Florida Senate - 2015                                    SB 1180
       
       
        
       By Senator Latvala
       
       
       
       
       
       20-01281B-15                                          20151180__
    1                        A bill to be entitled                      
    2         An act relating to the practice of pharmacy; amending
    3         s. 465.003, F.S.; defining a term; amending s.
    4         465.0276, F.S.; providing that the Florida Pharmacy
    5         Act does not prohibit the dispensing of a compounded
    6         drug by a veterinarian; amending ss. 409.9201,
    7         458.331, 459.015, 465.014, 465.015, 465.0156, 465.016,
    8         465.0197, 465.022, 465.023, 465.1901, 499.003, and
    9         893.02; conforming cross references; providing an
   10         effective date.
   11          
   12  Be It Enacted by the Legislature of the State of Florida:
   13  
   14         Section 1. Section 465.003, Florida Statutes, is reordered
   15  and amended, to read:
   16         465.003 Definitions.—As used in this chapter, the term:
   17         (1) “Administration” means the obtaining and giving of a
   18  single dose of medicinal drugs by a legally authorized person to
   19  a patient for her or his consumption.
   20         (3)(2) “Board” means the Board of Pharmacy.
   21         (7)(3) “Consultant pharmacist” means a pharmacist licensed
   22  by the department and certified as a consultant pharmacist
   23  pursuant to s. 465.0125.
   24         (8)(4) “Data communication device” means an electronic
   25  device that receives electronic information from one source and
   26  transmits or routes it to another, including, but not limited
   27  to, any such bridge, router, switch, or gateway.
   28         (9)(5) “Department” means the Department of Health.
   29         (10)(6) “Dispense” means the transfer of possession of one
   30  or more doses of a medicinal drug by a pharmacist to the
   31  ultimate consumer or her or his agent. As an element of
   32  dispensing, the pharmacist shall, prior to the actual physical
   33  transfer, interpret and assess the prescription order for
   34  potential adverse reactions, interactions, and dosage regimen
   35  she or he deems appropriate in the exercise of her or his
   36  professional judgment, and the pharmacist shall certify that the
   37  medicinal drug called for by the prescription is ready for
   38  transfer. The pharmacist shall also provide counseling on proper
   39  drug usage, either orally or in writing, if in the exercise of
   40  her or his professional judgment counseling is necessary. The
   41  actual sales transaction and delivery of such drug shall not be
   42  considered dispensing. The administration shall not be
   43  considered dispensing.
   44         (11)(7) “Institutional formulary system” means a method
   45  whereby the medical staff evaluates, appraises, and selects
   46  those medicinal drugs or proprietary preparations which in the
   47  medical staff’s clinical judgment are most useful in patient
   48  care, and which are available for dispensing by a practicing
   49  pharmacist in a Class II institutional pharmacy.
   50         (12)(8) “Medicinal drugs” or “drugs” means those substances
   51  or preparations commonly known as “prescription” or “legend”
   52  drugs which are required by federal or state law to be dispensed
   53  only on a prescription, but shall not include patents or
   54  proprietary preparations as hereafter defined.
   55         (16)(9) “Patent or proprietary preparation” means a
   56  medicine in its unbroken, original package which is sold to the
   57  public by, or under the authority of, the manufacturer or
   58  primary distributor thereof and which is not misbranded under
   59  the provisions of the Florida Drug and Cosmetic Act.
   60         (17)(10) “Pharmacist” means any person licensed pursuant to
   61  this chapter to practice the profession of pharmacy.
   62         (18)(11)(a) “Pharmacy” includes a community pharmacy, an
   63  institutional pharmacy, a nuclear pharmacy, a special pharmacy,
   64  and an Internet pharmacy.
   65         1. The term “community pharmacy” includes every location
   66  where medicinal drugs are compounded, dispensed, stored, or sold
   67  or where prescriptions are filled or dispensed on an outpatient
   68  basis.
   69         2. The term “institutional pharmacy” includes every
   70  location in a hospital, clinic, nursing home, dispensary,
   71  sanitarium, extended care facility, or other facility,
   72  hereinafter referred to as “health care institutions,” where
   73  medicinal drugs are compounded, dispensed, stored, or sold.
   74         3. The term “nuclear pharmacy” includes every location
   75  where radioactive drugs and chemicals within the classification
   76  of medicinal drugs are compounded, dispensed, stored, or sold.
   77  The term “nuclear pharmacy” does not include hospitals licensed
   78  under chapter 395 or the nuclear medicine facilities of such
   79  hospitals.
   80         4. The term “special pharmacy” includes every location
   81  where medicinal drugs are compounded, dispensed, stored, or sold
   82  if such locations are not otherwise defined in this subsection.
   83         5. The term “Internet pharmacy” includes locations not
   84  otherwise licensed or issued a permit under this chapter, within
   85  or outside this state, which use the Internet to communicate
   86  with or obtain information from consumers in this state and use
   87  such communication or information to fill or refill
   88  prescriptions or to dispense, distribute, or otherwise engage in
   89  the practice of pharmacy in this state. Any act described in
   90  this definition constitutes the practice of pharmacy as defined
   91  in subsection (20) (13).
   92         (b) The pharmacy department of any permittee shall be
   93  considered closed whenever a Florida licensed pharmacist is not
   94  present and on duty. The term “not present and on duty” shall
   95  not be construed to prevent a pharmacist from exiting the
   96  prescription department for the purposes of consulting or
   97  responding to inquiries or providing assistance to patients or
   98  customers, attending to personal hygiene needs, or performing
   99  any other function for which the pharmacist is responsible,
  100  provided that such activities are conducted in a manner
  101  consistent with the pharmacist’s responsibility to provide
  102  pharmacy services.
  103         (19)(12) “Pharmacy intern” means a person who is currently
  104  registered in, and attending, a duly accredited college or
  105  school of pharmacy, or who is a graduate of such a school or
  106  college of pharmacy, and who is duly and properly registered
  107  with the department as provided for under its rules.
  108         (20)(13) “Practice of the profession of pharmacy” includes
  109  compounding, dispensing, and consulting concerning contents,
  110  therapeutic values, and uses of any medicinal drug; consulting
  111  concerning therapeutic values and interactions of patent or
  112  proprietary preparations, whether pursuant to prescriptions or
  113  in the absence and entirely independent of such prescriptions or
  114  orders; and other pharmaceutical services. For purposes of this
  115  subsection, “other pharmaceutical services” means the monitoring
  116  of the patient’s drug therapy and assisting the patient in the
  117  management of his or her drug therapy, and includes review of
  118  the patient’s drug therapy and communication with the patient’s
  119  prescribing health care provider as licensed under chapter 458,
  120  chapter 459, chapter 461, or chapter 466, or similar statutory
  121  provision in another jurisdiction, or such provider’s agent or
  122  such other persons as specifically authorized by the patient,
  123  regarding the drug therapy. However, nothing in this subsection
  124  may be interpreted to permit an alteration of a prescriber’s
  125  directions, the diagnosis or treatment of any disease, the
  126  initiation of any drug therapy, the practice of medicine, or the
  127  practice of osteopathic medicine, unless otherwise permitted by
  128  law. “Practice of the profession of pharmacy” also includes any
  129  other act, service, operation, research, or transaction
  130  incidental to, or forming a part of, any of the foregoing acts,
  131  requiring, involving, or employing the science or art of any
  132  branch of the pharmaceutical profession, study, or training, and
  133  shall expressly permit a pharmacist to transmit information from
  134  persons authorized to prescribe medicinal drugs to their
  135  patients. The practice of the profession of pharmacy also
  136  includes the administration of vaccines to adults pursuant to s.
  137  465.189.
  138         (21)(14) “Prescription” includes any order for drugs or
  139  medicinal supplies written or transmitted by any means of
  140  communication by a duly licensed practitioner authorized by the
  141  laws of the state to prescribe such drugs or medicinal supplies
  142  and intended to be dispensed by a pharmacist. The term also
  143  includes an orally transmitted order by the lawfully designated
  144  agent of such practitioner. The term also includes an order
  145  written or transmitted by a practitioner licensed to practice in
  146  a jurisdiction other than this state, but only if the pharmacist
  147  called upon to dispense such order determines, in the exercise
  148  of her or his professional judgment, that the order is valid and
  149  necessary for the treatment of a chronic or recurrent illness.
  150  The term “prescription” also includes a pharmacist’s order for a
  151  product selected from the formulary created pursuant to s.
  152  465.186. Prescriptions may be retained in written form or the
  153  pharmacist may cause them to be recorded in a data processing
  154  system, provided that such order can be produced in printed form
  155  upon lawful request.
  156         (13)(15) “Nuclear pharmacist” means a pharmacist licensed
  157  by the department and certified as a nuclear pharmacist pursuant
  158  to s. 465.0126.
  159         (14) “Office use compounding” means the provision and
  160  administration of a compounded drug to a patient by a
  161  practitioner in the practitioner’s office or other treatment
  162  setting. In the case of veterinary drugs, office use compounding
  163  includes compounding for a veterinarian to dispense to the owner
  164  or caretaker of the animal patient.
  165         (4)(16) “Centralized prescription filling” means the
  166  filling of a prescription by one pharmacy upon request by
  167  another pharmacy to fill or refill the prescription. The term
  168  includes the performance by one pharmacy for another pharmacy of
  169  other pharmacy duties such as drug utilization review,
  170  therapeutic drug utilization review, claims adjudication, and
  171  the obtaining of refill authorizations.
  172         (2)(17) “Automated pharmacy system” means a mechanical
  173  system that delivers prescription drugs received from a Florida
  174  licensed pharmacy and maintains related transaction information.
  175         (6)(18) “Compounding” means combining, mixing, or altering
  176  the ingredients of one or more drugs or products to create
  177  another drug or product.
  178         (15)(19) “Outsourcing facility” means a single physical
  179  location registered as an outsourcing facility under the federal
  180  Drug Quality and Security Act, Pub. L. No. 113-54, at which
  181  sterile compounding of a drug or product is conducted.
  182         (5)(20) “Compounded sterile product” means a drug that is
  183  intended for parenteral administration, an ophthalmic or oral
  184  inhalation drug in aqueous format, or a drug or product that is
  185  required to be sterile under federal or state law or rule, which
  186  is produced through compounding, but is not approved by the
  187  United States Food and Drug Administration.
  188         Section 2. A new subsection (6) is added to section
  189  465.0276, Florida Statutes, to read:
  190         465.0276 Dispensing practitioner.—
  191         (6) Nothing in this chapter or the rules adopted thereunder
  192  prohibit a veterinarian from dispensing a compounded drug to an
  193  animal patient or its owner or caretaker.
  194         Section 3. Paragraph (a) of subsection (1) of section
  195  409.9201, Florida Statutes, is amended to read:
  196         409.9201 Medicaid fraud.—
  197         (1) As used in this section, the term:
  198         (a) “Prescription drug” means any drug, including, but not
  199  limited to, finished dosage forms or active ingredients that are
  200  subject to, defined in, or described in s. 503(b) of the Federal
  201  Food, Drug, and Cosmetic Act or in s. 465.003 s. 465.003(8), s.
  202  499.003(52), s. 499.007(13), or s. 499.82(10).
  203  
  204  The value of individual items of the legend drugs or goods or
  205  services involved in distinct transactions committed during a
  206  single scheme or course of conduct, whether involving a single
  207  person or several persons, may be aggregated when determining
  208  the punishment for the offense.
  209         Section 4. Paragraph (pp) of subsection (1) of section
  210  458.331, Florida Statutes, is amended to read:
  211         458.331 Grounds for disciplinary action; action by the
  212  board and department.—
  213         (1) The following acts constitute grounds for denial of a
  214  license or disciplinary action, as specified in s. 456.072(2):
  215         (pp) Applicable to a licensee who serves as the designated
  216  physician of a pain-management clinic as defined in s. 458.3265
  217  or s. 459.0137:
  218         1. Registering a pain-management clinic through
  219  misrepresentation or fraud;
  220         2. Procuring, or attempting to procure, the registration of
  221  a pain-management clinic for any other person by making or
  222  causing to be made, any false representation;
  223         3. Failing to comply with any requirement of chapter 499,
  224  the Florida Drug and Cosmetic Act; 21 U.S.C. ss. 301-392, the
  225  Federal Food, Drug, and Cosmetic Act; 21 U.S.C. ss. 821 et seq.,
  226  the Drug Abuse Prevention and Control Act; or chapter 893, the
  227  Florida Comprehensive Drug Abuse Prevention and Control Act;
  228         4. Being convicted or found guilty of, regardless of
  229  adjudication to, a felony or any other crime involving moral
  230  turpitude, fraud, dishonesty, or deceit in any jurisdiction of
  231  the courts of this state, of any other state, or of the United
  232  States;
  233         5. Being convicted of, or disciplined by a regulatory
  234  agency of the Federal Government or a regulatory agency of
  235  another state for, any offense that would constitute a violation
  236  of this chapter;
  237         6. Being convicted of, or entering a plea of guilty or nolo
  238  contendere to, regardless of adjudication, a crime in any
  239  jurisdiction of the courts of this state, of any other state, or
  240  of the United States which relates to the practice of, or the
  241  ability to practice, a licensed health care profession;
  242         7. Being convicted of, or entering a plea of guilty or nolo
  243  contendere to, regardless of adjudication, a crime in any
  244  jurisdiction of the courts of this state, of any other state, or
  245  of the United States which relates to health care fraud;
  246         8. Dispensing any medicinal drug based upon a communication
  247  that purports to be a prescription as defined in s. 465.003 s.
  248  465.003(14) or s. 893.02 if the dispensing practitioner knows or
  249  has reason to believe that the purported prescription is not
  250  based upon a valid practitioner-patient relationship; or
  251         9. Failing to timely notify the board of the date of his or
  252  her termination from a pain-management clinic as required by s.
  253  458.3265(2).
  254         Section 5. Paragraph (rr) of subsection (1) of section
  255  459.015, Florida Statutes, is amended to read:
  256         459.015 Grounds for disciplinary action; action by the
  257  board and department.—
  258         (1) The following acts constitute grounds for denial of a
  259  license or disciplinary action, as specified in s. 456.072(2):
  260         (rr) Applicable to a licensee who serves as the designated
  261  physician of a pain-management clinic as defined in s. 458.3265
  262  or s. 459.0137:
  263         1. Registering a pain-management clinic through
  264  misrepresentation or fraud;
  265         2. Procuring, or attempting to procure, the registration of
  266  a pain-management clinic for any other person by making or
  267  causing to be made, any false representation;
  268         3. Failing to comply with any requirement of chapter 499,
  269  the Florida Drug and Cosmetic Act; 21 U.S.C. ss. 301-392, the
  270  Federal Food, Drug, and Cosmetic Act; 21 U.S.C. ss. 821 et seq.,
  271  the Drug Abuse Prevention and Control Act; or chapter 893, the
  272  Florida Comprehensive Drug Abuse Prevention and Control Act;
  273         4. Being convicted or found guilty of, regardless of
  274  adjudication to, a felony or any other crime involving moral
  275  turpitude, fraud, dishonesty, or deceit in any jurisdiction of
  276  the courts of this state, of any other state, or of the United
  277  States;
  278         5. Being convicted of, or disciplined by a regulatory
  279  agency of the Federal Government or a regulatory agency of
  280  another state for, any offense that would constitute a violation
  281  of this chapter;
  282         6. Being convicted of, or entering a plea of guilty or nolo
  283  contendere to, regardless of adjudication, a crime in any
  284  jurisdiction of the courts of this state, of any other state, or
  285  of the United States which relates to the practice of, or the
  286  ability to practice, a licensed health care profession;
  287         7. Being convicted of, or entering a plea of guilty or nolo
  288  contendere to, regardless of adjudication, a crime in any
  289  jurisdiction of the courts of this state, of any other state, or
  290  of the United States which relates to health care fraud;
  291         8. Dispensing any medicinal drug based upon a communication
  292  that purports to be a prescription as defined in s. 465.003 s.
  293  465.003(14) or s. 893.02 if the dispensing practitioner knows or
  294  has reason to believe that the purported prescription is not
  295  based upon a valid practitioner-patient relationship; or
  296         9. Failing to timely notify the board of the date of his or
  297  her termination from a pain-management clinic as required by s.
  298  459.0137(2).
  299         Section 6. Subsection (1) of section 465.014, Florida
  300  Statutes, is amended to read:
  301         465.014 Pharmacy technician.—
  302         (1) A person other than a licensed pharmacist or pharmacy
  303  intern may not engage in the practice of the profession of
  304  pharmacy, except that a licensed pharmacist may delegate to
  305  pharmacy technicians who are registered pursuant to this section
  306  those duties, tasks, and functions that do not fall within the
  307  purview of s. 465.003 s. 465.003(13). All such delegated acts
  308  must be performed under the direct supervision of a licensed
  309  pharmacist who is responsible for all such acts performed by
  310  persons under his or her supervision. A registered pharmacy
  311  technician, under the supervision of a pharmacist, may initiate
  312  or receive communications with a practitioner or his or her
  313  agent, on behalf of a patient, regarding refill authorization
  314  requests. A licensed pharmacist may not supervise more than one
  315  registered pharmacy technician unless otherwise permitted by the
  316  guidelines adopted by the board. The board shall establish
  317  guidelines to be followed by licensees or permittees in
  318  determining the circumstances under which a licensed pharmacist
  319  may supervise more than one pharmacy technician.
  320         Section 7. Paragraph (c) of subsection (2) of section
  321  465.015, Florida Statutes, is amended to read:
  322         465.015 Violations and penalties.—
  323         (2) It is unlawful for any person:
  324         (c) To sell or dispense drugs as defined in s. 465.003 s.
  325  465.003(8) without first being furnished with a prescription.
  326         Section 8. Subsection (9) of section 465.0156, Florida
  327  Statutes, is amended to read:
  328         465.0156 Registration of nonresident pharmacies.—
  329         (9) Notwithstanding s. 465.003 s. 465.003(10), for purposes
  330  of this section, the registered pharmacy and the pharmacist
  331  designated by the registered pharmacy as the prescription
  332  department manager or the equivalent must be licensed in the
  333  state of location in order to dispense into this state.
  334         Section 9. Paragraph (s) of subsection (1) of section
  335  465.016, Florida Statutes, is amended to read:
  336         465.016 Disciplinary actions.—
  337         (1) The following acts constitute grounds for denial of a
  338  license or disciplinary action, as specified in s. 456.072(2):
  339         (s) Dispensing any medicinal drug based upon a
  340  communication that purports to be a prescription as defined by
  341  s. 465.003 s. 465.003(14) or s. 893.02 when the pharmacist knows
  342  or has reason to believe that the purported prescription is not
  343  based upon a valid practitioner-patient relationship.
  344         Section 10. Subsection (4) of section 465.0197, Florida
  345  Statutes, is amended to read:
  346         465.0197 Internet pharmacy permits.—
  347         (4) Notwithstanding s. 465.003 s. 465.003(10), for purposes
  348  of this section, the Internet pharmacy and the pharmacist
  349  designated by the Internet pharmacy as the prescription
  350  department manager or the equivalent must be licensed in the
  351  state of location in order to dispense into this state.
  352         Section 11. Paragraph (j) of subsection (5) of section
  353  465.022, Florida Statutes, is amended to read:
  354         465.022 Pharmacies; general requirements; fees.—
  355         (5) The department or board shall deny an application for a
  356  pharmacy permit if the applicant or an affiliated person,
  357  partner, officer, director, or prescription department manager
  358  or consultant pharmacist of record of the applicant:
  359         (j) Has dispensed any medicinal drug based upon a
  360  communication that purports to be a prescription as defined by
  361  s. 465.003 s. 465.003(14) or s. 893.02 when the pharmacist knows
  362  or has reason to believe that the purported prescription is not
  363  based upon a valid practitioner-patient relationship that
  364  includes a documented patient evaluation, including history and
  365  a physical examination adequate to establish the diagnosis for
  366  which any drug is prescribed and any other requirement
  367  established by board rule under chapter 458, chapter 459,
  368  chapter 461, chapter 463, chapter 464, or chapter 466.
  369  
  370  For felonies in which the defendant entered a plea of guilty or
  371  nolo contendere in an agreement with the court to enter a
  372  pretrial intervention or drug diversion program, the department
  373  shall deny the application if upon final resolution of the case
  374  the licensee has failed to successfully complete the program.
  375         Section 12. Paragraph (h) of subsection (1) of section
  376  465.023, Florida Statutes, is amended to read:
  377         465.023 Pharmacy permittee; disciplinary action.—
  378         (1) The department or the board may revoke or suspend the
  379  permit of any pharmacy permittee, and may fine, place on
  380  probation, or otherwise discipline any pharmacy permittee if the
  381  permittee, or any affiliated person, partner, officer, director,
  382  or agent of the permittee, including a person fingerprinted
  383  under s. 465.022(3), has:
  384         (h) Dispensed any medicinal drug based upon a communication
  385  that purports to be a prescription as defined by s. 465.003 s.
  386  465.003(14) or s. 893.02 when the pharmacist knows or has reason
  387  to believe that the purported prescription is not based upon a
  388  valid practitioner-patient relationship that includes a
  389  documented patient evaluation, including history and a physical
  390  examination adequate to establish the diagnosis for which any
  391  drug is prescribed and any other requirement established by
  392  board rule under chapter 458, chapter 459, chapter 461, chapter
  393  463, chapter 464, or chapter 466.
  394         Section 13. Section 465.1901, Florida Statutes, is amended
  395  to read:
  396         465.1901 Practice of orthotics and pedorthics.—The
  397  provisions of chapter 468 relating to orthotics or pedorthics do
  398  not apply to any licensed pharmacist or to any person acting
  399  under the supervision of a licensed pharmacist. The practice of
  400  orthotics or pedorthics by a pharmacist or any of the
  401  pharmacist’s employees acting under the supervision of a
  402  pharmacist shall be construed to be within the meaning of the
  403  term “practice of the profession of pharmacy” as set forth in s.
  404  465.003 s. 465.003(13), and shall be subject to regulation in
  405  the same manner as any other pharmacy practice. The Board of
  406  Pharmacy shall develop rules regarding the practice of orthotics
  407  and pedorthics by a pharmacist. Any pharmacist or person under
  408  the supervision of a pharmacist engaged in the practice of
  409  orthotics or pedorthics is not precluded from continuing that
  410  practice pending adoption of these rules.
  411         Section 14. Subsection (43) of section 499.003, Florida
  412  Statutes, is amended to read:
  413         499.003 Definitions of terms used in this part.—As used in
  414  this part, the term:
  415         (43) “Prescription drug” means a prescription, medicinal,
  416  or legend drug, including, but not limited to, finished dosage
  417  forms or active pharmaceutical ingredients subject to, defined
  418  by, or described by s. 503(b) of the federal act or s. 465.003
  419  s. 465.003(8), s. 499.007(13), subsection (32), or subsection
  420  (52), except that an active pharmaceutical ingredient is a
  421  prescription drug only if substantially all finished dosage
  422  forms in which it may be lawfully dispensed or administered in
  423  this state are also prescription drugs.
  424         Section 15. Subsection (22) of section 893.02, Florida
  425  Statutes, is amended to read:
  426         893.02 Definitions.—The following words and phrases as used
  427  in this chapter shall have the following meanings, unless the
  428  context otherwise requires:
  429         (22) “Prescription” means and includes an order for drugs
  430  or medicinal supplies written, signed, or transmitted by word of
  431  mouth, telephone, telegram, or other means of communication by a
  432  duly licensed practitioner licensed by the laws of the state to
  433  prescribe such drugs or medicinal supplies, issued in good faith
  434  and in the course of professional practice, intended to be
  435  filled, compounded, or dispensed by another person licensed by
  436  the laws of the state to do so, and meeting the requirements of
  437  s. 893.04. The term also includes an order for drugs or
  438  medicinal supplies so transmitted or written by a physician,
  439  dentist, veterinarian, or other practitioner licensed to
  440  practice in a state other than Florida, but only if the
  441  pharmacist called upon to fill such an order determines, in the
  442  exercise of his or her professional judgment, that the order was
  443  issued pursuant to a valid patient-physician relationship, that
  444  it is authentic, and that the drugs or medicinal supplies so
  445  ordered are considered necessary for the continuation of
  446  treatment of a chronic or recurrent illness. However, if the
  447  physician writing the prescription is not known to the
  448  pharmacist, the pharmacist shall obtain proof to a reasonable
  449  certainty of the validity of said prescription. A prescription
  450  order for a controlled substance shall not be issued on the same
  451  prescription blank with another prescription order for a
  452  controlled substance which is named or described in a different
  453  schedule, nor shall any prescription order for a controlled
  454  substance be issued on the same prescription blank as a
  455  prescription order for a medicinal drug, as defined in s.
  456  465.003 s. 465.003(8), which does not fall within the definition
  457  of a controlled substance as defined in this act.
  458         Section 16. This act shall take effect July 1, 2015.