Florida Senate - 2025                                     SB 632
       
       
        
       By Senator Martin
       
       
       
       
       
       33-00689-25                                            2025632__
    1                        A bill to be entitled                      
    2         An act relating to treatment of chronic and terminal
    3         illnesses; creating s. 499.0296, F.S.; defining terms;
    4         providing that chronically and terminally ill patients
    5         have the right, with assistance and guidance from
    6         their health care providers, to determine their
    7         individual courses of treatment; authorizing
    8         compounding pharmacies to obtain certain active
    9         pharmaceutical ingredients to provide the prescribed
   10         course of treatment in such cases, provided the active
   11         pharmaceutical ingredients meet specified conditions;
   12         providing applicability; providing construction;
   13         providing an effective date.
   14          
   15  Be It Enacted by the Legislature of the State of Florida:
   16  
   17         Section 1. Section 499.0296, Florida Statutes, is created
   18  to read:
   19         499.0296 Safe compounding to treat chronic or terminal
   20  illnesses.—
   21         (1) As used in this section, the term:
   22         (a) “Chronically ill patient” means a patient whose
   23  physician has diagnosed the patient with a long-term disease or
   24  condition that, if left untreated, may cause major irreversible
   25  morbidity and who might benefit from individualized or
   26  specialized medication that is not commercially available.
   27         (b) “Compounding pharmacy” means a pharmacy licensed under
   28  chapter 465 which is classified as a 503A pharmacy by the United
   29  States Food and Drug Administration to compound drugs according
   30  to prescriptions specific to particular patients.
   31         (c) “Monograph” means the quality standards for
   32  prescription drugs and dietary supplements which articulate the
   33  quality expectations for a drug or dietary supplement, including
   34  its identity, strength, purity, and performance.
   35         (d) “Terminally ill patient” means a patient whose
   36  physician has diagnosed the patient with a progressive disease
   37  or medical or surgical condition that causes significant
   38  functional impairment, is not considered by a treating physician
   39  to be reversible without the administration of life-sustaining
   40  procedures, and, taking into account the patient’s medical
   41  circumstances, will result in the patient’s death within 1 year
   42  after diagnosis if the condition runs its normal course.
   43         (2) Chronically ill patients and terminally ill patients
   44  have the right to determine, with the assistance and guidance of
   45  their health care providers, individual courses of treatment
   46  through the use of individualized or specialized prescription
   47  drugs obtained from a compounding pharmacy.
   48         (3) Compounding pharmacies licensed under chapter 465 may
   49  obtain active pharmaceutical ingredients that do not have a
   50  United States Pharmacopeia, National Formulary, or Food
   51  Chemicals Codex monograph for use in compounding to provide
   52  chronically ill patients and terminally ill patients with the
   53  prescribed individual course of treatment, provided the active
   54  pharmaceutical ingredient is:
   55         (a) Purchased from an active pharmaceutical ingredient
   56  manufacturer, repackager, relabeler, or wholesaler registered
   57  with the United States Food and Drug Administration; and
   58         (b) Shipped into this state in compliance with state law
   59  and arrives with a certificate of analysis detailing quality
   60  specifications, including any medications, dietary supplements,
   61  biologics, proteins, peptides, and amino acids that are already
   62  in use by compounding pharmacies in this state.
   63  
   64  This subsection does not apply if the active pharmaceutical
   65  ingredient is withdrawn or removed from the market for safety
   66  and efficacy reasons by the United States Food and Drug
   67  Administration or is placed on its Interim 503A Category 2 or 3
   68  Bulk Drug Substances List. Compounding pharmacies may use
   69  substances placed on the Interim 503A Category 2 or 3 Bulk Drug
   70  Substances List only if the substance meets the requirements of
   71  this section.
   72         (4) This section does not allow any treatment or use of
   73  medication that is intended to cause the death of the patient.
   74         Section 2. This act shall take effect July 1, 2025.