Senate Bill No. 444
(By Senator Walker)
[Introduced February 20, 1995; referred to the Committee
on Health and Human Resources.]
A BILL to amend and reenact section twelve-b, article five,
chapter thirty of the code of West Virginia, one thousand
nine hundred thirty-one, as amended, relating to pharmacists
and assistant pharmacists; definitions; and selection of
generic drug products.
Be it enacted by the Legislature of West Virginia:
That section twelve-b, article five, chapter thirty of the
code of West Virginia, one thousand nine hundred thirty-one, as
amended, be amended and reenacted to read as follows:
ARTICLE 5. PHARMACISTS, ASSISTANT PHARMACISTS.
§30-5-12b. Definitions; selection of generic drug products.
(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
(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 essentially the same therapeutic
efficacy and toxicity when administered to an individual.
(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) (1) The Legislature finds that:
(A) With respect to the substitutions of generic name drug
products, the safety and welfare of patients necessitate the
availability and use only of products that are equivalent in
therapeutic effect and toxicity to the prescribed drugs;
(B) Drug products are increasingly being developed and
prescribed in new and improved forms which employ advanced
medical technologies and safeguards to maximize their therapeutic
effect and minimize their toxicity; and
(C) Products which contain the same active ingredients but
which are manufactured in different forms and that utilize
different technologies may vary in efficacy or toxicity.
(2) It is therefore the policy of the Legislature, and a
principal purpose of this section, to ensure that such issues
regarding drug performance variability are considered in
determining which products may be substituted for use by
(b)(3) 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: Provided,
however, That no drug or drug product shall be substituted in
place of a prescribed drug or drug product if it utilizes a
different technology or mechanism to control, enhance or direct
the release, targeting, systemic absorption or other delivery of
a dosage regimen in the body. Every drug prescription order
shall contain an instruction on whether or not an equivalent
generic name drug or drug product may be substituted.
(4) 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 Necessary" or "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
Necessary' or the words 'Brand Medically Necessary' are written,
in the practitioner's own handwriting, on this prescription
(5) A verbal prescription order shall permit the pharmacist
to substitute an equivalent generic name drug or drug product
except where the prescribing practitioner or his or her agent
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.
(c) 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
subdivision (3), subsection (b) 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.
(d) A pharmacist may substitute a drug under subdivision (3), subsection (b) of this section only where there will be a
savings to the buyer. Where substitution is proper under
subdivision (3), subsection (b), 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.
(e) 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
(f) 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.
All drugs shall be labeled in accordance with the
instructions of the practitioner.
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 the name of the
manufacturer. The same notation will be made on the original
prescription retained by the pharmacist.
(g) 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
(3) Marking products with identification code or monogram;
(4) Labeling products with an expiration date.
(h) The West Virginia board of pharmacy shall establish by
rule 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.
(i) 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.
(j) 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.
(k) 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.
(l) The West Virginia board of pharmacy shall promulgate
and regulations setting standards for substituted drug
products, obtaining compliance with the provisions of this
section and enforcing the provisions of this section. 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
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
(m) 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.
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.
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.
NOTE: The purpose of this bill is to prohibit the
substitution by a pharmacist of a prescribed drug or drug product
with a generic drug or drug product if it utilizes a different
technology or mechanism to control, enhance or direct the
release, targeting or systemic absorption or other delivery
aspect of the prescribed drug or drug product.
Strike-throughs indicate language that would be stricken
from the present law, and underscoring indicates new language
that would be added.