58-17b-605 - Drug product equivalents.
58-17b-605. Drug product equivalents.
(1) A pharmacist or pharmacy intern dispensing a prescription order for a specific drugby brand or proprietary name may substitute a drug product equivalent, as defined in Section58-17b-102, for the prescribed drug only if:
(a) the purchaser specifically requests or consents to the substitution of a drug productequivalent;
(b) the drug product equivalent is of the same generic type and is designated thetherapeutic equivalent in the approved drug products with therapeutic equivalence evaluationsprepared by the Center for Drug Evaluation and Research of the Federal Food and DrugAdministration;
(c) the drug product equivalent is permitted to move in interstate commerce;
(d) the pharmacist or pharmacy intern counsels the patient on the use and the expectedresponse to the prescribed drug, whether a substitute or not, and the substitution is not otherwiseprohibited by this chapter;
(e) the prescribing practitioner has not indicated that a drug product equivalent may notbe substituted for the drug, as provided in Subsection (5); and
(f) the substitution is not otherwise prohibited by law.
(2) (a) Each out-of-state mail service pharmacy dispensing a drug product equivalent as asubstitute for another drug into this state shall notify the patient of the substitution either bytelephone or in writing.
(b) Each out-of-state mail service pharmacy shall comply with the requirements of thischapter with respect to a drug product equivalent substituted for another drug, including labelingand record keeping.
(3) Pharmacists or pharmacy interns may not substitute without the prescriber'sauthorization on trade name drug product prescriptions unless the product is currentlycategorized in the approved drug products with therapeutic equivalence evaluations prepared bythe Center for Drug Evaluation and Research of the Federal Food and Drug Administration as adrug product considered to be therapeutically equivalent to another drug product.
(4) A pharmacist or pharmacy intern who dispenses a prescription with a drug productequivalent under this section assumes no greater liability than would be incurred had thepharmacist or pharmacy intern dispensed the prescription with the drug product prescribed.
(5) (a) If, in the opinion of the prescribing practitioner, it is in the best interest of thepatient that a drug product equivalent not be substituted for a prescribed drug, the practitionermay indicate a prohibition on substitution either by writing "dispense as written" or signing in theappropriate space where two lines have been preprinted on a prescription order and captioned"dispense as written" or "substitution permitted".
(b) If the prescription is communicated orally by the prescribing practitioner to thepharmacist or pharmacy intern, the practitioner shall indicate the prohibition on substitution andthat indication shall be noted in writing by the pharmacist or pharmacy intern with the name ofthe practitioner and the words "orally by" and the initials of the pharmacist or pharmacy internwritten after it.
(6) A pharmacist or pharmacy intern who substitutes a drug product equivalent for aprescribed drug shall communicate the substitution to the purchaser. The drug productequivalent container shall be labeled with the name of the drug dispensed, and the pharmacist,pharmacy intern, or pharmacy technician shall indicate on the file copy of the prescription both
the name of the prescribed drug and the name of the drug product equivalent dispensed in itsplace.
(7) (a) For purposes of Subsection (7), "substitutes" means to substitute:
(i) a generic drug for another generic drug;
(ii) a generic drug for a nongeneric drug;
(iii) a nongeneric drug for another nongeneric drug; or
(iv) a nongeneric drug for a generic drug.
(b) A prescribing practitioner who makes a finding under Subsection (5)(a) for a patientwith a seizure disorder shall indicate a prohibition on substitution of a drug product equivalent inthe manner provided in Subsection (5)(a) or (b).
(c) Except as provided in Subsection (7)(d), a pharmacist or pharmacy intern who cannotdispense the prescribed drug as written, and who needs to substitute a drug product equivalent forthe drug prescribed to the patient to treat or prevent seizures shall notify the prescribingpractitioner prior to the substitution.
(d) Notification under Subsection (7)(c) is not required if the drug product equivalent ispaid for in whole or in part by Medicaid.
(8) Failure of a licensed medical practitioner to specify that no substitution is authorizeddoes not constitute evidence of negligence.
Amended by Chapter 205, 2008 General Session