(1) This chapter shall not be construed to prohibit the sale of home remedies or preparations commonly known as patents or proprietary preparations when sold only in original or unbroken packages, nor shall this chapter be construed to prevent businesses from engaging in the sale of sundries or patents or proprietary preparations.
(2) This chapter does not apply to a manufacturer, or its agent, holding an active manufacturer or third-party logistics provider permit under chapter 499, to the extent the manufacturer, or its agent, is engaged in the manufacture or distribution of dialysate, drugs, or devices necessary to perform home renal dialysis on patients with chronic kidney failure, if the dialysate, drugs, or devices are:
(a) Approved or cleared by the United States Food and Drug Administration; and
(b) Delivered in the original, sealed packaging after receipt of a physician’s order to dispense to:
1. A patient with chronic kidney failure, or the patient’s designee, for the patient’s self-administration of the dialysis therapy; or
2. A health care practitioner or an institution for administration or delivery of the dialysis therapy to a patient with chronic kidney failure.
History.—ss. 1, 7, ch. 79-226; ss. 2, 3, ch. 81-318; ss. 18, 26, 27, ch. 86-256; s. 59, ch. 91-137; s. 6, ch. 91-156; s. 4, ch. 91-429; s. 23, ch. 2016-230; s. 1, ch. 2018-50.
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.