Florida Senate - 2024                                    SB 1406
       By Senator Calatayud
       38-01176-24                                           20241406__
    1                        A bill to be entitled                      
    2         An act relating to restricted prescription drug
    3         distributors; amending s. 499.01, F.S.; exempting
    4         certain persons who engage in the receipt or
    5         distribution of prescription drugs for the sole
    6         purpose of processing the drugs’ destruction from
    7         specified inventory and vehicle security requirements;
    8         amending s. 499.05, F.S.; requiring the Department of
    9         Business and Professional Regulation to adopt less
   10         stringent rules for certain persons who engage in the
   11         receipt or distribution of prescription drugs for the
   12         sole purpose of processing the drugs’ destruction;
   13         providing requirements for such rules; providing an
   14         effective date.
   16  Be It Enacted by the Legislature of the State of Florida:
   18         Section 1. Paragraph (h) of subsection (2) of section
   19  499.01, Florida Statutes, is amended to read:
   20         499.01 Permits.—
   21         (2) The following permits are established:
   22         (h) Restricted prescription drug distributor permit.—
   23         1. A restricted prescription drug distributor permit is
   24  required for:
   25         a. Any person located in this state who engages in the
   26  distribution of a prescription drug, which distribution is not
   27  considered “wholesale distribution” under s. 499.003(48)(a).
   28         b. Any person located in this state who engages in the
   29  receipt or distribution of a prescription drug in this state for
   30  the purpose of processing its return or its destruction if such
   31  person is not the person initiating the return, the prescription
   32  drug wholesale supplier of the person initiating the return, or
   33  the manufacturer of the drug.
   34         c. A blood establishment located in this state which
   35  collects blood and blood components only from volunteer donors
   36  as defined in s. 381.06014 or pursuant to an authorized
   37  practitioner’s order for medical treatment or therapy and
   38  engages in the wholesale distribution of a prescription drug not
   39  described in s. 499.003(48)(j) to a health care entity. A mobile
   40  blood unit operated by a blood establishment permitted under
   41  this sub-subparagraph is not required to be separately
   42  permitted. The health care entity receiving a prescription drug
   43  distributed under this sub-subparagraph must be licensed as a
   44  closed pharmacy or provide health care services at that
   45  establishment. The blood establishment must operate in
   46  accordance with s. 381.06014 and may distribute only:
   47         (I) Prescription drugs indicated for a bleeding or clotting
   48  disorder or anemia;
   49         (II) Blood-collection containers approved under s. 505 of
   50  the federal act;
   51         (III) Drugs that are blood derivatives, or a recombinant or
   52  synthetic form of a blood derivative;
   53         (IV) Prescription drugs that are identified in rules
   54  adopted by the department and that are essential to services
   55  performed or provided by blood establishments and authorized for
   56  distribution by blood establishments under federal law; or
   57         (V) To the extent authorized by federal law, drugs
   58  necessary to collect blood or blood components from volunteer
   59  blood donors; for blood establishment personnel to perform
   60  therapeutic procedures under the direction and supervision of a
   61  licensed physician; and to diagnose, treat, manage, and prevent
   62  any reaction of a volunteer blood donor or a patient undergoing
   63  a therapeutic procedure performed under the direction and
   64  supervision of a licensed physician,
   66  as long as all of the health care services provided by the blood
   67  establishment are related to its activities as a registered
   68  blood establishment or the health care services consist of
   69  collecting, processing, storing, or administering human
   70  hematopoietic stem cells or progenitor cells or performing
   71  diagnostic testing of specimens if such specimens are tested
   72  together with specimens undergoing routine donor testing. The
   73  blood establishment may purchase and possess the drugs described
   74  in this sub-subparagraph without a health care clinic
   75  establishment permit.
   76         2.a.Except as provided in sub-subparagraph b., the
   77  storage, handling, and recordkeeping of these distributions by a
   78  person required to be permitted as a restricted prescription
   79  drug distributor must be in accordance with the requirements for
   80  wholesale distributors under s. 499.0121.
   81         b.A person who is required to be permitted as a restricted
   82  prescription drug distributor and who engages in the receipt or
   83  distribution of a prescription drug in this state for the sole
   84  purpose of processing its destruction is not required to comply
   85  with the inventory requirements of s. 499.0121(6)(d) or (8) or
   86  the vehicle security requirements of s. 499.0121(2)(c).
   87         3. A person who applies for a permit as a restricted
   88  prescription drug distributor, or for the renewal of such a
   89  permit, must provide to the department the information required
   90  under s. 499.012.
   91         4. The department may adopt rules regarding the
   92  distribution of prescription drugs by hospitals, health care
   93  entities, charitable organizations, other persons not involved
   94  in wholesale distribution, and blood establishments, which rules
   95  are necessary for the protection of the public health, safety,
   96  and welfare.
   97         5. A restricted prescription drug distributor permit is not
   98  required for distributions between pharmacies that each hold an
   99  active permit under chapter 465, have a common ownership, and
  100  are operating in a freestanding end-stage renal dialysis clinic,
  101  if such distributions are made to meet the immediate emergency
  102  medical needs of specifically identified patients and do not
  103  occur with such frequency as to amount to the regular and
  104  systematic supplying of that drug between the pharmacies. The
  105  department shall adopt rules establishing when the distribution
  106  of a prescription drug under this subparagraph amounts to the
  107  regular and systematic supplying of that drug.
  108         6. A restricted prescription drug distributor permit is not
  109  required for distributing medicinal drugs or prepackaged drug
  110  products between entities under common control that each hold
  111  either an active Class III institutional pharmacy permit under
  112  chapter 465 or an active health care clinic establishment permit
  113  under paragraph (r). For purposes of this subparagraph, the term
  114  “common control” has the same meaning as in s. 499.003(48)(a)3.
  115         Section 2. Subsection (3) of section 499.05, Florida
  116  Statutes, is amended to read:
  117         499.05 Rules.—
  118         (3) The department shall adopt rules regulating
  119  recordkeeping for and the storage, handling, and distribution of
  120  medical devices and over-the-counter drugs to protect the public
  121  from adulterated products; however, rules regulating persons who
  122  engage in the receipt or distribution of a prescription drug in
  123  this state for the sole purpose of processing its destruction
  124  must be less stringent than the requirements for wholesale
  125  distributors under s. 499.0121 and may not include the inventory
  126  requirements in s. 499.0121(6)(d) or (8) or the vehicle security
  127  requirements in s. 499.0121(2)(c).
  128         Section 3. This act shall take effect July 1, 2024.