(1) As used in this section, the terms “biological product,” “biosimilar,” and “interchangeable” have the same meanings as defined in s. 351 of the federal Public Health Service Act, 42 U.S.C. § 262.
(2) A pharmacist may only dispense a substitute biological product for the prescribed biological product if:

(a) The United States Food and Drug Administration has determined that the substitute biological product is biosimilar to and interchangeable for the prescribed biological product.

Terms Used In Florida Statutes 465.0252

  • Administration: means the obtaining and giving of a single dose of medicinal drugs by a legally authorized person to a patient for her or his consumption. See Florida Statutes 465.003
  • Board: means the Board of Pharmacy. See Florida Statutes 465.003
  • Dispense: means the transfer of possession of one or more doses of a medicinal drug by a pharmacist to the ultimate consumer or her or his agent. See Florida Statutes 465.003
  • person: includes individuals, children, firms, associations, joint adventures, partnerships, estates, trusts, business trusts, syndicates, fiduciaries, corporations, and all other groups or combinations. See Florida Statutes 1.01
  • Pharmacist: means any person licensed pursuant to this chapter to practice the profession of pharmacy. See Florida Statutes 465.003
  • Pharmacy: includes a community pharmacy, an institutional pharmacy, a nuclear pharmacy, a special pharmacy, and an Internet pharmacy. See Florida Statutes 465.003
  • Prescription: includes any order for drugs or medicinal supplies written or transmitted by any means of communication by a duly licensed practitioner authorized by the laws of the state to prescribe such drugs or medicinal supplies and intended to be dispensed by a pharmacist. See Florida Statutes 465.003
  • writing: includes handwriting, printing, typewriting, and all other methods and means of forming letters and characters upon paper, stone, wood, or other materials. See Florida Statutes 1.01
(b) The prescribing health care provider does not express a preference against substitution in writing, verbally, or electronically.
(c) The pharmacist notifies the person presenting the prescription of the substitution in the same manner as provided in s. 465.025(3)(a).
(d) The pharmacist retains a written or electronic record of the substitution for at least 2 years.
(3) A pharmacist who practices in a Class II, Modified Class II, or Class III institutional pharmacy shall comply with the notification provisions of paragraph (2)(c) by entering the substitution in the institution’s written medical record system or electronic medical record system.
(4) The board shall maintain on its public website a current list of biological products that the United States Food and Drug Administration has determined are biosimilar and interchangeable as provided in paragraph (2)(a).
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