Florida Senate - 2020                       CS for CS for SB 708
       By the Committees on Rules; and Health Policy; and Senator
       595-04241-20                                           2020708c2
    1                        A bill to be entitled                      
    2         An act relating to automated pharmacy systems;
    3         amending s. 465.0235, F.S.; authorizing a community
    4         pharmacy to use an automated pharmacy system under
    5         certain circumstances; requiring such community
    6         pharmacies to adopt, annually review, and maintain a
    7         record of, for a specified time period, certain
    8         policies and procedures; providing that certain
    9         medicinal drugs stored in an automated pharmacy system
   10         for outpatient dispensing are part of the inventory of
   11         the pharmacy providing services through such system;
   12         authorizing, rather than requiring, the Board of
   13         Pharmacy to adopt specified rules; deleting an
   14         obsolete date; providing an effective date.
   16  Be It Enacted by the Legislature of the State of Florida:
   18         Section 1. Section 465.0235, Florida Statutes, is amended
   19  to read:
   20         465.0235 Automated pharmacy systems used by long-term care
   21  facilities, hospices, or state correctional institutions or for
   22  outpatient dispensing.—
   23         (1) A pharmacy may provide pharmacy services to a long-term
   24  care facility or hospice licensed under chapter 400 or chapter
   25  429 or a state correctional institution operated under chapter
   26  944 through the use of an automated pharmacy system that need
   27  not be located at the same location as the pharmacy.
   28         (2) A community pharmacy, as defined in s. 465.003(11),
   29  which is licensed in this state may provide pharmacy services
   30  for outpatient dispensing through the use of an automated
   31  pharmacy system that need not be located at the same location as
   32  the community pharmacy if all of the following criteria are met:
   33         (a) The automated pharmacy system is under the supervision
   34  and control of the community pharmacy.
   35         (b)The automated pharmacy system is housed in an indoor
   36  environment area and in a location that increases patients’
   37  access to their prescriptions, including, but not limited to,
   38  medical facilities, places of business where essential goods and
   39  commodities are sold, rural areas of the state, large employer
   40  workplaces, and locations where access to a community pharmacy
   41  is limited.
   42         (c) The community pharmacy providing services through the
   43  automated pharmacy system notifies the board of the location of
   44  the automated pharmacy system and any changes in such location.
   45         (d) The automated pharmacy system has a mechanism that
   46  provides live, real-time patient counseling by a pharmacist, as
   47  defined in s. 465.003(10) and who is licensed in this state,
   48  before the dispensing of any medicinal drug.
   49         (e) The automated pharmacy system does not contain or
   50  dispense any controlled substance listed in s. 893.03 or 21
   51  U.S.C. s. 812.
   52         (f) The community pharmacy maintains a record of the
   53  medicinal drugs dispensed which includes the identity of the
   54  pharmacist responsible for verifying the accuracy of the dosage
   55  and directions and providing patient counseling.
   56         (g) The automated pharmacy system ensures the
   57  confidentiality of personal health information.
   58         (h)The community pharmacy maintains written policies and
   59  procedures to ensure the proper, safe, and secure functioning of
   60  the automated pharmacy system. The community pharmacy shall
   61  annually review the policies and procedures and maintain a
   62  record of them for a minimum of 4 years. The annual review must
   63  be documented in the community pharmacy’s records and must be
   64  made available to the board upon request. The policies and
   65  procedures must, at a minimum, address all of the following:
   66         1.Maintaining in good working order the automated pharmacy
   67  system and any accompanying electronic verification process.
   68         2.Ensuring the integrity of the automated pharmacy
   69  system’s drug identifier database and its ability to identify
   70  the person responsible for making database entries.
   71         3.Ensuring the accurate filling, stocking, and
   72  verification of the automated pharmacy system.
   73         4.Ensuring sanitary operation of the automated pharmacy
   74  system and prevention of cross-contamination of cells,
   75  cartridges, containers, cassettes, or packages.
   76         5.Testing the accuracy of the system and any accompanying
   77  electronic verification process. The automated pharmacy system
   78  and accompanying electronic verification process must, at a
   79  minimum, be tested before the first use of the system, upon
   80  restarting the system, and after a modification of the system or
   81  electronic verification process which alters the filling or
   82  electronic verification process.
   83         6.Training persons authorized to access, stock, restock,
   84  or use the system.
   85         7.Conducting routine and preventative maintenance of the
   86  automated pharmacy system, including calibration, if applicable.
   87         8.Removing expired, adulterated, misbranded, or recalled
   88  drugs from the automated pharmacy system.
   89         9.Preventing unauthorized persons from accessing the
   90  automated pharmacy system, including assigning, discontinuing,
   91  or modifying security access.
   92         10.Identifying and recording persons responsible for
   93  stocking and filling the automated pharmacy system.
   94         11.Ensuring compliance with state and federal law,
   95  including, but not limited to, all applicable labeling, storage,
   96  and security requirements.
   97         12.Maintaining an ongoing quality assurance program that
   98  monitors performance of the automated pharmacy system and any
   99  accompanying electronic verification process to ensure proper
  100  and accurate functioning, including tracking and documenting
  101  system errors. A community pharmacy must maintain such
  102  documentation for a minimum of 4 years and must produce it to
  103  the board upon request.
  104         (3)(2) Medicinal drugs stored in bulk or unit of use in an
  105  automated pharmacy system servicing a long-term care facility,
  106  hospice, or correctional institution, or for outpatient
  107  dispensing, are part of the inventory of the pharmacy providing
  108  pharmacy services to that facility, hospice, or institution, or
  109  for outpatient dispensing, and medicinal drugs delivered by the
  110  automated pharmacy system are considered to have been dispensed
  111  by that pharmacy.
  112         (4)(3) The operation of an automated pharmacy system must
  113  be under the supervision of a Florida-licensed pharmacist
  114  licensed in this state. To qualify as a supervisor for an
  115  automated pharmacy system, the pharmacist need not be physically
  116  present at the site of the automated pharmacy system and may
  117  supervise the system electronically. The Florida-licensed
  118  pharmacist shall be required to develop and implement policies
  119  and procedures designed to verify that the medicinal drugs
  120  delivered by the automated pharmacy dispensing system are
  121  accurate and valid and that the machine is properly restocked.
  122         (5)(4) The Legislature does not intend for this section to
  123  limit the current practice of pharmacy in this state. This
  124  section is intended to allow automated pharmacy systems to
  125  enhance the ability of a pharmacist to provide pharmacy services
  126  in locations that do not employ a full-time pharmacist. This
  127  section does not limit or replace the use of a consultant
  128  pharmacist.
  129         (6)(5) The board may shall adopt rules governing the use of
  130  an automated pharmacy systems. If adopted, such rules system by
  131  January 1, 2005, which must include all of the following
  132  specify:
  133         (a) Recordkeeping requirements.;
  134         (b) Security requirements.; and
  135         (c) Labeling requirements that permit the use of unit-dose
  136  medications if the facility, hospice, or institution maintains
  137  medication-administration records that include directions for
  138  use of the medication and the automated pharmacy system
  139  identifies all of the following:
  140         1. The dispensing pharmacy.;
  141         2. The prescription number.;
  142         3. The name of the patient.; and
  143         4. The name of the prescribing practitioner.
  144         Section 2. This act shall take effect July 1, 2020.