(LATE FILED)	Amendment
Bill No. 1575

Amendment No. 294769

CHAMBER ACTION
Senate		House
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1	Representative(s) Coley offered the following:
2
3	Amendment (with title amendment)
4	Between lines 923 and 924, insert:
5	Section 9.  Paragraph (h) of subsection (2) of section
6	499.012, Florida Statutes, is amended to read:
7	499.012  Wholesale distribution; definitions; permits;
8	applications; general requirements.--
9	(2)  The following types of wholesaler permits are
10	established:
11	(h)  Limited prescription drug veterinary wholesaler
12	permit.--Unless engaging in the activities of and permitted as a
13	prescription drug manufacturer, nonresident prescription drug
14	manufacturer, prescription drug wholesaler, or out-of-state
15	prescription drug wholesaler, a limited prescription drug
16	veterinary wholesaler permit is required for any person that
17	engages in the distribution in or into this state of veterinary
18	prescription drugs and prescription drugs subject to, defined
19	by, or described by s. 503(b) of the Federal Food, Drug, and
20	Cosmetic Act under the following conditions:
21	1.  The limited prescription drug veterinary wholesaler,
22	after being permitted as a limited prescription drug veterinary
23	wholesaler, only distributes person is engaged in the business
24	of wholesaling prescription and veterinary legend drugs to
25	persons:
26	a.  Licensed as veterinarians practicing on a full-time
27	basis;
28	b.  Owning a veterinary establishment permitted pursuant to
29	s. 474.215;
30	c.b.  Regularly and lawfully engaged in instruction in
31	veterinary medicine;
32	d.c.  Regularly and lawfully engaged in law enforcement
33	activities;
34	e.d.  For use in research not involving clinical use; or
35	f.e.  For use in chemical analysis or physical testing or
36	for purposes of instruction in law enforcement activities,
37	research, or testing;
38	g.  Holding a prescription drug veterinary wholesaler
39	permit or a limited prescription drug veterinary wholesaler
40	permit; or
41	h.  Holding an authorization, license, or permit issued by
42	another state to engage in the purchase or sale of prescription
43	drugs for wholesale distribution, provided such persons are
44	located outside of this state and are not authorized to purchase
45	or sell prescription drugs for wholesale distribution in or into
46	this state except as otherwise authorized in this subparagraph.
47	2.  No more than 30 percent of total annual prescription
48	drug sales may be prescription drugs approved for human use
49	which are subject to, defined by, or described by s. 503(b) of
50	the Federal Food, Drug, and Cosmetic Act.
51	3.  The limited prescription drug veterinary wholesaler
52	certifies under oath to the department that the wholesaler will
53	not knowingly distribute prescription drugs defined in s. 503(b)
54	of the Federal Food, Drug, and Cosmetic Act in any state to any
55	person other than those specified in subparagraph 1. The person
56	is not permitted, licensed, or otherwise authorized in any state
57	to wholesale prescription drugs subject to, defined by, or
58	described by s. 503(b) of the Federal Food, Drug, and Cosmetic
59	Act to any person who is authorized to sell, distribute,
60	purchase, trade, or use these drugs on or for humans.
61	4.  A limited prescription drug veterinary wholesaler that
62	applies to the department for a new permit or the renewal of a
63	permit must submit a bond of $20,000, or other equivalent means
64	of security acceptable to the department, such as an irrevocable
65	letter of credit or a deposit in a trust account or financial
66	institution, payable to the Florida Drug, Device, and Cosmetic
67	Trust Fund. The purpose of the bond is to secure payment of any
68	administrative penalties imposed by the department and any fees
69	and costs incurred by the department regarding that permit which
70	are authorized under state law and which the permittee fails to
71	pay 30 days after the fine or costs become final. The department
72	may make a claim against such bond or security until 1 year
73	after the permittee's license ceases to be valid or until 60
74	days after any administrative or legal proceeding authorized in
75	ss. 499.001-499.081 which involves the permittee is concluded,
76	including any appeal, whichever occurs later.
77	5.  A limited prescription drug veterinary wholesaler must
78	maintain at all times a license or permit to engage in the
79	wholesale distribution of prescription drugs in compliance with
80	laws of the state in which it is a resident.
81	6.  A limited prescription drug veterinary wholesaler must
82	comply with the requirements for wholesale distributors under s.
83	499.0121, except that a limited prescription drug veterinary
84	wholesaler is not required to provide a pedigree paper as
85	required by s. 499.0121(6)(f) upon the wholesale distribution of
86	a prescription drug to a veterinarian or to the owner of a
87	veterinary establishment permitted pursuant to s. 474.215.
88	7.  A limited prescription drug veterinary wholesaler may
89	not return to inventory for subsequent wholesale distribution
90	any prescription drug subject to, defined by, or described by s.
91	503(b) of the Federal Food, Drug, and Cosmetic Act which has
92	been returned by a veterinarian or by the owner of a veterinary
93	establishment permitted pursuant to s. 474.215.
94	8.  An out-of-state prescription drug wholesaler's permit
95	or a limited prescription drug veterinary wholesaler permit is
96	not required for an intracompany sale or transfer of a
97	prescription drug from an out-of-state establishment that is
98	duly licensed to engage in the wholesale distribution of
99	prescription drugs in its state of residence to a licensed
100	limited prescription drug veterinary wholesaler in this state if
101	both wholesalers conduct wholesale distributions of prescription
102	drugs under the same business name. The recordkeeping
103	requirements of s. 499.0121(6) must be followed for this
104	transaction.
105
106	======= T I T L E  A M E N D M E N T =======
107	Remove line 55 and insert:
108	language; amending s. 499.012, F.S.; revising permit
109	requirements for a limited prescription drug veterinary
110	wholesaler; providing for certain certification to the
111	Department of Health by a limited prescription drug veterinary
112	wholesaler; amending ss. 408.07, 409.9116, and 1009.65,

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