Florida Senate - 2012                        COMMITTEE AMENDMENT
       Bill No. CS for SB 762
       
       
       
       
       
       
                                Barcode 749074                          
       
                              LEGISLATIVE ACTION                        
                    Senate             .             House              
                  Comm: RCS            .                                
                  03/01/2012           .                                
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       The Committee on Budget Subcommittee on General Government
       Appropriations (Latvala) recommended the following:
       
    1         Senate Amendment to Amendment (657172) (with title
    2  amendment)
    3  
    4         Delete line 687
    5  and insert:
    6         Section 33. Subsections (17), (19), (20), and (43) of
    7  section 499.003, Florida Statutes, are amended to read:
    8         499.003 Definitions of terms used in this part.—As used in
    9  this part, the term:
   10         (17) “Distribute” or “distribution” means to sell; offer to
   11  sell; give away; transfer, whether by passage of title, physical
   12  movement, or both; deliver; or offer to deliver. The term does
   13  not mean to administer or dispense and does not include the
   14  billing and invoicing activities that commonly follow a
   15  wholesale distribution transaction.
   16         (19) “Drug” means an article that is:
   17         (a) Recognized in the current edition of the United States
   18  Pharmacopoeia and National Formulary, official Homeopathic
   19  Pharmacopoeia of the United States, or any supplement to any of
   20  those publications;
   21         (b) Intended for use in the diagnosis, cure, mitigation,
   22  treatment, therapy, or prevention of disease in humans or other
   23  animals;
   24         (c) Intended to affect the structure or any function of the
   25  body of humans or other animals; or
   26         (d) Intended for use as a component of any article
   27  specified in paragraph (a), paragraph (b), or paragraph (c), and
   28  includes active pharmaceutical ingredients, but does not include
   29  devices or their components, parts, or accessories. For purposes
   30  of this paragraph, an “active pharmaceutical ingredient”
   31  includes any substance or mixture of substances intended,
   32  represented, or labeled for use in drug manufacturing that
   33  furnishes or is intended to furnish, in a finished dosage form,
   34  any pharmacological activity or other direct effect in the
   35  diagnosis, cure, mitigation, treatment, therapy, or prevention
   36  of disease in humans or other animals, or to affect the
   37  structure or any function of the body of humans or other
   38  animals.
   39         (20) “Establishment” means a place of business which is at
   40  one general physical location and may extend to one or more
   41  contiguous suites, units, floors, or buildings operated and
   42  controlled exclusively by entities under common operation and
   43  control. Where multiple buildings are under common exclusive
   44  ownership, operation, and control, an intervening thoroughfare
   45  does not affect the contiguous nature of the buildings. For
   46  purposes of permitting, each suite, unit, floor, or building
   47  must be identified in the most recent permit application.
   48         (43) “Prescription drug” means a prescription, medicinal,
   49  or legend drug, including, but not limited to, finished dosage
   50  forms or active pharmaceutical ingredients subject to, defined
   51  by, or described by s. 503(b) of the Federal Food, Drug, and
   52  Cosmetic Act or s. 465.003(8), s. 499.007(13), or subsection
   53  (11), subsection (46), or subsection (53), except that an active
   54  pharmaceutical ingredient is a prescription drug only if
   55  substantially all finished dosage forms in which it may be
   56  lawfully dispensed or administered in this state are also
   57  prescription drugs.
   58         Section 34. Paragraphs (c) and (e) of subsection (2) of
   59  section 499.01, Florida Statutes, are amended, and subsection
   60  (3) is added to that section, to read:
   61         499.01 Permits.—
   62         (2) The following permits are established:
   63         (c) Nonresident prescription drug manufacturer permit.—A
   64  nonresident prescription drug manufacturer permit is required
   65  for any person that is a manufacturer of prescription drugs,
   66  unless permitted as a third party logistics provider, located
   67  outside of this state or outside the United States and that
   68  engages in the wholesale distribution in this state of such
   69  prescription drugs. Each such manufacturer must be permitted by
   70  the department and comply with all of the provisions required of
   71  a wholesale distributor under this part, except s. 499.01212.
   72         1. A person that distributes prescription drugs for which
   73  the person is not the manufacturer must also obtain an out-of
   74  state prescription drug wholesale distributor permit or third
   75  party logistics provider permit pursuant to this section to
   76  engage in the wholesale distribution of such prescription drugs.
   77  This subparagraph does not apply to a manufacturer as defined in
   78  s. 499.003(31)(e).
   79         2. Any such person must comply with the licensing or
   80  permitting requirements of the jurisdiction in which the
   81  establishment is located and the federal act, and any product
   82  wholesaled into this state must comply with this part. If a
   83  person intends to import prescription drugs from a foreign
   84  country into this state, the nonresident prescription drug
   85  manufacturer must provide to the department a list identifying
   86  each prescription drug it intends to import and document
   87  approval by the United States Food and Drug Administration for
   88  such importation.
   89         3. A nonresident prescription drug manufacturer permit is
   90  not required for a manufacturer to distribute a prescription
   91  drug active pharmaceutical ingredient that it manufactures to a
   92  prescription drug manufacturer permitted in this state in
   93  limited quantities intended for research and development and not
   94  for resale, or human use other than lawful clinical trials and
   95  biostudies authorized and regulated by federal law. A
   96  manufacturer claiming to be exempt from the permit requirements
   97  of this subparagraph and the prescription drug manufacturer
   98  purchasing and receiving the active pharmaceutical ingredient
   99  shall comply with the recordkeeping requirements of s.
  100  499.0121(6), but not the requirements of s. 499.01212. The
  101  prescription drug manufacturer purchasing and receiving the
  102  active pharmaceutical ingredient shall maintain on file a record
  103  of the FDA registration number; the out-of-state license,
  104  permit, or registration number; and, if available, a copy of the
  105  most current FDA inspection report, for all manufacturers from
  106  whom they purchase active pharmaceutical ingredients under this
  107  section. The department shall specify by rule the allowable
  108  number of transactions within a given period of time and the
  109  amount of active pharmaceutical ingredients that qualify as
  110  limited quantities for purposes of this exemption. The failure
  111  to comply with the requirements of this subparagraph, or rules
  112  adopted by the department to administer this subparagraph, for
  113  the purchase of prescription drug active pharmaceutical
  114  ingredients is a violation of s. 499.005(14).
  115         (e) Out-of-state prescription drug wholesale distributor
  116  permit.—An out-of-state prescription drug wholesale distributor
  117  is a wholesale distributor located outside this state which
  118  engages in the wholesale distribution of prescription drugs into
  119  this state and which must be permitted by the department and
  120  comply with all the provisions required of a wholesale
  121  distributor under this part. An out-of-state prescription drug
  122  wholesale distributor that applies to the department for a new
  123  permit or the renewal of a permit must submit a bond of
  124  $100,000, or other equivalent means of security acceptable to
  125  the department, such as an irrevocable letter of credit or a
  126  deposit in a trust account or financial institution, payable to
  127  the Florida Drug, Device, and Cosmetic Trust Fund. The purpose
  128  of the bond is to secure payment of any administrative penalties
  129  imposed by the department and any fees and costs incurred by the
  130  department regarding that permit which are authorized under
  131  state law and which the permittee fails to pay 30 days after the
  132  fine or costs become final. The department may make a claim
  133  against such bond or security until 1 year after the permittee’s
  134  license ceases to be valid or until 60 days after any
  135  administrative or legal proceeding authorized in this part which
  136  involves the permittee is concluded, including any appeal,
  137  whichever occurs later.
  138         1. The out-of-state prescription drug wholesale distributor
  139  must maintain at all times a license or permit to engage in the
  140  wholesale distribution of prescription drugs in compliance with
  141  laws of the state in which it is a resident.
  142         2. An out-of-state prescription drug wholesale distributor
  143  permit is not required for an intracompany sale or transfer of a
  144  prescription drug from an out-of-state establishment that is
  145  duly licensed as a prescription drug wholesale distributor, in
  146  its state of residence, to a licensed prescription drug
  147  wholesale distributor in this state, if both wholesale
  148  distributors conduct wholesale distributions of prescription
  149  drugs under the same business name. The recordkeeping
  150  requirements of ss. 499.0121(6) and 499.01212 must be followed
  151  for this transaction.
  152         (3)(a) A permit issued under this part is not required to
  153  distribute a prescription drug active pharmaceutical ingredient
  154  from an establishment located in the United States to an
  155  establishment located in this state permitted as a prescription
  156  drug manufacturer under this part for use by the recipient in
  157  preparing, deriving, processing, producing, or fabricating a
  158  prescription drug finished dosage form at the establishment in
  159  this state where the product is received under an approved and
  160  otherwise valid New Drug Approval Application, Abbreviated New
  161  Drug Application, New Animal Drug Application, or Therapeutic
  162  Biologic Application, provided that the application, active
  163  pharmaceutical ingredient, or finished dosage form has not been
  164  withdrawn or removed from the market in this country for public
  165  health reasons.
  166         1. Any distributor claiming exemption from permitting
  167  requirements pursuant to this paragraph shall maintain a
  168  license, permit, or registration to engage in the wholesale
  169  distribution of prescription drugs under the laws of the state
  170  from which the product is distributed.
  171         2. Any distributor claiming exemption from permitting
  172  requirements pursuant to this paragraph and the prescription
  173  drug manufacturer purchasing and receiving the active
  174  pharmaceutical ingredient shall comply with the recordkeeping
  175  requirements of s. 499.0121(6), but not the requirements of s.
  176  499.01212.
  177         (b) A permit issued under this part is not required to
  178  distribute limited quantities of a prescription drug that has
  179  not been repackaged from an establishment located in the United
  180  States to an establishment located in this state permitted as a
  181  prescription drug manufacturer under this part for research and
  182  development or to a holder of a letter of exemption issued by
  183  the department under s. 499.03(4) for research, teaching, or
  184  testing. The department shall define “limited quantities” by
  185  rule and may include the allowable number of transactions within
  186  a given period of time and the amounts of prescription drugs
  187  distributed into the state for purposes of this exemption.
  188         1. Any distributor claiming exemption from permitting
  189  requirements pursuant to this paragraph shall maintain a
  190  license, permit, or registration to engage in the wholesale
  191  distribution of prescription drugs under the laws of the state
  192  from which the product is distributed.
  193         2. All purchasers and recipients of any prescription drugs
  194  distributed pursuant to this paragraph shall ensure that the
  195  products are not resold or used, directly or indirectly, on
  196  humans except in lawful clinical trials and biostudies
  197  authorized and regulated by federal law.
  198         3. Any distributor claiming exemption from permitting
  199  requirements pursuant to this paragraph, and the purchaser and
  200  recipient of the prescription drug, shall comply with the
  201  recordkeeping requirements of s. 499.0121(6), but not the
  202  requirements of s. 499.01212.
  203         4. The immediate package or container of any active
  204  pharmaceutical ingredient distributed into the state that is
  205  intended for teaching, testing, research, and development shall
  206  bear a label prominently displaying the statement: “Caution:
  207  Research, Teaching, or Testing Only – Not for Manufacturing,
  208  Compounding, or Resale.”
  209         (c) An out-of-state prescription drug wholesale distributor
  210  permit is not required for an intracompany sale or transfer of a
  211  prescription drug from an out-of-state establishment that is
  212  duly licensed as a prescription drug wholesale distributor in
  213  its state of residence to a licensed prescription drug wholesale
  214  distributor in this state, if both wholesale distributors
  215  conduct wholesale distributions of prescription drugs under the
  216  same business name. The recordkeeping requirements of ss.
  217  499.0121(6) and 499.01212 must be followed for such
  218  transactions.
  219         (d) Persons receiving prescription drugs from a source
  220  claimed to be exempt from permitting requirements under this
  221  subsection shall maintain on file:
  222         1. A record of the FDA establishment registration number,
  223  if any;
  224         2. The resident state prescription drug wholesale
  225  distribution license, permit, or registration number; and
  226         3. A copy of the most recent resident state or FDA
  227  inspection report, for all distributors and establishments whom
  228  they purchase or receive prescription drugs under this
  229  subsection.
  230         (e) All persons claiming exemption from permitting
  231  requirements pursuant to this subsection who engage in the
  232  distribution of prescription drugs within or into the state are
  233  subject to this part, including ss. 499.005 and 499.0051, and
  234  shall make available, within 48 hours, to the department on
  235  request all records related to any prescription drugs
  236  distributed under this subsection, including those records
  237  described in s. 499.051(4), regardless of the location where the
  238  records are stored.
  239         (f) A person purchasing and receiving a prescription drug
  240  from a person claimed to be exempt from licensing requirements
  241  pursuant to this subsection shall report to the department in
  242  writing within 14 days after receiving any product that is
  243  misbranded or adulterated or that fails to meet minimum
  244  standards set forth in the official compendium or state or
  245  federal good manufacturing practices for identity, purity,
  246  potency, or sterility, regardless of whether the product is
  247  thereafter rehabilitated, quarantined, returned, or destroyed.
  248         (g) The department may adopt rules to administer this
  249  subsection which are necessary for the protection of the public
  250  health, safety, and welfare. Failure to comply with the
  251  requirements of this subsection, or rules adopted by the
  252  department to administer this subsection, is a violation of s.
  253  499.005(14), and a knowing failure is a violation of s.
  254  499.0051(4).
  255         (h) This subsection does not relieve any person from any
  256  requirement prescribed by law with respect to controlled
  257  substances as defined in the applicable federal and state laws.
  258         Section 35. This act shall take effect July 1, 2012.
  259  
  260  ================= T I T L E  A M E N D M E N T ================
  261  And the title is amended as follows:
  262  
  263         Delete line 757
  264  and insert:
  265  
  266         amending s. 499.003, F.S.; revising the definitions of
  267         the terms “distribute” or “distribution,” “drug,”
  268         “establishment,” and “prescription drug”; amending s.
  269         499.01, F.S.; deleting provisions relating to an
  270         exemption from nonresident prescription drug
  271         manufacturer permit requirements; deleting provisions
  272         relating to an exemption from out-of-state
  273         prescription drug wholesale distributor permit
  274         requirements for intracompany sale or transfer of
  275         prescription drugs; providing an exemption from permit
  276         requirements for the distribution into this state of
  277         prescription drug active pharmaceutical ingredients
  278         for incorporation into prescription drugs in finished
  279         dosage form; requiring a distributor claiming such
  280         exemption to maintain a valid license, permit, or
  281         registration in the state from which the prescription
  282         drug was distributed; requiring compliance with
  283         certain recordkeeping requirements; exempting
  284         compliance with pedigree paper requirements; providing
  285         an exemption from permit requirements for distribution
  286         into this state of limited quantities of a
  287         prescription drug that has not been repackaged, for
  288         research and development or to a holder of a letter of
  289         exemption issued by the Department of Business and
  290         Professional Regulation for research, teaching, or
  291         testing; granting the department authority to define
  292         “limited quantities” by rule and limit therein the
  293         number of transactions and amount of prescription
  294         drugs distributed into the state; requiring a
  295         distributor claiming such exemption to maintain a
  296         valid license, permit, or registration in the state
  297         from which the prescription drug was distributed;
  298         requiring all purchasers and recipients of such
  299         prescription drugs to ensure the products are not
  300         resold or used on humans except in lawful clinical
  301         trials and biostudies; requiring compliance with
  302         certain recordkeeping requirements; exempting
  303         compliance from pedigree paper requirements; providing
  304         labeling requirements for active pharmaceutical
  305         ingredients distributed within the state for teaching,
  306         testing, research, and development; exempting from
  307         out-of-state prescription drug wholesale distributor
  308         permit requirements intracompany transactions or the
  309         sale of prescription drugs from an out-of-state
  310         distributor to a distributor in this state if both
  311         distributors conduct wholesale distributions under the
  312         same business name; requiring compliance with
  313         recordkeeping and pedigree paper requirements;
  314         allowing distributors and recipients of prescription
  315         drugs claiming exemption from certain permitting
  316         requirements to maintain on file their FDA
  317         registration number, resident state distributor
  318         license or permit number, and most recent resident
  319         state or FDA inspection report; providing that persons
  320         claiming such exemptions are subject to part I of
  321         chapter 499, F.S., the Florida Drug and Cosmetic Act;
  322         requiring persons claiming such exemptions to make all
  323         records regarding prescription drug distribution
  324         available to the department, upon request, within 48
  325         hours; requiring submission of a report of mishandled
  326         or adulterated prescription drugs within 14 days after
  327         receipt of such drugs; authorizing the department to
  328         adopt rules; providing that failure to comply with
  329         requirements or rules governing such exemptions
  330         constitutes unlawful purchase or receipt of a
  331         prescription drug from a person not authorized to
  332         distribute prescription drugs to that purchaser or
  333         recipient; providing that knowing failure to comply
  334         with such requirements constitutes unlawful sale,
  335         distribution, purchase, trade, holding, or offering of
  336         a drug; providing penalties; providing construction
  337         with respect to federal and state laws relating to
  338         controlled substances; providing an effective date.