HB 1397

1
A bill to be entitled
2An act relating to drug distribution; amending s. 499.006,
3F.S.; providing that a drug is adulterated if it is a
4certain prescription drug that has been returned by a
5veterinarian to a limited prescription drug veterinary
6wholesaler; amending s. 499.01, F.S.; requiring a limited
7prescription drug veterinary wholesaler to obtain a permit
8for operation from the Department of Health; providing
9that a permit for a limited prescription drug veterinary
10wholesaler may not be issued to the address of certain
11health care entities; amending s. 499.012, F.S.; revising
12permit requirements for a veterinary prescription drug
13wholesaler that distributes prescription drugs;
14establishing a permit for a limited prescription drug
15veterinary wholesaler; providing requirements; providing
16an exception; amending s. 499.0121, F.S.; removing an
17expiration date on a provision relating to prescription
18drug recordkeeping; requiring certain information to be
19provided by certain prescription drug wholesalers to drug
20recipients; requiring drug manufacturers to file a list of
21authorized distributors with the department; requiring the
22department to publish certain information; amending s.
23499.0122, F.S.; redefining the term "veterinary legend
24drug retail establishment"; amending s. 499.041, F.S.;
25requiring the department to assess an annual fee within a
26certain monetary range for a limited prescription drug
27veterinary wholesaler permit; amending s. 499.065, F.S.;
28requiring the department to inspect each limited
29prescription drug veterinary wholesaler establishment;
30authorizing the department to determine that a limited
31prescription drug veterinary wholesaler establishment is
32an imminent danger to the public; providing an effective
33date.
34
35Be It Enacted by the Legislature of the State of Florida:
36
37     Section 1.  Section 499.006, Florida Statutes, is amended
38to read:
39     499.006  Adulterated drug or device.--A drug or device is
40adulterated:
41     (1)  If it consists in whole or in part of any filthy,
42putrid, or decomposed substance;
43     (2)  If it has been produced, prepared, packed, or held
44under conditions whereby it could have been contaminated with
45filth or rendered injurious to health;
46     (3)  If it is a drug and the methods used in, or the
47facilities or controls used for, its manufacture, processing,
48packing, or holding do not conform to, or are not operated or
49administered in conformity with, current good manufacturing
50practices to assure that the drug meets the requirements of ss.
51499.001-499.081 and that the drug has the identity and strength,
52and meets the standard of quality and purity, which it purports
53or is represented to possess;
54     (4)  If it is a drug and its container is composed, in
55whole or in part, of any poisonous or deleterious substance
56which could render the contents injurious to health;
57     (5)  If it is a drug and it bears or contains, for the
58purpose of coloring only, a color additive that is unsafe within
59the meaning of the federal act; or, if it is a color additive,
60the intended use of which in or on drugs is for the purpose of
61coloring only, and it is unsafe within the meaning of the
62federal act;
63     (6)  If it purports to be, or is represented as, a drug the
64name of which is recognized in the official compendium, and its
65strength differs from, or its quality or purity falls below, the
66standard set forth in such compendium. The determination as to
67strength, quality, or purity must be made in accordance with the
68tests or methods of assay set forth in such compendium, or, when
69such tests or methods of assay are absent or inadequate, in
70accordance with those tests or methods of assay prescribed under
71authority of the federal act. A drug defined in the official
72compendium is not adulterated under this subsection merely
73because it differs from the standard of strength, quality, or
74purity set forth for that drug in such compendium if its
75difference in strength, quality, or purity from such standard is
76plainly stated on its label;
77     (7)  If it is not subject to subsection (6) and its
78strength differs from, or its purity or quality falls below the
79standard of, that which it purports or is represented to
80possess;
81     (8)  If it is a drug:
82     (a)  With which any substance has been mixed or packed so
83as to reduce the quality or strength of the drug; or
84     (b)  For which any substance has been substituted wholly or
85in part;
86     (9)  If it is a drug or device for which the expiration
87date has passed; or
88     (10)  If it is a legend drug for which the required
89pedigree paper is nonexistent, fraudulent, or incomplete under
90the requirements of ss. 499.001-499.081 or applicable rules, or
91that has been purchased, held, sold, or distributed at any time
92by a person not authorized under federal or state law to do so;
93or.
94     (11)  If it is a prescription drug subject to, defined by,
95or described by s. 503(b) of the Federal Food, Drug, and
96Cosmetic Act which has been returned by a veterinarian to a
97limited prescription drug veterinary wholesaler.
98     Section 2.  Subsection (1) and paragraph (d) of subsection
99(2) of section 499.01, Florida Statutes, are amended to read:
100     499.01  Permits; applications; renewal; general
101requirements.--
102     (1)  Prior to operating, a permit is required for each
103person and establishment that intends to operate as:
104     (a)  A prescription drug manufacturer;
105     (b)  A prescription drug repackager;
106     (c)  An over-the-counter drug manufacturer;
107     (d)  A compressed medical gas manufacturer;
108     (e)  A device manufacturer;
109     (f)  A cosmetic manufacturer;
110     (g)  A prescription drug wholesaler;
111     (h)  A veterinary prescription drug wholesaler;
112     (i)  A compressed medical gas wholesaler;
113     (j)  An out-of-state prescription drug wholesaler;
114     (k)  A nonresident prescription drug manufacturer;
115     (l)  A freight forwarder;
116     (m)  A retail pharmacy drug wholesaler;
117     (n)  A veterinary legend drug retail establishment;
118     (o)  A medical oxygen retail establishment;
119     (p)  A complimentary drug distributor; or
120     (q)  A restricted prescription drug distributor; or.
121     (r)  A limited prescription drug veterinary wholesaler.
122     (2)
123     (d)  A permit for a prescription drug manufacturer,
124prescription drug repackager, prescription drug wholesaler,
125limited prescription drug veterinary wholesaler, or retail
126pharmacy wholesaler may not be issued to the address of a health
127care entity or to a pharmacy licensed under chapter 465, except
128as provided in this paragraph. The department may issue a
129prescription drug manufacturer permit to an applicant at the
130same address as a licensed nuclear pharmacy, which is a health
131care entity, for the purpose of manufacturing prescription drugs
132used in positron emission tomography or other
133radiopharmaceuticals, as listed in a rule adopted by the
134department pursuant to this paragraph. The purpose of this
135exemption is to assure availability of state-of-the-art
136pharmaceuticals that would pose a significant danger to the
137public health if manufactured at a separate establishment
138address from the nuclear pharmacy from which the prescription
139drugs are dispensed. The department may also issue a retail
140pharmacy wholesaler permit to the address of a community
141pharmacy licensed under chapter 465 which does not meet the
142definition of a closed pharmacy in s. 499.003.
143     Section 3.  Paragraph (g) of subsection (2) of section
144499.012, Florida Statutes, is amended, and paragraph (h) is
145added to that subsection, to read:
146     499.012  Wholesale distribution; definitions; permits;
147applications; general requirements.--
148     (2)  The following types of wholesaler permits are
149established:
150     (g)  A veterinary prescription drug wholesaler permit.--A
151veterinary prescription drug wholesaler permit is required for
152any person that engages in the distribution of veterinary
153prescription drugs in or into this state. A veterinary
154prescription drug wholesaler that also distributes prescription
155drugs subject to, defined by, or described by s. 503(b) of the
156Federal Food, Drug, and Cosmetic Act which it did not
157manufacture must obtain a permit as a prescription drug
158wholesaler, an or out-of-state prescription drug wholesaler, or
159a limited prescription drug veterinary wholesaler in lieu of the
160veterinary prescription drug wholesaler permit. A veterinary
161prescription drug wholesaler must comply with the requirements
162for wholesale distributors under s. 499.0121, except those set
163forth in s. 499.0121(6)(d), (e), or (f).
164     (h)  Limited prescription drug veterinary wholesaler
165permit.--Unless engaging in the activities of and permitted as a
166prescription drug manufacturer, nonresident prescription drug
167manufacturer, prescription drug wholesaler, or out-of-state
168prescription drug wholesaler, a limited prescription drug
169veterinary wholesaler permit is required for any person that
170engages in the distribution in or into this state of veterinary
171prescription drugs and prescription drugs subject to, defined
172by, or described by s. 503(b) of the Federal Food, Drug, and
173Cosmetic Act to veterinarians under the following conditions:
174     1.  The person is engaged in the business of wholesaling
175prescription and veterinary legend drugs to veterinarians on a
176full-time basis.
177     2.  No more than 30 percent of prescription drug sales may
178be prescription drugs approved for human use which are subject
179to, defined by, or described by s. 503(b) of the Federal Food,
180Drug, and Cosmetic Act.
181     3.  The person is not permitted, licensed, or otherwise
182authorized in any state to wholesale prescription drugs subject
183to, defined by, or described by s. 503(b) of the Federal Food,
184Drug, and Cosmetic Act to any person who is authorized to sell,
185distribute, purchase, trade, or use these drugs on or for
186humans.
187     4.  A limited prescription drug veterinary wholesaler that
188applies to the department for a new permit or the renewal of a
189permit must submit a bond of $20,000, or other equivalent means
190of security acceptable to the department, such as an irrevocable
191letter of credit or a deposit in a trust account or financial
192institution, payable to the Florida Drug, Device, and Cosmetic
193Trust Fund. The purpose of the bond is to secure payment of any
194administrative penalties imposed by the department and any fees
195and costs incurred by the department regarding that permit which
196are authorized under state law and which the permittee fails to
197pay 30 days after the fine or costs become final. The department
198may make a claim against such bond or security until 1 year
199after the permittee's license ceases to be valid or until 60
200days after any administrative or legal proceeding authorized in
201ss. 499.001-499.081 which involves the permittee is concluded,
202including any appeal, whichever occurs later.
203     5.  A limited prescription drug veterinary wholesaler must
204maintain at all times a license or permit to engage in the
205wholesale distribution of prescription drugs in compliance with
206laws of the state in which it is a resident.
207     6.  A limited prescription drug veterinary wholesaler must
208comply with the requirements for wholesale distributors under s.
209499.0121, except that a limited prescription drug veterinary
210wholesaler is not required to provide a pedigree paper as
211required by s. 499.0121(6)(f) upon the wholesale distribution of
212a prescription drug to a veterinarian.
213     7.  A limited prescription drug veterinary wholesaler may
214not return to inventory for subsequent wholesale distribution
215any prescription drug subject to, defined by, or described by s.
216503(b) of the Federal Food, Drug, and Cosmetic Act which has
217been returned by a veterinarian.
218     8.  An out-of-state prescription drug wholesaler's permit
219or a limited prescription drug veterinary wholesaler permit is
220not required for an intracompany sale or transfer of a
221prescription drug from an out-of-state establishment that is
222duly licensed to engage in the wholesale distribution of
223prescription drugs in its state of residence to a licensed
224limited prescription drug veterinary wholesaler in this state if
225both wholesalers conduct wholesale distributions of prescription
226drugs under the same business name. The recordkeeping
227requirements of s. 499.0121(6) must be followed for this
228transaction.
229     Section 4.  Paragraphs (d) and (f) of subsection (6) of
230section 499.0121, Florida Statutes, are amended to read:
231     499.0121  Storage and handling of prescription drugs;
232recordkeeping.--The department shall adopt rules to implement
233this section as necessary to protect the public health, safety,
234and welfare. Such rules shall include, but not be limited to,
235requirements for the storage and handling of prescription drugs
236and for the establishment and maintenance of prescription drug
237distribution records.
238     (6)  RECORDKEEPING.--The department shall adopt rules that
239require keeping such records of prescription drugs as are
240necessary for the protection of the public health.
241     (d)1.  Each person who is engaged in the wholesale
242distribution of a prescription drug, and who is not an
243authorized distributor of record for the drug manufacturer's
244products, must provide to each wholesale distributor of such
245drug, before the sale is made to such wholesale distributor, a
246written statement under oath identifying each previous sale of
247the drug back to the last authorized distributor of record, the
248lot number of the drug, and the sales invoice number of the
249invoice evidencing the sale of the drug. The written statement
250must accompany the drug to the next wholesale distributor. The
251department shall adopt rules relating to the requirements of
252this written statement. This paragraph does not apply to a
253manufacturer unless the manufacturer is performing the
254manufacturing operation of repackaging prescription drugs.
255     2.  Each wholesale distributor of prescription drugs must
256maintain separate and distinct from other required records all
257statements that are required under subparagraph 1. and paragraph
258(e).
259     3.  Each manufacturer of a prescription drug sold in this
260state must maintain at its corporate offices a current list of
261authorized distributors and must make such list available to the
262department upon request.
263     4.  Each manufacturer shall file a written list of all of
264the manufacturer's authorized distributors of record with the
265department. A manufacturer shall notify the department not later
266than 10 days after any change to the list. The department shall
267publish a list of all authorized distributors of record on its
268website.
269     5.  For the purposes of this subsection, the term
270"authorized distributors of record" means a wholesale
271distributor with whom a manufacturer has established an ongoing
272relationship to distribute the manufacturer's products.
273Effective March 1, 2004, an ongoing relationship is deemed to
274exist when a wholesale distributor, including any affiliated
275group, as defined in s. 1504 of the Internal Revenue Code, of
276which the wholesale distributor is a member:
277     a.  Is listed on the manufacturer's current list of
278authorized distributors of record.
279     b.  Annually purchases not less than 90 percent of all of
280its purchases of a manufacturer's prescription drug products,
281based on dollar volume, directly from that manufacturer and has
282total annual prescription drug sales of $100 million or more.
283     c.  Has reported to the department pursuant to s.
284499.012(3)(g)2. that the wholesale distributor has total annual
285prescription drug sales of $100 million or more, and has a
286verifiable account number issued by the manufacturer authorizing
287the wholesale distributor to purchase the manufacturer's drug
288products directly from that manufacturer and that wholesale
289distributor makes not fewer than 12 purchases of that
290manufacturer's drug products directly from the manufacturer
291using said verifiable account number in 12 months. The
292provisions of this sub-subparagraph apply with respect to a
293manufacturer that fails to file a copy of the manufacturer's
294list of authorized distributors of record with the department by
295July 1, 2003; that files a list of authorized distributors of
296record which contains fewer than 10 wholesale distributors
297permitted in this state, excluding the wholesale distributors
298described in sub-subparagraph b.; or that, as a result of
299changes to the list of authorized distributors of record filed
300with the department, has fewer than 10 wholesale distributors
301permitted in this state as authorized distributors of record,
302excluding the wholesale distributors described in sub-
303subparagraph b.
304
305A wholesale distributor that satisfies the requirements of sub-
306subparagraph b. or sub-subparagraph c. shall submit to the
307department documentation substantiating its qualification
308pursuant to sub-subparagraph b. or sub-subparagraph c. The
309department shall add those wholesale distributors that the
310department has determined have met the requirements of sub-
311subparagraph b. or sub-subparagraph c. to the list of authorized
312distributors of record on the department's website.
313     6.  This paragraph expires July 1, 2006.
314     (f)1.  Effective July 1, 2006, each person who is engaged
315in the wholesale distribution of a prescription drug and who is
316not the manufacturer of that drug must, before each wholesale
317distribution of such drug, provide to the person who receives
318the drug either:
319     a.  A pedigree paper as defined in s. 499.003(31); or
320     b.  Until December 31, 2008, if the prescription drug was
321purchased directly from the manufacturer, a statement in written
322or electronic form stating that the wholesale distributor or
323member of its affiliated group has purchased the specific unit
324of the prescription drug directly from the manufacturer, as
325defined in s. 499.012(1)(e), and is an authorized distributor of
326record as specified in subparagraph (d)5. In accordance with
327subparagraph (d)5., each manufacturer shall file a written list
328of all of the manufacturer's authorized distributors of record
329with the department by July 1, 2006. A manufacturer shall notify
330the department not later than 10 days after any change to the
331list. The department shall publish a list of all authorized
332distributors of record on its website.
333     2.  A repackager must comply with this paragraph.
334     3.  The pedigree paper requirements in this paragraph do
335not apply to compressed medical gases or veterinary legend
336drugs.
337     4.  Each wholesale distributor of prescription drugs must
338maintain separate and distinct from other required records all
339statements that are required under subparagraph 1.
340     5.  In order to verify compliance with subparagraph (d)1.,
341each manufacturer of a prescription drug sold in this state must
342make available upon request distribution documentation related
343to its sales of prescription drugs, regardless of whether the
344prescription drug was sold directly by the manufacturer to a
345person in Florida.
346     Section 5.  Paragraph (d) of subsection (1) of section
347499.0122, Florida Statutes, is amended to read:
348     499.0122  Medical oxygen and veterinary legend drug retail
349establishments; definitions, permits, general requirements.--
350     (1)  As used in this section, the term:
351     (d)  "Veterinary legend drug retail establishment" means a
352person permitted to sell veterinary legend drugs to the public
353or to veterinarians, but does not include a pharmacy licensed
354under chapter 465.
355     1.  The sale to the public must be based on a valid written
356order from a veterinarian licensed in this state who has a valid
357client-veterinarian relationship with the purchaser's animal.
358     2.  Veterinary legend drugs may not be sold in excess of
359the amount clearly indicated on the order or beyond the date
360indicated on the order.
361     3.  An order may not be valid for more than 1 year.
362     4.  A veterinary legend drug retail establishment may not
363purchase, sell, trade, or possess human prescription drugs or
364any controlled substance as defined in chapter 893.
365     5.  A veterinary legend drug retail establishment must sell
366a veterinary legend drug in the original, sealed manufacturer's
367container with all labeling intact and legible. The department
368may adopt by rule additional labeling requirements for the sale
369of a veterinary legend drug.
370     Section 6.  Paragraph (h) is added to subsection (2) of
371section 499.041, Florida Statutes, to read:
372     499.041  Schedule of fees for drug, device, and cosmetic
373applications and permits, product registrations, and free-sale
374certificates.--
375     (2)  The department shall assess an applicant that is
376required to have a wholesaling permit an annual fee within the
377ranges established in this section for the specific type of
378wholesaling.
379     (h)  The fee for a limited prescription drug veterinary
380wholesaler's permit may not be less than $300 or more than $500
381annually.
382     Section 7.  Subsections (1) and (3) of section 499.065,
383Florida Statutes, are amended to read:
384     499.065  Imminent danger.--
385     (1)  Notwithstanding s. 499.051, the department shall
386inspect each prescription drug wholesale establishment,
387prescription drug repackager establishment, veterinary
388prescription drug wholesale establishment, limited prescription
389drug veterinary wholesaler establishment, and retail pharmacy
390drug wholesaler establishment that is required to be permitted
391under this chapter as often as necessary to ensure compliance
392with applicable laws and rules. The department shall have the
393right of entry and access to these facilities at any reasonable
394time.
395     (3)  The department may determine that a prescription drug
396wholesale establishment, prescription drug repackager
397establishment, veterinary prescription drug wholesale
398establishment, limited prescription drug veterinary wholesaler
399establishment, or retail pharmacy drug wholesaler establishment
400that is required to be permitted under this chapter is an
401imminent danger to the public health and shall require its
402immediate closure if the establishment fails to comply with
403applicable laws and rules and, because of the failure, presents
404an imminent threat to the public's health, safety, or welfare.
405Any establishment so deemed and closed shall remain closed until
406allowed by the department or by judicial order to reopen.
407
408For purposes of this section, a refusal to allow entry to the
409department for inspection at reasonable times, or a failure or
410refusal to provide the department with required documentation
411for purposes of inspection, constitutes an imminent danger to
412the public health.
413     Section 8.  This act shall take effect July 1, 2006.


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