Senate Bill sb0926c1

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    Florida Senate - 2006                            CS for SB 926

    By the Committee on Health Care; and Senator Peaden





    587-2189-06

  1                      A bill to be entitled

  2         An act relating to drug distribution; amending

  3         s. 499.0121, F.S.; removing an expiration date

  4         on a provision relating to prescription drug

  5         recordkeeping; requiring that certain

  6         information be provided by certain prescription

  7         drug wholesalers to drug recipients; requiring

  8         drug manufacturers to file a list of authorized

  9         distributors with the department; requiring the

10         department to publish certain information;

11         providing an effective date.

12  

13  Be It Enacted by the Legislature of the State of Florida:

14  

15         Section 1.  Paragraphs (d) and (f) of subsection (6) of

16  section 499.0121, Florida Statutes, are amended to read:

17         499.0121  Storage and handling of prescription drugs;

18  recordkeeping.--The department shall adopt rules to implement

19  this section as necessary to protect the public health,

20  safety, and welfare. Such rules shall include, but not be

21  limited to, requirements for the storage and handling of

22  prescription drugs and for the establishment and maintenance

23  of prescription drug distribution records.

24         (6)  RECORDKEEPING.--The department shall adopt rules

25  that require keeping such records of prescription drugs as are

26  necessary for the protection of the public health.

27         (d)1.  Each person who is engaged in the wholesale

28  distribution of a prescription drug, and who is not an

29  authorized distributor of record for the drug manufacturer's

30  products, must provide to each wholesale distributor of such

31  drug, before the sale is made to such wholesale distributor, a

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    Florida Senate - 2006                            CS for SB 926
    587-2189-06




 1  written statement under oath identifying each previous sale of

 2  the drug back to the last authorized distributor of record,

 3  the lot number of the drug, and the sales invoice number of

 4  the invoice evidencing the sale of the drug. The written

 5  statement must accompany the drug to the next wholesale

 6  distributor. The department shall adopt rules relating to the

 7  requirements of this written statement. This paragraph does

 8  not apply to a manufacturer unless the manufacturer is

 9  performing the manufacturing operation of repackaging

10  prescription drugs.

11         2.  Each wholesale distributor of prescription drugs

12  must maintain separate and distinct from other required

13  records all statements that are required under subparagraph 1.

14  and paragraph (e).

15         3.  Each manufacturer of a prescription drug sold in

16  this state must maintain at its corporate offices a current

17  list of authorized distributors and must make such list

18  available to the department upon request.

19         4.  Each manufacturer shall file a written list of all

20  of the manufacturer's authorized distributors of record with

21  the department. A manufacturer shall notify the department not

22  later than 10 days after any change to the list. The

23  department shall publish a list of all authorized distributors

24  of record on its website.

25         5.  For the purposes of this subsection, the term

26  "authorized distributors of record" means a wholesale

27  distributor with whom a manufacturer has established an

28  ongoing relationship to distribute the manufacturer's

29  products. Effective March 1, 2004, an ongoing relationship is

30  deemed to exist when a wholesale distributor, including any

31  

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    Florida Senate - 2006                            CS for SB 926
    587-2189-06




 1  affiliated group, as defined in s. 1504 of the Internal

 2  Revenue Code, of which the wholesale distributor is a member:

 3         a.  Is listed on the manufacturer's current list of

 4  authorized distributors of record.

 5         b.  Annually purchases not less than 90 percent of all

 6  of its purchases of a manufacturer's prescription drug

 7  products, based on dollar volume, directly from that

 8  manufacturer and has total annual prescription drug sales of

 9  $100 million or more.

10         c.  Has reported to the department pursuant to s.

11  499.012(3)(g)2. that the wholesale distributor has total

12  annual prescription drug sales of $100 million or more, and

13  has a verifiable account number issued by the manufacturer

14  authorizing the wholesale distributor to purchase the

15  manufacturer's drug products directly from that manufacturer

16  and that wholesale distributor makes not fewer than 12

17  purchases of that manufacturer's drug products directly from

18  the manufacturer using said verifiable account number in 12

19  months. The provisions of this sub-subparagraph apply with

20  respect to a manufacturer that fails to file a copy of the

21  manufacturer's list of authorized distributors of record with

22  the department by July 1, 2003; that files a list of

23  authorized distributors of record which contains fewer than 10

24  wholesale distributors permitted in this state, excluding the

25  wholesale distributors described in sub-subparagraph b.; or

26  that, as a result of changes to the list of authorized

27  distributors of record filed with the department, has fewer

28  than 10 wholesale distributors permitted in this state as

29  authorized distributors of record, excluding the wholesale

30  distributors described in sub-subparagraph b.

31  

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    Florida Senate - 2006                            CS for SB 926
    587-2189-06




 1  A wholesale distributor that satisfies the requirements of

 2  sub-subparagraph b. or sub-subparagraph c. shall submit to the

 3  department documentation substantiating its qualification

 4  pursuant to sub-subparagraph b. or sub-subparagraph c. The

 5  department shall add those wholesale distributors that the

 6  department has determined have met the requirements of

 7  sub-subparagraph b. or sub-subparagraph c. to the list of

 8  authorized distributors of record on the department's website.

 9         6.  This paragraph expires July 1, 2006.

10         (f)1.  Effective July 1, 2006, each person who is

11  engaged in the wholesale distribution of a prescription drug

12  and who is not the manufacturer of that drug must, before each

13  wholesale distribution of such drug, provide to the person who

14  receives the drug either:

15         a.  A pedigree paper as defined in s. 499.003(31); or

16         b.  Until December 31, 2008, if the prescription drug

17  was purchased directly from the manufacturer, a statement in

18  written or electronic form stating that the wholesale

19  distributor or member of its affiliated group has purchased

20  the specific unit of the prescription drug directly from the

21  manufacturer, as defined in s. 499.012(1)(e), and is an

22  authorized distributor of record as specified in subparagraph

23  (d)5. In accordance with subparagraph (d)5., each manufacturer

24  shall file a written list of all of the manufacturer's

25  authorized distributors of record with the department by July

26  1, 2006. A manufacturer shall notify the department not later

27  than 10 days after any change to the list. The department

28  shall publish a list of all authorized distributors of record

29  on its website.

30         2.  A repackager must comply with this paragraph.

31  

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    Florida Senate - 2006                            CS for SB 926
    587-2189-06




 1         3.  The pedigree paper requirements in this paragraph

 2  do not apply to compressed medical gases or veterinary legend

 3  drugs.

 4         4.  Each wholesale distributor of prescription drugs

 5  must maintain separate and distinct from other required

 6  records all statements that are required under subparagraph 1.

 7         5.  In order to verify compliance with subparagraph

 8  (d)1., each manufacturer of a prescription drug sold in this

 9  state must make available upon request distribution

10  documentation related to its sales of prescription drugs,

11  regardless of whether the prescription drug was sold directly

12  by the manufacturer to a person in Florida.

13         Section 2.  This act shall take effect on July 1, 2006.

14  

15          STATEMENT OF SUBSTANTIAL CHANGES CONTAINED IN
                       COMMITTEE SUBSTITUTE FOR
16                         Senate Bill 926

17                                 

18  The bill revises requirements for certain prescription drug
    wholesalers to pass a pedigree paper that traces the
19  distribution history of a prescription drug from the
    manufacturer to the end-user.
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