Florida Senate - 2009                                    SB 1144
       
       
       
       By Senator Peaden
       
       
       
       
       2-00956B-09                                           20091144__
    1                        A bill to be entitled                      
    2         An act relating to manufacturers and purchasers of
    3         prescription drugs; amending s. 499.003, F.S.;
    4         redefining the term “manufacturer” as it relates to
    5         the Florida Drug and Cosmetic Act; amending s. 499.01,
    6         F.S.; revising the business entities that are eligible
    7         for a permit as a health care clinic establishment in
    8         order to purchase prescription drugs; providing an
    9         effective date.
   10         
   11  Be It Enacted by the Legislature of the State of Florida:
   12         
   13         Section 1. Subsection (31) of section 499.003, Florida
   14  Statutes, is amended to read:
   15         499.003 Definitions of terms used in this part.—As used in
   16  this part, the term:
   17         (31) “Manufacturer” means:
   18         (a) A person who prepares, derives, manufactures, or
   19  produces a drug, device, or cosmetic.
   20         (b) The holder or holders of a New Drug Application (NDA),
   21  an Abbreviated New Drug Application (ANDA), a Biologics License
   22  Application (BLA), or a New Animal Drug Application (NADA),
   23  provided such application has become effective or is otherwise
   24  approved consistent with s. 499.023.;
   25         (c)A co-licensee who has entered into an agreement with a
   26  co-licensed partner to manufacture or market a product
   27  consistent with the federal act.
   28         (d) A private label distributor for whom the private label
   29  distributor's prescription drugs are originally manufactured and
   30  labeled for the distributor and have not been repackaged.; or
   31         (e) The distribution point for one of the persons
   32  identified in paragraph (a), paragraph (b), paragraph (c), or
   33  paragraph (d) if the distribution point is:
   34         1.A member of the affiliated group of one of the persons
   35  identified in paragraph (a), paragraph (b), paragraph (c), or
   36  paragraph (d) who distributes prescription drugs manufactured by
   37  affiliated group members only. The distribution point that is an
   38  affiliated group member may acquire title to a prescription drug
   39  before distributing the prescription drug, is exempt from s.
   40  499.01(2)(c)1., and is a manufacturer for purposes of s.
   41  499.01212. As used in this subparagraph, the term “affiliated
   42  group” means an affiliated group as defined in 26 U.S.C. s.
   43  1504, as amended.
   44         2.A person under contract with one of the persons
   45  identified in paragraph (a), paragraph (b), paragraph (c), or
   46  paragraph (d) to distribute their prescription drugs, who may
   47  not take title to the prescription drugs, and who is permitted
   48  as a third-party logistics provider under s. 499.01 the
   49  manufacturer, contract manufacturer, or private label
   50  distributor whether the establishment is a member of the
   51  manufacturer's affiliated group or is a contract distribution
   52  site.
   53  The term excludes pharmacies that are operating in compliance
   54  with pharmacy practice standards as defined in chapter 465 and
   55  rules adopted under that chapter.
   56         Section 2. Paragraph (t) of subsection (2) of section
   57  499.01, Florida Statutes, is amended to read:
   58         499.01 Permits.—
   59         (2) The following permits are established:
   60         (t) Health care clinic establishment permit.—Effective
   61  January 1, 2009, a health care clinic establishment permit is
   62  required for the purchase of a prescription drug by a place of
   63  business at one general physical location owned and operated by
   64  a professional corporation or professional limited liability
   65  company described in chapter 621, any other legal entity through
   66  which qualified practitioners may practice their profession
   67  under state law, or a corporation that employs a veterinarian as
   68  a qualifying practitioner. For the purpose of this paragraph,
   69  the term “qualifying practitioner” means a licensed health care
   70  practitioner defined in s. 456.001 or a veterinarian licensed
   71  under chapter 474, who is authorized under the appropriate
   72  practice act to prescribe and administer a prescription drug.
   73         1. An establishment must provide, as part of the
   74  application required under s. 499.012, designation of a
   75  qualifying practitioner who will be responsible for complying
   76  with all legal and regulatory requirements related to the
   77  purchase, recordkeeping, storage, and handling of the
   78  prescription drugs. In addition, the designated qualifying
   79  practitioner shall be the practitioner whose name, establishment
   80  address, and license number is used on all distribution
   81  documents for prescription drugs purchased or returned by the
   82  health care clinic establishment. Upon initial appointment of a
   83  qualifying practitioner, the qualifying practitioner and the
   84  health care clinic establishment shall notify the department on
   85  a form furnished by the department within 10 days after such
   86  employment. In addition, the qualifying practitioner and health
   87  care clinic establishment shall notify the department within 10
   88  days after any subsequent change.
   89         2. The health care clinic establishment must employ a
   90  qualifying practitioner at each establishment.
   91         3. In addition to the remedies and penalties provided in
   92  this part, a violation of this chapter by the health care clinic
   93  establishment or qualifying practitioner constitutes grounds for
   94  discipline of the qualifying practitioner by the appropriate
   95  regulatory board.
   96         4. The purchase of prescription drugs by the health care
   97  clinic establishment is prohibited during any period of time
   98  when the establishment does not comply with this paragraph.
   99         5. A health care clinic establishment permit is not a
  100  pharmacy permit or otherwise subject to chapter 465. A health
  101  care clinic establishment that meets the criteria of a modified
  102  Class II institutional pharmacy under s. 465.019 is not eligible
  103  to be permitted under this paragraph.
  104         6. This paragraph does not prohibit a qualifying
  105  practitioner from purchasing prescription drugs.
  106         Section 3. This act shall take effect upon becoming a law.