Utah Code 58-17b-605.5. Interchangeable biological products
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(1) For the purposes of this section:
Terms Used In Utah Code 58-17b-605.5
- Drug: means :(26)(a)(i) a substance recognized in the official United States Pharmacopoeia, official Homeopathic Pharmacopoeia of the United States, or official National Formulary, or any supplement to any of them, intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in humans or animals;(26)(a)(ii) a substance that is required by any applicable federal or state law or rule to be dispensed by prescription only or is restricted to administration by practitioners only;(26)(a)(iii) a substance other than food intended to affect the structure or any function of the body of humans or other animals; and(26)(a)(iv) substances intended for use as a component of any substance specified in Subsections (26)(a)(i) through (iv). See Utah Code 58-17b-102
- Electronic transmission: means transmission of information in electronic form or the transmission of the exact visual image of a document by way of electronic equipment. See Utah Code 58-17b-102
- Manufacturer: means a person or business physically located in Utah licensed to be engaged in the manufacturing of drugs or devices. See Utah Code 58-17b-102
- Out-of-state mail service pharmacy: means a pharmaceutical facility located outside the state that is licensed and in good standing in another state, that:
(42)(a) ships, mails, or delivers by any lawful means a dispensed legend drug to a patient in this state pursuant to a lawfully issued prescription;(42)(b) provides information to a patient in this state on drugs or devices which may include, but is not limited to, advice relating to therapeutic values, potential hazards, and uses; or(42)(c) counsels pharmacy patients residing in this state concerning adverse and therapeutic effects of drugs. See Utah Code 58-17b-102- Pharmacist: means an individual licensed by this state to engage in the practice of pharmacy. See Utah Code 58-17b-102
- Pharmacy: means any place where:
(51)(a) drugs are dispensed;(51)(b) pharmaceutical care is provided;(51)(c) drugs are processed or handled for eventual use by a patient; or(51)(d) drugs are used for the purpose of analysis or research. See Utah Code 58-17b-102- Pharmacy intern: means an individual licensed by this state to engage in practice as a pharmacy intern. See Utah Code 58-17b-102
- Practitioner: means an individual currently licensed, registered, or otherwise authorized by the appropriate jurisdiction to prescribe and administer drugs in the course of professional practice. See Utah Code 58-17b-102
- Prescription: means an order issued:
(63)(a) by a licensed practitioner in the course of that practitioner's professional practice or by collaborative pharmacy practice agreement; and(63)(b) for a controlled substance or other prescription drug or device for use by a patient or an animal. See Utah Code 58-17b-102- State: when applied to the different parts of the United States, includes a state, district, or territory of the United States. See Utah Code 68-3-12.5
- United States: includes each state, district, and territory of the United States of America. See Utah Code 68-3-12.5
- Writing: includes :
(48)(a) printing;(48)(b) handwriting; and(48)(c) information stored in an electronic or other medium if the information is retrievable in a perceivable format. See Utah Code 68-3-12.5(1)(a) “Biological product” means the same as that term is defined in 42 U.S.C. § 262.(1)(b) “Interchangeable biological product” means a biological product that the federal Food and Drug Administration:(1)(b)(i) has:(1)(b)(i)(A) licensed; and(1)(b)(i)(B) determined meets the standards for interchangeability pursuant to 42 U.S.C. § 262(k)(4); or(1)(b)(ii) has determined is therapeutically equivalent as set forth in the latest edition of or supplement to the federal Food and Drug Administration’s Approved Drug Products with Therapeutic Equivalence Evaluations.(2) A pharmacist or pharmacy intern dispensing a prescription order for a specific biological product by brand or proprietary name may substitute an interchangeable biological product for the prescribed biological product only if:(2)(a) the purchaser specifically requests or consents to the substitute of an interchangeable biological product;(2)(b) the interchangeable biological product is permitted to move in interstate commerce;(2)(c) the pharmacist or pharmacy intern counsels the patient on the use and the expected response to the prescribed biological product, whether a substitute or not, and the substitution is not otherwise prohibited by this chapter;(2)(d) the prescribing practitioner has not prohibited the substitution of an interchangeable biological product for the prescribed biological product, as provided in Subsection (6); and(2)(e) the substitution is not otherwise prohibited by law.(3) Each out-of-state mail service pharmacy dispensing an interchangeable biological product as a substitute for another biological product into this state shall:(3)(a) notify the patient of the substitution either by telephone or in writing; and(3)(b) comply with the requirements of this chapter with respect to an interchangeable biological product substituted for another biological product, including labeling and record keeping.(4) Pharmacists or pharmacy interns may not substitute without the prescriber’s authorization biological product prescriptions unless the product has been determined by the United States Food and Drug Administration to be interchangeable with the prescribed biological product.(5) A pharmacist or pharmacy intern who dispenses a prescription with an interchangeable biological product under this section assumes no greater liability than would be incurred had the pharmacist or pharmacy intern dispensed the prescription with the biological product prescribed.(6)(6)(a) If, in the opinion of the prescribing practitioner, it is in the best interest of the patient that an interchangeable biological product not be substituted for a prescribed biological product, the practitioner may prohibit a substitution either by writing “dispense as written” or by 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)(6)(b)(i) If the prescription is communicated orally by the prescribing practitioner to the pharmacist or pharmacy intern, the practitioner shall direct the prohibition or substitution.(6)(b)(ii) The pharmacist or pharmacy intern shall make a written note of the practioner’s direction by writing the name of the practitioner and the words “orally by” and the initials of the pharmacist or pharmacy intern written after it.(7) A pharmacist or pharmacy intern who substitutes an interchangeable biological product for a prescribed biological product shall communicate the substitution to the purchaser. The interchangeable biological product container shall be labeled with the name of the interchangeable biological product dispensed, and the pharmacist, pharmacy intern, or pharmacy technician shall indicate on the file copy of the prescription both the name of the prescribed biological product and the name of the interchangeable biological product dispensed in its place.(8) Within five business days following the dispensing of a biological product, the dispensing pharmacist or the pharmacist’s designee shall make an entry of the specific product provided to the patient, including the name of the product and the manufacturer. The communication shall be conveyed by making an entry into an interoperable electronic medical records system, through an electronic prescribing technology, a pharmacy benefit management system, or a pharmacy record that is electronically accessible by the prescriber. Entry into an electronic records system as described in this Subsection (8) is presumed to provide notice to the prescriber. Otherwise, the pharmacist shall communicate the biological product dispensed to the prescriber using facsimile, telephone, electronic transmission, or other prevailing means, provided that communication shall not be required where:(8)(a) there is no FDA-approved interchangeable biological product for the product prescribed;(8)(b) a refill prescription is not changed from the product dispensed on the prior filling of the prescription; or(8)(c) the product is paid for using cash or cash equivalent.