Florida Senate - 2025                                     SB 906
       
       
        
       By Senator Collins
       
       
       
       
       
       14-00110B-25                                           2025906__
    1                        A bill to be entitled                      
    2         An act relating to pharmacy; amending s. 465.003,
    3         F.S.; revising the definition of the term “pharmacy”
    4         to include remote-site pharmacies; revising
    5         construction of the term “not present and on duty”;
    6         amending s. 465.014, F.S.; authorizing registered
    7         pharmacy technicians to handle the sales transactions
    8         and delivery of dispensed drugs under certain
    9         circumstances; providing an exception to certain
   10         supervision limitations; amending s. 465.015, F.S.;
   11         providing applicability; exempting certain registered
   12         pharmacy technicians from specified prohibitions;
   13         creating s. 465.0198, F.S.; defining terms; providing
   14         for the permitting of remote-site pharmacies;
   15         requiring that a licensed or consultant pharmacist
   16         serve as the prescription department manager of a
   17         remote-site pharmacy; requiring remote-site pharmacies
   18         to notify the Department of Health of a change in the
   19         pharmacy’s prescription department manager within a
   20         specified timeframe; providing requirements for
   21         remote-site pharmacies; authorizing remote-site
   22         pharmacies to store, hold, and dispense medicinal
   23         drugs; prohibiting the dispensing of Schedule II
   24         medications at remote-site pharmacies unless a
   25         pharmacist is present; requiring prescription
   26         department managers to visit remote-site pharmacies,
   27         based on a certain schedule, to perform specified
   28         tasks; prohibiting remote-site pharmacies from being
   29         open when the supervising pharmacy is closed unless a
   30         certain pharmacist is present or providing remote
   31         supervision at the remote-site pharmacy; authorizing
   32         the Board of Pharmacy to adopt specified rules;
   33         amending s. 465.022, F.S.; exempting registered
   34         pharmacists serving as prescription department
   35         managers for remote-site pharmacies from certain
   36         practice limitations; providing an effective date.
   37          
   38  Be It Enacted by the Legislature of the State of Florida:
   39  
   40         Section 1. Subsection (20) of section 465.003, Florida
   41  Statutes, is amended to read:
   42         465.003 Definitions.—As used in this chapter, the term:
   43         (20)(a) “Pharmacy” includes a community pharmacy, an
   44  institutional pharmacy, a nuclear pharmacy, a special pharmacy,
   45  and an Internet pharmacy, and a remote-site pharmacy.
   46         1. The term “community pharmacy” includes every location
   47  where medicinal drugs are compounded, dispensed, stored, or sold
   48  or where prescriptions are filled or dispensed on an outpatient
   49  basis.
   50         2. The term “institutional pharmacy” includes every
   51  location in a hospital, clinic, nursing home, dispensary,
   52  sanitarium, extended care facility, or other facility,
   53  hereinafter referred to as “health care institutions,” where
   54  medicinal drugs are compounded, dispensed, stored, or sold.
   55         3. The term “nuclear pharmacy” includes every location
   56  where radioactive drugs and chemicals within the classification
   57  of medicinal drugs are compounded, dispensed, stored, or sold.
   58  The term “nuclear pharmacy” does not include hospitals licensed
   59  under chapter 395 or the nuclear medicine facilities of such
   60  hospitals.
   61         4. The term “special pharmacy” includes every location
   62  where medicinal drugs are compounded, dispensed, stored, or sold
   63  if such locations are not otherwise defined in this subsection.
   64         5. The term “Internet pharmacy” includes locations not
   65  otherwise licensed or issued a permit under this chapter, within
   66  or outside this state, which use the Internet to communicate
   67  with or obtain information from consumers in this state and use
   68  such communication or information to fill or refill
   69  prescriptions or to dispense, distribute, or otherwise engage in
   70  the practice of pharmacy in this state. Any act described in
   71  this definition constitutes the practice of the profession of
   72  pharmacy.
   73         6.The term “remote-site pharmacy” includes every location
   74  where medicinal drugs are dispensed by a supervising pharmacist
   75  as defined in s. 465.0198 who is remotely supervising a
   76  registered pharmacy technician handling the sales transactions
   77  and delivery of the drugs.
   78         (b) The pharmacy department of any permittee is shall be
   79  considered closed whenever a Florida licensed pharmacist is not
   80  present and on duty. The term “not present and on duty” may
   81  shall not be construed to prevent any of the following:
   82         1. A pharmacist from exiting the prescription department
   83  for the purposes of consulting or responding to inquiries or
   84  providing assistance to patients or customers.
   85         2.A pharmacist from, attending to personal hygiene needs.
   86         3.A pharmacist from, or performing any other function for
   87  which the pharmacist is responsible, provided that such
   88  activities are conducted in a manner consistent with the
   89  pharmacist’s responsibility to provide pharmacy services.
   90         4.A supervising pharmacist as defined in s. 465.0198,
   91  acting in the capacity of a prescription department manager,
   92  from remotely supervising a registered pharmacy technician at a
   93  remote-site pharmacy.
   94         Section 2. Subsection (1) of section 465.014, Florida
   95  Statutes, is amended to read:
   96         465.014 Pharmacy technician.—
   97         (1) A person other than a licensed pharmacist or pharmacy
   98  intern may not engage in the practice of the profession of
   99  pharmacy, except that a licensed pharmacist may delegate to
  100  pharmacy technicians who are registered pursuant to this section
  101  those duties, tasks, and functions that do not fall within the
  102  purview of s. 465.003, and a registered pharmacy technician
  103  operating under remote supervision of a supervising pharmacist
  104  as defined in s. 465.0198 may handle the sales transactions and
  105  delivery of the dispensed drugs. All such delegated acts must be
  106  performed under the direct supervision of a licensed pharmacist
  107  who is responsible for all such acts performed by persons under
  108  his or her supervision. A registered pharmacy technician, under
  109  the supervision of a pharmacist, may initiate or receive
  110  communications with a practitioner or his or her agent, on
  111  behalf of a patient, regarding refill authorization requests. A
  112  licensed pharmacist may not supervise more than one registered
  113  pharmacy technician, except as provided in s. 465.0198 or unless
  114  otherwise permitted by the guidelines adopted by the board. The
  115  board shall establish guidelines to be followed by licensees or
  116  permittees in determining the circumstances under which a
  117  licensed pharmacist may supervise more than one pharmacy
  118  technician.
  119         Section 3. Paragraph (b) of subsection (1) and paragraph
  120  (b) of subsection (2) of section 465.015, Florida Statutes, are
  121  amended to read:
  122         465.015 Violations and penalties.—
  123         (1) It is unlawful for any person to own, operate,
  124  maintain, open, establish, conduct, or have charge of, either
  125  alone or with another person or persons, a pharmacy:
  126         (b) In which a person not licensed as a pharmacist in this
  127  state or not registered as an intern in this state or in which
  128  an intern who is not acting under the direct and immediate
  129  personal supervision of a licensed pharmacist fills, compounds,
  130  or dispenses any prescription or dispenses medicinal drugs. This
  131  paragraph does not apply to any person who owns, operates,
  132  maintains, opens, establishes, conducts, or has charge of a
  133  remote-site pharmacy under s. 465.0198.
  134         (2) It is unlawful for any person:
  135         (b) To fill, compound, or dispense prescriptions or to
  136  dispense medicinal drugs if such person does not hold an active
  137  license as a pharmacist in this state, is not registered as an
  138  intern in this state, or is an intern not acting under the
  139  direct and immediate personal supervision of a licensed
  140  pharmacist, or is not a registered pharmacy technician at a
  141  remote-site pharmacy who is acting under remote supervision of a
  142  licensed pharmacist pursuant to s. 465.0198.
  143         Section 4. Section 465.0198, Florida Statutes, is created
  144  to read:
  145         465.0198Remote-site pharmacy permits.—
  146         (1)As used in this section, the term:
  147         (a)“Supervising pharmacist” means a pharmacist licensed in
  148  this state who is employed by or under contract with a pharmacy
  149  licensed in this state and who remotely supervises registered
  150  pharmacy technicians at a remote-site pharmacy at a maximum
  151  ratio of one pharmacist to up to six registered pharmacy
  152  technicians.
  153         (b)“Supervising pharmacy” means a pharmacy licensed in
  154  this state which employs or contracts with a pharmacist licensed
  155  in this state who remotely supervises a registered pharmacy
  156  technician at a remote-site pharmacy at a maximum ratio of one
  157  pharmacist to up to six registered pharmacy technicians.
  158         (c)“Telepharmacy” means the practice of pharmacy by a
  159  pharmacist located in this state using telecommunications or
  160  other automations and technologies to provide or supervise the
  161  provision of pharmacy services to patients and their agents who
  162  are located at sites other than where the pharmacist is located,
  163  including dispensing of prescriptions to and counseling of
  164  patients.
  165         (2)Any person desiring a permit to operate a remote-site
  166  pharmacy must apply to the department. If the board certifies
  167  that the application complies with the laws and rules of the
  168  board, the department must issue the permit. A permit may not be
  169  issued unless a licensed pharmacist or consultant pharmacist is
  170  designated as the prescription department manager responsible
  171  for the oversight of the remote-site pharmacy. The permittee
  172  must notify the department within 10 days after any change of
  173  the prescription department manager.
  174         (3)A remote-site pharmacy must comply with all of the
  175  following:
  176         (a)Be jointly owned by or operated under a contract with a
  177  supervising pharmacy.
  178         (b)Operate only between the hours of 7 p.m. and 9 a.m., in
  179  accordance with subsection (6).
  180         (c)Maintain a video surveillance system that records
  181  continuously 24 hours a day, 7 days a week, and retain video
  182  surveillance recordings for at least 30 days.
  183         (d)Display a sign visible to the public indicating that
  184  the location is a remote-site pharmacy and that the facility is
  185  under 24-hour video surveillance.
  186         (e)Maintain a policies and procedures manual, which must
  187  be made available to the board or its agent upon request and
  188  must include, but need not be limited to, all of the following:
  189         1.A description of how the remote-site pharmacy will
  190  comply with federal and state laws and rules.
  191         2.The procedures for supervising the remote-site pharmacy
  192  and counseling its patients.
  193         3.The procedures for reviewing the prescription drug
  194  inventory and drug records maintained by the remote-site
  195  pharmacy.
  196         4.The policies and procedures for providing security
  197  adequate to protect the confidentiality and integrity of patient
  198  information.
  199         5.The written plan for recovery from an event that
  200  interrupts or prevents the prescription department manager from
  201  supervising the remote-site pharmacy’s operation.
  202         6.The procedures for use of the state prescription drug
  203  monitoring program by the prescription department manager before
  204  he or she may authorize the dispensing of any controlled
  205  substance.
  206         7.The procedures for maintaining a perpetual inventory of
  207  the controlled substances listed in Schedule II of s. 893.03.
  208         8.The specific duties, tasks, and functions that
  209  registered pharmacy technicians are authorized to perform at the
  210  remote-site pharmacy.
  211         (4)A remote-site pharmacy may store, hold, or dispense any
  212  medicinal drug, including proprietary drugs and controlled
  213  substances. However, a remote-site pharmacy may not dispense
  214  Schedule II controlled substances listed in s. 893.03 unless a
  215  pharmacist is present at the remote-site pharmacy.
  216         (5)The prescription department manager must visit the
  217  remote-site pharmacy, based on a schedule determined by the
  218  board, to inspect the pharmacy, address personnel matters, and
  219  provide clinical services for patients.
  220         (6)A remote-site pharmacy may only be open when the
  221  supervising pharmacy is open, unless a pharmacist employed by or
  222  under contract with the supervising pharmacy, or a pharmacy
  223  under contract with the supervising pharmacy, is present at the
  224  remote-site pharmacy or is providing remote supervision as
  225  required under this section.
  226         (7)The board may adopt rules as necessary to specify
  227  additional criteria for a remote-site pharmacy. Any additional
  228  criteria adopted by the board must be limited to rules
  229  concerning one or more of the following:
  230         (a)Application requirements.
  231         (b)Structural and equipment requirements.
  232         (c)Training requirements.
  233         (d)Inventory recordkeeping and storage requirements.
  234         Section 5. Paragraph (c) of subsection (11) of section
  235  465.022, Florida Statutes, is amended to read:
  236         465.022 Pharmacies; general requirements; fees.—
  237         (11) A permittee must notify the department of the identity
  238  of the prescription department manager within 10 days after
  239  employment. The prescription department manager must comply with
  240  the following requirements:
  241         (c) A registered pharmacist may not serve as the
  242  prescription department manager in more than one location,
  243  except when acting as a prescription department manager under s.
  244  465.0198, unless approved by the board.
  245         Section 6. This act shall take effect July 1, 2025.