
COMMITTEE SUBSTITUTE
FOR
H. B. 2611
(By Delegates Wills, Givens, Marshall, Perdue and Stemple)
(Originating in the Committee on Government Organization)
[March 27, 2001]
A BILL to amend and reenact sections one-b, three and twelve-b,
article five, chapter thirty of the code of West Virginia, one
thousand nine hundred thirty-one, as amended, relating to
dispensing prescription orders; redefining practitioner as it
affects pharmacists; deleting obsolete definition; and
prohibiting the dispensing of prescription orders in absence
of physician-patient relationship.
Be it enacted by the Legislature of West Virginia:


That sections one-b, three and twelve-b, article five, chapter
thirty of the code of West Virginia, one thousand nine hundred
thirty-one, as amended, be amended and reenacted, all to read as
follows:
ARTICLE 5. PHARMACISTS, PHARMACY TECHNICIANS, PHARMACY INTERNS

AND PHARMACIES.
§30-5-1b. Definitions.


The following words and phrases, as used in this article,
shall have the following meanings, unless the context otherwise
requires:


(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
dispensing; 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
prescribing patterns.


(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,
such the release is necessary to the
patient's health and well-being; to
such other persons or
governmental agencies authorized by law to receive
such 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;
and


(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
following activities:


(1) Evaluation of the prescription drug orders and patient
records for:


(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:


(A) Drug-drug;


(B) Drug-food;


(C) Drug-disease; and


(D) Adverse drug reactions.


(4) Evaluation of the prescription drug orders and patient
records for proper
utilization use, including over
utilization use
and under
utilization 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;
or


(4) An individual participating in a residency or fellowship program.


(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
such 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
such 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.


(p) "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.


(q) "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.


(r) "Person" means an individual, corporation, partnership,
association or any other legal entity, including government.


(s) "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.


(t) "Pharmacist" or "registered pharmacist" means an
individual currently licensed by this state to engage in the
practice of pharmacy and pharmaceutical care.


(u) "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
such the pharmacy and
personnel.


(v) "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.


(w) "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
article.


(x) "Practitioner" means an individual currently licensed,
registered or otherwise authorized by
the jurisdiction in which he
or she practices 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.


(y) "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.


(z) "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
prescription";


(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.


(aa) "Prescription drug order" means a lawful order of a
practitioner for a drug or device for a specific patient.


(bb) "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.


(cc) "USP-DI" means the United States
Pharmacopedia
Pharmacopeia-Dispensing Information.


(dd) "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 physician-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 certificates 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
served.

(f) Up to one third of the experience requirement for
licensure as a pharmacist may be fulfilled by an internship in a
foreign country.

(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 physician-patient
relationship wherein the physician has obtained information
adequate to support the prescription. An online or telephonic
evaluation by questionnaire is inadequate to establish an
appropriate physician-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 physician 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.
§30-5-12b. Definitions; selection of generic drug products;
exceptions; records; labels; manufacturing standards; rules;
notice of substitution; complaints; notice and hearing;
immunity.

(a) As used in this section:

(1) "Brand name" means the proprietary or trade name selected
by the manufacturer and placed upon a drug or drug product, its
container, label or wrapping at the time of packaging.

(2) "Generic name" means the official title of a drug or drug combination for which a new drug application, or an abbreviated new
drug application, has been approved by the United States food and
drug administration and is in effect.

(3) "Substitute" means to dispense without the prescriber's
express authorization a therapeutically equivalent generic drug
product in the place of the drug ordered or prescribed.

(4) "Equivalent" means drugs or drug products which are the
same amounts of identical active ingredients and same dosage form,
and which will provide the same therapeutic efficacy and toxicity
when administered to an individual and is approved by the United
States food and drug administration.


(5) "Practitioner" means a physician, an authorized Type A
physician assistant at the direction of his or her supervising
physician in accordance with the provisions of section sixteen,
article three of this chapter, osteopath, dentist, veterinarian,
podiatrist, optometrist or any other person duly licensed to
practice and to prescribe drugs under the laws of this state.

(b) A pharmacist who receives a prescription for a brand name
drug or drug product shall substitute a less expensive equivalent
generic name drug or drug product unless in the exercise of his or
her professional judgment the pharmacist believes that the less
expensive drug is not suitable for the particular patient:
Provided, That no substitution may be made by the pharmacist where the prescribing practitioner indicates that, in his or her
professional judgment, a specific brand name drug is medically
necessary for a particular patient.

(c) A written prescription order shall permit the pharmacist
to substitute an equivalent generic name drug or drug product
except where the prescribing practitioner has indicated in his or
her own handwriting the words "Brand Medically Necessary." The
following sentence shall be printed on the prescription form:
"This prescription may be filled with a generically equivalent drug
product unless the words 'Brand Medically Necessary' are written,
in the practitioner's own handwriting, on this prescription form.":
Provided, That "Brand Medically Necessary" may be indicated on the
prescription order other than in the prescribing practitioner's own
handwriting unless otherwise required by federal mandate.

(d) A verbal prescription order shall permit the pharmacist to
substitute an equivalent generic name drug or drug product except
where the prescribing practitioner shall indicate to the pharmacist
that the prescription is "Brand Necessary" or "Brand Medically
Necessary." The pharmacist shall note the instructions on the file
copy of the prescription or chart order form.

(e) No person may by trade rule, work rule, contract, or in
any other way prohibit, restrict, limit or attempt to prohibit,
restrict or limit the making of a generic name substitution under the provisions of this section. No employer or his or her agent
may use coercion or other means to interfere with the professional
judgment of the pharmacist in deciding which generic name drugs or
drug products shall be stocked or substituted: Provided, That this
section shall not be construed to permit the pharmacist to
generally refuse to substitute less expensive therapeutically
equivalent generic drugs for brand name drugs, and that any
pharmacist so refusing shall be subject to the penalties prescribed
in section twenty-two, article five, chapter thirty of this code.

(f) A pharmacist may substitute a drug pursuant to the
provisions of this section only where there will be a savings to
the buyer. Where substitution is proper pursuant to this section,
or where the practitioner prescribes the drug by generic name, the
pharmacist shall, consistent with his or her professional judgment,
dispense the lowest retail cost, effective brand which is in stock.

(g) All savings in the retail price of the prescription shall
be passed on to the purchaser; these savings shall be equal to the
difference between the retail price of the brand name product and
the customary and usual price of the generic product substituted
therefor: Provided, That in no event shall such savings be less
than the difference in acquisition cost of the brand name product
prescribed and the acquisition cost of the substituted product.

(h) Each pharmacy shall maintain a record of any substitution of an equivalent generic name drug product for a prescribed brand
name drug product on the file copy of a written or verbal
prescription or chart order. Such record shall include the
manufacturer and generic name of the drug product selected.

(i) All drugs shall be labeled in accordance with the
instructions of the practitioner.

(j) Unless the practitioner directs otherwise, the
prescription label on all drugs dispensed by the pharmacist shall
indicate the generic name using abbreviations if necessary and
either the name of the manufacturer or packager, whichever is
applicable in the pharmacist's discretion. The same notation will
be made on the original prescription retained by the pharmacist.

(k) A pharmacist may not dispense a product under the
provisions of this section unless the manufacturer has shown that
the drug has been manufactured with the following minimum good
manufacturing standards and practices by:

(1) Labeling products with the name of the original
manufacturer and control number;

(2) Maintaining quality control standards equal to or greater
than those of the United States Food and Drug Administration;

(3) Marking products with identification code or monogram; and

(4) Labeling products with an expiration date.

(l) The West Virginia board of pharmacy shall promulgate rules in accordance with the provisions of chapter twenty-nine-a of
this code which establish a formulary of generic type and brand
name drug products which are determined by the board to demonstrate
significant biological or therapeutic inequivalence and which, if
substituted, would pose a threat to the health and safety of
patients receiving prescription medication. The formulary shall be
promulgated by the board within ninety days of the date of passage
of this section, and may be amended in accordance with the
provisions of chapter twenty-nine-a of this code.

(m) No pharmacist shall substitute a generic named
therapeutically equivalent drug product for a prescribed brand name
drug product if the brand name drug product or the generic drug
type is listed on the formulary established by the West Virginia
board of pharmacy pursuant to this article, or is found to be in
violation of the requirements of the United States Food and Drug
Administration.

(n) Any pharmacist who substitutes any drug shall, either
personally or through his or her agent, assistant or employee,
notify the person presenting the prescription of such substitution.
The person presenting the prescription shall have the right to
refuse the substitution. Upon request the pharmacist shall relate
the retail price difference between the brand name and the drug
substituted for it.

(o) Every pharmacy shall post in a prominent place that is in
clear and unobstructed public view, at or near the place where
prescriptions are dispensed, a sign which shall read: "West
Virginia law requires pharmacists to substitute a less expensive
generic named therapeutically equivalent drug for a brand name
drug, if available, unless you or your physician direct otherwise."
The sign shall be printed with lettering of at least one and
one-half inches in height with appropriate margins and spacing as
prescribed by the West Virginia board of pharmacy.

(p) The West Virginia board of pharmacy shall promulgate rules
in accordance with the provisions of chapter twenty-nine-a of this
code setting standards for substituted drug products, obtaining
compliance with the provisions of this section and enforcing the
provisions of this section.

(q) Any person shall have the right to file a complaint with
the West Virginia board of pharmacy regarding any violation of the
provisions of this article. Such complaints shall be investigated
by the board of pharmacy.

(r) Fifteen days after the board has notified, by registered
mail, a person, firm, corporation or copartnership that such
person, firm, corporation or copartnership is suspected of being in
violation of a provision of this section, the board shall hold a
hearing on the matter. If, as a result of the hearing, the board determines that a person, firm, corporation or copartnership is
violating any of the provisions of this section, it may, in
addition to any penalties prescribed by section twenty-two of this
article, suspend or revoke the permit of any person, firm,
corporation or copartnership to operate a pharmacy.

(s) No pharmacist complying with the provisions of this
section shall be liable in any way for the dispensing of a generic
named therapeutically equivalent drug, substituted under the
provisions of this section, unless the generic named
therapeutically equivalent drug was incorrectly substituted.

(t) In no event where the pharmacist substitutes a drug under
the provisions of this section shall the prescribing physician be
liable in any action for loss, damage, injury or death of any
person occasioned by or arising from the use of the substitute drug
unless the original drug was incorrectly prescribed.

(u) Failure of a practitioner to specify that a specific brand
name is necessary for a particular patient shall not constitute
evidence of negligence unless the practitioner had reasonable cause
to believe that the health of the patient required the use of a
certain product and no other.