Florida Senate - 2018                              CS for SB 848
       
       
        
       By the Committee on Health Policy; and Senator Grimsley
       
       
       
       
       
       588-02911-18                                           2018848c1
    1                        A bill to be entitled                      
    2         An act relating to telepharmacy; amending s. 465.003,
    3         F.S.; revising and providing definitions; amending s.
    4         465.014, F.S.; authorizing a registered pharmacy
    5         technician to dispense medicinal drugs under certain
    6         conditions; amending s. 465.015, F.S.; conforming
    7         provisions to changes made by the act; creating s.
    8         465.0198, F.S.; providing permit requirements for
    9         remote dispensing site pharmacies; providing operating
   10         requirements and prohibitions for a remote dispensing
   11         site pharmacy; defining the term “clinic”; requiring
   12         the prescription department manager or other
   13         pharmacist employed by the supervising pharmacy to
   14         visit the remote dispensing site pharmacy; providing
   15         an experience requirement for a registered pharmacy
   16         technician working at a remote site pharmacy;
   17         prohibiting a registered pharmacy technician from
   18         performing sterile or nonsterile compounding;
   19         providing construction; amending s. 465.022, F.S.;
   20         authorizing a Florida licensed pharmacist to serve as
   21         the prescription drug manager at more than one remote
   22         dispensing site pharmacy under certain conditions;
   23         amending s. 465.0265, F.S.; conforming provisions to
   24         changes made by the act; providing an effective date.
   25          
   26  Be It Enacted by the Legislature of the State of Florida:
   27  
   28         Section 1. Subsection (11) of section 465.003, Florida
   29  Statutes, is amended to read:
   30         465.003 Definitions.—As used in this chapter, the term:
   31         (11)(a) “Pharmacy” includes a community pharmacy, an
   32  institutional pharmacy, a nuclear pharmacy, a special pharmacy,
   33  and an Internet pharmacy, and a remote dispensing site pharmacy.
   34         1. The term “community pharmacy” includes every location
   35  where medicinal drugs are compounded, dispensed, stored, or sold
   36  or where prescriptions are filled or dispensed on an outpatient
   37  basis.
   38         2. The term “institutional pharmacy” includes every
   39  location in a hospital, clinic, nursing home, dispensary,
   40  sanitarium, extended care facility, or other facility,
   41  hereinafter referred to as “health care institutions,” where
   42  medicinal drugs are compounded, dispensed, stored, or sold.
   43         3. The term “nuclear pharmacy” includes every location
   44  where radioactive drugs and chemicals within the classification
   45  of medicinal drugs are compounded, dispensed, stored, or sold.
   46  The term “nuclear pharmacy” does not include hospitals licensed
   47  under chapter 395 or the nuclear medicine facilities of such
   48  hospitals.
   49         4. The term “special pharmacy” includes every location
   50  where medicinal drugs are compounded, dispensed, stored, or sold
   51  if such locations are not otherwise defined in this subsection.
   52         5. The term “Internet pharmacy” includes locations not
   53  otherwise licensed or issued a permit under this chapter, within
   54  or outside this state, which use the Internet to communicate
   55  with or obtain information from consumers in this state and use
   56  such communication or information to fill or refill
   57  prescriptions or to dispense, distribute, or otherwise engage in
   58  the practice of pharmacy in this state. Any act described in
   59  this definition constitutes the practice of pharmacy as defined
   60  in subsection (13).
   61         6.The term “remote dispensing site pharmacy” includes
   62  every location where medicinal drugs are prepared by a
   63  registered pharmacy technician who is electronically supervised
   64  by an offsite pharmacist and dispensed pursuant to s. 465.014(1)
   65  to the patient after verification, certification, and counseling
   66  by the pharmacist.
   67         (b) The pharmacy department of any permittee shall be
   68  considered closed whenever a Florida licensed pharmacist is not
   69  present and on duty. The term “not present and on duty” may
   70  shall not be construed to prevent:
   71         1. A pharmacist from exiting the prescription department
   72  for the purposes of consulting or responding to inquiries or
   73  providing assistance to patients or customers;,
   74         2.A pharmacist attending to personal hygiene needs;, or
   75         3.A pharmacist performing any other function for which the
   76  pharmacist is responsible, provided that such activities are
   77  conducted in a manner consistent with the pharmacist’s
   78  responsibility to provide pharmacy services; or
   79         4.An offsite pharmacist from remotely supervising a
   80  registered pharmacy technician at a remote dispensing site
   81  pharmacy.
   82         Section 2. Subsection (1) of section 465.014, Florida
   83  Statutes, is amended to read:
   84         465.014 Pharmacy technician.—
   85         (1) A person other than a licensed pharmacist or pharmacy
   86  intern may not engage in the practice of the profession of
   87  pharmacy, except that a licensed pharmacist may delegate to
   88  pharmacy technicians who are registered pursuant to this section
   89  those duties, tasks, and functions that do not fall within the
   90  purview of s. 465.003(13). However, a registered pharmacy
   91  technician may dispense medicinal drugs when operating under the
   92  electronic supervision of an offsite Florida licensed pharmacist
   93  pursuant to s. 465.0198. All such delegated acts must be
   94  performed under the direct supervision of a licensed pharmacist
   95  who is responsible for all such acts performed by persons under
   96  his or her supervision. A registered pharmacy technician, under
   97  the supervision of a pharmacist, may initiate or receive
   98  communications with a practitioner or his or her agent, on
   99  behalf of a patient, regarding refill authorization requests. A
  100  licensed pharmacist may not supervise more than one registered
  101  pharmacy technician unless otherwise permitted by the guidelines
  102  adopted by the board. The board shall establish guidelines to be
  103  followed by licensees or permittees in determining the
  104  circumstances under which a licensed pharmacist may supervise
  105  more than one pharmacy technician.
  106         Section 3. Subsections (1) and (2) of section 465.015,
  107  Florida Statutes, are amended to read:
  108         465.015 Violations and penalties.—
  109         (1) It is unlawful for any person to own, operate,
  110  maintain, open, establish, conduct, or have charge of, either
  111  alone or with another person or persons, a pharmacy:
  112         (a) Which is not registered under the provisions of this
  113  chapter.
  114         (b) In which a person not licensed as a pharmacist in this
  115  state or not registered as an intern in this state or in which
  116  an intern who is not acting under the direct and immediate
  117  personal supervision of a licensed pharmacist fills, compounds,
  118  or dispenses any prescription or dispenses medicinal drugs. This
  119  paragraph does not apply to any person who owns, operates,
  120  maintains, opens, establishes, conducts, or has charge of a
  121  remote dispensing site pharmacy pursuant to s. 465.0198.
  122         (2) It is unlawful for any person:
  123         (a) To make a false or fraudulent statement, either for
  124  herself or himself or for another person, in any application,
  125  affidavit, or statement presented to the board or in any
  126  proceeding before the board.
  127         (b) To fill, compound, or dispense prescriptions or to
  128  dispense medicinal drugs if such person does not hold an active
  129  license as a pharmacist in this state, is not registered as an
  130  intern in this state, or is an intern not acting under the
  131  direct and immediate personal supervision of a licensed
  132  pharmacist. This paragraph does not apply to a registered
  133  pharmacy technician dispensing medicinal drugs pursuant to s.
  134  465.0198.
  135         (c) To sell or dispense drugs as defined in s. 465.003(8)
  136  without first being furnished with a prescription.
  137         (d) To sell samples or complimentary packages of drug
  138  products.
  139         Section 4. Section 465.0198, Florida Statutes, is created
  140  to read:
  141         465.0198Remote dispensing site pharmacy permits.—
  142         (1)Any person desiring a permit to operate a remote
  143  dispensing site pharmacy must apply to the department for a
  144  remote dispensing site pharmacy permit. If the board certifies
  145  that the application complies with the laws and board rules
  146  governing the practice of the profession of pharmacy, the
  147  department must issue the permit. A permit may not be issued
  148  unless a licensed pharmacist or consultant pharmacist is
  149  designated as the prescription department manager responsible
  150  for the oversight of the remote dispensing site pharmacy. The
  151  permittee must notify the department within 10 days after any
  152  change of the prescription department manager.
  153         (2)As a prerequisite to issuance of an initial permit or a
  154  permit for a change of location, the remote dispensing site
  155  pharmacy must pass an onsite inspection. The department must
  156  make the inspection within 90 days before issuance of the
  157  permit.
  158         (3)The remote dispensing site pharmacy must:
  159         (a)Be jointly owned by a supervising pharmacy or operated
  160  under a contract with a supervising pharmacy. For purposes of
  161  this subsection, “supervising pharmacy” means a licensed
  162  pharmacy in this state which employs a Florida licensed
  163  pharmacist who remotely supervises a registered pharmacy
  164  technician at a remote dispensing site pharmacy.
  165         (b)Display a sign visible to the public indicating that
  166  the location is a remote dispensing site pharmacy and that the
  167  facility is under 24-hour video surveillance. The remote
  168  dispensing site pharmacy must retain the video surveillance
  169  recordings for at least 45 days.
  170         (c) Be located in an area defined as rural pursuant to s.
  171  381.0406 and be at least 10 miles from an existing community
  172  pharmacy, unless the remote dispensing site pharmacy is located
  173  in a hospital licensed under chapter 395 or in a clinic. For
  174  purposes of this paragraph, the term “clinic” means an entity
  175  where health care services are provided to individuals and which
  176  tenders charges for reimbursement for such services, excluding a
  177  mobile clinic and a portable equipment provider.
  178         (4)A remote dispensing site pharmacy may not lose its
  179  permit based on the subsequent opening of a community pharmacy
  180  within 10 miles of the remote dispensing site pharmacy.
  181         (5)A remote dispensing site pharmacy may store, hold, and
  182  dispense all medicinal drugs including those listed in s.
  183  893.03(3)-(5). A remote dispensing pharmacy may not store, hold,
  184  or dispense narcotic controlled substances listed in s.
  185  893.03(2).
  186         (6)A remote dispensing site pharmacy may not perform
  187  centralized prescription filling, as defined in s. 465.003(16).
  188         (7)A remote dispensing site pharmacy must maintain a
  189  policy and procedures manual, which shall be made available to
  190  the board or its agent upon request. The policy and procedures
  191  manual shall include:
  192         (a)A description of how the pharmacy will comply with
  193  federal and state laws, rules, and regulations.
  194         (b)The procedure for supervising the remote dispensing
  195  site pharmacy and counseling its patients before the dispensing
  196  of any medicinal drug pursuant to this section.
  197         (c)The procedure for reviewing the prescription drug
  198  inventory and drug records maintained by the remote dispensing
  199  site pharmacy.
  200         (d)The policy and procedure for providing appropriate
  201  security to protect the confidentiality and integrity of patient
  202  information.
  203         (e)The written plan for recovery from an event that
  204  interrupts or prevents the pharmacist from supervising the
  205  remote dispensing site pharmacy’s operation.
  206         (f)The procedure by which a supervising pharmacist
  207  consults the state prescription drug monitoring program before
  208  authorizing any controlled substance for dispensing and reports
  209  the dispensing of a controlled substance as required under s.
  210  893.055.
  211         (g)The specific duties, tasks, and functions that a
  212  registered pharmacy technician is authorized to perform at the
  213  remote dispensing site pharmacy.
  214         (8)The prescription department manager or other pharmacist
  215  employed by the supervising pharmacy must visit the remote
  216  dispensing site pharmacy, based on a schedule designated by the
  217  board, to inspect the pharmacy, address personnel matters, and
  218  provide clinical services for patients.
  219         (9)A registered pharmacy technician must have completed at
  220  least 2,080 hours of experience at a pharmacy within the 2 years
  221  immediately preceding the date on which the registered pharmacy
  222  technician begins employment at the remote dispensing site
  223  pharmacy.
  224         (10)A registered pharmacy technician working at a remote
  225  dispensing site pharmacy may not perform sterile or complex
  226  nonsterile compounding.
  227         (11)This section does not alter the supervision
  228  requirements established in s. 465.014.
  229         Section 5. Paragraph (c) of subsection (11) of section
  230  465.022, Florida Statutes, is amended to read:
  231         465.022 Pharmacies; general requirements; fees.—
  232         (11) A permittee must notify the department of the identity
  233  of the prescription department manager within 10 days after
  234  employment. The prescription department manager must comply with
  235  the following requirements:
  236         (c) A Florida licensed registered pharmacist may not serve
  237  as the prescription department manager in more than one location
  238  unless approved by the board. However, a Florida licensed
  239  pharmacist may serve as a prescription department manager for no
  240  more than two remote dispensing site pharmacies, if such
  241  pharmacies are under common control.
  242         Section 6. Subsection (1) of section 465.0265, Florida
  243  Statutes, is amended to read:
  244         465.0265 Centralized prescription filling.—
  245         (1) Except as otherwise provided in this chapter, a
  246  pharmacy licensed under this chapter may perform centralized
  247  prescription filling for another pharmacy, provided that the
  248  pharmacies have the same owner or have a written contract
  249  specifying the services to be provided by each pharmacy, the
  250  responsibilities of each pharmacy, and the manner in which the
  251  pharmacies will comply with federal and state laws, rules, and
  252  regulations.
  253         Section 7. This act shall take effect July 1, 2018.