Senate Bill sb0926c1
CODING: Words stricken are deletions; words underlined are additions.
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
1
CODING: Words stricken are deletions; words underlined are additions.
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
2
CODING: Words stricken are deletions; words underlined are additions.
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
3
CODING: Words stricken are deletions; words underlined are additions.
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
4
CODING: Words stricken are deletions; words underlined are additions.
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.
20
21
22
23
24
25
26
27
28
29
30
31
5
CODING: Words stricken are deletions; words underlined are additions.