CS for CS for SB 1144                            First Engrossed
       
       
       
       
       
       
       
       
       20091144e1
       
    1                        A bill to be entitled                      
    2         An act relating to prescription drugs; amending s.
    3         499.003, F.S.; revising the definition of the term
    4         “manufacturer” for purposes of the Florida Drug and
    5         Cosmetic Act; requiring certain manufacturers to
    6         disclose the names of affiliated group members to the
    7         Department of Health; amending s. 499.01, F.S.;
    8         revising requirements for a prescription drug
    9         manufacturer permit, nonresident prescription drug
   10         manufacturer permit, and health care clinic
   11         establishment permit; amending s. 499.0121, F.S.;
   12         clarifying that a wholesale distributor is required to
   13         maintain pedigree papers separately from other records
   14         of prescription drugs under certain circumstances;
   15         amending s. 499.01212, F.S.; revising requirements for
   16         a pedigree paper; providing an effective date.
   17  
   18  Be It Enacted by the Legislature of the State of Florida:
   19  
   20         Section 1. Subsection (31) of section 499.003, Florida
   21  Statutes, is amended to read:
   22         499.003 Definitions of terms used in this part.—As used in
   23  this part, the term:
   24         (31) “Manufacturer” means:
   25         (a) A person who prepares, derives, manufactures, or
   26  produces a drug, device, or cosmetic;.
   27         (b) The holder or holders of a New Drug Application (NDA),
   28  an Abbreviated New Drug Application (ANDA), a Biologics License
   29  Application (BLA), or a New Animal Drug Application (NADA),
   30  provided such application has become effective or is otherwise
   31  approved consistent with s. 499.023;
   32         (c) A private label distributor for whom the private label
   33  distributor’s prescription drugs are originally manufactured and
   34  labeled for the distributor and have not been repackaged; or the
   35  distribution point for the manufacturer, contract manufacturer,
   36  or private label distributor whether the establishment is a
   37  member of the manufacturer’s affiliated group or is a contract
   38  distribution site.
   39         (d) A person registered under the federal act as a
   40  manufacturer of a prescription drug, who is described in
   41  paragraph (a), paragraph (b), or paragraph (c), who has entered
   42  into a written agreement with another prescription drug
   43  manufacturer that authorizes either manufacturer to distribute
   44  the prescription drug identified in the agreement as the
   45  manufacturer of that drug consistent with the federal act and
   46  its implementing regulations;
   47         (e) A member of an affiliated group that includes, but is
   48  not limited to, persons described in paragraph (a), paragraph
   49  (b), paragraph (c), or paragraph (d), which member distributes
   50  prescription drugs, whether or not obtaining title to the drugs,
   51  only for the manufacturer of the drugs who is also a member of
   52  the affiliated group. As used in this paragraph, the term
   53  “affiliated group” means an affiliated group as defined in s.
   54  1504 of the Internal Revenue Code of 1986, as amended. The
   55  manufacturer must disclose the names of all of its affiliated
   56  group members to the department; or
   57         (f) A person permitted as a third party logistics provider,
   58  only while providing warehousing, distribution, or other
   59  logistics services on behalf of a person described in paragraph
   60  (a), paragraph (b), paragraph (c), paragraph (d), or paragraph
   61  (e).
   62  
   63  The term does not include a pharmacy excludes pharmacies that is
   64  are operating in compliance with pharmacy practice standards as
   65  defined in chapter 465 and rules adopted under that chapter.
   66         Section 2. Paragraphs (a), (c), and (t) of subsection (2)
   67  of section 499.01, Florida Statutes, are amended to read:
   68         499.01 Permits.—
   69         (2) The following permits are established:
   70         (a) Prescription drug manufacturer permit.—A prescription
   71  drug manufacturer permit is required for any person that is a
   72  manufacturer of manufactures a prescription drug and that
   73  manufactures or distributes such prescription drugs in this
   74  state.
   75         1. A person that operates an establishment permitted as a
   76  prescription drug manufacturer may engage in wholesale
   77  distribution of prescription drugs manufactured at that
   78  establishment and must comply with all of the provisions of this
   79  part, except s. 499.01212, and the rules adopted under this
   80  part, except s. 499.01212, that apply to a wholesale
   81  distributor.
   82         2. A prescription drug manufacturer must comply with all
   83  appropriate state and federal good manufacturing practices.
   84         (c) Nonresident prescription drug manufacturer permit.—A
   85  nonresident prescription drug manufacturer permit is required
   86  for any person that is a manufacturer of prescription drugs, or
   87  the distribution point for a manufacturer of prescription drugs
   88  unless permitted as a third party logistics provider, and
   89  located outside of this state, or that is an entity to whom an
   90  approved new drug application has been issued by the United
   91  States Food and Drug Administration, or the contracted
   92  manufacturer of the approved new drug application holder, and
   93  located outside the United States and that, which engages in the
   94  wholesale distribution in this state of such the prescription
   95  drugs it manufactures or is responsible for manufacturing. Each
   96  such manufacturer or entity must be permitted by the department
   97  and comply with all of the provisions required of a wholesale
   98  distributor under this part, except s. 499.01212.
   99         1. A person that distributes prescription drugs for which
  100  the person is not the manufacturer that it did not manufacture
  101  must also obtain an out-of-state prescription drug wholesale
  102  distributor permit or third party logistics provider permit
  103  pursuant to this section to engage in the wholesale distribution
  104  of such the prescription drugs manufactured by another person
  105  and comply with the requirements of an out-of-state prescription
  106  drug wholesale distributor. This subparagraph does not apply to
  107  a manufacturer as defined in s. 499.003(31)(e).
  108         2. Any such person must comply with the licensing or
  109  permitting requirements of the jurisdiction in which the
  110  establishment is located and the federal act, and any product
  111  wholesaled into this state must comply with this part. If a
  112  person intends to import prescription drugs from a foreign
  113  country into this state, the nonresident prescription drug
  114  manufacturer must provide to the department a list identifying
  115  each prescription drug it intends to import and document
  116  approval by the United States Food and Drug Administration for
  117  such importation.
  118         3. A nonresident prescription drug manufacturer permit is
  119  not required for a manufacturer to distribute a prescription
  120  drug active pharmaceutical ingredient that it manufactures to a
  121  prescription drug manufacturer permitted in this state in
  122  limited quantities intended for research and development and not
  123  for resale, or human use other than lawful clinical trials and
  124  biostudies authorized and regulated by federal law. A
  125  manufacturer claiming to be exempt from the permit requirements
  126  of this subparagraph and the prescription drug manufacturer
  127  purchasing and receiving the active pharmaceutical ingredient
  128  shall comply with the recordkeeping requirements of s.
  129  499.0121(6), but not the requirements of s. 499.01212. The
  130  prescription drug manufacturer purchasing and receiving the
  131  active pharmaceutical ingredient shall maintain on file a record
  132  of the FDA registration number; the out-of-state license,
  133  permit, or registration number; and, if available, a copy of the
  134  most current FDA inspection report, for all manufacturers from
  135  whom they purchase active pharmaceutical ingredients under this
  136  section. The department shall specify by rule the allowable
  137  number of transactions within a given period of time and the
  138  amount of active pharmaceutical ingredients that qualify as
  139  limited quantities for purposes of this exemption. The failure
  140  to comply with the requirements of this subparagraph, or rules
  141  adopted by the department to administer this subparagraph, for
  142  the purchase of prescription drug active pharmaceutical
  143  ingredients is a violation of s. 499.005(14).
  144         (t) Health care clinic establishment permit.—Effective
  145  January 1, 2009, a health care clinic establishment permit is
  146  required for the purchase of a prescription drug by a place of
  147  business at one general physical location that provides health
  148  care or veterinary services, which is owned and operated by a
  149  business entity that has been issued a federal employer tax
  150  identification number professional corporation or professional
  151  limited liability company described in chapter 621, or a
  152  corporation that employs a veterinarian as a qualifying
  153  practitioner. For the purpose of this paragraph, the term
  154  “qualifying practitioner” means a licensed health care
  155  practitioner defined in s. 456.001, or a veterinarian licensed
  156  under chapter 474, who is authorized under the appropriate
  157  practice act to prescribe and administer a prescription drug.
  158         1. An establishment must provide, as part of the
  159  application required under s. 499.012, designation of a
  160  qualifying practitioner who will be responsible for complying
  161  with all legal and regulatory requirements related to the
  162  purchase, recordkeeping, storage, and handling of the
  163  prescription drugs. In addition, the designated qualifying
  164  practitioner shall be the practitioner whose name, establishment
  165  address, and license number is used on all distribution
  166  documents for prescription drugs purchased or returned by the
  167  health care clinic establishment. Upon initial appointment of a
  168  qualifying practitioner, the qualifying practitioner and the
  169  health care clinic establishment shall notify the department on
  170  a form furnished by the department within 10 days after such
  171  employment. In addition, the qualifying practitioner and health
  172  care clinic establishment shall notify the department within 10
  173  days after any subsequent change.
  174         2. The health care clinic establishment must employ a
  175  qualifying practitioner at each establishment.
  176         3. In addition to the remedies and penalties provided in
  177  this part, a violation of this chapter by the health care clinic
  178  establishment or qualifying practitioner constitutes grounds for
  179  discipline of the qualifying practitioner by the appropriate
  180  regulatory board.
  181         4. The purchase of prescription drugs by the health care
  182  clinic establishment is prohibited during any period of time
  183  when the establishment does not comply with this paragraph.
  184         5. A health care clinic establishment permit is not a
  185  pharmacy permit or otherwise subject to chapter 465. A health
  186  care clinic establishment that meets the criteria of a modified
  187  Class II institutional pharmacy under s. 465.019 is not eligible
  188  to be permitted under this paragraph.
  189         6. This paragraph does not apply to the purchase of a
  190  prescription drug by prohibit a licensed qualifying practitioner
  191  under his or her license from purchasing prescription drugs.
  192         Section 3. Paragraph (e) of subsection (6) of section
  193  499.0121, Florida Statutes, is amended to read:
  194         499.0121 Storage and handling of prescription drugs;
  195  recordkeeping.—The department shall adopt rules to implement
  196  this section as necessary to protect the public health, safety,
  197  and welfare. Such rules shall include, but not be limited to,
  198  requirements for the storage and handling of prescription drugs
  199  and for the establishment and maintenance of prescription drug
  200  distribution records.
  201         (6) RECORDKEEPING.—The department shall adopt rules that
  202  require keeping such records of prescription drugs as are
  203  necessary for the protection of the public health.
  204         (e) When pedigree papers are required by this part, a
  205  wholesale distributor must maintain the pedigree papers separate
  206  and distinct from other records required under this part
  207  chapter.
  208         Section 4. Paragraph (b) of subsection (2) of section
  209  499.01212, Florida Statutes, is amended to read:
  210         499.01212 Pedigree paper.—
  211         (2) FORMAT.—A pedigree paper must contain the following
  212  information:
  213         (b) For all other wholesale distributions of prescription
  214  drugs:
  215         1. The quantity, dosage form, and strength of the
  216  prescription drugs.
  217         2. The lot numbers of the prescription drugs.
  218         3. The name and address of each owner of the prescription
  219  drug and his or her signature.
  220         4. Shipping information, including the name and address of
  221  each person certifying delivery or receipt of the prescription
  222  drug.
  223         5. An invoice number, a shipping document number, or
  224  another number uniquely identifying the transaction.
  225         6. A certification that the recipient wholesale distributor
  226  has authenticated the pedigree papers.
  227         7. The unique serialization of the prescription drug, if
  228  the manufacturer or repackager has uniquely serialized the
  229  individual prescription drug unit.
  230         8. The name, address, telephone number, and, if available,
  231  e-mail contact information of each wholesale distributor
  232  involved in the chain of the prescription drug’s custody.
  233  
  234  When an affiliated group member obtains title to a prescription
  235  drug before distributing the prescription drug as the
  236  manufacturer under s. 499.003(31)(e), information regarding the
  237  distribution between those affiliated group members may be
  238  omitted from a pedigree paper required under this paragraph for
  239  subsequent distributions of that prescription drug.
  240         Section 5. This act shall take effect October 1, 2009.