HB 1201CS

CHAMBER ACTION




1The Committee on Health Care recommends the following:
2
3     Committee Substitute
4     Remove the entire bill and insert:
5
A bill to be entitled
6An act relating to veterinary prescription drugs; amending
7s. 499.003, F.S.; providing a definition; amending s.
8499.01, F.S.; requiring a person or establishment to
9obtain a permit in order to operate as a veterinary
10prescription drug wholesaler; amending s. 499.012, F.S.;
11requiring a person to have a veterinary prescription drug
12wholesaler permit to distribute veterinary prescription
13drugs in or into this state; requiring a veterinary
14prescription drug wholesaler who also distributes human
15prescription drugs that it did not manufacture to obtain a
16prescription drug wholesaler or out-of-state prescription
17drug wholesaler permit in lieu of the veterinary
18prescription drug wholesaler permit; amending s. 499.0121,
19F.S.; requiring certain prescription wholesalers and
20repackagers to use due diligence when purchasing
21prescription drugs from certain distributors; amending s.
22499.041, F.S.; requiring an annual fee for a veterinary
23prescription drug wholesaler's permit; amending s.
24499.065, F.S.; requiring the Department of Health to
25inspect veterinary prescription drug wholesale
26establishments; authorizing the department to close the
27establishment if it creates an imminent danger to the
28public health; providing an effective date.
29
30Be It Enacted by the Legislature of the State of Florida:
31
32     Section 1.  Subsection (40) is added to section 499.003,
33Florida Statutes, to read:
34     499.003  Definitions of terms used in ss. 499.001-
35499.081.--As used in ss. 499.001-499.081, the term:
36     (40)  "Veterinary prescription drug wholesaler" means any
37person engaged in wholesale distribution of veterinary
38prescription drugs in or into this state.
39     Section 2.  Subsection (1) of section 499.01, Florida
40Statutes, is amended to read:
41     499.01  Permits; applications; renewal; general
42requirements.--
43     (1)  Prior to operating, a permit is required for each
44person and establishment that intends to operate as:
45     (a)  A prescription drug manufacturer;
46     (b)  A prescription drug repackager;
47     (c)  An over-the-counter drug manufacturer;
48     (d)  A compressed medical gas manufacturer;
49     (e)  A device manufacturer;
50     (f)  A cosmetic manufacturer;
51     (g)  A prescription drug wholesaler;
52     (h)  A veterinary prescription drug wholesaler;
53     (i)(h)  A compressed medical gas wholesaler;
54     (j)(i)  An out-of-state prescription drug wholesaler;
55     (k)(j)  A nonresident prescription drug manufacturer;
56     (l)(k)  A freight forwarder;
57     (m)(l)  A retail pharmacy drug wholesaler;
58     (n)(m)  A veterinary legend drug retail establishment;
59     (o)(n)  A medical oxygen retail establishment;
60     (p)(o)  A complimentary drug distributor; or
61     (q)(p)  A restricted prescription drug distributor.
62     Section 3.  Paragraph (g) is added to subsection (2) of
63section 499.012, Florida Statutes, to read:
64     499.012  Wholesale distribution; definitions; permits;
65applications; general requirements.--
66     (2)  The following types of wholesaler permits are
67established:
68     (g)  A veterinary prescription drug wholesaler permit. A
69veterinary prescription drug wholesaler permit is required for
70any person who engages in the distribution of veterinary
71prescription drugs in or into this state. A veterinary
72prescription drug wholesaler who also distributes prescription
73drugs subject to, defined by, or described by s. 503(b) of the
74Federal Food, Drug, and Cosmetic Act that it did not manufacture
75must obtain a permit as a prescription drug wholesaler or out-
76of-state prescription drug wholesaler in lieu of the veterinary
77prescription drug wholesaler permit. A veterinary prescription
78drug wholesaler must comply with the requirements for wholesale
79distributors under s. 499.0121, except those set forth in s.
80499.0121(6)(d), (e), and (f).
81     Section 4.  Subsection (12) of section 499.0121, Florida
82Statutes, is amended to read:
83     499.0121  Storage and handling of prescription drugs;
84recordkeeping.--The department shall adopt rules to implement
85this section as necessary to protect the public health, safety,
86and welfare. Such rules shall include, but not be limited to,
87requirements for the storage and handling of prescription drugs
88and for the establishment and maintenance of prescription drug
89distribution records.
90     (12)  DUE DILIGENCE OF SUPPLIERS.--Prior to purchasing any
91prescription drugs from another wholesale drug distributor, a
92wholesale drug distributor, a prescription drug wholesaler, an
93out-of-state prescription drug wholesaler, or a prescription
94drug repackager must:
95     (a)  Enter an agreement with the selling wholesale drug
96distributor by which the selling wholesale drug distributor will
97indemnify the purchasing wholesale drug distributor for any loss
98caused to the purchasing wholesale drug distributor related to
99the purchase of drugs from the selling wholesale drug
100distributor which are determined to be counterfeit or to have
101been distributed in violation of any federal or state law
102governing the distribution of drugs.
103     (b)  Determine that the selling wholesale drug distributor
104has insurance coverage of not less than the greater of 1 percent
105of the amount of total dollar volume of the prescription drug
106sales reported to the department under pursuant to s.
107499.012(3)(g) or $500,000; however the coverage need not exceed
108$2 million.
109     (c)  Obtain information from the selling wholesale drug
110distributor, including the length of time the selling wholesale
111drug distributor has been licensed in this state, a copy of the
112selling wholesale drug distributor's licenses or permits, and
113background information concerning the ownership of the selling
114wholesale drug distributor, including the experience of the
115wholesale distributor in the wholesale distribution of
116prescription drugs.
117     (d)  Verify that the selling wholesale drug distributor's
118Florida permit is valid.
119     (e)  Inspect the selling wholesale drug distributor's
120licensed establishment to document that it has a policies and
121procedures manual relating to the distribution of drugs, the
122appropriate temperature controlled environment for drugs
123requiring temperature control, an alarm system, appropriate
124access restrictions, and procedures to ensure that records
125related to the wholesale distribution of prescription drugs are
126maintained as required by law:
127     1.  Before purchasing any drug from the wholesale drug
128distributor, and at least once each subsequent year; or
129     2.  Before purchasing any drug from the wholesale drug
130distributor, and each subsequent year obtain a complete copy of
131the most recent inspection report for the establishment which
132was prepared by the department or the regulatory authority
133responsible for wholesale drug distributors in the state in
134which the establishment is located.
135     Section 5.  Paragraph (g) is added to subsection (2) of
136section 499.041, Florida Statutes, to read:
137     499.041  Schedule of fees for drug, device, and cosmetic
138applications and permits, product registrations, and free-sale
139certificates.--
140     (2)  The department shall assess an applicant that is
141required to have a wholesaling permit an annual fee within the
142ranges established in this section for the specific type of
143wholesaling.
144     (g)  The fee for a veterinary prescription drug
145wholesaler's permit may not be less than $300 nor more than $500
146annually.
147     Section 6.  Section 499.065, Florida Statutes, is amended
148to read:
149     499.065  Imminent danger.--
150     (1)  Notwithstanding s. 499.051, the department shall
151inspect each prescription drug wholesale establishment,
152prescription drug repackager establishment, veterinary
153prescription drug wholesale establishment, and retail pharmacy
154drug wholesaler establishment that is required to be permitted
155under this chapter as often as necessary to ensure compliance
156with applicable laws and rules. The department shall have the
157right of entry and access to these facilities at any reasonable
158time.
159     (2)  To protect the public from prescription drugs that are
160adulterated or otherwise unfit for human or animal consumption,
161the department may examine, sample, seize, and stop the sale or
162use of prescription drugs to determine the condition of those
163drugs. The department may immediately seize and remove any
164prescription drugs if the Secretary of Health or his or her
165designee determines that the such prescription drugs represent a
166threat to the public health. The owner of any property seized
167under this section may, within 10 days after the seizure, apply
168to a court of competent jurisdiction for whatever relief is
169appropriate. At any time after 10 days, the department may
170destroy the drugs as contraband.
171     (3)  The department may determine that a prescription drug
172wholesale establishment, prescription drug repackager
173establishment, veterinary prescription drug wholesale
174establishment, or retail pharmacy drug wholesaler establishment
175that is required to be permitted under this chapter is an
176imminent danger to the public health and shall require its
177immediate closure if the such establishment fails to comply with
178applicable laws and rules and, because of the such failure,
179presents an imminent threat to the public's health, safety, or
180welfare. Any establishment so deemed and closed shall remain
181closed until allowed by the department or by judicial order to
182reopen.
183
184For purposes of this section, a refusal to allow entry to the
185department for inspection at reasonable times, or a failure or
186refusal to provide the department with required documentation
187for purposes of inspection, constitutes an imminent danger to
188the public health.
189     Section 7.  This act shall take effect July 1, 2004.


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