Florida § 465.0252 Substitution of interchangeable biosimilar products

Florida Statutes

§ 465.0252 — Substitution of interchangeable biosimilar products

Florida § 465.0252

TitleXXXII

Ch. 465PHARMACY

This text of Florida § 465.0252 (Substitution of interchangeable biosimilar products) is published on Counsel Stack Legal Research, covering Florida primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook

Fla. Stat. § 465.0252 (2026).

Text

(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

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(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).