Amendment
Bill No. 0685

Amendment No. 274439

CHAMBER ACTION
Senate		House
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1	Representative(s) Benson offered the following:
2
3	Amendment (with title amendment)
4	Remove everything after the enacting clause and insert:
5	Section 1.  Subsection (31) of section 499.003, Florida
6	Statutes, is amended to read:
7	499.003  Definitions of terms used in ss. 499.001-
8	499.081.--As used in ss. 499.001-499.081, the term:
9	(31)  "Pedigree paper" means:
10	(a)  A document required pursuant to s. 499.0121(6)(d) or
11	(e); or
12	(b)1.  Effective July 1, 2006, a document or electronic
13	form approved by the Department of Health and containing
14	information that records each distribution of any given legend
15	drug, from sale by a pharmaceutical manufacturer, through
16	acquisition and sale by any wholesaler or repackager, until
17	final sale to a pharmacy or other person administering or
18	dispensing the drug. The information required to be included on
19	the form approved by the department pursuant to this
20	subparagraph a legend drug's pedigree paper must at least detail
21	the amount of the legend drug; its dosage form and strength; its
22	lot numbers; the name and address of each owner of the legend
23	drug and his or her signature; its shipping information,
24	including the name and address of each person certifying
25	delivery or receipt of the legend drug; an invoice number, a
26	shipping document number, or another number uniquely identifying
27	the transaction; and a certification that the recipient
28	wholesaler has authenticated the pedigree papers. If the
29	manufacturer or repackager has uniquely serialized the
30	individual legend drug unit, that identifier must also be
31	included on the form approved pursuant to this subparagraph
32	pedigree. It must also include the name, address, telephone
33	number and, if available, e-mail contact information of each
34	wholesaler involved in the chain of the legend drug's custody;
35	or
36	2.  A statement, under oath, in written or electronic form,
37	confirming that a wholesale distributor purchases and receives
38	the specific unit of the prescription drug directly from the
39	manufacturer of the prescription drug and distributes the
40	prescription drug directly to a chain pharmacy warehouse or a
41	person authorized by law to purchase prescription drugs for the
42	purpose of administering or dispensing the drug, as defined in
43	s. 465.003. For purposes of this paragraph, the term "chain
44	pharmacy warehouse" means a wholesale distributor permitted
45	pursuant to s. 499.01 that maintains a physical location for
46	prescription drugs that functions solely as a central warehouse
47	to perform intracompany transfers of such drugs to a member of
48	its affiliated group as described in s. 499.0121(6)(h)1.
49	a.  The following information must be included on the form
50	approved by the department pursuant to this subparagraph:
51	(I)  The following statement: "This wholesale distributor
52	purchased the specific unit of the prescription drug directly
53	from the manufacturer."
54	(II)  The names and addresses of the manufacturer, the
55	wholesaler, and the purchaser of the prescription drug.
56	(III)  The name of the prescription drug as it appears on
57	the label.
58	(IV)  The quantity, dosage form, and strength of the
59	prescription drug.
60	b.  The wholesale distributor must also maintain and make
61	available to the department, upon request, the point of origin
62	of the prescription drug, including intracompany transfers; the
63	date of the shipment from the manufacturer to the wholesale
64	distributor; the lot number of such drug; and the invoice number
65	from the manufacturer.
66
67	The department may shall adopt rules and forms a form relating
68	to the requirements of this subsection paragraph no later than
69	90 days after the effective date of this act.
70	Section 2.  Subsection (29) of section 499.005, Florida
71	Statutes, is amended to read:
72	499.005  Prohibited acts.--It is unlawful for a person to
73	perform or cause the performance of any of the following acts in
74	this state:
75	(29)  The receipt of a prescription drug pursuant to a
76	wholesale distribution without either first receiving a pedigree
77	paper that was attested to as accurate and complete by the
78	wholesale distributor or complying with the provisions of s.
79	499.0121(6)(f)6.
80	Section 3.  Paragraph (f) of subsection (6) of section
81	499.0121, Florida Statutes, is amended to read:
82	499.0121  Storage and handling of prescription drugs;
83	recordkeeping.--The department shall adopt rules to implement
84	this section as necessary to protect the public health, safety,
85	and welfare. Such rules shall include, but not be limited to,
86	requirements for the storage and handling of prescription drugs
87	and for the establishment and maintenance of prescription drug
88	distribution records.
89	(6)  RECORDKEEPING.--The department shall adopt rules that
90	require keeping such records of prescription drugs as are
91	necessary for the protection of the public health.
92	(f)1.  Effective July 1, 2006, each person who is engaged
93	in the wholesale distribution of a prescription drug and who is
94	not the manufacturer of that drug must, before each wholesale
95	distribution of such drug, provide to the person who receives
96	the drug a pedigree paper as defined in s. 499.003(31).
97	2.  A repackager must comply with this paragraph.
98	3.  The pedigree paper requirements in this paragraph do
99	not apply to compressed medical gases or veterinary legend
100	drugs.
101	4.  Each wholesale distributor of prescription drugs must
102	maintain separate and distinct from other required records all
103	statements that are required under subparagraph 1.
104	5.  In order to verify compliance with subparagraph (d)1.,
105	each manufacturer of a prescription drug sold in this state must
106	make available upon request distribution documentation related
107	to its sales of prescription drugs, regardless of whether the
108	prescription drug was sold directly by the manufacturer to a
109	person in Florida.
110	6.  Subparagraph 1. is satisfied when a wholesale
111	distributor takes title to, but not possession of, a
112	prescription drug and the prescription drug's manufacturer ships
113	the prescription drug directly to a person authorized by law to
114	purchase prescription drugs for the purpose of administering or
115	dispensing the drug, as defined in s. 465.003, or a member of an
116	affiliated group, as described in paragraph (h), with the
117	exception of a repackager.
118	a.  The wholesale distributor must deliver to the recipient
119	of the prescription drug, within 14 days after the shipment
120	notification from the manufacturer, an invoice and the following
121	sworn statement: "This wholesale distributor purchased the
122	specific unit of the prescription drug listed on the invoice
123	directly from the manufacturer, and the specific unit of
124	prescription drug was shipped by the manufacturer directly to a
125	person authorized by law to administer or dispense the legend
126	drug, as defined in s. 465.003, Florida Statutes, or a member of
127	an affiliated group, as described in s. 499.0121(6)(h), Florida
128	Statutes, with the exception of a repackager." The invoice must
129	contain a unique cross-reference to the shipping document sent
130	by the manufacturer to the recipient of the prescription drug.
131	b.  The recipient of the prescription drug must acquire,
132	within 14 days after receipt of the prescription drug, a
133	shipping document from the manufacturer that contains, at a
134	minimum:
135	(I)  The name and address of the manufacturer, including
136	the point of origin of the shipment, and the names and addresses
137	of the wholesaler and the purchaser.
138	(II)  The name of the prescription drug as it appears on
139	the label.
140	(III)  The quantity, dosage form, and strength of the
141	prescription drug.
142	(IV)  The date of the shipment from the manufacturer.
143	c.  The wholesale distributor must also maintain and make
144	available to the department, upon request, the lot number of
145	such drug if not contained in the shipping document acquired by
146	the recipient.
147	7.  Failure of the recipient to acquire, or the wholesale
148	distributor to deliver, the documentation required under
149	subparagraph 6. shall constitute failure to acquire or deliver a
150	pedigree paper under s. 499.0051. Forgery by the recipient or
151	the wholesale distributor of the documentation required to be
152	acquired or delivered under subparagraph 6. shall constitute
153	forgery of a pedigree paper under s. 499.0051.
154	8.  The department may, by rule, specify alternatives to
155	compliance with subparagraph 1. for a prescription drug in the
156	inventory of a permitted prescription drug wholesaler as of June
157	30, 2006, and the return of a prescription drug purchased prior
158	to July 1, 2006. The department may specify time limits for such
159	alternatives.
160	Section 4.  This act shall take effect July 1, 2006.
161
162
163	======= T I T L E  A M E N D M E N T ==========
164	Remove the entire title and insert:
165	A bill to be entitled
166	An act relating to drug distribution; amending s. 499.003,
167	F.S.; revising the definition of the term "pedigree
168	paper"; authorizing the Department of Health to adopt
169	rules and forms relating to pedigree paper requirements;
170	amending s. 499.005, F.S.; revising a prohibited acts
171	provision relating to pedigree papers; amending s.
172	499.0121, F.S.; requiring certain wholesale distributors
173	taking title to a prescription drug to provide an invoice
174	to the recipient containing certain information; requiring
175	a recipient of a prescription drug to acquire from the
176	manufacturer a shipping document containing specified
177	information; requiring wholesale distributor to make
178	certain information available to the department; providing
179	for penalties; authorizing the department to adopt certain
180	rules relating to the inventory and return of certain
181	prescription drugs; providing an effective date.

CODING: Words stricken are deletions; words underlined are additions.