Florida Senate - 2021                        COMMITTEE AMENDMENT
       Bill No. CS for SB 700
                              LEGISLATIVE ACTION                        
                    Senate             .             House              

       Appropriations Subcommittee on Health and Human Services
       (Rodriguez) recommended the following:
    1         Senate Amendment to Amendment (645592) (with title
    2  amendment)
    4         Between lines 134 and 135
    5  insert:
    6         Section 5. Paragraph (a) of subsection (11) of section
    7  465.003, Florida Statutes, is amended to read
    8         465.003 Definitions.—As used in this chapter, the term:
    9         (11)(a) “Pharmacy” includes a community pharmacy, an
   10  institutional pharmacy, a nuclear pharmacy, a special pharmacy,
   11  and an Internet pharmacy, and a remote-site pharmacy.
   12         1. The term “community pharmacy” includes every location
   13  where medicinal drugs are compounded, dispensed, stored, or sold
   14  or where prescriptions are filled or dispensed on an outpatient
   15  basis.
   16         2. The term “institutional pharmacy” includes every
   17  location in a hospital, clinic, nursing home, dispensary,
   18  sanitarium, extended care facility, or other facility,
   19  hereinafter referred to as “health care institutions,” where
   20  medicinal drugs are compounded, dispensed, stored, or sold.
   21         3. The term “nuclear pharmacy” includes every location
   22  where radioactive drugs and chemicals within the classification
   23  of medicinal drugs are compounded, dispensed, stored, or sold.
   24  The term “nuclear pharmacy” does not include hospitals licensed
   25  under chapter 395 or the nuclear medicine facilities of such
   26  hospitals.
   27         4. The term “special pharmacy” includes every location
   28  where medicinal drugs are compounded, dispensed, stored, or sold
   29  if such locations are not otherwise defined in this subsection.
   30         5. The term “Internet pharmacy” includes locations not
   31  otherwise licensed or issued a permit under this chapter, within
   32  or outside this state, which use the Internet to communicate
   33  with or obtain information from consumers in this state and use
   34  such communication or information to fill or refill
   35  prescriptions or to dispense, distribute, or otherwise engage in
   36  the practice of pharmacy in this state. Any act described in
   37  this definition constitutes the practice of pharmacy as defined
   38  in subsection (13).
   39         6.The term “remote-site pharmacy” or “remote site”
   40  includes every location within a community mental health center
   41  or clinic as defined in s. 394.455 in which medicinal drugs are
   42  compounded or dispensed by a registered pharmacy technician who
   43  is remotely supervised by an off-site pharmacist acting in the
   44  capacity of a prescription department manager.
   45         Section 6. Section 465.0198, Florida Statutes, is created
   46  to read:
   47         465.0198 Remote-site pharmacy permits.—
   48         (1)As used in this section, the term “supervising
   49  pharmacy” means a pharmacy licensed in this state which employs
   50  a licensed pharmacist who remotely supervises a registered
   51  pharmacy technician at a remote-site pharmacy.
   52         (2)Any person desiring a permit to operate a remote-site
   53  pharmacy must apply to the department. If the board certifies
   54  that the application complies with the laws and rules of the
   55  board, the department must issue the permit. A permit may not be
   56  issued unless a licensed pharmacist or consultant pharmacist is
   57  designated as the prescription department manager responsible
   58  for the oversight of the remote site. The permittee must notify
   59  the department within 10 days after any change of the
   60  prescription department manager.
   61         (3)A remote-site pharmacy must comply with all of the
   62  following:
   63         (a)Be jointly owned by or operated under a contract with a
   64  supervising pharmacy.
   65         (b)Maintain a video surveillance system that records
   66  continuously 24 hours per day and retain video surveillance
   67  recordings for at least 45 days.
   68         (c)Display a sign visible to the public indicating that
   69  the location is a remote-site pharmacy and that the facility is
   70  under 24-hour video surveillance.
   71         (d)Maintain a policies and procedures manual, which must
   72  be made available to the board or its agent upon request, and
   73  must include, but need not be limited to, all of the following:
   74         1.A description of how the pharmacy will comply with
   75  federal and state laws and rules.
   76         2.The procedures for supervising the remote site and
   77  counseling its patients.
   78         3.The procedures for reviewing the prescription drug
   79  inventory and drug records maintained by the remote site.
   80         4.The policies and procedures for providing security
   81  adequate to protect the confidentiality and integrity of patient
   82  information.
   83         5.The written plan for recovery from an event that
   84  interrupts or prevents the prescription department manager from
   85  supervising the remote site’s operation.
   86         6.The procedures for use of the state prescription drug
   87  monitoring program by the prescription department manager before
   88  he or she may authorize the dispensing of any controlled
   89  substance.
   90         7.The procedures for maintaining a perpetual inventory of
   91  the controlled substances listed in s. 893.03(2).
   92         8.The specific duties, tasks, and functions that
   93  registered pharmacy technicians are authorized to perform at the
   94  remote site.
   95         (4)A remote-site pharmacy is not considered a pharmacy
   96  location for purposes of network access in managed care
   97  programs.
   98         (5)A remote-site pharmacy may store, hold, or dispense any
   99  medicinal drug.
  100         (6)A remote-site pharmacy may not perform centralized
  101  prescription filling as defined in s. 465.003(16).
  102         (7)The prescription department manager must visit the
  103  remote site, based on a schedule determined by the board, to
  104  inspect the pharmacy, address personnel matters, and provide
  105  clinical services for patients.
  106         (8)A registered pharmacist may serve as the prescription
  107  department manager for up to three remote-site pharmacies that
  108  are under common control of the same supervising pharmacy.
  110  ================= T I T L E  A M E N D M E N T ================
  111  And the title is amended as follows:
  112         Between lines 207 and 208
  113  insert:
  114         amending s. 465.003, F.S.; revising the definition of
  115         the term “pharmacy”; creating s. 465.0198, F.S.;
  116         defining the term “supervising pharmacy”; providing
  117         for the permitting of remote-site pharmacies;
  118         requiring a licensed or consultant pharmacist to serve
  119         as the prescription department manager of a remote
  120         site; requiring remote-site pharmacies to notify the
  121         Department of Health of a change in the pharmacy’s
  122         prescription department manager within a specified
  123         timeframe; providing requirements for remote-site
  124         pharmacies; providing that remote-site pharmacies are
  125         not considered pharmacy locations for purposes of
  126         network access in managed care programs; authorizing
  127         remote-site pharmacies to store, hold, and dispense
  128         medicinal drugs; prohibiting remote-site pharmacies
  129         from performing centralized prescription filling;
  130         requiring prescription department managers to visit
  131         remote sites, based on a certain schedule, to perform
  132         specified tasks; authorizing registered pharmacists to
  133         serve as prescription department managers for up to
  134         three remote-site pharmacies under certain
  135         circumstances;