HB 685

1
A bill to be entitled
2An act relating to veterinary drug distribution; amending
3s. 499.006, F.S.; providing that a drug is adulterated if
4it is a certain prescription drug that has been returned
5by a veterinarian to a limited prescription drug
6veterinary wholesaler; amending s. 499.01, F.S.; requiring
7a limited prescription drug veterinary wholesaler to
8obtain a permit for operation from the Department of
9Health; providing that a permit for a limited prescription
10drug veterinary wholesaler may not be issued to the
11address of certain health care entities; amending s.
12499.012, F.S.; revising permit requirements for a
13veterinary prescription drug wholesaler that distributes
14prescription drugs; establishing a permit for a limited
15prescription drug veterinary wholesaler; providing
16requirements; providing an exception; amending s.
17499.0122, F.S.; redefining the term "veterinary legend
18drug retail establishment"; amending s. 499.041, F.S.;
19requiring the department to assess an annual fee within a
20certain monetary range for a limited prescription drug
21veterinary wholesaler permit; amending s. 499.065, F.S.;
22requiring the department to inspect each limited
23prescription drug veterinary wholesaler establishment;
24authorizing the department to determine that a limited
25prescription drug veterinary wholesaler establishment is
26an imminent danger to the public; providing an effective
27date.
28
29Be It Enacted by the Legislature of the State of Florida:
30
31     Section 1.  Section 499.006, Florida Statutes, is amended
32to read:
33     499.006  Adulterated drug or device.--A drug or device is
34adulterated:
35     (1)  If it consists in whole or in part of any filthy,
36putrid, or decomposed substance;
37     (2)  If it has been produced, prepared, packed, or held
38under conditions whereby it could have been contaminated with
39filth or rendered injurious to health;
40     (3)  If it is a drug and the methods used in, or the
41facilities or controls used for, its manufacture, processing,
42packing, or holding do not conform to, or are not operated or
43administered in conformity with, current good manufacturing
44practices to assure that the drug meets the requirements of ss.
45499.001-499.081 and that the drug has the identity and strength,
46and meets the standard of quality and purity, which it purports
47or is represented to possess;
48     (4)  If it is a drug and its container is composed, in
49whole or in part, of any poisonous or deleterious substance
50which could render the contents injurious to health;
51     (5)  If it is a drug and it bears or contains, for the
52purpose of coloring only, a color additive that is unsafe within
53the meaning of the federal act; or, if it is a color additive,
54the intended use of which in or on drugs is for the purpose of
55coloring only, and it is unsafe within the meaning of the
56federal act;
57     (6)  If it purports to be, or is represented as, a drug the
58name of which is recognized in the official compendium, and its
59strength differs from, or its quality or purity falls below, the
60standard set forth in such compendium. The determination as to
61strength, quality, or purity must be made in accordance with the
62tests or methods of assay set forth in such compendium, or, when
63such tests or methods of assay are absent or inadequate, in
64accordance with those tests or methods of assay prescribed under
65authority of the federal act. A drug defined in the official
66compendium is not adulterated under this subsection merely
67because it differs from the standard of strength, quality, or
68purity set forth for that drug in such compendium if its
69difference in strength, quality, or purity from such standard is
70plainly stated on its label;
71     (7)  If it is not subject to subsection (6) and its
72strength differs from, or its purity or quality falls below the
73standard of, that which it purports or is represented to
74possess;
75     (8)  If it is a drug:
76     (a)  With which any substance has been mixed or packed so
77as to reduce the quality or strength of the drug; or
78     (b)  For which any substance has been substituted wholly or
79in part;
80     (9)  If it is a drug or device for which the expiration
81date has passed; or
82     (10)  If it is a legend drug for which the required
83pedigree paper is nonexistent, fraudulent, or incomplete under
84the requirements of ss. 499.001-499.081 or applicable rules, or
85that has been purchased, held, sold, or distributed at any time
86by a person not authorized under federal or state law to do so;
87or.
88     (11)  If it is a prescription drug subject to, defined by,
89or described by s. 503(b) of the Federal Food, Drug, and
90Cosmetic Act which has been returned by a veterinarian to a
91limited prescription drug veterinary wholesaler.
92     Section 2.  Subsection (1) and paragraph (d) of subsection
93(2) of section 499.01, Florida Statutes, are amended to read:
94     499.01  Permits; applications; renewal; general
95requirements.--
96     (1)  Prior to operating, a permit is required for each
97person and establishment that intends to operate as:
98     (a)  A prescription drug manufacturer;
99     (b)  A prescription drug repackager;
100     (c)  An over-the-counter drug manufacturer;
101     (d)  A compressed medical gas manufacturer;
102     (e)  A device manufacturer;
103     (f)  A cosmetic manufacturer;
104     (g)  A prescription drug wholesaler;
105     (h)  A veterinary prescription drug wholesaler;
106     (i)  A compressed medical gas wholesaler;
107     (j)  An out-of-state prescription drug wholesaler;
108     (k)  A nonresident prescription drug manufacturer;
109     (l)  A freight forwarder;
110     (m)  A retail pharmacy drug wholesaler;
111     (n)  A veterinary legend drug retail establishment;
112     (o)  A medical oxygen retail establishment;
113     (p)  A complimentary drug distributor; or
114     (q)  A restricted prescription drug distributor; or.
115     (r)  A limited prescription drug veterinary wholesaler.
116     (2)
117     (d)  A permit for a prescription drug manufacturer,
118prescription drug repackager, prescription drug wholesaler,
119limited prescription drug veterinary wholesaler, or retail
120pharmacy wholesaler may not be issued to the address of a health
121care entity or to a pharmacy licensed under chapter 465, except
122as provided in this paragraph. The department may issue a
123prescription drug manufacturer permit to an applicant at the
124same address as a licensed nuclear pharmacy, which is a health
125care entity, for the purpose of manufacturing prescription drugs
126used in positron emission tomography or other
127radiopharmaceuticals, as listed in a rule adopted by the
128department pursuant to this paragraph. The purpose of this
129exemption is to assure availability of state-of-the-art
130pharmaceuticals that would pose a significant danger to the
131public health if manufactured at a separate establishment
132address from the nuclear pharmacy from which the prescription
133drugs are dispensed. The department may also issue a retail
134pharmacy wholesaler permit to the address of a community
135pharmacy licensed under chapter 465 which does not meet the
136definition of a closed pharmacy in s. 499.003.
137     Section 3.  Paragraph (g) of subsection (2) of section
138499.012, Florida Statutes, is amended, and paragraph (h) is
139added to that subsection, to read:
140     499.012  Wholesale distribution; definitions; permits;
141applications; general requirements.--
142     (2)  The following types of wholesaler permits are
143established:
144     (g)  A veterinary prescription drug wholesaler permit.--A
145veterinary prescription drug wholesaler permit is required for
146any person that engages in the distribution of veterinary
147prescription drugs in or into this state. A veterinary
148prescription drug wholesaler that also distributes prescription
149drugs subject to, defined by, or described by s. 503(b) of the
150Federal Food, Drug, and Cosmetic Act which it did not
151manufacture must obtain a permit as a prescription drug
152wholesaler, an or out-of-state prescription drug wholesaler, or
153a limited prescription drug veterinary wholesaler in lieu of the
154veterinary prescription drug wholesaler permit. A veterinary
155prescription drug wholesaler must comply with the requirements
156for wholesale distributors under s. 499.0121, except those set
157forth in s. 499.0121(6)(d), (e), or (f).
158     (h)  Limited prescription drug veterinary wholesaler
159permit.--Unless engaging in the activities of and permitted as a
160prescription drug manufacturer, nonresident prescription drug
161manufacturer, prescription drug wholesaler, or out-of-state
162prescription drug wholesaler, a limited prescription drug
163veterinary wholesaler permit is required for any person that
164engages in the distribution in or into this state of veterinary
165prescription drugs and prescription drugs subject to, defined
166by, or described by s. 503(b) of the Federal Food, Drug, and
167Cosmetic Act to veterinarians under the following conditions:
168     1.  The person is engaged in the business of wholesaling
169prescription and veterinary legend drugs to veterinarians on a
170full-time basis.
171     2.  No more than 30 percent of prescription drug sales may
172be prescription drugs approved for human use which are subject
173to, defined by, or described by s. 503(b) of the Federal Food,
174Drug, and Cosmetic Act.
175     3.  The person is not permitted, licensed, or otherwise
176authorized in any state to wholesale prescription drugs subject
177to, defined by, or described by s. 503(b) of the Federal Food,
178Drug, and Cosmetic Act to any person who is authorized to sell,
179distribute, purchase, trade, or use these drugs on or for
180humans.
181     4.  A limited prescription drug veterinary wholesaler that
182applies to the department for a new permit or the renewal of a
183permit must submit a bond of $20,000, or other equivalent means
184of security acceptable to the department, such as an irrevocable
185letter of credit or a deposit in a trust account or financial
186institution, payable to the Florida Drug, Device, and Cosmetic
187Trust Fund. The purpose of the bond is to secure payment of any
188administrative penalties imposed by the department and any fees
189and costs incurred by the department regarding that permit which
190are authorized under state law and which the permittee fails to
191pay 30 days after the fine or costs become final. The department
192may make a claim against such bond or security until 1 year
193after the permittee's license ceases to be valid or until 60
194days after any administrative or legal proceeding authorized in
195ss. 499.001-499.081 which involves the permittee is concluded,
196including any appeal, whichever occurs later.
197     5.  A limited prescription drug veterinary wholesaler must
198maintain at all times a license or permit to engage in the
199wholesale distribution of prescription drugs in compliance with
200laws of the state in which it is a resident.
201     6.  A limited prescription drug veterinary wholesaler must
202comply with the requirements for wholesale distributors under s.
203499.0121, except that a limited prescription drug veterinary
204wholesaler is not required to provide a pedigree paper as
205required by s. 499.0121(6)(f) upon the wholesale distribution of
206a prescription drug to a veterinarian.
207     7.  A limited prescription drug veterinary wholesaler may
208not return to inventory for subsequent wholesale distribution
209any prescription drug subject to, defined by, or described by s.
210503(b) of the Federal Food, Drug, and Cosmetic Act which has
211been returned by a veterinarian.
212     8.  An out-of-state prescription drug wholesaler's permit
213or a limited prescription drug veterinary wholesaler permit is
214not required for an intracompany sale or transfer of a
215prescription drug from an out-of-state establishment that is
216duly licensed to engage in the wholesale distribution of
217prescription drugs in its state of residence to a licensed
218limited prescription drug veterinary wholesaler in this state if
219both wholesalers conduct wholesale distributions of prescription
220drugs under the same business name. The recordkeeping
221requirements of s. 499.0121(6) must be followed for this
222transaction.
223     Section 4.  Paragraph (d) of subsection (1) of section
224499.0122, Florida Statutes, is amended to read:
225     499.0122  Medical oxygen and veterinary legend drug retail
226establishments; definitions, permits, general requirements.--
227     (1)  As used in this section, the term:
228     (d)  "Veterinary legend drug retail establishment" means a
229person permitted to sell veterinary legend drugs to the public
230or to veterinarians, but does not include a pharmacy licensed
231under chapter 465.
232     1.  The sale to the public must be based on a valid written
233order from a veterinarian licensed in this state who has a valid
234client-veterinarian relationship with the purchaser's animal.
235     2.  Veterinary legend drugs may not be sold in excess of
236the amount clearly indicated on the order or beyond the date
237indicated on the order.
238     3.  An order may not be valid for more than 1 year.
239     4.  A veterinary legend drug retail establishment may not
240purchase, sell, trade, or possess human prescription drugs or
241any controlled substance as defined in chapter 893.
242     5.  A veterinary legend drug retail establishment must sell
243a veterinary legend drug in the original, sealed manufacturer's
244container with all labeling intact and legible. The department
245may adopt by rule additional labeling requirements for the sale
246of a veterinary legend drug.
247     Section 5.  Paragraph (h) is added to subsection (2) of
248section 499.041, Florida Statutes, to read:
249     499.041  Schedule of fees for drug, device, and cosmetic
250applications and permits, product registrations, and free-sale
251certificates.--
252     (2)  The department shall assess an applicant that is
253required to have a wholesaling permit an annual fee within the
254ranges established in this section for the specific type of
255wholesaling.
256     (h)  The fee for a limited prescription drug veterinary
257wholesaler's permit may not be less than $300 or more than $500
258annually.
259     Section 6.  Subsections (1) and (3) of section 499.065,
260Florida Statutes, are amended to read:
261     499.065  Imminent danger.--
262     (1)  Notwithstanding s. 499.051, the department shall
263inspect each prescription drug wholesale establishment,
264prescription drug repackager establishment, veterinary
265prescription drug wholesale establishment, limited prescription
266drug veterinary wholesaler establishment, and retail pharmacy
267drug wholesaler establishment that is required to be permitted
268under this chapter as often as necessary to ensure compliance
269with applicable laws and rules. The department shall have the
270right of entry and access to these facilities at any reasonable
271time.
272     (3)  The department may determine that a prescription drug
273wholesale establishment, prescription drug repackager
274establishment, veterinary prescription drug wholesale
275establishment, limited prescription drug veterinary wholesaler
276establishment, or retail pharmacy drug wholesaler establishment
277that is required to be permitted under this chapter is an
278imminent danger to the public health and shall require its
279immediate closure if the establishment fails to comply with
280applicable laws and rules and, because of the failure, presents
281an imminent threat to the public's health, safety, or welfare.
282Any establishment so deemed and closed shall remain closed until
283allowed by the department or by judicial order to reopen.
284
285For purposes of this section, a refusal to allow entry to the
286department for inspection at reasonable times, or a failure or
287refusal to provide the department with required documentation
288for purposes of inspection, constitutes an imminent danger to
289the public health.
290     Section 7.  This act shall take effect July 1, 2006.


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