Florida Senate - 2020                        COMMITTEE AMENDMENT
       Bill No. CS for SB 708
                              LEGISLATIVE ACTION                        
                    Senate             .             House              

       The Committee on Rules (Hutson) recommended the following:
    1         Senate Amendment (with title amendment)
    3         Delete everything after the enacting clause
    4  and insert:
    5         Section 1. Section 465.0235, Florida Statutes, is amended
    6  to read:
    7         465.0235 Automated pharmacy systems used by long-term care
    8  facilities, hospices, or state correctional institutions or for
    9  outpatient dispensing.—
   10         (1) A pharmacy may provide pharmacy services to a long-term
   11  care facility or hospice licensed under chapter 400 or chapter
   12  429 or a state correctional institution operated under chapter
   13  944 through the use of an automated pharmacy system that need
   14  not be located at the same location as the pharmacy.
   15         (2) A community pharmacy, as defined in s. 465.003(11),
   16  which is licensed in this state may provide pharmacy services
   17  for outpatient dispensing through the use of an automated
   18  pharmacy system that need not be located at the same location as
   19  the community pharmacy if:
   20         (a) The automated pharmacy system is under the supervision
   21  and control of the community pharmacy.
   22         (b)The automated pharmacy system is housed in an indoor
   23  environment area and in a location that increases patients’
   24  access to their prescriptions, including, but not limited to,
   25  medical facilities, places of business where essential goods and
   26  commodities are sold, rural areas of the state, large employer
   27  workplaces, and locations where access to a community pharmacy
   28  is limited.
   29         (c) The community pharmacy providing services through the
   30  automated pharmacy system notifies the board of the location of
   31  the automated pharmacy system and any changes in such location.
   32         (d) The automated pharmacy system has a mechanism that
   33  provides live, real-time patient counseling by a pharmacist, as
   34  defined in s. 465.003(10) and who is licensed in this state,
   35  before the dispensing of any medicinal drug.
   36         (e) The automated pharmacy system does not contain or
   37  dispense any controlled substance listed in s. 893.03 or 21
   38  U.S.C. s. 812.
   39         (f) The community pharmacy maintains a record of the
   40  medicinal drugs dispensed which includes the identity of the
   41  pharmacist responsible for verifying the accuracy of the dosage
   42  and directions and providing patient counseling.
   43         (g) The automated pharmacy system ensures the
   44  confidentiality of personal health information.
   45         (h)The community pharmacy maintains written policies and
   46  procedures to ensure the proper, safe, and secure functioning of
   47  the automated pharmacy system. The community pharmacy shall
   48  annually review the policies and procedures and maintain a
   49  record of them for a minimum of 4 years. The annual review must
   50  be documented in the community pharmacy’s records and must be
   51  made available to the board upon request. The policies and
   52  procedures must, at a minimum, address all of the following:
   53         1.Maintaining in good working order the automated pharmacy
   54  system and any accompanying electronic verification process.
   55         2.Ensuring the integrity of the automated pharmacy
   56  system’s drug identifier database and its ability to identify
   57  the person responsible for making database entries.
   58         3.Ensuring the accurate filling, stocking, and
   59  verification of the automated pharmacy system.
   60         4.Ensuring sanitary operation of the automated pharmacy
   61  system and prevention of cross-contamination of cells,
   62  cartridges, containers, cassettes, or packages.
   63         5.Testing the accuracy of the system and any accompanying
   64  electronic verification process. The automated pharmacy system
   65  and accompanying electronic verification process must, at a
   66  minimum, be tested before the first use of the system, upon
   67  restarting the system, and after a modification of the system or
   68  electronic verification process which alters the filling or
   69  electronic verification process.
   70         6.Training persons authorized to access, stock, restock,
   71  or use the system.
   72         7.Conducting routine and preventative maintenance of the
   73  automated pharmacy system, including calibration, if applicable.
   74         8.Removing expired, adulterated, misbranded, or recalled
   75  drugs from the automated pharmacy system.
   76         9.Preventing unauthorized persons from accessing the
   77  automated pharmacy system, including assigning, discontinuing,
   78  or modifying security access.
   79         10.Identifying and recording persons responsible for
   80  stocking and filling the automated pharmacy system.
   81         11.Ensuring compliance with state and federal law,
   82  including, but not limited to, all applicable labeling, storage,
   83  and security requirements.
   84         12.Maintaining an ongoing quality assurance program that
   85  monitors performance of the automated pharmacy system and any
   86  accompanying electronic verification process to ensure proper
   87  and accurate functioning, including tracking and documenting
   88  system errors. A community pharmacy must maintain such
   89  documentation for a minimum of 4 years and must produce it to
   90  the board upon request.
   91         (3)(2) Medicinal drugs stored in bulk or unit of use in an
   92  automated pharmacy system servicing a long-term care facility,
   93  hospice, or correctional institution, or for outpatient
   94  dispensing, are part of the inventory of the pharmacy providing
   95  pharmacy services to that facility, hospice, or institution, or
   96  for outpatient dispensing, and medicinal drugs delivered by the
   97  automated pharmacy system are considered to have been dispensed
   98  by that pharmacy.
   99         (4)(3) The operation of an automated pharmacy system must
  100  be under the supervision of a Florida-licensed pharmacist
  101  licensed in this state. To qualify as a supervisor for an
  102  automated pharmacy system, the pharmacist need not be physically
  103  present at the site of the automated pharmacy system and may
  104  supervise the system electronically. The Florida-licensed
  105  pharmacist shall be required to develop and implement policies
  106  and procedures designed to verify that the medicinal drugs
  107  delivered by the automated pharmacy dispensing system are
  108  accurate and valid and that the machine is properly restocked.
  109         (5)(4) The Legislature does not intend for this section to
  110  limit the current practice of pharmacy in this state. This
  111  section is intended to allow automated pharmacy systems to
  112  enhance the ability of a pharmacist to provide pharmacy services
  113  in locations that do not employ a full-time pharmacist. This
  114  section does not limit or replace the use of a consultant
  115  pharmacist.
  116         (6)(5) The board may shall adopt rules governing the use of
  117  an automated pharmacy systems. If adopted, such rules system by
  118  January 1, 2005, which must include all of the following
  119  specify:
  120         (a) Recordkeeping requirements.;
  121         (b) Security requirements.; and
  122         (c) Labeling requirements that permit the use of unit-dose
  123  medications if the facility, hospice, or institution maintains
  124  medication-administration records that include directions for
  125  use of the medication and the automated pharmacy system
  126  identifies all of the following:
  127         1. The dispensing pharmacy.;
  128         2. The prescription number.;
  129         3. The name of the patient.; and
  130         4. The name of the prescribing practitioner.
  131         Section 2. This act shall take effect July 1, 2020.
  133  ================= T I T L E  A M E N D M E N T ================
  134  And the title is amended as follows:
  135         Delete everything before the enacting clause
  136  and insert:
  137                        A bill to be entitled                      
  138         An act relating to automated pharmacy systems;
  139         amending s. 465.0235, F.S.; authorizing a community
  140         pharmacy to use an automated pharmacy system under
  141         certain circumstances; providing that certain
  142         medicinal drugs stored in an automated pharmacy system
  143         for outpatient dispensing are part of the inventory of
  144         the pharmacy providing services through such system;
  145         requiring community pharmacies to adopt certain
  146         policies and procedures; authorizing, rather than
  147         requiring, the Board of Pharmacy to adopt specified
  148         rules; deleting an obsolete date; providing an
  149         effective date.