Florida Senate - 2006 SENATOR AMENDMENT
Bill No. HB 371, 1st Eng.
Barcode 422560
CHAMBER ACTION
Senate House
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05/05/2006 11:06 PM .
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11 Senator Peaden moved the following amendment:
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13 Senate Amendment (with title amendment)
14 Between lines 205 and 206,
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16 insert:
17 Section 3. Subsection (31) of section 499.003, Florida
18 Statutes, is amended to read:
19 499.003 Definitions of terms used in ss.
20 499.001-499.081.--As used in ss. 499.001-499.081, the term:
21 (31) "Pedigree paper" means:
22 (a) A document required pursuant to s. 499.0121(6)(d)
23 or (e); or
24 (b)1. Effective July 1, 2006, a document or electronic
25 form approved by the Department of Health and containing
26 information that records each distribution of any given legend
27 drug, from sale by a pharmaceutical manufacturer, through
28 acquisition and sale by any wholesaler or repackager, until
29 final sale to a pharmacy or other person administering or
30 dispensing the drug. The information required to be included
31 on the form approved by the department pursuant to this
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Florida Senate - 2006 SENATOR AMENDMENT
Bill No. HB 371, 1st Eng.
Barcode 422560
1 subparagraph a legend drug's pedigree paper must at least
2 detail the amount of the legend drug; its dosage form and
3 strength; its lot numbers; the name and address of each owner
4 of the legend drug and his or her signature; its shipping
5 information, including the name and address of each person
6 certifying delivery or receipt of the legend drug; an invoice
7 number, a shipping document number, or another number uniquely
8 identifying the transaction; and a certification that the
9 recipient wholesaler has authenticated the pedigree papers. If
10 the manufacturer or repackager has uniquely serialized the
11 individual legend drug unit, that identifier must also be
12 included on the form approved pursuant to this subparagraph
13 pedigree. It must also include the name, address, telephone
14 number and, if available, e-mail contact information of each
15 wholesaler involved in the chain of the legend drug's custody;
16 or
17 2. A statement, under oath, in written or electronic
18 form, confirming that a wholesale distributor purchases and
19 receives the specific unit of the prescription drug directly
20 from the manufacturer of the prescription drug and distributes
21 the prescription drug directly to a chain pharmacy warehouse
22 or a person authorized by law to purchase prescription drugs
23 for the purpose of administering or dispensing the drug, as
24 defined in s. 465.003. For purposes of this paragraph, the
25 term "chain pharmacy warehouse" means a wholesale distributor
26 permitted pursuant to s. 499.01 that maintains a physical
27 location for prescription drugs that functions solely as a
28 central warehouse to perform intracompany transfers of such
29 drugs to a member of its affiliated group as described in s.
30 499.0121(6)(h)1.
31 a. The following information must be included on the
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Florida Senate - 2006 SENATOR AMENDMENT
Bill No. HB 371, 1st Eng.
Barcode 422560
1 form approved by the department pursuant to this subparagraph:
2 (I) The following statement: "This wholesale
3 distributor purchased the specific unit of the prescription
4 drug directly from the manufacturer."
5 (II) The manufacturers' national drug code identifier
6 and the name and address of the wholesaler and the purchaser
7 of the prescription drug.
8 (III) The name of the prescription drug as it appears
9 on the label.
10 (IV) The quantity, dosage form, and strength of the
11 prescription drug.
12 b. The wholesale distributor must also maintain and
13 make available to the department, upon request, the point of
14 origin of the prescription drugs, including intracompany
15 transfers; the date of the shipment from the manufacturer to
16 the wholesale distributor; the lot numbers of such drugs; and
17 the invoice numbers from the manufacturer.
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19 The department may shall adopt rules and forms a form relating
20 to the requirements of this subsection paragraph no later than
21 90 days after the effective date of this act.
22 Section 4. Subsection (29) of section 499.005, Florida
23 Statutes, is amended to read:
24 499.005 Prohibited acts.--It is unlawful for a person
25 to perform or cause the performance of any of the following
26 acts in this state:
27 (29) The receipt of a prescription drug pursuant to a
28 wholesale distribution without either first receiving a
29 pedigree paper that was attested to as accurate and complete
30 by the wholesale distributor or complying with the provisions
31 of s. 499.0121(6)(f)6.
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Florida Senate - 2006 SENATOR AMENDMENT
Bill No. HB 371, 1st Eng.
Barcode 422560
1 Section 5. Paragraph (f) of subsection (6) of section
2 499.0121, Florida Statutes, is amended to read:
3 499.0121 Storage and handling of prescription drugs;
4 recordkeeping.--The department shall adopt rules to implement
5 this section as necessary to protect the public health,
6 safety, and welfare. Such rules shall include, but not be
7 limited to, requirements for the storage and handling of
8 prescription drugs and for the establishment and maintenance
9 of prescription drug distribution records.
10 (6) RECORDKEEPING.--The department shall adopt rules
11 that require keeping such records of prescription drugs as are
12 necessary for the protection of the public health.
13 (f)1. Effective July 1, 2006, each person who is
14 engaged in the wholesale distribution of a prescription drug
15 and who is not the manufacturer of that drug must, before each
16 wholesale distribution of such drug, provide to the person who
17 receives the drug a pedigree paper as defined in s.
18 499.003(31).
19 2. A repackager must comply with this paragraph.
20 3. The pedigree paper requirements in this paragraph
21 do not apply to compressed medical gases or veterinary legend
22 drugs.
23 4. Each wholesale distributor of prescription drugs
24 must maintain separate and distinct from other required
25 records all statements that are required under subparagraph 1.
26 5. In order to verify compliance with subparagraph
27 (d)1., each manufacturer of a prescription drug sold in this
28 state must make available upon request distribution
29 documentation related to its sales of prescription drugs,
30 regardless of whether the prescription drug was sold directly
31 by the manufacturer to a person in Florida.
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Florida Senate - 2006 SENATOR AMENDMENT
Bill No. HB 371, 1st Eng.
Barcode 422560
1 6. Subparagraph 1. is satisfied when a wholesale
2 distributor takes title to, but not possession of, a
3 prescription drug and the prescription drug's manufacturer
4 ships the prescription drug directly to a person authorized by
5 law to purchase prescription drugs for the purpose of
6 administering or dispensing the drug, as defined in s.
7 465.003, or a member of an affiliated group, as described in
8 paragraph (h), with the exception of a repackager.
9 a. The wholesale distributor must deliver to the
10 recipient of the prescription drug, within 14 days after the
11 shipment notification from the manufacturer, an invoice and
12 the following sworn statement: "This wholesale distributor
13 purchased the specific unit of the prescription drug listed on
14 the invoice directly from the manufacturer, and the specific
15 unit of prescription drug was shipped by the manufacturer
16 directly to a person authorized by law to administer or
17 dispense the legend drug, as defined in s. 465.003, Florida
18 Statutes, or a member of an affiliated group, as described in
19 s. 499.0121(6)(h), Florida Statutes, with the exception of a
20 repackager." The invoice must contain a unique cross-reference
21 to the shipping document sent by the manufacturer to the
22 recipient of the prescription drug.
23 b. The manufacturer of the prescription drug shipped
24 directly to the recipient under this section must provide and
25 the recipient of the prescription drug must acquire, within 14
26 days after receipt of the prescription drug, a shipping
27 document from the manufacturer that contains, at a minimum:
28 (I) The name and address of the manufacturer,
29 including the point of origin of the shipment, and the names
30 and addresses of the wholesaler and the purchaser.
31 (II) The name of the prescription drug as it appears
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Florida Senate - 2006 SENATOR AMENDMENT
Bill No. HB 371, 1st Eng.
Barcode 422560
1 on the label.
2 (III) The quantity, dosage form, and strength of the
3 prescription drug.
4 (IV) The date of the shipment from the manufacturer.
5 c. The wholesale distributor must also maintain and
6 make available to the department, upon request, the lot number
7 of such drug if not contained in the shipping document
8 acquired by the recipient.
9 7. Failure of the manufacturer to provide, the
10 recipient to acquire, or the wholesale distributor to deliver,
11 the documentation required under subparagraph 6. shall
12 constitute failure to acquire or deliver a pedigree paper
13 under s. 499.0051. Forgery by the manufacturer, the recipient
14 or the wholesale distributor of the documentation required to
15 be acquired or delivered under subparagraph 6. shall
16 constitute forgery of a pedigree paper under s. 499.0051.
17 8. The department may, by rule, specify alternatives
18 to compliance with subparagraph 1. for a prescription drug in
19 the inventory of a permitted prescription drug wholesaler as
20 of June 30, 2006, and the return of a prescription drug
21 purchased prior to July 1, 2006. The department may specify
22 time limits for such alternatives.
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24 (Redesignate subsequent sections.)
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27 ================ T I T L E A M E N D M E N T ===============
28 And the title is amended as follows:
29 On line 26, after the semicolon,
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31 insert:
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Florida Senate - 2006 SENATOR AMENDMENT
Bill No. HB 371, 1st Eng.
Barcode 422560
1 amending s. 499.003, F.S.; revising the
2 definition of the term "pedigree paper";
3 authorizing the Department of Health to adopt
4 rules and forms relating to pedigree paper
5 requirements; amending s. 499.005, F.S.;
6 revising a prohibited acts provision relating
7 to pedigree papers; amending s. 499.0121, F.S.;
8 requiring certain wholesale distributors taking
9 title to a prescription drug to provide an
10 invoice to the recipient containing certain
11 information; requiring a recipient of a
12 prescription drug to acquire from the
13 manufacturer a shipping document containing
14 specified information; requiring wholesale
15 distributor to make certain information
16 available to the department; providing for
17 penalties; authorizing the department to adopt
18 certain rules relating to the inventory and
19 return of certain prescription drugs;
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