Florida Senate - 2018                             CS for SB 1128
       By the Committee on Health Policy; and Senator Stargel
       588-02616-18                                          20181128c1
    1                        A bill to be entitled                      
    2         An act relating to pharmacies; amending s. 465.003,
    3         F.S.; revising and providing definitions; 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; providing
    7         requirements for such pharmacies; conforming
    8         provisions to changes made by the act; amending s.
    9         465.0252, F.S.; revising notice requirements to
   10         conform to changes made by the act; amending s.
   11         499.003, F.S.; providing and revising definitions;
   12         amending s. 499.01, F.S.; authorizing the distribution
   13         of medicinal drugs and prepackaged drug products
   14         without a specified permit under certain conditions;
   15         deleting a provision exempting certain drug
   16         repackagers from specified permit requirements;
   17         providing an effective date.
   19  Be It Enacted by the Legislature of the State of Florida:
   21         Section 1. Subsections (7) and (13) of section 465.003,
   22  Florida Statutes, are amended, and subsections (21) and (22) are
   23  added to that section, to read:
   24         465.003 Definitions.—As used in this chapter, the term:
   25         (7) “Institutional formulary system” means a method whereby
   26  the medical staff evaluates, appraises, and selects those
   27  medicinal drugs or proprietary preparations which in the medical
   28  staff’s clinical judgment are most useful in patient care, and
   29  which are available for dispensing by a practicing pharmacist in
   30  a Class II or Class III institutional pharmacy.
   31         (13) “Practice of the profession of pharmacy” includes
   32  compounding, dispensing, and consulting concerning contents,
   33  therapeutic values, and uses of any medicinal drug; consulting
   34  concerning therapeutic values and interactions of patent or
   35  proprietary preparations, whether pursuant to prescriptions or
   36  in the absence and entirely independent of such prescriptions or
   37  orders; and conducting other pharmaceutical services. For
   38  purposes of this subsection, “other pharmaceutical services”
   39  means the monitoring of the patient’s drug therapy and assisting
   40  the patient in the management of his or her drug therapy, and
   41  includes review of the patient’s drug therapy and communication
   42  with the patient’s prescribing health care provider as licensed
   43  under chapter 458, chapter 459, chapter 461, or chapter 466, or
   44  similar statutory provision in another jurisdiction, or such
   45  provider’s agent or such other persons as specifically
   46  authorized by the patient, regarding the drug therapy. However,
   47  nothing in this subsection may be interpreted to permit an
   48  alteration of a prescriber’s directions, the diagnosis or
   49  treatment of any disease, the initiation of any drug therapy,
   50  the practice of medicine, or the practice of osteopathic
   51  medicine, unless otherwise permitted by law. “Practice of the
   52  profession of pharmacy” also includes any other act, service,
   53  operation, research, or transaction incidental to, or forming a
   54  part of, any of the foregoing acts, requiring, involving, or
   55  employing the science or art of any branch of the pharmaceutical
   56  profession, study, or training, and shall expressly permit a
   57  pharmacist to transmit information from persons authorized to
   58  prescribe medicinal drugs to their patients. The practice of the
   59  profession of pharmacy also includes the administration of
   60  vaccines to adults pursuant to s. 465.189 and the preparation of
   61  prepackaged drug products in facilities holding Class III
   62  institutional pharmacy permits.
   63         (21)“Central distribution facility” means a facility under
   64  common control with a hospital holding a Class III institutional
   65  pharmacy permit that may dispense, distribute, compound, or fill
   66  prescriptions for medicinal drugs; prepare prepackaged drug
   67  products; and conduct other pharmaceutical services.
   68         (22)“Common control” means the power to direct or cause
   69  the direction of the management and policies of a person or an
   70  organization, whether by ownership of stock, voting rights,
   71  contract, or otherwise.
   72         Section 2. Subsection (2) of section 465.004, Florida
   73  Statutes, is amended to read:
   74         465.004 Board of Pharmacy.—
   75         (2) Seven members of the board must be licensed pharmacists
   76  who are residents of this state and who have been engaged in the
   77  practice of the profession of pharmacy in this state for at
   78  least 4 years and, to the extent practicable, represent the
   79  various pharmacy practice settings. Of the pharmacist members,
   80  two must be currently engaged in the practice of pharmacy in a
   81  community pharmacy, two must be currently engaged in the
   82  practice of pharmacy in a Class II, institutional pharmacy or a
   83  Modified Class II, or Class III institutional pharmacy, and
   84  three must be pharmacists licensed in this state irrespective of
   85  practice setting. The remaining two members must be residents of
   86  the state who have never been licensed as pharmacists and who
   87  are in no way connected with the practice of the profession of
   88  pharmacy. No person may be appointed as a consumer member who is
   89  in any way connected with a drug manufacturer or wholesaler. At
   90  least one member of the board must be 60 years of age or older.
   91  The Governor shall appoint members to the board in accordance
   92  with this subsection as members’ terms expire or as a vacancy
   93  occurs until the composition of the board complies with the
   94  requirements of this subsection.
   95         Section 3. Subsections (4) and (6) of section 465.019,
   96  Florida Statutes, are amended, and paragraph (d) is added to
   97  subsection (2) of that section, to read:
   98         465.019 Institutional pharmacies; permits.—
   99         (2) The following classes of institutional pharmacies are
  100  established:
  101         (d)1.“Class III institutional pharmacies” are those
  102  institutional pharmacies, including central distribution
  103  facilities, affiliated with a hospital that provide the same
  104  services that are authorized by a Class II institutional
  105  pharmacy permit. Class III institutional pharmacies may also:
  106         a.Dispense, distribute, compound, and fill prescriptions
  107  for medicinal drugs.
  108         b.Prepare prepackaged drug products.
  109         c.Conduct other pharmaceutical services for the affiliated
  110  hospital and for entities under common control that are each
  111  permitted under this chapter to possess medicinal drugs.
  112         d.Provide the services in sub-subparagraphs a.-c. to an
  113  entity under common control which holds an active health care
  114  clinic establishment permit as required under s. 499.01(2)(r).
  115         2.A Class III institutional pharmacy shall maintain
  116  policies and procedures addressing:
  117         a.The consultant pharmacist responsible for pharmaceutical
  118  services.
  119         b.Safe practices for the preparation, dispensing,
  120  prepackaging, distribution, and transportation of medicinal
  121  drugs and prepackaged drug products.
  122         c.Recordkeeping to monitor the movement, distribution, and
  123  transportation of medicinal drugs and prepackaged drug products.
  124         d.Recordkeeping of pharmacy staff responsible for each
  125  step in the preparation, dispensing, prepackaging,
  126  transportation, and distribution of medicinal drugs and
  127  prepackaged drug products.
  128         e.Medicinal drugs and prepackaged drug products that may
  129  not be safely distributed among Class III institutional
  130  pharmacies.
  131         (4) Medicinal drugs shall be dispensed in an institutional
  132  pharmacy to outpatients only when that institution has secured a
  133  community pharmacy permit from the department. However, an
  134  individual licensed to prescribe medicinal drugs in this state
  135  may dispense up to a 24-hour supply of a medicinal drug to any
  136  patient of an emergency department of a hospital that operates a
  137  Class II or Class III institutional pharmacy, provided that the
  138  physician treating the patient in such hospital’s emergency
  139  department determines that the medicinal drug is warranted and
  140  that community pharmacy services are not readily accessible,
  141  geographically or otherwise, to the patient. Such dispensing
  142  from the emergency department must be in accordance with the
  143  procedures of the hospital. For any such patient for whom a
  144  medicinal drug is warranted for a period to exceed 24 hours, an
  145  individual licensed to prescribe such drug must dispense a 24
  146  hour supply of such drug to the patient and must provide the
  147  patient with a prescription for such drug for use after the
  148  initial 24-hour period. The board may adopt rules necessary to
  149  carry out the provisions of this subsection.
  150         (6) In a Class II or Class III institutional pharmacy, an
  151  institutional formulary system may be adopted with approval of
  152  the medical staff for the purpose of identifying those medicinal
  153  drugs, proprietary preparations, biologics, biosimilars, and
  154  biosimilar interchangeables that may be dispensed by the
  155  pharmacists employed in such institution. A facility with a
  156  Class II or Class III institutional pharmacy permit which is
  157  operating under the formulary system shall establish policies
  158  and procedures for the development of the system in accordance
  159  with the joint standards of the American Hospital Association
  160  and American Society of Hospital Pharmacists for the utilization
  161  of a hospital formulary system, which formulary shall be
  162  approved by the medical staff.
  163         Section 4. Subsection (3) of section 465.0252, Florida
  164  Statutes, is amended to read:
  165         465.0252 Substitution of interchangeable biosimilar
  166  products.—
  167         (3) A pharmacist who practices in a Class II, or Modified
  168  Class II, or Class III institutional pharmacy shall comply with
  169  the notification provisions of paragraph (2)(c) by entering the
  170  substitution in the institution’s written medical record system
  171  or electronic medical record system.
  172         Section 5. Subsection (39) of section 499.003, Florida
  173  Statutes, is amended, and paragraphs (w) and (x) are added to
  174  subsection (48) of that section, to read:
  175         499.003 Definitions of terms used in this part.—As used in
  176  this part, the term:
  177         (39) “Prepackaged drug product” means a drug that
  178  originally was in finished packaged form sealed by a
  179  manufacturer and that is placed in a properly labeled container
  180  by a pharmacy or practitioner authorized to dispense pursuant to
  181  chapter 465 for the purpose of dispensing or by a facility
  182  holding a Class III institutional pharmacy permit in the
  183  establishment in which the prepackaging occurred.
  184         (48) “Wholesale distribution” means the distribution of a
  185  prescription drug to a person other than a consumer or patient,
  186  or the receipt of a prescription drug by a person other than the
  187  consumer or patient, but does not include:
  188         (w)A hospital covered by s. 340B of the Public Health
  189  Service Act, 42 U.S.C. s. 256b, that arranges for a prescription
  190  drug wholesale distributor to distribute prescription drugs
  191  covered under that act directly to a contract pharmacy. Such
  192  hospital is exempt from obtaining a restricted prescription drug
  193  distributor permit under s. 499.01(2)(h).
  194         (x)The dispensing or distribution of a medicinal drug by a
  195  Class III institutional pharmacy pursuant to s. 465.019.
  196         Section 6. Paragraphs (b) and (h) of subsection (2) and
  197  subsection (5) of section 499.01, Florida Statutes, are amended
  198  to read:
  199         499.01 Permits.—
  200         (2) The following permits are established:
  201         (b) Prescription drug repackager permit.—A prescription
  202  drug repackager permit is required for any person that
  203  repackages a prescription drug in this state.
  204         1. A person that operates an establishment permitted as a
  205  prescription drug repackager may engage in distribution of
  206  prescription drugs repackaged at that establishment and must
  207  comply with all of the provisions of this part and the rules
  208  adopted under this part that apply to a prescription drug
  209  manufacturer.
  210         2. A prescription drug repackager must comply with all
  211  appropriate state and federal good manufacturing practices.
  212         3.A prescription drug repackager permit is not required
  213  for distributing medicinal drugs or prepackaged drug products
  214  between entities under common control which each hold an active
  215  Class III institutional pharmacy permit under chapter 465 or an
  216  active health care clinic establishment permit under paragraph
  217  (r). For purposes of this subparagraph, the term “common
  218  control” has the same meaning as in s. 499.003(48)(a)3.
  219         (h) Restricted prescription drug distributor permit.—
  220         1. A restricted prescription drug distributor permit is
  221  required for:
  222         a. Any person located in this state who engages in the
  223  distribution of a prescription drug, which distribution is not
  224  considered “wholesale distribution” under s. 499.003(48)(a).
  225         b. Any person located in this state who engages in the
  226  receipt or distribution of a prescription drug in this state for
  227  the purpose of processing its return or its destruction if such
  228  person is not the person initiating the return, the prescription
  229  drug wholesale supplier of the person initiating the return, or
  230  the manufacturer of the drug.
  231         c. A blood establishment located in this state which
  232  collects blood and blood components only from volunteer donors
  233  as defined in s. 381.06014 or pursuant to an authorized
  234  practitioner’s order for medical treatment or therapy and
  235  engages in the wholesale distribution of a prescription drug not
  236  described in s. 499.003(48)(j) to a health care entity. A mobile
  237  blood unit operated by a blood establishment permitted under
  238  this sub-subparagraph is not required to be separately
  239  permitted. The health care entity receiving a prescription drug
  240  distributed under this sub-subparagraph must be licensed as a
  241  closed pharmacy or provide health care services at that
  242  establishment. The blood establishment must operate in
  243  accordance with s. 381.06014 and may distribute only:
  244         (I) Prescription drugs indicated for a bleeding or clotting
  245  disorder or anemia;
  246         (II) Blood-collection containers approved under s. 505 of
  247  the federal act;
  248         (III) Drugs that are blood derivatives, or a recombinant or
  249  synthetic form of a blood derivative;
  250         (IV) Prescription drugs that are identified in rules
  251  adopted by the department and that are essential to services
  252  performed or provided by blood establishments and authorized for
  253  distribution by blood establishments under federal law; or
  254         (V) To the extent authorized by federal law, drugs
  255  necessary to collect blood or blood components from volunteer
  256  blood donors; for blood establishment personnel to perform
  257  therapeutic procedures under the direction and supervision of a
  258  licensed physician; and to diagnose, treat, manage, and prevent
  259  any reaction of a volunteer blood donor or a patient undergoing
  260  a therapeutic procedure performed under the direction and
  261  supervision of a licensed physician,
  263  as long as all of the health care services provided by the blood
  264  establishment are related to its activities as a registered
  265  blood establishment or the health care services consist of
  266  collecting, processing, storing, or administering human
  267  hematopoietic stem cells or progenitor cells or performing
  268  diagnostic testing of specimens if such specimens are tested
  269  together with specimens undergoing routine donor testing. The
  270  blood establishment may purchase and possess the drugs described
  271  in this sub-subparagraph without a health care clinic
  272  establishment permit.
  273         2. Storage, handling, and recordkeeping of these
  274  distributions by a person required to be permitted as a
  275  restricted prescription drug distributor must be in accordance
  276  with the requirements for wholesale distributors under s.
  277  499.0121.
  278         3. A person who applies for a permit as a restricted
  279  prescription drug distributor, or for the renewal of such a
  280  permit, must provide to the department the information required
  281  under s. 499.012.
  282         4. The department may adopt rules regarding the
  283  distribution of prescription drugs by hospitals, health care
  284  entities, charitable organizations, other persons not involved
  285  in wholesale distribution, and blood establishments, which rules
  286  are necessary for the protection of the public health, safety,
  287  and welfare.
  288         5. A restricted prescription drug distributor permit is not
  289  required for distributions between pharmacies that each hold an
  290  active permit under chapter 465, have a common ownership, and
  291  are operating in a freestanding end-stage renal dialysis clinic,
  292  if such distributions are made to meet the immediate emergency
  293  medical needs of specifically identified patients and do not
  294  occur with such frequency as to amount to the regular and
  295  systematic supplying of that drug between the pharmacies. The
  296  department shall adopt rules establishing when the distribution
  297  of a prescription drug under this subparagraph amounts to the
  298  regular and systematic supplying of that drug.
  299         6.A restricted prescription drug distributor permit is not
  300  required for distributing medicinal drugs or prepackaged drug
  301  products between entities under common control that each hold
  302  either an active Class III institutional pharmacy permit under
  303  chapter 465 or an active health care clinic establishment permit
  304  under paragraph (2)(r). For purposes of this subparagraph, the
  305  term “common control” has the same meaning as in s.
  306  499.003(48)(a)3.
  307         (5)A prescription drug repackager permit issued under this
  308  part is not required for a restricted prescription drug
  309  distributor permitholder that is a health care entity to
  310  repackage prescription drugs in this state for its own use or
  311  for distribution to hospitals or other health care entities in
  312  the state for their own use, pursuant to s. 499.003(48)(a)3.,
  313  if:
  314         (a)The prescription drug distributor notifies the
  315  department, in writing, of its intention to engage in
  316  repackaging under this exemption, 30 days before engaging in the
  317  repackaging of prescription drugs at the permitted
  318  establishment;
  319         (b)The prescription drug distributor is under common
  320  control with the hospitals or other health care entities to
  321  which the prescription drug distributor is distributing
  322  prescription drugs. As used in this paragraph, “common control”
  323  means the power to direct or cause the direction of the
  324  management and policies of a person or an organization, whether
  325  by ownership of stock, voting rights, contract, or otherwise;
  326         (c)The prescription drug distributor repackages the
  327  prescription drugs in accordance with current state and federal
  328  good manufacturing practices; and
  329         (d)The prescription drug distributor labels the
  330  prescription drug it repackages in accordance with state and
  331  federal laws and rules.
  333  The prescription drug distributor is exempt from the product
  334  registration requirements of s. 499.015 with regard to the
  335  prescription drugs that it repackages and distributes under this
  336  subsection. A prescription drug distributor that repackages and
  337  distributes prescription drugs under this subsection to a not
  338  for-profit rural hospital, as defined in s. 395.602, is not
  339  required to comply with paragraph (c) or paragraph (d), but must
  340  provide to each health care entity for which it repackages, for
  341  each prescription drug that is repackaged and distributed, the
  342  information required by department rule for labeling
  343  prescription drugs. The department shall adopt rules to ensure
  344  the safety and integrity of prescription drugs repackaged and
  345  distributed under this subsection, including rules regarding
  346  prescription drug manufacturing and labeling requirements.
  347         Section 7. This act shall take effect July 1, 2018.