days per week and for a
minimum of forty (40) hours per week, provide a toll-free telephone
service directly to the pharmacist in charge of the out-of-state
pharmacy. The pharmacist shall be available to both the patient and
each licensed and practicing in-state pharmacist for the purpose of
facilitating communication between the patient and the West
Virginia pharmacists with access to the patient's prescription
records. The toll-free number shall be placed on a label affixed to
each container of drugs dispensed to patients within this state.
(h) Every out-of-state pharmacy, when doing business in West
Virginia through means including, but not limited to, electronic
communications, facsimile, internet, or telephone shall:
(1) Comply with all requirements set forth in article nine, chapter sixty-a of this code.
(2) Prior to obtaining an permit to operate through the
internet, receive and display in every medium in which it
advertises itself a seal of approval from the National Associations
of Boards of Pharmacy certifying that it is a Verified Internet
Pharmacy Practice Site. The Verified Internet Pharmacy Practice
Site approval and accreditation shall be maintained and remain
(3) Certify to the board the percentage of its annual business
conducted via the internet and submit such supporting documentation
as requested by the board, and in a form or application required by
the board, when it applies for permit or renewal.
(4) Use the address on file with the West Virginia board of
pharmacy as the return address on the labels of any package shipped
into or within the state. The return address shall be placed on the
package in a clear and prominent manner.
NOTE: The purpose of this bill is to add and refine
definitions of out-of-state pharmacy, patient-practitioner
relationship, and legitimate medical purpose. The bill also
provides clarification for certain licensures and permits issued by
the Board of Pharmacy and establishes guidelines for issuance of
permits for out-of-state pharmacies.
Strike-throughs indicate language that would be stricken from
the present law, and underscoring indicates new language that would