HB 1201

1
A bill to be entitled
2An act relating to veterinary prescription drugs; amending
3s. 499.003, F.S.; providing a definition; amending s.
4499.01, F.S.; requiring a person or establishment to
5obtain a permit in order to operate as a veterinary
6prescription drug wholesaler; amending s. 499.012, F.S.;
7requiring a person to have a veterinary prescription drug
8wholesaler permit to distribute veterinary prescription
9drugs in or into this state; requiring a veterinary
10prescription drug wholesaler who also distributes human
11prescription drugs that it did not manufacture to obtain a
12prescription drug wholesaler or out-of-state prescription
13drug wholesaler permit in lieu of the veterinary
14prescription drug wholesaler permit; amending s. 499.0121,
15F.S.; requiring certain prescription wholesalers and
16repackagers to use due diligence when purchasing
17prescription drugs from certain distributors; amending s.
18499.041, F.S.; requiring an annual fee for a veterinary
19prescription drug wholesaler's permit; amending s.
20499.065, F.S.; requiring the Department of Health to
21inspect veterinary prescription drug wholesale
22establishments; authorizing the department to close the
23establishment if it creates an imminent danger to the
24public health; providing an effective date.
25
26Be It Enacted by the Legislature of the State of Florida:
27
28     Section 1.  Subsection (40) is added to section 499.003,
29Florida Statutes, to read:
30     499.003  Definitions of terms used in ss. 499.001-
31499.081.--As used in ss. 499.001-499.081, the term:
32     (40)  "Veterinary prescription drug wholesaler" means any
33person engaged in wholesale distribution of veterinary
34prescription drugs in or into this state.
35     Section 2.  Subsection (1) of section 499.01, Florida
36Statutes, is amended to read:
37     499.01  Permits; applications; renewal; general
38requirements.--
39     (1)  Prior to operating, a permit is required for each
40person and establishment that intends to operate as:
41     (a)  A prescription drug manufacturer;
42     (b)  A prescription drug repackager;
43     (c)  An over-the-counter drug manufacturer;
44     (d)  A compressed medical gas manufacturer;
45     (e)  A device manufacturer;
46     (f)  A cosmetic manufacturer;
47     (g)  A prescription drug wholesaler;
48     (h)  A veterinary prescription drug wholesaler;
49     (i)(h)  A compressed medical gas wholesaler;
50     (j)(i)  An out-of-state prescription drug wholesaler;
51     (k)(j)  A nonresident prescription drug manufacturer;
52     (l)(k)  A freight forwarder;
53     (m)(l)  A retail pharmacy drug wholesaler;
54     (n)(m)  A veterinary legend drug retail establishment;
55     (o)(n)  A medical oxygen retail establishment;
56     (p)(o)  A complimentary drug distributor; or
57     (q)(p)  A restricted prescription drug distributor.
58     Section 3.  Paragraph (g) is added to subsection (2) of
59section 499.012, Florida Statutes, to read:
60     499.012  Wholesale distribution; definitions; permits;
61applications; general requirements.--
62     (2)  The following types of wholesaler permits are
63established:
64     (g)  A veterinary prescription drug wholesaler permit. A
65veterinary prescription drug wholesaler permit is required for
66any person who engages in the distribution of veterinary
67prescription drugs in or into this state. A veterinary
68prescription drug wholesaler who also distributes prescription
69drugs subject to, defined by, or described by s. 503(b) of the
70Federal Food, Drug, and Cosmetic Act that it did not manufacture
71must obtain a permit as a prescription drug wholesaler or out-
72of-state prescription drug wholesaler in lieu of the veterinary
73prescription drug wholesaler permit. A veterinary prescription
74drug wholesaler must comply with the requirements for wholesale
75distributors under s. 499.0121, except those set forth in s.
76499.0121(6)(d), (e), and (f).
77     Section 4.  Subsection (12) of section 499.0121, Florida
78Statutes, is amended to read:
79     499.0121  Storage and handling of prescription drugs;
80recordkeeping.--The department shall adopt rules to implement
81this section as necessary to protect the public health, safety,
82and welfare. Such rules shall include, but not be limited to,
83requirements for the storage and handling of prescription drugs
84and for the establishment and maintenance of prescription drug
85distribution records.
86     (12)  DUE DILIGENCE OF SUPPLIERS.--Prior to purchasing any
87prescription drugs from another wholesale drug distributor, a
88prescription drug wholesaler, an out-of-state prescription drug
89wholesaler, or a prescription drug repackager a wholesale drug
90distributor must:
91     (a)  Enter an agreement with the selling wholesale drug
92distributor by which the selling wholesale drug distributor will
93indemnify the purchasing wholesale drug distributor for any loss
94caused to the purchasing wholesale drug distributor related to
95the purchase of drugs from the selling wholesale drug
96distributor which are determined to be counterfeit or to have
97been distributed in violation of any federal or state law
98governing the distribution of drugs.
99     (b)  Determine that the selling wholesale drug distributor
100has insurance coverage of not less than the greater of 1 percent
101of the amount of total dollar volume of the prescription drug
102sales reported to the department under pursuant to s.
103499.012(3)(g) or $500,000; however the coverage need not exceed
104$2 million.
105     (c)  Obtain information from the selling wholesale drug
106distributor, including the length of time the selling wholesale
107drug distributor has been licensed in this state, a copy of the
108selling wholesale drug distributor's licenses or permits, and
109background information concerning the ownership of the selling
110wholesale drug distributor, including the experience of the
111wholesale distributor in the wholesale distribution of
112prescription drugs.
113     (d)  Verify that the selling wholesale drug distributor's
114Florida permit is valid.
115     (e)  Inspect the selling wholesale drug distributor's
116licensed establishment to document that it has a policies and
117procedures manual relating to the distribution of drugs, the
118appropriate temperature controlled environment for drugs
119requiring temperature control, an alarm system, appropriate
120access restrictions, and procedures to ensure that records
121related to the wholesale distribution of prescription drugs are
122maintained as required by law:
123     1.  Before purchasing any drug from the wholesale drug
124distributor, and at least once each subsequent year; or
125     2.  Before purchasing any drug from the wholesale drug
126distributor, and each subsequent year obtain a complete copy of
127the most recent inspection report for the establishment which
128was prepared by the department or the regulatory authority
129responsible for wholesale drug distributors in the state in
130which the establishment is located.
131     Section 5.  Paragraph (g) is added to subsection (2) of
132section 499.041, Florida Statutes, to read:
133     499.041  Schedule of fees for drug, device, and cosmetic
134applications and permits, product registrations, and free-sale
135certificates.--
136     (2)  The department shall assess an applicant that is
137required to have a wholesaling permit an annual fee within the
138ranges established in this section for the specific type of
139wholesaling.
140     (g)  The fee for a veterinary prescription drug
141wholesaler's permit may not be less than $300 nor more than $500
142annually.
143     Section 6.  Section 499.065, Florida Statutes, is amended
144to read:
145     499.065  Imminent danger.--
146     (1)  Notwithstanding s. 499.051, the department shall
147inspect each prescription drug wholesale establishment,
148prescription drug repackager establishment, veterinary
149prescription drug wholesale establishment, and retail pharmacy
150drug wholesaler establishment that is required to be permitted
151under this chapter as often as necessary to ensure compliance
152with applicable laws and rules. The department shall have the
153right of entry and access to these facilities at any reasonable
154time.
155     (2)  To protect the public from prescription drugs that are
156adulterated or otherwise unfit for human or animal consumption,
157the department may examine, sample, seize, and stop the sale or
158use of prescription drugs to determine the condition of those
159drugs. The department may immediately seize and remove any
160prescription drugs if the Secretary of Health or his or her
161designee determines that the such prescription drugs represent a
162threat to the public health. The owner of any property seized
163under this section may, within 10 days after the seizure, apply
164to a court of competent jurisdiction for whatever relief is
165appropriate. At any time after 10 days, the department may
166destroy the drugs as contraband.
167     (3)  The department may determine that a prescription drug
168wholesale establishment, prescription drug repackager
169establishment, veterinary prescription drug wholesale
170establishment, or retail pharmacy drug wholesaler establishment
171that is required to be permitted under this chapter is an
172imminent danger to the public health and shall require its
173immediate closure if the such establishment fails to comply with
174applicable laws and rules and, because of the such failure,
175presents an imminent threat to the public's health, safety, or
176welfare. Any establishment so deemed and closed shall remain
177closed until allowed by the department or by judicial order to
178reopen.
179
180For purposes of this section, a refusal to allow entry to the
181department for inspection at reasonable times, or a failure or
182refusal to provide the department with required documentation
183for purposes of inspection, constitutes an imminent danger to
184the public health.
185     Section 7.  This act shall take effect July 1, 2004.


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