Florida Senate - 2006 COMMITTEE AMENDMENT
Bill No. CS for SB 926
Barcode 894412
CHAMBER ACTION
Senate House
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04/25/2006 09:53 PM .
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11 The Committee on Judiciary (Campbell) recommended the
12 following amendment:
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14 Senate Amendment (with title amendment)
15 On page 1, line 14,
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17 insert:
18 Section 1. Subsection (31) of section 499.003, Florida
19 Statutes, is amended to read:
20 499.003 Definitions of terms used in ss.
21 499.001-499.081.--As used in ss. 499.001-499.081, the term:
22 (31) "Pedigree paper" means:
23 (a) A document required pursuant to s. 499.0121(6)(d)
24 or (e); or
25 (b) Effective July 1, 2006:,
26 1. A document or electronic form approved by the
27 Department of Health and containing information that records
28 each distribution of any given legend drug, from sale by a
29 pharmaceutical manufacturer, through acquisition and sale by
30 any wholesaler or repackager, until final sale to a pharmacy
31 or other person administering or dispensing the drug; or.
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Florida Senate - 2006 COMMITTEE AMENDMENT
Bill No. CS for SB 926
Barcode 894412
1 2. A written statement under oath that:
2 a. If the establishment is not a member of an
3 affiliated group: "This establishment purchased the specific
4 unit of the prescription drug directly from the manufacturer";
5 or
6 b. If the establishment is a member of an affiliated
7 group: "This establishment or a member of my affiliated group
8 purchased the specific unit of the prescription drug directly
9 from the manufacturer."
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11 The information required to be included on the form prescribed
12 by the Department of Health pursuant to subparagraph 1. a
13 legend drug's pedigree paper must at least detail the amount
14 of the legend drug; its dosage form and strength; its lot
15 numbers; the name and address of each owner of the legend drug
16 and his or her signature; its shipping information, including
17 the name and address of each person certifying delivery or
18 receipt of the legend drug; an invoice number, a shipping
19 document number, or another number uniquely identifying the
20 transaction; and a certification that the recipient wholesaler
21 has authenticated the pedigree papers. If the manufacturer or
22 repackager has uniquely serialized the individual legend drug
23 unit, that identifier must also be included on the form
24 prescribed by the Department of Health pursuant to
25 subparagraph 1. pedigree. It must also include the name,
26 address, telephone number and, if available, e-mail contact
27 information of each wholesaler involved in the chain of the
28 legend drug's custody. The department shall adopt rules and a
29 form relating to the requirements of subparagraph 1. this
30 paragraph no later than 90 days after the effective date of
31 this act.
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Florida Senate - 2006 COMMITTEE AMENDMENT
Bill No. CS for SB 926
Barcode 894412
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2 (Redesignate subsequent sections.)
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5 ================ T I T L E A M E N D M E N T ===============
6 And the title is amended as follows:
7 On page 1, line 2, after the semicolon,
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9 insert:
10 amending s. 499.003, F.S.; redefining the term
11 "pedigree paper";
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