Florida Senate - 2018                        COMMITTEE AMENDMENT
       Bill No. SB 848
       
       
       
       
       
       
                                Ì442488OÎ442488                         
       
                              LEGISLATIVE ACTION                        
                    Senate             .             House              
                  Comm: RCS            .                                
                  02/06/2018           .                                
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       The Committee on Health Policy (Grimsley) recommended the
       following:
       
    1         Senate Amendment (with title amendment)
    2  
    3         Delete everything after the enacting clause
    4  and insert:
    5         Section 1. Subsection (11) of section 465.003, Florida
    6  Statutes, is amended to read:
    7         465.003 Definitions.—As used in this chapter, the term:
    8         (11)(a) “Pharmacy” includes a community pharmacy, an
    9  institutional pharmacy, a nuclear pharmacy, a special pharmacy,
   10  and an Internet pharmacy, and a remote dispensing site pharmacy.
   11         1. The term “community pharmacy” includes every location
   12  where medicinal drugs are compounded, dispensed, stored, or sold
   13  or where prescriptions are filled or dispensed on an outpatient
   14  basis.
   15         2. The term “institutional pharmacy” includes every
   16  location in a hospital, clinic, nursing home, dispensary,
   17  sanitarium, extended care facility, or other facility,
   18  hereinafter referred to as “health care institutions,” where
   19  medicinal drugs are compounded, dispensed, stored, or sold.
   20         3. The term “nuclear pharmacy” includes every location
   21  where radioactive drugs and chemicals within the classification
   22  of medicinal drugs are compounded, dispensed, stored, or sold.
   23  The term “nuclear pharmacy” does not include hospitals licensed
   24  under chapter 395 or the nuclear medicine facilities of such
   25  hospitals.
   26         4. The term “special pharmacy” includes every location
   27  where medicinal drugs are compounded, dispensed, stored, or sold
   28  if such locations are not otherwise defined in this subsection.
   29         5. The term “Internet pharmacy” includes locations not
   30  otherwise licensed or issued a permit under this chapter, within
   31  or outside this state, which use the Internet to communicate
   32  with or obtain information from consumers in this state and use
   33  such communication or information to fill or refill
   34  prescriptions or to dispense, distribute, or otherwise engage in
   35  the practice of pharmacy in this state. Any act described in
   36  this definition constitutes the practice of pharmacy as defined
   37  in subsection (13).
   38         6.The term “remote dispensing site pharmacy” includes
   39  every location where medicinal drugs are prepared by a
   40  registered pharmacy technician who is electronically supervised
   41  by an offsite pharmacist and dispensed pursuant to s. 465.014(1)
   42  to the patient after verification, certification, and counseling
   43  by the pharmacist.
   44         (b) The pharmacy department of any permittee shall be
   45  considered closed whenever a Florida licensed pharmacist is not
   46  present and on duty. The term “not present and on duty” may
   47  shall not be construed to prevent:
   48         1. A pharmacist from exiting the prescription department
   49  for the purposes of consulting or responding to inquiries or
   50  providing assistance to patients or customers;,
   51         2.A pharmacist attending to personal hygiene needs;, or
   52         3.A pharmacist performing any other function for which the
   53  pharmacist is responsible, provided that such activities are
   54  conducted in a manner consistent with the pharmacist’s
   55  responsibility to provide pharmacy services; or
   56         4.An offsite pharmacist from remotely supervising a
   57  registered pharmacy technician at a remote dispensing site
   58  pharmacy.
   59         Section 2. Subsection (1) of section 465.014, Florida
   60  Statutes, is amended to read:
   61         465.014 Pharmacy technician.—
   62         (1) A person other than a licensed pharmacist or pharmacy
   63  intern may not engage in the practice of the profession of
   64  pharmacy, except that a licensed pharmacist may delegate to
   65  pharmacy technicians who are registered pursuant to this section
   66  those duties, tasks, and functions that do not fall within the
   67  purview of s. 465.003(13). However, a registered pharmacy
   68  technician may dispense medicinal drugs when operating under the
   69  electronic supervision of an offsite Florida licensed pharmacist
   70  pursuant to s. 465.0198. All such delegated acts must be
   71  performed under the direct supervision of a licensed pharmacist
   72  who is responsible for all such acts performed by persons under
   73  his or her supervision. A registered pharmacy technician, under
   74  the supervision of a pharmacist, may initiate or receive
   75  communications with a practitioner or his or her agent, on
   76  behalf of a patient, regarding refill authorization requests. A
   77  licensed pharmacist may not supervise more than one registered
   78  pharmacy technician unless otherwise permitted by the guidelines
   79  adopted by the board. The board shall establish guidelines to be
   80  followed by licensees or permittees in determining the
   81  circumstances under which a licensed pharmacist may supervise
   82  more than one pharmacy technician.
   83         Section 3. Subsections (1) and (2) of section 465.015,
   84  Florida Statutes, are amended to read:
   85         465.015 Violations and penalties.—
   86         (1) It is unlawful for any person to own, operate,
   87  maintain, open, establish, conduct, or have charge of, either
   88  alone or with another person or persons, a pharmacy:
   89         (a) Which is not registered under the provisions of this
   90  chapter.
   91         (b) In which a person not licensed as a pharmacist in this
   92  state or not registered as an intern in this state or in which
   93  an intern who is not acting under the direct and immediate
   94  personal supervision of a licensed pharmacist fills, compounds,
   95  or dispenses any prescription or dispenses medicinal drugs. This
   96  paragraph does not apply to any person who owns, operates,
   97  maintains, opens, establishes, conducts, or has charge of a
   98  remote dispensing site pharmacy pursuant to s. 465.0198.
   99         (2) It is unlawful for any person:
  100         (a) To make a false or fraudulent statement, either for
  101  herself or himself or for another person, in any application,
  102  affidavit, or statement presented to the board or in any
  103  proceeding before the board.
  104         (b) To fill, compound, or dispense prescriptions or to
  105  dispense medicinal drugs if such person does not hold an active
  106  license as a pharmacist in this state, is not registered as an
  107  intern in this state, or is an intern not acting under the
  108  direct and immediate personal supervision of a licensed
  109  pharmacist. This paragraph does not apply to a registered
  110  pharmacy technician dispensing medicinal drugs pursuant to s.
  111  465.0198.
  112         (c) To sell or dispense drugs as defined in s. 465.003(8)
  113  without first being furnished with a prescription.
  114         (d) To sell samples or complimentary packages of drug
  115  products.
  116         Section 4. Section 465.0198, Florida Statutes, is created
  117  to read:
  118         465.0198Remote dispensing site pharmacy permits.—
  119         (1)Any person desiring a permit to operate a remote
  120  dispensing site pharmacy must apply to the department for a
  121  remote dispensing site pharmacy permit. If the board certifies
  122  that the application complies with the laws and board rules
  123  governing the practice of the profession of pharmacy, the
  124  department must issue the permit. A permit may not be issued
  125  unless a licensed pharmacist or consultant pharmacist is
  126  designated as the prescription department manager responsible
  127  for the oversight of the remote dispensing site pharmacy. The
  128  permittee must notify the department within 10 days after any
  129  change of the prescription department manager.
  130         (2)As a prerequisite to issuance of an initial permit or a
  131  permit for a change of location, the remote dispensing site
  132  pharmacy must pass an onsite inspection. The department must
  133  make the inspection within 90 days before issuance of the
  134  permit.
  135         (3)The remote dispensing site pharmacy must:
  136         (a)Be jointly owned by a supervising pharmacy or operated
  137  under a contract with a supervising pharmacy. For purposes of
  138  this subsection, “supervising pharmacy” means a licensed
  139  pharmacy in this state which employs a Florida licensed
  140  pharmacist who remotely supervises a registered pharmacy
  141  technician at a remote dispensing site pharmacy.
  142         (b)Display a sign visible to the public indicating that
  143  the location is a remote dispensing site pharmacy and that the
  144  facility is under 24-hour video surveillance. The remote
  145  dispensing site pharmacy must retain the video surveillance
  146  recordings for at least 45 days.
  147         (c) Be located in an area defined as rural pursuant to s.
  148  381.0406 and be at least 10 miles from an existing community
  149  pharmacy, unless the remote dispensing site pharmacy is located
  150  in a hospital licensed under chapter 395 or in a clinic. For
  151  purposes of this paragraph, the term “clinic” means an entity
  152  where health care services are provided to individuals and which
  153  tenders charges for reimbursement for such services, excluding a
  154  mobile clinic and a portable equipment provider.
  155         (4)A remote dispensing site pharmacy may not lose its
  156  permit based on the subsequent opening of a community pharmacy
  157  within 10 miles of the remote dispensing site pharmacy.
  158         (5)A remote dispensing site pharmacy may store, hold, and
  159  dispense all medicinal drugs including those listed in s.
  160  893.03(3)-(5). A remote dispensing pharmacy may not store, hold,
  161  or dispense narcotic controlled substances listed in s.
  162  893.03(2).
  163         (6)A remote dispensing site pharmacy may not perform
  164  centralized prescription filling, as defined in s. 465.003(16).
  165         (7)A remote dispensing site pharmacy must maintain a
  166  policy and procedures manual, which shall be made available to
  167  the board or its agent upon request. The policy and procedures
  168  manual shall include:
  169         (a)A description of how the pharmacy will comply with
  170  federal and state laws, rules, and regulations.
  171         (b)The procedure for supervising the remote dispensing
  172  site pharmacy and counseling its patients before the dispensing
  173  of any medicinal drug pursuant to this section.
  174         (c)The procedure for reviewing the prescription drug
  175  inventory and drug records maintained by the remote dispensing
  176  site pharmacy.
  177         (d)The policy and procedure for providing appropriate
  178  security to protect the confidentiality and integrity of patient
  179  information.
  180         (e)The written plan for recovery from an event that
  181  interrupts or prevents the pharmacist from supervising the
  182  remote dispensing site pharmacy’s operation.
  183         (f)The procedure by which a supervising pharmacist
  184  consults the state prescription drug monitoring program before
  185  authorizing any controlled substance for dispensing and reports
  186  the dispensing of a controlled substance as required under s.
  187  893.055.
  188         (g)The specific duties, tasks, and functions that a
  189  registered pharmacy technician is authorized to perform at the
  190  remote dispensing site pharmacy.
  191         (8)The prescription department manager or other pharmacist
  192  employed by the supervising pharmacy must visit the remote
  193  dispensing site pharmacy, based on a schedule designated by the
  194  board, to inspect the pharmacy, address personnel matters, and
  195  provide clinical services for patients.
  196         (9)A registered pharmacy technician must have completed at
  197  least 2,080 hours of experience at a pharmacy within the 2 years
  198  immediately preceding the date on which the registered pharmacy
  199  technician begins employment at the remote dispensing site
  200  pharmacy.
  201         (10)A registered pharmacy technician working at a remote
  202  dispensing site pharmacy may not perform sterile or complex
  203  nonsterile compounding.
  204         (11)This section does not alter the supervision
  205  requirements established in s. 465.014.
  206         Section 5. Paragraph (c) of subsection (11) of section
  207  465.022, Florida Statutes, is amended to read:
  208         465.022 Pharmacies; general requirements; fees.—
  209         (11) A permittee must notify the department of the identity
  210  of the prescription department manager within 10 days after
  211  employment. The prescription department manager must comply with
  212  the following requirements:
  213         (c) A Florida licensed registered pharmacist may not serve
  214  as the prescription department manager in more than one location
  215  unless approved by the board. However, a Florida licensed
  216  pharmacist may serve as a prescription department manager for no
  217  more than two remote dispensing site pharmacies, if such
  218  pharmacies are under common control.
  219         Section 6. Subsection (1) of section 465.0265, Florida
  220  Statutes, is amended to read:
  221         465.0265 Centralized prescription filling.—
  222         (1) Except as otherwise provided in this chapter, a
  223  pharmacy licensed under this chapter may perform centralized
  224  prescription filling for another pharmacy, provided that the
  225  pharmacies have the same owner or have a written contract
  226  specifying the services to be provided by each pharmacy, the
  227  responsibilities of each pharmacy, and the manner in which the
  228  pharmacies will comply with federal and state laws, rules, and
  229  regulations.
  230         Section 7. This act shall take effect July 1, 2018.
  231  
  232  ================= T I T L E  A M E N D M E N T ================
  233  And the title is amended as follows:
  234         Delete everything before the enacting clause
  235  and insert:
  236                        A bill to be entitled                      
  237         An act relating to telepharmacy; amending s. 465.003,
  238         F.S.; revising and providing definitions; amending s.
  239         465.014, F.S.; authorizing a registered pharmacy
  240         technician to dispense medicinal drugs under certain
  241         conditions; amending s. 465.015, F.S.; conforming
  242         provisions to changes made by the act; creating s.
  243         465.0198, F.S.; providing permit requirements for
  244         remote dispensing site pharmacies; providing operating
  245         requirements and prohibitions for a remote dispensing
  246         site pharmacy; defining the term “clinic”; requiring
  247         the prescription department manager or other
  248         pharmacist employed by the supervising pharmacy to
  249         visit the remote dispensing site pharmacy; providing
  250         an experience requirement for a registered pharmacy
  251         technician working at a remote site pharmacy;
  252         prohibiting a registered pharmacy technician from
  253         performing sterile or nonsterile compounding;
  254         providing construction; amending s. 465.022, F.S.;
  255         authorizing a Florida licensed pharmacist to serve as
  256         the prescription drug manager at more than one remote
  257         dispensing site pharmacy under certain conditions;
  258         amending s. 465.0265, F.S.; conforming provisions to
  259         changes made by the act; providing an effective date.