This text of Utah § 58-17b-605 (Drug product equivalents and similar drug products.) is published on Counsel Stack Legal Research, covering Utah primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.
(1)For the purposes of this section:
(1)(a) (1)(a)(i) "Drug" is as defined in Section 58-17b-102.
(1)(a)(ii) "Drug" includes a "biological product" as defined in Section 58-17b-605.5.
(1)(b) "Drug product equivalent" meansa drug product that is designated as the therapeutic equivalent of another drug product in the Approved Drug Products with Therapeutic Equivalence Evaluations prepared by the Center for Drug Evaluation and Research of the United States Food and Drug Administration.
(1)(c) "Osteopathic Physician and Surgeon's Licensing Board" means the board created in Section 58-68-201.
(1)(d) "Medical Licensing Board" means the board created in Section 58-67-201.
(1)(e) "Therapeutically similar drug product" means a drug product that:
(1)(e)(i) provides a similar level of therapeutic be
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(1) For the purposes of this section:
(1)(a) (1)(a)(i) "Drug" is as defined in Section 58-17b-102.
(1)(a)(ii) "Drug" includes a "biological product" as defined in Section 58-17b-605.5.
(1)(b) "Drug product equivalent" meansa drug product that is designated as the therapeutic equivalent of another drug product in the Approved Drug Products with Therapeutic Equivalence Evaluations prepared by the Center for Drug Evaluation and Research of the United States Food and Drug Administration.
(1)(c) "Osteopathic Physician and Surgeon's Licensing Board" means the board created in Section 58-68-201.
(1)(d) "Medical Licensing Board" means the board created in Section 58-67-201.
(1)(e) "Therapeutically similar drug product" means a drug product that:
(1)(e)(i) provides a similar level of therapeutic benefit and risk to a patient as another drug product; and
(1)(e)(ii) is on the list of therapeutically similar drugs created by the division in accordance with Subsection (9).
(2) A pharmacist or pharmacy intern dispensing a prescription order for a specific drug by brand or proprietary name may substitute:
(2)(a) a drug product equivalent for the prescribed drug if:
(2)(a)(i) the purchaser specifically requests or consents to the substitution of a drug product equivalent;
(2)(a)(ii) the drug product equivalent is of the same generic type and is designated the therapeutic equivalent in the approved drug products with therapeutic equivalence evaluations prepared by the Center for Drug Evaluation and Research of the Federal Food and Drug Administration;
(2)(a)(iii) the drug product equivalent is permitted to move in interstate commerce;
(2)(a)(iv) the pharmacist or pharmacy intern counsels the patient on the use and the expected response to the prescribed drug, whether a substitute or not;
(2)(a)(v) the substitution is not otherwise prohibited by law; and
(2)(a)(vi) the prescribing practitioner has not indicated that a drug product equivalent may not be substituted for the drug, as provided in Subsection (6); or
(2)(b) a therapeutically similar drug product if:
(2)(b)(i) the prescriber has written "similar substitution authorized" on the prescription for the prescribed drug;
(2)(b)(ii) the therapeutically similar drug product is listed on the therapeutically similar drug list described in Subsection (9) as a drug that can be substituted for the prescribed drug;
(2)(b)(iii) the purchaser specifically requests or consents to the substitution of the therapeutically similar drug;
(2)(b)(iv) the dispensed therapeutically similar drug product is permitted to move in interstate commerce;
(2)(b)(v) the pharmacist or pharmacy intern counsels the patient on the use and the expected response to the therapeutically similar drug product;
(2)(b)(vi) the substitution is not otherwise prohibited by law; and
(2)(b)(vii) the substitution:
(2)(b)(vii)(A) results in a decreased cost to the patient;
(2)(b)(vii)(B) is covered on the patient's health benefit plan formulary as a preferred drug or at the same or lower payment tier;
(2)(b)(vii)(C) is necessary because the pharmacist does not have the originally prescribed medication available to dispense to the patient; or
(2)(b)(vii)(D) would be beneficial to the patient for any reason if the patient and pharmacist mutually agree that the substitution would benefit the patient.
(3) (3)(a) Each out-of-state mail service pharmacy dispensing a drug product equivalent or a therapeutically similar drug product as a substitute for another drug into this state shall notify the patient of the substitution either by telephone or in writing.
(3)(b) Each out-of-state mail service pharmacy shall comply with the requirements of this chapter with respect to a drug product equivalent or a therapeutically similar drug product substituted for another drug, including labeling and record keeping.
(4) (4)(a) Pharmacists or pharmacy interns may not substitute without the prescriber's authorization on trade name drug product prescriptions unless the product is currently categorized in the approved drug products with therapeutic equivalence evaluations prepared by the Center for Drug Evaluation and Research of the Federal Food and Drug Administration as a drug product considered to be therapeutically equivalent to another drug product.
(4)(b) A pharmacist or pharmacy intern that substitutes a drug product for a therapeutically similar drug product under Subsection (2)(b), for any prescription intended to last longer than 30 days, shall notify the prescriber that the pharmacist or pharmacy intern substituted the drug.
(5) A pharmacist or pharmacy intern who dispenses a prescription with a drug product equivalent or a therapeutically similar drug product under this section assumes no greater liability than would be incurred had the pharmacist or pharmacy intern dispensed the prescription with the drug product prescribed.
(6) (6)(a) If, in the opinion of the prescribing practitioner, it is in the best interest of the patient that a drug product equivalent not be substituted for a prescribed drug, the practitioner may indicate a prohibition on substitution either by writing "dispense as written" or signing in the appropriate space where two lines have been preprinted on a prescription order and captioned "dispense as written" or "substitution permitted".
(6)(b) If the prescription is communicated orally by the prescribing practitioner to the pharmacist or pharmacy intern, the practitioner shall indicate the prohibition on substitution and that indication shall be noted in writing by the pharmacist or pharmacy intern with the name of the practitioner and the words "orally by" and the initials of the pharmacist or pharmacy intern written after it.
(7) (7)(a) A pharmacist or pharmacy intern who substitutes a drug product equivalent or therapeutically similar drug product for a prescribed drug shall communicate the substitution to the purchaser.
(7)(b) The drug product equivalent or therapeutically similar drug product container shall be labeled with the name of the drug dispensed.
(7)(c) 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 or the therapeutically similar drug product dispensed in place of the prescribed drug.
(8) (8)(a) For purposes of this Subsection (8), "substitutes" means to substitute:
(8)(a)(i) a generic drug for another generic drug;
(8)(a)(ii) a generic drug for a nongeneric drug;
(8)(a)(iii) a nongeneric drug for another nongeneric drug; or
(8)(a)(iv) a nongeneric drug for a generic drug.
(8)(b) A prescribing practitioner who makes a finding under Subsection (6)(a) for a patient with a seizure disorder shall indicate a prohibition on substitution of a drug product equivalent in the manner provided in Subsection (6)(a) or (b).
(8)(c) Except as provided in Subsection (8)(d), a pharmacist or pharmacy intern who cannot dispense the prescribed drug as written, and who needs to substitute a drug product equivalent for the drug prescribed to the patient to treat or prevent seizures shall notify the prescribing practitioner prior to the substitution.
(8)(d) Notification under Subsection (8)(c) is not required if the drug product equivalent is paid for in whole or in part by Medicaid.
(9) (9)(a) In accordance with Title 63G, Chapter 3, Utah Administrative Rulemaking Act, and in consultation with the board and the Medical Licensing Board , the division shall create a therapeutically similar drug product list that contains lists of drug products that are therapeutically similar to each other.
(9)(b) The division may not add a drug product to the therapeutically similar drug product list if the addition is opposed by:
(9)(b)(i) the board; or
(9)(b)(ii) the Medical Licensing Board.
(9)(c) When considering a drug to be added to the therapeutically similar drug product list, the division shall consult with each board described in Subsection (9)(b).
(9)(d) When consulting with the division under Subsection (9)(c), a board described in Subsection (9)(b) may:
(9)(d)(i) review clinical practice guidelines;
(9)(d)(ii) review peer-reviewed studies; and
(9)(d)(iii) consult with medical specialists who are familiar with the drug under consideration.
(9)(e) When creating the therapeutically similar drug product list, before considering any other types of drugs, the division shall consider:
(9)(e)(i) albuterol inhalers;
(9)(e)(ii) injectable forms of insulin; and
(9)(e)(iii) diabetic test strips.
(9)(f) The division may, in consultation with each board described in Subsection (9)(b), create standards in rule for considering drug products that should be added to the therapeutically similar drug product list.
(10) Failure of a licensed medical practitioner to specify that no substitution is authorized does not constitute evidence of negligence.