(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.
Structure Florida Statutes
Title XXXII - Regulation of Professions and Occupations
465.002 - Legislative Findings; Intent.
465.005 - Authority to Make Rules.
465.006 - Disposition of Fees; Expenditures.
465.007 - Licensure by Examination.
465.0075 - Licensure by Endorsement; Requirements; Fee.
465.009 - Continuing Professional Pharmaceutical Education.
465.012 - Reactivation of License; Continuing Education.
465.0125 - Consultant Pharmacist License; Application, Renewal, Fees; Responsibilities; Rules.
465.0126 - Nuclear Pharmacist License; Application, Renewal, Fees.
465.013 - Registration of Pharmacy Interns.
465.014 - Pharmacy Technician.
465.015 - Violations and Penalties.
465.0155 - Standards of Practice.
465.0156 - Registration of Nonresident Pharmacies.
465.0157 - International Export Pharmacy Permit.
465.0158 - Nonresident Sterile Compounding Permit.
465.016 - Disciplinary Actions.
465.0161 - Distribution of Medicinal Drugs Without a Permit.
465.017 - Authority to Inspect; Disposal.
465.018 - Community Pharmacies; Permits.
465.019 - Institutional Pharmacies; Permits.
465.0193 - Nuclear Pharmacy Permits.
465.0196 - Special Pharmacy Permits.
465.0197 - Internet Pharmacy Permits.
465.022 - Pharmacies; General Requirements; Fees.
465.023 - Pharmacy Permittee; Disciplinary Action.
465.024 - Promoting Sale of Certain Drugs Prohibited.
465.0244 - Information Disclosure.
465.025 - Substitution of Drugs.
465.0251 - Generic Drugs; Removal From Formulary Under Specified Circumstances.
465.0252 - Substitution of Interchangeable Biosimilar Products.
465.0255 - Expiration Date of Medicinal Drugs; Display; Related Use and Storage Instructions.
465.026 - Filling of Certain Prescriptions.
465.0265 - Centralized Prescription Filling.
465.0275 - Emergency Prescription Refill.
465.0276 - Dispensing Practitioner.
465.035 - Dispensing of Medicinal Drugs Pursuant to Facsimile of Prescription.
465.185 - Rebates Prohibited; Penalties.
465.186 - Pharmacist’s Order for Medicinal Drugs; Dispensing Procedure; Development of Formulary.
465.1865 - Collaborative Pharmacy Practice for Chronic Health Conditions.
465.187 - Sale of Medicinal Drugs.
465.188 - Medicaid Audits of Pharmacies.
465.189 - Administration of Vaccines and Epinephrine Autoinjection.
465.1893 - Administration of Antipsychotic Medication by Injection.
465.1895 - Testing or Screening for and Treatment of Minor, Nonchronic Health Conditions.