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Chapter 480-51 INTERCHANGEABLE BIOLOGICAL PRODUCTS

Rule 480-51-.01 Definitions

(1) "Biological product" means a biological product as defined in subsection (i) of section 351 of the Public Health Service Act, 42 U.S.C. Section 262.
(2) "Interchangeable biological product" means a biological product that the federal Food and Drug Administration has determined meets the standards set forth in subsection (k)(4) of 42 U.S.C. 262 or has been deemed therapeutically equivalent by the federal Food and Drug Administration.

Rule 480-51-.02 Substituting Interchangeable Biological Products

(1) If a practitioner of the healing arts prescribes a biological product by its nonproprietary name, the pharmacist may substitute the biological product with an interchangeable biological product, but shall dispense the lowest retail-priced interchangeable biological product, which is in stock.
(2) Substitutions as provided in this rule are authorized for the express purpose of making available to the consumer the lowest retail priced interchangeable biological product which is in stock.
(3) Whenever a substitution is made:
(a) The pharmacist shall record on the original prescription the fact that there has been a substitution and the identity of the dispensed interchangeable biological product and its manufacturer. Such prescription shall be maintained for two years and shall be available for inspection by the board or its representative.
(b) The pharmacist shall affix to the prescription label or container or an auxiliary label, the name of the interchangeable biological product, with an explanation of "interchangeable biological product for (insert name of prescribed biological product)" or similar language to indicate substitution has occurred, unless the prescribing practitioner indicated that the name of the biological product may not appear upon the prescription label.
1. This labeling requirement does not apply to biological products dispensed for in-patient hospital services, to hospital-administered biological products for outpatients, or to biological products in specialty packaging for dosing purposes. This labeling requirement does apply to hospital retail pharmacies and to any biological products dispensed by a hospital for a patient's use or administration at home.
(4) The substitution of any biological product by a registered pharmacist pursuant to this rule section does not constitute the practice of medicine.
(5) A patient for whom a prescription biological product order is intended may instruct a pharmacist not to substitute an interchangeable biological product in lieu of a prescribed biological product.
(6) A practitioner of the healing arts may instruct the pharmacist not to substitute an interchangeable biological product in lieu of a prescribed biological product by including the words "brand necessary" in the body of the prescription.
(a) When a prescription is a hard copy biological product order, such indication of brand necessary must be in the practitioner's own handwriting and shall not be printed, applied by rubber stamp, or any such similar means.
(b) When the prescription is an electronic prescription drug or biological product order, the words "brand necessary" are not required to be in the practitioner's own handwriting and may be included on the prescription in any manner or by any method.
(c) When a practitioner has designated "brand necessary" on an electronic biological product order, an interchangeable biological product shall not be substituted without the practitioner's express consent, which shall be documented by the pharmacist on the prescription and by the practitioner in the patient's medical record.
(7) Within forty-eight (48) hours, excluding weekends and holidays, following the dispensing of a biological product, the dispensing pharmacist or the pharmacist's designee shall communicate to the prescriber the specific product provided to the patient, including the name of the biological product and the manufacturer.
(a) The communication shall be conveyed by making an entry into an interoperable electronic medical records system or through electronic prescribing technology or a pharmacy record that is electronically accessible by the prescriber. Otherwise, the pharmacist shall communicate the biological product dispensed to the prescriber by using facsimile, telephone, electronic transmission, or other prevailing means, provided that communication shall not be required where:
1. There is no interchangeable biological product approved by the federal Food and Drug Administration for the prescribed product; or
2. A refill prescription is not changed from the product dispensed on the prior filling of the prescription.
(8) A link for the current list of all biological products determined by the federal Food and Drug Administration to be interchangeable with a specific biological products is available on the Board's website.