Florida Senate - 2006 COMMITTEE AMENDMENT
Bill No. SB 926
Barcode 755694
CHAMBER ACTION
Senate House
.
.
1 Comm: RCS .
04/04/2006 11:38 PM .
2 .
.
3 .
.
4 ______________________________________________________________
5
6
7
8
9
10 ______________________________________________________________
11 The Committee on Health Care (Peaden) recommended the
12 following amendment:
13
14 Senate Amendment (with title amendment)
15 Delete everything after the enacting clause
16
17 and insert:
18 Section 1. Paragraphs (d) and (f) of subsection (6) of
19 section 499.0121, Florida Statutes, are amended to read:
20 499.0121 Storage and handling of prescription drugs;
21 recordkeeping.--The department shall adopt rules to implement
22 this section as necessary to protect the public health,
23 safety, and welfare. Such rules shall include, but not be
24 limited to, requirements for the storage and handling of
25 prescription drugs and for the establishment and maintenance
26 of prescription drug distribution records.
27 (6) RECORDKEEPING.--The department shall adopt rules
28 that require keeping such records of prescription drugs as are
29 necessary for the protection of the public health.
30 (d)1. Each person who is engaged in the wholesale
31 distribution of a prescription drug, and who is not an
1
8:15 AM 03/27/06 s0926c-he02-kon
Florida Senate - 2006 COMMITTEE AMENDMENT
Bill No. SB 926
Barcode 755694
1 authorized distributor of record for the drug manufacturer's
2 products, must provide to each wholesale distributor of such
3 drug, before the sale is made to such wholesale distributor, a
4 written statement under oath identifying each previous sale of
5 the drug back to the last authorized distributor of record,
6 the lot number of the drug, and the sales invoice number of
7 the invoice evidencing the sale of the drug. The written
8 statement must accompany the drug to the next wholesale
9 distributor. The department shall adopt rules relating to the
10 requirements of this written statement. This paragraph does
11 not apply to a manufacturer unless the manufacturer is
12 performing the manufacturing operation of repackaging
13 prescription drugs.
14 2. Each wholesale distributor of prescription drugs
15 must maintain separate and distinct from other required
16 records all statements that are required under subparagraph 1.
17 and paragraph (e).
18 3. Each manufacturer of a prescription drug sold in
19 this state must maintain at its corporate offices a current
20 list of authorized distributors and must make such list
21 available to the department upon request.
22 4. Each manufacturer shall file a written list of all
23 of the manufacturer's authorized distributors of record with
24 the department. A manufacturer shall notify the department not
25 later than 10 days after any change to the list. The
26 department shall publish a list of all authorized distributors
27 of record on its website.
28 5. For the purposes of this subsection, the term
29 "authorized distributors of record" means a wholesale
30 distributor with whom a manufacturer has established an
31 ongoing relationship to distribute the manufacturer's
2
8:15 AM 03/27/06 s0926c-he02-kon
Florida Senate - 2006 COMMITTEE AMENDMENT
Bill No. SB 926
Barcode 755694
1 products. Effective March 1, 2004, an ongoing relationship is
2 deemed to exist when a wholesale distributor, including any
3 affiliated group, as defined in s. 1504 of the Internal
4 Revenue Code, of which the wholesale distributor is a member:
5 a. Is listed on the manufacturer's current list of
6 authorized distributors of record.
7 b. Annually purchases not less than 90 percent of all
8 of its purchases of a manufacturer's prescription drug
9 products, based on dollar volume, directly from that
10 manufacturer and has total annual prescription drug sales of
11 $100 million or more.
12 c. Has reported to the department pursuant to s.
13 499.012(3)(g)2. that the wholesale distributor has total
14 annual prescription drug sales of $100 million or more, and
15 has a verifiable account number issued by the manufacturer
16 authorizing the wholesale distributor to purchase the
17 manufacturer's drug products directly from that manufacturer
18 and that wholesale distributor makes not fewer than 12
19 purchases of that manufacturer's drug products directly from
20 the manufacturer using said verifiable account number in 12
21 months. The provisions of this sub-subparagraph apply with
22 respect to a manufacturer that fails to file a copy of the
23 manufacturer's list of authorized distributors of record with
24 the department by July 1, 2003; that files a list of
25 authorized distributors of record which contains fewer than 10
26 wholesale distributors permitted in this state, excluding the
27 wholesale distributors described in sub-subparagraph b.; or
28 that, as a result of changes to the list of authorized
29 distributors of record filed with the department, has fewer
30 than 10 wholesale distributors permitted in this state as
31 authorized distributors of record, excluding the wholesale
3
8:15 AM 03/27/06 s0926c-he02-kon
Florida Senate - 2006 COMMITTEE AMENDMENT
Bill No. SB 926
Barcode 755694
1 distributors described in sub-subparagraph b.
2
3 A wholesale distributor that satisfies the requirements of
4 sub-subparagraph b. or sub-subparagraph c. shall submit to the
5 department documentation substantiating its qualification
6 pursuant to sub-subparagraph b. or sub-subparagraph c. The
7 department shall add those wholesale distributors that the
8 department has determined have met the requirements of
9 sub-subparagraph b. or sub-subparagraph c. to the list of
10 authorized distributors of record on the department's website.
11 6. This paragraph expires July 1, 2006.
12 (f)1. Effective July 1, 2006, each person who is
13 engaged in the wholesale distribution of a prescription drug
14 and who is not the manufacturer of that drug must, before each
15 wholesale distribution of such drug, provide to the person who
16 receives the drug either:
17 a. A pedigree paper as defined in s. 499.003(31); or
18 b. Until December 31, 2008, if the prescription drug
19 was purchased directly from the manufacturer, a statement in
20 written or electronic form stating that the wholesale
21 distributor or member of its affiliated group has purchased
22 the specific unit of the prescription drug directly from the
23 manufacturer, as defined in s. 499.012(1)(e), and is an
24 authorized distributor of record as specified in subparagraph
25 (d)5. In accordance with subparagraph (d)5., each manufacturer
26 shall file a written list of all of the manufacturer's
27 authorized distributors of record with the department by July
28 1, 2006. A manufacturer shall notify the department not later
29 than 10 days after any change to the list. The department
30 shall publish a list of all authorized distributors of record
31 on its website.
4
8:15 AM 03/27/06 s0926c-he02-kon
Florida Senate - 2006 COMMITTEE AMENDMENT
Bill No. SB 926
Barcode 755694
1 2. A repackager must comply with this paragraph.
2 3. The pedigree paper requirements in this paragraph
3 do not apply to compressed medical gases or veterinary legend
4 drugs.
5 4. Each wholesale distributor of prescription drugs
6 must maintain separate and distinct from other required
7 records all statements that are required under subparagraph 1.
8 5. In order to verify compliance with subparagraph
9 (d)1., each manufacturer of a prescription drug sold in this
10 state must make available upon request distribution
11 documentation related to its sales of prescription drugs,
12 regardless of whether the prescription drug was sold directly
13 by the manufacturer to a person in Florida.
14 Section 2. This act shall take effect on July 1, 2006.
15
16
17 ================ T I T L E A M E N D M E N T ===============
18 And the title is amended as follows:
19 Delete everything before the enacting clause
20
21 and insert:
22 A bill to be entitled
23 An act relating to drug distribution; amending
24 s. 499.0121, F.S.; removing an expiration date
25 on a provision relating to prescription drug
26 recordkeeping; requiring that certain
27 information be provided by certain prescription
28 drug wholesalers to drug recipients; requiring
29 drug manufacturers to file a list of authorized
30 distributors with the department; requiring the
31 department to publish certain information;
5
8:15 AM 03/27/06 s0926c-he02-kon
Florida Senate - 2006 COMMITTEE AMENDMENT
Bill No. SB 926
Barcode 755694
1 providing an effective date.
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
31
6
8:15 AM 03/27/06 s0926c-he02-kon