Amendment
Bill No. 1540

Amendment No. 666703

CHAMBER ACTION
Senate		House
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1	Representative(s) Homan offered the following:
2
3	Amendment (with title amendment)
4	On page 2, between line(s) 5-6, insert:
5	Section 1.  Subsections (28) and (31) of section 499.003,
6	Florida Statutes, are 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	(28)  "Manufacturer" means a person who prepares, derives,
10	manufactures, or produces a drug, device, or cosmetic. The term
11	excludes pharmacies that are operating in compliance with
12	pharmacy practice standards as defined in chapter 465 and rules
13	adopted under that chapter. This term also means the holder of
14	an approved new drug application, abbreviated new drug
15	application, or new animal drug application; a private label
16	distributor if the private label distributor's prescription
17	drugs are originally manufactured and labeled for the
18	distributor and have not been repackaged; or the distribution
19	point establishment for the manufacturer, contract manufacturer,
20	or private label distributor, whether the establishment is a
21	member of the manufacturer's affiliated group or is a contract
22	distribution site, only to the extent that the contract
23	distribution distributes the drugs of the manufacturer.
24	(31)  "Pedigree paper" means:
25	(a)  A document required pursuant to s. 499.0121(6)(d) or
26	(e); or
27	(b)1.  Effective July 1, 2006, a document or electronic
28	form approved by the Department of Health and containing
29	information that records each distribution of any given legend
30	drug, from sale by a pharmaceutical manufacturer, through
31	acquisition and sale by any wholesaler or repackager, until
32	final sale to a pharmacy or other person administering or
33	dispensing the drug; or.
34	2.  Effective July 1, 2006, a statement, under oath, in
35	written or electronic form, given when a wholesale distribution
36	company purchases and receives the specific unit of the
37	prescription drug directly from the manufacturer of the
38	prescription drug, and distributes the prescription drug
39	directly to a chain pharmacy warehouse or a person authorized by
40	law to purchase prescription drugs, for the purpose of
41	administering or dispensing the drug pursuant to s. 465.003.
42	a.  For purposes of this subparagraph, the term "wholesale
43	distribution company" means a wholesale distributor, as defined
44	in s. 499.012(1)(b), that performs intracompany transfers of
45	specific units of prescription drugs to another wholesale
46	distributor that is a member of its affiliated group as
47	described in s. 499.012(1)(d)2.b.
48	b.  For purposes of this subparagraph, the term
49	"intracompany transfers" may not include transfers of
50	prescription drugs if those specific units of the prescription
51	drugs were not purchased directly from the manufacturer.
52	c.  For purposes of this subparagraph, "chain pharmacy
53	warehouse" means a wholesale distributor permitted pursuant to
54	s. 499.012 that maintains a physical location for prescription
55	drugs that functions solely as a central warehouse to perform
56	intra-company transfers of such drugs to a member of its
57	affiliated group, as described in s. 499.0121(6)(h)1.
58	(c)  The information required to be included on the form
59	approved by the department pursuant to subparagraph (b)1. a
60	legend drug's pedigree paper must at least detail the amount of
61	the legend drug; its dosage form and strength; its lot numbers;
62	the name and address of each owner of the legend drug and his or
63	her signature; its shipping information, including the name and
64	address of each person certifying delivery or receipt of the
65	legend drug; an invoice number, a shipping document number, or
66	another number uniquely identifying the transaction; and a
67	certification that the recipient wholesaler has authenticated
68	the pedigree papers. If the manufacturer or repackager has
69	uniquely serialized the individual legend drug unit, that
70	identifier must also be included on the form approved by the
71	department pursuant to subparagraph (b)1. pedigree. It must also
72	include the name, address, telephone number and, if available,
73	e-mail contact information of each wholesaler involved in the
74	chain of the legend drug's custody. The department shall adopt
75	rules and a form relating to the requirements of this paragraph
76	no later than 90 days after the effective date of this act.
77	(d)1.  The information required to be included pursuant to
78	subparagraph (b)2. must include:
79	a.  A written statement that states: "This wholesale
80	distribution company purchased the specific unit of the
81	prescription drug directly from the manufacturer."
82	b.  The manufacturer's National Drug Code identifier that
83	provides the name of the manufacturer and the name and address
84	of the wholesaler and the purchaser of the prescription drug.
85	c.  The name of the prescription drug as it was provided by
86	the manufacturer.
87	d.  The quantity, dosage form, and strength of the
88	prescription drug.
89	2.  The wholesale distribution company shall also maintain
90	and make available to the department, upon request, the name and
91	shipping address of the manufacturer from whom the prescription
92	drugs were purchased; the dates of shipment and invoice numbers
93	from the manufacturer to the wholesale distribution company for
94	such prescription drugs; lot numbers of such prescription drugs
95	received by the wholesale distribution company; and any records
96	of any intracompany transfers within the wholesale distribution
97	company of such prescription drugs.
98	(e)  The department may adopt rules and forms relating to
99	the requirements of this subsection.
100	Section 2.  Subsection (29) of section 499.005, Florida
101	Statutes, is amended to read:
102	499.005  Prohibited acts.--It is unlawful for a person to
103	perform or cause the performance of any of the following acts in
104	this state:
105	(29)  The receipt of a prescription drug pursuant to a
106	wholesale distribution without either first receiving a pedigree
107	paper that was attested to as accurate and complete by the
108	wholesale distributor or complying with the provisions of s.
109	499.0121(6)(f)6.
110	Section 3.  Paragraph (f) of subsection (6) of section
111	499.0121, Florida Statutes, is amended to read:
112	499.0121  Storage and handling of prescription drugs;
113	recordkeeping.--The department shall adopt rules to implement
114	this section as necessary to protect the public health, safety,
115	and welfare. Such rules shall include, but not be limited to,
116	requirements for the storage and handling of prescription drugs
117	and for the establishment and maintenance of prescription drug
118	distribution records.
119	(6)  RECORDKEEPING.--The department shall adopt rules that
120	require keeping such records of prescription drugs as are
121	necessary for the protection of the public health.
122	(f)1.  Effective July 1, 2006, each person who is engaged
123	in the wholesale distribution of a prescription drug and who is
124	not the manufacturer of that drug must, before each wholesale
125	distribution of such drug, provide to the person who receives
126	the drug a pedigree paper as defined in s. 499.003(31).
127	2.  A repackager must comply with this paragraph.
128	3.  The pedigree paper requirements in this paragraph do
129	not apply to compressed medical gases or veterinary legend
130	drugs.
131	4.  Each wholesale distributor of prescription drugs must
132	maintain separate and distinct from other required records all
133	statements that are required under subparagraph 1.
134	5.  In order to verify compliance with subparagraph (d)1.,
135	each manufacturer of a prescription drug sold in this state must
136	make available upon request distribution documentation related
137	to its sales of prescription drugs, regardless of whether the
138	prescription drug was sold directly by the manufacturer to a
139	person in Florida.
140	6.  The provisions of subparagraph (f)1. are satisfied when
141	a wholesale distributor takes title to, but not possession of, a
142	prescription drug, and the prescription drug's manufacturer
143	ships the prescription drug directly to a person authorized by
144	law to purchase prescription drugs for the purpose of
145	administering or dispensing the drug pursuant to s. 465.003 or a
146	member of an affiliated group, as described in subparagraph
147	(h)1.
148	a.  The wholesale distributor must deliver to the recipient
149	of the prescription drug, within 14 days of the shipment
150	notification from the manufacturer, an invoice and the following
151	sworn statement: "This wholesale distribution company purchased
152	the specific unit of the prescription drug, listed on the
153	invoice, directly from the manufacturer and has been notified by
154	the manufacturer that the specific unit of prescription drug was
155	shipped by the manufacturer directly to a person authorized by
156	law to administer or dispense the legend drug pursuant to s.
157	465.003, Florida Statutes, or a member of an affiliated group,
158	as described in s. 499.0121(6)(h)1., Florida Statutes." The
159	invoice must contain a clear cross-reference to the shipping
160	document sent by the manufacturer to the recipient of the
161	prescription drug.
162	b.  The recipient of the prescription drug must acquire,
163	within 14 days of receipt of the prescription drug, a shipping
164	document from the manufacturer that contains, at a minimum:
165	(I)  The name and address of the manufacturer, including
166	the point of origin of the shipment, the wholesaler, and such
167	purchaser.
168	(II)  The name of the prescription drug as it appears on
169	the label.
170	(III)  The quantity, dosage form, and strength of the
171	prescription drug.
172	(IV)  The date of the shipment from the manufacturer.
173	c.  The wholesale distributor must also maintain and make
174	available to the department, upon request, the lot number of
175	such drug if the applicable lot numbers are provided to the
176	wholesale distributor by the manufacturer and are not contained
177	in the shipping document received by such recipient.
178	7.  Failure of the purchaser to acquire, or the wholesale
179	distributor or manufacturer to deliver, the documentation
180	required under subparagraph (f)6. shall constitute failure to
181	acquire or deliver a pedigree paper under s. 499.0051. Forgery
182	by the purchaser, wholesale distributor, or manufacturer of the
183	documentation required to be acquired or delivered under
184	subparagraph (f)6. shall constitute forgery of a pedigree paper
185	under s. 499.0051.
186	8.  The department may by rule define alternatives to
187	compliance with subparagraph (f)1. for a prescription drug in
188	the inventory of a permitted prescription drug wholesaler as of
189	June 30, 2006, and the return of a prescription drug purchased
190	prior to July 1, 2006. The department may specify time limits
191	for such alternatives.
192
193
194	========= T I T L E  A M E N D M E N T =========
195	On page 1, line(s) 2-3,
196	remove:  all of said lines
197
198	and insert:
199	An act relating to drug distribution;  amending s. 499.003,
200	F.S.; revising definitions; authorizing the Department of Health
201	to adopt rules and forms relating to pedigree paper
202	requirements; amending s. 499.005, F.S.; revising a provision
203	relating to prohibited acts; amending s. 499.0121, F.S.;
204	revising requirements relating to the storage and handling of
205	prescription drugs; amending s. 499.006, F.S.;

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