Source: http://www.legis.state.wv.us/WVCODE/code.cfm?chap=30&art=5&section=2A
Timestamp: 2016-09-27 07:30:37
Document Index: 268821636

Matched Legal Cases: ['§30', '§30', '§30', '§30', '§30', '§30']

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§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. (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 thirty-four of this article. (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, electronic 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 or pharmacy 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. WVC 30 - 5 - 12 B
§30-5-12b. Definitions; selection of generic drug products;
exceptions; records; labels; manufacturing
standards; rules; notice of substitution;
complaints; notice and hearing; immunity.
(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
(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 of this article.
(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, electronic 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;
(l) The West Virginia Board of Pharmacy shall promulgate rules
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
(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
(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
(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
code setting standards for substituted drug products, obtaining
compliance with the provisions of this section and enforcing the
(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.
§30-5-14. Prohibiting the dispensing of prescription orders in absence of practitioner-patient relationship. A pharmacist may not compound or dispense any prescription order when he or she has knowledge that the prescription was issued by a practitioner without establishing a valid practitioner-patient relationship. An online or telephonic evaluation by questionnaire, or an online or telephonic consultation, is inadequate to establish a valid practitioner-patient relationship: Provided, That this prohibition does not apply: (1) In a documented emergency; (2) In an on-call or cross-coverage situation; (3) For the treatment of sexually transmitted diseases by expedited partner therapy as set forth in article four-f, chapter sixteen of this code; or (4) 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. WVC 30 - 5 - 14 §30-5-14. Prohibiting the dispensing of prescription orders in
absence of practitioner-patient relationship.
A pharmacist may not compound or dispense any prescription
order when he or she has knowledge that the prescription was issued
by a practitioner without establishing a valid practitioner-patient
relationship. An online or telephonic evaluation by questionnaire,
or an online or telephonic consultation, is inadequate to establish
a valid practitioner-patient relationship: Provided, That this
prohibition does not apply:
(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.
§30-5-34. Criminal offenses. (a) When, as a result of an investigation under this article or otherwise, the board has reason to believe that a person authorized under this article has committed a criminal offense under this article, the board may bring its information to the attention of an appropriate law-enforcement official. (b) Any person who intentionally practices, or presents himself or herself out as qualified to practice pharmacist care or to assist in the practice of pharmacist care, or uses any title, word or abbreviation to indicate to or induce others to believe he or she is licensed to practice as a pharmacist or pharmacist technician without obtaining an active, valid West Virginia license to practice that profession; or With a license that is: (1) Expired, suspended or lapsed; or (2) Inactive, revoked, suspended as a result of disciplinary action, or surrendered; is guilty of a misdemeanor and, upon conviction thereof, shall be fined not more than ten thousand dollars. WVC 30 - 5 - 34 §30-5-34. Criminal offenses.
otherwise, the board has reason to believe that a person authorized
under this article has committed a criminal offense the board may
bring its information to the attention of an appropriate
law-enforcement official.