Florida Senate - 2016                      CS for CS for SB 1604
       
       
        
       By the Committees on Appropriations; and Health Policy; and
       Senator Grimsley
       
       576-04227-16                                          20161604c2
    1                        A bill to be entitled                      
    2         An act relating to drugs, devices, and cosmetics;
    3         amending s. 499.003, F.S.; providing, revising, and
    4         deleting definitions for purposes of the Florida Drug
    5         and Cosmetic Act; requiring rulemaking; specifying a
    6         default rule until the Department of Business and
    7         Professional Regulation adopts a rule; amending s.
    8         499.005, F.S.; revising prohibited acts related to the
    9         distribution of prescription drugs; conforming a
   10         cross-reference; amending s. 499.0051, F.S.;
   11         prohibiting the distribution of prescription drugs
   12         without delivering a transaction history, transaction
   13         information, and transaction statement; providing
   14         penalties; deleting provisions and revising
   15         terminology related to pedigree papers, to conform to
   16         changes made by the act; amending s. 499.006, F.S.;
   17         conforming provisions; amending s. 499.01, F.S.;
   18         requiring nonresident prescription drug repackagers to
   19         obtain an operating permit; authorizing a manufacturer
   20         to engage in the wholesale distribution of
   21         prescription drugs; providing for the issuance of
   22         virtual prescription drug manufacturer permits and
   23         virtual nonresident prescription drug manufacturer
   24         permits to certain persons; providing exceptions from
   25         certain virtual manufacturer requirements; requiring a
   26         nonresident prescription drug repackager permit for
   27         certain persons; deleting surety bond requirements for
   28         prescription drug wholesale distributors; requiring
   29         that certain persons obtain an out-of-state
   30         prescription drug wholesale distributor permit;
   31         providing that a restricted prescription drug
   32         distributor permit is not required for distributions
   33         between certain pharmacies; requiring the Department
   34         of Business and Professional Regulation to establish
   35         by rule when such distribution constitutes regular and
   36         systematic supplying of a prescription drug; requiring
   37         certain third party logistic providers to be licensed;
   38         requiring research and development labeling on certain
   39         prescription drug active pharmaceutical ingredient
   40         packaging; requiring certain manufacturers to create
   41         and maintain certain records; requiring certain
   42         prescription drug distributors to provide certain
   43         information to health care entities for which they
   44         repackage prescription drugs; requiring the department
   45         to adopt rules concerning repackaged prescription drug
   46         safety and integrity; amending s. 499.012, F.S.;
   47         providing for issuance of a prescription drug
   48         manufacturer permit or retail pharmacy drug wholesale
   49         distributor permit when an applicant at the same
   50         address is a licensed nuclear pharmacy or community
   51         pharmacy; providing for the expiration of deficient
   52         permit applications; requiring trade secret
   53         information submitted by an applicant to be maintained
   54         as a trade secret; authorizing the quadrennial renewal
   55         of permits; providing for calculation of fees for such
   56         permit renewals; revising procedures and application
   57         requirements for permit renewals; providing for late
   58         renewal fees; allowing a permittee who submits a
   59         renewal application to continue operations; removing
   60         certain application requirements for renewal of a
   61         permit; requiring bonds or other surety of a specified
   62         amount; requiring proof of inspection of
   63         establishments used in wholesale distribution;
   64         authorizing the Department of Business and
   65         Professional Regulation to contract for the collection
   66         of electronic fingerprints under certain
   67         circumstances; providing information that may be
   68         submitted in lieu of certain application requirements
   69         for specified permits and certifications; removing
   70         provisions relating to annual renewal and expiration
   71         of permits; conforming cross-references; amending s.
   72         499.01201, F.S.; conforming provisions; amending s.
   73         499.0121, F.S.; revising prescription drug
   74         recordkeeping requirements; specifying recordkeeping
   75         requirements for manufacturers and repackagers of
   76         medical devices, over-the-counter drugs, and
   77         cosmetics; increasing the quantity of unit doses of a
   78         controlled substance that may be ordered in any given
   79         month by a customer without triggering a requirement
   80         that a wholesale distributor perform a reasonableness
   81         assessment; conforming provisions; amending s.
   82         499.015, F.S.; providing for the expiration, renewal,
   83         and issuance of certain drug, device, and cosmetic
   84         product registrations; providing for product
   85         registration fees; amending ss. 499.03, 499.05, and
   86         499.051, F.S.; conforming provisions to changes made
   87         by the act; amending s. 499.066, F.S.; authorizing the
   88         issuance of nondisciplinary citations; authorizing the
   89         department to adopt rules designating violations for
   90         which a citation may be issued; authorizing the
   91         department to recover investigative costs pursuant to
   92         the citation; specifying a time limitation for
   93         issuance of a citation; providing for service of a
   94         citation; amending s. 499.82, F.S.; revising the
   95         definition of “wholesale distribution” for purposes of
   96         medical gas requirements; amending s. 499.89, F.S.;
   97         conforming provisions; repealing s. 499.01212, F.S.,
   98         relating to pedigree papers; amending ss. 409.9201,
   99         499.067, 794.075, and 921.0022, F.S.; conforming
  100         cross-references; providing an effective date.
  101          
  102  Be It Enacted by the Legislature of the State of Florida:
  103  
  104         Section 1. Section 499.003, Florida Statutes, is amended to
  105  read:
  106         499.003 Definitions of terms used in this part.—As used in
  107  this part, the term:
  108         (1)“Active pharmaceutical ingredient” includes any
  109  substance or mixture of substances intended, represented, or
  110  labeled for use in drug manufacturing that furnishes or is
  111  intended to furnish, in a finished dosage form, any
  112  pharmacological activity or other direct effect in the
  113  diagnosis, cure, mitigation, treatment, therapy, or prevention
  114  of disease in humans or other animals, or to affect the
  115  structure or any function of the body of humans or animals.
  116         (2)(1) “Advertisement” means any representation
  117  disseminated in any manner or by any means, other than by
  118  labeling, for the purpose of inducing, or which is likely to
  119  induce, directly or indirectly, the purchase of drugs, devices,
  120  or cosmetics.
  121         (3)“Affiliate” means a business entity that has a
  122  relationship with another business entity in which, directly or
  123  indirectly:
  124         (a)The business entity controls, or has the power to
  125  control, the other business entity; or
  126         (b)A third party controls, or has the power to control,
  127  both business entities.
  128         (2)“Affiliated group” means an affiliated group as defined
  129  by s. 1504 of the Internal Revenue Code of 1986, as amended,
  130  which is composed of chain drug entities, including at least 50
  131  retail pharmacies, warehouses, or repackagers, which are members
  132  of the same affiliated group. The affiliated group must disclose
  133  the names of all its members to the department.
  134         (4)(3) “Affiliated party” means:
  135         (a) A director, officer, trustee, partner, or committee
  136  member of a permittee or applicant or a subsidiary or service
  137  corporation of the permittee or applicant;
  138         (b) A person who, directly or indirectly, manages,
  139  controls, or oversees the operation of a permittee or applicant,
  140  regardless of whether such person is a partner, shareholder,
  141  manager, member, officer, director, independent contractor, or
  142  employee of the permittee or applicant;
  143         (c) A person who has filed or is required to file a
  144  personal information statement pursuant to s. 499.012(9) or is
  145  required to be identified in an application for a permit or to
  146  renew a permit pursuant to s. 499.012(8); or
  147         (d) The five largest natural shareholders that own at least
  148  5 percent of the permittee or applicant.
  149         (5)(4) “Applicant” means a person applying for a permit or
  150  certification under this part.
  151         (5)“Authenticate” means to affirmatively verify upon
  152  receipt of a prescription drug that each transaction listed on
  153  the pedigree paper has occurred.
  154         (a)A wholesale distributor is not required to open a
  155  sealed, medical convenience kit to authenticate a pedigree paper
  156  for a prescription drug contained within the kit.
  157         (b)Authentication of a prescription drug included in a
  158  sealed, medical convenience kit shall be limited to verifying
  159  the transaction and pedigree information received.
  160         (6) “Certificate of free sale” means a document prepared by
  161  the department which certifies a drug, device, or cosmetic, that
  162  is registered with the department, as one that can be legally
  163  sold in the state.
  164         (7) “Chain pharmacy warehouse” means a wholesale
  165  distributor permitted pursuant to s. 499.01 that maintains a
  166  physical location for prescription drugs that functions solely
  167  as a central warehouse to perform intracompany transfers of such
  168  drugs between members of an affiliate to a member of its
  169  affiliated group.
  170         (8) “Closed pharmacy” means a pharmacy that is licensed
  171  under chapter 465 and purchases prescription drugs for use by a
  172  limited patient population and not for wholesale distribution or
  173  sale to the public. The term does not include retail pharmacies.
  174         (9) “Color” includes black, white, and intermediate grays.
  175         (10) “Color additive” means, with the exception of any
  176  material that has been or hereafter is exempt under the federal
  177  act, a material that:
  178         (a) Is a dye pigment, or other substance, made by a process
  179  of synthesis or similar artifice, or extracted, isolated, or
  180  otherwise derived, with or without intermediate or final change
  181  of identity from a vegetable, animal, mineral, or other source;
  182  or
  183         (b) When added or applied to a drug or cosmetic or to the
  184  human body, or any part thereof, is capable alone, or through
  185  reaction with other substances, of imparting color thereto.
  186         (11) “Contraband prescription drug” means any adulterated
  187  drug, as defined in s. 499.006, any counterfeit drug, as defined
  188  in this section, and also means any prescription drug for which
  189  a transaction history, transaction information, or transaction
  190  statement pedigree paper does not exist, or for which the
  191  transaction history, transaction information, or transaction
  192  statement pedigree paper in existence has been forged,
  193  counterfeited, falsely created, or contains any altered, false,
  194  or misrepresented matter.
  195         (12) “Cosmetic” means an article, with the exception of
  196  soap, that is:
  197         (a) Intended to be rubbed, poured, sprinkled, or sprayed
  198  on; introduced into; or otherwise applied to the human body or
  199  any part thereof for cleansing, beautifying, promoting
  200  attractiveness, or altering the appearance; or
  201         (b) Intended for use as a component of any such article.
  202         (13) “Counterfeit drug,” “counterfeit device,” or
  203  “counterfeit cosmetic” means a drug, device, or cosmetic which,
  204  or the container, seal, or labeling of which, without
  205  authorization, bears the trademark, trade name, or other
  206  identifying mark, imprint, or device, or any likeness thereof,
  207  of a drug, device, or cosmetic manufacturer, processor, packer,
  208  or distributor other than the person that in fact manufactured,
  209  processed, packed, or distributed that drug, device, or cosmetic
  210  and which thereby falsely purports or is represented to be the
  211  product of, or to have been packed or distributed by, that other
  212  drug, device, or cosmetic manufacturer, processor, packer, or
  213  distributor.
  214         (14) “Department” means the Department of Business and
  215  Professional Regulation.
  216         (15) “Device” means any instrument, apparatus, implement,
  217  machine, contrivance, implant, in vitro reagent, or other
  218  similar or related article, including its components, parts, or
  219  accessories, which is:
  220         (a) Recognized in the current edition of the United States
  221  Pharmacopoeia and National Formulary, or any supplement thereof,
  222         (b) Intended for use in the diagnosis, cure, mitigation,
  223  treatment, therapy, or prevention of disease in humans or other
  224  animals, or
  225         (c) Intended to affect the structure or any function of the
  226  body of humans or other animals,
  227  
  228  and that does not achieve any of its principal intended purposes
  229  through chemical action within or on the body of humans or other
  230  animals and which is not dependent upon being metabolized for
  231  the achievement of any of its principal intended purposes.
  232         (16) “Distribute” or “distribution” means to sell,
  233  purchase, trade, deliver, handle, store, or receive to sell;
  234  offer to sell; give away; transfer, whether by passage of title,
  235  physical movement, or both; deliver; or offer to deliver. The
  236  term does not mean to administer or dispense and does not
  237  include the billing and invoicing activities that commonly
  238  follow a wholesale distribution transaction.
  239         (17)“Drop shipment” means the sale of a prescription drug
  240  from a manufacturer to a wholesale distributor, where the
  241  wholesale distributor takes title to, but not possession of, the
  242  prescription drug, and the manufacturer of the prescription drug
  243  ships the prescription drug directly to a chain pharmacy
  244  warehouse or a person authorized by law to purchase prescription
  245  drugs for the purpose of administering or dispensing the drug,
  246  as defined in s. 465.003.
  247         (17)(18) “Drug” means an article that is:
  248         (a) Recognized in the current edition of the United States
  249  Pharmacopoeia and National Formulary, official Homeopathic
  250  Pharmacopoeia of the United States, or any supplement to any of
  251  those publications;
  252         (b) Intended for use in the diagnosis, cure, mitigation,
  253  treatment, therapy, or prevention of disease in humans or other
  254  animals;
  255         (c) Intended to affect the structure or any function of the
  256  body of humans or other animals; or
  257         (d) Intended for use as a component of any article
  258  specified in paragraph (a), paragraph (b), or paragraph (c), and
  259  includes active pharmaceutical ingredients, but does not include
  260  devices or their nondrug components, parts, or accessories. For
  261  purposes of this paragraph, an “active pharmaceutical
  262  ingredient” includes any substance or mixture of substances
  263  intended, represented, or labeled for use in drug manufacturing
  264  that furnishes or is intended to furnish, in a finished dosage
  265  form, any pharmacological activity or other direct effect in the
  266  diagnosis, cure, mitigation, treatment, therapy, or prevention
  267  of disease in humans or other animals, or to affect the
  268  structure or any function of the body of humans or other
  269  animals.
  270         (18)(19) “Establishment” means a place of business which is
  271  at one general physical location and may extend to one or more
  272  contiguous suites, units, floors, or buildings operated and
  273  controlled exclusively by entities under common operation and
  274  control. Where multiple buildings are under common exclusive
  275  ownership, operation, and control, an intervening thoroughfare
  276  does not affect the contiguous nature of the buildings. For
  277  purposes of permitting, each suite, unit, floor, or building
  278  must be identified in the most recent permit application.
  279         (19)(20) “Federal act” means the Federal Food, Drug, and
  280  Cosmetic Act, 21 U.S.C. ss. 301 et seq.; 52 Stat. 1040 et seq.
  281         (20)(21) “Freight forwarder” means a person who receives
  282  prescription drugs which are owned by another person and
  283  designated by that person for export, and exports those
  284  prescription drugs.
  285         (21)(22) “Health care entity” means a closed pharmacy or
  286  any person, organization, or business entity that provides
  287  diagnostic, medical, surgical, or dental treatment or care, or
  288  chronic or rehabilitative care, but does not include any
  289  wholesale distributor or retail pharmacy licensed under state
  290  law to deal in prescription drugs. However, a blood
  291  establishment is a health care entity that may engage in the
  292  wholesale distribution of prescription drugs under s.
  293  499.01(2)(h)1.c. 499.01(2)(g)1.c.
  294         (22)(23) “Health care facility” means a health care
  295  facility licensed under chapter 395.
  296         (23)(24) “Hospice” means a corporation licensed under part
  297  IV of chapter 400.
  298         (24)(25) “Hospital” means a facility as defined in s.
  299  395.002 and licensed under chapter 395.
  300         (25)(26) “Immediate container” does not include package
  301  liners.
  302         (26)(27) “Label” means a display of written, printed, or
  303  graphic matter upon the immediate container of any drug, device,
  304  or cosmetic. A requirement made by or under authority of this
  305  part or rules adopted under this part that any word, statement,
  306  or other information appear on the label is not complied with
  307  unless such word, statement, or other information also appears
  308  on the outside container or wrapper, if any, of the retail
  309  package of such drug, device, or cosmetic or is easily legible
  310  through the outside container or wrapper.
  311         (27)(28) “Labeling” means all labels and other written,
  312  printed, or graphic matters:
  313         (a) Upon a drug, device, or cosmetic, or any of its
  314  containers or wrappers; or
  315         (b) Accompanying or related to such drug, device, or
  316  cosmetic.
  317         (28)(29) “Manufacture” means the preparation, deriving,
  318  compounding, propagation, processing, producing, or fabrication
  319  of any drug, device, or cosmetic.
  320         (29)(30) “Manufacturer” means:
  321         (a) A person who holds a New Drug Application, an
  322  Abbreviated New Drug Application, a Biologics License
  323  Application, or a New Animal Drug Application approved under the
  324  federal act or a license issued under s. 351 of the Public
  325  Health Service Act, 42 U.S.C. s. 262, for such drug or
  326  biologics, or if such drug or biologics are not the subject of
  327  an approved application or license, the person who manufactured
  328  the drug or biologics prepares, derives, manufactures, or
  329  produces a drug, device, or cosmetic;
  330         (b) A co-licensed partner of the person described in
  331  paragraph (a) who obtains the drug or biologics directly from a
  332  person described in paragraph (a), paragraph (c), or this
  333  paragraph The holder or holders of a New Drug Application (NDA),
  334  an Abbreviated New Drug Application (ANDA), a Biologics License
  335  Application (BLA), or a New Animal Drug Application (NADA),
  336  provided such application has become effective or is otherwise
  337  approved consistent with s. 499.023;
  338         (c) An affiliate of a person described in paragraph (a),
  339  paragraph (b), or this paragraph that receives the drug or
  340  biologics directly from a person described in paragraph (a),
  341  paragraph (b), or this paragraph A private label distributor for
  342  whom the private label distributor’s prescription drugs are
  343  originally manufactured and labeled for the distributor and have
  344  not been repackaged; or
  345         (d) A person who manufactures a device or a cosmetic. A
  346  person registered under the federal act as a manufacturer of a
  347  prescription drug, who is described in paragraph (a), paragraph
  348  (b), or paragraph (c), who has entered into a written agreement
  349  with another prescription drug manufacturer that authorizes
  350  either manufacturer to distribute the prescription drug
  351  identified in the agreement as the manufacturer of that drug
  352  consistent with the federal act and its implementing
  353  regulations;
  354         (e)A member of an affiliated group that includes, but is
  355  not limited to, persons described in paragraph (a), paragraph
  356  (b), paragraph (c), or paragraph (d), which member distributes
  357  prescription drugs, whether or not obtaining title to the drugs,
  358  only for the manufacturer of the drugs who is also a member of
  359  the affiliated group. As used in this paragraph, the term
  360  “affiliated group” means an affiliated group as defined in s.
  361  1504 of the Internal Revenue Code of 1986, as amended. The
  362  manufacturer must disclose the names of all of its affiliated
  363  group members to the department; or
  364         (f)A person permitted as a third party logistics provider,
  365  only while providing warehousing, distribution, or other
  366  logistics services on behalf of a person described in paragraph
  367  (a), paragraph (b), paragraph (c), paragraph (d), or paragraph
  368  (e).
  369  
  370  The term does not include a pharmacy that is operating in
  371  compliance with pharmacy practice standards as defined in
  372  chapter 465 and rules adopted under that chapter.
  373         (30)(31) “Medical convenience kit” means packages or units
  374  that contain combination products as defined in 21 C.F.R. s.
  375  3.2(e)(2).
  376         (31)(32) “Medical gas” means any liquefied or vaporized gas
  377  that is a prescription drug, whether alone or in combination
  378  with other gases, and as defined in the federal act.
  379         (32)(33) “New drug” means:
  380         (a) Any drug the composition of which is such that the drug
  381  is not generally recognized, among experts qualified by
  382  scientific training and experience to evaluate the safety and
  383  effectiveness of drugs, as safe and effective for use under the
  384  conditions prescribed, recommended, or suggested in the labeling
  385  of that drug; or
  386         (b) Any drug the composition of which is such that the
  387  drug, as a result of investigations to determine its safety and
  388  effectiveness for use under certain conditions, has been
  389  recognized for use under such conditions, but which drug has
  390  not, other than in those investigations, been used to a material
  391  extent or for a material time under such conditions.
  392         (34)“Normal distribution chain” means a wholesale
  393  distribution of a prescription drug in which the wholesale
  394  distributor or its wholly owned subsidiary purchases and
  395  receives the specific unit of the prescription drug directly
  396  from the manufacturer and distributes the prescription drug
  397  directly, or through up to two intracompany transfers, to a
  398  chain pharmacy warehouse or a person authorized by law to
  399  purchase prescription drugs for the purpose of administering or
  400  dispensing the drug, as defined in s. 465.003. For purposes of
  401  this subsection, the term “intracompany” means any transaction
  402  or transfer between any parent, division, or subsidiary wholly
  403  owned by a corporate entity.
  404         (33)(35) “Nursing home” means a facility licensed under
  405  part II of chapter 400.
  406         (34)(36) “Official compendium” means the current edition of
  407  the official United States Pharmacopoeia and National Formulary,
  408  or any supplement thereto.
  409         (37)“Pedigree paper” means a document in written or
  410  electronic form approved by the department which contains
  411  information required by s. 499.01212 regarding the sale and
  412  distribution of any given prescription drug.
  413         (35)(38) “Permittee” means any person holding a permit
  414  issued under this chapter pursuant to s. 499.012.
  415         (36)(39) “Person” means any individual, child, joint
  416  venture, syndicate, fiduciary, partnership, corporation,
  417  division of a corporation, firm, trust, business trust, company,
  418  estate, public or private institution, association,
  419  organization, group, city, county, city and county, political
  420  subdivision of this state, other governmental agency within this
  421  state, and any representative, agent, or agency of any of the
  422  foregoing, or any other group or combination of the foregoing.
  423         (37)(40) “Pharmacist” means a person licensed under chapter
  424  465.
  425         (38)(41) “Pharmacy” means an entity licensed under chapter
  426  465.
  427         (39)(42) “Prepackaged drug product” means a drug that
  428  originally was in finished packaged form sealed by a
  429  manufacturer and that is placed in a properly labeled container
  430  by a pharmacy or practitioner authorized to dispense pursuant to
  431  chapter 465 for the purpose of dispensing in the establishment
  432  in which the prepackaging occurred.
  433         (40)(43) “Prescription drug” means a prescription,
  434  medicinal, or legend drug, including, but not limited to,
  435  finished dosage forms or active pharmaceutical ingredients
  436  subject to, defined by, or described by s. 503(b) of the federal
  437  act or s. 465.003(8), s. 499.007(13), subsection (31) (32), or
  438  subsection (47) (52), except that an active pharmaceutical
  439  ingredient is a prescription drug only if substantially all
  440  finished dosage forms in which it may be lawfully dispensed or
  441  administered in this state are also prescription drugs.
  442         (41)(44) “Prescription drug label” means any display of
  443  written, printed, or graphic matter upon the immediate container
  444  of any prescription drug before it is dispensed prior to its
  445  dispensing to an individual patient pursuant to a prescription
  446  of a practitioner authorized by law to prescribe.
  447         (42)(45) “Prescription label” means any display of written,
  448  printed, or graphic matter upon the immediate container of any
  449  prescription drug dispensed pursuant to a prescription of a
  450  practitioner authorized by law to prescribe.
  451         (46)“Primary wholesale distributor” means any wholesale
  452  distributor that:
  453         (a)Purchased 90 percent or more of the total dollar volume
  454  of its purchases of prescription drugs directly from
  455  manufacturers in the previous year; and
  456         (b)1.Directly purchased prescription drugs from not fewer
  457  than 50 different prescription drug manufacturers in the
  458  previous year; or
  459         2.Has, or the affiliated group, as defined in s. 1504 of
  460  the Internal Revenue Code, of which the wholesale distributor is
  461  a member has, not fewer than 250 employees.
  462         (c)For purposes of this subsection, “directly from
  463  manufacturers” means:
  464         1.Purchases made by the wholesale distributor directly
  465  from the manufacturer of prescription drugs; and
  466         2.Transfers from a member of an affiliated group, as
  467  defined in s. 1504 of the Internal Revenue Code, of which the
  468  wholesale distributor is a member, if:
  469         a.The affiliated group purchases 90 percent or more of the
  470  total dollar volume of its purchases of prescription drugs from
  471  the manufacturer in the previous year; and
  472         b.The wholesale distributor discloses to the department
  473  the names of all members of the affiliated group of which the
  474  wholesale distributor is a member and the affiliated group
  475  agrees in writing to provide records on prescription drug
  476  purchases by the members of the affiliated group not later than
  477  48 hours after the department requests access to such records,
  478  regardless of the location where the records are stored.
  479         (43)(47) “Proprietary drug,” or “OTC drug,” means a patent
  480  or over-the-counter drug in its unbroken, original package,
  481  which drug is sold to the public by, or under the authority of,
  482  the manufacturer or primary distributor thereof, is not
  483  misbranded under the provisions of this part, and can be
  484  purchased without a prescription.
  485         (44)(48) “Repackage” includes repacking or otherwise
  486  changing the container, wrapper, or labeling to further the
  487  distribution of the drug, device, or cosmetic.
  488         (45)(49) “Repackager” means a person who repackages. The
  489  term excludes pharmacies that are operating in compliance with
  490  pharmacy practice standards as defined in chapter 465 and rules
  491  adopted under that chapter.
  492         (46)(50) “Retail pharmacy” means a community pharmacy
  493  licensed under chapter 465 that purchases prescription drugs at
  494  fair market prices and provides prescription services to the
  495  public.
  496         (51)“Secondary wholesale distributor” means a wholesale
  497  distributor that is not a primary wholesale distributor.
  498         (47)(52) “Veterinary prescription drug” means a
  499  prescription drug intended solely for veterinary use. The label
  500  of the drug must bear the statement, “Caution: Federal law
  501  restricts this drug to sale by or on the order of a licensed
  502  veterinarian.”
  503         (48)(53) “Wholesale distribution” means the distribution of
  504  a prescription drug to a person drugs to persons other than a
  505  consumer or patient, or the receipt of a prescription drug by a
  506  person other than the consumer or patient, but does not include:
  507         (a) Any of the following activities, which is not a
  508  violation of s. 499.005(21) if such activity is conducted in
  509  accordance with s. 499.01(2)(h) 499.01(2)(g):
  510         1. The purchase or other acquisition by a hospital or other
  511  health care entity that is a member of a group purchasing
  512  organization of a prescription drug for its own use from the
  513  group purchasing organization or from other hospitals or health
  514  care entities that are members of that organization.
  515         2. The distribution sale, purchase, or trade of a
  516  prescription drug or an offer to distribute sell, purchase, or
  517  trade a prescription drug by a charitable organization described
  518  in s. 501(c)(3) of the Internal Revenue Code of 1986, as amended
  519  and revised, to a nonprofit affiliate of the organization to the
  520  extent otherwise permitted by law.
  521         3. The distribution sale, purchase, or trade of a
  522  prescription drug or an offer to sell, purchase, or trade a
  523  prescription drug among hospitals or other health care entities
  524  that are under common control. For purposes of this
  525  subparagraph, “common control” means the power to direct or
  526  cause the direction of the management and policies of a person
  527  or an organization, whether by ownership of stock, by voting
  528  rights, by contract, or otherwise.
  529         4. The distribution sale, purchase, trade, or other
  530  transfer of a prescription drug from or for any federal, state,
  531  or local government agency or any entity eligible to purchase
  532  prescription drugs at public health services prices pursuant to
  533  Pub. L. No. 102-585, s. 602 to a contract provider or its
  534  subcontractor for eligible patients of the agency or entity
  535  under the following conditions:
  536         a. The agency or entity must obtain written authorization
  537  for the distribution sale, purchase, trade, or other transfer of
  538  a prescription drug under this subparagraph from the Secretary
  539  of Business and Professional Regulation or his or her designee.
  540         b. The contract provider or subcontractor must be
  541  authorized by law to administer or dispense prescription drugs.
  542         c. In the case of a subcontractor, the agency or entity
  543  must be a party to and execute the subcontract.
  544         d. The contract provider and subcontractor must maintain
  545  and produce immediately for inspection all records of movement
  546  or transfer of all the prescription drugs belonging to the
  547  agency or entity, including, but not limited to, the records of
  548  receipt and disposition of prescription drugs. Each contractor
  549  and subcontractor dispensing or administering these drugs must
  550  maintain and produce records documenting the dispensing or
  551  administration. Records that are required to be maintained
  552  include, but are not limited to, a perpetual inventory itemizing
  553  drugs received and drugs dispensed by prescription number or
  554  administered by patient identifier, which must be submitted to
  555  the agency or entity quarterly.
  556         e. The contract provider or subcontractor may administer or
  557  dispense the prescription drugs only to the eligible patients of
  558  the agency or entity or must return the prescription drugs for
  559  or to the agency or entity. The contract provider or
  560  subcontractor must require proof from each person seeking to
  561  fill a prescription or obtain treatment that the person is an
  562  eligible patient of the agency or entity and must, at a minimum,
  563  maintain a copy of this proof as part of the records of the
  564  contractor or subcontractor required under sub-subparagraph d.
  565         f. In addition to the departmental inspection authority set
  566  forth in s. 499.051, the establishment of the contract provider
  567  and subcontractor and all records pertaining to prescription
  568  drugs subject to this subparagraph shall be subject to
  569  inspection by the agency or entity. All records relating to
  570  prescription drugs of a manufacturer under this subparagraph
  571  shall be subject to audit by the manufacturer of those drugs,
  572  without identifying individual patient information.
  573         (b) Any of the following activities, which is not a
  574  violation of s. 499.005(21) if such activity is conducted in
  575  accordance with rules established by the department:
  576         1. The distribution sale, purchase, or trade of a
  577  prescription drug among federal, state, or local government
  578  health care entities that are under common control and are
  579  authorized to purchase such prescription drug.
  580         2. The distribution sale, purchase, or trade of a
  581  prescription drug or an offer to distribute sell, purchase, or
  582  trade a prescription drug for emergency medical reasons, which
  583  may include. For purposes of this subparagraph, The term
  584  “emergency medical reasons” includes transfers of prescription
  585  drugs by a retail pharmacy to another retail pharmacy to
  586  alleviate a temporary shortage. For purposes of this
  587  subparagraph, a drug shortage not caused by a public health
  588  emergency does not constitute an emergency medical reason.
  589         3. The distribution transfer of a prescription drug
  590  acquired by a medical director on behalf of a licensed emergency
  591  medical services provider to that emergency medical services
  592  provider and its transport vehicles for use in accordance with
  593  the provider’s license under chapter 401.
  594         4.The revocation of a sale or the return of a prescription
  595  drug to the person’s prescription drug wholesale supplier.
  596         4.5. The donation of a prescription drug by a health care
  597  entity to a charitable organization that has been granted an
  598  exemption under s. 501(c)(3) of the Internal Revenue Code of
  599  1986, as amended, and that is authorized to possess prescription
  600  drugs.
  601         5.6. The distribution transfer of a prescription drug by a
  602  person authorized to purchase or receive prescription drugs to a
  603  person licensed or permitted to handle reverse distributions or
  604  destruction under the laws of the jurisdiction in which the
  605  person handling the reverse distribution or destruction receives
  606  the drug.
  607         6.7. The distribution transfer of a prescription drug by a
  608  hospital or other health care entity to a person licensed under
  609  this part to repackage prescription drugs for the purpose of
  610  repackaging the prescription drug for use by that hospital, or
  611  other health care entity and other health care entities that are
  612  under common control, if ownership of the prescription drugs
  613  remains with the hospital or other health care entity at all
  614  times. In addition to the recordkeeping requirements of s.
  615  499.0121(6), the hospital or health care entity that distributes
  616  transfers prescription drugs pursuant to this subparagraph must
  617  reconcile all drugs distributed transferred and returned and
  618  resolve any discrepancies in a timely manner.
  619         (c)Intracompany distribution of any drug between members
  620  of an affiliate or within a manufacturer.
  621         (d)The distribution of a prescription drug by the
  622  manufacturer of the prescription drug.
  623         (e)(c) The distribution of prescription drug samples by
  624  manufacturers’ representatives or distributors’ representatives
  625  conducted in accordance with s. 499.028.
  626         (f)The distribution of a prescription drug by a third
  627  party logistics provider permitted or licensed pursuant to and
  628  operating in compliance with the laws of this state and federal
  629  law if such third-party logistics provider does not take
  630  ownership of the prescription drug.
  631         (g)The distribution of a prescription drug, or an offer to
  632  distribute a prescription drug by a repackager registered as a
  633  drug establishment with the United States Food and Drug
  634  Administration that has taken ownership or possession of the
  635  prescription drug and repacks it in accordance with this part.
  636         (h)The purchase or other acquisition by a dispenser,
  637  hospital, or other health care entity of a prescription drug for
  638  use by such dispenser, hospital, or other health care entity.
  639         (i)The distribution of a prescription drug by a hospital
  640  or other health care entity, or by a wholesale distributor or
  641  manufacturer operating at the direction of the hospital or other
  642  health care entity, to a repackager for the purpose of
  643  repackaging the prescription drug for use by that hospital, or
  644  other health care entity and other health care entities that are
  645  under common control, if ownership of the prescription drug
  646  remains with the hospital or other health care entity at all
  647  times.
  648         (j)(d) The distribution sale, purchase, or trade of blood
  649  and blood components intended for transfusion. As used in this
  650  paragraph, the term “blood” means whole blood collected from a
  651  single donor and processed for transfusion or further
  652  manufacturing, and the term “blood components” means that part
  653  of the blood separated by physical or mechanical means.
  654         (k)(e) The lawful dispensing of a prescription drug in
  655  accordance with chapter 465.
  656         (l)(f) The distribution sale, purchase, or trade of a
  657  prescription drug between pharmacies as a result of a sale,
  658  transfer, merger, or consolidation of all or part of the
  659  business of the pharmacies from or with another pharmacy,
  660  whether accomplished as a purchase and sale of stock or of
  661  business assets.
  662         (m)The distribution of minimal quantities of prescription
  663  drugs by a licensed retail pharmacy to a licensed practitioner
  664  for office use in compliance with chapter 465 and rules adopted
  665  thereunder. The department shall adopt rules specifying the
  666  quantities of prescription drugs which are considered to be
  667  minimal quantities. However, until such rules are adopted,
  668  minimal quantities distributed may not exceed 3 percent of the
  669  retail pharmacy’s total annual purchases of prescription drugs.
  670         (n)The distribution of an intravenous prescription drug
  671  that, by its formulation, is intended for the replenishment of
  672  fluids and electrolytes, such as sodium, chloride, and potassium
  673  or calories, such as dextrose and amino acids.
  674         (o)The distribution of an intravenous prescription drug
  675  used to maintain the equilibrium of water and minerals in the
  676  body, such as dialysis solutions.
  677         (p)The distribution of a prescription drug that is
  678  intended for irrigation or sterile water, whether intended for
  679  such purposes or for injection.
  680         (q)The distribution of an exempt medical convenience kit
  681  pursuant to 21 U.S.C. s. 353(e)(4)(M).
  682         (r)A common carrier that transports a prescription drug,
  683  if the common carrier does not take ownership of the
  684  prescription drug.
  685         (s)Saleable drug returns when conducted by a dispenser.
  686         (t)Facilitating the distribution of a prescription drug by
  687  providing solely administrative services, including processing
  688  of orders and payments.
  689         (u)The distribution by a charitable organization described
  690  in s. 501(c)(3) of the Internal Revenue Code of prescription
  691  drugs donated to or supplied at a reduced price to the
  692  charitable organization to:
  693         1.A licensed health care practitioner, as defined in s.
  694  456.001, who is authorized under the appropriate practice act to
  695  prescribe and administer prescription drugs;
  696         2.A health care clinic establishment permitted pursuant to
  697  chapter 499; or
  698         3.The Department of Health or the licensed medical
  699  director of a government agency health care entity, authorized
  700  to possess prescription drugs, for storage and use in the
  701  treatment of persons in need of emergency medical services,
  702  including controlling communicable diseases or providing
  703  protection from unsafe conditions that pose an imminent threat
  704  to public health,
  705  
  706  if the distributor and the receiving entity receive no direct or
  707  indirect financial benefit other than tax benefits related to
  708  charitable contributions. Distributions under this section that
  709  involve controlled substances must comply with all state and
  710  federal regulations pertaining to the handling of controlled
  711  substances.
  712         (v)The distribution of medical gas pursuant to part III of
  713  this chapter.
  714         (49)(54) “Wholesale distributor” means a any person, other
  715  than a manufacturer, a manufacturer’s co-licensed partner, a
  716  third-party logistics provider, or a repackager, who is engaged
  717  in wholesale distribution of prescription drugs in or into this
  718  state, including, but not limited to, manufacturers;
  719  repackagers; own-label distributors; jobbers; private-label
  720  distributors; brokers; warehouses, including manufacturers’ and
  721  distributors’ warehouses, chain drug warehouses, and wholesale
  722  drug warehouses; independent wholesale drug traders; exporters;
  723  retail pharmacies; and the agents thereof that conduct wholesale
  724  distributions.
  725         Section 2. Subsections (21), (28), and (29) of section
  726  499.005, Florida Statutes, are amended to read:
  727         499.005 Prohibited acts.—It is unlawful for a person to
  728  perform or cause the performance of any of the following acts in
  729  this state:
  730         (21) The wholesale distribution of any prescription drug
  731  that was:
  732         (a) Purchased by a public or private hospital or other
  733  health care entity; or
  734         (b) Donated or supplied at a reduced price to a charitable
  735  organization,
  736  
  737  unless the wholesale distribution of the prescription drug is
  738  authorized in s. 499.01(2)(h)1.c. 499.01(2)(g)1.c.
  739         (28) Failure to acquire or deliver a transaction history,
  740  transaction information, or transaction statement pedigree paper
  741  as required under this part and rules adopted under this part.
  742         (29)The receipt of a prescription drug pursuant to a
  743  wholesale distribution without having previously received or
  744  simultaneously receiving a pedigree paper that was attested to
  745  as accurate and complete by the wholesale distributor as
  746  required under this part.
  747         Section 3. Subsections (4) through (17) of section
  748  499.0051, Florida Statutes, are renumbered as subsections (3)
  749  through (16), respectively, and subsections (1) and (2), present
  750  subsection (3), paragraphs (h) and (i) of present subsection
  751  (12), paragraph (d) of present subsection (13), and present
  752  subsection (15) of that section are amended, to read:
  753         499.0051 Criminal acts.—
  754         (1) FAILURE TO MAINTAIN OR DELIVER TRANSACTION HISTORY,
  755  TRANSACTION INFORMATION, OR TRANSACTION STATEMENT PEDIGREE
  756  PAPERS.—
  757         (a) A person, other than a manufacturer, engaged in the
  758  wholesale distribution of prescription drugs who fails to
  759  deliver to another person a complete and accurate transaction
  760  history, transaction information, or transaction statement
  761  pedigree papers concerning a prescription drug or contraband
  762  prescription drug, as required by this chapter and rules adopted
  763  under this chapter, before prior to, or simultaneous with, the
  764  transfer of the prescription drug or contraband prescription
  765  drug to another person commits a felony of the third degree,
  766  punishable as provided in s. 775.082, s. 775.083, or s. 775.084.
  767         (b) A person engaged in the wholesale distribution of
  768  prescription drugs who fails to acquire a complete and accurate
  769  transaction history, transaction information, or transaction
  770  statement pedigree papers concerning a prescription drug or
  771  contraband prescription drug, as required by this chapter and
  772  rules adopted under this chapter, before prior to, or
  773  simultaneous with, the receipt of the prescription drug or
  774  contraband prescription drug from another person commits a
  775  felony of the third degree, punishable as provided in s.
  776  775.082, s. 775.083, or s. 775.084.
  777         (c) Any person who knowingly destroys, alters, conceals, or
  778  fails to maintain a complete and accurate transaction history,
  779  transaction information, or transaction statement pedigree
  780  papers concerning any prescription drug or contraband
  781  prescription drug, as required by this chapter and rules adopted
  782  under this chapter, in his or her possession commits a felony of
  783  the third degree, punishable as provided in s. 775.082, s.
  784  775.083, or s. 775.084.
  785         (2)FAILURE TO AUTHENTICATE PEDIGREE PAPERS.—Effective July
  786  1, 2006:
  787         (a)A person engaged in the wholesale distribution of
  788  prescription drugs who is in possession of pedigree papers
  789  concerning prescription drugs or contraband prescription drugs
  790  and who fails to authenticate the matters contained in the
  791  pedigree papers and who nevertheless attempts to further
  792  distribute prescription drugs or contraband prescription drugs
  793  commits a felony of the third degree, punishable as provided in
  794  s. 775.082, s. 775.083, or s. 775.084.
  795         (b)A person in possession of pedigree papers concerning
  796  prescription drugs or contraband prescription drugs who falsely
  797  swears or certifies that he or she has authenticated the matters
  798  contained in the pedigree papers commits a felony of the third
  799  degree, punishable as provided in s. 775.082, s. 775.083, or s.
  800  775.084.
  801         (2)(3) KNOWING FORGERY OF TRANSACTION HISTORY, TRANSACTION
  802  INFORMATION, OR TRANSACTION STATEMENT PEDIGREE PAPERS.—A person
  803  who knowingly forges, counterfeits, or falsely creates any
  804  transaction history, transaction information, or transaction
  805  statement pedigree paper; who falsely represents any factual
  806  matter contained on any transaction history, transaction
  807  information, or transaction statement pedigree paper; or who
  808  knowingly omits to record material information required to be
  809  recorded in a transaction history, transaction information, or
  810  transaction statement pedigree paper, commits a felony of the
  811  second degree, punishable as provided in s. 775.082, s. 775.083,
  812  or s. 775.084.
  813         (11)(12) ADULTERATED AND MISBRANDED DRUGS; FALSE
  814  ADVERTISEMENT; FAILURE TO MAINTAIN RECORDS RELATING TO DRUGS.
  815  Any person who violates any of the following provisions commits
  816  a misdemeanor of the second degree, punishable as provided in s.
  817  775.082 or s. 775.083; but, if the violation is committed after
  818  a conviction of such person under this subsection has become
  819  final, such person commits a misdemeanor of the first degree,
  820  punishable as provided in s. 775.082 or s. 775.083, or as
  821  otherwise provided in this part:
  822         (h) The failure to maintain records related to a drug as
  823  required by this part and rules adopted under this part, except
  824  for transaction histories, transaction information, or
  825  transaction statements pedigree papers, invoices, or shipping
  826  documents related to prescription drugs.
  827         (i) The possession of any drug in violation of this part,
  828  except if the violation relates to a deficiency in transaction
  829  histories, transaction information, or transaction statements
  830  pedigree papers.
  831         (12)(13) REFUSAL TO ALLOW INSPECTION; SELLING, PURCHASING,
  832  OR TRADING DRUG SAMPLES; FAILURE TO MAINTAIN RECORDS RELATING TO
  833  PRESCRIPTION DRUGS.—Any person who violates any of the following
  834  provisions commits a felony of the third degree, punishable as
  835  provided in s. 775.082, s. 775.083, or s. 775.084, or as
  836  otherwise provided in this part:
  837         (d) The failure to receive, maintain, or provide invoices
  838  and shipping documents, other than pedigree papers, if
  839  applicable, related to the distribution of a prescription drug.
  840         (15) FALSE ADVERTISEMENT.—A publisher, radio broadcast
  841  licensee, or agency or medium for the dissemination of an
  842  advertisement, except the manufacturer, repackager, wholesale
  843  distributor, or seller of the article to which a false
  844  advertisement relates, is not liable under subsection (11) (12),
  845  subsection (12) (13), or subsection (13) (14) by reason of the
  846  dissemination by him or her of such false advertisement, unless
  847  he or she has refused, on the request of the department, to
  848  furnish to the department the name and post office address of
  849  the manufacturer, repackager, wholesale distributor, seller, or
  850  advertising agency that asked him or her to disseminate such
  851  advertisement.
  852         Section 4. Section 499.006, Florida Statutes, is amended to
  853  read:
  854         499.006 Adulterated drug or device.—A drug or device is
  855  adulterated, if any of the following apply:
  856         (1) If It consists in whole or in part of any filthy,
  857  putrid, or decomposed substance.;
  858         (2) If It has been produced, prepared, packed, or held
  859  under conditions whereby it could have been contaminated with
  860  filth or rendered injurious to health.;
  861         (3) If It is a drug and the methods used in, or the
  862  facilities or controls used for, its manufacture, processing,
  863  packing, or holding do not conform to, or are not operated or
  864  administered in conformity with, current good manufacturing
  865  practices to assure that the drug meets the requirements of this
  866  part and that the drug has the identity and strength, and meets
  867  the standard of quality and purity, which it purports or is
  868  represented to possess.;
  869         (4) If It is a drug and its container is composed, in whole
  870  or in part, of any poisonous or deleterious substance which
  871  could render the contents injurious to health.;
  872         (5) If It is a drug and it bears or contains, for the
  873  purpose of coloring only, a color additive that is unsafe within
  874  the meaning of the federal act; or, if it is a color additive,
  875  the intended use of which in or on drugs is for the purpose of
  876  coloring only, and it is unsafe within the meaning of the
  877  federal act.;
  878         (6) If It purports to be, or is represented as, a drug the
  879  name of which is recognized in the official compendium, and its
  880  strength differs from, or its quality or purity falls below, the
  881  standard set forth in such compendium. The determination as to
  882  strength, quality, or purity must be made in accordance with the
  883  tests or methods of assay set forth in such compendium, or, when
  884  such tests or methods of assay are absent or inadequate, in
  885  accordance with those tests or methods of assay prescribed under
  886  authority of the federal act. A drug defined in the official
  887  compendium is not adulterated under this subsection merely
  888  because it differs from the standard of strength, quality, or
  889  purity set forth for that drug in such compendium if its
  890  difference in strength, quality, or purity from such standard is
  891  plainly stated on its label.;
  892         (7) If It is not subject to subsection (6) and its strength
  893  differs from, or its purity or quality falls below the standard
  894  of, that which it purports or is represented to possess.;
  895         (8) If It is a drug:
  896         (a) With which any substance has been mixed or packed so as
  897  to reduce the quality or strength of the drug; or
  898         (b) For which any substance has been substituted wholly or
  899  in part.;
  900         (9) If It is a drug or device for which the expiration date
  901  has passed.;
  902         (10) If It is a prescription drug for which the required
  903  transaction history, transaction information, or transaction
  904  statement pedigree paper is nonexistent, fraudulent, or
  905  incomplete under the requirements of this part or applicable
  906  rules, or that has been purchased, held, sold, or distributed at
  907  any time by a person not authorized under federal or state law
  908  to do so.; or
  909         (11) If It is a prescription drug subject to, defined by,
  910  or described by s. 503(b) of the Federal Food, Drug, and
  911  Cosmetic Act which has been returned by a veterinarian to a
  912  limited prescription drug veterinary wholesale distributor.
  913         Section 5. Section 499.01, Florida Statutes, is amended to
  914  read:
  915         499.01 Permits.—
  916         (1) Before Prior to operating, a permit is required for
  917  each person and establishment that intends to operate as:
  918         (a) A prescription drug manufacturer;
  919         (b) A prescription drug repackager;
  920         (c) A nonresident prescription drug manufacturer;
  921         (d)A nonresident prescription drug repackager;
  922         (e)(d) A prescription drug wholesale distributor;
  923         (f)(e) An out-of-state prescription drug wholesale
  924  distributor;
  925         (g)(f) A retail pharmacy drug wholesale distributor;
  926         (h)(g) A restricted prescription drug distributor;
  927         (i)(h) A complimentary drug distributor;
  928         (j)(i) A freight forwarder;
  929         (k)(j) A veterinary prescription drug retail establishment;
  930         (l)(k) A veterinary prescription drug wholesale
  931  distributor;
  932         (m)(l) A limited prescription drug veterinary wholesale
  933  distributor;
  934         (n)(m) An over-the-counter drug manufacturer;
  935         (o)(n) A device manufacturer;
  936         (p)(o) A cosmetic manufacturer;
  937         (q)(p) A third party logistics provider; or
  938         (r)(q) A health care clinic establishment.
  939         (2) The following permits are established:
  940         (a) Prescription drug manufacturer permit.—A prescription
  941  drug manufacturer permit is required for any person that is a
  942  manufacturer of a prescription drug and that manufactures or
  943  distributes such prescription drugs in this state.
  944         1. A person that operates an establishment permitted as a
  945  prescription drug manufacturer may engage in wholesale
  946  distribution of prescription drugs for which the person is the
  947  manufacturer manufactured at that establishment and must comply
  948  with s. 499.0121 and all other of the provisions of this part,
  949  except s. 499.01212, and the rules adopted under this part,
  950  except s. 499.01212, which apply to a wholesale distributor. The
  951  department shall adopt rules for issuing a virtual prescription
  952  drug manufacturer permit to a person who engages in the
  953  manufacture of prescription drugs but does not make or take
  954  physical possession of any prescription drugs. The rules adopted
  955  by the department under this section may exempt virtual
  956  manufacturers from certain establishment, security, and storage
  957  requirements set forth in s. 499.0121.
  958         2. A prescription drug manufacturer must comply with all
  959  appropriate state and federal good manufacturing practices.
  960         3. A blood establishment, as defined in s. 381.06014,
  961  operating in a manner consistent with the provisions of 21
  962  C.F.R. parts 211 and 600-640, and manufacturing only the
  963  prescription drugs described in s. 499.003(48)(j) 499.003(53)(d)
  964  is not required to be permitted as a prescription drug
  965  manufacturer under this paragraph or to register products under
  966  s. 499.015.
  967         (b) Prescription drug repackager permit.—A prescription
  968  drug repackager permit is required for any person that
  969  repackages a prescription drug in this state.
  970         1. A person that operates an establishment permitted as a
  971  prescription drug repackager may engage in wholesale
  972  distribution of prescription drugs repackaged at that
  973  establishment and must comply with all of the provisions of this
  974  part and the rules adopted under this part that apply to a
  975  prescription drug manufacturer wholesale distributor.
  976         2. A prescription drug repackager must comply with all
  977  appropriate state and federal good manufacturing practices.
  978         (c) Nonresident prescription drug manufacturer permit.—A
  979  nonresident prescription drug manufacturer permit is required
  980  for any person that is a manufacturer of prescription drugs,
  981  unless permitted as a third party logistics provider, located
  982  outside of this state or outside the United States and that
  983  engages in the wholesale distribution in this state of such
  984  prescription drugs. Each such manufacturer must be permitted by
  985  the department and comply with all of the provisions required of
  986  a prescription drug manufacturer wholesale distributor under
  987  this part, except s. 499.01212. The department shall adopt rules
  988  for issuing a virtual nonresident prescription drug manufacturer
  989  permit to a person who engages in the manufacture of
  990  prescription drugs but does not make or take physical possession
  991  of any prescription drugs. The rules adopted by the department
  992  under this section may exempt virtual nonresident manufacturers
  993  from certain establishment, security, and storage requirements
  994  set forth in s. 499.0121.
  995         1. A person that distributes prescription drugs for which
  996  the person is not the manufacturer must also obtain an out-of
  997  state prescription drug wholesale distributor permit or third
  998  party logistics provider permit pursuant to this section to
  999  engage in the wholesale distribution of such prescription drugs
 1000  when required by this part. This subparagraph does not apply to
 1001  a manufacturer that distributes prescription drugs only for the
 1002  manufacturer of the prescription drugs where both manufacturers
 1003  are affiliates as defined in s. 499.003(30)(e).
 1004         2. Any such person must comply with the licensing or
 1005  permitting requirements of the jurisdiction in which the
 1006  establishment is located and the federal act, and any
 1007  prescription drug distributed product wholesaled into this state
 1008  must comply with this part. If a person intends to import
 1009  prescription drugs from a foreign country into this state, the
 1010  nonresident prescription drug manufacturer must provide to the
 1011  department a list identifying each prescription drug it intends
 1012  to import and document approval by the United States Food and
 1013  Drug Administration for such importation.
 1014         (d)Nonresident prescription drug repackager permit.–A
 1015  nonresident prescription drug repackager permit is required for
 1016  any person located outside of this state, but within the United
 1017  States or its territories, that repackages prescription drugs
 1018  and engages in the distribution of such prescription drugs into
 1019  this state.
 1020         1.A nonresident prescription drug repackager must comply
 1021  with all of the provisions of this section and the rules adopted
 1022  under this section that apply to a prescription drug
 1023  manufacturer.
 1024         2.A nonresident prescription drug repackager must be
 1025  permitted by the department and comply with all appropriate
 1026  state and federal good manufacturing practices.
 1027         3.A nonresident prescription drug repackager must be
 1028  registered as a drug establishment with the United States Food
 1029  and Drug Administration.
 1030         (e)(d)Prescription drug wholesale distributor permit.—A
 1031  prescription drug wholesale distributor permit is required for
 1032  any person who is a wholesale distributor of prescription drugs
 1033  and that may engage in the wholesale distributes such
 1034  distribution of prescription drugs in this state. A prescription
 1035  drug wholesale distributor that applies to the department for a
 1036  new permit or the renewal of a permit must submit a bond of
 1037  $100,000, or other equivalent means of security acceptable to
 1038  the department, such as an irrevocable letter of credit or a
 1039  deposit in a trust account or financial institution, payable to
 1040  the Professional Regulation Trust Fund. The purpose of the bond
 1041  is to secure payment of any administrative penalties imposed by
 1042  the department and any fees and costs incurred by the department
 1043  regarding that permit which are authorized under state law and
 1044  which the permittee fails to pay 30 days after the fine or costs
 1045  become final. The department may make a claim against such bond
 1046  or security until 1 year after the permittee’s license ceases to
 1047  be valid or until 60 days after any administrative or legal
 1048  proceeding authorized in this part which involves the permittee
 1049  is concluded, including any appeal, whichever occurs later. The
 1050  department may adopt rules for issuing a prescription drug
 1051  wholesale distributor-broker permit to a person who engages in
 1052  the wholesale distribution of prescription drugs and does not
 1053  take physical possession of any prescription drugs.
 1054         (f)(e)Out-of-state prescription drug wholesale distributor
 1055  permit.—An out-of-state prescription drug wholesale distributor
 1056  permit is required for any person that is a wholesale
 1057  distributor located outside this state, but within the United
 1058  States or its territories, which engages in the wholesale
 1059  distribution of prescription drugs into this state and which
 1060  must be permitted by the department and comply with all the
 1061  provisions required of a wholesale distributor under this part.
 1062  An out-of-state prescription drug wholesale distributor that
 1063  applies to the department for a new permit or the renewal of a
 1064  permit must submit a bond of $100,000, or other equivalent means
 1065  of security acceptable to the department, such as an irrevocable
 1066  letter of credit or a deposit in a trust account or financial
 1067  institution, payable to the Professional Regulation Trust Fund.
 1068  The purpose of the bond is to secure payment of any
 1069  administrative penalties imposed by the department and any fees
 1070  and costs incurred by the department regarding that permit which
 1071  are authorized under state law and which the permittee fails to
 1072  pay 30 days after the fine or costs become final. The department
 1073  may make a claim against such bond or security until 1 year
 1074  after the permittee’s license ceases to be valid or until 60
 1075  days after any administrative or legal proceeding authorized in
 1076  this part which involves the permittee is concluded, including
 1077  any appeal, whichever occurs later. The out-of-state
 1078  prescription drug wholesale distributor must maintain at all
 1079  times a license or permit to engage in the wholesale
 1080  distribution of prescription drugs in compliance with laws of
 1081  the state in which it is a resident. If the state from which the
 1082  wholesale distributor distributes prescription drugs does not
 1083  require a license to engage in the wholesale distribution of
 1084  prescription drugs, the distributor must be licensed as a
 1085  wholesale distributor as required by the federal act.
 1086         (g)(f)Retail pharmacy drug wholesale distributor permit.—A
 1087  retail pharmacy drug wholesale distributor is a retail pharmacy
 1088  engaged in wholesale distribution of prescription drugs within
 1089  this state under the following conditions:
 1090         1. The pharmacy must obtain a retail pharmacy drug
 1091  wholesale distributor permit pursuant to this part and the rules
 1092  adopted under this part.
 1093         2. The wholesale distribution activity does not exceed 30
 1094  percent of the total annual purchases of prescription drugs. If
 1095  the wholesale distribution activity exceeds the 30-percent
 1096  maximum, the pharmacy must obtain a prescription drug wholesale
 1097  distributor permit.
 1098         3. The transfer of prescription drugs that appear in any
 1099  schedule contained in chapter 893 is subject to chapter 893 and
 1100  the federal Comprehensive Drug Abuse Prevention and Control Act
 1101  of 1970.
 1102         4. The transfer is between a retail pharmacy and another
 1103  retail pharmacy, or a Modified Class II institutional pharmacy,
 1104  or a health care practitioner licensed in this state and
 1105  authorized by law to dispense or prescribe prescription drugs.
 1106         5. All records of sales of prescription drugs subject to
 1107  this section must be maintained separate and distinct from other
 1108  records and comply with the recordkeeping requirements of this
 1109  part.
 1110         (h)(g)Restricted prescription drug distributor permit.—
 1111         1. A restricted prescription drug distributor permit is
 1112  required for:
 1113         a. Any person located in this state who engages in the
 1114  distribution of a prescription drug, which distribution is not
 1115  considered “wholesale distribution” under s. 499.003(48)(a)
 1116  499.003(53)(a).
 1117         b. Any person located in this state who engages in the
 1118  receipt or distribution of a prescription drug in this state for
 1119  the purpose of processing its return or its destruction if such
 1120  person is not the person initiating the return, the prescription
 1121  drug wholesale supplier of the person initiating the return, or
 1122  the manufacturer of the drug.
 1123         c. A blood establishment located in this state which
 1124  collects blood and blood components only from volunteer donors
 1125  as defined in s. 381.06014 or pursuant to an authorized
 1126  practitioner’s order for medical treatment or therapy and
 1127  engages in the wholesale distribution of a prescription drug not
 1128  described in s. 499.003(48)(j) 499.003(53)(d) to a health care
 1129  entity. A mobile blood unit operated by a blood establishment
 1130  permitted under this sub-subparagraph is not required to be
 1131  separately permitted. The health care entity receiving a
 1132  prescription drug distributed under this sub-subparagraph must
 1133  be licensed as a closed pharmacy or provide health care services
 1134  at that establishment. The blood establishment must operate in
 1135  accordance with s. 381.06014 and may distribute only:
 1136         (I) Prescription drugs indicated for a bleeding or clotting
 1137  disorder or anemia;
 1138         (II) Blood-collection containers approved under s. 505 of
 1139  the federal act;
 1140         (III) Drugs that are blood derivatives, or a recombinant or
 1141  synthetic form of a blood derivative;
 1142         (IV) Prescription drugs that are identified in rules
 1143  adopted by the department and that are essential to services
 1144  performed or provided by blood establishments and authorized for
 1145  distribution by blood establishments under federal law; or
 1146         (V) To the extent authorized by federal law, drugs
 1147  necessary to collect blood or blood components from volunteer
 1148  blood donors; for blood establishment personnel to perform
 1149  therapeutic procedures under the direction and supervision of a
 1150  licensed physician; and to diagnose, treat, manage, and prevent
 1151  any reaction of a volunteer blood donor or a patient undergoing
 1152  a therapeutic procedure performed under the direction and
 1153  supervision of a licensed physician,
 1154  
 1155  as long as all of the health care services provided by the blood
 1156  establishment are related to its activities as a registered
 1157  blood establishment or the health care services consist of
 1158  collecting, processing, storing, or administering human
 1159  hematopoietic stem cells or progenitor cells or performing
 1160  diagnostic testing of specimens if such specimens are tested
 1161  together with specimens undergoing routine donor testing. The
 1162  blood establishment may purchase and possess the drugs described
 1163  in this sub-subparagraph without a health care clinic
 1164  establishment permit.
 1165         2. Storage, handling, and recordkeeping of these
 1166  distributions by a person required to be permitted as a
 1167  restricted prescription drug distributor must be in accordance
 1168  with the requirements for wholesale distributors under s.
 1169  499.0121, but not those set forth in s. 499.01212 if the
 1170  distribution occurs pursuant to sub-subparagraph 1.a. or sub
 1171  subparagraph 1.b.
 1172         3. A person who applies for a permit as a restricted
 1173  prescription drug distributor, or for the renewal of such a
 1174  permit, must provide to the department the information required
 1175  under s. 499.012.
 1176         4. The department may adopt rules regarding the
 1177  distribution of prescription drugs by hospitals, health care
 1178  entities, charitable organizations, other persons not involved
 1179  in wholesale distribution, and blood establishments, which rules
 1180  are necessary for the protection of the public health, safety,
 1181  and welfare.
 1182         5.A restricted prescription drug distributor permit is not
 1183  required for distributions between pharmacies that each hold an
 1184  active permit under chapter 465, have a common ownership, and
 1185  are operating in a freestanding end-stage renal dialysis clinic,
 1186  if such distributions are made to meet the immediate emergency
 1187  medical needs of specifically identified patients and do not
 1188  occur with such frequency as to amount to the regular and
 1189  systematic supplying of that drug between the pharmacies. The
 1190  department shall adopt rules establishing when the distribution
 1191  of a prescription drug under this subparagraph amounts to the
 1192  regular and systematic supplying of that drug.
 1193         (i)(h)Complimentary drug distributor permit.—A
 1194  complimentary drug distributor permit is required for any person
 1195  that engages in the distribution of a complimentary drug,
 1196  subject to the requirements of s. 499.028.
 1197         (j)(i)Freight forwarder permit.—A freight forwarder permit
 1198  is required for any person that engages in the distribution of a
 1199  prescription drug as a freight forwarder unless the person is a
 1200  common carrier. The storage, handling, and recordkeeping of such
 1201  distributions must comply with the requirements for wholesale
 1202  distributors under s. 499.0121, but not those set forth in s.
 1203  499.01212. A freight forwarder must provide the source of the
 1204  prescription drugs with a validated airway bill, bill of lading,
 1205  or other appropriate documentation to evidence the exportation
 1206  of the product.
 1207         (k)(j)Veterinary prescription drug retail establishment
 1208  permit.—A veterinary prescription drug retail establishment
 1209  permit is required for any person that sells veterinary
 1210  prescription drugs to the public but does not include a pharmacy
 1211  licensed under chapter 465.
 1212         1. The sale to the public must be based on a valid written
 1213  order from a veterinarian licensed in this state who has a valid
 1214  client-veterinarian relationship with the purchaser’s animal.
 1215         2. Veterinary prescription drugs may not be sold in excess
 1216  of the amount clearly indicated on the order or beyond the date
 1217  indicated on the order.
 1218         3. An order may not be valid for more than 1 year.
 1219         4. A veterinary prescription drug retail establishment may
 1220  not purchase, sell, trade, or possess human prescription drugs
 1221  or any controlled substance as defined in chapter 893.
 1222         5. A veterinary prescription drug retail establishment must
 1223  sell a veterinary prescription drug in the original, sealed
 1224  manufacturer’s container with all labeling intact and legible.
 1225  The department may adopt by rule additional labeling
 1226  requirements for the sale of a veterinary prescription drug.
 1227         6. A veterinary prescription drug retail establishment must
 1228  comply with all of the wholesale distribution requirements of s.
 1229  499.0121.
 1230         7. Prescription drugs sold by a veterinary prescription
 1231  drug retail establishment pursuant to a practitioner’s order may
 1232  not be returned into the retail establishment’s inventory.
 1233         (l)(k)Veterinary prescription drug wholesale distributor
 1234  permit.—A veterinary prescription drug wholesale distributor
 1235  permit is required for any person that engages in the
 1236  distribution of veterinary prescription drugs in or into this
 1237  state. A veterinary prescription drug wholesale distributor that
 1238  also distributes prescription drugs subject to, defined by, or
 1239  described by s. 503(b) of the Federal Food, Drug, and Cosmetic
 1240  Act which it did not manufacture must obtain a permit as a
 1241  prescription drug wholesale distributor, an out-of-state
 1242  prescription drug wholesale distributor, or a limited
 1243  prescription drug veterinary wholesale distributor in lieu of
 1244  the veterinary prescription drug wholesale distributor permit. A
 1245  veterinary prescription drug wholesale distributor must comply
 1246  with the requirements for wholesale distributors under s.
 1247  499.0121, but not those set forth in s. 499.01212.
 1248         (m)(l)Limited prescription drug veterinary wholesale
 1249  distributor permit.—Unless engaging in the activities of and
 1250  permitted as a prescription drug manufacturer, nonresident
 1251  prescription drug manufacturer, prescription drug wholesale
 1252  distributor, or out-of-state prescription drug wholesale
 1253  distributor, a limited prescription drug veterinary wholesale
 1254  distributor permit is required for any person that engages in
 1255  the distribution in or into this state of veterinary
 1256  prescription drugs and prescription drugs subject to, defined
 1257  by, or described by s. 503(b) of the Federal Food, Drug, and
 1258  Cosmetic Act under the following conditions:
 1259         1. The person is engaged in the business of wholesaling
 1260  prescription and veterinary prescription drugs to persons:
 1261         a. Licensed as veterinarians practicing on a full-time
 1262  basis;
 1263         b. Regularly and lawfully engaged in instruction in
 1264  veterinary medicine;
 1265         c. Regularly and lawfully engaged in law enforcement
 1266  activities;
 1267         d. For use in research not involving clinical use; or
 1268         e. For use in chemical analysis or physical testing or for
 1269  purposes of instruction in law enforcement activities, research,
 1270  or testing.
 1271         2. No more than 30 percent of total annual prescription
 1272  drug sales may be prescription drugs approved for human use
 1273  which are subject to, defined by, or described by s. 503(b) of
 1274  the Federal Food, Drug, and Cosmetic Act.
 1275         3. The person does not distribute in any jurisdiction
 1276  prescription drugs subject to, defined by, or described by s.
 1277  503(b) of the Federal Food, Drug, and Cosmetic Act to any person
 1278  who is authorized to sell, distribute, purchase, trade, or use
 1279  these drugs on or for humans.
 1280         4. A limited prescription drug veterinary wholesale
 1281  distributor that applies to the department for a new permit or
 1282  the renewal of a permit must submit a bond of $20,000, or other
 1283  equivalent means of security acceptable to the department, such
 1284  as an irrevocable letter of credit or a deposit in a trust
 1285  account or financial institution, payable to the Professional
 1286  Regulation Trust Fund. The purpose of the bond is to secure
 1287  payment of any administrative penalties imposed by the
 1288  department and any fees and costs incurred by the department
 1289  regarding that permit which are authorized under state law and
 1290  which the permittee fails to pay 30 days after the fine or costs
 1291  become final. The department may make a claim against such bond
 1292  or security until 1 year after the permittee’s license ceases to
 1293  be valid or until 60 days after any administrative or legal
 1294  proceeding authorized in this part which involves the permittee
 1295  is concluded, including any appeal, whichever occurs later.
 1296         5. A limited prescription drug veterinary wholesale
 1297  distributor must maintain at all times a license or permit to
 1298  engage in the wholesale distribution of prescription drugs in
 1299  compliance with laws of the state in which it is a resident.
 1300         6. A limited prescription drug veterinary wholesale
 1301  distributor must comply with the requirements for wholesale
 1302  distributors under s. ss. 499.0121 and 499.01212, except that a
 1303  limited prescription drug veterinary wholesale distributor is
 1304  not required to provide a pedigree paper as required by s.
 1305  499.01212 upon the wholesale distribution of a prescription drug
 1306  to a veterinarian.
 1307         7. A limited prescription drug veterinary wholesale
 1308  distributor may not return to inventory for subsequent wholesale
 1309  distribution any prescription drug subject to, defined by, or
 1310  described by s. 503(b) of the Federal Food, Drug, and Cosmetic
 1311  Act which has been returned by a veterinarian.
 1312         8. A limited prescription drug veterinary wholesale
 1313  distributor permit is not required for an intracompany sale or
 1314  transfer of a prescription drug from an out-of-state
 1315  establishment that is duly licensed to engage in the wholesale
 1316  distribution of prescription drugs in its state of residence to
 1317  a licensed limited prescription drug veterinary wholesale
 1318  distributor in this state if both wholesale distributors conduct
 1319  wholesale distributions of prescription drugs under the same
 1320  business name. The recordkeeping requirements of s. ss.
 1321  499.0121(6) and 499.01212 must be followed for this transaction.
 1322         (n)(m)Over-the-counter drug manufacturer permit.—An over
 1323  the-counter drug manufacturer permit is required for any person
 1324  that engages in the manufacture or repackaging of an over-the
 1325  counter drug.
 1326         1. An over-the-counter drug manufacturer may not possess or
 1327  purchase prescription drugs.
 1328         2. A pharmacy is exempt from obtaining an over-the-counter
 1329  drug manufacturer permit if it is operating in compliance with
 1330  pharmacy practice standards as defined in chapter 465 and the
 1331  rules adopted under that chapter.
 1332         3. An over-the-counter drug manufacturer must comply with
 1333  all appropriate state and federal good manufacturing practices.
 1334         (o)(n)Device manufacturer permit.—
 1335         1. A device manufacturer permit is required for any person
 1336  that engages in the manufacture, repackaging, or assembly of
 1337  medical devices for human use in this state, except that a
 1338  permit is not required if:
 1339         a. The person is engaged only in manufacturing,
 1340  repackaging, or assembling a medical device pursuant to a
 1341  practitioner’s order for a specific patient; or
 1342         b. The person does not manufacture, repackage, or assemble
 1343  any medical devices or components for such devices, except those
 1344  devices or components which are exempt from registration
 1345  pursuant to s. 499.015(8).
 1346         2. A manufacturer or repackager of medical devices in this
 1347  state must comply with all appropriate state and federal good
 1348  manufacturing practices and quality system rules.
 1349         3. The department shall adopt rules related to storage,
 1350  handling, and recordkeeping requirements for manufacturers of
 1351  medical devices for human use.
 1352         (p)(o)Cosmetic manufacturer permit.—A cosmetic
 1353  manufacturer permit is required for any person that manufactures
 1354  or repackages cosmetics in this state. A person that only labels
 1355  or changes the labeling of a cosmetic but does not open the
 1356  container sealed by the manufacturer of the product is exempt
 1357  from obtaining a permit under this paragraph.
 1358         (q)(p)Third party logistics provider permit.—A third party
 1359  logistics provider permit is required for any person that
 1360  contracts with a prescription drug wholesale distributor or
 1361  prescription drug manufacturer to provide warehousing,
 1362  distribution, or other logistics services on behalf of a
 1363  manufacturer, or wholesale distributor, or dispenser, but who
 1364  does not take title to the prescription drug or have
 1365  responsibility to direct the sale or disposition of the
 1366  prescription drug. A third party logistics provider located
 1367  outside of this state, must be licensed in the state or
 1368  territory from which the prescription drug is distributed by the
 1369  third party logistics provider. If the state or territory from
 1370  which the third party logistics provider originates does not
 1371  require a license to operate as a third party logistics
 1372  provider, the third party logistics provider must be licensed as
 1373  a third party logistics provider as required by the federal act.
 1374  Each third party logistics provider permittee shall comply with
 1375  s. the requirements for wholesale distributors under ss.
 1376  499.0121 and 499.01212, with the exception of those wholesale
 1377  distributions described in s. 499.01212(3)(a), and other rules
 1378  that the department requires.
 1379         (r)(q)Health care clinic establishment permit.Effective
 1380  January 1, 2009, A health care clinic establishment permit is
 1381  required for the purchase of a prescription drug by a place of
 1382  business at one general physical location that provides health
 1383  care or veterinary services, which is owned and operated by a
 1384  business entity that has been issued a federal employer tax
 1385  identification number. For the purpose of this paragraph, the
 1386  term “qualifying practitioner” means a licensed health care
 1387  practitioner defined in s. 456.001, or a veterinarian licensed
 1388  under chapter 474, who is authorized under the appropriate
 1389  practice act to prescribe and administer a prescription drug.
 1390         1. An establishment must provide, as part of the
 1391  application required under s. 499.012, designation of a
 1392  qualifying practitioner who will be responsible for complying
 1393  with all legal and regulatory requirements related to the
 1394  purchase, recordkeeping, storage, and handling of the
 1395  prescription drugs. In addition, the designated qualifying
 1396  practitioner shall be the practitioner whose name, establishment
 1397  address, and license number is used on all distribution
 1398  documents for prescription drugs purchased or returned by the
 1399  health care clinic establishment. Upon initial appointment of a
 1400  qualifying practitioner, the qualifying practitioner and the
 1401  health care clinic establishment shall notify the department on
 1402  a form furnished by the department within 10 days after such
 1403  employment. In addition, the qualifying practitioner and health
 1404  care clinic establishment shall notify the department within 10
 1405  days after any subsequent change.
 1406         2. The health care clinic establishment must employ a
 1407  qualifying practitioner at each establishment.
 1408         3. In addition to the remedies and penalties provided in
 1409  this part, a violation of this chapter by the health care clinic
 1410  establishment or qualifying practitioner constitutes grounds for
 1411  discipline of the qualifying practitioner by the appropriate
 1412  regulatory board.
 1413         4. The purchase of prescription drugs by the health care
 1414  clinic establishment is prohibited during any period of time
 1415  when the establishment does not comply with this paragraph.
 1416         5. A health care clinic establishment permit is not a
 1417  pharmacy permit or otherwise subject to chapter 465. A health
 1418  care clinic establishment that meets the criteria of a modified
 1419  Class II institutional pharmacy under s. 465.019 is not eligible
 1420  to be permitted under this paragraph.
 1421         6. This paragraph does not apply to the purchase of a
 1422  prescription drug by a licensed practitioner under his or her
 1423  license.
 1424         (3) A nonresident prescription drug manufacturer permit is
 1425  not required for a manufacturer to distribute a prescription
 1426  drug active pharmaceutical ingredient that it manufactures to a
 1427  prescription drug manufacturer permitted in this state in
 1428  limited quantities intended for research and development and not
 1429  for resale or human use other than lawful clinical trials and
 1430  biostudies authorized and regulated by federal law. A
 1431  manufacturer claiming to be exempt from the permit requirements
 1432  of this subsection and the prescription drug manufacturer
 1433  purchasing and receiving the active pharmaceutical ingredient
 1434  shall comply with the recordkeeping requirements of s.
 1435  499.0121(6), but not the requirements of s. 499.01212. The
 1436  prescription drug manufacturer purchasing and receiving the
 1437  active pharmaceutical ingredient shall maintain on file a record
 1438  of the FDA registration number; if available, the out-of-state
 1439  license, permit, or registration number; and, if available, a
 1440  copy of the most current FDA inspection report, for all
 1441  manufacturers from whom they purchase active pharmaceutical
 1442  ingredients under this section. The department shall define the
 1443  term “limited quantities” by rule, and may include the allowable
 1444  number of transactions within a given period of time and the
 1445  amount of prescription drugs distributed into the state for
 1446  purposes of this exemption. The failure to comply with the
 1447  requirements of this subsection, or rules adopted by the
 1448  department to administer this subsection, for the purchase of
 1449  prescription drug active pharmaceutical ingredients is a
 1450  violation of s. 499.005(14), and a knowing failure is a
 1451  violation of s. 499.0051(3) 499.0051(4).
 1452         (a)The immediate package or container of a prescription
 1453  drug active pharmaceutical ingredient distributed into the state
 1454  that is intended for research and development under this
 1455  subsection shall bear a label prominently displaying the
 1456  statement: “Caution: Research and Development Only—Not for
 1457  Manufacturing, Compounding, or Resale.”
 1458         (b)A prescription drug manufacturer that obtains a
 1459  prescription drug active pharmaceutical ingredient under this
 1460  subsection for use in clinical trials and or biostudies
 1461  authorized and regulated by federal law must create and maintain
 1462  records detailing the specific clinical trials or biostudies for
 1463  which the prescription drug active pharmaceutical ingredient was
 1464  obtained.
 1465         (4)(a) A permit issued under this part is not required to
 1466  distribute a prescription drug active pharmaceutical ingredient
 1467  from an establishment located in the United States to an
 1468  establishment located in this state permitted as a prescription
 1469  drug manufacturer under this part for use by the recipient in
 1470  preparing, deriving, processing, producing, or fabricating a
 1471  prescription drug finished dosage form at the establishment in
 1472  this state where the product is received under an approved and
 1473  otherwise valid New Drug Approval Application, Abbreviated New
 1474  Drug Application, New Animal Drug Application, or Therapeutic
 1475  Biologic Application, provided that the application, active
 1476  pharmaceutical ingredient, or finished dosage form has not been
 1477  withdrawn or removed from the market in this country for public
 1478  health reasons.
 1479         1. Any distributor claiming exemption from permitting
 1480  requirements pursuant to this paragraph shall maintain a
 1481  license, permit, or registration to engage in the wholesale
 1482  distribution of prescription drugs under the laws of the state
 1483  from which the product is distributed. If the state from which
 1484  the prescription drugs are distributed does not require a
 1485  license to engage in the wholesale distribution of prescription
 1486  drugs, the distributor must be licensed as a wholesale
 1487  distributor as required by the federal act.
 1488         2. Any distributor claiming exemption from permitting
 1489  requirements pursuant to this paragraph and the prescription
 1490  drug manufacturer purchasing and receiving the active
 1491  pharmaceutical ingredient shall comply with the recordkeeping
 1492  requirements of s. 499.0121(6), but not the requirements of s.
 1493  499.01212.
 1494         (b) A permit issued under this part is not required to
 1495  distribute limited quantities of a prescription drug that has
 1496  not been repackaged from an establishment located in the United
 1497  States to an establishment located in this state permitted as a
 1498  prescription drug manufacturer under this part for research and
 1499  development or to a holder of a letter of exemption issued by
 1500  the department under s. 499.03(4) for research, teaching, or
 1501  testing. The department shall define “limited quantities” by
 1502  rule and may include the allowable number of transactions within
 1503  a given period of time and the amounts of prescription drugs
 1504  distributed into the state for purposes of this exemption.
 1505         1. Any distributor claiming exemption from permitting
 1506  requirements pursuant to this paragraph shall maintain a
 1507  license, permit, or registration to engage in the wholesale
 1508  distribution of prescription drugs under the laws of the state
 1509  from which the product is distributed. If the state from which
 1510  the prescription drugs are distributed does not require a
 1511  license to engage in the wholesale distribution of prescription
 1512  drugs, the distributor must be licensed as a wholesale
 1513  distributor as required by the federal act.
 1514         2. All purchasers and recipients of any prescription drugs
 1515  distributed pursuant to this paragraph shall ensure that the
 1516  products are not resold or used, directly or indirectly, on
 1517  humans except in lawful clinical trials and biostudies
 1518  authorized and regulated by federal law.
 1519         3. Any distributor claiming exemption from permitting
 1520  requirements pursuant to this paragraph, and the purchaser and
 1521  recipient of the prescription drug, shall comply with the
 1522  recordkeeping requirements of s. 499.0121(6), but not the
 1523  requirements of s. 499.01212.
 1524         4. The immediate package or container of any active
 1525  pharmaceutical ingredient distributed into the state that is
 1526  intended for teaching, testing, research, and development shall
 1527  bear a label prominently displaying the statement: “Caution:
 1528  Research, Teaching, or Testing Only – Not for Manufacturing,
 1529  Compounding, or Resale.”
 1530         (c) An out-of-state prescription drug wholesale distributor
 1531  permit is not required for an intracompany sale or transfer of a
 1532  prescription drug from an out-of-state establishment that is
 1533  duly licensed as a prescription drug wholesale distributor in
 1534  its state of residence to a licensed prescription drug wholesale
 1535  distributor in this state, if both wholesale distributors
 1536  conduct wholesale distributions of prescription drugs under the
 1537  same business name. The recordkeeping requirements of s. ss.
 1538  499.0121(6) and 499.01212 must be followed for such
 1539  transactions.
 1540         (d) Persons receiving prescription drugs from a source
 1541  claimed to be exempt from permitting requirements under this
 1542  subsection shall maintain on file:
 1543         1. A record of the FDA establishment registration number,
 1544  if any;
 1545         2. The resident state or federal license, registration, or
 1546  permit that authorizes the source to distribute prescription
 1547  drugs drug wholesale distribution license, permit, or
 1548  registration number; and
 1549         3. A copy of the most recent resident state or FDA
 1550  inspection report, for all distributors and establishments from
 1551  whom they purchase or receive prescription drugs under this
 1552  subsection.
 1553         (e) All persons claiming exemption from permitting
 1554  requirements pursuant to this subsection who engage in the
 1555  distribution of prescription drugs within or into the state are
 1556  subject to this part, including ss. 499.005 and 499.0051, and
 1557  shall make available, within 48 hours, to the department on
 1558  request all records related to any prescription drugs
 1559  distributed under this subsection, including those records
 1560  described in s. 499.051(4), regardless of the location where the
 1561  records are stored.
 1562         (f) A person purchasing and receiving a prescription drug
 1563  from a person claimed to be exempt from licensing requirements
 1564  pursuant to this subsection shall report to the department in
 1565  writing within 14 days after receiving any product that is
 1566  misbranded or adulterated or that fails to meet minimum
 1567  standards set forth in the official compendium or state or
 1568  federal good manufacturing practices for identity, purity,
 1569  potency, or sterility, regardless of whether the product is
 1570  thereafter rehabilitated, quarantined, returned, or destroyed.
 1571         (g) The department may adopt rules to administer this
 1572  subsection which are necessary for the protection of the public
 1573  health, safety, and welfare. Failure to comply with the
 1574  requirements of this subsection, or rules adopted by the
 1575  department to administer this subsection, is a violation of s.
 1576  499.005(14), and a knowing failure is a violation of s.
 1577  499.0051(3) 499.0051(4).
 1578         (h) This subsection does not relieve any person from any
 1579  requirement prescribed by law with respect to controlled
 1580  substances as defined in the applicable federal and state laws.
 1581         (5) A prescription drug repackager permit issued under this
 1582  part is not required for a restricted prescription drug
 1583  distributor permitholder that is a health care entity to
 1584  repackage prescription drugs in this state for its own use or
 1585  for distribution to hospitals or other health care entities in
 1586  the state for their own use, pursuant to s. 499.003(48)(a)3.
 1587  499.003(53)(a)3., if:
 1588         (a) The prescription drug distributor notifies the
 1589  department, in writing, of its intention to engage in
 1590  repackaging under this exemption, 30 days before engaging in the
 1591  repackaging of prescription drugs at the permitted
 1592  establishment;
 1593         (b) The prescription drug distributor is under common
 1594  control with the hospitals or other health care entities to
 1595  which the prescription drug distributor is distributing
 1596  prescription drugs. As used in this paragraph, “common control”
 1597  means the power to direct or cause the direction of the
 1598  management and policies of a person or an organization, whether
 1599  by ownership of stock, voting rights, contract, or otherwise;
 1600         (c) The prescription drug distributor repackages the
 1601  prescription drugs in accordance with current state and federal
 1602  good manufacturing practices; and
 1603         (d) The prescription drug distributor labels the
 1604  prescription drug it repackages in accordance with state and
 1605  federal laws and rules.
 1606  
 1607  The prescription drug distributor is exempt from the product
 1608  registration requirements of s. 499.015 with regard to the
 1609  prescription drugs that it repackages and distributes under this
 1610  subsection. A prescription drug distributor that repackages and
 1611  distributes prescription drugs under this subsection to a not
 1612  for-profit rural hospital, as defined in s. 395.602, is not
 1613  required to comply with paragraph (c) or paragraph (d), but must
 1614  provide to each health care entity for which it repackages, for
 1615  each prescription drug that is repackaged and distributed, the
 1616  information required by department rule for labeling
 1617  prescription drugs. The department shall adopt rules to ensure
 1618  the safety and integrity of prescription drugs repackaged and
 1619  distributed under this subsection, including rules regarding
 1620  prescription drug manufacturing and labeling requirements.
 1621         Section 6. Section 499.012, Florida Statutes, is amended to
 1622  read:
 1623         499.012 Permit application requirements.—
 1624         (1)(a) A permit issued pursuant to this part may be issued
 1625  only to a natural person who is at least 18 years of age or to
 1626  an applicant that is not a natural person if each person who,
 1627  directly or indirectly, manages, controls, or oversees the
 1628  operation of that applicant is at least 18 years of age.
 1629         (b) An establishment that is a place of residence may not
 1630  receive a permit and may not operate under this part.
 1631         (c) A person that applies for or renews a permit to
 1632  manufacture or distribute prescription drugs may not use a name
 1633  identical to the name used by any other establishment or
 1634  licensed person authorized to purchase prescription drugs in
 1635  this state, except that a restricted drug distributor permit
 1636  issued to a health care entity will be issued in the name in
 1637  which the institutional pharmacy permit is issued and a retail
 1638  pharmacy drug wholesale distributor will be issued a permit in
 1639  the name of its retail pharmacy permit.
 1640         (d) A permit for a prescription drug manufacturer,
 1641  prescription drug repackager, prescription drug wholesale
 1642  distributor, limited prescription drug veterinary wholesale
 1643  distributor, or retail pharmacy drug wholesale distributor may
 1644  not be issued to the address of a health care entity or to a
 1645  pharmacy licensed under chapter 465, except as provided in this
 1646  paragraph. The department may issue a prescription drug
 1647  manufacturer permit to an applicant at the same address as a
 1648  licensed nuclear pharmacy, which is a health care entity, even
 1649  if the nuclear pharmacy holds a special sterile compounding
 1650  permit under chapter 465, for the purpose of manufacturing
 1651  prescription drugs used in positron emission tomography or other
 1652  radiopharmaceuticals, as listed in a rule adopted by the
 1653  department pursuant to this paragraph. The purpose of this
 1654  exemption is to assure availability of state-of-the-art
 1655  pharmaceuticals that would pose a significant danger to the
 1656  public health if manufactured at a separate establishment
 1657  address from the nuclear pharmacy from which the prescription
 1658  drugs are dispensed. The department may also issue a retail
 1659  pharmacy drug wholesale distributor permit to the address of a
 1660  community pharmacy licensed under chapter 465, even if the
 1661  community pharmacy holds a special sterile compounding permit
 1662  under chapter 465, as long as the community pharmacy which does
 1663  not meet the definition of a closed pharmacy in s. 499.003.
 1664         (e) A county or municipality may not issue an occupational
 1665  license for any licensing period beginning on or after October
 1666  1, 2003, for any establishment that requires a permit pursuant
 1667  to this part, unless the establishment exhibits a current permit
 1668  issued by the department for the establishment. Upon
 1669  presentation of the requisite permit issued by the department,
 1670  an occupational license may be issued by the municipality or
 1671  county in which application is made. The department shall
 1672  furnish to local agencies responsible for issuing occupational
 1673  licenses a current list of all establishments licensed pursuant
 1674  to this part.
 1675         (2) Notwithstanding subsection (6), a permitted person in
 1676  good standing may change the type of permit issued to that
 1677  person by completing a new application for the requested permit,
 1678  paying the amount of the difference in the permit fees if the
 1679  fee for the new permit is more than the fee for the original
 1680  permit, and meeting the applicable permitting conditions for the
 1681  new permit type. The new permit expires on the expiration date
 1682  of the original permit being changed; however, a new permit for
 1683  a prescription drug wholesale distributor, an out-of-state
 1684  prescription drug wholesale distributor, or a retail pharmacy
 1685  drug wholesale distributor shall expire on the expiration date
 1686  of the original permit or 1 year after the date of issuance of
 1687  the new permit, whichever is earlier. A refund may not be issued
 1688  if the fee for the new permit is less than the fee that was paid
 1689  for the original permit.
 1690         (3)(a) A written application for a permit or to renew a
 1691  permit must be filed with the department on forms furnished by
 1692  the department. The department shall establish, by rule, the
 1693  form and content of the application to obtain or renew a permit.
 1694  The applicant must submit to the department with the application
 1695  a statement that swears or affirms that the information is true
 1696  and correct.
 1697         (b)Upon a determination that 2 years have elapsed since
 1698  the department notified an applicant for permit, certification,
 1699  or product registration of a deficiency in the application and
 1700  that the applicant has failed to cure the deficiency, the
 1701  application shall expire. The determination regarding the 2-year
 1702  lapse of time shall be based on documentation that the
 1703  department notified the applicant of the deficiency in
 1704  accordance with s. 120.60.
 1705         (c)Information submitted by an applicant on an application
 1706  required pursuant to this subsection which is a trade secret, as
 1707  defined in s. 812.081, shall be maintained by the department as
 1708  trade secret information pursuant to s. 499.051(7).
 1709         (4)(a) Except for a permit for a prescription drug
 1710  wholesale distributor or an out-of-state prescription drug
 1711  wholesale distributor, an application for a permit must include:
 1712         1. The name, full business address, and telephone number of
 1713  the applicant;
 1714         2. All trade or business names used by the applicant;
 1715         3. The address, telephone numbers, and the names of contact
 1716  persons for each facility used by the applicant for the storage,
 1717  handling, and distribution of prescription drugs;
 1718         4. The type of ownership or operation, such as a
 1719  partnership, corporation, or sole proprietorship; and
 1720         5. The names of the owner and the operator of the
 1721  establishment, including:
 1722         a. If an individual, the name of the individual;
 1723         b. If a partnership, the name of each partner and the name
 1724  of the partnership;
 1725         c. If a corporation, the name and title of each corporate
 1726  officer and director, the corporate names, and the name of the
 1727  state of incorporation;
 1728         d. If a sole proprietorship, the full name of the sole
 1729  proprietor and the name of the business entity;
 1730         e. If a limited liability company, the name of each member,
 1731  the name of each manager, the name of the limited liability
 1732  company, and the name of the state in which the limited
 1733  liability company was organized; and
 1734         f. Any other relevant information that the department
 1735  requires.
 1736         (b) Upon approval of the application by the department and
 1737  payment of the required fee, the department shall issue a permit
 1738  to the applicant, if the applicant meets the requirements of
 1739  this part and rules adopted under this part.
 1740         (c) Any change in information required under paragraph (a)
 1741  must be submitted to the department before the change occurs.
 1742         (d) The department shall consider, at a minimum, the
 1743  following factors in reviewing the qualifications of persons to
 1744  be permitted under this part:
 1745         1. The applicant’s having been found guilty, regardless of
 1746  adjudication, in a court of this state or other jurisdiction, of
 1747  a violation of a law that directly relates to a drug, device, or
 1748  cosmetic. A plea of nolo contendere constitutes a finding of
 1749  guilt for purposes of this subparagraph.
 1750         2. The applicant’s having been disciplined by a regulatory
 1751  agency in any state for any offense that would constitute a
 1752  violation of this part.
 1753         3. Any felony conviction of the applicant under a federal,
 1754  state, or local law;
 1755         4. The applicant’s past experience in manufacturing or
 1756  distributing drugs, devices, or cosmetics;
 1757         5. The furnishing by the applicant of false or fraudulent
 1758  material in any application made in connection with
 1759  manufacturing or distributing drugs, devices, or cosmetics;
 1760         6. Suspension or revocation by a federal, state, or local
 1761  government of any permit currently or previously held by the
 1762  applicant for the manufacture or distribution of any drugs,
 1763  devices, or cosmetics;
 1764         7. Compliance with permitting requirements under any
 1765  previously granted permits;
 1766         8. Compliance with requirements to maintain or make
 1767  available to the state permitting authority or to federal,
 1768  state, or local law enforcement officials those records required
 1769  under this section; and
 1770         9. Any other factors or qualifications the department
 1771  considers relevant to and consistent with the public health and
 1772  safety.
 1773         (5) Except for a permit for a prescription drug wholesale
 1774  distributor or an out-of-state prescription drug wholesale
 1775  distributor:
 1776         (a) The department shall adopt rules for the biennial
 1777  renewal of permits; however, the department may issue up to a 4
 1778  year permit to selected permittees notwithstanding any other
 1779  provision of law. Fees for such renewal may not exceed the fee
 1780  caps set forth in s. 499.041 on an annualized basis as
 1781  authorized by law.
 1782         (b) The department shall renew a permit upon receipt of the
 1783  renewal application and renewal fee if the applicant meets the
 1784  requirements established under this part and the rules adopted
 1785  under this part.
 1786         (c) At least 90 days before the expiration date of a
 1787  permit, the department shall forward a permit renewal
 1788  notification to the permittee at the mailing address of the
 1789  permitted establishment on file with the department. The permit
 1790  renewal notification must state conspicuously the date on which
 1791  the permit for the establishment will expire and that the
 1792  establishment may not operate unless the permit for the
 1793  establishment is renewed timely. A permit, unless sooner
 1794  suspended or revoked, automatically expires 2 years after the
 1795  last day of the anniversary month in which the permit was
 1796  originally issued.
 1797         (d) A permit issued under this part may be renewed by
 1798  making application for renewal on forms furnished by the
 1799  department and paying the appropriate fees.
 1800         1.If a prescription drug wholesale distributor or an out
 1801  of-state prescription drug wholesale distributor renewal
 1802  application and fee are submitted and postmarked later than 45
 1803  days before the expiration date of the permit, the permit may be
 1804  renewed only upon payment of a late renewal fee of $100, plus
 1805  the required renewal fee.
 1806         2. If any other a renewal application and fee are submitted
 1807  and postmarked after the expiration date of the permit, the
 1808  permit may be renewed only upon payment of a late renewal
 1809  delinquent fee of $100, plus the required renewal fee, not later
 1810  than 60 days after the expiration date.
 1811         3.A permittee who submits a renewal application in
 1812  accordance with this paragraph may continue to operate under its
 1813  permit, unless the permit is suspended or revoked, until final
 1814  disposition of the renewal application.
 1815         4.(d) Failure to renew a permit in accordance with this
 1816  section precludes any future renewal of that permit. If a permit
 1817  issued pursuant to this part has expired and cannot be renewed,
 1818  before an establishment may engage in activities that require a
 1819  permit under this part, the establishment must submit an
 1820  application for a new permit, pay the applicable application
 1821  fee, the initial permit fee, and all applicable penalties, and
 1822  be issued a new permit by the department.
 1823         (6) A permit issued by the department is nontransferable.
 1824  Each permit is valid only for the person or governmental unit to
 1825  which it is issued and is not subject to sale, assignment, or
 1826  other transfer, voluntarily or involuntarily; nor is a permit
 1827  valid for any establishment other than the establishment for
 1828  which it was originally issued.
 1829         (a) A person permitted under this part must notify the
 1830  department before making a change of address. The department
 1831  shall set a change of location fee not to exceed $100.
 1832         (b)1. An application for a new permit is required when a
 1833  majority of the ownership or controlling interest of a permitted
 1834  establishment is transferred or assigned or when a lessee agrees
 1835  to undertake or provide services to the extent that legal
 1836  liability for operation of the establishment will rest with the
 1837  lessee. The application for the new permit must be made before
 1838  the date of the sale, transfer, assignment, or lease.
 1839         2. A permittee that is authorized to distribute
 1840  prescription drugs may transfer such drugs to the new owner or
 1841  lessee under subparagraph 1. only after the new owner or lessee
 1842  has been approved for a permit to distribute prescription drugs.
 1843         (c) If an establishment permitted under this part closes,
 1844  the owner must notify the department in writing before the
 1845  effective date of closure and must:
 1846         1. Return the permit to the department;
 1847         2. If the permittee is authorized to distribute
 1848  prescription drugs, indicate the disposition of such drugs,
 1849  including the name, address, and inventory, and provide the name
 1850  and address of a person to contact regarding access to records
 1851  that are required to be maintained under this part. Transfer of
 1852  ownership of prescription drugs may be made only to persons
 1853  authorized to possess prescription drugs under this part.
 1854  
 1855  The department may revoke the permit of any person that fails to
 1856  comply with the requirements of this subsection.
 1857         (7) A permit must be posted in a conspicuous place on the
 1858  licensed premises.
 1859         (8) An application for a permit or to renew a permit for a
 1860  prescription drug wholesale distributor or an out-of-state
 1861  prescription drug wholesale distributor submitted to the
 1862  department must include:
 1863         (a) The name, full business address, and telephone number
 1864  of the applicant.
 1865         (b) All trade or business names used by the applicant.
 1866         (c) The address, telephone numbers, and the names of
 1867  contact persons for each facility used by the applicant for the
 1868  storage, handling, and distribution of prescription drugs.
 1869         (d) The type of ownership or operation, such as a
 1870  partnership, corporation, or sole proprietorship.
 1871         (e) The names of the owner and the operator of the
 1872  establishment, including:
 1873         1. If an individual, the name of the individual.
 1874         2. If a partnership, the name of each partner and the name
 1875  of the partnership.
 1876         3. If a corporation:
 1877         a. The name, address, and title of each corporate officer
 1878  and director.
 1879         b. The name and address of the corporation, resident agent
 1880  of the corporation, the resident agent’s address, and the
 1881  corporation’s state of incorporation.
 1882         c. The name and address of each shareholder of the
 1883  corporation that owns 5 percent or more of the outstanding stock
 1884  of the corporation.
 1885         4. If a sole proprietorship, the full name of the sole
 1886  proprietor and the name of the business entity.
 1887         5. If a limited liability company:
 1888         a. The name and address of each member.
 1889         b. The name and address of each manager.
 1890         c. The name and address of the limited liability company,
 1891  the resident agent of the limited liability company, and the
 1892  name of the state in which the limited liability company was
 1893  organized.
 1894         (f) If applicable, the name and address of each affiliate
 1895  of member of the affiliated group of which the applicant is a
 1896  member.
 1897         (g)1.The applicant’s gross annual receipts attributable to
 1898  prescription drug wholesale distribution activities for the
 1899  previous tax year. For an application for a new permit, the
 1900  estimated annual dollar volume of prescription drug sales of the
 1901  applicant, the estimated annual percentage of the applicant’s
 1902  total company sales that are prescription drugs, the applicant’s
 1903  estimated annual total dollar volume of purchases of
 1904  prescription drugs, and the applicant’s estimated annual total
 1905  dollar volume of prescription drug purchases directly from
 1906  manufacturers.
 1907         2.For an application to renew a permit, the total dollar
 1908  volume of prescription drug sales in the previous year, the
 1909  total dollar volume of prescription drug sales made in the
 1910  previous 6 months, the percentage of total company sales that
 1911  were prescription drugs in the previous year, the total dollar
 1912  volume of purchases of prescription drugs in the previous year,
 1913  and the total dollar volume of prescription drug purchases
 1914  directly from manufacturers in the previous year.
 1915  
 1916  Such portions of the information required pursuant to this
 1917  paragraph which are a trade secret, as defined in s. 812.081,
 1918  shall be maintained by the department as trade secret
 1919  information is required to be maintained under s. 499.051.
 1920         (h) The tax year of the applicant.
 1921         (i) A copy of the deed for the property on which
 1922  applicant’s establishment is located, if the establishment is
 1923  owned by the applicant, or a copy of the applicant’s lease for
 1924  the property on which applicant’s establishment is located that
 1925  has an original term of not less than 1 calendar year, if the
 1926  establishment is not owned by the applicant.
 1927         (j) A list of all licenses and permits issued to the
 1928  applicant by any other state which authorize the applicant to
 1929  purchase or possess prescription drugs.
 1930         (k) The name of the manager of the establishment that is
 1931  applying for the permit or to renew the permit, the next four
 1932  highest ranking employees responsible for prescription drug
 1933  wholesale operations for the establishment, and the name of all
 1934  affiliated parties for the establishment, together with the
 1935  personal information statement and fingerprints required
 1936  pursuant to subsection (9) for each of such persons.
 1937         (l) The name of each of the applicant’s designated
 1938  representatives as required by subsection (15) (16), together
 1939  with the personal information statement and fingerprints
 1940  required pursuant to subsection (9) for each such person.
 1941         (m) Evidence of a surety bond in this state or any other
 1942  state in the United States in the amount of $100,000. If the
 1943  annual gross receipts of the applicant’s previous tax year is
 1944  $10 million or less, evidence of a surety bond in the amount of
 1945  $25,000. The specific language of the surety bond must include
 1946  the State of Florida as a beneficiary, payable to the
 1947  Professional Regulation Trust Fund. In lieu of the surety bond,
 1948  the applicant may provide other equivalent security such as an
 1949  irrevocable letter of credit, or a deposit in a trust account or
 1950  financial institution, which includes the State of Florida as a
 1951  beneficiary, payable to the Professional Regulation Trust Fund.
 1952  The purpose of the bond or other security is to secure payment
 1953  of any administrative penalties imposed by the department and
 1954  any fees and costs incurred by the department regarding that
 1955  permit which are authorized under state law and which the
 1956  permittee fails to pay 30 days after the fine or costs become
 1957  final. The department may make a claim against such bond or
 1958  security until 1 year after the permittee’s license ceases to be
 1959  valid or until 60 days after any administrative or legal
 1960  proceeding authorized in this part which involves the permittee
 1961  is concluded, including any appeal, whichever occurs later. For
 1962  an applicant that is a secondary wholesale distributor, each of
 1963  the following:
 1964         1.A personal background information statement containing
 1965  the background information and fingerprints required pursuant to
 1966  subsection (9) for each person named in the applicant’s response
 1967  to paragraphs (k) and (l) and for each affiliated party of the
 1968  applicant.
 1969         2.If any of the five largest shareholders of the
 1970  corporation seeking the permit is a corporation, the name,
 1971  address, and title of each corporate officer and director of
 1972  each such corporation; the name and address of such corporation;
 1973  the name of such corporation’s resident agent, such
 1974  corporation’s resident agent’s address, and such corporation’s
 1975  state of its incorporation; and the name and address of each
 1976  shareholder of such corporation that owns 5 percent or more of
 1977  the stock of such corporation.
 1978         3.The name and address of all financial institutions in
 1979  which the applicant has an account which is used to pay for the
 1980  operation of the establishment or to pay for drugs purchased for
 1981  the establishment, together with the names of all persons that
 1982  are authorized signatories on such accounts. The portions of the
 1983  information required pursuant to this subparagraph which are a
 1984  trade secret, as defined in s. 812.081, shall be maintained by
 1985  the department as trade secret information is required to be
 1986  maintained under s. 499.051.
 1987         4.The sources of all funds and the amounts of such funds
 1988  used to purchase or finance purchases of prescription drugs or
 1989  to finance the premises on which the establishment is to be
 1990  located.
 1991         5.If any of the funds identified in subparagraph 4. were
 1992  borrowed, copies of all promissory notes or loans used to obtain
 1993  such funds.
 1994         (n)For establishments used in wholesale distribution,
 1995  proof of an inspection conducted by the department, the United
 1996  States Food and Drug Administration, or another governmental
 1997  entity charged with the regulation of good manufacturing
 1998  practices related to wholesale distribution of prescription
 1999  drugs, within timeframes set forth by the department in
 2000  departmental rules, which demonstrates substantial compliance
 2001  with current good manufacturing practices applicable to
 2002  wholesale distribution of prescription drugs. The department may
 2003  recognize another state’s inspection of a wholesale distributor
 2004  located in that state if such state’s laws are deemed to be
 2005  substantially equivalent to the law of this state by the
 2006  department. The department may accept an inspection by a third
 2007  party accreditation or inspection service which meets the
 2008  criteria set forth in department rule.
 2009         (o)(n) Any other relevant information that the department
 2010  requires, including, but not limited to, any information related
 2011  to whether the applicant satisfies the definition of a primary
 2012  wholesale distributor or a secondary wholesale distributor.
 2013         (p)(o) Documentation of the credentialing policies and
 2014  procedures required by s. 499.0121(15).
 2015         (9)(a) Each person required by subsection (8) or subsection
 2016  (15) to provide a personal information statement and
 2017  fingerprints shall provide the following information to the
 2018  department on forms prescribed by the department:
 2019         1. The person’s places of residence for the past 7 years.
 2020         2. The person’s date and place of birth.
 2021         3. The person’s occupations, positions of employment, and
 2022  offices held during the past 7 years.
 2023         4. The principal business and address of any business,
 2024  corporation, or other organization in which each such office of
 2025  the person was held or in which each such occupation or position
 2026  of employment was carried on.
 2027         5. Whether the person has been, during the past 7 years,
 2028  the subject of any proceeding for the revocation of any license
 2029  and, if so, the nature of the proceeding and the disposition of
 2030  the proceeding.
 2031         6. Whether, during the past 7 years, the person has been
 2032  enjoined, temporarily or permanently, by a court of competent
 2033  jurisdiction from violating any federal or state law regulating
 2034  the possession, control, or distribution of prescription drugs,
 2035  together with details concerning any such event.
 2036         7. A description of any involvement by the person with any
 2037  business, including any investments, other than the ownership of
 2038  stock in a publicly traded company or mutual fund, during the
 2039  past 4 7 years, which manufactured, administered, prescribed,
 2040  distributed, or stored pharmaceutical products and any lawsuits
 2041  in which such businesses were named as a party.
 2042         8. A description of any felony criminal offense of which
 2043  the person, as an adult, was found guilty, regardless of whether
 2044  adjudication of guilt was withheld or whether the person pled
 2045  guilty or nolo contendere. A criminal offense committed in
 2046  another jurisdiction which would have been a felony in this
 2047  state must be reported. If the person indicates that a criminal
 2048  conviction is under appeal and submits a copy of the notice of
 2049  appeal of that criminal offense, the applicant must, within 15
 2050  days after the disposition of the appeal, submit to the
 2051  department a copy of the final written order of disposition.
 2052         9. A photograph of the person taken in the previous 180 30
 2053  days.
 2054         10. A set of fingerprints for the person on a form and
 2055  under procedures specified by the department, together with
 2056  payment of an amount equal to the costs incurred by the
 2057  department for the criminal record check of the person.
 2058         11. The name, address, occupation, and date and place of
 2059  birth for each member of the person’s immediate family who is 18
 2060  years of age or older. As used in this subparagraph, the term
 2061  “member of the person’s immediate family” includes the person’s
 2062  spouse, children, parents, siblings, the spouses of the person’s
 2063  children, and the spouses of the person’s siblings.
 2064         12. Any other relevant information that the department
 2065  requires.
 2066         (b) The information required pursuant to paragraph (a)
 2067  shall be provided under oath.
 2068         (c) The department shall submit the fingerprints provided
 2069  by a person for initial licensure to the Department of Law
 2070  Enforcement for a statewide criminal record check and for
 2071  forwarding to the Federal Bureau of Investigation for a national
 2072  criminal record check of the person. The department shall submit
 2073  the fingerprints provided by a person as a part of a renewal
 2074  application to the Department of Law Enforcement for a statewide
 2075  criminal record check, and for forwarding to the Federal Bureau
 2076  of Investigation for a national criminal record check, for the
 2077  initial renewal of a permit after January 1, 2004; for any
 2078  subsequent renewal of a permit, the department shall submit the
 2079  required information for a statewide and national criminal
 2080  record check of the person. Any person who as a part of an
 2081  initial permit application or initial permit renewal after
 2082  January 1, 2004, submits to the department a set of fingerprints
 2083  required for the criminal record check required in this
 2084  paragraph are shall not be required to provide a subsequent set
 2085  of fingerprints for a criminal record check to the department,
 2086  if the person has undergone a criminal record check as a
 2087  condition of the issuance of an initial permit or the initial
 2088  renewal of a permit of an applicant after January 1, 2004. The
 2089  department is authorized to contract with private vendors, or
 2090  enter into interagency agreements, to collect electronic
 2091  fingerprints where fingerprints are required for registration,
 2092  certification, or the licensure process or where criminal
 2093  history record checks are required.
 2094         (d)For purposes of applying for renewal of a permit under
 2095  subsection (8) or certification under subsection (16), a person
 2096  may submit the following in lieu of satisfying the requirements
 2097  of paragraphs (a), (b), and (c):
 2098         1.A photograph of the individual taken within 180 days;
 2099  and
 2100         2.A copy of the personal information statement form most
 2101  recently submitted to the department and a certification under
 2102  oath, on a form specified by the department, that the individual
 2103  has reviewed the previously submitted personal information
 2104  statement form and that the information contained therein
 2105  remains unchanged.
 2106         (10) The department may deny an application for a permit or
 2107  refuse to renew a permit for a prescription drug wholesale
 2108  distributor or an out-of-state prescription drug wholesale
 2109  distributor if:
 2110         (a) The applicant has not met the requirements for the
 2111  permit.
 2112         (b) The management, officers, or directors of the applicant
 2113  or any affiliated party are found by the department to be
 2114  incompetent or untrustworthy.
 2115         (c) The applicant is so lacking in experience in managing a
 2116  wholesale distributor as to make the issuance of the proposed
 2117  permit hazardous to the public health.
 2118         (d) The applicant is so lacking in experience in managing a
 2119  wholesale distributor as to jeopardize the reasonable promise of
 2120  successful operation of the wholesale distributor.
 2121         (e) The applicant is lacking in experience in the
 2122  distribution of prescription drugs.
 2123         (f) The applicant’s past experience in manufacturing or
 2124  distributing prescription drugs indicates that the applicant
 2125  poses a public health risk.
 2126         (g) The applicant is affiliated directly or indirectly
 2127  through ownership, control, or other business relations, with
 2128  any person or persons whose business operations are or have been
 2129  detrimental to the public health.
 2130         (h) The applicant, or any affiliated party, has been found
 2131  guilty of or has pleaded guilty or nolo contendere to any felony
 2132  or crime punishable by imprisonment for 1 year or more under the
 2133  laws of the United States, any state, or any other country,
 2134  regardless of whether adjudication of guilt was withheld.
 2135         (i) The applicant or any affiliated party has been charged
 2136  with a felony in a state or federal court and the disposition of
 2137  that charge is pending during the application review or renewal
 2138  review period.
 2139         (j) The applicant has furnished false or fraudulent
 2140  information or material in any application made in this state or
 2141  any other state in connection with obtaining a permit or license
 2142  to manufacture or distribute drugs, devices, or cosmetics.
 2143         (k) That a federal, state, or local government permit
 2144  currently or previously held by the applicant, or any affiliated
 2145  party, for the manufacture or distribution of any drugs,
 2146  devices, or cosmetics has been disciplined, suspended, or
 2147  revoked and has not been reinstated.
 2148         (l) The applicant does not possess the financial or
 2149  physical resources to operate in compliance with the permit
 2150  being sought, this chapter, and the rules adopted under this
 2151  chapter.
 2152         (m) The applicant or any affiliated party receives,
 2153  directly or indirectly, financial support and assistance from a
 2154  person who was an affiliated party of a permittee whose permit
 2155  was subject to discipline or was suspended or revoked, other
 2156  than through the ownership of stock in a publicly traded company
 2157  or a mutual fund.
 2158         (n) The applicant or any affiliated party receives,
 2159  directly or indirectly, financial support and assistance from a
 2160  person who has been found guilty of any violation of this part
 2161  or chapter 465, chapter 501, or chapter 893, any rules adopted
 2162  under this part or those chapters, any federal or state drug
 2163  law, or any felony where the underlying facts related to drugs,
 2164  regardless of whether the person has been pardoned, had her or
 2165  his civil rights restored, or had adjudication withheld, other
 2166  than through the ownership of stock in a publicly traded company
 2167  or a mutual fund.
 2168         (o) The applicant for renewal of a permit under s.
 2169  499.01(2)(e) or (f) 499.01(2)(d) or (e) has not actively engaged
 2170  in the wholesale distribution of prescription drugs, as
 2171  demonstrated by the regular and systematic distribution of
 2172  prescription drugs throughout the year as evidenced by not fewer
 2173  than 12 wholesale distributions in the previous year and not
 2174  fewer than three wholesale distributions in the previous 6
 2175  months.
 2176         (p) Information obtained in response to s. 499.01(2)(e) or
 2177  (f) 499.01(2)(d) or (e) demonstrates it would not be in the best
 2178  interest of the public health, safety, and welfare to issue a
 2179  permit.
 2180         (q) The applicant does not possess the financial standing
 2181  and business experience for the successful operation of the
 2182  applicant.
 2183         (r) The applicant or any affiliated party has failed to
 2184  comply with the requirements for manufacturing or distributing
 2185  prescription drugs under this part, similar federal laws,
 2186  similar laws in other states, or the rules adopted under such
 2187  laws.
 2188         (11) Upon approval of the application by the department and
 2189  payment of the required fee, the department shall issue or renew
 2190  a prescription drug wholesale distributor or an out-of-state
 2191  prescription drug wholesale distributor permit to the applicant.
 2192         (12)For a permit for a prescription drug wholesale
 2193  distributor or an out-of-state prescription drug wholesale
 2194  distributor:
 2195         (a)The department shall adopt rules for the annual renewal
 2196  of permits. At least 90 days before the expiration of a permit,
 2197  the department shall forward a permit renewal notification and
 2198  renewal application to the prescription drug wholesale
 2199  distributor or out-of-state prescription drug wholesale
 2200  distributor at the mailing address of the permitted
 2201  establishment on file with the department. The permit renewal
 2202  notification must state conspicuously the date on which the
 2203  permit for the establishment will expire and that the
 2204  establishment may not operate unless the permit for the
 2205  establishment is renewed timely.
 2206         (b)A permit, unless sooner suspended or revoked,
 2207  automatically expires 1 year after the last day of the
 2208  anniversary month in which the permit was originally issued. A
 2209  permit may be renewed by making application for renewal on forms
 2210  furnished by the department and paying the appropriate fees. If
 2211  a renewal application and fee are submitted and postmarked after
 2212  45 days prior to the expiration date of the permit, the permit
 2213  may be renewed only upon payment of a late renewal fee of $100,
 2214  plus the required renewal fee. A permittee that has submitted a
 2215  renewal application in accordance with this paragraph may
 2216  continue to operate under its permit, unless the permit is
 2217  suspended or revoked, until final disposition of the renewal
 2218  application.
 2219         (c)Failure to renew a permit in accordance with this
 2220  section precludes any future renewal of that permit. If a permit
 2221  issued pursuant to this section has expired and cannot be
 2222  renewed, before an establishment may engage in activities that
 2223  require a permit under this part, the establishment must submit
 2224  an application for a new permit; pay the applicable application
 2225  fee, initial permit fee, and all applicable penalties; and be
 2226  issued a new permit by the department.
 2227         (12)(13) A person that engages in wholesale distribution of
 2228  prescription drugs in this state must have a wholesale
 2229  distributor’s permit issued by the department, except as noted
 2230  in this section. Each establishment must be separately permitted
 2231  except as noted in this subsection.
 2232         (a) A separate establishment permit is not required when a
 2233  permitted prescription drug wholesale distributor consigns a
 2234  prescription drug to a pharmacy that is permitted under chapter
 2235  465 and located in this state, provided that:
 2236         1. The consignor wholesale distributor notifies the
 2237  department in writing of the contract to consign prescription
 2238  drugs to a pharmacy along with the identity and location of each
 2239  consignee pharmacy;
 2240         2. The pharmacy maintains its permit under chapter 465;
 2241         3. The consignor wholesale distributor, which has no legal
 2242  authority to dispense prescription drugs, complies with all
 2243  wholesale distribution requirements of s. ss. 499.0121 and
 2244  499.01212 with respect to the consigned drugs and maintains
 2245  records documenting the transfer of title or other completion of
 2246  the wholesale distribution of the consigned prescription drugs;
 2247         4. The distribution of the prescription drug is otherwise
 2248  lawful under this chapter and other applicable law;
 2249         5. Open packages containing prescription drugs within a
 2250  pharmacy are the responsibility of the pharmacy, regardless of
 2251  how the drugs are titled; and
 2252         6. The pharmacy dispenses the consigned prescription drug
 2253  in accordance with the limitations of its permit under chapter
 2254  465 or returns the consigned prescription drug to the consignor
 2255  wholesale distributor. In addition, a person who holds title to
 2256  prescription drugs may transfer the drugs to a person permitted
 2257  or licensed to handle the reverse distribution or destruction of
 2258  drugs. Any other distribution by and means of the consigned
 2259  prescription drug by any person, not limited to the consignor
 2260  wholesale distributor or consignee pharmacy, to any other person
 2261  is prohibited.
 2262         (b) A wholesale distributor’s permit is not required for
 2263  the one-time transfer of title of a pharmacy’s lawfully acquired
 2264  prescription drug inventory by a pharmacy with a valid permit
 2265  issued under chapter 465 to a consignor prescription drug
 2266  wholesale distributor, permitted under this chapter, in
 2267  accordance with a written consignment agreement between the
 2268  pharmacy and that wholesale distributor if the permitted
 2269  pharmacy and the permitted prescription drug wholesale
 2270  distributor comply with all of the provisions of paragraph (a)
 2271  and the prescription drugs continue to be within the permitted
 2272  pharmacy’s inventory for dispensing in accordance with the
 2273  limitations of the pharmacy permit under chapter 465. A
 2274  consignor drug wholesale distributor may not use the pharmacy as
 2275  a wholesale distributor through which it distributes the
 2276  prescription drugs to other pharmacies. Nothing in this section
 2277  is intended to prevent a wholesale distributor from obtaining
 2278  this inventory in the event of nonpayment by the pharmacy.
 2279         (c) A separate establishment permit is not required when a
 2280  permitted prescription drug wholesale distributor operates
 2281  temporary transit storage facilities for the sole purpose of
 2282  storage, for up to 16 hours, of a delivery of prescription drugs
 2283  when the wholesale distributor was temporarily unable to
 2284  complete the delivery to the recipient.
 2285         (d) The department shall require information from each
 2286  wholesale distributor as part of the permit and renewal of such
 2287  permit, as required under this section.
 2288         (13)(14) Personnel employed in wholesale distribution must
 2289  have appropriate education and experience to enable them to
 2290  perform their duties in compliance with state permitting
 2291  requirements.
 2292         (14)(15) The name of a permittee or establishment on a
 2293  prescription drug wholesale distributor permit or an out-of
 2294  state prescription drug wholesale distributor permit may not
 2295  include any indicia of attainment of any educational degree, any
 2296  indicia that the permittee or establishment possesses a
 2297  professional license, or any name or abbreviation that the
 2298  department determines is likely to cause confusion or mistake or
 2299  that the department determines is deceptive, including that of
 2300  any other entity authorized to purchase prescription drugs.
 2301         (15)(16)(a) Each establishment that is issued an initial or
 2302  renewal permit as a prescription drug wholesale distributor or
 2303  an out-of-state prescription drug wholesale distributor must
 2304  designate in writing to the department at least one natural
 2305  person to serve as the designated representative of the
 2306  wholesale distributor. Such person must have an active
 2307  certification as a designated representative from the
 2308  department.
 2309         (b) To be certified as a designated representative, a
 2310  natural person must:
 2311         1. Submit an application on a form furnished by the
 2312  department and pay the appropriate fees.
 2313         2. Be at least 18 years of age.
 2314         3. Have at least 2 years of verifiable full-time:
 2315         a. Work experience in a pharmacy licensed in this state or
 2316  another state, where the person’s responsibilities included, but
 2317  were not limited to, recordkeeping for prescription drugs;
 2318         b. Managerial experience with a prescription drug wholesale
 2319  distributor licensed in this state or in another state; or
 2320         c. Managerial experience with the United States Armed
 2321  Forces, where the person’s responsibilities included, but were
 2322  not limited to, recordkeeping, warehousing, distributing, or
 2323  other logistics services pertaining to prescription drugs.
 2324         4. Receive a passing score of at least 75 percent on an
 2325  examination given by the department regarding federal laws
 2326  governing distribution of prescription drugs and this part and
 2327  the rules adopted by the department governing the wholesale
 2328  distribution of prescription drugs. This requirement shall be
 2329  effective 1 year after the results of the initial examination
 2330  are mailed to the persons that took the examination. The
 2331  department shall offer such examinations at least four times
 2332  each calendar year.
 2333         5. Provide the department with a personal information
 2334  statement and fingerprints pursuant to subsection (9).
 2335         (c) The department may deny an application for
 2336  certification as a designated representative or may suspend or
 2337  revoke a certification of a designated representative pursuant
 2338  to s. 499.067.
 2339         (d) A designated representative:
 2340         1. Must be actively involved in and aware of the actual
 2341  daily operation of the wholesale distributor.
 2342         2. Must be employed full time in a managerial position by
 2343  the wholesale distributor.
 2344         3. Must be physically present at the establishment during
 2345  normal business hours, except for time periods when absent due
 2346  to illness, family illness or death, scheduled vacation, or
 2347  other authorized absence.
 2348         4. May serve as a designated representative for only one
 2349  wholesale distributor at any one time.
 2350         (e) A wholesale distributor must notify the department when
 2351  a designated representative leaves the employ of the wholesale
 2352  distributor. Such notice must be provided to the department
 2353  within 10 business days after the last day of designated
 2354  representative’s employment with the wholesale distributor.
 2355         (f) A wholesale distributor may not operate under a
 2356  prescription drug wholesale distributor permit or an out-of
 2357  state prescription drug wholesale distributor permit for more
 2358  than 10 business days after the designated representative leaves
 2359  the employ of the wholesale distributor, unless the wholesale
 2360  distributor employs another designated representative and
 2361  notifies the department within 10 business days of the identity
 2362  of the new designated representative.
 2363         Section 7. Section 499.01201, Florida Statutes, is amended
 2364  to read:
 2365         499.01201 Agency for Health Care Administration review and
 2366  use of statute and rule violation or compliance data.
 2367  Notwithstanding any other provision provisions of law to the
 2368  contrary, the Agency for Health Care Administration may not:
 2369         (1) Review or use any violation or alleged violation of s.
 2370  499.0121(6) or s. 499.01212, or any rules adopted under that
 2371  section those sections, as a ground for denying or withholding
 2372  any payment of a Medicaid reimbursement to a pharmacy licensed
 2373  under chapter 465; or
 2374         (2) Review or use compliance with s. 499.0121(6) or s.
 2375  499.01212, or any rules adopted under that section those
 2376  sections, as the subject of any audit of Medicaid-related
 2377  records held by a pharmacy licensed under chapter 465.
 2378         Section 8. Paragraph (d) of subsection (4), subsection (6),
 2379  and paragraph (b) of subsection (15) of section 499.0121,
 2380  Florida Statutes, are amended to read:
 2381         499.0121 Storage and handling of prescription drugs;
 2382  recordkeeping.—The department shall adopt rules to implement
 2383  this section as necessary to protect the public health, safety,
 2384  and welfare. Such rules shall include, but not be limited to,
 2385  requirements for the storage and handling of prescription drugs
 2386  and for the establishment and maintenance of prescription drug
 2387  distribution records.
 2388         (4) EXAMINATION OF MATERIALS AND RECORDS.—
 2389         (d) Upon receipt, a wholesale distributor must review
 2390  records required under this section for the acquisition of
 2391  prescription drugs for accuracy and completeness, considering
 2392  the total facts and circumstances surrounding the transactions
 2393  and the wholesale distributors involved. This includes
 2394  authenticating each transaction listed on a pedigree paper, as
 2395  defined in s. 499.003(37).
 2396         (6) RECORDKEEPING.—The department shall adopt rules that
 2397  require keeping such records of prescription drugs, including
 2398  active pharmaceutical ingredients, as are necessary for the
 2399  protection of the public health.
 2400         (a) The following persons must maintain business records
 2401  that include the information specified in paragraph (b)
 2402  Wholesale distributors must establish and maintain inventories
 2403  and records of all transactions regarding the receipt and
 2404  distribution or other disposition of prescription drugs. These
 2405  records must provide a complete audit trail from receipt to sale
 2406  or other disposition, be readily retrievable for inspection, and
 2407  include, at a minimum, the following information:
 2408         1. Persons permitted or required to be permitted under
 2409  chapter 499 to engage in the manufacture, repackaging, or
 2410  distribution of active pharmaceutical ingredients or
 2411  prescription drugs. The source of the drugs, including the name
 2412  and principal address of the seller or transferor, and the
 2413  address of the location from which the drugs were shipped;
 2414         2. Persons other than those set forth in subparagraph 1.
 2415  that engage in the receipt of active pharmaceutical ingredients
 2416  or prescription drugs. The name, principal address, and state
 2417  license permit or registration number of the person authorized
 2418  to purchase prescription drugs;
 2419         3. The name, strength, dosage form, and quantity of the
 2420  drugs received and distributed or disposed of;
 2421         4. The dates of receipt and distribution or other
 2422  disposition of the drugs; and
 2423         5. Any financial documentation supporting the transaction.
 2424         (b) Business records for persons specified in paragraph (a)
 2425  must include:
 2426         1.The name and address of the seller, and the Florida
 2427  permit number of the seller if such seller is not exempt from
 2428  Florida permitting requirements, of the active pharmaceutical
 2429  ingredient or prescription drug.
 2430         2.The address of the location the active pharmaceutical
 2431  ingredient or prescription drug was shipped from.
 2432         3.The distribution date of the active pharmaceutical
 2433  ingredient or prescription drug.
 2434         4.The name, strength, and quantity, and the National Drug
 2435  Code if such code has been assigned, of the distributed active
 2436  pharmaceutical ingredient or prescription drug.
 2437         5.The name and Florida permit number of the person that
 2438  purchased the active pharmaceutical ingredient or prescription
 2439  drug.
 2440         6.The financial data, including the unit type and unit
 2441  price, for the distributions involving active pharmaceutical
 2442  ingredients or prescription drugs.
 2443         7.The date and method of disposition of the active
 2444  pharmaceutical ingredient or prescription drug. Inventories and
 2445  records must be made available for inspection and photocopying
 2446  by authorized federal, state, or local officials for a period of
 2447  2 years following disposition of the drugs or 3 years after the
 2448  creation of the records, whichever period is longer.
 2449         (c) Each manufacturer or repackager of medical devices,
 2450  over-the-counter drugs, or cosmetics must maintain business
 2451  records that include:
 2452         1.The name and address of the seller or transferor of the
 2453  product.
 2454         2.The address of the location the product was shipped
 2455  from.
 2456         3.The date of the sale or distribution of the product.
 2457         4.The name and quantity of the product involved.
 2458         5.The name and address of the person who purchased the
 2459  product Records described in this section that are kept at the
 2460  inspection site or that can be immediately retrieved by computer
 2461  or other electronic means must be readily available for
 2462  authorized inspection during the retention period. Records that
 2463  are kept at a central location outside of this state and that
 2464  are not electronically retrievable must be made available for
 2465  inspection within 2 working days after a request by an
 2466  authorized official of a federal, state, or local law
 2467  enforcement agency. Records that are maintained at a central
 2468  location within this state must be maintained at an
 2469  establishment that is permitted pursuant to this part and must
 2470  be readily available.
 2471         (d) Persons permitted, or required to be permitted, under
 2472  this chapter to engage in the manufacture, repackaging, or
 2473  distribution of active pharmaceutical ingredients or
 2474  prescription drugs; or the manufacture or repackaging of medical
 2475  devices, over-the-counter drugs, and cosmetics; must establish,
 2476  maintain, or have the capability to create a current inventory
 2477  of the active pharmaceutical ingredients, prescription drugs,
 2478  over-the-counter drugs, cosmetics, and devices at an
 2479  establishment where activities specified in this paragraph are
 2480  undertaken and must be able to produce such inventory for
 2481  inspection by the department within 2 business days Each
 2482  manufacturer or repackager of medical devices, over-the-counter
 2483  drugs, or cosmetics must maintain records that include the name
 2484  and principal address of the seller or transferor of the
 2485  product, the address of the location from which the product was
 2486  shipped, the date of the transaction, the name and quantity of
 2487  the product involved, and the name and principal address of the
 2488  person who purchased the product.
 2489         (e) Business records required to be kept pursuant to this
 2490  section, and that are kept at the inspection site or can be
 2491  immediately retrieved by computer or other electronic means,
 2492  must be readily available for authorized inspection during the
 2493  retention period. Records kept at a central location outside of
 2494  this state which are not electronically retrievable must be made
 2495  available for inspection within 2 working days after a request
 2496  by an authorized official of a federal, state, or local law
 2497  enforcement agency. Records maintained at a central location
 2498  within this state must be maintained at an establishment that is
 2499  permitted pursuant to this part and such records must be readily
 2500  available for inspection When pedigree papers are required by
 2501  this part, a wholesale distributor must maintain the pedigree
 2502  papers separate and distinct from other records required under
 2503  this part.
 2504         (f)Records required to be kept pursuant to this subsection
 2505  must be maintained as specified for a period of not less than 6
 2506  years from the date of disposition of the active pharmaceutical
 2507  ingredients, prescription drugs, over-the-counter drugs, medical
 2508  devices, or cosmetics.
 2509         (g)To the extent that prescription drugs are also products
 2510  as defined in the federal act, as amended, and the information
 2511  required by the business records requirements of this section
 2512  are also included in the tracking and tracing requirements of
 2513  the federal act, as amended, and departmental rules, the
 2514  manufacturer, wholesale distributor, repackager, or dispenser
 2515  must follow both the requirements of the federal act, as
 2516  amended, and departmental rules.
 2517         (15) DUE DILIGENCE OF PURCHASERS.—
 2518         (b) A wholesale distributor must take reasonable measures
 2519  to identify its customers, understand the normal and expected
 2520  transactions conducted by those customers, and identify those
 2521  transactions that are suspicious in nature. A wholesale
 2522  distributor must establish internal policies and procedures for
 2523  identifying suspicious orders and preventing suspicious
 2524  transactions. A wholesale distributor must assess orders for
 2525  more greater than 7,500 5,000 unit doses of any one controlled
 2526  substance in any one month to determine whether the purchase is
 2527  reasonable. In making such assessments, a wholesale distributor
 2528  may consider the purchasing entity’s clinical business needs,
 2529  location, and population served, in addition to other factors
 2530  established in the distributor’s policies and procedures. A
 2531  wholesale distributor must report to the department any
 2532  regulated transaction involving an extraordinary quantity of a
 2533  listed chemical, an uncommon method of payment or delivery, or
 2534  any other circumstance that the regulated person believes may
 2535  indicate that the listed chemical will be used in violation of
 2536  the law. The wholesale distributor shall maintain records that
 2537  document the report submitted to the department in compliance
 2538  with this paragraph.
 2539         Section 9. Subsection (4) of section 499.015, Florida
 2540  Statues, is amended to read:
 2541         499.015 Registration of drugs, devices, and cosmetics;
 2542  issuance of certificates of free sale.—
 2543         (4) Unless a registration is renewed, it expires 2 years
 2544  after the last day of the month in which it was issued. Any
 2545  product registration issued or renewed on or after July 1, 2016,
 2546  shall expire on the same date as the manufacturer or repackager
 2547  permit of the person seeking to register the product. If the
 2548  first product registration issued to a person on or after July
 2549  1, 2016, expires less than 366 days after issuance, the fee for
 2550  product registration shall be $15. If the first product
 2551  registration issued to a person on or after July 1, 2016,
 2552  expires more than 365 days after issuance, the fee for product
 2553  registration shall be $30. The department may issue a stop-sale
 2554  notice or order against a person that is subject to the
 2555  requirements of this section and that fails to comply with this
 2556  section within 31 days after the date the registration expires.
 2557  The notice or order shall prohibit such person from selling or
 2558  causing to be sold any drugs, devices, or cosmetics covered by
 2559  this part until he or she complies with the requirements of this
 2560  section.
 2561         Section 10. Subsection (1) of section 499.03, Florida
 2562  Statutes, is amended to read:
 2563         499.03 Possession of certain drugs without prescriptions
 2564  unlawful; exemptions and exceptions.—
 2565         (1) A person may not possess, or possess with intent to
 2566  sell, dispense, or deliver, any habit-forming, toxic, harmful,
 2567  or new drug subject to s. 499.003(32) 499.003(33), or
 2568  prescription drug as defined in s. 499.003(40) 499.003(43),
 2569  unless the possession of the drug has been obtained by a valid
 2570  prescription of a practitioner licensed by law to prescribe the
 2571  drug. However, this section does not apply to the delivery of
 2572  such drugs to persons included in any of the classes named in
 2573  this subsection, or to the agents or employees of such persons,
 2574  for use in the usual course of their businesses or practices or
 2575  in the performance of their official duties, as the case may be;
 2576  nor does this section apply to the possession of such drugs by
 2577  those persons or their agents or employees for such use:
 2578         (a) A licensed pharmacist or any person under the licensed
 2579  pharmacist’s supervision while acting within the scope of the
 2580  licensed pharmacist’s practice;
 2581         (b) A licensed practitioner authorized by law to prescribe
 2582  prescription drugs or any person under the licensed
 2583  practitioner’s supervision while acting within the scope of the
 2584  licensed practitioner’s practice;
 2585         (c) A qualified person who uses prescription drugs for
 2586  lawful research, teaching, or testing, and not for resale;
 2587         (d) A licensed hospital or other institution that procures
 2588  such drugs for lawful administration or dispensing by
 2589  practitioners;
 2590         (e) An officer or employee of a federal, state, or local
 2591  government; or
 2592         (f) A person that holds a valid permit issued by the
 2593  department pursuant to this part which authorizes that person to
 2594  possess prescription drugs.
 2595         Section 11. Paragraphs (i) through (p) of subsection (1) of
 2596  section 499.05, Florida Statutes, are amended to read:
 2597         499.05 Rules.—
 2598         (1) The department shall adopt rules to implement and
 2599  enforce this chapter with respect to:
 2600         (i) Additional conditions that qualify as an emergency
 2601  medical reason under s. 499.003(48)(b)2. 499.003(53)(b)2. or s.
 2602  499.82.
 2603         (j)Procedures and forms relating to the pedigree paper
 2604  requirement of s. 499.01212.
 2605         (j)(k) The protection of the public health, safety, and
 2606  welfare regarding good manufacturing practices that
 2607  manufacturers and repackagers must follow to ensure the safety
 2608  of the products.
 2609         (k)(l) Information required from each retail establishment
 2610  pursuant to s. 499.012(3) or s. 499.83(2)(c), including
 2611  requirements for prescriptions or orders.
 2612         (l)(m) The recordkeeping, storage, and handling with
 2613  respect to each of the distributions of prescription drugs
 2614  specified in s. 499.003(48)(a)-(v) 499.003(53)(a)-(d) or s.
 2615  499.82(14).
 2616         (n)Alternatives to compliance with s. 499.01212 for a
 2617  prescription drug in the inventory of a permitted prescription
 2618  drug wholesale distributor as of June 30, 2006, and the return
 2619  of a prescription drug purchased prior to July 1, 2006. The
 2620  department may specify time limits for such alternatives.
 2621         (m)(o) Wholesale distributor reporting requirements of s.
 2622  499.0121(14).
 2623         (n)(p) Wholesale distributor credentialing and distribution
 2624  requirements of s. 499.0121(15).
 2625         Section 12. Subsection (7) of section 499.051, Florida
 2626  Statutes, is amended to read:
 2627         499.051 Inspections and investigations.—
 2628         (7) The complaint and all information obtained pursuant to
 2629  the investigation by the department are confidential and exempt
 2630  from s. 119.07(1) and s. 24(a), Art. I of the State Constitution
 2631  until the investigation and the enforcement action are
 2632  completed. However, trade secret information contained therein
 2633  as defined by s. 812.081(1)(c) shall remain confidential and
 2634  exempt from the provisions of s. 119.07(1) and s. 24(a), Art. I
 2635  of the State Constitution, as long as the information is
 2636  retained by the department. This subsection does not prohibit
 2637  the department from using such information for regulatory or
 2638  enforcement proceedings under this chapter or from providing
 2639  such information to any law enforcement agency or any other
 2640  regulatory agency. However, the receiving agency shall keep such
 2641  records confidential and exempt as provided in this subsection.
 2642  In addition, this subsection is not intended to prevent
 2643  compliance with the provisions of s. 499.01212, and the pedigree
 2644  papers required in that section shall not be deemed a trade
 2645  secret.
 2646         Section 13. Subsection (8) is added to section 499.066,
 2647  Florida Statutes, to read:
 2648         499.066 Penalties; remedies.—In addition to other penalties
 2649  and other enforcement provisions:
 2650         (8)(a)The department shall adopt rules to permit the
 2651  issuance of remedial, nondisciplinary citations. A citation
 2652  shall be issued to the person alleged to have committed a
 2653  violation and contain the person’s name, address, and license
 2654  number, if applicable, a brief factual statement, the sections
 2655  of the law allegedly violated, and the monetary assessment and
 2656  or other remedial measures imposed. The citation must clearly
 2657  state that the person may choose, in lieu of accepting the
 2658  citation, to have the department rescind the citation and
 2659  conduct an investigation pursuant to s. 499.051. If the person
 2660  does not dispute the matter in the citation with the department
 2661  within 30 days after the citation is served, the citation
 2662  becomes a final order and does not constitute discipline.
 2663         (b)The department shall adopt rules designating violations
 2664  for which a citation may be issued. The rules shall designate as
 2665  citable those violations for which there is no substantial
 2666  threat to the public health, safety, or welfare.
 2667         (c)The department is entitled to recover the costs of
 2668  investigation, in addition to any penalty provided according to
 2669  department rule, as part of the penalty levied pursuant to the
 2670  citation.
 2671         (d)A citation must be issued within 12 months after the
 2672  filing of the complaint that is the basis for the citation.
 2673         (e)Service of a citation may be made by personal service
 2674  or certified mail, restricted delivery, to the person at the
 2675  person’s last known address of record with the department or to
 2676  the person’s Florida registered agent.
 2677         (f)The department has authority to, and shall adopt rules
 2678  to, designate those violations for which a person is subject to
 2679  the issuance of a citation and designate the monetary
 2680  assessments and or other remedial measures that must be taken
 2681  for those violations. The department has continuous authority to
 2682  amend its rules adopted pursuant to this section.
 2683         Section 14. Subsection (14) of section 499.82, Florida
 2684  Statutes, is amended to read:
 2685         499.82 Definitions.—As used in this part, the term:
 2686         (14) “Wholesale distribution” means the distribution of
 2687  medical gas to a person other than a consumer or patient.
 2688  Wholesale distribution of medical gases does not include:
 2689         (a) The sale, purchase, or trade of a medical gas; an offer
 2690  to sell, purchase, or trade a medical gas; or the dispensing of
 2691  a medical gas pursuant to a prescription;
 2692         (b) Activities exempt from the definition of wholesale
 2693  distribution in s. 499.003; or
 2694         (c) The sale, purchase, or trade of a medical gas or an
 2695  offer to sell, purchase, or trade a medical gas for emergency
 2696  medical reasons; or
 2697         (d)Other transactions excluded from the definition of
 2698  wholesale distribution under the federal act or regulations
 2699  implemented under the federal act related to medical gas.
 2700         Section 15. Subsection (4) of section 499.89, Florida
 2701  Statutes, is amended to read:
 2702         499.89 Recordkeeping.—
 2703         (4)A pedigree paper is not required for distributing or
 2704  dispensing medical gas.
 2705         Section 16. Section 499.01212, Florida Statutes, is
 2706  repealed.
 2707         Section 17. Paragraph (a) of subsection (1) of section
 2708  409.9201, Florida Statutes, is amended to read:
 2709         409.9201 Medicaid fraud.—
 2710         (1) As used in this section, the term:
 2711         (a) “Prescription drug” means any drug, including, but not
 2712  limited to, finished dosage forms or active ingredients that are
 2713  subject to, defined in, or described in s. 503(b) of the Federal
 2714  Food, Drug, and Cosmetic Act or in s. 465.003(8), s. 499.003(47)
 2715  499.003(52), s. 499.007(13), or s. 499.82(10).
 2716  
 2717  The value of individual items of the legend drugs or goods or
 2718  services involved in distinct transactions committed during a
 2719  single scheme or course of conduct, whether involving a single
 2720  person or several persons, may be aggregated when determining
 2721  the punishment for the offense.
 2722         Section 18. Paragraph (b) of subsection (1) of section
 2723  499.067, Florida Statutes, is amended to read:
 2724         499.067 Denial, suspension, or revocation of permit,
 2725  certification, or registration.—
 2726         (1)
 2727         (b) The department may deny an application for a permit or
 2728  certification, or suspend or revoke a permit or certification,
 2729  if the department finds that:
 2730         1. The applicant is not of good moral character or that it
 2731  would be a danger or not in the best interest of the public
 2732  health, safety, and welfare if the applicant were issued a
 2733  permit or certification.
 2734         2. The applicant has not met the requirements for the
 2735  permit or certification.
 2736         3. The applicant is not eligible for a permit or
 2737  certification for any of the reasons enumerated in s. 499.012.
 2738         4. The applicant, permittee, or person certified under s.
 2739  499.012(15) s. 499.012(16) demonstrates any of the conditions
 2740  enumerated in s. 499.012.
 2741         5. The applicant, permittee, or person certified under s.
 2742  499.012(15) s. 499.012(16) has committed any violation of this
 2743  chapter.
 2744         Section 19. Subsection (1) of section 794.075, Florida
 2745  Statutes, is amended to read:
 2746         794.075 Sexual predators; erectile dysfunction drugs.—
 2747         (1) A person may not possess a prescription drug, as
 2748  defined in s. 499.003(40) 499.003(43), for the purpose of
 2749  treating erectile dysfunction if the person is designated as a
 2750  sexual predator under s. 775.21.
 2751         Section 20. Paragraphs (d), (f), (i), and (j) of subsection
 2752  (3) of section 921.0022, Florida Statutes, are amended to read:
 2753         921.0022 Criminal Punishment Code; offense severity ranking
 2754  chart.—
 2755         (3) OFFENSE SEVERITY RANKING CHART
 2756         (d) LEVEL 4
 2757  
 2758  
 2759  FloridaStatute    FelonyDegree           Description            
 2760  316.1935(3)(a)       2nd   Driving at high speed or with wanton disregard for safety while fleeing or attempting to elude law enforcement officer who is in a patrol vehicle with siren and lights activated.
 2761  499.0051(1)          3rd   Failure to maintain or deliver transaction history, transaction information, or transaction statements pedigree papers.
 2762  499.0051(2)          3rd   Failure to authenticate pedigree papers.
 2763  499.0051(5) 499.0051(6)   2nd   Knowing sale or delivery, or possession with intent to sell, contraband prescription drugs.
 2764  517.07(1)            3rd   Failure to register securities.   
 2765  517.12(1)            3rd   Failure of dealer, associated person, or issuer of securities to register.
 2766  784.07(2)(b)         3rd   Battery of law enforcement officer, firefighter, etc.
 2767  784.074(1)(c)        3rd   Battery of sexually violent predators facility staff.
 2768  784.075              3rd   Battery on detention or commitment facility staff.
 2769  784.078              3rd   Battery of facility employee by throwing, tossing, or expelling certain fluids or materials.
 2770  784.08(2)(c)         3rd   Battery on a person 65 years of age or older.
 2771  784.081(3)           3rd   Battery on specified official or employee.
 2772  784.082(3)           3rd   Battery by detained person on visitor or other detainee.
 2773  784.083(3)           3rd   Battery on code inspector.        
 2774  784.085              3rd   Battery of child by throwing, tossing, projecting, or expelling certain fluids or materials.
 2775  787.03(1)            3rd   Interference with custody; wrongly takes minor from appointed guardian.
 2776  787.04(2)            3rd   Take, entice, or remove child beyond state limits with criminal intent pending custody proceedings.
 2777  787.04(3)            3rd   Carrying child beyond state lines with criminal intent to avoid producing child at custody hearing or delivering to designated person.
 2778  787.07               3rd   Human smuggling.                  
 2779  790.115(1)           3rd   Exhibiting firearm or weapon within 1,000 feet of a school.
 2780  790.115(2)(b)        3rd   Possessing electric weapon or device, destructive device, or other weapon on school property.
 2781  790.115(2)(c)        3rd   Possessing firearm on school property.
 2782  800.04(7)(c)         3rd   Lewd or lascivious exhibition; offender less than 18 years.
 2783  810.02(4)(a)         3rd   Burglary, or attempted burglary, of an unoccupied structure; unarmed; no assault or battery.
 2784  810.02(4)(b)         3rd   Burglary, or attempted burglary, of an unoccupied conveyance; unarmed; no assault or battery.
 2785  810.06               3rd   Burglary; possession of tools.    
 2786  810.08(2)(c)         3rd   Trespass on property, armed with firearm or dangerous weapon.
 2787  812.014(2)(c)3.      3rd   Grand theft, 3rd degree $10,000 or more but less than $20,000.
 2788  812.014 (2)(c)4.-10.   3rd   Grand theft, 3rd degree, a will, firearm, motor vehicle, livestock, etc.
 2789  812.0195(2)          3rd   Dealing in stolen property by use of the Internet; property stolen $300 or more.
 2790  817.563(1)           3rd   Sell or deliver substance other than controlled substance agreed upon, excluding s. 893.03(5) drugs.
 2791  817.568(2)(a)        3rd   Fraudulent use of personal identification information.
 2792  817.625(2)(a)        3rd   Fraudulent use of scanning device or reencoder.
 2793  828.125(1)           2nd   Kill, maim, or cause great bodily harm or permanent breeding disability to any registered horse or cattle.
 2794  837.02(1)            3rd   Perjury in official proceedings.  
 2795  837.021(1)           3rd   Make contradictory statements in official proceedings.
 2796  838.022              3rd   Official misconduct.              
 2797  839.13(2)(a)         3rd   Falsifying records of an individual in the care and custody of a state agency.
 2798  839.13(2)(c)         3rd   Falsifying records of the Department of Children and Families.
 2799  843.021              3rd   Possession of a concealed handcuff key by a person in custody.
 2800  843.025              3rd   Deprive law enforcement, correctional, or correctional probation officer of means of protection or communication.
 2801  843.15(1)(a)         3rd   Failure to appear while on bail for felony (bond estreature or bond jumping).
 2802  847.0135(5)(c)       3rd   Lewd or lascivious exhibition using computer; offender less than 18 years.
 2803  874.05(1)(a)         3rd   Encouraging or recruiting another to join a criminal gang.
 2804  893.13(2)(a)1.       2nd   Purchase of cocaine (or other s. 893.03(1)(a), (b), or (d), (2)(a), (2)(b), or (2)(c)4. drugs).
 2805  914.14(2)            3rd   Witnesses accepting bribes.       
 2806  914.22(1)            3rd   Force, threaten, etc., witness, victim, or informant.
 2807  914.23(2)            3rd   Retaliation against a witness, victim, or informant, no bodily injury.
 2808  918.12               3rd   Tampering with jurors.            
 2809  934.215              3rd   Use of two-way communications device to facilitate commission of a crime.
 2810  
 2811         (f) LEVEL 6
 2812  
 2813  
 2814  FloridaStatute    FelonyDegree           Description            
 2815  316.027(2)(b)        2nd   Leaving the scene of a crash involving serious bodily injury.
 2816  316.193(2)(b)        3rd   Felony DUI, 4th or subsequent conviction.
 2817  400.9935(4)(c)       2nd   Operating a clinic, or offering services requiring licensure, without a license.
 2818  499.0051(2) 499.0051(3)   2nd   Knowing forgery of transaction history, transaction information, or transaction statement pedigree papers.
 2819  499.0051(3) 499.0051(4)   2nd   Knowing purchase or receipt of prescription drug from unauthorized person.
 2820  499.0051(4) 499.0051(5)   2nd   Knowing sale or transfer of prescription drug to unauthorized person.
 2821  775.0875(1)          3rd   Taking firearm from law enforcement officer.
 2822  784.021(1)(a)        3rd   Aggravated assault; deadly weapon without intent to kill.
 2823  784.021(1)(b)        3rd   Aggravated assault; intent to commit felony.
 2824  784.041              3rd   Felony battery; domestic battery by strangulation.
 2825  784.048(3)           3rd   Aggravated stalking; credible threat.
 2826  784.048(5)           3rd   Aggravated stalking of person under 16.
 2827  784.07(2)(c)         2nd   Aggravated assault on law enforcement officer.
 2828  784.074(1)(b)        2nd   Aggravated assault on sexually violent predators facility staff.
 2829  784.08(2)(b)         2nd   Aggravated assault on a person 65 years of age or older.
 2830  784.081(2)           2nd   Aggravated assault on specified official or employee.
 2831  784.082(2)           2nd   Aggravated assault by detained person on visitor or other detainee.
 2832  784.083(2)           2nd   Aggravated assault on code inspector.
 2833  787.02(2)            3rd   False imprisonment; restraining with purpose other than those in s. 787.01.
 2834  790.115(2)(d)        2nd   Discharging firearm or weapon on school property.
 2835  790.161(2)           2nd   Make, possess, or throw destructive device with intent to do bodily harm or damage property.
 2836  790.164(1)           2nd   False report of deadly explosive, weapon of mass destruction, or act of arson or violence to state property.
 2837  790.19               2nd   Shooting or throwing deadly missiles into dwellings, vessels, or vehicles.
 2838  794.011(8)(a)        3rd   Solicitation of minor to participate in sexual activity by custodial adult.
 2839  794.05(1)            2nd   Unlawful sexual activity with specified minor.
 2840  800.04(5)(d)         3rd   Lewd or lascivious molestation; victim 12 years of age or older but less than 16 years of age; offender less than 18 years.
 2841  800.04(6)(b)         2nd   Lewd or lascivious conduct; offender 18 years of age or older.
 2842  806.031(2)           2nd   Arson resulting in great bodily harm to firefighter or any other person.
 2843  810.02(3)(c)         2nd   Burglary of occupied structure; unarmed; no assault or battery.
 2844  810.145(8)(b)        2nd   Video voyeurism; certain minor victims; 2nd or subsequent offense.
 2845  812.014(2)(b)1.      2nd   Property stolen $20,000 or more, but less than $100,000, grand theft in 2nd degree.
 2846  812.014(6)           2nd   Theft; property stolen $3,000 or more; coordination of others.
 2847  812.015(9)(a)        2nd   Retail theft; property stolen $300 or more; second or subsequent conviction.
 2848  812.015(9)(b)        2nd   Retail theft; property stolen $3,000 or more; coordination of others.
 2849  812.13(2)(c)         2nd   Robbery, no firearm or other weapon (strong-arm robbery).
 2850  817.4821(5)          2nd   Possess cloning paraphernalia with intent to create cloned cellular telephones.
 2851  825.102(1)           3rd   Abuse of an elderly person or disabled adult.
 2852  825.102(3)(c)        3rd   Neglect of an elderly person or disabled adult.
 2853  825.1025(3)          3rd   Lewd or lascivious molestation of an elderly person or disabled adult.
 2854  825.103(3)(c)        3rd   Exploiting an elderly person or disabled adult and property is valued at less than $10,000.
 2855  827.03(2)(c)         3rd   Abuse of a child.                 
 2856  827.03(2)(d)         3rd   Neglect of a child.               
 2857  827.071(2) & (3)     2nd   Use or induce a child in a sexual performance, or promote or direct such performance.
 2858  836.05               2nd   Threats; extortion.               
 2859  836.10               2nd   Written threats to kill or do bodily injury.
 2860  843.12               3rd   Aids or assists person to escape. 
 2861  847.011              3rd   Distributing, offering to distribute, or possessing with intent to distribute obscene materials depicting minors.
 2862  847.012              3rd   Knowingly using a minor in the production of materials harmful to minors.
 2863  847.0135(2)          3rd   Facilitates sexual conduct of or with a minor or the visual depiction of such conduct.
 2864  914.23               2nd   Retaliation against a witness, victim, or informant, with bodily injury.
 2865  944.35(3)(a)2.       3rd   Committing malicious battery upon or inflicting cruel or inhuman treatment on an inmate or offender on community supervision, resulting in great bodily harm.
 2866  944.40               2nd   Escapes.                          
 2867  944.46               3rd   Harboring, concealing, aiding escaped prisoners.
 2868  944.47(1)(a)5.       2nd   Introduction of contraband (firearm, weapon, or explosive) into correctional facility.
 2869  951.22(1)            3rd   Intoxicating drug, firearm, or weapon introduced into county facility.
 2870  
 2871         (i) LEVEL 9
 2872  
 2873  FloridaStatute            FelonyDegree         Description         
 2874  316.193 (3)(c)3.b.             1st     DUI manslaughter; failing to render aid or give information.
 2875  327.35 (3)(c)3.b.              1st     BUI manslaughter; failing to render aid or give information.
 2876  409.920 (2)(b)1.c.             1st     Medicaid provider fraud; $50,000 or more.
 2877  499.0051(8) 499.0051(9)        1st     Knowing sale or purchase of contraband prescription drugs resulting in great bodily harm.
 2878  560.123(8)(b)3.                1st     Failure to report currency or payment instruments totaling or exceeding $100,000 by money transmitter.
 2879  560.125(5)(c)                  1st     Money transmitter business by unauthorized person, currency, or payment instruments totaling or exceeding $100,000.
 2880  655.50(10)(b)3.                1st     Failure to report financial transactions totaling or exceeding $100,000 by financial institution.
 2881  775.0844                       1st     Aggravated white collar crime.
 2882  782.04(1)                      1st     Attempt, conspire, or solicit to commit premeditated murder.
 2883  782.04(3)                    1st,PBL   Accomplice to murder in connection with arson, sexual battery, robbery, burglary, aggravated fleeing or eluding with serious bodily injury or death, and other specified felonies.
 2884  782.051(1)                     1st     Attempted felony murder while perpetrating or attempting to perpetrate a felony enumerated in s. 782.04(3).
 2885  782.07(2)                      1st     Aggravated manslaughter of an elderly person or disabled adult.
 2886  787.01(1)(a)1.               1st,PBL   Kidnapping; hold for ransom or reward or as a shield or hostage.
 2887  787.01(1)(a)2.               1st,PBL   Kidnapping with intent to commit or facilitate commission of any felony.
 2888  787.01(1)(a)4.               1st,PBL   Kidnapping with intent to interfere with performance of any governmental or political function.
 2889  787.02(3)(a)                 1st,PBL   False imprisonment; child under age 13; perpetrator also commits aggravated child abuse, sexual battery, or lewd or lascivious battery, molestation, conduct, or exhibition.
 2890  787.06(3)(c)1.                 1st     Human trafficking for labor and services of an unauthorized alien child.
 2891  787.06(3)(d)                   1st     Human trafficking using coercion for commercial sexual activity of an unauthorized adult alien.
 2892  787.06(3)(f)1.               1st,PBL   Human trafficking for commercial sexual activity by the transfer or transport of any child from outside Florida to within the state.
 2893  790.161                        1st     Attempted capital destructive device offense.
 2894  790.166(2)                   1st,PBL   Possessing, selling, using, or attempting to use a weapon of mass destruction.
 2895  794.011(2)                     1st     Attempted sexual battery; victim less than 12 years of age.
 2896  794.011(2)                    Life     Sexual battery; offender younger than 18 years and commits sexual battery on a person less than 12 years.
 2897  794.011(4)(a)                1st,PBL   Sexual battery, certain circumstances; victim 12 years of age or older but younger than 18 years; offender 18 years or older.
 2898  794.011(4)(b)                  1st     Sexual battery, certain circumstances; victim and offender 18 years of age or older.
 2899  794.011(4)(c)                  1st     Sexual battery, certain circumstances; victim 12 years of age or older; offender younger than 18 years.
 2900  794.011(4)(d)                1st,PBL   Sexual battery, certain circumstances; victim 12 years of age or older; prior conviction for specified sex offenses.
 2901  794.011(8)(b)                1st,PBL   Sexual battery; engage in sexual conduct with minor 12 to 18 years by person in familial or custodial authority.
 2902  794.08(2)                      1st     Female genital mutilation; victim younger than 18 years of age.
 2903  800.04(5)(b)                  Life     Lewd or lascivious molestation; victim less than 12 years; offender 18 years or older.
 2904  812.13(2)(a)                 1st,PBL   Robbery with firearm or other deadly weapon.
 2905  812.133(2)(a)                1st,PBL   Carjacking; firearm or other deadly weapon.
 2906  812.135(2)(b)                  1st     Home-invasion robbery with weapon.
 2907  817.535(3)(b)                  1st     Filing false lien or other unauthorized document; second or subsequent offense; property owner is a public officer or employee.
 2908  817.535(4)(a)2.                1st     Filing false claim or other unauthorized document; defendant is incarcerated or under supervision.
 2909  817.535(5)(b)                  1st     Filing false lien or other unauthorized document; second or subsequent offense; owner of the property incurs financial loss as a result of the false instrument.
 2910  817.568(7)                   2nd,PBL   Fraudulent use of personal identification information of an individual under the age of 18 by his or her parent, legal guardian, or person exercising custodial authority.
 2911  827.03(2)(a)                   1st     Aggravated child abuse.     
 2912  847.0145(1)                    1st     Selling, or otherwise transferring custody or control, of a minor.
 2913  847.0145(2)                    1st     Purchasing, or otherwise obtaining custody or control, of a minor.
 2914  859.01                         1st     Poisoning or introducing bacteria, radioactive materials, viruses, or chemical compounds into food, drink, medicine, or water with intent to kill or injure another person.
 2915  893.135                        1st     Attempted capital trafficking offense.
 2916  893.135(1)(a)3.                1st     Trafficking in cannabis, more than 10,000 lbs.
 2917  893.135 (1)(b)1.c.             1st     Trafficking in cocaine, more than 400 grams, less than 150 kilograms.
 2918  893.135 (1)(c)1.c.             1st     Trafficking in illegal drugs, more than 28 grams, less than 30 kilograms.
 2919  893.135 (1)(c)2.d.             1st     Trafficking in hydrocodone, 200 grams or more, less than 30 kilograms.
 2920  893.135 (1)(c)3.d.             1st     Trafficking in oxycodone, 100 grams or more, less than 30 kilograms.
 2921  893.135 (1)(d)1.c.             1st     Trafficking in phencyclidine, more than 400 grams.
 2922  893.135 (1)(e)1.c.             1st     Trafficking in methaqualone, more than 25 kilograms.
 2923  893.135 (1)(f)1.c.             1st     Trafficking in amphetamine, more than 200 grams.
 2924  893.135 (1)(h)1.c.             1st     Trafficking in gamma-hydroxybutyric acid (GHB), 10 kilograms or more.
 2925  893.135 (1)(j)1.c.             1st     Trafficking in 1,4-Butanediol, 10 kilograms or more.
 2926  893.135 (1)(k)2.c.             1st     Trafficking in Phenethylamines, 400 grams or more.
 2927  896.101(5)(c)                  1st     Money laundering, financial instruments totaling or exceeding $100,000.
 2928  896.104(4)(a)3.                1st     Structuring transactions to evade reporting or registration requirements, financial transactions totaling or exceeding $100,000.
 2929  
 2930         (j) LEVEL 10
 2931  
 2932  FloridaStatute             FelonyDegree         Description        
 2933  499.0051(9) 499.0051(10)       1st      Knowing sale or purchase of contraband prescription drugs resulting in death.
 2934  782.04(2)                    1st,PBL    Unlawful killing of human; act is homicide, unpremeditated.
 2935  782.07(3)                      1st      Aggravated manslaughter of a child.
 2936  787.01(1)(a)3.               1st,PBL    Kidnapping; inflict bodily harm upon or terrorize victim.
 2937  787.01(3)(a)                   Life     Kidnapping; child under age 13, perpetrator also commits aggravated child abuse, sexual battery, or lewd or lascivious battery, molestation, conduct, or exhibition.
 2938  787.06(3)(g)                   Life     Human trafficking for commercial sexual activity of a child under the age of 18 or mentally defective or incapacitated person.
 2939  787.06(4)(a)                   Life     Selling or buying of minors into human trafficking.
 2940  794.011(3)                     Life     Sexual battery; victim 12 years or older, offender uses or threatens to use deadly weapon or physical force to cause serious injury.
 2941  812.135(2)(a)                1st,PBL    Home-invasion robbery with firearm or other deadly weapon.
 2942  876.32                         1st      Treason against the state. 
 2943  
 2944  
 2945         Section 21. This act shall take effect July 1, 2016.