Florida Senate - 2009                        COMMITTEE AMENDMENT
       Bill No. SB 1144
       
       
       
       
       
       
                                Barcode 620570                          
       
                              LEGISLATIVE ACTION                        
                    Senate             .             House              
                  Comm: RCS            .                                
                  03/25/2009           .                                
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       The Committee on Health Regulation (Jones) recommended the
       following:
       
    1         Senate Amendment (with title amendment)
    2  
    3         Delete everything after the enacting clause
    4  and insert:
    5         Section 1. Paragraph (a) of subsection (1) of section
    6  409.9201, Florida Statutes, is amended to read:
    7         409.9201 Medicaid fraud.—
    8         (1) As used in this section, the term:
    9         (a) “Prescription drug” means any drug, including, but not
   10  limited to, finished dosage forms or active ingredients that are
   11  subject to, defined by, or described by s. 503(b) of the Federal
   12  Food, Drug, and Cosmetic Act or by s. 465.003(8), s. 499.003(46)
   13  or (53) s. 499.003(45) or (52), or s. 499.007(13).
   14  
   15  The value of individual items of the legend drugs or goods or
   16  services involved in distinct transactions committed during a
   17  single scheme or course of conduct, whether involving a single
   18  person or several persons, may be aggregated when determining
   19  the punishment for the offense.
   20         Section 2. Subsection (3) of section 465.0265, Florida
   21  Statutes, is amended to read:
   22         465.0265 Centralized prescription filling.—
   23         (3) The filling, delivery, and return of a prescription by
   24  one pharmacy for another pursuant to this section shall not be
   25  construed as the filling of a transferred prescription as set
   26  forth in s. 465.026 or as a wholesale distribution as set forth
   27  in s. 499.003(54) s. 499.003(53).
   28         Section 3. Subsections (31) through (54) of section
   29  499.003, Florida Statutes, are amended to read:
   30         499.003 Definitions of terms used in this part.—As used in
   31  this part, the term:
   32         (31) “Manufacturer” means:
   33         (a) A person who prepares, derives, manufactures, or
   34  produces a drug, device, or cosmetic.
   35         (b) The holder or holders of a New Drug Application (NDA),
   36  an Abbreviated New Drug Application (ANDA), a Biologics License
   37  Application (BLA), or a New Animal Drug Application (NADA),
   38  provided such application has become effective or is otherwise
   39  approved consistent with s. 499.023.;
   40         (c) A private label distributor for whom the private label
   41  distributor’s prescription drugs are originally manufactured and
   42  labeled for the distributor and have not been repackaged; or the
   43  distribution point for the manufacturer, contract manufacturer,
   44  or private label distributor whether the establishment is a
   45  member of the manufacturer’s affiliated group or is a contract
   46  distribution site.
   47         (d)A person registered under the federal act as a
   48  manufacturer who has entered into a written agreement with
   49  another manufacturer that authorizes either manufacturer to
   50  distribute a prescription drug, which is identified in the
   51  agreement, as the manufacturer of that drug consistent with the
   52  federal act.
   53  
   54  The term excludes pharmacies that are operating in compliance
   55  with pharmacy practice standards as defined in chapter 465 and
   56  rules adopted under that chapter.
   57         (32) Manufacturer’s distributormeans a person permitted
   58  under this part as a prescription drug manufacturer’s
   59  distributor.
   60         (33)(32) “New drug” means:
   61         (a) Any drug the composition of which is such that the drug
   62  is not generally recognized, among experts qualified by
   63  scientific training and experience to evaluate the safety and
   64  effectiveness of drugs, as safe and effective for use under the
   65  conditions prescribed, recommended, or suggested in the labeling
   66  of that drug; or
   67         (b) Any drug the composition of which is such that the
   68  drug, as a result of investigations to determine its safety and
   69  effectiveness for use under certain conditions, has been
   70  recognized for use under such conditions, but which drug has
   71  not, other than in those investigations, been used to a material
   72  extent or for a material time under such conditions.
   73         (34)(33) “Normal distribution chain” means a wholesale
   74  distribution of a prescription drug in which the wholesale
   75  distributor or its wholly owned subsidiary purchases and
   76  receives the specific unit of the prescription drug directly
   77  from the manufacturer or manufacturer’s distributor; receives
   78  the specific unit of the prescription drug directly from the
   79  manufacturer, manufacturer’s distributor, or manufacturer’s
   80  third-party logistics provider; and distributes the prescription
   81  drug directly, or through up to two intracompany transfers, to a
   82  chain pharmacy warehouse or a person authorized by law to
   83  purchase prescription drugs for the purpose of administering or
   84  dispensing the drug, as defined in s. 465.003. For purposes of
   85  this subsection, the term “intracompany” means any transaction
   86  or transfer between any parent, division, or subsidiary wholly
   87  owned by a corporate entity.
   88         (35)(34) “Nursing home” means a facility licensed under
   89  part II of chapter 400.
   90         (36)(35) “Official compendium” means the current edition of
   91  the official United States Pharmacopoeia and National Formulary,
   92  or any supplement thereto.
   93         (37)(36) “Pedigree paper” means a document in written or
   94  electronic form approved by the department which contains
   95  information required by s. 499.01212 regarding the sale and
   96  distribution of any given prescription drug.
   97         (38)(37) “Permittee” means any person holding a permit
   98  issued pursuant to s. 499.012.
   99         (39)(38) “Person” means any individual, child, joint
  100  venture, syndicate, fiduciary, partnership, corporation,
  101  division of a corporation, firm, trust, business trust, company,
  102  estate, public or private institution, association,
  103  organization, group, city, county, city and county, political
  104  subdivision of this state, other governmental agency within this
  105  state, and any representative, agent, or agency of any of the
  106  foregoing, or any other group or combination of the foregoing.
  107         (40)(39) “Pharmacist” means a person licensed under chapter
  108  465.
  109         (41)(40) “Pharmacy” means an entity licensed under chapter
  110  465.
  111         (42)(41) “Prepackaged drug product” means a drug that
  112  originally was in finished packaged form sealed by a
  113  manufacturer and that is placed in a properly labeled container
  114  by a pharmacy or practitioner authorized to dispense pursuant to
  115  chapter 465 for the purpose of dispensing in the establishment
  116  in which the prepackaging occurred.
  117         (43)(42) “Prescription drug” means a prescription,
  118  medicinal, or legend drug, including, but not limited to,
  119  finished dosage forms or active ingredients subject to, defined
  120  by, or described by s. 503(b) of the Federal Food, Drug, and
  121  Cosmetic Act or s. 465.003(8), s. 499.007(13), or subsection
  122  (11), subsection (48) (47), or subsection (53) (52).
  123         (44)(43) “Prescription drug label” means any display of
  124  written, printed, or graphic matter upon the immediate container
  125  of any prescription drug prior to its dispensing to an
  126  individual patient pursuant to a prescription of a practitioner
  127  authorized by law to prescribe.
  128         (45)(44) “Prescription label” means any display of written,
  129  printed, or graphic matter upon the immediate container of any
  130  prescription drug dispensed pursuant to a prescription of a
  131  practitioner authorized by law to prescribe.
  132         (46)(45) “Prescription medical oxygen” means oxygen USP
  133  which is a drug that can only be sold on the order or
  134  prescription of a practitioner authorized by law to prescribe.
  135  The label of prescription medical oxygen must comply with
  136  current labeling requirements for oxygen under the Federal Food,
  137  Drug, and Cosmetic Act.
  138         (47)(46) “Primary wholesale distributor” means any
  139  wholesale distributor that:
  140         (a) Purchased 90 percent or more of the total dollar volume
  141  of its purchases of prescription drugs directly from
  142  manufacturers in the previous year; and
  143         (b)1. Directly purchased prescription drugs from not fewer
  144  than 50 different prescription drug manufacturers in the
  145  previous year; or
  146         2. Has, or the affiliated group, as defined in s. 1504 of
  147  the Internal Revenue Code, of which the wholesale distributor is
  148  a member has, not fewer than 250 employees.
  149         (c) For purposes of this subsection, “directly from
  150  manufacturers” means:
  151         1. Purchases made by the wholesale distributor directly
  152  from the manufacturer of prescription drugs; and
  153         2. Transfers from a member of an affiliated group, as
  154  defined in s. 1504 of the Internal Revenue Code, of which the
  155  wholesale distributor is a member, if:
  156         a. The affiliated group purchases 90 percent or more of the
  157  total dollar volume of its purchases of prescription drugs from
  158  the manufacturer in the previous year; and
  159         b. The wholesale distributor discloses to the department
  160  the names of all members of the affiliated group of which the
  161  wholesale distributor is a member and the affiliated group
  162  agrees in writing to provide records on prescription drug
  163  purchases by the members of the affiliated group not later than
  164  48 hours after the department requests access to such records,
  165  regardless of the location where the records are stored.
  166         (48)(47) “Proprietary drug,” or “OTC drug,” means a patent
  167  or over-the-counter drug in its unbroken, original package,
  168  which drug is sold to the public by, or under the authority of,
  169  the manufacturer or primary distributor thereof, is not
  170  misbranded under the provisions of this part, and can be
  171  purchased without a prescription.
  172         (49)(48) “Repackage” includes repacking or otherwise
  173  changing the container, wrapper, or labeling to further the
  174  distribution of the drug, device, or cosmetic.
  175         (50)(49) “Repackager” means a person who repackages. The
  176  term excludes pharmacies that are operating in compliance with
  177  pharmacy practice standards as defined in chapter 465 and rules
  178  adopted under that chapter.
  179         (51)(50) “Retail pharmacy” means a community pharmacy
  180  licensed under chapter 465 that purchases prescription drugs at
  181  fair market prices and provides prescription services to the
  182  public.
  183         (52)(51) “Secondary wholesale distributor” means a
  184  wholesale distributor that is not a primary wholesale
  185  distributor.
  186         (53)(52) “Veterinary prescription drug” means a
  187  prescription drug intended solely for veterinary use. The label
  188  of the drug must bear the statement, “Caution: Federal law
  189  restricts this drug to sale by or on the order of a licensed
  190  veterinarian.”
  191         (54)(53) “Wholesale distribution” means distribution of
  192  prescription drugs to persons other than a consumer or patient,
  193  but does not include:
  194         (a) Any of the following activities, which is not a
  195  violation of s. 499.005(21) if such activity is conducted in
  196  accordance with s. 499.01(2)(g):
  197         1. The purchase or other acquisition by a hospital or other
  198  health care entity that is a member of a group purchasing
  199  organization of a prescription drug for its own use from the
  200  group purchasing organization or from other hospitals or health
  201  care entities that are members of that organization.
  202         2. The sale, purchase, or trade of a prescription drug or
  203  an offer to sell, purchase, or trade a prescription drug by a
  204  charitable organization described in s. 501(c)(3) of the
  205  Internal Revenue Code of 1986, as amended and revised, to a
  206  nonprofit affiliate of the organization to the extent otherwise
  207  permitted by law.
  208         3. The sale, purchase, or trade of a prescription drug or
  209  an offer to sell, purchase, or trade a prescription drug among
  210  hospitals or other health care entities that are under common
  211  control. For purposes of this subparagraph, “common control”
  212  means the power to direct or cause the direction of the
  213  management and policies of a person or an organization, whether
  214  by ownership of stock, by voting rights, by contract, or
  215  otherwise.
  216         4. The sale, purchase, trade, or other transfer of a
  217  prescription drug from or for any federal, state, or local
  218  government agency or any entity eligible to purchase
  219  prescription drugs at public health services prices pursuant to
  220  Pub. L. No. 102-585, s. 602 to a contract provider or its
  221  subcontractor for eligible patients of the agency or entity
  222  under the following conditions:
  223         a. The agency or entity must obtain written authorization
  224  for the sale, purchase, trade, or other transfer of a
  225  prescription drug under this subparagraph from the State Surgeon
  226  General or his or her designee.
  227         b. The contract provider or subcontractor must be
  228  authorized by law to administer or dispense prescription drugs.
  229         c. In the case of a subcontractor, the agency or entity
  230  must be a party to and execute the subcontract.
  231         d. A contract provider or subcontractor must maintain
  232  separate and apart from other prescription drug inventory any
  233  prescription drugs of the agency or entity in its possession.
  234         e. The contract provider and subcontractor must maintain
  235  and produce immediately for inspection all records of movement
  236  or transfer of all the prescription drugs belonging to the
  237  agency or entity, including, but not limited to, the records of
  238  receipt and disposition of prescription drugs. Each contractor
  239  and subcontractor dispensing or administering these drugs must
  240  maintain and produce records documenting the dispensing or
  241  administration. Records that are required to be maintained
  242  include, but are not limited to, a perpetual inventory itemizing
  243  drugs received and drugs dispensed by prescription number or
  244  administered by patient identifier, which must be submitted to
  245  the agency or entity quarterly.
  246         f. The contract provider or subcontractor may administer or
  247  dispense the prescription drugs only to the eligible patients of
  248  the agency or entity or must return the prescription drugs for
  249  or to the agency or entity. The contract provider or
  250  subcontractor must require proof from each person seeking to
  251  fill a prescription or obtain treatment that the person is an
  252  eligible patient of the agency or entity and must, at a minimum,
  253  maintain a copy of this proof as part of the records of the
  254  contractor or subcontractor required under sub-subparagraph e.
  255         g. In addition to the departmental inspection authority set
  256  forth in s. 499.051, the establishment of the contract provider
  257  and subcontractor and all records pertaining to prescription
  258  drugs subject to this subparagraph shall be subject to
  259  inspection by the agency or entity. All records relating to
  260  prescription drugs of a manufacturer under this subparagraph
  261  shall be subject to audit by the manufacturer of those drugs,
  262  without identifying individual patient information.
  263         (b) Any of the following activities, which is not a
  264  violation of s. 499.005(21) if such activity is conducted in
  265  accordance with rules established by the department:
  266         1. The sale, purchase, or trade of a prescription drug
  267  among federal, state, or local government health care entities
  268  that are under common control and are authorized to purchase
  269  such prescription drug.
  270         2. The sale, purchase, or trade of a prescription drug or
  271  an offer to sell, purchase, or trade a prescription drug for
  272  emergency medical reasons. For purposes of this subparagraph,
  273  the term “emergency medical reasons” includes transfers of
  274  prescription drugs by a retail pharmacy to another retail
  275  pharmacy to alleviate a temporary shortage.
  276         3. The transfer of a prescription drug acquired by a
  277  medical director on behalf of a licensed emergency medical
  278  services provider to that emergency medical services provider
  279  and its transport vehicles for use in accordance with the
  280  provider’s license under chapter 401.
  281         4. The revocation of a sale or the return of a prescription
  282  drug to the person’s prescription drug wholesale supplier.
  283         5. The donation of a prescription drug by a health care
  284  entity to a charitable organization that has been granted an
  285  exemption under s. 501(c)(3) of the Internal Revenue Code of
  286  1986, as amended, and that is authorized to possess prescription
  287  drugs.
  288         6. The transfer of a prescription drug by a person
  289  authorized to purchase or receive prescription drugs to a person
  290  licensed or permitted to handle reverse distributions or
  291  destruction under the laws of the jurisdiction in which the
  292  person handling the reverse distribution or destruction receives
  293  the drug.
  294         7. The transfer of a prescription drug by a hospital or
  295  other health care entity to a person licensed under this part to
  296  repackage prescription drugs for the purpose of repackaging the
  297  prescription drug for use by that hospital, or other health care
  298  entity and other health care entities that are under common
  299  control, if ownership of the prescription drugs remains with the
  300  hospital or other health care entity at all times. In addition
  301  to the recordkeeping requirements of s. 499.0121(6), the
  302  hospital or health care entity that transfers prescription drugs
  303  pursuant to this subparagraph must reconcile all drugs
  304  transferred and returned and resolve any discrepancies in a
  305  timely manner.
  306         (c) The distribution of prescription drug samples by
  307  manufacturers’ representatives or distributors’ representatives
  308  conducted in accordance with s. 499.028.
  309         (d) The sale, purchase, or trade of blood and blood
  310  components intended for transfusion. As used in this paragraph,
  311  the term “blood” means whole blood collected from a single donor
  312  and processed for transfusion or further manufacturing, and the
  313  term “blood components” means that part of the blood separated
  314  by physical or mechanical means.
  315         (e) The lawful dispensing of a prescription drug in
  316  accordance with chapter 465.
  317         (f) The sale, purchase, or trade of a prescription drug
  318  between pharmacies as a result of a sale, transfer, merger, or
  319  consolidation of all or part of the business of the pharmacies
  320  from or with another pharmacy, whether accomplished as a
  321  purchase and sale of stock or of business assets.
  322         (55)(54) “Wholesale distributor” means any person engaged
  323  in wholesale distribution of prescription drugs in or into this
  324  state, including, but not limited to, manufacturers;
  325  repackagers; own-label distributors; jobbers; private-label
  326  distributors; brokers; warehouses, including manufacturers’ and
  327  distributors’ warehouses, chain drug warehouses, and wholesale
  328  drug warehouses; independent wholesale drug traders; exporters;
  329  retail pharmacies; and the agents thereof that conduct wholesale
  330  distributions.
  331         Section 4. Section 499.01, Florida Statutes, is amended to
  332  read:
  333         499.01 Permits.—
  334         (1) Prior to operating, a permit is required for each
  335  person and establishment that intends to operate as:
  336         (a) A prescription drug manufacturer;
  337         (b) A prescription drug repackager;
  338         (c) A nonresident prescription drug manufacturer;
  339         (d) A prescription drug wholesale distributor;
  340         (e) An out-of-state prescription drug wholesale
  341  distributor;
  342         (f) A retail pharmacy drug wholesale distributor;
  343         (g) A restricted prescription drug distributor;
  344         (h) A complimentary drug distributor;
  345         (i) A freight forwarder;
  346         (j) A veterinary prescription drug retail establishment;
  347         (k) A veterinary prescription drug wholesale distributor;
  348         (l) A limited prescription drug veterinary wholesale
  349  distributor;
  350         (m) A medical oxygen retail establishment;
  351         (n) A compressed medical gas wholesale distributor;
  352         (o) A compressed medical gas manufacturer;
  353         (p) An over-the-counter drug manufacturer;
  354         (q) A device manufacturer;
  355         (r) A cosmetic manufacturer;
  356         (s) A third-party third party logistics provider; or
  357         (t) A health care clinic establishment; or.
  358         (u)A prescription drug manufacturer’s distributor.
  359         (2) The following permits are established:
  360         (a) Prescription drug manufacturer permit.—A prescription
  361  drug manufacturer permit is required for any person or entity
  362  that is a manufacturer of manufactures a prescription drug and
  363  manufactures or distributes its prescription drugs at or from an
  364  establishment in this state.
  365         1. A person that operates an establishment permitted as a
  366  prescription drug manufacturer may engage in wholesale
  367  distribution of prescription drugs manufactured at that
  368  establishment and must comply with all the provisions of this
  369  part and the rules adopted under this part that apply to a
  370  wholesale distributor, except the provisions in s. 499.01212.
  371         2. A prescription drug manufacturer must comply with all
  372  appropriate state and federal good manufacturing practices.
  373         (b) Prescription drug repackager permit.—A prescription
  374  drug repackager permit is required for any person that
  375  repackages a prescription drug in this state.
  376         1. A person that operates an establishment permitted as a
  377  prescription drug repackager may engage in wholesale
  378  distribution of prescription drugs repackaged at that
  379  establishment and must comply with all the provisions of this
  380  part and the rules adopted under this part that apply to a
  381  wholesale distributor.
  382         2. A prescription drug repackager must comply with all
  383  appropriate state and federal good manufacturing practices.
  384         (c) Nonresident prescription drug manufacturer permit.—A
  385  nonresident prescription drug manufacturer permit is required
  386  for any person that is a manufacturer of prescription drugs, or
  387  the distribution point for a manufacturer of prescription drugs
  388  unless permitted as a third party logistics provider, and
  389  located outside of this state, or that is an entity to whom an
  390  approved new drug application has been issued by the United
  391  States Food and Drug Administration, or the contracted
  392  manufacturer of the approved new drug application holder, and
  393  located outside the United States, which engages in the
  394  wholesale distribution in this state of the prescription drugs
  395  it manufactures or is responsible for manufacturing. Each such
  396  manufacturer or entity must be permitted by the department and
  397  comply with all the provisions required of a wholesale
  398  distributor under this part, except s. 499.01212.
  399         1. A person that distributes prescription drugs for which
  400  he or she is not the manufacturer that it did not manufacture
  401  must also obtain an out-of-state prescription drug wholesale
  402  distributor permit, third-party logistics provider permit, or
  403  prescription drug manufacturer’s distributor permit, as
  404  applicable, pursuant to this section to engage in the wholesale
  405  distribution of the prescription drugs for which it is not the
  406  manufacturer manufactured by another person and comply with the
  407  requirements of that permit for the wholesale distribution of
  408  those prescription drugs for which the person is not the
  409  manufacturer an out-of-state prescription drug wholesale
  410  distributor.
  411         2. Any such person must comply with the licensing or
  412  permitting requirements of the jurisdiction in which the
  413  establishment is located and the federal act, and any product
  414  wholesaled into this state must comply with this part. If a
  415  person intends to import prescription drugs from a foreign
  416  country into this state, the nonresident prescription drug
  417  manufacturer must provide to the department a list identifying
  418  each prescription drug it intends to import and document
  419  approval by the United States Food and Drug Administration for
  420  such importation.
  421         3. A nonresident prescription drug manufacturer permit,
  422  prescription drug manufacturer’s distributor permit, or third
  423  party logistics provider permit is not required for a
  424  manufacturer to distribute, directly or through the
  425  manufacturer’s distributor or third-party logistics provider, a
  426  prescription drug active pharmaceutical ingredient that it
  427  manufactures to a prescription drug manufacturer permitted in
  428  this state in limited quantities intended for research and
  429  development and not for resale, or human use other than lawful
  430  clinical trials and biostudies authorized and regulated by
  431  federal law. A manufacturer, manufacturer’s distributor, or
  432  third-party logistics provider claiming to be exempt from the
  433  permit requirements of this subparagraph and the prescription
  434  drug manufacturer purchasing and receiving the active
  435  pharmaceutical ingredient shall comply with the recordkeeping
  436  requirements of s. 499.0121(6), but not the requirements of s.
  437  499.01212. The prescription drug manufacturer purchasing and
  438  receiving the active pharmaceutical ingredient shall maintain on
  439  file a record of the FDA registration number; the out-of-state
  440  license, permit, or registration number; and, if available, a
  441  copy of the most current FDA inspection report, for all
  442  manufacturers, manufacturer’s distributors, or third-party
  443  logistics providers from whom they purchase and receive active
  444  pharmaceutical ingredients under this section. The department
  445  shall specify by rule the allowable number of transactions
  446  within a given period of time and the amount of active
  447  pharmaceutical ingredients that qualify as limited quantities
  448  for purposes of this exemption. The failure to comply with the
  449  requirements of this subparagraph, or rules adopted by the
  450  department to administer this subparagraph, for the purchase of
  451  prescription drug active pharmaceutical ingredients is a
  452  violation of s. 499.005(14).
  453         (d) Prescription drug wholesale distributor permit.—A
  454  prescription drug wholesale distributor is a wholesale
  455  distributor that may engage in the wholesale distribution of
  456  prescription drugs. A prescription drug wholesale distributor
  457  that applies to the department for a new permit or the renewal
  458  of a permit must submit a bond of $100,000, or other equivalent
  459  means of security acceptable to the department, such as an
  460  irrevocable letter of credit or a deposit in a trust account or
  461  financial institution, payable to the Florida Drug, Device, and
  462  Cosmetic Trust Fund. The purpose of the bond is to secure
  463  payment of any administrative penalties imposed by the
  464  department and any fees and costs incurred by the department
  465  regarding that permit which are authorized under state law and
  466  which the permittee fails to pay 30 days after the fine or costs
  467  become final. The department may make a claim against such bond
  468  or security until 1 year after the permittee’s license ceases to
  469  be valid or until 60 days after any administrative or legal
  470  proceeding authorized in this part which involves the permittee
  471  is concluded, including any appeal, whichever occurs later. The
  472  department may adopt rules for issuing a prescription drug
  473  wholesale distributor-broker permit to a person who engages in
  474  the wholesale distribution of prescription drugs and does not
  475  take physical possession of any prescription drugs.
  476         (e) Out-of-state prescription drug wholesale distributor
  477  permit.—An out-of-state prescription drug wholesale distributor
  478  is a wholesale distributor located outside this state which
  479  engages in the wholesale distribution of prescription drugs into
  480  this state and which must be permitted by the department and
  481  comply with all the provisions required of a wholesale
  482  distributor under this part. An out-of-state prescription drug
  483  wholesale distributor that applies to the department for a new
  484  permit or the renewal of a permit must submit a bond of
  485  $100,000, or other equivalent means of security acceptable to
  486  the department, such as an irrevocable letter of credit or a
  487  deposit in a trust account or financial institution, payable to
  488  the Florida Drug, Device, and Cosmetic Trust Fund. The purpose
  489  of the bond is to secure payment of any administrative penalties
  490  imposed by the department and any fees and costs incurred by the
  491  department regarding that permit which are authorized under
  492  state law and which the permittee fails to pay 30 days after the
  493  fine or costs become final. The department may make a claim
  494  against such bond or security until 1 year after the permittee’s
  495  license ceases to be valid or until 60 days after any
  496  administrative or legal proceeding authorized in this part which
  497  involves the permittee is concluded, including any appeal,
  498  whichever occurs later.
  499         1. The out-of-state prescription drug wholesale distributor
  500  must maintain at all times a license or permit to engage in the
  501  wholesale distribution of prescription drugs in compliance with
  502  laws of the state in which it is a resident.
  503         2. An out-of-state prescription drug wholesale distributor
  504  permit is not required for an intracompany sale or transfer of a
  505  prescription drug from an out-of-state establishment that is
  506  duly licensed as a prescription drug wholesale distributor, in
  507  its state of residence, to a licensed prescription drug
  508  wholesale distributor in this state, if both wholesale
  509  distributors conduct wholesale distributions of prescription
  510  drugs under the same business name. The recordkeeping
  511  requirements of ss. 499.0121(6) and 499.01212 must be followed
  512  for this transaction.
  513         (f) Retail pharmacy drug wholesale distributor permit.—A
  514  retail pharmacy drug wholesale distributor is a retail pharmacy
  515  engaged in wholesale distribution of prescription drugs within
  516  this state under the following conditions:
  517         1. The pharmacy must obtain a retail pharmacy drug
  518  wholesale distributor permit pursuant to this part and the rules
  519  adopted under this part.
  520         2. The wholesale distribution activity does not exceed 30
  521  percent of the total annual purchases of prescription drugs. If
  522  the wholesale distribution activity exceeds the 30-percent
  523  maximum, the pharmacy must obtain a prescription drug wholesale
  524  distributor permit.
  525         3. The transfer of prescription drugs that appear in any
  526  schedule contained in chapter 893 is subject to chapter 893 and
  527  the federal Comprehensive Drug Abuse Prevention and Control Act
  528  of 1970.
  529         4. The transfer is between a retail pharmacy and another
  530  retail pharmacy, or a Modified Class II institutional pharmacy,
  531  or a health care practitioner licensed in this state and
  532  authorized by law to dispense or prescribe prescription drugs.
  533         5. All records of sales of prescription drugs subject to
  534  this section must be maintained separate and distinct from other
  535  records and comply with the recordkeeping requirements of this
  536  part.
  537         (g) Restricted prescription drug distributor permit.—A
  538  restricted prescription drug distributor permit is required for
  539  any person that engages in the distribution of a prescription
  540  drug, which distribution is not considered “wholesale
  541  distribution” under s. 499.003(54)(a) s. 499.003(53)(a).
  542         1. A person who engages in the receipt or distribution of a
  543  prescription drug in this state for the purpose of processing
  544  its return or its destruction must obtain a permit as a
  545  restricted prescription drug distributor if such person is not
  546  the person initiating the return, the prescription drug
  547  wholesale supplier of the person initiating the return, or the
  548  manufacturer of the drug.
  549         2. Storage, handling, and recordkeeping of these
  550  distributions must comply with the requirements for wholesale
  551  distributors under s. 499.0121, but not those set forth in s.
  552  499.01212.
  553         3. A person who applies for a permit as a restricted
  554  prescription drug distributor, or for the renewal of such a
  555  permit, must provide to the department the information required
  556  under s. 499.012.
  557         4. The department may adopt rules regarding the
  558  distribution of prescription drugs by hospitals, health care
  559  entities, charitable organizations, or other persons not
  560  involved in wholesale distribution, which rules are necessary
  561  for the protection of the public health, safety, and welfare.
  562         (h) Complimentary drug distributor permit.—A complimentary
  563  drug distributor permit is required for any person that engages
  564  in the distribution of a complimentary drug, subject to the
  565  requirements of s. 499.028.
  566         (i) Freight forwarder permit.—A freight forwarder permit is
  567  required for any person that engages in the distribution of a
  568  prescription drug as a freight forwarder unless the person is a
  569  common carrier. The storage, handling, and recordkeeping of such
  570  distributions must comply with the requirements for wholesale
  571  distributors under s. 499.0121, but not those set forth in s.
  572  499.01212. A freight forwarder must provide the source of the
  573  prescription drugs with a validated airway bill, bill of lading,
  574  or other appropriate documentation to evidence the exportation
  575  of the product.
  576         (j) Veterinary prescription drug retail establishment
  577  permit.—A veterinary prescription drug retail establishment
  578  permit is required for any person that sells veterinary
  579  prescription drugs to the public but does not include a pharmacy
  580  licensed under chapter 465.
  581         1. The sale to the public must be based on a valid written
  582  order from a veterinarian licensed in this state who has a valid
  583  client-veterinarian relationship with the purchaser’s animal.
  584         2. Veterinary prescription drugs may not be sold in excess
  585  of the amount clearly indicated on the order or beyond the date
  586  indicated on the order.
  587         3. An order may not be valid for more than 1 year.
  588         4. A veterinary prescription drug retail establishment may
  589  not purchase, sell, trade, or possess human prescription drugs
  590  or any controlled substance as defined in chapter 893.
  591         5. A veterinary prescription drug retail establishment must
  592  sell a veterinary prescription drug in the original, sealed
  593  manufacturer’s container with all labeling intact and legible.
  594  The department may adopt by rule additional labeling
  595  requirements for the sale of a veterinary prescription drug.
  596         6. A veterinary prescription drug retail establishment must
  597  comply with all of the wholesale distribution requirements of s.
  598  499.0121.
  599         7. Prescription drugs sold by a veterinary prescription
  600  drug retail establishment pursuant to a practitioner’s order may
  601  not be returned into the retail establishment’s inventory.
  602         (k) Veterinary prescription drug wholesale distributor
  603  permit.—A veterinary prescription drug wholesale distributor
  604  permit is required for any person that engages in the
  605  distribution of veterinary prescription drugs in or into this
  606  state. A veterinary prescription drug wholesale distributor that
  607  also distributes prescription drugs subject to, defined by, or
  608  described by s. 503(b) of the Federal Food, Drug, and Cosmetic
  609  Act which it did not manufacture must obtain a permit as a
  610  prescription drug wholesale distributor, an out-of-state
  611  prescription drug wholesale distributor, or a limited
  612  prescription drug veterinary wholesale distributor in lieu of
  613  the veterinary prescription drug wholesale distributor permit. A
  614  veterinary prescription drug wholesale distributor must comply
  615  with the requirements for wholesale distributors under s.
  616  499.0121, but not those set forth in s. 499.01212.
  617         (l) Limited prescription drug veterinary wholesale
  618  distributor permit.—Unless engaging in the activities of and
  619  permitted as a prescription drug manufacturer, nonresident
  620  prescription drug manufacturer, prescription drug wholesale
  621  distributor, or out-of-state prescription drug wholesale
  622  distributor, a limited prescription drug veterinary wholesale
  623  distributor permit is required for any person that engages in
  624  the distribution in or into this state of veterinary
  625  prescription drugs and prescription drugs subject to, defined
  626  by, or described by s. 503(b) of the Federal Food, Drug, and
  627  Cosmetic Act under the following conditions:
  628         1. The person is engaged in the business of wholesaling
  629  prescription and veterinary prescription drugs to persons:
  630         a. Licensed as veterinarians practicing on a full-time
  631  basis;
  632         b. Regularly and lawfully engaged in instruction in
  633  veterinary medicine;
  634         c. Regularly and lawfully engaged in law enforcement
  635  activities;
  636         d. For use in research not involving clinical use; or
  637         e. For use in chemical analysis or physical testing or for
  638  purposes of instruction in law enforcement activities, research,
  639  or testing.
  640         2. No more than 30 percent of total annual prescription
  641  drug sales may be prescription drugs approved for human use
  642  which are subject to, defined by, or described by s. 503(b) of
  643  the Federal Food, Drug, and Cosmetic Act.
  644         3. The person does not distribute in any jurisdiction
  645  prescription drugs subject to, defined by, or described by s.
  646  503(b) of the Federal Food, Drug, and Cosmetic Act to any person
  647  who is authorized to sell, distribute, purchase, trade, or use
  648  these drugs on or for humans.
  649         4. A limited prescription drug veterinary wholesale
  650  distributor that applies to the department for a new permit or
  651  the renewal of a permit must submit a bond of $20,000, or other
  652  equivalent means of security acceptable to the department, such
  653  as an irrevocable letter of credit or a deposit in a trust
  654  account or financial institution, payable to the Florida Drug,
  655  Device, and Cosmetic Trust Fund. The purpose of the bond is to
  656  secure payment of any administrative penalties imposed by the
  657  department and any fees and costs incurred by the department
  658  regarding that permit which are authorized under state law and
  659  which the permittee fails to pay 30 days after the fine or costs
  660  become final. The department may make a claim against such bond
  661  or security until 1 year after the permittee’s license ceases to
  662  be valid or until 60 days after any administrative or legal
  663  proceeding authorized in this part which involves the permittee
  664  is concluded, including any appeal, whichever occurs later.
  665         5. A limited prescription drug veterinary wholesale
  666  distributor must maintain at all times a license or permit to
  667  engage in the wholesale distribution of prescription drugs in
  668  compliance with laws of the state in which it is a resident.
  669         6. A limited prescription drug veterinary wholesale
  670  distributor must comply with the requirements for wholesale
  671  distributors under ss. 499.0121 and 499.01212, except that a
  672  limited prescription drug veterinary wholesale distributor is
  673  not required to provide a pedigree paper as required by s.
  674  499.01212 upon the wholesale distribution of a prescription drug
  675  to a veterinarian.
  676         7. A limited prescription drug veterinary wholesale
  677  distributor may not return to inventory for subsequent wholesale
  678  distribution any prescription drug subject to, defined by, or
  679  described by s. 503(b) of the Federal Food, Drug, and Cosmetic
  680  Act which has been returned by a veterinarian.
  681         8. A limited prescription drug veterinary wholesale
  682  distributor permit is not required for an intracompany sale or
  683  transfer of a prescription drug from an out-of-state
  684  establishment that is duly licensed to engage in the wholesale
  685  distribution of prescription drugs in its state of residence to
  686  a licensed limited prescription drug veterinary wholesale
  687  distributor in this state if both wholesale distributors conduct
  688  wholesale distributions of prescription drugs under the same
  689  business name. The recordkeeping requirements of ss. 499.0121(6)
  690  and 499.01212 must be followed for this transaction.
  691         (m) Medical oxygen retail establishment permit.—A medical
  692  oxygen retail establishment permit is required for any person
  693  that sells medical oxygen to patients only. The sale must be
  694  based on an order from a practitioner authorized by law to
  695  prescribe. The term does not include a pharmacy licensed under
  696  chapter 465.
  697         1. A medical oxygen retail establishment may not possess,
  698  purchase, sell, or trade any prescription drug other than
  699  medical oxygen.
  700         2. A medical oxygen retail establishment may refill medical
  701  oxygen for an individual patient based on an order from a
  702  practitioner authorized by law to prescribe. A medical oxygen
  703  retail establishment that refills medical oxygen must comply
  704  with all appropriate state and federal good manufacturing
  705  practices.
  706         3. A medical oxygen retail establishment must comply with
  707  all of the wholesale distribution requirements of s. 499.0121.
  708         4. Prescription medical oxygen sold by a medical oxygen
  709  retail establishment pursuant to a practitioner’s order may not
  710  be returned into the retail establishment’s inventory.
  711         (n) Compressed medical gas wholesale distributor permit.—A
  712  compressed medical gas wholesale distributor is a wholesale
  713  distributor that is limited to the wholesale distribution of
  714  compressed medical gases to other than the consumer or patient.
  715  The compressed medical gas must be in the original sealed
  716  container that was purchased by that wholesale distributor. A
  717  compressed medical gas wholesale distributor may not possess or
  718  engage in the wholesale distribution of any prescription drug
  719  other than compressed medical gases. The department shall adopt
  720  rules that govern the wholesale distribution of prescription
  721  medical oxygen for emergency use. With respect to the emergency
  722  use of prescription medical oxygen, those rules may not be
  723  inconsistent with rules and regulations of federal agencies
  724  unless the Legislature specifically directs otherwise.
  725         (o) Compressed medical gas manufacturer permit.—A
  726  compressed medical gas manufacturer permit is required for any
  727  person that engages in the manufacture of compressed medical
  728  gases or repackages compressed medical gases from one container
  729  to another.
  730         1. A compressed medical gas manufacturer may not
  731  manufacture or possess any prescription drug other than
  732  compressed medical gases.
  733         2. A compressed medical gas manufacturer may engage in
  734  wholesale distribution of compressed medical gases manufactured
  735  at that establishment and must comply with all the provisions of
  736  this part and the rules adopted under this part that apply to a
  737  wholesale distributor.
  738         3. A compressed medical gas manufacturer must comply with
  739  all appropriate state and federal good manufacturing practices.
  740         (p) Over-the-counter drug manufacturer permit.—An over-the
  741  counter drug manufacturer permit is required for any person that
  742  engages in the manufacture or repackaging of an over-the-counter
  743  drug.
  744         1. An over-the-counter drug manufacturer may not possess or
  745  purchase prescription drugs.
  746         2. A pharmacy is exempt from obtaining an over-the-counter
  747  drug manufacturer permit if it is operating in compliance with
  748  pharmacy practice standards as defined in chapter 465 and the
  749  rules adopted under that chapter.
  750         3. An over-the-counter drug manufacturer must comply with
  751  all appropriate state and federal good manufacturing practices.
  752         (q) Device manufacturer permit.—A device manufacturer
  753  permit is required for any person that engages in the
  754  manufacture, repackaging, or assembly of medical devices for
  755  human use in this state, except that a permit is not required if
  756  the person is engaged only in manufacturing, repackaging, or
  757  assembling a medical device pursuant to a practitioner’s order
  758  for a specific patient.
  759         1. A manufacturer or repackager of medical devices in this
  760  state must comply with all appropriate state and federal good
  761  manufacturing practices and quality system rules.
  762         2. The department shall adopt rules related to storage,
  763  handling, and recordkeeping requirements for manufacturers of
  764  medical devices for human use.
  765         (r) Cosmetic manufacturer permit.—A cosmetic manufacturer
  766  permit is required for any person that manufactures or
  767  repackages cosmetics in this state. A person that only labels or
  768  changes the labeling of a cosmetic but does not open the
  769  container sealed by the manufacturer of the product is exempt
  770  from obtaining a permit under this paragraph.
  771         (s) Third-party Third party logistics provider permit.—A
  772  third-party third party logistics provider permit is required
  773  for any person that contracts with a prescription drug wholesale
  774  distributor or prescription drug manufacturer to provide
  775  warehousing, distribution, or other logistics services on behalf
  776  of a manufacturer or wholesale distributor, but who does not
  777  take title to the prescription drug or have responsibility to
  778  direct the sale or disposition of the prescription drug. Each
  779  third-party third party logistics provider permittee shall
  780  comply with the requirements for wholesale distributors under
  781  ss. 499.0121 and 499.01212, with the exception of those
  782  wholesale distributions described in s. 499.01212(3)(a), and
  783  other rules that the department requires.
  784         (t) Health care clinic establishment permit.—Effective
  785  January 1, 2009, a health care clinic establishment permit is
  786  required for the purchase of a prescription drug by a place of
  787  business at one general physical location owned and operated by
  788  a legal business entity that has been issued a federal tax
  789  identification number and through which qualified practitioners
  790  practice their profession under state law a professional
  791  corporation or professional limited liability company described
  792  in chapter 621, or a corporation that employs a veterinarian as
  793  a qualifying practitioner. For the purpose of this paragraph,
  794  the term “qualifying practitioner” means a licensed health care
  795  practitioner defined in s. 456.001 or a veterinarian licensed
  796  under chapter 474, who is authorized under the appropriate
  797  practice act to prescribe and administer a prescription drug.
  798         1. An establishment must provide, as part of the
  799  application required under s. 499.012, designation of a
  800  qualifying practitioner who will be responsible for complying
  801  with all legal and regulatory requirements related to the
  802  purchase, recordkeeping, storage, and handling of the
  803  prescription drugs. In addition, the designated qualifying
  804  practitioner shall be the practitioner whose name, establishment
  805  address, and license number is used on all distribution
  806  documents for prescription drugs purchased or returned by the
  807  health care clinic establishment. Upon initial appointment of a
  808  qualifying practitioner, the qualifying practitioner and the
  809  health care clinic establishment shall notify the department on
  810  a form furnished by the department within 10 days after such
  811  employment. In addition, the qualifying practitioner and health
  812  care clinic establishment shall notify the department within 10
  813  days after any subsequent change.
  814         2. The health care clinic establishment must employ a
  815  qualifying practitioner at each establishment.
  816         3. In addition to the remedies and penalties provided in
  817  this part, a violation of this chapter by the health care clinic
  818  establishment or qualifying practitioner constitutes grounds for
  819  discipline of the qualifying practitioner by the appropriate
  820  regulatory board.
  821         4. The purchase of prescription drugs by the health care
  822  clinic establishment is prohibited during any period of time
  823  when the establishment does not comply with this paragraph.
  824         5. A health care clinic establishment permit is not a
  825  pharmacy permit or otherwise subject to chapter 465. A health
  826  care clinic establishment that meets the criteria of a modified
  827  Class II institutional pharmacy under s. 465.019 is not eligible
  828  to be permitted under this paragraph.
  829         6. This paragraph does not prohibit a licensed qualifying
  830  practitioner whose professional license authorizes the
  831  practitioner to prescribe prescription drugs from purchasing
  832  prescription drugs under his or her practice license.
  833         7. This paragraph does not authorize the holder of this
  834  permit to purchase or possess controlled substances listed in s.
  835  893.03 or federal law.
  836         8. Prescription drugs that may be distributed to the holder
  837  of this permit are limited to those prescription drugs that can
  838  be lawfully prescribed by the qualifying practitioner.
  839         (u)Prescription drug manufacturer’s distributor permit.—A
  840  prescription drug manufacturer’s distributor permit is required
  841  for any person who engages in the wholesale distribution of
  842  prescription drugs in or into this state of which a member of
  843  the person’s affiliated group is the manufacturer of the
  844  prescription drug, unless the person is permitted as a
  845  prescription drug wholesale distributor, an out-of-state
  846  prescription drug wholesale distributor, or a third-party
  847  logistics provider. A person permitted as a prescription drug
  848  wholesale distributor, out-of-state prescription drug wholesale
  849  distributor, or a third-party logistics provider may change to a
  850  prescription drug manufacturer’s distributor permit as provided
  851  in s. 499.012(2). A prescription drug manufacturer’s distributor
  852  permitee shall distribute only prescription drugs manufactured
  853  by members of its affiliated group and shall acquire title to
  854  the prescription drugs before distributing them. Each
  855  prescription drug manufacturer’s distributor permittee or
  856  applicant shall:
  857         1.Identify, by name, address, and federal tax
  858  identification number, all affiliated group members on a
  859  document that is signed by a state-licensed certified public
  860  accountant who certifies that the applicant is a member of the
  861  affiliated group and each member has been identified on the
  862  document. This document must be submitted as a part of the
  863  application for a prescription drug manufacturer’s distributor
  864  permit and within 30 days after any change in the membership of
  865  the affiliated group; and
  866         2.Comply with the requirements for wholesale distributors
  867  under s. 499.0121
  868  
  869  As used in this paragraph, the term “affiliated group” means an
  870  affiliated group as defined in 26 U.S.C. s. 1504, as amended.
  871         Section 5. Paragraph (d) of subsection (1) of section
  872  499.012, Florida Statutes, is amended to read:
  873         499.012 Permit application requirements.—
  874         (1)
  875         (d) A permit for a prescription drug manufacturer,
  876  prescription drug repackager, prescription drug wholesale
  877  distributor, limited prescription drug veterinary wholesale
  878  distributor, or retail pharmacy drug wholesale distributor, or
  879  prescription drug manufacturer’s distributor may not be issued
  880  to the address of a health care entity or to a pharmacy licensed
  881  under chapter 465, except as provided in this paragraph. The
  882  department may issue a prescription drug manufacturer permit to
  883  an applicant at the same address as a licensed nuclear pharmacy,
  884  which is a health care entity, for the purpose of manufacturing
  885  prescription drugs used in positron emission tomography or other
  886  radiopharmaceuticals, as listed in a rule adopted by the
  887  department pursuant to this paragraph. The purpose of this
  888  exemption is to assure availability of state-of-the-art
  889  pharmaceuticals that would pose a significant danger to the
  890  public health if manufactured at a separate establishment
  891  address from the nuclear pharmacy from which the prescription
  892  drugs are dispensed. The department may also issue a retail
  893  pharmacy drug wholesale distributor permit to the address of a
  894  community pharmacy licensed under chapter 465 which does not
  895  meet the definition of a closed pharmacy in s. 499.003.
  896         Section 6. Paragraph (d) of subsection (4) and paragraph
  897  (e) of subsection (6) of section 499.0121, Florida Statutes, are
  898  amended to read:
  899         499.0121 Storage and handling of prescription drugs;
  900  recordkeeping.—The department shall adopt rules to implement
  901  this section as necessary to protect the public health, safety,
  902  and welfare. Such rules shall include, but not be limited to,
  903  requirements for the storage and handling of prescription drugs
  904  and for the establishment and maintenance of prescription drug
  905  distribution records.
  906         (4) EXAMINATION OF MATERIALS AND RECORDS.—
  907         (d) Upon receipt, a wholesale distributor must review
  908  records required under this section for the acquisition of
  909  prescription drugs for accuracy and completeness, considering
  910  the total facts and circumstances surrounding the transactions
  911  and the wholesale distributors involved. This includes
  912  authenticating each transaction listed on a pedigree paper, as
  913  defined in s. 499.003(36).
  914         (6) RECORDKEEPING.—The department shall adopt rules that
  915  require keeping such records of prescription drugs as are
  916  necessary for the protection of the public health.
  917         (e) When a pedigree paper is required by this part, a
  918  wholesale distributor must maintain pedigree papers separate and
  919  distinct from other records required under this part chapter.
  920         Section 7. Paragraphs (a) and (b) of subsection (2) of
  921  section 499.01211, Florida Statutes, are amended to read:
  922         499.01211 Drug Wholesale Distributor Advisory Council.—
  923         (2) The State Surgeon General, or his or her designee, and
  924  the Secretary of Health Care Administration, or her or his
  925  designee, shall be members of the council. The State Surgeon
  926  General shall appoint nine additional members to the council who
  927  shall be appointed to a term of 4 years each, as follows:
  928         (a) Three different persons each of whom is employed by a
  929  different prescription drug wholesale distributor licensed under
  930  this part which operates nationally and is a primary wholesale
  931  distributor, as defined in s. 499.003(46).
  932         (b) One person employed by a prescription drug wholesale
  933  distributor licensed under this part which is a secondary
  934  wholesale distributor, as defined in s. 499.003(51).
  935         Section 8. Section 499.01212, Florida Statutes, is amended
  936  to read:
  937         499.01212 Pedigree paper.—
  938         (1) APPLICATION.—Each person who is engaged in the
  939  wholesale distribution of a prescription drug must, prior to or
  940  simultaneous with each wholesale distribution, provide a
  941  pedigree paper to the person who receives the drug.
  942         (2) FORMAT.—A pedigree paper must contain the following
  943  information:
  944         (a) For the wholesale distribution of a prescription drug
  945  within the normal distribution chain:
  946         1. The following statement: “This wholesale distributor
  947  purchased the specific unit of the prescription drug directly
  948  from the manufacturer or manufacturer’s distributor.”
  949         2. The manufacturer’s national drug code identifier and the
  950  name and address of the wholesale distributor and the purchaser
  951  of the prescription drug.
  952         3. The name of the prescription drug as it appears on the
  953  label.
  954         4. The quantity, dosage form, and strength of the
  955  prescription drug.
  956  
  957  The wholesale distributor must also maintain and make available
  958  to the department, upon request, the point of origin of the
  959  prescription drugs, including intracompany transfers, the date
  960  of the shipment from the manufacturer, manufacturer’s
  961  distributor, or manufacturer’s third-party logistics provider to
  962  the wholesale distributor, the lot numbers of such drugs, and
  963  the invoice numbers from the manufacturer or manufacturer’s
  964  distributor.
  965         (b) For all other wholesale distributions of prescription
  966  drugs:
  967         1. The quantity, dosage form, and strength of the
  968  prescription drugs.
  969         2. The lot numbers of the prescription drugs.
  970         3. The name and address of each owner of the prescription
  971  drug and his or her signature.
  972         4. Shipping information, including the name and address of
  973  each person certifying delivery or receipt of the prescription
  974  drug.
  975         5. An invoice number, a shipping document number, or
  976  another number uniquely identifying the transaction. When a
  977  manufacturer uses a manufacturer’s distributor to sell the
  978  manufacturer’s prescription drugs, the invoice number, shipping
  979  document number, or other number uniquely identifying the
  980  transaction between the manufacturer and manufacturer’s
  981  distributor may be omitted from the pedigree paper.
  982         6. A certification that the recipient wholesale distributor
  983  has authenticated the pedigree papers.
  984         7. The unique serialization of the prescription drug, if
  985  the manufacturer or repackager has uniquely serialized the
  986  individual prescription drug unit.
  987         8. The name, address, telephone number, and, if available,
  988  e-mail contact information of each wholesale distributor,
  989  including each third-party logistics provider and manufacturer’s
  990  distributor involved in the chain of the prescription drug’s
  991  custody.
  992         (3) EXCEPTIONS.—A pedigree paper is not required for:
  993         (a) The wholesale distribution of a prescription drug by
  994  the manufacturer, by the manufacturer’s distributor, or by a
  995  third-party third party logistics provider performing a
  996  wholesale distribution of a prescription drug for a
  997  manufacturer.
  998         (b) The wholesale distribution of a prescription drug by a
  999  freight forwarder within the authority of a freight forwarder
 1000  permit.
 1001         (c) The wholesale distribution of a prescription drug by a
 1002  limited prescription drug veterinary wholesale distributor to a
 1003  veterinarian.
 1004         (d) The wholesale distribution of a compressed medical gas.
 1005         (e) The wholesale distribution of a veterinary prescription
 1006  drug.
 1007         (f) A drop shipment, provided:
 1008         1. The wholesale distributor delivers to the recipient of
 1009  the prescription drug, within 14 days after the shipment
 1010  notification from the manufacturer or manufacturer’s
 1011  distributor, an invoice and the following sworn statement: “This
 1012  wholesale distributor purchased the specific unit of the
 1013  prescription drug listed on the invoice directly from the
 1014  manufacturer or manufacturer’s distributor, and the specific
 1015  unit of prescription drug was shipped by the manufacturer,
 1016  manufacturer’s distributor, or manufacturer’s third-party
 1017  logistics provider directly to a person authorized by law to
 1018  administer or dispense the legend drug, as defined in s.
 1019  465.003, Florida Statutes, or a member of an affiliated group,
 1020  with the exception of a repackager.” The invoice must contain a
 1021  unique cross-reference to the shipping document sent by the
 1022  manufacturer, manufacturer’s distributor, or manufacturer’s
 1023  third-party logistics provider to the recipient of the
 1024  prescription drug.
 1025         2. The manufacturer or manufacturer’s distributor of the
 1026  prescription drug shipped directly to the recipient provides and
 1027  the recipient of the prescription drug acquires, within 14 days
 1028  after receipt of the prescription drug, a shipping document from
 1029  the manufacturer, manufacturer’s distributor, or manufacturer’s
 1030  third-party logistics provider which that contains, at a
 1031  minimum:
 1032         a. The name and address of the manufacturer or
 1033  manufacturer’s distributor, including the point of origin of the
 1034  shipment, and the names and addresses of the wholesale
 1035  distributor and the purchaser.
 1036         b. The name of the prescription drug as it appears on the
 1037  label.
 1038         c. The quantity, dosage form, and strength of the
 1039  prescription drug.
 1040         d. The date of the shipment from the manufacturer,
 1041  manufacturer’s distributor, or manufacturer’s third-party
 1042  logistics provider.
 1043         3. The wholesale distributor maintains and makes available
 1044  to the department, upon request, the lot number of such drug if
 1045  not contained in the shipping document acquired by the
 1046  recipient.
 1047         4. The wholesale distributor that takes title to, but not
 1048  possession of, the prescription drug is not a member of the
 1049  affiliated group that receives the prescription drug directly
 1050  from the manufacturer.
 1051  
 1052  Failure of the manufacturer, manufacturer’s distributor, or
 1053  manufacturer’s third-party logistics provider to provide, the
 1054  recipient to acquire, or the wholesale distributor to deliver
 1055  the documentation required under this paragraph shall constitute
 1056  failure to acquire or deliver a pedigree paper under ss.
 1057  499.005(28) and 499.0051. Forgery by the manufacturer,
 1058  manufacturer’s distributor, or manufacturer’s third-party
 1059  logistics provider, the recipient, or the wholesale distributor
 1060  of the documentation required to be acquired or delivered under
 1061  this paragraph shall constitute forgery of a pedigree paper
 1062  under s. 499.0051.
 1063         (g) The wholesale distribution of a prescription drug by a
 1064  warehouse within an affiliated group to a warehouse or retail
 1065  pharmacy within its affiliated group, provided:
 1066         1. Any affiliated group member that purchases or receives a
 1067  prescription drug from outside the affiliated group must receive
 1068  a pedigree paper if the prescription drug is distributed in or
 1069  into this state and a pedigree paper is required under this
 1070  section and must authenticate the documentation as required in
 1071  s. 499.0121(4), regardless of whether the affiliated group
 1072  member is directly subject to regulation under this part; and
 1073         2. The affiliated group makes available, within 48 hours,
 1074  to the department on request to one or more of its members all
 1075  records related to the purchase or acquisition of prescription
 1076  drugs by members of the affiliated group, regardless of the
 1077  location where the records are stored, if the prescription drugs
 1078  were distributed in or into this state.
 1079         (h) The repackaging of prescription drugs by a repackager
 1080  solely for distribution to its affiliated group members for the
 1081  exclusive distribution to and among retail pharmacies that are
 1082  members of the affiliated group to which the repackager is a
 1083  member.
 1084         1. The repackager must:
 1085         a. For all repackaged prescription drugs distributed in or
 1086  into this state, state in writing under oath with each
 1087  distribution of a repackaged prescription drug to an affiliated
 1088  group member warehouse or repackager: “All repackaged
 1089  prescription drugs are purchased by the affiliated group
 1090  directly from the manufacturer, manufacturer’s distributor, or
 1091  from a prescription drug wholesale distributor that purchased
 1092  the prescription drugs directly from the manufacturer or
 1093  manufacturer’s distributor.”
 1094         b. Purchase all prescription drugs it repackages:
 1095         (I) Directly from the manufacturer or manufacturer’s
 1096  distributor; or
 1097         (II) From a prescription drug wholesale distributor that
 1098  purchased the prescription drugs directly from the manufacturer
 1099  or manufacturer’s distributor.
 1100         c. Maintain records in accordance with this section to
 1101  document that it purchased the prescription drugs directly from
 1102  the manufacturer, manufacturer’s distributor, or that its
 1103  prescription drug wholesale supplier purchased the prescription
 1104  drugs directly from the manufacturer or manufacturer’s
 1105  distributor.
 1106         2. All members of the affiliated group must provide, within
 1107  48 hours, to agents of the department on request to one or more
 1108  of its members records of purchases by all members of the
 1109  affiliated group of prescription drugs that have been
 1110  repackaged, regardless of the location at which the records are
 1111  stored or at which the repackager is located.
 1112         Section 9. Subsection (1) of section 499.03, Florida
 1113  Statutes, is amended to read:
 1114         499.03 Possession of certain drugs without prescriptions
 1115  unlawful; exemptions and exceptions.—
 1116         (1) A person may not possess, or possess with intent to
 1117  sell, dispense, or deliver, any habit-forming, toxic, harmful,
 1118  or new drug subject to s. 499.003(32), or prescription drug as
 1119  defined in s. 499.003(42), unless the possession of the drug has
 1120  been obtained by a valid prescription of a practitioner licensed
 1121  by law to prescribe the drug. However, this section does not
 1122  apply to the delivery of such drugs to persons included in any
 1123  of the classes named in this subsection, or to the agents or
 1124  employees of such persons, for use in the usual course of their
 1125  businesses or practices or in the performance of their official
 1126  duties, as the case may be; nor does this section apply to the
 1127  possession of such drugs by those persons or their agents or
 1128  employees for such use:
 1129         (a) A licensed pharmacist or any person under the licensed
 1130  pharmacist’s supervision while acting within the scope of the
 1131  licensed pharmacist’s practice;
 1132         (b) A licensed practitioner authorized by law to prescribe
 1133  prescription drugs or any person under the licensed
 1134  practitioner’s supervision while acting within the scope of the
 1135  licensed practitioner’s practice;
 1136         (c) A qualified person who uses prescription drugs for
 1137  lawful research, teaching, or testing, and not for resale;
 1138         (d) A licensed hospital or other institution that procures
 1139  such drugs for lawful administration or dispensing by
 1140  practitioners;
 1141         (e) An officer or employee of a federal, state, or local
 1142  government; or
 1143         (f) A person that holds a valid permit issued by the
 1144  department pursuant to this part which authorizes that person to
 1145  possess prescription drugs.
 1146         Section 10. Subsection (2) of section 499.041, Florida
 1147  Statutes, is amended, and subsection (11) is added to that
 1148  section, to read:
 1149         499.041 Schedule of fees for drug, device, and cosmetic
 1150  applications and permits, product registrations, and free-sale
 1151  certificates.—
 1152         (2) The department shall assess an applicant that is
 1153  required to have a wholesaling permit an annual fee within the
 1154  ranges established in this section for the specific type of
 1155  wholesaling.
 1156         (a) The fee for a prescription drug wholesale distributor
 1157  permit may not be less than $300 or more than $800 annually.
 1158         (b) The fee for a compressed medical gas wholesale
 1159  distributor permit may not be less than $200 or more than $300
 1160  annually.
 1161         (c) The fee for an out-of-state prescription drug wholesale
 1162  distributor permit may not be less than $300 or more than $800
 1163  annually.
 1164         (d) The fee for a nonresident prescription drug
 1165  manufacturer permit may not be less than $300 or more than $500
 1166  annually.
 1167         (e) The fee for a retail pharmacy drug wholesale
 1168  distributor permit may not be less than $35 or more than $50
 1169  annually.
 1170         (f) The fee for a freight forwarder permit may not be less
 1171  than $200 or more than $300 annually.
 1172         (g) The fee for a veterinary prescription drug wholesale
 1173  distributor permit may not be less than $300 or more than $500
 1174  annually.
 1175         (h) The fee for a limited prescription drug veterinary
 1176  wholesale distributor permit may not be less than $300 or more
 1177  than $500 annually.
 1178         (i) The fee for a third-party third party logistics
 1179  provider permit may not be less than $200 or more than $300
 1180  annually.
 1181         (j)The fee for a prescription drug manufacturer’s
 1182  distributor permit may not be less than $500 or more than $750
 1183  annually.
 1184         (11)The department shall retain a fee of $150 or 50
 1185  percent of the permit or certification fee, whichever is less,
 1186  from each person applying for a permit or certification if the
 1187  application is withdrawn or becomes void.
 1188         Section 11. Paragraph (m) of subsection (1) of section
 1189  499.05, Florida Statutes, is amended to read:
 1190         499.05 Rules.—
 1191         (1) The department shall adopt rules to implement and
 1192  enforce this part with respect to:
 1193         (m) The recordkeeping, storage, and handling with respect
 1194  to each of the distributions of prescription drugs specified in
 1195  s. 499.003(54)(a)-(d) s. 499.003(53)(a)-(d).
 1196         Section 12. Subsection (1) of section 794.075, Florida
 1197  Statutes, is amended to read:
 1198         794.075 Sexual predators; erectile dysfunction drugs.—
 1199         (1) A person may not possess a prescription drug, as
 1200  defined in s. 499.003(43) s. 499.003(42), for the purpose of
 1201  treating erectile dysfunction if the person is designated as a
 1202  sexual predator under s. 775.21.
 1203         Section 13. (1) Notwithstanding the purchase of a
 1204  prescription drug from the manufacturer’s distributor, a person
 1205  who is required to comply with the pedigree paper provisions
 1206  under s. 499.01212, Florida Statutes, may continue to use the
 1207  statement provided in s. 499.01212, Florida Statutes (2008),
 1208  until September 30, 2010, for the wholesale distribution of a
 1209  prescription drug that:
 1210         (a)Is within the normal distribution chain as provided in
 1211  s. 499.01212(2)(a), Florida Statutes;
 1212         (b)Qualifies as a drop shipment as provided in s.
 1213  499.01212(3)(f), Florida Statutes; or
 1214         (c)Is a repackaged prescription drug as provided in s.
 1215  499.01212(3)(h), Florida Statutes.
 1216         (2)This section is repealed October 1, 2010.
 1217         Section 14. This act shall take effect October 1, 2009.
 1218  
 1219  ================= T I T L E  A M E N D M E N T ================
 1220         And the title is amended as follows:
 1221         Delete everything before the enacting clause
 1222  and insert:
 1223                        A bill to be entitled                      
 1224         An act relating to manufacturers and purchasers of
 1225         prescription drugs; amending ss. 409.9201 and
 1226         465.0265, F.S.; conforming cross-references; amending
 1227         s. 499.003, F.S.; defining new terms and redefining
 1228         terms related to the Florida Drug and Cosmetic Act;
 1229         amending s. 499.01, F.S.; authorizing a prescription
 1230         drug manufacturer’s distributor permit and revising
 1231         the requirements related to certain other permits;
 1232         conforming a cross-reference; amending s. 499.012,
 1233         F.S.; restricting issuance of a permit for a
 1234         prescription drug manufacturer’s distributor at
 1235         certain addresses; amending s. 499.0121, F.S.;
 1236         eliminating cross-references to defined terms and
 1237         clarifying a recordkeeping requirement related to
 1238         pedigree papers; amending s. 499.01211, F.S.;
 1239         eliminating cross-references for certain defined
 1240         terms; amending s. 499.01212, F.S.; revising
 1241         requirements for a pedigree paper; amending s. 499.03,
 1242         F.S.; eliminating cross-references for certain defined
 1243         terms; amending s. 499.041, F.S.; establishing a fee
 1244         for the prescription drug manufacturer’s distributor
 1245         permit; authorizing the Department of Health to retain
 1246         a specified monetary amount as a fee if an application
 1247         submitted under the Florida Drug and Cosmetic Act is
 1248         withdrawn or becomes void; amending ss. 499.05 and
 1249         794.075, F.S.; conforming cross-references;
 1250         authorizing certain statements to be used on certain
 1251         pedigree papers until a specified date; providing an
 1252         effective date.