Florida Senate - 2018                                    SB 1128
       By Senator Stargel
       22-00467E-18                                          20181128__
    1                        A bill to be entitled                      
    2         An act relating to pharmacy; amending s. 465.003,
    3         F.S.; defining and redefining terms; amending s.
    4         465.004, F.S.; revising the membership of the Board of
    5         Pharmacy; amending s. 465.019, F.S.; establishing
    6         Class III institutional pharmacies; authorizing such
    7         pharmacies to dispense, compound, and fill
    8         prescriptions, prepare prepackaged drug products, and
    9         conduct other pharmaceutical services between certain
   10         entities under common control; defining the term
   11         “common control”; providing that the lawful dispensing
   12         and distribution of medicinal drugs by Class III
   13         institutional pharmacies is not considered wholesale
   14         distribution; requiring such pharmacies to maintain
   15         certain policies and procedures; conforming provisions
   16         to changes made by the act; amending s. 465.0252,
   17         F.S.; conforming a provision to changes made by the
   18         act; amending s. 499.003, F.S.; revising the
   19         definition of the term “prepackaged drug product”;
   20         amending s. 499.01, F.S.; providing that a
   21         prescription drug repackager permit and a restricted
   22         prescription drug distributor permit are not required
   23         for the distribution of medicinal drugs or prepackaged
   24         drug products between entities under common control
   25         under certain circumstances; providing that a certain
   26         hospital is not required to hold a restricted
   27         prescription drug distributor permit under certain
   28         circumstances; deleting a provision exempting certain
   29         drug repackagers from specified permit requirements;
   30         providing an effective date.
   32  Be It Enacted by the Legislature of the State of Florida:
   34         Section 1. Subsections (7) and (13) of section 465.003,
   35  Florida Statutes, are amended, and subsection (21) is added to
   36  that section, to read:
   37         465.003 Definitions.—As used in this chapter, the term:
   38         (7) “Institutional formulary system” means a method whereby
   39  the medical staff evaluates, appraises, and selects those
   40  medicinal drugs or proprietary preparations that which in the
   41  medical staff’s clinical judgment are most useful in patient
   42  care, and that which are available for dispensing by a
   43  practicing pharmacist in a Class II or Class III institutional
   44  pharmacy.
   45         (13) “Practice of the profession of pharmacy” includes
   46  compounding, dispensing, and consulting concerning contents,
   47  therapeutic values, and uses of any medicinal drug; consulting
   48  concerning therapeutic values and interactions of patent or
   49  proprietary preparations, whether pursuant to prescriptions or
   50  in the absence and entirely independent of such prescriptions or
   51  orders; and conducting other pharmaceutical services. For
   52  purposes of this subsection, “other pharmaceutical services”
   53  means the monitoring of the patient’s drug therapy and assisting
   54  the patient in the management of his or her drug therapy, and
   55  includes review of the patient’s drug therapy and communication
   56  with the patient’s prescribing health care provider as licensed
   57  under chapter 458, chapter 459, chapter 461, or chapter 466, or
   58  similar statutory provision in another jurisdiction, or such
   59  provider’s agent or such other persons as specifically
   60  authorized by the patient, regarding the drug therapy. However,
   61  nothing in this subsection may be interpreted to permit an
   62  alteration of a prescriber’s directions, the diagnosis or
   63  treatment of any disease, the initiation of any drug therapy,
   64  the practice of medicine, or the practice of osteopathic
   65  medicine, unless otherwise permitted by law. “Practice of the
   66  profession of pharmacy” also includes any other act, service,
   67  operation, research, or transaction incidental to, or forming a
   68  part of, any of the foregoing acts, requiring, involving, or
   69  employing the science or art of any branch of the pharmaceutical
   70  profession, study, or training, and shall expressly permit a
   71  pharmacist to transmit information from persons authorized to
   72  prescribe medicinal drugs to their patients. The practice of the
   73  profession of pharmacy also includes the administration of
   74  vaccines to adults pursuant to s. 465.189 and the preparation of
   75  prepackaged drug products in facilities holding Class III
   76  institutional pharmacy permits.
   77         (21)“Central distribution facility” means a facility under
   78  common control with a hospital holding a Class III institutional
   79  pharmacy permit which may dispense, distribute, compound, or
   80  fill prescriptions for medicinal drugs; prepare prepackaged drug
   81  products; and conduct other pharmaceutical services.
   82         Section 2. Subsection (2) of section 465.004, Florida
   83  Statutes, is amended to read:
   84         465.004 Board of Pharmacy.—
   85         (2) Seven members of the board must be licensed pharmacists
   86  who are residents of this state and who have been engaged in the
   87  practice of the profession of pharmacy in this state for at
   88  least 4 years and, to the extent practicable, represent the
   89  various pharmacy practice settings. Of the pharmacist members,
   90  two must be currently engaged in the practice of pharmacy in a
   91  community pharmacy, two must be currently engaged in the
   92  practice of pharmacy in a Class II, institutional pharmacy or a
   93  modified Class II, or Class III institutional pharmacy, and
   94  three must be pharmacists licensed in this state irrespective of
   95  practice setting. The remaining two members must be residents of
   96  the state who have never been licensed as pharmacists and who
   97  are in no way connected with the practice of the profession of
   98  pharmacy. No person may be appointed as a consumer member who is
   99  in any way connected with a drug manufacturer or wholesaler. At
  100  least one member of the board must be 60 years of age or older.
  101  The Governor shall appoint members to the board in accordance
  102  with this subsection as members’ terms expire or as a vacancy
  103  occurs until the composition of the board complies with the
  104  requirements of this subsection.
  105         Section 3. Subsections (4) and (6) of section 465.019,
  106  Florida Statutes, are amended, and paragraph (d) is added to
  107  subsection (2) of that section, to read:
  108         465.019 Institutional pharmacies; permits.—
  109         (2) The following classes of institutional pharmacies are
  110  established:
  111         (d)1.“Class III institutional pharmacies” are those
  112  institutional pharmacies, including central distribution
  113  facilities, which are affiliated with a hospital and provide the
  114  same services as those authorized for Class II institutional
  115  pharmacies in subsection (6). Class III institutional pharmacies
  116  may dispense, distribute, compound, and fill prescriptions for
  117  medicinal drugs; prepare prepackaged drug products; and conduct
  118  other pharmaceutical services for the affiliated hospital and
  119  entities under common control, each of which must be permitted
  120  under this chapter to possess medicinal drugs. A Class III
  121  institutional pharmacy may provide such medicinal drugs, drug
  122  products, and pharmaceutical services to an entity under common
  123  control that holds an active health care clinic establishment
  124  permit as described in s. 499.01(2)(r). For purposes of this
  125  chapter, the term “common control” means the power to direct or
  126  cause the direction of the management and policies of a person
  127  or an organization, whether by ownership of stock, voting
  128  rights, contract, or other means. The dispensing or distribution
  129  of a medicinal drug by a Class III institutional pharmacy
  130  pursuant to this section is not considered wholesale
  131  distribution as defined in s. 499.003.
  132         2.A Class III institutional pharmacy shall maintain
  133  policies and procedures that identify or otherwise address:
  134         a.The consultant pharmacist responsible for pharmaceutical
  135  services.
  136         b.Safe practices for the preparation, dispensing,
  137  prepackaging, distribution, and transportation of medicinal
  138  drugs and prepackaged drug products.
  139         c.Recordkeeping to monitor the movement, distribution, and
  140  transportation of medicinal drugs and prepackaged drug products.
  141         d.Recordkeeping of pharmacy staff responsible for each
  142  step in the preparation, dispensing, prepackaging,
  143  transportation, and distribution of medicinal drugs and
  144  prepackaged drug products.
  145         e.Medicinal drugs and prepackaged drug products that may
  146  not be safely distributed among Class III institutional
  147  pharmacies.
  148         (4) Medicinal drugs shall be dispensed in an institutional
  149  pharmacy to outpatients only when that institution has secured a
  150  community pharmacy permit from the department. However, an
  151  individual licensed to prescribe medicinal drugs in this state
  152  may dispense up to a 24-hour supply of a medicinal drug to any
  153  patient of an emergency department of a hospital that operates a
  154  Class II or Class III institutional pharmacy, provided that the
  155  physician treating the patient in such hospital’s emergency
  156  department determines that the medicinal drug is warranted and
  157  that community pharmacy services are not readily accessible,
  158  geographically or otherwise, to the patient. Such dispensing
  159  from the emergency department must be in accordance with the
  160  procedures of the hospital. For any such patient for whom a
  161  medicinal drug is warranted for a period to exceed 24 hours, an
  162  individual licensed to prescribe such drug must dispense a 24
  163  hour supply of such drug to the patient and must provide the
  164  patient with a prescription for such drug for use after the
  165  initial 24-hour period. The board may adopt rules necessary to
  166  carry out the provisions of this subsection.
  167         (6) In a Class II or Class III institutional pharmacy, an
  168  institutional formulary system may be adopted with approval of
  169  the medical staff for the purpose of identifying those medicinal
  170  drugs, proprietary preparations, biologics, biosimilars, and
  171  biosimilar interchangeables that may be dispensed by the
  172  pharmacists employed in such institution. A facility with a
  173  Class II or Class III institutional pharmacy permit which is
  174  operating under the formulary system shall establish policies
  175  and procedures for the development of the system in accordance
  176  with the joint standards of the American Hospital Association
  177  and American Society of Hospital Pharmacists for the utilization
  178  of a hospital formulary system, which formulary shall be
  179  approved by the medical staff.
  180         Section 4. Subsection (3) of section 465.0252, Florida
  181  Statutes, is amended to read:
  182         465.0252 Substitution of interchangeable biosimilar
  183  products.—
  184         (3) A pharmacist who practices in a Class II, or modified
  185  Class II, or Class III institutional pharmacy shall comply with
  186  the notification provisions of paragraph (2)(c) by entering the
  187  substitution in the institution’s written medical record system
  188  or electronic medical record system.
  189         Section 5. Subsection (39) of section 499.003, Florida
  190  Statutes, is amended to read:
  191         499.003 Definitions of terms used in this part.—As used in
  192  this part, the term:
  193         (39) “Prepackaged drug product” means a drug that
  194  originally was in finished packaged form sealed by a
  195  manufacturer and that is placed in a properly labeled container
  196  by a pharmacy or practitioner authorized to dispense pursuant to
  197  chapter 465 for the purpose of dispensing in the establishment
  198  in which the prepackaging occurred.
  199         Section 6. Paragraphs (b) and (h) of subsection (2) and
  200  subsection (5) of section 499.01, Florida Statutes, are amended
  201  to read:
  202         499.01 Permits.—
  203         (2) The following permits are established:
  204         (b) Prescription drug repackager permit.—A prescription
  205  drug repackager permit is required for any person that
  206  repackages a prescription drug in this state.
  207         1. A person that operates an establishment permitted as a
  208  prescription drug repackager may engage in distribution of
  209  prescription drugs repackaged at that establishment and must
  210  comply with all of the provisions of this part and the rules
  211  adopted under this part that apply to a prescription drug
  212  manufacturer.
  213         2. A prescription drug repackager must comply with all
  214  appropriate state and federal good manufacturing practices.
  215         3. A prescription drug repackager permit is not required
  216  for the distribution of medicinal drugs or prepackaged drug
  217  products between entities under common control if each entity
  218  holds an active Class III institutional pharmacy permit under
  219  chapter 465 or an active health care clinic establishment permit
  220  under paragraph (r). For purposes of this subparagraph, the term
  221  “common control” means the same as in s. 465.019(2).
  222         (h) Restricted prescription drug distributor permit.—
  223         1. A restricted prescription drug distributor permit is
  224  required for:
  225         a. Any person located in this state who engages in the
  226  distribution of a prescription drug, which distribution is not
  227  considered “wholesale distribution” under s. 499.003(48)(a).
  228         b. Any person located in this state who engages in the
  229  receipt or distribution of a prescription drug in this state for
  230  the purpose of processing its return or its destruction if such
  231  person is not the person initiating the return, the prescription
  232  drug wholesale supplier of the person initiating the return, or
  233  the manufacturer of the drug.
  234         c. A blood establishment located in this state which
  235  collects blood and blood components only from volunteer donors
  236  as defined in s. 381.06014 or pursuant to an authorized
  237  practitioner’s order for medical treatment or therapy and
  238  engages in the wholesale distribution of a prescription drug not
  239  described in s. 499.003(48)(j) to a health care entity. A mobile
  240  blood unit operated by a blood establishment permitted under
  241  this sub-subparagraph is not required to be separately
  242  permitted. The health care entity receiving a prescription drug
  243  distributed under this sub-subparagraph must be licensed as a
  244  closed pharmacy or provide health care services at that
  245  establishment. The blood establishment must operate in
  246  accordance with s. 381.06014 and may distribute only:
  247         (I) Prescription drugs indicated for a bleeding or clotting
  248  disorder or anemia;
  249         (II) Blood-collection containers approved under s. 505 of
  250  the federal act;
  251         (III) Drugs that are blood derivatives, or a recombinant or
  252  synthetic form of a blood derivative;
  253         (IV) Prescription drugs that are identified in rules
  254  adopted by the department and that are essential to services
  255  performed or provided by blood establishments and authorized for
  256  distribution by blood establishments under federal law; or
  257         (V) To the extent authorized by federal law, drugs
  258  necessary to collect blood or blood components from volunteer
  259  blood donors; for blood establishment personnel to perform
  260  therapeutic procedures under the direction and supervision of a
  261  licensed physician; and to diagnose, treat, manage, and prevent
  262  any reaction of a volunteer blood donor or a patient undergoing
  263  a therapeutic procedure performed under the direction and
  264  supervision of a licensed physician,
  266  as long as all of the health care services provided by the blood
  267  establishment are related to its activities as a registered
  268  blood establishment or the health care services consist of
  269  collecting, processing, storing, or administering human
  270  hematopoietic stem cells or progenitor cells or performing
  271  diagnostic testing of specimens if such specimens are tested
  272  together with specimens undergoing routine donor testing. The
  273  blood establishment may purchase and possess the drugs described
  274  in this sub-subparagraph without a health care clinic
  275  establishment permit.
  276         2. Storage, handling, and recordkeeping of these
  277  distributions by a person required to be permitted as a
  278  restricted prescription drug distributor must be in accordance
  279  with the requirements for wholesale distributors under s.
  280  499.0121.
  281         3. A person who applies for a permit as a restricted
  282  prescription drug distributor, or for the renewal of such a
  283  permit, must provide to the department the information required
  284  under s. 499.012.
  285         4. The department may adopt rules regarding the
  286  distribution of prescription drugs by hospitals, health care
  287  entities, charitable organizations, other persons not involved
  288  in wholesale distribution, and blood establishments, which rules
  289  are necessary for the protection of the public health, safety,
  290  and welfare.
  291         5. A restricted prescription drug distributor permit is not
  292  required for distributions between pharmacies that each hold an
  293  active permit under chapter 465, have a common ownership, and
  294  are operating in a freestanding end-stage renal dialysis clinic,
  295  if such distributions are made to meet the immediate emergency
  296  medical needs of specifically identified patients and do not
  297  occur with such frequency as to amount to the regular and
  298  systematic supplying of that drug between the pharmacies. The
  299  department shall adopt rules establishing when the distribution
  300  of a prescription drug under this subparagraph amounts to the
  301  regular and systematic supplying of that drug.
  302         6.A restricted prescription drug distributor permit is not
  303  required for the distribution of medicinal drugs or prepackaged
  304  drug products between entities under common control if each
  305  entity holds an active Class III institutional pharmacy permit
  306  under chapter 465 or an active health care clinic establishment
  307  permit under paragraph (r). For purposes of this subparagraph,
  308  the term “common control” means the same as in s. 465.019(2).
  309         7. A restricted prescription drug distributor permit is not
  310  required for a hospital covered by s. 340B of the Public Health
  311  Service Act, 42 U.S.C. s. 256b, if such hospital arranges for a
  312  prescription drug wholesale distributor to distribute
  313  prescription drugs covered under that act directly to a contract
  314  pharmacy.
  315         (5)A prescription drug repackager permit issued under this
  316  part is not required for a restricted prescription drug
  317  distributor permitholder that is a health care entity to
  318  repackage prescription drugs in this state for its own use or
  319  for distribution to hospitals or other health care entities in
  320  the state for their own use, pursuant to s. 499.003(48)(a)3.,
  321  if:
  322         (a)The prescription drug distributor notifies the
  323  department, in writing, of its intention to engage in
  324  repackaging under this exemption, 30 days before engaging in the
  325  repackaging of prescription drugs at the permitted
  326  establishment;
  327         (b)The prescription drug distributor is under common
  328  control with the hospitals or other health care entities to
  329  which the prescription drug distributor is distributing
  330  prescription drugs. As used in this paragraph, “common control”
  331  means the power to direct or cause the direction of the
  332  management and policies of a person or an organization, whether
  333  by ownership of stock, voting rights, contract, or otherwise;
  334         (c)The prescription drug distributor repackages the
  335  prescription drugs in accordance with current state and federal
  336  good manufacturing practices; and
  337         (d)The prescription drug distributor labels the
  338  prescription drug it repackages in accordance with state and
  339  federal laws and rules.
  341  The prescription drug distributor is exempt from the product
  342  registration requirements of s. 499.015 with regard to the
  343  prescription drugs that it repackages and distributes under this
  344  subsection. A prescription drug distributor that repackages and
  345  distributes prescription drugs under this subsection to a not
  346  for-profit rural hospital, as defined in s. 395.602, is not
  347  required to comply with paragraph (c) or paragraph (d), but must
  348  provide to each health care entity for which it repackages, for
  349  each prescription drug that is repackaged and distributed, the
  350  information required by department rule for labeling
  351  prescription drugs. The department shall adopt rules to ensure
  352  the safety and integrity of prescription drugs repackaged and
  353  distributed under this subsection, including rules regarding
  354  prescription drug manufacturing and labeling requirements.
  355         Section 7. This act shall take effect July 1, 2018.