SB 369 — Relating to generic drug products

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Red = new code to be enacted WEST virginia legislature regular session Enrolled Committee Substitute for Senate Bill 369 Senators Takubo, Stollings, and Baldwin, original sponsors [Originating[Passed inMarch the8, Committee2019; on the Judiciary;

Reportedin oneffect January90 30,days 2019]from passage]     AAN BILLACT to amend and reenact §30-5-12b of the Code of West Virginia, 1931, as amended, relating generally to generic drug products;

pharmacists, pharmacy technicians, pharmacy internsinterns, and pharmacies.

(2)(4) (4) “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)(5) (5) “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)(6) (6) “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.

Provided, That no a substitution may not 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.

(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 indicates to the pharmacist that the prescription is “Brand Necessary” or “Brand Medically Necessary”.

(e) No A person may not 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 An employer or his or her agent may not 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 may 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 is subject to the penalties prescribed §30-5-34 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 purchaser.

(g) (g) AllIf a pharmacist substitutes a drug pursuant to the provisions of this section, the patient shall receive the savings which shall be equal to the difference in the retailpatient’s priceacquisition cost of the prescriptionproduct shallprescribed beand passedthe onacquisition tocost of the purchaser;substituted product:

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 (g) If a pharmacist substitutes a drug pursuant to the provisions of this section, the patient shall receive the savings which shall be equal to the difference in the patient’s acquisition cost of the product prescribed and the acquisition cost of the substituted product:

Such The record shall include the manufacturer and generic name of the drug product selected.

(l) The West Virginia Board of Pharmacy shall promulgate rules in accordance with the provisions of chapter twenty-nine-a §29A-3-1 et seq.

The formulary shall be promulgated by the board within 90 days of the date of passage of this section and may be amended in accordance with the provisions of said that chapter.

(m) No A pharmacist shall may not 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 the substitution.

The person presenting the prescription shall have the right to may refuse the substitution.

(p) The West Virginia Board of Pharmacy shall promulgate rules in accordance with the provisions of §29A-3-1 et seq.

and The board has the primary responsibility for enforcing the provisions of this section.

(q) Any person shall have the right to may file a complaint with the West Virginia Board of Pharmacy regarding any violation of the provisions of this article.

Such The 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 the 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.

(s) No A pharmacist or pharmacy complying with the provisions of this section shall may not 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 may 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 may 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.