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.;
7providing that the distribution of veterinary prescription
8drugs is not included within the meaning of the terms
9"wholesale distribution" or "wholesale distributor" of
10prescription drugs; amending s. 499.041, F.S.; requiring
11an annual fee for a veterinary prescription drug
12wholesaler's permit; amending s. 499.065, F.S.; requiring
13the Department of Health to inspect veterinary
14prescription drug wholesale establishments; authorizing
15the department to close such establishment if it creates
16an imminent danger to the public health; providing an
17effective date.
18
19Be It Enacted by the Legislature of the State of Florida:
20
21     Section 1.  Subsection (40) is added to section 499.003,
22Florida Statutes, to read:
23     499.003  Definitions of terms used in ss. 499.001-
24499.081.--As used in ss. 499.001-499.081, the term:
25     (40)  "Veterinary prescription drug wholesaler" means any
26person engaged in wholesale distribution of veterinary
27prescription drugs in or into this state. A veterinary
28prescription drug wholesaler may not sell any veterinary
29prescription drugs to any person or entity other than an animal
30health entity.
31     Section 2.  Subsection (1) of section 499.01, Florida
32Statutes, is amended to read:
33     499.01  Permits; applications; renewal; general
34requirements.--
35     (1)  Prior to operating, a permit is required for each
36person and establishment that intends to operate as:
37     (a)  A prescription drug manufacturer;
38     (b)  A prescription drug repackager;
39     (c)  An over-the-counter drug manufacturer;
40     (d)  A compressed medical gas manufacturer;
41     (e)  A device manufacturer;
42     (f)  A cosmetic manufacturer;
43     (g)  A prescription drug wholesaler;
44     (h)  A compressed medical gas wholesaler;
45     (i)  An out-of-state prescription drug wholesaler;
46     (j)  A nonresident prescription drug manufacturer;
47     (k)  A freight forwarder;
48     (l)  A retail pharmacy drug wholesaler;
49     (m)  A veterinary legend drug retail establishment;
50     (n)  A medical oxygen retail establishment;
51     (o)  A complimentary drug distributor; or
52     (p)  A restricted prescription drug distributor; or.
53     (q)  A veterinary prescription drug wholesaler.
54     Section 3.  Paragraphs (a) and (b) of subsection (1) of
55section 499.012, Florida Statutes, are amended to read:
56     499.012  Wholesale distribution; definitions; permits;
57applications; general requirements.--
58     (1)  As used in this section, the term:
59     (a)  "Wholesale distribution" means distribution of
60prescription drugs to persons other than a consumer or patient,
61but does not include:
62     1.  Any of the following activities, which is not a
63violation of s. 499.005(21) if such activity is conducted in
64accordance with s. 499.014:
65     a.  The purchase or other acquisition by a hospital or
66other health care entity that is a member of a group purchasing
67organization of a prescription drug for its own use from the
68group purchasing organization or from other hospitals or health
69care entities that are members of that organization.
70     b.  The sale, purchase, or trade of a prescription drug or
71an offer to sell, purchase, or trade a prescription drug by a
72charitable organization described in s. 501(c)(3) of the
73Internal Revenue Code of 1986, as amended and revised, to a
74nonprofit affiliate of the organization to the extent otherwise
75permitted by law.
76     c.  The sale, purchase, or trade of a prescription drug or
77an offer to sell, purchase, or trade a prescription drug among
78hospitals or other health care entities that are under common
79control. For purposes of this section, "common control" means
80the power to direct or cause the direction of the management and
81policies of a person or an organization, whether by ownership of
82stock, by voting rights, by contract, or otherwise.
83     d.  The sale, purchase, trade, or other transfer of a
84prescription drug from or for any federal, state, or local
85government agency or any entity eligible to purchase
86prescription drugs at public health services prices pursuant to
87Pub. L. No. 102-585, s. 602 to a contract provider or its
88subcontractor for eligible patients of the agency or entity
89under the following conditions:
90     (I)  The agency or entity must obtain written authorization
91for the sale, purchase, trade, or other transfer of a
92prescription drug under this sub-subparagraph from the Secretary
93of Health or his or her designee.
94     (II)  The contract provider or subcontractor must be
95authorized by law to administer or dispense prescription drugs.
96     (III)  In the case of a subcontractor, the agency or entity
97must be a party to and execute the subcontract.
98     (IV)  A contract provider or subcontractor must maintain
99separate and apart from other prescription drug inventory any
100prescription drugs of the agency or entity in its possession.
101     (V)  The contract provider and subcontractor must maintain
102and produce immediately for inspection all records of movement
103or transfer of all the prescription drugs belonging to the
104agency or entity, including, but not limited to, the records of
105receipt and disposition of prescription drugs. Each contractor
106and subcontractor dispensing or administering these drugs must
107maintain and produce records documenting the dispensing or
108administration. Records that are required to be maintained
109include, but are not limited to, a perpetual inventory itemizing
110drugs received and drugs dispensed by prescription number or
111administered by patient identifier, which must be submitted to
112the agency or entity quarterly.
113     (VI)  The contract provider or subcontractor may administer
114or dispense the prescription drugs only to the eligible patients
115of the agency or entity or must return the prescription drugs
116for or to the agency or entity. The contract provider or
117subcontractor must require proof from each person seeking to
118fill a prescription or obtain treatment that the person is an
119eligible patient of the agency or entity and must, at a minimum,
120maintain a copy of this proof as part of the records of the
121contractor or subcontractor required under sub-sub-subparagraph
122(V).
123     (VII)  In addition to the departmental inspection authority
124set forth in s. 499.051, the establishment of the contract
125provider and subcontractor and all records pertaining to
126prescription drugs subject to this sub-subparagraph shall be
127subject to inspection by the agency or entity. All records
128relating to prescription drugs of a manufacturer under this sub-
129subparagraph shall be subject to audit by the manufacturer of
130those drugs, without identifying individual patient information.
131     2.  Any of the following activities, which is not a
132violation of s. 499.005(21) if such activity is conducted in
133accordance with rules established by the department:
134     a.  The sale, purchase, or trade of a prescription drug
135among federal, state, or local government health care entities
136that are under common control and are authorized to purchase
137such prescription drug.
138     b.  The sale, purchase, or trade of a prescription drug or
139an offer to sell, purchase, or trade a prescription drug for
140emergency medical reasons. For purposes of this sub-
141subparagraph, the term "emergency medical reasons" includes
142transfers of prescription drugs by a retail pharmacy to another
143retail pharmacy to alleviate a temporary shortage.
144     c.  The transfer of a prescription drug acquired by a
145medical director on behalf of a licensed emergency medical
146services provider to that emergency medical services provider
147and its transport vehicles for use in accordance with the
148provider's license under chapter 401.
149     d.  The revocation of a sale or the return of a
150prescription drug to the person's prescription drug wholesale
151supplier.
152     e.  The donation of a prescription drug by a health care
153entity to a charitable organization that has been granted an
154exemption under s. 501(c)(3) of the Internal Revenue Code of
1551986, as amended, and that is authorized to possess prescription
156drugs.
157     f.  The transfer of a prescription drug by a person
158authorized to purchase or receive prescription drugs to a person
159licensed or permitted to handle reverse distributions or
160destruction under the laws of the jurisdiction in which the
161person handling the reverse distribution or destruction receives
162the drug.
163     g.  The transfer of a prescription drug by a hospital or
164other health care entity to a person licensed under this chapter
165to repackage prescription drugs for the purpose of repackaging
166the prescription drug for use by that hospital, or other health
167care entity and other health care entities that are under common
168control, if ownership of the prescription drugs remains with the
169hospital or other health care entity at all times. In addition
170to the recordkeeping requirements of s. 499.0121(6), the
171hospital or health care entity that transfers prescription drugs
172pursuant to this sub-subparagraph must reconcile all drugs
173transferred and returned and resolve any discrepancies in a
174timely manner.
175     3.  The distribution of prescription drug samples by
176manufacturers' representatives or distributors' representatives
177conducted in accordance with s. 499.028.
178     4.  The sale, purchase, or trade of blood and blood
179components intended for transfusion. As used in this
180subparagraph, the term "blood" means whole blood collected from
181a single donor and processed either for transfusion or further
182manufacturing, and the term "blood components" means that part
183of the blood separated by physical or mechanical means.
184     5.  The lawful dispensing of a prescription drug in
185accordance with chapter 465.
186     6.  The distribution of veterinary prescription drugs.
187     (b)  "Wholesale distributor" means any person engaged in
188wholesale distribution of prescription drugs, other than
189veterinary prescription drugs, in or into this state, including,
190but not limited to, manufacturers; repackagers; own-label
191distributors; jobbers; private-label distributors; brokers;
192warehouses, including manufacturers' and distributors'
193warehouses, chain drug warehouses, and wholesale drug
194warehouses; independent wholesale drug traders; exporters;
195retail pharmacies; and the agents thereof that conduct wholesale
196distributions.
197     Section 4.  Paragraph (h) is added to subsection (1) of
198section 499.041, Florida Statutes, to read:
199     499.041  Schedule of fees for drug, device, and cosmetic
200applications and permits, product registrations, and free-sale
201certificates.--
202     (1)  The department shall assess applicants requiring a
203manufacturing permit an annual fee within the ranges established
204in this section for the specific type of manufacturer.
205     (h)  The fee for a veterinary prescription drug
206wholesaler's permit may not be less than $300 or more than $500
207annually.
208     Section 5.  Section 499.065, Florida Statutes, is amended
209to read:
210     499.065  Imminent danger.--
211     (1)  Notwithstanding s. 499.051, the department shall
212inspect each prescription drug wholesale establishment,
213prescription drug repackager establishment, veterinary
214prescription drug wholesale establishment, and retail pharmacy
215drug wholesaler establishment that is required to be permitted
216under this chapter as often as necessary to ensure compliance
217with applicable laws and rules. The department shall have the
218right of entry and access to these facilities at any reasonable
219time.
220     (2)  To protect the public from prescription drugs that are
221adulterated or otherwise unfit for human or animal consumption,
222the department may examine, sample, seize, and stop the sale or
223use of prescription drugs to determine the condition of those
224drugs. The department may immediately seize and remove any
225prescription drugs if the Secretary of Health or his or her
226designee determines that such prescription drugs represent a
227threat to the public health. The owner of any property seized
228under this section may, within 10 days after the seizure, apply
229to a court of competent jurisdiction for whatever relief is
230appropriate. At any time after 10 days, the department may
231destroy the drugs as contraband.
232     (3)  The department may determine that a prescription drug
233wholesale establishment, prescription drug repackager
234establishment, veterinary prescription drug wholesale
235establishment, or retail pharmacy drug wholesaler establishment
236that is required to be permitted under this chapter is an
237imminent danger to the public health and require its immediate
238closure if such establishment fails to comply with applicable
239laws and rules and, because of such failure, presents an
240imminent threat to the public's health, safety, or welfare. Any
241establishment so deemed and closed shall remain closed until
242allowed by the department or by judicial order to reopen.
243
244For purposes of this section, a refusal to allow entry to the
245department for inspection at reasonable times, or a failure or
246refusal to provide the department with required documentation
247for purposes of inspection, constitutes an imminent danger to
248the public health.
249     Section 6.  This act shall take effect July 1, 2004.


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