Bill Text: FL S0444 | 2024 | Regular Session | Introduced


Bill Title: Pharmacy

Spectrum: Partisan Bill (Republican 1-0)

Status: (Failed) 2024-03-08 - Died in Health Policy [S0444 Detail]

Download: Florida-2024-S0444-Introduced.html
       Florida Senate - 2024                                     SB 444
       
       
        
       By Senator Collins
       
       
       
       
       
       14-00445A-24                                           2024444__
    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 “dispense”;
    4         revising the definition of the term “pharmacy” to
    5         include remote-site pharmacies; revising construction
    6         of the term “not present and on duty”; amending s.
    7         465.014, F.S.; authorizing registered pharmacy
    8         technicians to dispense medicinal 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 the terms
   14         “supervising pharmacy” and “telepharmacy”; providing
   15         for the permitting of remote-site pharmacies;
   16         requiring a licensed or consultant pharmacist to serve
   17         as the prescription department manager of a remote
   18         site pharmacy; requiring remote-site pharmacies to
   19         notify the Department of Health of a change in the
   20         pharmacy’s prescription department manager within a
   21         specified timeframe; providing requirements for
   22         remote-site pharmacies; authorizing remote-site
   23         pharmacies to store, hold, and dispense medicinal
   24         drugs; prohibiting the dispensing of Schedule II
   25         medications at remote-site pharmacies unless a
   26         pharmacist is present; requiring prescription
   27         department managers to visit remote-site pharmacies,
   28         based on a certain schedule, to perform specified
   29         tasks; prohibiting remote-site pharmacies from being
   30         open when the supervising pharmacy is closed unless a
   31         certain pharmacist is present or providing remote
   32         supervision at the remote-site pharmacy; prohibiting
   33         registered pharmacists from serving as prescription
   34         department managers for more than three remote-site
   35         pharmacies under certain circumstances; authorizing
   36         the Board of Pharmacy to adopt specified rules;
   37         amending s. 465.022, F.S.; exempting registered
   38         pharmacists serving as prescription department
   39         managers for remote-site pharmacies from certain
   40         practice limitations; providing an effective date.
   41          
   42  Be It Enacted by the Legislature of the State of Florida:
   43  
   44         Section 1. Subsections (13) and (20) of section 465.003,
   45  Florida Statutes, are amended to read:
   46         465.003 Definitions.—As used in this chapter, the term:
   47         (13) “Dispense” means the transfer of possession of one or
   48  more doses of a medicinal drug by a pharmacist, or by a
   49  registered pharmacy technician who is remotely supervised by an
   50  offsite pharmacist, to the ultimate consumer or her or his
   51  agent. As an element of dispensing, the pharmacist shall, prior
   52  to the actual physical transfer, interpret and assess the
   53  prescription order for potential adverse reactions,
   54  interactions, and dosage regimen she or he deems appropriate in
   55  the exercise of her or his professional judgment, and the
   56  pharmacist shall certify that the medicinal drug called for by
   57  the prescription is ready for transfer. The pharmacist shall
   58  also provide counseling on proper drug usage, either orally or
   59  in writing, if in the exercise of her or his professional
   60  judgment counseling is necessary. The actual sales transaction
   61  and delivery of such drug shall not be considered dispensing.
   62  The administration shall not be considered dispensing.
   63         (20)(a) “Pharmacy” includes a community pharmacy, an
   64  institutional pharmacy, a nuclear pharmacy, a special pharmacy,
   65  and an Internet pharmacy, and a remote-site pharmacy.
   66         1. The term “community pharmacy” includes every location
   67  where medicinal drugs are compounded, dispensed, stored, or sold
   68  or where prescriptions are filled or dispensed on an outpatient
   69  basis.
   70         2. The term “institutional pharmacy” includes every
   71  location in a hospital, clinic, nursing home, dispensary,
   72  sanitarium, extended care facility, or other facility,
   73  hereinafter referred to as “health care institutions,” where
   74  medicinal drugs are compounded, dispensed, stored, or sold.
   75         3. The term “nuclear pharmacy” includes every location
   76  where radioactive drugs and chemicals within the classification
   77  of medicinal drugs are compounded, dispensed, stored, or sold.
   78  The term “nuclear pharmacy” does not include hospitals licensed
   79  under chapter 395 or the nuclear medicine facilities of such
   80  hospitals.
   81         4. The term “special pharmacy” includes every location
   82  where medicinal drugs are compounded, dispensed, stored, or sold
   83  if such locations are not otherwise defined in this subsection.
   84         5. The term “Internet pharmacy” includes locations not
   85  otherwise licensed or issued a permit under this chapter, within
   86  or outside this state, which use the Internet to communicate
   87  with or obtain information from consumers in this state and use
   88  such communication or information to fill or refill
   89  prescriptions or to dispense, distribute, or otherwise engage in
   90  the practice of pharmacy in this state. Any act described in
   91  this definition constitutes the practice of the profession of
   92  pharmacy.
   93         6.The term “remote-site pharmacy” includes every location
   94  where medicinal drugs are dispensed by a registered pharmacy
   95  technician who is remotely supervised by an offsite pharmacist
   96  acting in the capacity of a prescription department manager.
   97         (b) The pharmacy department of any permittee is shall be
   98  considered closed whenever a Florida licensed pharmacist is not
   99  present and on duty. The term “not present and on duty” may
  100  shall not be construed to prevent any of the following:
  101         1. A pharmacist from exiting the prescription department
  102  for the purposes of consulting or responding to inquiries or
  103  providing assistance to patients or customers.
  104         2.A pharmacist from, attending to personal hygiene needs.
  105         3.A pharmacist from, or performing any other function for
  106  which the pharmacist is responsible, provided that such
  107  activities are conducted in a manner consistent with the
  108  pharmacist’s responsibility to provide pharmacy services.
  109         4.An offsite pharmacist, acting in the capacity of a
  110  prescription department manager, from remotely supervising a
  111  registered pharmacy technician at a remote-site pharmacy.
  112         Section 2. Subsection (1) of section 465.014, Florida
  113  Statutes, is amended to read:
  114         465.014 Pharmacy technician.—
  115         (1) A person other than a licensed pharmacist or pharmacy
  116  intern may not engage in the practice of the profession of
  117  pharmacy, except that a licensed pharmacist may delegate to
  118  pharmacy technicians who are registered pursuant to this section
  119  those duties, tasks, and functions that do not fall within the
  120  purview of s. 465.003, and a registered pharmacy technician
  121  operating under remote supervision of an offsite pharmacist
  122  under s. 465.0198 may dispense medicinal drugs under such
  123  supervision. All such delegated acts must be performed under the
  124  direct supervision of a licensed pharmacist who is responsible
  125  for all such acts performed by persons under his or her
  126  supervision. A registered pharmacy technician, under the
  127  supervision of a pharmacist, may initiate or receive
  128  communications with a practitioner or his or her agent, on
  129  behalf of a patient, regarding refill authorization requests. A
  130  licensed pharmacist may not supervise more than one registered
  131  pharmacy technician, except as provided in s. 465.0198 or unless
  132  otherwise permitted by the guidelines adopted by the board. The
  133  board shall establish guidelines to be followed by licensees or
  134  permittees in determining the circumstances under which a
  135  licensed pharmacist may supervise more than one pharmacy
  136  technician.
  137         Section 3. Paragraph (b) of subsection (1) and paragraph
  138  (b) of subsection (2) of section 465.015, Florida Statutes, are
  139  amended to read:
  140         465.015 Violations and penalties.—
  141         (1) It is unlawful for any person to own, operate,
  142  maintain, open, establish, conduct, or have charge of, either
  143  alone or with another person or persons, a pharmacy:
  144         (b) In which a person not licensed as a pharmacist in this
  145  state or not registered as an intern in this state or in which
  146  an intern who is not acting under the direct and immediate
  147  personal supervision of a licensed pharmacist fills, compounds,
  148  or dispenses any prescription or dispenses medicinal drugs. This
  149  paragraph does not apply to any person who owns, operates,
  150  maintains, opens, establishes, conducts, or has charge of a
  151  remote-site pharmacy under s. 465.0198.
  152         (2) It is unlawful for any person:
  153         (b) To fill, compound, or dispense prescriptions or to
  154  dispense medicinal drugs if such person does not hold an active
  155  license as a pharmacist in this state, is not registered as an
  156  intern in this state, or is an intern not acting under the
  157  direct and immediate personal supervision of a licensed
  158  pharmacist, or is not a registered pharmacy technician at a
  159  remote-site pharmacy who is acting under remote supervision of a
  160  licensed pharmacist pursuant to s. 465.0198.
  161         Section 4. Section 465.0198, Florida Statutes, is created
  162  to read:
  163         465.0198 Remote-site pharmacy permits.—
  164         (1)As used in this section, the term:
  165         (a)Supervising pharmacy” means a pharmacy licensed in
  166  this state which employs or contracts with a pharmacist licensed
  167  in this state who remotely supervises a registered pharmacy
  168  technician at a remote-site pharmacy at a ratio of one
  169  pharmacist to up to six registered pharmacy technicians.
  170         (b)“Telepharmacy” means the practice of pharmacy by a
  171  pharmacist located in this state using telecommunications or
  172  other automations and technologies to provide or supervise the
  173  provision of pharmacy services to patients and their agents who
  174  are located at sites other than where the pharmacist is located,
  175  including dispensing of prescriptions to and counseling of
  176  patients.
  177         (2)Any person desiring a permit to operate a remote-site
  178  pharmacy must apply to the department. If the board certifies
  179  that the application complies with the laws and rules of the
  180  board, the department must issue the permit. A permit may not be
  181  issued unless a licensed pharmacist or consultant pharmacist is
  182  designated as the prescription department manager responsible
  183  for the oversight of the remote-site pharmacy. The permittee
  184  must notify the department within 10 days after any change of
  185  the prescription department manager.
  186         (3)A remote-site pharmacy must comply with all of the
  187  following:
  188         (a)Be jointly owned by or operated under a contract with a
  189  supervising pharmacy.
  190         (b)Maintain a video surveillance system that records
  191  continuously 24 hours per day and retain video surveillance
  192  recordings for at least 30 days.
  193         (c)Display a sign visible to the public indicating that
  194  the location is a remote-site pharmacy and that the facility is
  195  under 24-hour video surveillance.
  196         (d)Maintain a policies and procedures manual, which must
  197  be made available to the board or its agent upon request and
  198  must include, but need not be limited to, all of the following:
  199         1.A description of how the pharmacy will comply with
  200  federal and state laws and rules.
  201         2.The procedures for supervising the remote-site pharmacy
  202  and counseling its patients.
  203         3.The procedures for reviewing the prescription drug
  204  inventory and drug records maintained by the remote-site
  205  pharmacy.
  206         4.The policies and procedures for providing security
  207  adequate to protect the confidentiality and integrity of patient
  208  information.
  209         5.The written plan for recovery from an event that
  210  interrupts or prevents the prescription department manager from
  211  supervising the remote-site pharmacy’s operation.
  212         6.The procedures for use of the state prescription drug
  213  monitoring program by the prescription department manager before
  214  he or she may authorize the dispensing of any controlled
  215  substance.
  216         7.The procedures for maintaining a perpetual inventory of
  217  the controlled substances listed in Schedule II of s. 893.03.
  218         8.The specific duties, tasks, and functions that
  219  registered pharmacy technicians are authorized to perform at the
  220  remote-site pharmacy.
  221         (4)A remote-site pharmacy may store, hold, or dispense any
  222  medicinal drug, including proprietary drugs and controlled
  223  substances. However, a remote-site pharmacy may not dispense
  224  Schedule II controlled substances listed in s. 893.03 unless a
  225  pharmacist is present at the remote-site pharmacy.
  226         (5)The prescription department manager must visit the
  227  remote-site pharmacy, based on a schedule determined by the
  228  board, to inspect the pharmacy, address personnel matters, and
  229  provide clinical services for patients.
  230         (6)A remote-site pharmacy may not be open when the
  231  supervising pharmacy is closed, unless a pharmacist employed by
  232  or under contract with the supervising pharmacy, or a pharmacy
  233  under contract with the supervising pharmacy, is present at the
  234  remote-site pharmacy or is providing remote supervision as
  235  required under this section.
  236         (7)A registered pharmacist may not serve as the
  237  prescription department manager for more than three remote-site
  238  pharmacies that are under common control of the same supervising
  239  pharmacy, at a ratio of one pharmacist to up to six registered
  240  pharmacy technicians at each remote-site pharmacy.
  241         (8)The board may adopt rules as necessary to specify
  242  additional criteria for a remote-site pharmacy. Any additional
  243  criteria adopted by the board must be limited to rules
  244  concerning one or more of the following:
  245         (a)Application requirements.
  246         (b)Structural and equipment requirements.
  247         (c)Training requirements.
  248         (d)Inventory recordkeeping and storage requirements.
  249         Section 5. Paragraph (c) of subsection (11) of section
  250  465.022, Florida Statutes, is amended to read:
  251         465.022 Pharmacies; general requirements; fees.—
  252         (11) A permittee must notify the department of the identity
  253  of the prescription department manager within 10 days after
  254  employment. The prescription department manager must comply with
  255  the following requirements:
  256         (c) A registered pharmacist may not serve as the
  257  prescription department manager in more than one location,
  258  except as authorized under s. 465.0198, unless approved by the
  259  board.
  260         Section 6. This act shall take effect July 1, 2024.

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