Florida Senate - 2018                        COMMITTEE AMENDMENT
       Bill No. SB 1128
                              LEGISLATIVE ACTION                        
                    Senate             .             House              

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