465.0252

Substitution of interchangeable biosimilar products.

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465.0252 Substitution of interchangeable biosimilar products.—

(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. s. 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.

(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).

History.—s. 2, ch. 2013-102; s. 4, ch. 2018-95.

Notes of Decisions

Cited in 1 case, 2020–2020 · leading case: Teva Pharmaceuticals USA, Inc. v. United States Food and Drug Administration

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Teva Pharmaceuticals USA, Inc. v. United States Food and Drug Administration (2020) dcd “, Fla. Stat. § 465.0252 (1), (2); Va. Code §§ 54.”

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