Florida Senate - 2008 (Corrected Copy) SB 2756
By Senator Peaden
2-03453A-08 20082756__
1
A bill to be entitled
2
An act relating to prescription drugs; amending ss.
4
amending s. 499.002, F.S.; requiring the Department of
5
Health to administer and enforce ch. 499, F.S.;
6
authorizing the department to administer oaths, take
7
depositions, issue and serve subpoenas, and compel the
8
attendance of witnesses and the production of books,
9
papers, documents, or other evidence; requiring the
10
appropriate prosecuting officer to initiate proceedings;
11
providing that the department is not required to report
12
minor violations under certain circumstances; providing
13
that certain carriers engaged in interstate commerce are
14
not subject to ch. 499, F.S., under certain circumstances;
15
amending s. 499.003, F.S.; revising and providing
16
definitions; repealing s. 499.004, F.S., relating to the
17
administration and enforcement by the department of
18
provisions governing the repackaging and distribution of
19
drugs; amending s. 499.005, F.S.; conforming provisions to
20
changes made by the act; amending s. 499.0051, F.S.;
21
substituting the phrase "legend drug" for the phrase
22
"prescription drug" with regard to criminal acts;
23
providing that trafficking in contraband prescription
24
drugs is a third-degree felony; providing that it is a
25
first-degree felony to sell or purchase contraband
26
prescription drugs resulting in great bodily harm or
27
death; prohibiting the violation of s. 499.005, F.S.,
28
related to certain prohibited acts regarding devices and
29
cosmetics; providing penalties; providing an exception for
30
certain persons or entities with regard to the
31
dissemination of false advertisement; providing that the
32
misbranding or adulteration of drugs is a first-degree
33
felony; prohibiting false or misleading advertisement and
34
failure to maintain records related to drugs; providing
35
penalties; providing that it is a third-degree felony to
36
refuse to allow the department to inspect certain
37
establishments or vehicles, to sell, purchase, or trade
38
drug samples, to fail to maintain records or obtain
39
certain permits relating to prescription drugs, or to
40
possess adulterated or misbranded prescription drugs
41
outside a designated quarantine area; providing that it is
42
a second-degree felony to commit certain other violations;
43
repealing s. 499.0053, F.S., relating to the department's
44
power to administer oaths, take depositions, and issue and
45
serve subpoenas; repealing s. 499.00535, F.S., relating to
46
the sale or purchase of contraband legend drugs resulting
47
in great bodily harm; amending s. 499.0054, F.S.;
48
requiring the department to review a representation made
49
in an advertisement to determine whether it is false or
50
misleading; providing exceptions to classifying certain
51
advertisements as false or misleading; repealing s.
52
499.00545, F.S., relating to the sale or purchase of
53
contraband legend drugs resulting in death; repealing s.
54
499.0055, F.S., relating to false or misleading
55
advertisement; repealing s. 499.0057, F.S., relating to
56
certain advertisement exemptions; amending s. 499.006,
57
F.S.; conforming provisions; amending s. 499.007, F.S.;
58
conforming provisions; providing that a drug or device is
59
misbranded if it is an active pharmaceutical ingredient in
60
bulk form and does not bear a label containing certain
62
conforming provisions; amending s. 499.01, F.S.; providing
63
requirements for obtaining a permit to operate as a drug
64
manufacturer, a drug repackager, a drug wholesale
65
distributor, a restricted prescription drug distributor, a
66
freight forwarder, a drug retail establishment, a medical
67
gas wholesale distributor or manufacturer, or a device
68
manufacturer; providing requirements for such permits;
69
deleting certain permit requirements; amending s. 499.012,
70
F.S.; providing application requirements for persons and
71
establishments to obtain a permit; requiring the
72
department to consider certain factors in reviewing the
73
qualifications of persons who apply for certain permits;
74
providing for the renewal of a permit; authorizing the
75
department to adopt rules for applying for a permit;
76
providing for the expiration of certain permits;
77
prohibiting the renewal of certain permits under certain
78
conditions; requiring that a permit be conspicuously
79
posted; deleting the definition of certain terms and
80
redefining them in s. 499.003, F.S.; providing
81
requirements and additional information for a permit
82
application for a prescription drug wholesale distributor
83
or an out-of-state prescription drug wholesale
84
distributor; authorizing the department to deny or refuse
85
to renew a permit for a prescription drug wholesale
86
distributor or an out-of-state prescription drug wholesale
87
distributor under certain conditions; conforming
88
provisions; deleting the department's authorization to
89
adopt rules governing recordkeeping, storage, and handling
90
with respect to the distribution of certain prescription
91
drugs; amending s. 499.01201, F.S.; conforming provisions;
92
amending s. 499.0121, F.S.; requiring the department to
93
adopt rules requiring manufacturers and repackagers of
94
medical devices, certain drugs, or cosmetics to maintain
95
certain records; directing the department to adopt rules
96
requiring a wholesale distributor to maintain pedigree
97
papers separate and distinct from other required records;
98
deleting a requirement that a person who is engaged in the
99
wholesale distribution of a prescription drug and who is
100
not the manufacturer of that drug provide to the person
101
who receives the drug a pedigree paper; deleting the
102
department's requirement to adopt rules with regard to
103
recordkeeping by affiliated groups; conforming cross-
104
references; amending s. 499.01211, F.S.; conforming
105
provisions and cross-references; creating s. 499.01213,
106
F.S.; requiring a person who is engaged in the wholesale
107
distribution of a prescription drug to provide to the
108
person who receives the drug a pedigree paper; providing
109
for required information in a pedigree paper; requiring a
110
wholesale distributor to maintain and make available to
111
the department certain information; providing exceptions
112
to the requirement of a pedigree paper; repealing s.
113
499.0122, F.S., relating to medical oxygen and veterinary
114
legend drug retail establishments; repealing s. 499.013,
115
F.S., relating to manufacturers and repackagers of drugs,
116
devices, and cosmetics; repealing s. 499.014, F.S.,
117
relating to the distribution of legend drugs by hospitals,
118
health care entities, charitable organizations, and return
121
provisions and cross-references; amending ss. 499.032 and
122
499.033, F.S.; conforming a provision to changes made by
123
the act; amending s. 499.039, F.S.; conforming a provision
125
F.S.; conforming provisions to changes made by the act;
126
amending s. 499.05, F.S.; conforming provisions; requiring
127
the department to adopt rules with regard to procedures
128
and forms relating to pedigree paper requirements,
129
manufacturing practices, information required from retail
130
establishments, recordkeeping, storage, and handling with
131
respect to the distribution of certain prescription drugs,
132
concerning alternatives to compliance with the requirement
133
of certain pedigree papers, and concerning the return of
134
prescription drugs purchased before a specified date;
136
conforming provisions; amending s. 499.062, F.S.;
137
conforming a provision; requiring an officer or employee
138
of the department to give notice that an article is the
139
subject of a seizure; requiring the officer or employee to
140
warn persons not to remove or dispose of the article;
141
providing a penalty; requiring the department to petition
142
the court for an order of condemnation or sale of a seized
143
article; requiring the proceeds of the sale of drugs,
144
devices, or cosmetics to be deposited in the Florida Drug,
145
Device, and Cosmetic Trust Fund within the department;
146
requiring the department officer or employee to remove the
147
tag from the seized article under certain circumstances;
148
repealing s. 499.063, F.S., relating to seizure of a drug,
149
device, or cosmetic; repealing s. 499.064, F.S., relating
150
to condemnation, sale, and release of a seized article;
152
provisions; amending s. 499.0661, F.S.; deleting the
153
definition of the term "permittee"; conforming provisions;
154
amending s. 499.067, F.S.; conforming provisions and
155
cross-references; repealing s. 499.069, F.S., relating to
156
criminal punishment for violations of s. 499.005, F.S.,
157
related to devices and cosmetics; repealing s. 499.0691,
158
F.S., relating to criminal punishment for violations
159
related to drugs and dissemination of false advertisement;
160
repealing s. 499.07, F.S., relating to the duty of the
161
prosecuting officer; repealing s. 499.071, F.S., relating
162
to the issuance of warnings for minor violations;
163
repealing s. 499.081, F.S., relating to the exemption of
164
carriers in interstate commerce; amending s. 895.02, F.S.,
165
conforming cross-references; amending s. 921.0022, F.S.;
166
conforming cross-references and provisions; providing an
167
effective date.
168
169
Be It Enacted by the Legislature of the State of Florida:
170
171
Section 1. Paragraph (a) of subsection (1) of section
172
409.9201, Florida Statutes, is amended to read:
173
409.9201 Medicaid fraud.--
174
(1) As used in this section, the term:
175
(a) "Legend drug" means any drug, including, but not
176
limited to, finished dosage forms or active ingredients that are
177
subject to, defined by, or described by s. 503(b) of the Federal
178
Food, Drug, and Cosmetic Act or by s. 499.007(13) or s.
180
181
The value of individual items of the legend drugs or goods or
182
services involved in distinct transactions committed during a
183
single scheme or course of conduct, whether involving a single
184
person or several persons, may be aggregated when determining the
185
punishment for the offense.
186
Section 2. Subsection (3) of section 465.0265, Florida
187
Statutes, is amended to read:
188
465.0265 Centralized prescription filling.--
189
(3) The filling, delivery, and return of a prescription by
190
one pharmacy for another pursuant to this section shall not be
191
construed as the filling of a transferred prescription as set
192
forth in s. 465.026 or as a wholesale distribution as set forth
194
Section 3. Section 499.002, Florida Statutes, is amended to
195
read:
196
499.002 Purpose, administration, enforcement, and exemption
198
to:
199
(1) This part is intended to:
200
(a) Safeguard the public health and promote the public
201
welfare by protecting the public from injury by product use and
202
by merchandising deceit involving drugs, devices, and cosmetics.
203
(b)(2) Provide uniform legislation to be administered so
204
far as practicable in conformity with the provisions of, and
205
regulations issued under the authority of, the Federal Food,
206
Drug, and Cosmetic Act and that portion of the Federal Trade
207
Commission Act which expressly prohibits the false advertisement
208
of drugs, devices, and cosmetics.
209
(c)(3) Promote thereby uniformity of such state and federal
210
laws, and their administration and enforcement, throughout the
211
United States.
212
(2) The department shall administer and enforce this part
213
to prevent fraud, adulteration, misbranding, or false advertising
214
in the preparation, manufacture, repackaging, or distribution of
215
drugs, devices, and cosmetics.
216
(3) For the purpose of any investigation or proceeding
217
conducted by the department under this part, the department may
218
administer oaths, take depositions, issue and serve subpoenas,
219
and compel the attendance of witnesses and the production of
220
books, papers, documents, or other evidence. The department shall
221
exercise this power on its own initiative. Challenges to, and
222
enforcement of, the subpoenas and orders shall be handled as
223
provided in s. 120.569.
224
(4) Each state attorney, county attorney, or municipal
225
attorney to whom the department or its designated agent reports
226
any violation of this part shall cause appropriate proceedings to
227
be instituted in the proper courts without delay and to be
228
prosecuted in the manner required by law.
229
(5) This part does not require the department to report,
230
for the institution of proceedings under this part, minor
231
violations of this part when it believes that the public interest
232
will be adequately served in the circumstances by a suitable
233
written notice or warning.
234
(6) Carriers engaged in interstate commerce are not subject
235
to this part if they are engaged in the usual course of business
236
as carriers.
237
Section 4. Section 499.003, Florida Statutes, is amended to
238
read:
241
(1) "Advertisement" means any representation disseminated
242
in any manner or by any means, other than by labeling, for the
243
purpose of inducing, or which is likely to induce, directly or
244
indirectly, the purchase of drugs, devices, or cosmetics.
245
(2) "Affiliated group" means an affiliated group as defined
246
by s. 1504 of the Internal Revenue Code of 1986, as amended,
247
which is composed of chain drug entities, including at least 50
248
retail pharmacies, warehouses, or repackagers, which are members
249
of the same affiliated group, if the affiliated group:
250
(a) Discloses to the department the names of all its
251
members; and
252
(b) Agrees in writing to provide records on prescription
253
drug purchases by members of the affiliated group no later than
254
48 hours after the department requests such records, regardless
255
of the location where the records are stored.
256
(3)(2) "Affiliated party" means:
257
(a) A director, officer, trustee, partner, or committee
258
member of a permittee or applicant or a subsidiary or service
259
corporation of the permittee or applicant;
260
(b) A person who, directly or indirectly, manages,
261
controls, or oversees the operation of a permittee or applicant,
262
regardless of whether such person is a partner, shareholder,
263
manager, member, officer, director, independent contractor, or
264
employee of the permittee or applicant;
265
(c) A person who has filed or is required to file a
266
personal information statement pursuant to s. 499.012(9) s.
267
499.012(4) or is required to be identified in an application for
268
a permit or to renew a permit pursuant to s. 499.012(8) s.
269
499.012(3); or
270
(d) The five largest natural shareholders that own at least
271
5 percent of the permittee or applicant.
272
(4)(3) "Applicant" means a person applying for a permit or
274
(5)(4) "Authenticate" means to affirmatively verify before
275
any distribution of a prescription legend drug occurs that each
276
transaction listed on the pedigree paper has occurred.
277
(6) "Authorized recipient" means a person authorized by law
278
to purchase, possess, administer, dispense, or receive
279
prescription drugs and a person authorized by law to administer
280
the drug as defined in s. 465.003. An authorized recipient
281
includes an entity of which a person authorized by law to
282
administer the drug, as defined in s. 465.003, is a member,
283
officer, employee, or agent, including, but not limited to, a
284
professional corporation or a professional limited liability
285
company described in chapter 621 of the Business Organizations
286
Code.
287
(7)(5) "Certificate of free sale" means a document prepared
288
by the department which certifies a drug, device, or cosmetic,
289
that is registered with the department, as one that can be
290
legally sold in the state.
291
(8) "Chain pharmacy warehouse" means a wholesale
292
distributor permitted pursuant to s. 499.01 which maintains a
293
physical location for prescription drugs that functions solely as
294
a central warehouse to perform intracompany transfers of such
295
drugs to members of its affiliated group.
296
(9)(6) "Closed pharmacy" means a pharmacy that is licensed
297
under chapter 465 and purchases prescription drugs for use by a
298
limited patient population and not for wholesale distribution or
299
sale to the public. The term does not include retail pharmacies.
300
(10) "Co-licensed product" means a prescription drug in
301
which two or more parties have the right to engage in the
302
manufacturing or marketing or both of such drug consistent with
303
the FDA's implementation of the Prescription Drug Marketing Act
304
of 1987, Public Law 100-293.
305
(11) "Co-licensee" means a party or parties to a co-
306
licensed product.
307
(12)(7) "Color" includes black, white, and intermediate
308
grays.
309
(13)(8) "Color additive" means, with the exception of any
310
material that has been or hereafter is exempt under the federal
311
act, a material that:
312
(a) Is a dye pigment, or other substance, made by a process
313
of synthesis or similar artifice, or extracted, isolated, or
314
otherwise derived, with or without intermediate or final change
315
of identity from a vegetable, animal, mineral, or other source;
316
or
317
(b) When added or applied to a drug or cosmetic or to the
318
human body, or any part thereof, is capable alone, or through
319
reaction with other substances, of imparting color thereto;
320
321
except that the term does not include any material which has been
322
or hereafter is exempt under the federal act.
323
(14)(9) "Compressed medical gas" means any liquefied or
324
vaporized gas that is a prescription drug, whether it is alone or
325
in combination with other gases.
326
(15)(10) "Contraband prescription legend drug" means any
327
adulterated drug, as defined in s. 499.006, or any counterfeit
328
drug, as defined in this section, and also means any prescription
329
legend drug for which a pedigree paper does not exist, or for
330
which the pedigree paper in existence has been forged,
331
counterfeited, falsely created, or contains any altered, false,
332
or misrepresented matter.
333
(16)(11) "Cosmetic" means, with the exception of soap, an
334
article that is:
335
(a) Intended to be rubbed, poured, sprinkled, or sprayed
336
on; introduced into; or otherwise applied to the human body or
337
any part thereof for cleansing, beautifying, promoting
338
attractiveness, or altering the appearance; or
339
(b) Intended for use as a component of any such article;
340
341
except that the term does not include soap.
342
(17)(12) "Counterfeit drug, counterfeit device, or
343
counterfeit cosmetic" means a drug, device, or cosmetic which, or
344
the container, seal, or labeling of which, without authorization,
345
bears the trademark, trade name, or other identifying mark,
346
imprint, or device, or any likeness thereof, of a drug, device,
347
or cosmetic manufacturer, processor, packer, or distributor other
348
than the person that in fact manufactured, processed, packed, or
349
distributed that drug, device, or cosmetic and which thereby
350
falsely purports or is represented to be the product of, or to
351
have been packed or distributed by, that other drug, device, or
352
cosmetic manufacturer, processor, packer, or distributor.
353
(18)(13) "Department" means the Department of Health.
354
(19)(14) "Device" means any instrument, apparatus,
355
implement, machine, contrivance, implant, in vitro reagent, or
356
other similar or related article, including its components,
357
parts, or accessories, which is:
358
(a) Recognized in the current edition of the United States
359
Pharmacopoeia and National Formulary, or any supplement thereof,
360
(b) Intended for use in the diagnosis, cure, mitigation,
361
treatment, therapy, or prevention of disease in humans or other
362
animals, or
363
(c) Intended to affect the structure or any function of the
364
body of humans or other animals,
365
366
and which does not achieve any of its principal intended purposes
367
through chemical action within or on the body of humans or other
368
animals and which is not dependent upon being metabolized for the
369
achievement of any of its principal intended purposes.
370
(20)(15) "Distribute or distribution" means to sell; offer
371
to sell; give away; transfer, whether by passage of title,
372
physical movement, or both; deliver; or offer to deliver. The
373
term does not mean: to administer or dispense.
374
(a) The administration or dispensing of a prescription
375
drug; or
376
(b) Intracompany sales by a manufacturer of prescription
377
drugs manufactured by that manufacturer or by a co-licensee,
378
meaning any transaction or transfer between any division,
379
subsidiary, parent, or affiliated or related company under common
380
ownership and control of a corporate entity or any transaction or
381
transfer between co-licensed entities of co-licensed products.
382
(21) "Drop shipment" means the sale of a prescription drug
383
from a manufacturer to a wholesale distributor, where the
384
wholesale distributor takes title to, but not possession of, the
385
prescription drug and the manufacturer of the prescription drug
386
ships the prescription drug directly to a chain pharmacy
387
warehouse or a person authorized by law to purchase prescription
388
drugs for the purpose of administering or dispensing the drug, as
389
defined in s. 465.003.
390
(16) "Diverted from the legal channels of distribution for
391
prescription drugs" means an adulterated drug pursuant to s.
392
499.006(10).
393
(22)(17) "Drug" means an article that is:
394
(a) Recognized in the current edition of the United States
395
Pharmacopoeia and National Formulary, official Homeopathic
396
Pharmacopoeia of the United States, or any supplement to any of
397
those publications;
398
(b) Intended for use in the diagnosis, cure, mitigation,
399
treatment, therapy, or prevention of disease in humans or other
400
animals;
401
(c) Intended to affect the structure or any function of the
402
body of humans or other animals; or
403
(d) Intended for use as a component of any article
404
specified in paragraph (a), paragraph (b), or paragraph (c), but
405
does not include devices or their components, parts, or
406
accessories.
407
(23)(18) "Establishment" means a place of business at one
408
general physical location.
409
(24)(19) "Federal act" means the Federal Food, Drug, and
410
Cosmetic Act, 21 U.S.C. ss. 301 et seq.; 52 Stat. 1040 et seq.
411
(25)(20) "Freight forwarder" means a person who receives
412
prescription legend drugs that which are owned by another person
413
and designated by that person for export, and who exports those
414
prescription legend drugs.
415
(26) "Health care clinic" means a health care clinic
416
licensed under part X of chapter 400.
417
(27)(21) "Health care entity" means a closed pharmacy or
418
any person, organization, or business entity that provides
419
diagnostic, medical, surgical, or dental treatment or care, or
420
chronic or rehabilitative care, but does not include any
421
wholesale distributor or retail pharmacy licensed under state law
422
to deal in prescription drugs.
423
(28) "Health care facility" means a health care facility
424
licensed under chapter 395.
425
(29) "Hospice" means a corporation licensed under part IV
426
of chapter 400.
427
(30) "Hospital" means a facility as defined in s. 395.002
428
and licensed under chapter 395.
429
(31)(22) "Immediate container" does not include package
430
liners.
431
(32) "Intracompany transfer" means any sale, purchase,
432
trade, transfer, or distribution of prescription drugs between
433
any division, subsidiary, parent, or affiliated or related
434
company under common ownership and control of a corporate entity
435
or any transaction or transfer between co-licensed entities of a
436
co-licensed product.
437
(33)(23) "Label" means a display of written, printed, or
438
graphic matter upon the immediate container of any drug, device,
439
or cosmetic. A requirement made by or under authority of this
441
sections that any word, statement, or other information appear on
442
the label is not complied with unless such word, statement, or
443
other information also appears on the outside container or
444
wrapper, if any, of the retail package of such drug, device, or
445
cosmetic or is easily legible through the outside container or
446
wrapper.
447
(34)(24) "Labeling" means all labels and other written,
448
printed, or graphic matters:
449
(a) Upon a drug, device, or cosmetic, or any of its
450
containers or wrappers; or
451
(b) Accompanying or related to such drug, device, or
452
cosmetic.
453
(25) "Legend drug," "prescription drug," or "medicinal
454
drug" means any drug, including, but not limited to, finished
455
dosage forms, or active ingredients subject to, defined by, or
456
described by s. 503(b) of the Federal Food, Drug, and Cosmetic
458
(c).
459
(26) "Legend drug label" means any display of written,
460
printed, or graphic matter upon the immediate container of any
461
legend drug prior to its dispensing to an individual patient
462
pursuant to a prescription of a practitioner authorized by law to
463
prescribe.
464
(35)(27) "Manufacture" means the preparation, deriving,
465
compounding, propagation, processing, producing, or fabrication
466
of any drug, device, or cosmetic.
467
(36)(28) "Manufacturer" means a person who prepares,
468
derives, manufactures, or produces a drug, device, or cosmetic,
469
or any division, subsidiary, parent, or affiliated or related
470
company under common ownership and control of that person, or a
471
co-licensee of that person. The term excludes pharmacies that are
472
operating in compliance with pharmacy practice standards as
473
defined in chapter 465 and rules adopted under that chapter.
474
(37)(29) "New drug" means:
475
(a) Any drug the composition of which is such that the drug
476
is not generally recognized, among experts qualified by
477
scientific training and experience to evaluate the safety and
478
effectiveness of drugs, as safe and effective for use under the
479
conditions prescribed, recommended, or suggested in the labeling
480
of that drug; or
481
(b) Any drug the composition of which is such that the
482
drug, as a result of investigations to determine its safety and
483
effectiveness for use under certain conditions, has been
484
recognized for use under such conditions, but which drug has not,
485
other than in those investigations, been used to a material
486
extent or for a material time under such conditions.
487
(38) "Normal distribution chain" means a wholesale
488
distribution of a prescription drug where the wholesale
489
distributor purchases and receives the specific unit of the
490
prescription drug directly from the manufacturer and distributes
491
the prescription drug directly, or through any intracompany
492
transfers, to a chain pharmacy warehouse or a person authorized
493
by law to purchase prescription drugs for the purpose of
494
administering or dispensing the drug, as defined in s. 465.003.
495
(39) "Nursing home" means a facility licensed under part II
496
of chapter 400.
497
(40)(30) "Official compendium" means the current edition of
498
the official United States Pharmacopoeia and National Formulary,
499
or any supplement thereto.
500
(41)(31) "Pedigree paper" means:
501
(a) Effective July 1, 2006, a document in written or
502
electronic form approved by the department which contains of
503
Health and containing information required by s. 499.01211
504
regarding the sale and that records each distribution of any
505
given prescription legend drug., from sale by a pharmaceutical
506
manufacturer, through acquisition and sale by any wholesaler or
507
repackager, until final sale to a pharmacy or other person
508
administering or dispensing the drug. The information required to
509
be included on the form approved by the department pursuant to
510
this paragraph must at least detail the amount of the legend
511
drug; its dosage form and strength; its lot numbers; the name and
512
address of each owner of the legend drug and his or her
513
signature; its shipping information, including the name and
514
address of each person certifying delivery or receipt of the
515
legend drug; an invoice number, a shipping document number, or
516
another number uniquely identifying the transaction; and a
517
certification that the recipient wholesaler has authenticated the
518
pedigree papers. If the manufacturer or repackager has uniquely
519
serialized the individual legend drug unit, that identifier must
520
also be included on the form approved pursuant to this paragraph.
521
It must also include the name, address, telephone number and, if
522
available, e-mail contact information of each wholesaler involved
523
in the chain of the legend drug's custody; or
524
(b) A statement, under oath, in written or electronic form,
525
confirming that a wholesale distributor purchases and receives
526
the specific unit of the prescription drug directly from the
527
manufacturer of the prescription drug and distributes the
528
prescription drug directly, or through an intracompany transfer,
529
to a chain pharmacy warehouse or a person authorized by law to
530
purchase prescription drugs for the purpose of administering or
531
dispensing the drug, as defined in s. 465.003. For purposes of
532
this subsection, the term "chain pharmacy warehouse" means a
533
wholesale distributor permitted pursuant to s. 499.01 that
534
maintains a physical location for prescription drugs that
535
functions solely as a central warehouse to perform intracompany
536
transfers of such drugs to a member of its affiliated group as
537
described in s. 499.0121(6)(f)1.
538
1. The information required to be included pursuant to this
539
paragraph must include:
540
a. The following statement: "This wholesale distributor
541
purchased the specific unit of the prescription drug directly
542
from the manufacturer."
543
b. The manufacturer's national drug code identifier and the
544
name and address of the wholesaler and the purchaser of the
545
prescription drug.
546
c. The name of the prescription drug as it appears on the
547
label.
548
d. The quantity, dosage form, and strength of the
549
prescription drug.
550
2. The wholesale distributor must also maintain and make
551
available to the department, upon request, the point of origin of
552
the prescription drugs, including intracompany transfers; the
553
date of the shipment from the manufacturer to the wholesale
554
distributor; the lot numbers of such drugs; and the invoice
555
numbers from the manufacturer.
556
557
The department may adopt rules and forms relating to the
558
requirements of this subsection.
559
(42) "Permittee" means any person holding a permit issued
560
pursuant to s. 499.012.
561
(43)(32) "Person" means any individual, child, joint
562
venture, syndicate, fiduciary, partnership, corporation, division
563
of a corporation, firm, trust, business trust, company, estate,
564
public or private institution, association, organization, group,
565
city, county, city and county, political subdivision of this
566
state, other governmental agency within this state, and any
567
representative, agent, or agency of any of the foregoing, or any
568
other group or combination of the foregoing.
569
(44) "Pharmacist" means a person licensed under chapter
570
465.
571
(45) "Pharmacy" means an entity licensed under chapter 465.
572
(46)(33) "Prepackaged drug product" means a drug that
573
originally was in finished packaged form sealed by a manufacturer
574
and that is placed in a properly labeled container by a pharmacy
575
or practitioner authorized to dispense pursuant to chapter 465
576
for the purpose of dispensing in the establishment in which the
577
prepackaging occurred.
578
(47) "Prescribing practitioner" means a physician licensed
579
under chapter 458 or chapter 459 or any other medical
580
professional with authority under state law to prescribe cancer
581
medication.
582
(48) "Prescription drug" means a prescription or legend
583
drug, including, but not limited to, finished dosage forms or
584
active ingredients subject to, defined by, or described by s.
585
503(b) of the Federal Food, Drug, and Cosmetic Act or s.
587
499.003(54).
588
(49) "Prescription drug label" means any display of
589
written, printed, or graphic matter upon the immediate container
590
of any prescription drug prior to its dispensing to an individual
591
patient pursuant to a prescription of a practitioner authorized
592
by law to prescribe.
593
(50)(34) "Prescription label" means any display of written,
594
printed, or graphic matter upon the immediate container of any
595
prescription legend drug dispensed pursuant to a prescription of
596
a practitioner authorized by law to prescribe.
597
(51)(35) "Prescription medical oxygen" means oxygen USP
598
which is a drug that can only be sold on the order or
599
prescription of a practitioner authorized by law to prescribe.
600
The label of prescription medical oxygen must comply with current
601
labeling requirements for oxygen under the Federal Food, Drug,
602
and Cosmetic Act.
603
(52) "Primary wholesale distributor" means any wholesale
604
distributor that:
605
(a) Purchased 90 percent or more of the total dollar volume
606
of its purchases of prescription drugs directly from
607
manufacturers in the previous year; and
608
(b)1. Directly purchased prescription drugs from not fewer
609
than 50 different prescription drug manufacturers in the previous
610
year; or
611
2. Has, or is a member of an affiliated group, as defined
612
in s. 1504 of the Internal Revenue Code, which has no fewer than
613
250 employees.
614
(53) "Directly from a manufacturer" or "directly from
615
manufacturers" means:
616
(a) Purchases made by the wholesale distributor directly
617
from the manufacturer of prescription drugs; and
618
(b) Transfers from a member of an affiliated group, as
619
defined in s. 1504 of the Internal Revenue Code, of which the
620
wholesale distributor is a member, if:
621
1. The affiliated group purchases 90 percent or more of the
622
total dollar volume of its purchases of prescription drugs from
623
the manufacturer in the previous year; and
624
2. The wholesale distributor discloses to the department
625
the names of all members of the affiliated group of which the
626
wholesale distributor is a member and the affiliated group agrees
627
in writing to provide records on prescription drug purchases by
628
the members of the affiliated group no later than 48 hours after
629
the department requests access to such records, regardless of the
630
location where the records are stored.
631
(54)(36) "Proprietary drug," or "OTC drug," means a patent
632
or over-the-counter drug in its unbroken, original package, which
633
drug is sold to the public by, or under the authority of, the
634
manufacturer or primary distributor thereof, is not misbranded
636
purchased without a prescription.
637
(55)(37) "Repackage" includes repacking or otherwise
638
changing the container, wrapper, or labeling to further the
639
distribution of the drug, device, or cosmetic.
640
(56)(38) "Repackager" means a person who repackages. The
641
term excludes pharmacies that are operating in compliance with
642
pharmacy practice standards as defined in chapter 465 and rules
643
adopted under that chapter.
644
(57) "Retail pharmacy" means a community pharmacy licensed
645
under chapter 465 which purchases prescription drugs at fair
646
market prices and provides prescription services to the public.
647
(58) "Secondary wholesale distributor" means a wholesale
648
distributor that is not a primary wholesaler.
649
(59)(39) "Veterinary prescription drug" means a
650
prescription legend drug intended solely for veterinary use. The
651
label of the drug must bear the statement, "Caution: Federal law
652
restricts this drug to sale by or on the order of a licensed
653
veterinarian."
654
(40) "Veterinary prescription drug wholesaler" means any
655
person engaged in wholesale distribution of veterinary
656
prescription drugs in or into this state.
657
(60) "Wholesale distribution" means distribution of
658
prescription drugs to persons other than a consumer or patient,
659
but does not include:
660
(a) Any of the following activities, which is not a
661
violation of s. 499.005(21) if such activity is conducted in
662
accordance with s. 499.01(2)(g):
663
1. The purchase or other acquisition by a hospital or other
664
health care entity that is a member of a group purchasing
665
organization of a prescription drug for its own use from the
666
group purchasing organization or from other hospitals or health
667
care entities that are members of that organization.
668
2. The sale, purchase, or trade of a prescription drug or
669
an offer to sell, purchase, or trade a prescription drug by a
670
charitable organization described in s. 501(c)(3) of the Internal
671
Revenue Code of 1986, as amended and revised, to a nonprofit
672
affiliate of the organization to the extent otherwise permitted
673
by law.
674
3. The sale, purchase, or trade of a prescription drug or
675
an offer to sell, purchase, or trade a prescription drug among
676
hospitals or other health care entities that are under common
677
control. For purposes of this section, "common control" means the
678
power to direct or cause the direction of the management and
679
policies of a person or an organization, whether by ownership of
680
stock, by voting rights, by contract, or otherwise.
681
4. The sale, purchase, trade, or other transfer of a
682
prescription drug from or for any federal, state, or local
683
government agency or any entity eligible to purchase prescription
684
drugs at public health services prices pursuant to Pub. L. No.
685
102-585, s. 602 to a contract provider or its subcontractor for
686
eligible patients of the agency or entity under the following
687
conditions:
688
a. The agency or entity must obtain written authorization
689
for the sale, purchase, trade, or other transfer of a
690
prescription drug under this sub-subparagraph from the State
691
Surgeon General or his or her designee.
692
b. The contract provider or subcontractor must be
693
authorized by law to administer or dispense prescription drugs.
694
c. In the case of a subcontractor, the agency or entity
695
must be a party to and execute the subcontract.
696
d. A contract provider or subcontractor must maintain
697
separate and apart from other prescription drug inventory any
698
prescription drugs of the agency or entity in its possession.
699
e. The contract provider or subcontractor must maintain and
700
produce immediately for inspection all records of movement or
701
transfer of all the prescription drugs belonging to the agency or
702
entity, including, but not limited to, the records of receipt and
703
disposition of prescription drugs. Each contractor and
704
subcontractor dispensing or administering these drugs must
705
maintain and produce records documenting the dispensing or
706
administration. Records that are required to be maintained
707
include, but are not limited to, a perpetual inventory itemizing
708
drugs received and drugs dispensed by prescription number or
709
administered by patient identifier, which must be submitted to
710
the agency or entity quarterly.
711
f. The contract provider or subcontractor may administer or
712
dispense the prescription drugs only to the eligible patients of
713
the agency or entity or must return the prescription drugs to the
714
agency or entity. The contract provider or subcontractor must
715
require proof from each person seeking to fill a prescription or
716
obtain treatment that the person is an eligible patient of the
717
agency or entity and must, at a minimum, maintain a copy of this
718
proof as part of the records of the contractor or subcontractor
719
required under sub-subparagraph e.
720
g. In addition to the departmental inspection authority set
721
forth in s. 499.051, the establishment of the contract provider
722
and subcontractor and all records pertaining to prescription
723
drugs subject to this sub-subparagraph shall be subject to
724
inspection by the agency or entity. All records relating to
725
prescription drugs of a manufacturer under this subparagraph are
726
subject to audit by the manufacturer of those drugs, without
727
identifying individual patient information.
728
(b) Any of the following activities, which is not a
729
violation of s. 499.005(21) if such activity is conducted in
730
accordance with rules established by the department:
731
1. The sale, purchase, or trade of a prescription drug
732
among federal, state, or local government health care entities
733
that are under common control and are authorized to purchase such
734
prescription drug.
735
2. The sale, purchase, or trade of a prescription drug or
736
an offer to sell, purchase, or trade a prescription drug for
737
emergency medical reasons. For purposes of this sub-subparagraph,
738
the term "emergency medical reasons" includes transfers of
739
prescription drugs by a retail pharmacy to another retail
740
pharmacy to alleviate a temporary shortage.
741
3. The transfer of a prescription drug acquired by a
742
medical director on behalf of a licensed emergency medical
743
services provider to that emergency medical services provider and
744
its transport vehicles for use in accordance with the provider's
745
license under chapter 401.
746
4. The revocation of a sale or the return of a prescription
747
drug to the person's prescription drug wholesale supplier.
748
5. The donation of a prescription drug by a health care
749
entity to a charitable organization that has been granted an
750
exemption under s. 501(c)(3) of the Internal Revenue Code of
751
1986, as amended, and that is authorized to possess prescription
752
drugs.
753
6. The transfer of a prescription drug by a person
754
authorized to purchase or receive prescription drugs to a person
755
licensed or permitted to handle reverse distributions or
756
destruction under the laws of the jurisdiction in which the
757
person handling the reverse distribution or destruction receives
758
the drug.
759
7. The transfer of a prescription drug by a hospital or
760
other health care entity to a person licensed under this chapter
761
to repackage prescription drugs for the purpose of repackaging
762
the prescription drug for use by that hospital or other health
763
care entity and other health care entities that are under common
764
control, if ownership of the prescription drugs remains with the
765
hospital or other health care entity at all times. In addition to
766
the recordkeeping requirements of s. 499.0121(6), the hospital or
767
health care entity that transfers prescription drugs pursuant to
768
this subparagraph must reconcile all drugs transferred and
769
returned and resolve any discrepancies in a timely manner.
770
(c) The distribution of prescription drug samples by
771
manufacturers' representatives or distributors' representatives
772
conducted in accordance with s. 499.028.
773
(d) The sale, purchase, or trade of blood and blood
774
components intended for transfusion. As used in this
775
subparagraph, the term "blood" means whole blood collected from a
776
single donor and processed for transfusion or further
777
manufacturing, and the term "blood components" means that part of
778
the blood separated by physical or mechanical means.
779
(e) The lawful dispensing of a prescription drug in
780
accordance with chapter 465.
781
(f) The sale, purchase, or trade of a prescription drug
782
between pharmacies as a result of a sale, transfer, merger, or
783
consolidation of all or part of the business of the pharmacies
784
from or with another pharmacy, whether accomplished as a purchase
785
and sale of stock or of business assets.
786
(g) The intracompany sale of prescription drugs, meaning
787
any transaction or transfer between any division, subsidiary,
788
parent, or affiliated or related company under common ownership
789
and control of a corporate entity or any transaction or transfer
790
between co-licensed entities of a co-licensed product.
791
(61) "Wholesale distributor" means any person engaged in
792
wholesale distribution of prescription drugs in or into this
793
state, including, but not limited to, manufacturers; repackagers;
794
own-label distributors; jobbers; private-label distributors;
795
brokers; warehouses, including manufacturers' and distributors'
796
warehouses, chain drug warehouses, and wholesale drug warehouses;
797
independent wholesale drug traders; exporters; retail pharmacies;
798
and the agents thereof that conduct wholesale distributions.
799
Section 5. Section 499.004, Florida Statutes, is repealed.
800
Section 6. Section 499.005, Florida Statutes, is amended to
801
read:
802
499.005 Prohibited acts.--It is unlawful for a person to
803
perform or cause the performance of any of the following acts in
804
this state:
805
(1) The manufacture, repackaging, sale, delivery, or
806
holding or offering for sale of any drug, device, or cosmetic
807
that is adulterated or misbranded or has otherwise been rendered
808
unfit for human or animal use.
809
(2) The adulteration or misbranding of any drug, device, or
810
cosmetic.
811
(3) The receipt of any drug, device, or cosmetic that is
812
adulterated or misbranded, and the delivery or proffered delivery
813
of such drug, device, or cosmetic, for pay or otherwise.
814
(4) The sale, distribution, purchase, trade, holding, or
815
offering of any drug, device, or cosmetic in violation of this
817
(5) The dissemination of any false or misleading
818
advertisement of a drug, device, or cosmetic.
819
(6) The refusal or constructive refusal:
820
(a) To allow the department to enter or inspect an
821
establishment in which drugs, devices, or cosmetics are
822
manufactured, processed, repackaged, sold, brokered, or held;
823
(b) To allow inspection of any record of that
824
establishment;
825
(c) To allow the department to enter and inspect any
826
vehicle that is being used to transport drugs, devices, or
827
cosmetics; or
828
(d) To allow the department to take samples of any drug,
829
device, or cosmetic.
830
(7) The purchase or sale of prescription drugs for
831
wholesale distribution in exchange for currency, as defined in s.
832
560.103(6).
833
(8) Committing any act that causes a drug, device, or
834
cosmetic to be a counterfeit drug, device, or cosmetic; or
835
selling, dispensing, or holding for sale a counterfeit drug,
836
device, or cosmetic.
837
(9) The alteration, mutilation, destruction, obliteration,
838
or removal of the whole or any part of the labeling of a drug,
839
device, or cosmetic, or the doing of any other act with respect
840
to a drug, device, or cosmetic, if the act is done while the
841
drug, device, or cosmetic is held for sale and the act results in
842
the drug, device, or cosmetic being misbranded.
843
(10) Forging; counterfeiting; simulating; falsely
844
representing any drug, device, or cosmetic; or, without the
845
authority of the manufacturer, using any mark, stamp, tag, label,
846
or other identification device authorized or required by rules
848
(11) The use, on the labeling of any drug or in any
849
advertisement relating to such drug, of any representation or
850
suggestion that an application of the drug is effective when it
851
is not or that the drug complies with this part ss. 499.001-
852
499.081 when it does not.
853
(12) The possession of any drug in violation of this part
855
(13) The sale, delivery, holding, or offering for sale of
856
any self-testing kits designed to tell persons their status
857
concerning human immunodeficiency virus or acquired immune
858
deficiency syndrome or related disorders or conditions. This
859
prohibition does shall not apply to home access HIV test kits
860
approved for distribution and sale by the United States Food and
861
Drug Administration.
862
(14) The purchase or receipt of a legend drug from a person
863
that is not authorized under this chapter to distribute
864
prescription legend drugs to that purchaser or recipient.
865
(15) The sale or transfer of a prescription legend drug to
866
a person that is not authorized under the law of the jurisdiction
867
in which the person receives the drug to purchase or possess
868
prescription legend drugs from the person selling or transferring
869
the prescription legend drug.
870
(16) The purchase or receipt of a compressed medical gas
871
from a person that is not authorized under this chapter to
872
distribute compressed medical gases.
873
(17) The sale, purchase, or trade, or the offer to sell,
874
purchase, or trade, a drug sample as defined in s. 499.028; the
875
distribution of a drug sample in violation of s. 499.028; or the
876
failure to otherwise comply with s. 499.028.
877
(18) Failure to maintain records as required by this part
879
sections.
880
(19) Providing the department with false or fraudulent
881
records, or making false or fraudulent statements, regarding any
882
matter within the provisions of this chapter.
883
(20) The importation of a prescription legend drug except
884
as provided by s. 801(d) of the Federal Food, Drug, and Cosmetic
885
Act.
886
(21) The wholesale distribution of any prescription drug
887
that was:
888
(a) Purchased by a public or private hospital or other
889
health care entity; or
890
(b) Donated or supplied at a reduced price to a charitable
891
organization.
892
(22) Failure to obtain a permit or registration, or
893
operating without a valid permit when a permit or registration is
895
(23) Obtaining or attempting to obtain a prescription drug
896
or device by fraud, deceit, misrepresentation or subterfuge, or
897
engaging in misrepresentation or fraud in the distribution of a
898
drug or device.
899
(24) The distribution of a legend device to the patient or
900
ultimate consumer without a prescription or order from a
901
practitioner licensed by law to use or prescribe the device.
902
(25) Charging a dispensing fee for dispensing,
903
administering, or distributing a prescription drug sample.
904
(26) Removing a pharmacy's dispensing label from a
905
dispensed prescription drug with the intent to further distribute
906
the prescription drug.
907
(27) Distributing a prescription drug that was previously
908
dispensed by a licensed pharmacy, unless such distribution was
909
authorized in chapter 465 or the rules adopted under chapter 465.
910
(28) Failure to acquire obtain or deliver pass on a
911
pedigree paper where required under this part.
912
(29) The receipt of a prescription drug pursuant to a
913
wholesale distribution without either first receiving a pedigree
914
paper that was attested to as accurate and complete by the
915
wholesale distributor, where required under this part or
916
complying with the provisions of s. 499.0121(6)(d)5.
917
Section 7. Section 499.0051, Florida Statutes, is amended
918
to read:
919
499.0051 Criminal acts involving contraband or adulterated
920
drugs.--
921
(1) FAILURE TO MAINTAIN OR DELIVER PEDIGREE PAPERS.--
922
(a) A person, other than a manufacturer, engaged in the
923
wholesale distribution of prescription legend drugs who fails to
924
deliver to another person complete and accurate pedigree papers
925
concerning a prescription legend drug or contraband prescription
926
legend drug prior to transferring the prescription legend drug or
927
contraband prescription legend drug to another person commits a
928
felony of the third degree, punishable as provided in s. 775.082,
930
(b) A person engaged in the wholesale distribution of
931
prescription legend drugs who fails to acquire complete and
932
accurate pedigree papers concerning a prescription legend drug or
933
contraband prescription legend drug prior to obtaining the legend
934
drug or contraband prescription legend drug from another person
935
commits a felony of the third degree, punishable as provided in
937
(c) Any person who knowingly destroys, alters, conceals, or
938
fails to maintain complete and accurate pedigree papers
939
concerning any prescription legend drug or contraband
940
prescription legend drug in his or her possession commits a
941
felony of the third degree, punishable as provided in s. 775.082,
943
(2) FAILURE TO AUTHENTICATE PEDIGREE PAPERS.--Effective
944
July 1, 2006:
945
(a) A person engaged in the wholesale distribution of
946
prescription legend drugs who is in possession of pedigree papers
947
concerning legend drugs or contraband prescription legend drugs
948
and who fails to authenticate the matters contained in the
949
pedigree papers and who nevertheless attempts to further
950
distribute prescription legend drugs or contraband prescription
951
legend drugs commits a felony of the third degree, punishable as
953
(b) A person in possession of pedigree papers concerning
954
prescription legend drugs or contraband prescription legend drugs
955
who falsely swears or certifies that he or she has authenticated
956
the matters contained in the pedigree papers commits a felony of
957
the third degree, punishable as provided in s. 775.082, s.
959
(c) Authentication of pedigree for a prescription drug
960
included in a sealed, medical convenience kit shall be limited to
961
verifying the transaction and pedigree information received and
962
assuming that the kit contains what is included in the
963
accompanying pedigree. Such verification shall satisfy the
964
requirements of the statute for those products.
965
(3) KNOWING FORGERY OF PEDIGREE PAPERS.--A person who
966
knowingly forges, counterfeits, or falsely creates any pedigree
967
paper; who falsely represents any factual matter contained on any
968
pedigree paper; or who knowingly omits to record material
969
information required to be recorded in a pedigree paper, commits
970
a felony of the second degree, punishable as provided in s.
972
(4) KNOWING PURCHASE OR RECEIPT OF PRESCRIPTION LEGEND DRUG
973
FROM UNAUTHORIZED PERSON.--A person who knowingly purchases or
974
receives from a person not authorized to distribute prescription
975
legend drugs under this chapter a prescription legend drug in a
976
wholesale distribution transaction commits a felony of the second
978
979
(5) KNOWING SALE OR TRANSFER OF PRESCRIPTION LEGEND DRUG TO
980
UNAUTHORIZED PERSON.--A person who knowingly sells or transfers
981
to a person not authorized to purchase or possess prescription
982
legend drugs, under the law of the jurisdiction in which the
983
person receives the drug, a prescription legend drug in a
984
wholesale distribution transaction commits a felony of the second
986
987
(6) KNOWING SALE OR DELIVERY, OR POSSESSION WITH INTENT TO
988
SELL, CONTRABAND PRESCRIPTION LEGEND DRUGS.--A person who is
989
knowingly in actual or constructive possession of any amount of
990
contraband prescription legend drugs, who knowingly sells or
991
delivers, or who possesses with intent to sell or deliver any
992
amount of contraband prescription legend drugs, commits a felony
993
of the second degree, punishable as provided in s. 775.082, s.
995
(7) TRAFFICKING IN CONTRABAND PRESCRIPTION DRUGS.--A person
996
who knowingly sells, purchases, manufactures, delivers, or brings
997
into this state, or who is knowingly in actual or constructive
998
possession of any amount of contraband prescription drugs valued
999
at $25,000 or more, commits a felony of the first degree,
1001
(a) Upon conviction, each defendant shall be ordered to pay
1002
a mandatory fine according to the following schedule:
1003
1. If the value of contraband prescription drugs involved
1004
is $25,000 or more, but less than $100,000, the defendant shall
1005
pay a mandatory fine of $25,000. If the defendant is a
1006
corporation or other person that is not a natural person, it
1007
shall pay a mandatory fine of $75,000.
1008
2. If the value of contraband prescription drugs involved
1009
is $100,000 or more, but less than $250,000, the defendant shall
1010
pay a mandatory fine of $100,000. If the defendant is a
1011
corporation or other person that is not a natural person, it
1012
shall pay a mandatory fine of $300,000.
1013
3. If the value of contraband prescription drugs involved
1014
is $250,000 or more, the defendant shall pay a mandatory fine of
1015
$200,000. If the defendant is a corporation or other person that
1016
is not a natural person, it shall pay a mandatory fine of
1017
$600,000.
1018
(b) As used in this section, the term "value" means the
1019
market value of the property at the time and place of the offense
1020
or, if such cannot be satisfactorily ascertained, the cost of
1021
replacement of the property within a reasonable time after the
1022
offense. Amounts of value of separate contraband prescription
1023
drugs involved in distinct transactions for the distribution of
1024
the contraband prescription drugs committed pursuant to one
1025
scheme or course of conduct, whether involving the same person or
1026
several persons, may be aggregated in determining the punishment
1027
of the offense.
1028
(8)(7) FORGERY OF PRESCRIPTION LABELS OR PRESCRIPTION
1029
LEGEND DRUG LABELS.--A person who knowingly forges, counterfeits,
1030
or falsely creates any prescription label or prescription legend
1031
drug label, or who falsely represents any factual matter
1032
contained on any prescription label or prescription legend drug
1033
label, commits a felony of the first degree, punishable as
1035
(9) SALE OR PURCHASE OF CONTRABAND PRESCRIPTION DRUGS
1036
RESULTING IN GREAT BODILY HARM.--A person who knowingly sells,
1037
purchases, manufactures, delivers, or brings into this state, or
1038
who is knowingly in actual or constructive possession of any
1039
amount of contraband prescription drugs, and whose acts in
1040
violation of this section result in great bodily harm to a
1041
person, commits a felony of the first degree, as provided in s.
1043
(10) SALE OR PURCHASE OF CONTRABAND PRESCRIPTION DRUGS
1044
RESULTING IN DEATH.--A person who knowingly manufactures, sells,
1045
purchases, delivers, or brings into this state, or who is
1046
knowingly in actual or constructive possession of any amount of
1047
contraband prescription drugs, and whose acts in violation of
1048
this section result in the death of a person, commits a felony of
1049
the first degree, punishable by a term of years not exceeding
1051
(11) VIOLATIONS OF S. 499.005 RELATED TO DEVICES AND
1052
COSMETICS; DISSEMINATION OF FALSE ADVERTISEMENT.--Any person who
1053
violates any of the provisions of s. 499.005 with respect to a
1054
device or cosmetic commits a misdemeanor of the second degree,
1056
violation is committed after a conviction of such person under
1057
this section has become final, such person is guilty of a
1058
misdemeanor of the first degree, punishable as provided in s.
1060
except that any person who violates s. 499.005(8) or s.
1061
499.005(10) with respect to a device or cosmetic commits a felony
1062
of the third degree, punishable as provided in s. 775.082, s.
1064
publisher, radio broadcast licensee, or agency or medium for the
1065
dissemination of an advertisement, except the manufacturer,
1066
wholesaler, or seller of the article to which a false
1067
advertisement relates, is not liable under this section by reason
1068
of the dissemination by him or her of such false advertisement,
1069
unless he or she has refused, on the request of the department,
1070
to furnish to the department the name and post office address of
1071
the manufacturer, wholesaler, seller, or advertising agency that
1072
asked him or her to disseminate such advertisement.
1073
(12) ADULTERATED AND MISBRANDED DRUGS; FALSE ADVERTISEMENT;
1074
FAILURE TO MAINTAIN RECORDS RELATING TO DRUGS.--Any person who
1075
violates any of the following provisions commits a misdemeanor of
1076
the second degree, punishable as provided in s. 775.082 or s.
1077
775.083; but, if the violation is committed after a conviction of
1078
such person under this section has become final, such person
1079
commits a misdemeanor of the first degree, punishable as provided
1081
part:
1082
(a) The manufacture, repackaging, sale, delivery, or
1083
holding or offering for sale of any drug that is adulterated or
1084
misbranded or has otherwise been rendered unfit for human or
1085
animal use.
1086
(b) The adulteration or misbranding of any drug intended
1087
for further distribution.
1088
(c) The receipt of any drug that is adulterated or
1089
misbranded, and the delivery or proffered delivery of such drug,
1090
for pay or otherwise.
1091
(d) The dissemination of any false or misleading
1092
advertisement of a drug.
1093
(e) The use, on the labeling of any drug or in any
1094
advertisement relating to such drug, of any representation or
1095
suggestion that an application of the drug is effective when it
1096
is not or that the drug complies with this part when it does not.
1097
(f) The purchase or receipt of a compressed medical gas
1098
from a person that is not authorized under this chapter to
1099
distribute compressed medical gases.
1100
(g) Charging a dispensing fee for dispensing,
1101
administering, or distributing a prescription drug sample.
1102
(h) The failure to maintain records related to a drug as
1103
required by this part and rules adopted under this part, except
1104
for pedigree papers, invoices, or shipping documents related to
1105
prescription drugs.
1106
(i) The possession of any drug in violation of this part,
1107
except if the violation relates to a deficiency in pedigree
1108
papers.
1109
(13) REFUSAL TO ALLOW INSPECTION; SELLING, PURCHASING, OR
1110
TRADING DRUG SAMPLES; FAILURE TO MAINTAIN RECORDS RELATING TO
1111
PRESCRIPTION DRUGS.--Any person who violates any of the following
1112
provisions commits a felony of the third degree, punishable as
1114
otherwise provided in this part.
1115
(a) The refusal or constructive refusal to allow:
1116
1. The department to enter or inspect an establishment in
1117
which drugs are manufactured, processed, repackaged, sold,
1118
brokered, or held;
1119
2. Inspection of any record of that establishment;
1120
3. The department to enter and inspect any vehicle that is
1121
being used to transport drugs; or
1122
4. The department to take samples of any drug.
1123
(b) The sale, purchase, or trade, or the offer to sell,
1124
purchase, or trade, a drug sample as defined in s. 499.028; the
1125
distribution of a drug sample in violation of s. 499.028; or the
1126
failure to otherwise comply with s. 499.028.
1127
(c) Providing the department with false or fraudulent
1128
records, or making false or fraudulent statements, regarding any
1129
matter within the provisions of this chapter related to a drug.
1130
(d) The failure to receive, maintain, or provide invoices
1131
and shipping documents, other than pedigree papers, if
1132
applicable, related to the distribution of a prescription drug.
1133
(e) The importation of a prescription drug for wholesale
1134
distribution, except as provided by s. 801(d) of the Federal
1135
Food, Drug, and Cosmetic Act.
1136
(f) The wholesale distribution of any prescription drug
1137
that was:
1138
1. Purchased by a public or private hospital or other
1139
health care entity; or
1140
2. Donated or supplied at a reduced price to a charitable
1141
organization.
1142
(g) The failure to obtain a permit as a prescription drug
1143
wholesale distributor or nonresident manufacturer when a permit
1144
is required by this part for that activity.
1145
(h) Knowingly possessing any adulterated or misbranded
1146
prescription drug outside of a designated quarantine area.
1147
(i) The purchase or sale of a prescription drug for
1148
wholesale distribution in exchange for currency, as defined in s.
1149
560.103(6).
1150
(14) OTHER VIOLATIONS.--Any person who violates any of the
1151
following provisions commits a felony of the second degree,
1153
or as otherwise provided in this part.
1154
(a) Knowingly manufacturing, repackaging, selling,
1155
delivering, or holding or offering for sale any drug that is
1156
adulterated or misbranded or has otherwise been rendered unfit
1157
for human or animal use.
1158
(b) Knowingly adulterating a drug that is intended for
1159
further distribution.
1160
(c) Knowingly receiving a drug that is adulterated and
1161
delivering or proffering delivery of such drug for pay or
1162
otherwise.
1163
(d) Committing any act that causes a drug to be a
1164
counterfeit drug, or selling, dispensing, or knowingly holding
1165
for sale a counterfeit drug.
1166
(e) Forging, counterfeiting, simulating, or falsely
1167
representing any drug, or, without the authority of the
1168
manufacturer, using any mark, stamp, tag, label, or other
1169
identification device authorized or required by rules adopted
1170
under this part.
1171
(f) Knowingly obtaining or attempting to obtain a
1172
prescription drug for wholesale distribution by fraud, deceit,
1173
misrepresentation, or subterfuge, or engaging in
1174
misrepresentation or fraud in the distribution of a drug.
1175
(g) Removing a pharmacy's dispensing label from a dispensed
1176
prescription drug with the intent to further distribute the
1177
prescription drug.
1178
(h) Knowingly distributing a prescription drug that was
1179
previously dispensed by a licensed pharmacy, unless such
1180
distribution was authorized in chapter 465 or the rules adopted
1181
under chapter 465.
1182
(15) FALSE ADVERTISEMENT.--A publisher, radio broadcast
1183
licensee, or agency or medium for the dissemination of an
1184
advertisement, except the manufacturer, repackager, wholesale
1185
distributor, or seller of the article to which a false
1186
advertisement relates, is not liable under subsection (12),
1187
subsection (13), or subsection (14) by reason of the
1188
dissemination by him or her of such false advertisement, unless
1189
he or she has refused, on the request of the department, to
1190
furnish to the department the name and post office address of the
1191
manufacturer, repackager, wholesaler, seller, or advertising
1192
agency that asked him or her to disseminate such advertisement.
1193
Section 8. Section 499.0053, Florida Statutes, is repealed.
1194
Section 9. Section 499.00535, Florida Statutes, is
1195
repealed.
1196
Section 10. Section 499.0054, Florida Statutes, is amended
1197
to read:
1198
499.0054 Advertising and labeling of drugs, devices, and
1199
cosmetics; exemptions.--
1200
(1) It is a violation of the Florida Drug and Cosmetic Act
1201
to perform or cause the performance of any of the following acts:
1202
(a)(1) The dissemination of any false advertisement of any
1203
drug, device, or cosmetic. An advertisement is false if it is
1204
false or misleading in any way.
1205
(b)(2) The distribution in commerce of any drug, device, or
1206
cosmetic, if its labeling or advertising is in violation of ss.
1208
(c)(3) The manufacturing, repackaging, packaging, selling,
1209
delivery, holding, or offering for sale of any drug, device, or
1210
cosmetic for which the advertising or labeling is false or
1211
misleading.
1212
(d)(4) The advertising of any drug, device, or cosmetic
1213
that is adulterated or misbranded.
1214
(e)(5) The receiving in commerce of any drug, device, or
1215
cosmetic that is falsely advertised or labeled or the delivering
1216
or proffering for delivery of any such drug, device, or cosmetic.
1217
(f)(6) The advertising or labeling of any product
1218
containing ephedrine, a salt of ephedrine, an isomer of
1219
ephedrine, or a salt of an isomer of ephedrine, for the
1220
indication of stimulation, mental alertness, weight loss,
1221
appetite control, energy, or other indications not approved by
1222
the pertinent United States Food and Drug Administration Over-
1223
the-Counter Final or Tentative Final Monograph or approved new
1224
drug application under the federal act. In determining compliance
1225
with this requirement, the department may consider the following
1226
factors:
1227
1.(a) The packaging of the product.
1228
2.(b) The name and labeling of the product.
1229
3.(c) The manner of distribution, advertising, and
1230
promotion of the product, including verbal representations at the
1231
point of sale.
1232
4.(d) The duration, scope, and significance of abuse of the
1233
particular product.
1234
(g)(7) The advertising of any drug or device represented to
1235
have any effect in any of the following conditions, disorders,
1236
diseases, or processes:
1237
1.(a) Blood disorders.
1238
2.(b) Bone or joint diseases.
1239
3.(c) Kidney diseases or disorders.
1240
4.(d) Cancer.
1241
5.(e) Diabetes.
1242
6.(f) Gall bladder diseases or disorders.
1243
7.(g) Heart and vascular diseases.
1244
8.(h) High blood pressure.
1245
9.(i) Diseases or disorders of the ear or auditory
1246
apparatus, including hearing loss or deafness.
1247
10.(j) Mental disease or mental retardation.
1248
11.(k) Paralysis.
1249
12.(l) Prostate gland disorders.
1250
13.(m) Conditions of the scalp affecting hair loss.
1251
14.(n) Baldness.
1252
15.(o) Endocrine disorders.
1253
16.(p) Sexual impotence.
1254
17.(q) Tumors.
1255
18.(r) Venereal diseases.
1256
19.(s) Varicose ulcers.
1257
20.(t) Breast enlargement.
1258
21.(u) Purifying blood.
1259
22.(v) Metabolic disorders.
1260
23.(w) Immune system disorders or conditions affecting the
1261
immune system.
1262
24.(x) Extension of life expectancy.
1263
25.(y) Stress and tension.
1264
26.(z) Brain stimulation or performance.
1265
27.(aa) The body's natural defense mechanisms.
1266
28.(bb) Blood flow.
1267
29.(cc) Depression.
1268
30.(dd) Human immunodeficiency virus or acquired immune
1269
deficiency syndrome or related disorders or conditions.
1270
(h)(8) The representation or suggestion in labeling or
1271
advertising that an article is approved under this part ss.
1273
(2) In determining whether an advertisement is false or
1274
misleading, the department shall review the representations made
1275
or suggested by statement, word, design, device, sound, or any
1276
combination thereof within the advertisement and the extent to
1277
which the advertisement fails to reveal material facts with
1278
respect to consequences that can result from the use of the drug,
1279
device, or cosmetic to which the advertisement relates under the
1280
conditions of use prescribed in the labeling or advertisement.
1281
(3)(a) An advertisement that is not prohibited under
1282
paragraph (1)(a) is not prohibited under paragraph (1)(g) if it
1283
is disseminated:
1284
1. To the public solely to advertise the product for those
1285
indications that are safe and effective indications and the
1286
product is safe and effective for self-medication, as established
1287
by the United States Food and Drug Administration; or
1288
2. Only to members of the medical, dental, pharmaceutical,
1289
or veterinary professions or appears only in the scientific
1290
periodicals of these professions.
1291
(b) Compliance with this part and the rules adopted under
1292
this part does not create any legal presumption that a drug or
1293
device is safe or effective.
1294
Section 11. Section 499.00545, Florida Statutes, is
1295
repealed.
1296
Section 12. Section 499.0055, Florida Statutes, is
1297
repealed.
1298
Section 13. Section 499.0057, Florida Statutes, is
1299
repealed.
1300
Section 14. Section 499.006, Florida Statutes, is amended
1301
to read:
1302
499.006 Adulterated drug or device.--A drug or device is
1303
adulterated:
1304
(1) If it consists in whole or in part of any filthy,
1305
putrid, or decomposed substance;
1306
(2) If it has been produced, prepared, packed, or held
1307
under conditions whereby it could have been contaminated with
1308
filth or rendered injurious to health;
1309
(3) If it is a drug and the methods used in, or the
1310
facilities or controls used for, its manufacture, processing,
1311
packing, or holding do not conform to, or are not operated or
1312
administered in conformity with, current good manufacturing
1313
practices to assure that the drug meets the requirements of this
1315
strength, and meets the standard of quality and purity, which it
1316
purports or is represented to possess;
1317
(4) If it is a drug and its container is composed, in whole
1318
or in part, of any poisonous or deleterious substance which could
1319
render the contents injurious to health;
1320
(5) If it is a drug and it bears or contains, for the
1321
purpose of coloring only, a color additive that is unsafe within
1322
the meaning of the federal act; or, if it is a color additive,
1323
the intended use of which in or on drugs is for the purpose of
1324
coloring only, and it is unsafe within the meaning of the federal
1325
act;
1326
(6) If it purports to be, or is represented as, a drug the
1327
name of which is recognized in the official compendium, and its
1328
strength differs from, or its quality or purity falls below, the
1329
standard set forth in such compendium. The determination as to
1330
strength, quality, or purity must be made in accordance with the
1331
tests or methods of assay set forth in such compendium, or, when
1332
such tests or methods of assay are absent or inadequate, in
1333
accordance with those tests or methods of assay prescribed under
1334
authority of the federal act. A drug defined in the official
1335
compendium is not adulterated under this subsection merely
1336
because it differs from the standard of strength, quality, or
1337
purity set forth for that drug in such compendium if its
1338
difference in strength, quality, or purity from such standard is
1339
plainly stated on its label;
1340
(7) If it is not subject to subsection (6) and its strength
1341
differs from, or its purity or quality falls below the standard
1342
of, that which it purports or is represented to possess;
1343
(8) If it is a drug:
1344
(a) With which any substance has been mixed or packed so as
1345
to reduce the quality or strength of the drug; or
1346
(b) For which any substance has been substituted wholly or
1347
in part;
1348
(9) If it is a drug or device for which the expiration date
1349
has passed;
1350
(10) If it is a legend drug for which the required pedigree
1351
paper is nonexistent, fraudulent, or incomplete under the
1353
rules, or that has been purchased, held, sold, or distributed at
1354
any time by a person not authorized under federal or state law to
1355
do so; or
1356
(11) If it is a prescription drug subject to, defined by,
1357
or described by s. 503(b) of the Federal Food, Drug, and Cosmetic
1358
Act which has been returned by a veterinarian to a limited
1359
prescription drug veterinary wholesaler.
1360
Section 15. Section 499.007, Florida Statutes, is amended
1361
to read:
1362
499.007 Misbranded drug or device.--A drug or device is
1363
misbranded:
1364
(1) If its labeling is in any way false or misleading.
1365
(2) Unless, If in package form, it does not bear bears a
1366
label containing:
1367
(a) The name and place of business of the manufacturer,
1368
repackager, or distributor of the finished dosage form of the
1369
drug. For the purpose of this paragraph, the finished dosage form
1370
of a prescription medicinal drug is that form of the drug which
1371
is, or is intended to be, dispensed or administered to the
1372
patient and requires no further manufacturing or processing other
1373
than packaging, reconstitution, and labeling; and
1374
(b) An accurate statement of the quantity of the contents
1375
in terms of weight, measure, or numerical count; however, under
1376
this section, reasonable variations are permitted, and the
1377
department shall establish by rule exemptions for small packages.
1378
(3) If it is an active pharmaceutical ingredient in bulk
1379
form and does not bear a label containing:
1380
(a) The name and place of business of the manufacturer,
1381
repackager, or distributor; and
1382
(b) An accurate statement of the quantity of the contents
1383
in terms of weight, measure, or numerical count.
1384
(4)(3) If any word, statement, or other information
1386
the label or labeling is not prominently placed thereon with such
1387
conspicuousness as compared with other words, statements,
1388
designs, or devices in the labeling, and in such terms, as to
1389
render the word, statement, or other information likely to be
1390
read and understood under customary conditions of purchase and
1391
use.
1392
(5)(4) If it is a drug and is not designated solely by a
1393
name recognized in an official compendium and, unless its label
1394
does not bear bears:
1395
(a) The common or usual name of the drug, if any; and
1396
(b) In case it is fabricated from two or more ingredients,
1397
the common or usual name and quantity of each active ingredient.
1398
(6)(5) If Unless its labeling does not bear bears:
1399
(a) Adequate directions for use; and
1400
(b) Adequate warnings against use in those pathological
1401
conditions in which its use may be dangerous to health or against
1402
use by children if its use may be dangerous to health, or against
1403
unsafe dosage or methods or duration of administration or
1404
application, in such manner and form as are necessary for the
1405
protection of users.
1406
(7)(6) If it purports to be a drug the name of which is
1407
recognized in the official compendium, and unless it is not
1408
packaged and labeled as prescribed therein; however, the method
1409
of packaging may be modified with the consent of the department.
1410
(8)(7) If it has been found by the department to be a drug
1411
liable to deterioration, and unless it is not packaged in such
1412
form and manner, and its label bears a statement of such
1413
precautions, as the department by rule requires as necessary to
1414
protect the public health. Such rule may not be established for
1415
any drug recognized in an official compendium until the
1416
department has informed the appropriate body charged with the
1417
revision of such compendium of the need for such packaging or
1418
labeling requirements and that body has failed within a
1419
reasonable time to prescribe such requirements.
1420
(9)(8) If it is:
1421
(a) A drug and its container or finished dosage form is so
1422
made, formed, or filled as to be misleading;
1423
(b) An imitation of another drug; or
1424
(c) Offered for sale under the name of another drug.
1425
(10)(9) If it is dangerous to health when used in the
1426
dosage or with the frequency or duration prescribed, recommended,
1427
or suggested in the labeling of the drug.
1428
(11)(10) If it is, purports to be, or is represented as a
1429
drug composed wholly or partly of insulin, and unless:
1430
(a) It is not from a batch with respect to which a
1431
certificate has been issued pursuant to s. 506 of the federal
1432
act; and
1433
(b) The certificate is in effect with respect to the drug.
1434
(12)(11) If it is, purports to be, or is represented as a
1435
drug composed wholly or partly of any kind of antibiotic
1436
requiring certification under the federal act, and unless:
1437
(a) It is not from a batch with respect to which a
1438
certificate has been issued pursuant to s. 507 of the federal
1439
act; and
1440
(b) The certificate is in effect with respect to the drug.;
1441
1442
However, this subsection does not apply to any drug or class of
1443
drugs exempted by regulations adopted under s. 507(c) or (d) of
1444
the federal act.
1445
(13)(12) If it is a drug intended for use by humans which
1446
is a habit-forming drug or which, because of its toxicity or
1447
other potentiality for harmful effect, or the method of its use,
1448
or the collateral measures necessary to its use, is not safe for
1449
use except under the supervision of a practitioner licensed by
1450
law to administer such drugs; or which is limited by an effective
1451
application under s. 505 of the federal act to use under the
1452
professional supervision of a practitioner licensed by law to
1453
prescribe such drug, if unless it is not dispensed only:
1454
(a) Upon the written prescription of a practitioner
1455
licensed by law to prescribe such drug;
1456
(b) Upon an oral prescription of such practitioner, which
1457
is reduced promptly to writing and filled by the pharmacist; or
1458
(c) By refilling any such written or oral prescription, if
1459
such refilling is authorized by the prescriber either in the
1460
original prescription or by oral order which is reduced promptly
1461
to writing and filled by the pharmacist.
1462
1463
This subsection does not relieve any person from any requirement
1464
prescribed by law with respect to controlled substances as
1465
defined in the applicable federal and state laws.
1466
(14)(13) If it is a drug that is subject to paragraph
1467
(13)(a) (12)(a), and if, at any time before it is dispensed, its
1468
label does not fails to bear the statement:
1469
(a) "Caution: Federal Law Prohibits Dispensing Without
1470
Prescription";
1471
(b) "Rx Only";
1472
(c) The prescription symbol followed by the word "Only"; or
1473
(d) "Caution: State Law Prohibits Dispensing Without
1474
Prescription."
1475
(15)(14) If it is a drug that is not subject to paragraph
1476
(13)(a)(12)(a), if at any time before it is dispensed its label
1477
bears the statement of caution required in subsection (14) (13).
1478
(16)(15) If it is a color additive, the intended use of
1479
which in or on drugs is for the purpose of coloring only, and
1480
unless its packaging and labeling are not in conformity with the
1481
packaging and labeling requirements that apply to such color
1482
additive and are prescribed under the federal act.
1483
1484
A drug dispensed by filling or refilling a written or oral
1485
prescription of a practitioner licensed by law to prescribe such
1486
drug is exempt from the requirements of this section, except
1487
subsections (1), (9)(8), (11)(10), and (12)(11) and the packaging
1488
requirements of subsections (7)(6) and (8)(7), if the drug bears
1489
a label that contains the name and address of the dispenser or
1490
seller, the prescription number and the date the prescription was
1491
written or filled, the name of the prescriber and the name of the
1492
patient, and the directions for use and cautionary statements.
1493
This exemption does not apply to any drug dispensed in the course
1494
of the conduct of a business of dispensing drugs pursuant to
1495
diagnosis by mail or to any drug dispensed in violation of
1496
subsection (13) (12). The department may, by rule, exempt drugs
1498
compliance with that subsection is not necessary to protect the
1499
public health, safety, and welfare.
1500
Section 16. Section 499.008, Florida Statutes, is amended
1501
to read:
1502
499.008 Adulterated cosmetics.--A cosmetic is adulterated:
1503
(1) If it bears or contains any poisonous or deleterious
1504
substance that is injurious to users under the conditions of use
1505
prescribed in the labeling or advertisement thereof or under such
1506
conditions of use as are customary or usual.; However, this
1507
subsection does not apply to coal-tar hair dye:
1508
(a) The label of which bears the following legend
1509
conspicuously displayed thereon: "Caution: This product contains
1510
ingredients which may cause skin irritation on certain
1511
individuals, and a preliminary test according to accompanying
1512
directions should first be made. This product must not be used
1513
for dyeing the eyelashes or eyebrows; to do so may cause
1514
blindness"; and
1515
(b) The labeling of which bears adequate directions for
1516
such preliminary testing.
1517
1518
For the purposes of this subsection and subsection (4), the term
1519
"hair dye" does not include eyelash dyes or eyebrow dyes.
1520
(2) If it consists in whole or in part of any filthy,
1521
putrid, or decomposed substance.
1522
(3) If it has been produced, prepared, packed, or held
1523
under conditions whereby it could have become contaminated with
1524
filth or whereby it could have been rendered injurious to health.
1525
(4) If it is not a hair dye and it is, or it bears or
1526
contains, a color additive that is unsafe within the meaning of
1527
the federal act.
1528
1529
For the purposes of subsections (1) and (4), the term "hair dye"
1530
does not include eyelash dyes or eyebrow dyes.
1531
Section 17. Section 499.009, Florida Statutes, is amended
1532
to read:
1533
499.009 Misbranded cosmetics.--A cosmetic is misbranded:
1534
(1) If its labeling is false or misleading in any
1535
particular.
1536
(2) Unless, If in package form, it does not bear bears a
1537
label containing:
1538
(a) The name and place of business of the manufacturer,
1539
packer, or distributor;
1540
(b) An accurate statement of the quantity of the contents
1541
in terms of weight, measure, or numerical count; however, under
1542
this paragraph reasonable variations are permitted, and the
1543
department shall establish by rule exemptions for small packages;
1544
and
1545
(c) A declaration of ingredients in descending order of
1546
predominance, or as otherwise required by federal law.
1547
(3) If any word, statement, or other information required
1549
on the label or labeling is not prominently placed thereon with
1550
such conspicuousness as compared with other words, statements,
1551
designs, or devices in the labeling, and in such terms, as to
1552
render the word, statement, or other information likely to be
1553
read and understood by an individual under customary conditions
1554
of purchase and use.
1555
(4) If its container is so made, formed, or filled as to be
1556
misleading.
1557
(5) Unless, If it is a color additive, its packaging and
1558
labeling are not in conformity with the packaging and labeling
1559
requirements applicable to that color additive prescribed under
1560
the federal act. This subsection does not apply to packages of
1561
color additives that, with respect to their use for cosmetics,
1562
are marketed and intended for use only in or on hair dyes.
1563
Section 18. Section 499.01, Florida Statutes, is amended to
1564
read:
1565
499.01 Permits; applications; renewal; general
1566
requirements.--
1567
(1) Prior to operating, a permit is required for each
1568
person and establishment that intends to operate as:
1569
(a) A prescription drug manufacturer;
1570
(b) A prescription drug repackager;
1571
(c) A nonresident prescription drug manufacturer;
1572
(d) A prescription drug wholesale distributor;
1573
(e) An out-of-state prescription drug wholesale
1574
distributor;
1575
(f) A retail pharmacy drug wholesale distributor;
1576
(g) A restricted prescription drug distributor;
1577
(h) A complimentary drug distributor;
1578
(i) A freight forwarder;
1579
(j) A veterinary prescription drug retail establishment;
1580
(k) A veterinary prescription drug wholesale distributor;
1581
(l) A limited prescription drug veterinary wholesale
1582
distributor;
1583
(m) A medical oxygen retail establishment;
1584
(n) A compressed medical gas wholesale distributor;
1585
(o) A compressed medical gas manufacturer;
1586
(p)(c) An over-the-counter drug manufacturer;
1587
(d) A compressed medical gas manufacturer;
1588
(q)(e) A device manufacturer; or
1589
(r)(f) A cosmetic manufacturer.;
1590
(g) A prescription drug wholesaler;
1591
(h) A veterinary prescription drug wholesaler;
1592
(i) A compressed medical gas wholesaler;
1593
(j) An out-of-state prescription drug wholesaler;
1594
(k) A nonresident prescription drug manufacturer;
1595
(l) A freight forwarder;
1596
(m) A retail pharmacy drug wholesaler;
1597
(n) A veterinary legend drug retail establishment;
1598
(o) A medical oxygen retail establishment;
1599
(p) A complimentary drug distributor;
1600
(q) A restricted prescription drug distributor; or
1601
(r) A limited prescription drug veterinary wholesaler.
1602
(2) The following types of permits are established:
1603
(a) Prescription drug manufacturer permit.--A prescription
1604
drug manufacturer permit is required for any person that
1605
manufactures a prescription drug in this state.
1606
1. A person that operates an establishment permitted as a
1607
prescription drug manufacturer may engage in wholesale
1608
distribution of prescription drugs manufactured at that
1609
establishment and shall comply with all the provisions of this
1610
part and the rules adopted under this part which apply to a
1611
wholesale distributor.
1612
2. A prescription drug manufacturer shall comply with all
1613
appropriate state and federal good manufacturing practices.
1614
(b) Prescription drug repackager permit.--A prescription
1615
drug repackager permit is required for any person that repackages
1616
a prescription drug in this state.
1617
1. A person that operates an establishment permitted as a
1618
prescription drug repackager may engage in wholesale distribution
1619
of prescription drugs repackaged at that establishment and must
1620
comply with all the provisions of this part and the rules adopted
1621
under this part which apply to a wholesale distributor.
1622
2. A prescription drug repackager shall comply with all
1623
appropriate state and federal good manufacturing practices.
1624
(c) Nonresident prescription drug manufacturer permit.--A
1625
nonresident prescription drug manufacturer permit is required for
1626
any person that is a manufacturer of prescription drugs, or the
1627
distribution point for a manufacturer of prescription drugs, and
1628
located outside of this state, or that is an entity to whom an
1629
approved new drug application has been issued by the United
1630
States Food and Drug Administration, or the contracted
1631
manufacturer of the approved new drug application holder, and
1632
located outside the United States, which engages in the wholesale
1633
distribution in this state of the prescription drugs it
1634
manufactures or is responsible for manufacturing. Each such
1635
manufacturer or entity must be permitted by the department and
1636
comply with all the provisions required of a wholesale
1637
distributor under this part, except s. 499.01213.
1638
1. A person that distributes prescription drugs that it did
1639
not manufacture must also obtain an out-of-state prescription
1640
drug wholesale distributor permit pursuant to this section to
1641
engage in the wholesale distribution of the prescription drugs
1642
manufactured by another person and comply with the requirements
1643
of an out-of-state prescription drug wholesale distributor.
1644
2. Any such person must comply with the licensing or
1645
permitting requirements of the jurisdiction in which the
1646
establishment is located and the federal act, and any product
1647
wholesaled into this state must comply with this part. If a
1648
person intends to import prescription drugs from a foreign
1649
country into this state, the nonresident prescription drug
1650
manufacturer must provide to the department a list identifying
1651
each prescription drug it intends to import and document approval
1652
by the United States Food and Drug Administration for such
1653
importation.
1654
(d) A prescription drug wholesale distributor permit.--A
1655
prescription drug wholesale distributor is a wholesale
1656
distributor that may engage in the wholesale distribution of
1657
prescription drugs. A prescription drug wholesale distributor
1658
that applies to the department for a new permit or the renewal of
1659
a permit must submit a bond of $100,000, or other equivalent
1660
means of security acceptable to the department, such as an
1661
irrevocable letter of credit or a deposit in a trust account or
1662
financial institution, payable to the Florida Drug, Device, and
1663
Cosmetic Trust Fund. The purpose of the bond is to secure payment
1664
of any administrative penalties imposed by the department and any
1665
fees and costs incurred by the department regarding that permit
1666
which are authorized under state law and which the permittee
1667
fails to pay within 30 days after the fine or costs become final.
1668
The department may make a claim against such bond or security
1669
until 1 year after the permittee's license ceases to be valid or
1670
until 60 days after any administrative or legal proceeding
1671
authorized in this part which involves the permittee is
1672
concluded, including any appeal, whichever occurs later. The
1673
department may adopt rules for issuing a prescription drug
1674
wholesale distributor-broker permit to a person who engages in
1675
the wholesale distribution of prescription drugs and does not
1676
take physical possession of any prescription drugs.
1677
(e) An out-of-state prescription drug wholesale distributor
1678
permit.--An out-of-state prescription drug wholesale distributor
1679
is a wholesale distributor located outside this state which
1680
engages in the wholesale distribution of prescription drugs into
1681
this state and which must be permitted by the department and
1682
comply with all the provisions required of a wholesale
1683
distributor under this part. An out-of-state prescription drug
1684
wholesale distributor that applies to the department for a new
1685
permit or the renewal of a permit must submit a bond of $100,000,
1686
or other equivalent means of security acceptable to the
1687
department, such as an irrevocable letter of credit or a deposit
1688
in a trust account or financial institution, payable to the
1689
Florida Drug, Device, and Cosmetic Trust Fund. The purpose of the
1690
bond is to secure payment of any administrative penalties imposed
1691
by the department and any fees and costs incurred by the
1692
department regarding that permit which are authorized under state
1693
law and which the permittee fails to pay within 30 days after the
1694
fine or costs become final. The department may make a claim
1695
against such bond or security until 1 year after the permittee's
1696
license ceases to be valid or until 60 days after any
1697
administrative or legal proceeding authorized in this part which
1698
involves the permittee is concluded, including any appeal,
1699
whichever occurs later.
1700
1. The out-of-state prescription drug wholesale distributor
1701
must maintain at all times a license or permit to engage in the
1702
wholesale distribution of prescription drugs in compliance with
1703
laws of the state in which it is a resident.
1704
2. An out-of-state prescription drug wholesale distributor
1705
permit is not required for an intracompany sale or transfer of a
1706
prescription drug from an out-of-state establishment that is duly
1707
licensed as a prescription drug wholesale distributor, in its
1708
state of residence, to a licensed prescription drug wholesale
1709
distributor in this state, if both wholesaler distributors
1710
conduct wholesale distributions of prescription drugs under the
1711
same business name. The recordkeeping requirements of ss.
1713
(f) A retail pharmacy wholesale distributor permit.--A
1714
retail pharmacy wholesale distributor is a retail pharmacy
1715
engaged in wholesale distribution of prescription drugs within
1716
this state under the following conditions:
1717
1. The pharmacy must obtain a retail pharmacy wholesaler
1718
distributor permit pursuant to this part and the rules adopted
1719
under this part.
1720
2. The wholesale distribution activity does not exceed 30
1721
percent of the total annual purchases of prescription drugs. If
1722
the wholesale distribution activity exceeds the 30-percent
1723
maximum, the pharmacy must obtain a prescription drug wholesaler
1724
distributor permit.
1725
3. The transfer of prescription drugs that appear in any
1726
schedule contained in chapter 893 is subject to chapter 893 and
1727
the federal Comprehensive Drug Abuse Prevention and Control Act
1728
of 1970.
1729
4. The transfer is between a retail pharmacy and another
1730
retail pharmacy, or a Modified Class II institutional pharmacy,
1731
or a health care practitioner licensed in this state and
1732
authorized by law to dispense or prescribe prescription drugs.
1733
5. All records of sales of prescription drugs subject to
1734
this section must be maintained separate and distinct from other
1735
records and comply with the recordkeeping requirements of this
1736
part.
1737
(g) Restricted prescription drug distributor permit.--A
1738
restricted prescription drug distributor permit is required for
1739
any person that engages in the distribution of a prescription
1740
drug, which distribution is not considered "wholesale
1741
distribution" under s. 499.003(60)(a).
1742
1. A person who engages in the receipt or distribution of a
1743
prescription drug in this state for the purpose of processing its
1744
return or its destruction must obtain a permit as a restricted
1745
prescription drug distributor if such person is not the person
1746
initiating the return, the prescription drug wholesale supplier
1747
of the person initiating the return, or the manufacturer of the
1748
drug.
1749
2. Storage, handling, and recordkeeping of these
1750
distributions must comply with the requirements for wholesale
1751
distributors under s. 499.0121, except those set forth in s.
1752
499.01213.
1753
3. A person who applies for a permit as a restricted
1754
prescription drug distributor, or for the renewal of such a
1755
permit, shall provide to the department the information required
1756
under s. 499.012.
1757
4. The department may adopt rules regarding the
1758
distribution of prescription drugs by hospitals, health care
1759
entities, charitable organizations, or other persons not involved
1760
in wholesale distribution, which rules are necessary for the
1761
protection of the public health, safety, and welfare.
1762
(h) Complimentary drug distributor permit.--A complimentary
1763
drug distributor permit is required for any person that engages
1764
in the distribution of a complimentary drug, subject to the
1765
requirements of s. 499.028.
1766
(i) Freight forwarder permit.--A freight forwarder permit
1767
is required for any person that engages in the distribution of a
1768
prescription drug as a freight forwarder unless the person is a
1769
common carrier. The storage, handling, and recordkeeping of such
1770
distributions must comply with the requirements for wholesale
1771
distributors under s. 499.0121, except those set forth in s.
1772
499.01213. A freight forwarder must provide the source of the
1773
prescription drugs with a validated airway bill, bill of lading,
1774
or other appropriate documentation to evidence the exportation of
1775
the product.
1776
(j) Veterinary prescription drug retail establishment
1777
permit.--A veterinary prescription drug retail establishment
1778
permit is required for any person that sells veterinary
1779
prescription drugs to the public, but does not include a pharmacy
1780
licensed under chapter 465.
1781
1. The sale to the public must be based on a valid written
1782
order from a veterinarian licensed in this state who has a valid
1783
client-veterinarian relationship with the purchaser's animal.
1784
2. Veterinary prescription drugs may not be sold in excess
1785
of the amount clearly indicated on the order or beyond the date
1786
indicated on the order.
1787
3. An order may not be valid for more than 1 year.
1788
4. A veterinary prescription drug retail establishment may
1789
not purchase, sell, trade, or possess human prescription drugs or
1790
any controlled substance as defined in chapter 893.
1791
5. A veterinary prescription drug retail establishment must
1792
sell a veterinary prescription drug in the original, sealed
1793
manufacturer's container with all labeling intact and legible.
1794
The department may adopt by rule additional labeling requirements
1795
for the sale of a veterinary prescription drug.
1796
6. A veterinary prescription drug retail establishment must
1797
comply with all of the wholesale distribution requirements of s.
1798
1799
7. A prescription drug sold by a veterinary prescription
1800
drug retail establishment pursuant to a practitioner's order may
1801
not be returned into the retail establishment's inventory.
1802
(k) A veterinary prescription drug wholesale distributor
1803
permit.--A veterinary prescription drug wholesale distributor
1804
permit is required for any person that engages in the
1805
distribution of veterinary prescription drugs in or into this
1806
state. A veterinary prescription drug wholesale distributor that
1807
also distributes prescription drugs subject to, defined by, or
1808
described by s. 503(b) of the Federal Food, Drug, and Cosmetic
1809
Act which it did not manufacture must obtain a permit as a
1810
prescription drug wholesale distributor, an out-of-state
1811
prescription drug wholesale distributor, or a limited
1812
prescription drug veterinary wholesale distributor in lieu of the
1813
veterinary prescription drug wholesale distributor permit. A
1814
veterinary prescription drug wholesale distributor must comply
1815
with the requirements for wholesale distributors under s.
1817
(l) Limited prescription drug veterinary wholesale
1818
distributor permit.--Unless engaging in the activities of and
1819
permitted as a prescription drug manufacturer, nonresident
1820
prescription drug manufacturer, prescription drug wholesale
1821
distributor, or out-of-state prescription drug wholesale
1822
distributor, a limited prescription drug veterinary wholesale
1823
distributor permit is required for any person that engages in the
1824
distribution in or into this state of veterinary prescription
1825
drugs and prescription drugs subject to, defined by, or described
1826
by s. 503(b) of the Federal Food, Drug, and Cosmetic Act under
1827
the following conditions:
1828
1. The person is engaged in the business of wholesaling
1829
prescription and veterinary legend drugs to persons:
1830
a. Licensed as veterinarians practicing on a full-time
1831
basis;
1832
b. Regularly and lawfully engaged in instruction in
1833
veterinary medicine;
1834
c. Regularly and lawfully engaged in law enforcement
1835
activities;
1836
d. For use in research not involving clinical use; or
1837
e. For use in chemical analysis or physical testing or for
1838
purposes of instruction in law enforcement activities, research,
1839
or testing.
1840
2. No more than 30 percent of total annual prescription
1841
drug sales may be prescription drugs approved for human use which
1842
are subject to, defined by, or described by s. 503(b) of the
1843
Federal Food, Drug, and Cosmetic Act.
1844
3. The person does not distribute in any state prescription
1845
drugs subject to, defined by, or described by s. 503(b) of the
1846
Federal Food, Drug, and Cosmetic Act to any person who is
1847
authorized to sell, distribute, purchase, trade, or use these
1848
drugs on or for humans.
1849
4. A limited prescription drug veterinary wholesale
1850
distributor that applies to the department for a new permit or
1851
the renewal of a permit must submit a bond of $20,000, or other
1852
equivalent means of security acceptable to the department, such
1853
as an irrevocable letter of credit or a deposit in a trust
1854
account or financial institution, payable to the Florida Drug,
1855
Device, and Cosmetic Trust Fund. The purpose of the bond is to
1856
secure payment of any administrative penalties imposed by the
1857
department and any fees and costs incurred by the department
1858
regarding that permit which are authorized under state law and
1859
which the permittee fails to pay within 30 days after the fine or
1860
costs become final. The department may make a claim against such
1861
bond or security until 1 year after the permittee's license
1862
ceases to be valid or until 60 days after any administrative or
1863
legal proceeding authorized in this part which involves the
1864
permittee is concluded, including any appeal, whichever occurs
1865
later.
1866
5. A limited prescription drug veterinary wholesale
1867
distributor must maintain at all times a license or permit to
1868
engage in the wholesale distribution of prescription drugs in
1869
compliance with laws of the state in which it is a resident.
1870
6. A limited prescription drug veterinary wholesale
1871
distributor must comply with the requirements for wholesale
1872
distributors under s. 499.0121, except that a limited
1873
prescription drug veterinary wholesale distributor is not
1874
required to provide a pedigree paper as required by s. 499.01213
1875
upon the wholesale distribution of a prescription drug to a
1876
veterinarian.
1877
7. A limited prescription drug veterinary wholesale
1878
distributor may not return to inventory for subsequent wholesale
1879
distribution any prescription drug subject to, defined by, or
1880
described by s. 503(b) of the Federal Food, Drug, and Cosmetic
1881
Act which has been returned by a veterinarian.
1882
8. A limited prescription drug veterinary wholesale
1883
distributor permit is not required for an intracompany sale or
1884
transfer of a prescription drug from an out-of-state
1885
establishment that is duly licensed to engage in the wholesale
1886
distribution of prescription drugs in its state of residence to a
1887
licensed limited prescription drug veterinary wholesale
1888
distributor in this state if both wholesale distributors conduct
1889
wholesale distributions of prescription drugs under the same
1890
business name. The recordkeeping requirements of ss. 499.0121(6)
1891
and 499.01213 must be followed for this transaction.
1892
(m) Medical oxygen retail establishment permit.--A medical
1893
oxygen retail establishment permit is required for any person
1894
that sells medical oxygen to patients only. The sale must be
1895
based on an order from a practitioner authorized by law to
1896
prescribe. The term does not include a pharmacy licensed under
1897
chapter 465.
1898
1. A medical oxygen retail establishment may not possess,
1899
purchase, sell, or trade any prescription drug other than medical
1900
oxygen.
1901
2. A medical oxygen retail establishment may refill medical
1902
oxygen for an individual patient based on an order from a
1903
practitioner authorized by law to prescribe. A medical oxygen
1904
retail establishment that refills medical oxygen must comply with
1905
all appropriate state and federal good manufacturing practices.
1906
3. A medical oxygen retail establishment must comply with
1907
all of the wholesale distribution requirements of s. 499.0121.
1908
4. Prescription medical oxygen sold by a medical oxygen
1909
retail establishment pursuant to a practitioner's order may not
1910
be returned into the retail establishment's inventory.
1911
(n) A compressed medical gas wholesaler distributor
1912
permit.--A compressed medical gas wholesale distributor is a
1913
wholesale distributor that is limited to the wholesale
1914
distribution of compressed medical gases to other than the
1915
consumer or patient. The compressed medical gas must be in the
1916
original sealed container that was purchased by that wholesale
1917
distributor. A compressed medical gas wholesale distributor may
1918
not possess or engage in the wholesale distribution of any
1919
prescription drug other than compressed medical gases. The
1920
department shall adopt rules that govern the wholesale
1921
distribution of prescription medical oxygen for emergency use.
1922
With respect to the emergency use of prescription medical oxygen,
1923
those rules may not be inconsistent with rules and regulations of
1924
federal agencies unless the Legislature specifically directs
1925
otherwise.
1926
(o) Compressed medical gas manufacturer permit.--A
1927
compressed medical gas manufacturer permit is required for any
1928
person that engages in the manufacture of compressed medical
1929
gases or repackages compressed medical gases from one container
1930
to another.
1931
1. A compressed medical gas manufacturer may not
1932
manufacture or possess any prescription drug other than
1933
compressed medical gases.
1934
2. A compressed medical gas manufacturer may engage in
1935
wholesale distribution of compressed medical gases manufactured
1936
at that establishment and must comply with all the provisions of
1937
this part and the rules adopted under this part which apply to a
1938
wholesale distributor.
1939
3. A compressed medical gas manufacturer must comply with
1940
all appropriate state and federal good manufacturing practices.
1941
(p) Over-the-counter drug manufacturer permit.-- An over-
1942
the-counter drug manufacturer permit is required for any person
1943
that engages in the manufacture or repackaging of an over-the-
1944
counter drug.
1945
1. An over-the-counter drug manufacturer may not possess or
1946
purchase prescription drugs.
1947
2. A pharmacy is exempt from obtaining an over-the-counter
1948
drug manufacturer's permit if it is operating in compliance with
1949
pharmacy practice standards as defined in chapter 465 and the
1950
rules adopted under that chapter.
1951
3. An over-the-counter drug manufacturer must comply with
1952
all appropriate state and federal good manufacturing practices.
1953
(q) Device manufacturer permit.--A device manufacturer
1954
permit is required for any person that engages in the
1955
manufacture, repackaging, or assembly of medical devices for
1956
human use in this state, except that a permit is not required if
1957
the person is engaged only in manufacturing, repackaging, or
1958
assembling a medical device pursuant to a practitioner's order
1959
for a specific patient.
1960
1. A manufacturer or repackager of medical devices in this
1961
state must comply with all appropriate state and federal good
1962
manufacturing practices and quality system rules.
1963
2. The department shall adopt rules related to storage,
1964
handling, and recordkeeping requirements for manufacturers of
1965
medical devices for human use.
1966
(r) Cosmetic manufacturer permit.--A cosmetic manufacturer
1967
permit is required for any person that manufactures or repackages
1968
cosmetics in this state. A person that only labels or changes the
1969
labeling of a cosmetic but does not open the container sealed by
1970
the manufacturer of the product is exempt from obtaining a permit
1971
under this paragraph.
1973
be issued only to a natural person who is at least 18 years of
1974
age or to an applicant that is not a natural person if each
1975
person who, directly or indirectly, manages, controls, or
1976
oversees the operation of that applicant is at least 18 years of
1977
age.
1978
(b) An establishment that is a place of residence may not
1980
(c) A person that applies for or renews a permit to
1981
manufacture or distribute legend drugs may not use a name
1982
identical to the name used by any other establishment or licensed
1983
person authorized to purchase prescription drugs in this state,
1984
except that a restricted drug distributor permit issued to a
1985
health care entity will be issued in the name in which the
1986
institutional pharmacy permit is issued and a retail pharmacy
1987
drug wholesaler will be issued a permit in the name of its retail
1988
pharmacy permit.
1989
(d) A permit for a prescription drug manufacturer,
1990
prescription drug repackager, prescription drug wholesaler,
1991
limited prescription drug veterinary wholesaler, or retail
1992
pharmacy wholesaler may not be issued to the address of a health
1993
care entity or to a pharmacy licensed under chapter 465, except
1994
as provided in this paragraph. The department may issue a
1995
prescription drug manufacturer permit to an applicant at the same
1996
address as a licensed nuclear pharmacy, which is a health care
1997
entity, for the purpose of manufacturing prescription drugs used
1998
in positron emission tomography or other radiopharmaceuticals, as
1999
listed in a rule adopted by the department pursuant to this
2000
paragraph. The purpose of this exemption is to assure
2001
availability of state-of-the-art pharmaceuticals that would pose
2002
a significant danger to the public health if manufactured at a
2003
separate establishment address from the nuclear pharmacy from
2004
which the prescription drugs are dispensed. The department may
2005
also issue a retail pharmacy wholesaler permit to the address of
2006
a community pharmacy licensed under chapter 465 which does not
2007
meet the definition of a closed pharmacy in s. 499.003.
2008
(e) A county or municipality may not issue an occupational
2009
license for any licensing period beginning on or after October 1,
2010
2003, for any establishment that requires a permit pursuant to
2012
permit issued by the department for the establishment. Upon
2013
presentation of the requisite permit issued by the department, an
2014
occupational license may be issued by the municipality or county
2015
in which application is made. The department shall furnish to
2016
local agencies responsible for issuing occupational licenses a
2017
current list of all establishments licensed pursuant to ss.
2019
(3) Notwithstanding subsection (7), a permitted person in
2020
good standing may change the type of permit issued to that person
2021
by completing a new application for the requested permit, paying
2022
the amount of the difference in the permit fees if the fee for
2023
the new permit is more than the fee for the original permit, and
2024
meeting the applicable permitting conditions for the new permit
2025
type. The new permit expires on the expiration date of the
2026
original permit being changed; however, a new permit for a
2027
prescription drug wholesaler, an out-of-state prescription drug
2028
wholesaler, or a retail pharmacy drug wholesaler shall expire on
2029
the expiration date of the original permit or 1 year after the
2030
date of issuance of the new permit, whichever is earlier. A
2031
refund may not be issued if the fee for the new permit is less
2032
than the fee that was paid for the original permit.
2033
(4) A written application for a permit or to renew a permit
2034
must be filed with the department on forms furnished by the
2035
department. The department shall establish, by rule, the form and
2036
content of the application to obtain or renew a permit. The
2037
applicant must submit to the department with the application a
2038
statement that swears or affirms that the information is true and
2039
correct.
2040
(5)(a) Except for a permit for a prescription drug
2041
wholesaler or an out-of-state prescription drug wholesaler, an
2042
application for a permit must include:
2043
1. The name, full business address, and telephone number of
2044
the applicant;
2045
2. All trade or business names used by the applicant;
2046
3. The address, telephone numbers, and the names of contact
2047
persons for each facility used by the applicant for the storage,
2048
handling, and distribution of prescription drugs;
2049
4. The type of ownership or operation, such as a
2050
partnership, corporation, or sole proprietorship; and
2051
5. The names of the owner and the operator of the
2052
establishment, including:
2053
a. If an individual, the name of the individual;
2054
b. If a partnership, the name of each partner and the name
2055
of the partnership;
2056
c. If a corporation, the name and title of each corporate
2057
officer and director, the corporate names, and the name of the
2058
state of incorporation;
2059
d. If a sole proprietorship, the full name of the sole
2060
proprietor and the name of the business entity;
2061
e. If a limited liability company, the name of each member,
2062
the name of each manager, the name of the limited liability
2063
company, and the name of the state in which the limited liability
2064
company was organized; and
2065
f. Any other relevant information that the department
2066
requires.
2067
(b) Upon approval of the application by the department and
2068
payment of the required fee, the department shall issue a permit
2069
to the applicant, if the applicant meets the requirements of ss.
2071
(c) Any change in information required under paragraph (a)
2072
must be submitted to the department before the change occurs.
2073
(d) The department shall consider, at a minimum, the
2074
following factors in reviewing the qualifications of persons to
2076
1. The applicant's having been found guilty, regardless of
2077
adjudication, in a court of this state or other jurisdiction, of
2078
a violation of a law that directly relates to a drug, device, or
2079
cosmetic. A plea of nolo contendere constitutes a finding of
2080
guilt for purposes of this subparagraph.
2081
2. The applicant's having been disciplined by a regulatory
2082
agency in any state for any offense that would constitute a
2084
3. Any felony conviction of the applicant under a federal,
2085
state, or local law;
2086
4. The applicant's past experience in manufacturing or
2087
distributing drugs, devices, or cosmetics;
2088
5. The furnishing by the applicant of false or fraudulent
2089
material in any application made in connection with manufacturing
2090
or distributing drugs, devices, or cosmetics;
2091
6. Suspension or revocation by a federal, state, or local
2092
government of any permit currently or previously held by the
2093
applicant for the manufacture or distribution of any drugs,
2094
devices, or cosmetics;
2095
7. Compliance with permitting requirements under any
2096
previously granted permits;
2097
8. Compliance with requirements to maintain or make
2098
available to the state permitting authority or to federal, state,
2099
or local law enforcement officials those records required under
2100
this section; and
2101
9. Any other factors or qualifications the department
2102
considers relevant to and consistent with the public health and
2103
safety.
2104
(6) Except for permits for prescription drug wholesalers or
2105
out-of-state prescription drug wholesalers:
2106
(a) The department shall adopt rules for the biennial
2107
renewal of permits.
2108
(b) The department shall renew a permit upon receipt of the
2109
renewal application and renewal fee if the applicant meets the
2111
adopted under those sections.
2112
(c) A permit, unless sooner suspended or revoked,
2113
automatically expires 2 years after the last day of the
2114
anniversary month in which the permit was originally issued. A
2116
application for renewal on forms furnished by the department and
2117
paying the appropriate fees. If a renewal application and fee are
2118
submitted and postmarked after the expiration date of the permit,
2119
the permit may be renewed only upon payment of a late renewal
2120
delinquent fee of $100, plus the required renewal fee, not later
2121
than 60 days after the expiration date.
2122
(d) Failure to renew a permit in accordance with this
2123
section precludes any future renewal of that permit. If a permit
2124
issued pursuant to this section has expired and cannot be
2125
renewed, before an establishment may engage in activities that
2127
must submit an application for a new permit, pay the applicable
2128
application fee, the initial permit fee, and all applicable
2129
penalties, and be issued a new permit by the department.
2130
(7) A permit issued by the department is nontransferable.
2131
Each permit is valid only for the person or governmental unit to
2132
which it is issued and is not subject to sale, assignment, or
2133
other transfer, voluntarily or involuntarily; nor is a permit
2134
valid for any establishment other than the establishment for
2135
which it was originally issued.
2137
notify the department before making a change of address. The
2138
department shall set a change of location fee not to exceed $100.
2139
(b)1. An application for a new permit is required when a
2140
majority of the ownership or controlling interest of a permitted
2141
establishment is transferred or assigned or when a lessee agrees
2142
to undertake or provide services to the extent that legal
2143
liability for operation of the establishment will rest with the
2144
lessee. The application for the new permit must be made before
2145
the date of the sale, transfer, assignment, or lease.
2146
2. A permittee that is authorized to distribute legend
2147
drugs may transfer such drugs to the new owner or lessee under
2148
subparagraph 1. only after the new owner or lessee has been
2149
approved for a permit to distribute legend drugs.
2151
closes, the owner must notify the department in writing before
2152
the effective date of closure and must:
2153
1. Return the permit to the department;
2154
2. If the permittee is authorized to distribute legend
2155
drugs, indicate the disposition of such drugs, including the
2156
name, address, and inventory, and provide the name and address of
2157
a person to contact regarding access to records that are required
2159
of legend drugs may be made only to persons authorized to possess
2161
2162
The department may revoke the permit of any person that fails to
2163
comply with the requirements of this subsection.
2164
(8) A permit must be posted in a conspicuous place on the
2165
licensed premises.
2166
Section 19. Section 499.012, Florida Statutes, is amended
2167
to read:
2168
499.012 Permit application Wholesale distribution;
2169
definitions; permits; applications; general requirements.--
2170
(1)(a) A permit issued pursuant to this part may be issued
2171
only to a natural person who is at least 18 years of age or to an
2172
applicant that is not a natural person if each person who,
2173
directly or indirectly, manages, controls, or oversees the
2174
operation of that applicant is at least 18 years of age.
2175
(b) An establishment that is a place of residence may not
2176
receive a permit and may not operate under this part.
2177
(c) A person that applies for or renews a permit to
2178
manufacture or distribute prescription drugs may not use a name
2179
identical to the name used by any other establishment or licensed
2180
person authorized to purchase prescription drugs in this state,
2181
except that a restricted drug distributor permit issued to a
2182
health care entity will be issued in the name in which the
2183
institutional pharmacy permit is issued and a retail pharmacy
2184
drug wholesale distributor will be issued a permit in the name of
2185
its retail pharmacy permit.
2186
(d) A permit for a prescription drug manufacturer,
2187
prescription drug repackager, prescription drug wholesale
2188
distributor, limited prescription drug veterinary wholesale
2189
distributor, or retail pharmacy wholesale distributor may not be
2190
issued to the address of a health care entity or to a pharmacy
2191
licensed under chapter 465, except as provided in this paragraph.
2192
The department may issue a prescription drug manufacturer permit
2193
to an applicant at the same address as a licensed nuclear
2194
pharmacy, which is a health care entity, for the purpose of
2195
manufacturing prescription drugs used in positron emission
2196
tomography or other radiopharmaceuticals, as listed in a rule
2197
adopted by the department pursuant to this paragraph. The purpose
2198
of this exemption is to assure availability of state-of-the-art
2199
pharmaceuticals that would pose a significant danger to the
2200
public health if manufactured at a separate establishment address
2201
from the nuclear pharmacy from which the prescription drugs are
2202
dispensed. The department may also issue a retail pharmacy
2203
wholesale distributor permit to the address of a community
2204
pharmacy licensed under chapter 465 which does not meet the
2205
definition of a closed pharmacy in s. 499.003.
2206
(e) A county or municipality may not issue an occupational
2207
license for any licensing period beginning on or after October 1,
2208
2003, for any establishment that requires a permit pursuant to
2209
this part unless the establishment exhibits a current permit
2210
issued by the department for the establishment. Upon presentation
2211
of the requisite permit issued by the department, an occupational
2212
license may be issued by the municipality or county in which
2213
application is made. The department shall furnish to local
2214
agencies responsible for issuing occupational licenses a current
2215
list of all establishments licensed pursuant to this part.
2216
(2) Notwithstanding subsection (6), a permitted person in
2217
good standing may change the type of permit issued to that person
2218
by completing a new application for the requested permit, paying
2219
the amount of the difference in the permit fees if the fee for
2220
the new permit is more than the fee for the original permit, and
2221
meeting the applicable permitting conditions for the new permit
2222
type. The new permit expires on the expiration date of the
2223
original permit being changed; however, a new permit for a
2224
prescription drug wholesale distributor, an out-of-state
2225
prescription drug wholesale distributor, or a retail pharmacy
2226
drug wholesale distributor shall expire on the expiration date of
2227
the original permit or 1 year after the date of issuance of the
2228
new permit, whichever is earlier. A refund may not be issued if
2229
the fee for the new permit is less than the fee that was paid for
2230
the original permit.
2231
(3) A written application for a permit or to renew a permit
2232
must be filed with the department on forms furnished by the
2233
department. The department shall establish, by rule, the form and
2234
content of the application to obtain or renew a permit. The
2235
applicant must submit to the department with the application a
2236
statement that swears or affirms that the information is true and
2237
correct.
2238
(4)(a) Except for a permit for a prescription drug
2239
wholesale distributor or an out-of-state prescription drug
2240
wholesale distributor, an application for a permit must include:
2241
1. The name, full business address, and telephone number of
2242
the applicant;
2243
2. All trade or business names used by the applicant;
2244
3. The address, telephone numbers, and the names of contact
2245
persons for each facility used by the applicant for the storage,
2246
handling, and distribution of prescription drugs;
2247
4. The type of ownership or operation, such as a
2248
partnership, corporation, or sole proprietorship; and
2249
5. The names of the owner and the operator of the
2250
establishment, including:
2251
a. If an individual, the name of the individual;
2252
b. If a partnership, the name of each partner and the name
2253
of the partnership;
2254
c. If a corporation, the name and title of each corporate
2255
officer and director, the corporate names, and the name of the
2256
state of incorporation;
2257
d. If a sole proprietorship, the full name of the sole
2258
proprietor and the name of the business entity;
2259
e. If a limited liability company, the name of each member,
2260
the name of each manager, the name of the limited liability
2261
company, and the name of the state in which the limited liability
2262
company was organized; and
2263
f. Any other relevant information that the department
2264
requires.
2265
(b) Upon approval of the application by the department and
2266
payment of the required fee, the department shall issue a permit
2267
to the applicant, if the applicant meets the requirements of this
2268
part and rules adopted under this part.
2269
(c) Any change in information required under paragraph (a)
2270
must be submitted to the department before the change occurs.
2271
(d) The department shall consider, at a minimum, the
2272
following factors in reviewing the qualifications of persons to
2273
be permitted under this part:
2274
1. The applicant's having been found guilty, regardless of
2275
adjudication, in a court of this state or other jurisdiction, of
2276
a violation of a law that directly relates to a drug, device, or
2277
cosmetic. A plea of nolo contendere constitutes a finding of
2278
guilt for purposes of this subparagraph.
2279
2. The applicant's having been disciplined by a regulatory
2280
agency in any state for any offense that would constitute a
2281
violation of this part.
2282
3. Any felony conviction of the applicant under a federal,
2283
state, or local law;
2284
4. The applicant's past experience in manufacturing or
2285
distributing drugs, devices, or cosmetics;
2286
5. The furnishing by the applicant of false or fraudulent
2287
material in any application made in connection with manufacturing
2288
or distributing drugs, devices, or cosmetics;
2289
6. Suspension or revocation by a federal, state, or local
2290
government of any permit currently or previously held by the
2291
applicant for the manufacture or distribution of any drugs,
2292
devices, or cosmetics;
2293
7. Compliance with permitting requirements under any
2294
previously granted permits;
2295
8. Compliance with requirements to maintain or make
2296
available to the state permitting authority or to federal, state,
2297
or local law enforcement officials those records required under
2298
this section; and
2299
9. Any other factors or qualifications the department
2300
considers relevant to and consistent with the public health and
2301
safety.
2302
(5) Except for a permit for a prescription drug wholesaler
2303
distributor or an out-of-state prescription drug wholesaler
2304
distributor:
2305
(a) The department shall adopt rules for the biennial
2306
renewal of permits.
2307
(b) The department shall renew a permit upon receipt of the
2308
renewal application and renewal fee if the applicant meets the
2309
requirements established under this part and the rules adopted
2310
under this part.
2311
(c) A permit, unless sooner suspended or revoked,
2312
automatically expires 2 years after the last day of the
2313
anniversary month in which the permit was originally issued. A
2314
permit issued under this part may be renewed by making
2315
application for renewal on forms furnished by the department and
2316
paying the appropriate fees. If a renewal application and fee are
2317
submitted and postmarked after the expiration date of the permit,
2318
the permit may be renewed only upon payment of a late renewal
2319
delinquent fee of $100, plus the required renewal fee, not later
2320
than 60 days after the expiration date.
2321
(d) Failure to renew a permit in accordance with this
2322
section precludes any future renewal of that permit. If a permit
2323
issued pursuant to this section has expired and cannot be
2324
renewed, before an establishment may engage in activities that
2325
require a permit under this part the establishment must submit an
2326
application for a new permit, pay the applicable application fee,
2327
the initial permit fee, and all applicable penalties, and be
2328
issued a new permit by the department.
2329
(6) A permit issued by the department is nontransferable.
2330
Each permit is valid only for the person or governmental unit to
2331
which it is issued and is not subject to sale, assignment, or
2332
other transfer, voluntarily or involuntarily; nor is a permit
2333
valid for any establishment other than the establishment for
2334
which it was originally issued.
2335
(a) A person permitted under this part must notify the
2336
department before making a change of address. The department
2337
shall set a change of location fee not to exceed $100.
2338
(b)1. An application for a new permit is required when a
2339
majority of the ownership or controlling interest of a permitted
2340
establishment is transferred or assigned or when a lessee agrees
2341
to undertake or provide services to the extent that legal
2342
liability for operation of the establishment will rest with the
2343
lessee. The application for the new permit must be made before
2344
the date of the sale, transfer, assignment, or lease.
2345
2. A permittee that is authorized to distribute
2346
prescription drugs may transfer such drugs to the new owner or
2347
lessee under subparagraph 1. only after the new owner or lessee
2348
has been approved for a permit to distribute prescription drugs.
2349
(c) If an establishment permitted under this part closes,
2350
the owner must notify the department in writing before the
2351
effective date of closure and must:
2352
1. Return the permit to the department;
2353
2. If the permittee is authorized to distribute
2354
prescription drugs, indicate the disposition of such drugs,
2355
including the name, address, and inventory, and provide the name
2356
and address of a person to contact regarding access to records
2357
that are required to be maintained under this part. Transfer of
2358
ownership of prescription drugs may be made only to persons
2359
authorized to possess prescription drugs under this part.
2360
2361
The department may revoke the permit of any person that fails to
2362
comply with the requirements of this subsection.
2363
(7) A permit must be posted in a conspicuous place on the
2364
licensed premises.
2365
(1) As used in this section, the term:
2366
(a) "Wholesale distribution" means distribution of
2367
prescription drugs to persons other than a consumer or patient,
2368
but does not include:
2369
1. Any of the following activities, which is not a
2370
violation of s. 499.005(21) if such activity is conducted in
2371
accordance with s. 499.014:
2372
a. The purchase or other acquisition by a hospital or other
2373
health care entity that is a member of a group purchasing
2374
organization of a prescription drug for its own use from the
2375
group purchasing organization or from other hospitals or health
2376
care entities that are members of that organization.
2377
b. The sale, purchase, or trade of a prescription drug or
2378
an offer to sell, purchase, or trade a prescription drug by a
2379
charitable organization described in s. 501(c)(3) of the Internal
2380
Revenue Code of 1986, as amended and revised, to a nonprofit
2381
affiliate of the organization to the extent otherwise permitted
2382
by law.
2383
c. The sale, purchase, or trade of a prescription drug or
2384
an offer to sell, purchase, or trade a prescription drug among
2385
hospitals or other health care entities that are under common
2386
control. For purposes of this section, "common control" means the
2387
power to direct or cause the direction of the management and
2388
policies of a person or an organization, whether by ownership of
2389
stock, by voting rights, by contract, or otherwise.
2390
d. The sale, purchase, trade, or other transfer of a
2391
prescription drug from or for any federal, state, or local
2392
government agency or any entity eligible to purchase prescription
2393
drugs at public health services prices pursuant to Pub. L. No.
2394
102-585, s. 602 to a contract provider or its subcontractor for
2395
eligible patients of the agency or entity under the following
2396
conditions:
2397
(I) The agency or entity must obtain written authorization
2398
for the sale, purchase, trade, or other transfer of a
2399
prescription drug under this sub-subparagraph from the State
2400
Surgeon General or his or her designee.
2401
(II) The contract provider or subcontractor must be
2402
authorized by law to administer or dispense prescription drugs.
2403
(III) In the case of a subcontractor, the agency or entity
2404
must be a party to and execute the subcontract.
2405
(IV) A contract provider or subcontractor must maintain
2406
separate and apart from other prescription drug inventory any
2407
prescription drugs of the agency or entity in its possession.
2408
(V) The contract provider and subcontractor must maintain
2409
and produce immediately for inspection all records of movement or
2410
transfer of all the prescription drugs belonging to the agency or
2411
entity, including, but not limited to, the records of receipt and
2412
disposition of prescription drugs. Each contractor and
2413
subcontractor dispensing or administering these drugs must
2414
maintain and produce records documenting the dispensing or
2415
administration. Records that are required to be maintained
2416
include, but are not limited to, a perpetual inventory itemizing
2417
drugs received and drugs dispensed by prescription number or
2418
administered by patient identifier, which must be submitted to
2419
the agency or entity quarterly.
2420
(VI) The contract provider or subcontractor may administer
2421
or dispense the prescription drugs only to the eligible patients
2422
of the agency or entity or must return the prescription drugs for
2423
or to the agency or entity. The contract provider or
2424
subcontractor must require proof from each person seeking to fill
2425
a prescription or obtain treatment that the person is an eligible
2426
patient of the agency or entity and must, at a minimum, maintain
2427
a copy of this proof as part of the records of the contractor or
2428
subcontractor required under sub-sub-subparagraph (V).
2429
(VII) In addition to the departmental inspection authority
2430
set forth in s. 499.051, the establishment of the contract
2431
provider and subcontractor and all records pertaining to
2432
prescription drugs subject to this sub-subparagraph shall be
2433
subject to inspection by the agency or entity. All records
2434
relating to prescription drugs of a manufacturer under this sub-
2435
subparagraph shall be subject to audit by the manufacturer of
2436
those drugs, without identifying individual patient information.
2437
2. Any of the following activities, which is not a
2438
violation of s. 499.005(21) if such activity is conducted in
2439
accordance with rules established by the department:
2440
a. The sale, purchase, or trade of a prescription drug
2441
among federal, state, or local government health care entities
2442
that are under common control and are authorized to purchase such
2443
prescription drug.
2444
b. The sale, purchase, or trade of a prescription drug or
2445
an offer to sell, purchase, or trade a prescription drug for
2446
emergency medical reasons. For purposes of this sub-subparagraph,
2447
the term "emergency medical reasons" includes transfers of
2448
prescription drugs by a retail pharmacy to another retail
2449
pharmacy to alleviate a temporary shortage.
2450
c. The transfer of a prescription drug acquired by a
2451
medical director on behalf of a licensed emergency medical
2452
services provider to that emergency medical services provider and
2453
its transport vehicles for use in accordance with the provider's
2454
license under chapter 401.
2455
d. The revocation of a sale or the return of a prescription
2456
drug to the person's prescription drug wholesale supplier.
2457
e. The donation of a prescription drug by a health care
2458
entity to a charitable organization that has been granted an
2459
exemption under s. 501(c)(3) of the Internal Revenue Code of
2460
1986, as amended, and that is authorized to possess prescription
2461
drugs.
2462
f. The transfer of a prescription drug by a person
2463
authorized to purchase or receive prescription drugs to a person
2464
licensed or permitted to handle reverse distributions or
2465
destruction under the laws of the jurisdiction in which the
2466
person handling the reverse distribution or destruction receives
2467
the drug.
2468
g. The transfer of a prescription drug by a hospital or
2469
other health care entity to a person licensed under this chapter
2470
to repackage prescription drugs for the purpose of repackaging
2471
the prescription drug for use by that hospital, or other health
2472
care entity and other health care entities that are under common
2473
control, if ownership of the prescription drugs remains with the
2474
hospital or other health care entity at all times. In addition to
2475
the recordkeeping requirements of s. 499.0121(6), the hospital or
2476
health care entity that transfers prescription drugs pursuant to
2477
this sub-subparagraph must reconcile all drugs transferred and
2478
returned and resolve any discrepancies in a timely manner.
2479
3. The distribution of prescription drug samples by
2480
manufacturers' representatives or distributors' representatives
2481
conducted in accordance with s. 499.028.
2482
4. The sale, purchase, or trade of blood and blood
2483
components intended for transfusion. As used in this
2484
subparagraph, the term "blood" means whole blood collected from a
2485
single donor and processed either for transfusion or further
2486
manufacturing, and the term "blood components" means that part of
2487
the blood separated by physical or mechanical means.
2488
5. The lawful dispensing of a prescription drug in
2489
accordance with chapter 465.
2490
6. The sale, purchase, or trade of a prescription drug
2491
between pharmacies as a result of a sale, transfer, merger, or
2492
consolidation of all or part of the business of the pharmacies
2493
from or with another pharmacy, whether accomplished as a purchase
2494
and sale of stock or of business assets.
2495
(b) "Wholesale distributor" means any person engaged in
2496
wholesale distribution of prescription drugs in or into this
2497
state, including, but not limited to, manufacturers; repackagers;
2498
own-label distributors; jobbers; private-label distributors;
2499
brokers; warehouses, including manufacturers' and distributors'
2500
warehouses, chain drug warehouses, and wholesale drug warehouses;
2501
independent wholesale drug traders; exporters; retail pharmacies;
2502
and the agents thereof that conduct wholesale distributions.
2503
(c) "Retail pharmacy" means a community pharmacy licensed
2504
under chapter 465 that purchases prescription drugs at fair
2505
market prices and provides prescription services to the public.
2506
(d) "Primary wholesaler" means any wholesale distributor
2507
that:
2508
1. Purchased 90 percent or more of the total dollar volume
2509
of its purchases of prescription drugs directly from
2510
manufacturers in the previous year; and
2511
2.a. Directly purchased prescription drugs from not fewer
2512
than 50 different prescription drug manufacturers in the previous
2513
year; or
2514
b. Has, or the affiliated group, as defined in s. 1504 of
2515
the Internal Revenue Code, of which the wholesale distributor is
2516
a member has, not fewer than 250 employees.
2517
(e) "Directly from a manufacturer" means:
2518
1. Purchases made by the wholesale distributor directly
2519
from the manufacturer of prescription drugs; and
2520
2. Transfers from a member of an affiliated group, as
2521
defined in s. 1504 of the Internal Revenue Code, of which the
2522
wholesale distributor is a member, if:
2523
a. The affiliated group purchases 90 percent or more of the
2524
total dollar volume of its purchases of prescription drugs from
2525
the manufacturer in the previous year; and
2526
b. The wholesale distributor discloses to the department
2527
the names of all members of the affiliated group of which the
2528
wholesale distributor is a member and the affiliated group agrees
2529
in writing to provide records on prescription drug purchases by
2530
the members of the affiliated group not later than 48 hours after
2531
the department requests access to such records, regardless of the
2532
location where the records are stored.
2533
(f) "Secondary wholesaler" means a wholesale distributor
2534
that is not a primary wholesaler.
2535
(2) The following types of wholesaler permits are
2536
established:
2537
(a) A prescription drug wholesaler's permit.--A
2538
prescription drug wholesaler is a wholesale distributor that may
2539
engage in the wholesale distribution of prescription drugs. A
2540
prescription drug wholesaler that applies to the department for a
2541
new permit or the renewal of a permit must submit a bond of
2542
$100,000, or other equivalent means of security acceptable to the
2543
department, such as an irrevocable letter of credit or a deposit
2544
in a trust account or financial institution, payable to the
2545
Florida Drug, Device, and Cosmetic Trust Fund. The purpose of the
2546
bond is to secure payment of any administrative penalties imposed
2547
by the department and any fees and costs incurred by the
2548
department regarding that permit which are authorized under state
2549
law and which the permittee fails to pay 30 days after the fine
2550
or costs become final. The department may make a claim against
2551
such bond or security until 1 year after the permittee's license
2552
ceases to be valid or until 60 days after any administrative or
2554
the permittee is concluded, including any appeal, whichever
2555
occurs later. The department may adopt rules for issuing a
2556
prescription drug wholesaler-broker permit to a person who
2557
engages in the wholesale distribution of prescription drugs and
2558
does not take physical possession of any prescription drugs.
2559
(b) A compressed medical gas wholesaler's permit.--A
2560
compressed medical gas wholesaler is a wholesale distributor that
2561
is limited to the wholesale distribution of compressed medical
2562
gases to other than the consumer or patient. The compressed
2563
medical gas must be in the original sealed container that was
2564
purchased by that wholesaler. A compressed medical gas wholesaler
2565
may not possess or engage in the wholesale distribution of any
2566
prescription drug other than compressed medical gases. The
2567
department shall adopt rules that govern the wholesale
2568
distribution of prescription medical oxygen for emergency use.
2569
With respect to the emergency use of prescription medical oxygen,
2570
those rules may not be inconsistent with rules and regulations of
2571
federal agencies unless the Legislature specifically directs
2572
otherwise.
2573
(c) An out-of-state prescription drug wholesaler's
2574
permit.--An out-of-state prescription drug wholesaler is a
2575
wholesale distributor located outside this state which engages in
2576
the wholesale distribution of prescription drugs into this state
2577
and which must be permitted by the department and comply with all
2578
the provisions required of a wholesale distributor under ss.
2580
that applies to the department for a new permit or the renewal of
2581
a permit must submit a bond of $100,000, or other equivalent
2582
means of security acceptable to the department, such as an
2583
irrevocable letter of credit or a deposit in a trust account or
2584
financial institution, payable to the Florida Drug, Device, and
2585
Cosmetic Trust Fund. The purpose of the bond is to secure payment
2586
of any administrative penalties imposed by the department and any
2587
fees and costs incurred by the department regarding that permit
2588
which are authorized under state law and which the permittee
2589
fails to pay 30 days after the fine or costs become final. The
2590
department may make a claim against such bond or security until 1
2591
year after the permittee's license ceases to be valid or until 60
2592
days after any administrative or legal proceeding authorized in
2594
including any appeal, whichever occurs later.
2595
1. The out-of-state drug wholesaler must maintain at all
2596
times a license or permit to engage in the wholesale distribution
2597
of prescription drugs in compliance with laws of the state in
2598
which it is a resident.
2599
2. An out-of-state prescription drug wholesaler's permit is
2600
not required for an intracompany sale or transfer of a
2601
prescription drug from an out-of-state establishment that is duly
2602
licensed as a prescription drug wholesaler, in its state of
2603
residence, to a licensed prescription drug wholesaler in this
2604
state, if both wholesalers conduct wholesale distributions of
2605
prescription drugs under the same business name. The
2606
recordkeeping requirements of s. 499.0121(6) must be followed for
2607
this transaction.
2608
(d) A retail pharmacy wholesaler's permit.--A retail
2609
pharmacy wholesaler is a retail pharmacy engaged in wholesale
2610
distribution of prescription drugs within this state under the
2611
following conditions:
2612
1. The pharmacy must obtain a retail pharmacy wholesaler's
2614
under those sections.
2615
2. The wholesale distribution activity does not exceed 30
2616
percent of the total annual purchases of prescription drugs. If
2617
the wholesale distribution activity exceeds the 30-percent
2618
maximum, the pharmacy must obtain a prescription drug
2619
wholesaler's permit.
2620
3. The transfer of prescription drugs that appear in any
2621
schedule contained in chapter 893 is subject to chapter 893 and
2622
the federal Comprehensive Drug Abuse Prevention and Control Act
2623
of 1970.
2624
4. The transfer is between a retail pharmacy and another
2625
retail pharmacy, or a Modified Class II institutional pharmacy,
2626
or a health care practitioner licensed in this state and
2627
authorized by law to dispense or prescribe prescription drugs.
2628
5. All records of sales of prescription drugs subject to
2629
this section must be maintained separate and distinct from other
2630
records and comply with the recordkeeping requirements of ss.
2632
(e) Nonresident prescription drug manufacturer permit.--A
2633
nonresident prescription drug manufacturer permit is required for
2634
any person that is a manufacturer of prescription drugs, or the
2635
distribution point for a manufacturer of prescription drugs, and
2636
located outside of this state, or that is an entity to whom an
2637
approved new drug application has been issued by the United
2638
States Food and Drug Administration, or the contracted
2639
manufacturer of the approved new drug application holder, and
2640
located outside the United States, which engages in the wholesale
2641
distribution in this state of the prescription drugs it
2642
manufactures or is responsible for manufacturing. Each such
2643
manufacturer or entity must be permitted by the department and
2644
comply with all the provisions required of a wholesale
2646
1. A person that distributes prescription drugs that it did
2647
not manufacture must also obtain an out-of-state prescription
2648
drug wholesaler permit pursuant to this section to engage in the
2649
wholesale distribution of the prescription drugs manufactured by
2650
another person and comply with the requirements of an out-of-
2651
state prescription drug wholesaler.
2652
2. Any such person must comply with the licensing or
2653
permitting requirements of the jurisdiction in which the
2654
establishment is located and the federal act, and any product
2656
If a person intends to import prescription drugs from a foreign
2657
country into this state, the nonresident prescription drug
2658
manufacturer must provide to the department a list identifying
2659
each prescription drug it intends to import and document approval
2660
by the United States Food and Drug Administration for such
2661
importation.
2662
(f) Freight forwarder permit.--A freight forwarder permit
2663
is required for any person that engages in the distribution of a
2664
legend drug as a freight forwarder unless the person is a common
2665
carrier. The storage, handling, and recordkeeping of such
2666
distributions must comply with the requirements for wholesale
2667
distributors under s. 499.0121, except those set forth in s.
2668
499.0121(6)(d). A freight forwarder must provide the source of
2669
the legend drugs with a validated airway bill, bill of lading, or
2670
other appropriate documentation to evidence the exportation of
2671
the product.
2672
(g) A veterinary prescription drug wholesaler permit.--A
2673
veterinary prescription drug wholesaler permit is required for
2674
any person that engages in the distribution of veterinary
2675
prescription drugs in or into this state. A veterinary
2676
prescription drug wholesaler that also distributes prescription
2677
drugs subject to, defined by, or described by s. 503(b) of the
2678
Federal Food, Drug, and Cosmetic Act which it did not manufacture
2679
must obtain a permit as a prescription drug wholesaler, an out-
2680
of-state prescription drug wholesaler, or a limited prescription
2681
drug veterinary wholesaler in lieu of the veterinary prescription
2682
drug wholesaler permit. A veterinary prescription drug wholesaler
2683
must comply with the requirements for wholesale distributors
2685
(h) Limited prescription drug veterinary wholesaler
2686
permit.--Unless engaging in the activities of and permitted as a
2687
prescription drug manufacturer, nonresident prescription drug
2688
manufacturer, prescription drug wholesaler, or out-of-state
2689
prescription drug wholesaler, a limited prescription drug
2690
veterinary wholesaler permit is required for any person that
2691
engages in the distribution in or into this state of veterinary
2692
prescription drugs and prescription drugs subject to, defined by,
2693
or described by s. 503(b) of the Federal Food, Drug, and Cosmetic
2694
Act under the following conditions:
2695
1. The person is engaged in the business of wholesaling
2696
prescription and veterinary legend drugs to persons:
2697
a. Licensed as veterinarians practicing on a full-time
2698
basis;
2699
b. Regularly and lawfully engaged in instruction in
2700
veterinary medicine;
2701
c. Regularly and lawfully engaged in law enforcement
2702
activities;
2703
d. For use in research not involving clinical use; or
2704
e. For use in chemical analysis or physical testing or for
2705
purposes of instruction in law enforcement activities, research,
2706
or testing.
2707
2. No more than 30 percent of total annual prescription
2708
drug sales may be prescription drugs approved for human use which
2709
are subject to, defined by, or described by s. 503(b) of the
2710
Federal Food, Drug, and Cosmetic Act.
2711
3. The person is not permitted, licensed, or otherwise
2712
authorized in any state to wholesale prescription drugs subject
2713
to, defined by, or described by s. 503(b) of the Federal Food,
2714
Drug, and Cosmetic Act to any person who is authorized to sell,
2715
distribute, purchase, trade, or use these drugs on or for humans.
2716
4. A limited prescription drug veterinary wholesaler that
2717
applies to the department for a new permit or the renewal of a
2718
permit must submit a bond of $20,000, or other equivalent means
2719
of security acceptable to the department, such as an irrevocable
2720
letter of credit or a deposit in a trust account or financial
2721
institution, payable to the Florida Drug, Device, and Cosmetic
2722
Trust Fund. The purpose of the bond is to secure payment of any
2723
administrative penalties imposed by the department and any fees
2724
and costs incurred by the department regarding that permit which
2725
are authorized under state law and which the permittee fails to
2726
pay 30 days after the fine or costs become final. The department
2727
may make a claim against such bond or security until 1 year after
2728
the permittee's license ceases to be valid or until 60 days after
2729
any administrative or legal proceeding authorized in ss. 499.001-
2730
499.081 which involves the permittee is concluded, including any
2731
appeal, whichever occurs later.
2732
5. A limited prescription drug veterinary wholesaler must
2733
maintain at all times a license or permit to engage in the
2734
wholesale distribution of prescription drugs in compliance with
2735
laws of the state in which it is a resident.
2736
6. A limited prescription drug veterinary wholesaler must
2737
comply with the requirements for wholesale distributors under s.
2738
499.0121, except that a limited prescription drug veterinary
2739
wholesaler is not required to provide a pedigree paper as
2740
required by s. 499.0121(6)(d) upon the wholesale distribution of
2741
a prescription drug to a veterinarian.
2742
7. A limited prescription drug veterinary wholesaler may
2743
not return to inventory for subsequent wholesale distribution any
2744
prescription drug subject to, defined by, or described by s.
2745
503(b) of the Federal Food, Drug, and Cosmetic Act which has been
2746
returned by a veterinarian.
2747
8. An out-of-state prescription drug wholesaler's permit or
2748
a limited prescription drug veterinary wholesaler permit is not
2749
required for an intracompany sale or transfer of a prescription
2750
drug from an out-of-state establishment that is duly licensed to
2751
engage in the wholesale distribution of prescription drugs in its
2752
state of residence to a licensed limited prescription drug
2753
veterinary wholesaler in this state if both wholesalers conduct
2754
wholesale distributions of prescription drugs under the same
2755
business name. The recordkeeping requirements of s. 499.0121(6)
2756
must be followed for this transaction.
2757
(8)(3) An application for a permit or to renew a permit for
2758
a prescription drug wholesale distributor wholesaler or an out-
2759
of-state prescription drug wholesale distributor wholesaler
2760
submitted to the department must include:
2761
(a) The name, full business address, and telephone number
2762
of the applicant.
2763
(b) All trade or business names used by the applicant.
2764
(c) The address, telephone numbers, and the names of
2765
contact persons for each facility used by the applicant for the
2766
storage, handling, and distribution of prescription drugs.
2767
(d) The type of ownership or operation, such as a
2768
partnership, corporation, or sole proprietorship.
2769
(e) The names of the owner and the operator of the
2770
establishment, including:
2771
1. If an individual, the name of the individual.
2772
2. If a partnership, the name of each partner and the name
2773
of the partnership.
2774
3. If a corporation:
2775
a. The name, address, and title of each corporate officer
2776
and director.
2777
b. The name and address of the corporation, resident agent
2778
of the corporation, the resident agent's address, and the
2779
corporation's state of incorporation.
2780
c. The name and address of each shareholder of the
2781
corporation that owns 5 percent or more of the outstanding stock
2782
of the corporation.
2783
4. If a sole proprietorship, the full name of the sole
2784
proprietor and the name of the business entity.
2785
5. If a limited liability company:
2786
a. The name and address of each member.
2787
b. The name and address of each manager.
2788
c. The name and address of the limited liability company,
2789
the resident agent of the limited liability company, and the name
2790
of the state in which the limited liability company was
2791
organized.
2792
(f) If applicable, the name and address of each member of
2793
the affiliated group of which the applicant is a member.
2794
(g)1. For an application for a new permit, the estimated
2795
annual dollar volume of prescription drug sales of the applicant,
2796
the estimated annual percentage of the applicant's total company
2797
sales that are prescription drugs, the applicant's estimated
2798
annual total dollar volume of purchases of prescription drugs,
2799
and the applicant's estimated annual total dollar volume of
2800
prescription drug purchases directly from manufacturers.
2801
2. For an application to renew a permit, the total dollar
2802
volume of prescription drug sales in the previous year, the total
2803
dollar volume of prescription drug sales made in the previous 6
2804
months, the percentage of total company sales that were
2805
prescription drugs in the previous year, the total dollar volume
2806
of purchases of prescription drugs in the previous year, and the
2807
total dollar volume of prescription drug purchases directly from
2808
manufacturers in the previous year.
2809
2810
Such portions of the information required pursuant to this
2811
paragraph which are a trade secret, as defined in s. 812.081,
2812
shall be maintained by the department as trade secret information
2813
is required to be maintained under s. 499.051.
2814
(h) The tax year of the applicant.
2815
(i) A copy of the deed for the property on which
2816
applicant's establishment is located, if the establishment is
2817
owned by the applicant, or a copy of the applicant's lease for
2818
the property on which applicant's establishment is located that
2819
has an original term of not less than 1 calendar year, if the
2820
establishment is not owned by the applicant.
2821
(j) A list of all licenses and permits issued to the
2822
applicant by any other state which authorize the applicant to
2823
purchase or possess prescription drugs.
2824
(k) The name of the manager of the establishment that is
2825
applying for the permit or to renew the permit, the next four
2826
highest ranking employees responsible for prescription drug
2827
wholesale operations for the establishment, and the name of all
2828
affiliated parties for the establishment, together with the
2829
personal information statement and fingerprints required pursuant
2830
to subsection (9) (4) for each of such persons.
2831
(l) The name of each of the applicant's designated
2832
representatives as required by subsection (16) (11), together
2833
with the personal information statement and fingerprints required
2834
pursuant to subsection (9) (4) for each such person.
2835
(m) For an applicant that is a secondary wholesaler, each
2836
of the following:
2837
1. A personal background information statement containing
2838
the background information and fingerprints required pursuant to
2839
subsection (9) (4) for each person named in the applicant's
2840
response to paragraphs (k) and (l) and for each affiliated party
2841
of the applicant.
2842
2. If any of the five largest shareholders of the
2843
corporation seeking the permit is a corporation, the name,
2844
address, and title of each corporate officer and director of each
2845
such corporation; the name and address of such corporation; the
2846
name of such corporation's resident agent, such corporation's
2847
resident agent's address, and such corporation's state of its
2848
incorporation; and the name and address of each shareholder of
2849
such corporation that owns 5 percent or more of the stock of such
2850
corporation.
2851
3. The name and address of all financial institutions in
2852
which the applicant has an account which is used to pay for the
2853
operation of the establishment or to pay for drugs purchased for
2854
the establishment, together with the names of all persons that
2855
are authorized signatories on such accounts. The portions of the
2856
information required pursuant to this subparagraph which are a
2857
trade secret, as defined in s. 812.081, shall be maintained by
2858
the department as trade secret information is required to be
2859
maintained under s. 499.051.
2860
4. The sources of all funds and the amounts of such funds
2861
used to purchase or finance purchases of prescription drugs or to
2862
finance the premises on which the establishment is to be located.
2863
5. If any of the funds identified in subparagraph 4. were
2864
borrowed, copies of all promissory notes or loans used to obtain
2865
such funds.
2866
(n) Any other relevant information that the department
2867
requires, including, but not limited to, any information related
2868
to whether the applicant satisfies the definition of a primary
2869
wholesaler or a secondary wholesaler.
2870
(9)(4)(a) Each person required by subsection (8)(3) to
2871
provide a personal information statement and fingerprints shall
2872
provide the following information to the department on forms
2873
prescribed by the department:
2874
1. The person's places of residence for the past 7 years.
2875
2. The person's date and place of birth.
2876
3. The person's occupations, positions of employment, and
2877
offices held during the past 7 years.
2878
4. The principal business and address of any business,
2879
corporation, or other organization in which each such office of
2880
the person was held or in which each such occupation or position
2881
of employment was carried on.
2882
5. Whether the person has been, during the past 7 years,
2883
the subject of any proceeding for the revocation of any license
2884
and, if so, the nature of the proceeding and the disposition of
2885
the proceeding.
2886
6. Whether, during the past 7 years, the person has been
2887
enjoined, either temporarily or permanently, by a court of
2888
competent jurisdiction from violating any federal or state law
2889
regulating the possession, control, or distribution of
2890
prescription drugs, together with details concerning any such
2891
event.
2892
7. A description of any involvement by the person with any
2893
business, including any investments, other than the ownership of
2894
stock in a publicly traded company or mutual fund, during the
2895
past 7 years, which manufactured, administered, prescribed,
2896
distributed, or stored pharmaceutical products and any lawsuits
2897
in which such businesses were named as a party.
2898
8. A description of any felony criminal offense of which
2899
the person, as an adult, was found guilty, regardless of whether
2900
adjudication of guilt was withheld or whether the person pled
2901
guilty or nolo contendere. A criminal offense committed in
2902
another jurisdiction which would have been a felony in this state
2903
must be reported. If the person indicates that a criminal
2904
conviction is under appeal and submits a copy of the notice of
2905
appeal of that criminal offense, the applicant must, within 15
2906
days after the disposition of the appeal, submit to the
2907
department a copy of the final written order of disposition.
2908
9. A photograph of the person taken in the previous 30
2909
days.
2910
10. A set of fingerprints for the person on a form and
2911
under procedures specified by the department, together with
2912
payment of an amount equal to the costs incurred by the
2913
department for the criminal record check of the person.
2914
11. The name, address, occupation, and date and place of
2915
birth for each member of the person's immediate family who is 18
2916
years of age or older. As used in this subparagraph, the term
2917
"member of the person's immediate family" includes the person's
2918
spouse, children, parents, siblings, the spouses of the person's
2919
children, and the spouses of the person's siblings.
2920
12. Any other relevant information that the department
2921
requires.
2922
(b) The information required pursuant to paragraph (a)
2923
shall be provided under oath.
2924
(c) The department shall submit the fingerprints provided
2925
by a person for initial licensure to the Department of Law
2926
Enforcement for a statewide criminal record check and for
2927
forwarding to the Federal Bureau of Investigation for a national
2928
criminal record check of the person. The department shall submit
2929
the fingerprints provided by a person as a part of a renewal
2930
application to the Department of Law Enforcement for a statewide
2931
criminal record check, and for forwarding to the Federal Bureau
2932
of Investigation for a national criminal record check, for the
2933
initial renewal of a permit after January 1, 2004; for any
2934
subsequent renewal of a permit, the department shall submit the
2935
required information for a statewide and national criminal record
2936
check of the person. Any person who as a part of an initial
2937
permit application or initial permit renewal after January 1,
2938
2004, submits to the department a set of fingerprints required
2939
for the criminal record check required in this paragraph shall
2940
not be required to provide a subsequent set of fingerprints for a
2941
criminal record check to the department, if the person has
2942
undergone a criminal record check as a condition of the issuance
2943
of an initial permit or the initial renewal of a permit of an
2944
applicant after January 1, 2004.
2945
(10)(5) The department may deny an application for a permit
2946
or refuse to renew a permit for a prescription drug wholesale
2947
distributor wholesaler or an out-of-state prescription drug
2948
wholesale distributor wholesaler if:
2949
(a) The applicant has not met the requirements for the
2950
permit.
2951
(b) The management, officers, or directors of the applicant
2952
or any affiliated party are found by the department to be
2953
incompetent or untrustworthy.
2954
(c) The applicant is so lacking in experience in managing a
2955
wholesale distributor as to make the issuance of the proposed
2956
permit hazardous to the public health.
2957
(d) The applicant is so lacking in experience in managing a
2958
wholesale distributor as to jeopardize the reasonable promise of
2959
successful operation of the wholesale distributor.
2960
(e) The applicant is lacking in experience in the
2961
distribution of prescription drugs.
2962
(f) The applicant's past experience in manufacturing or
2963
distributing prescription drugs indicates that the applicant
2964
poses a public health risk.
2965
(g) The applicant is affiliated directly or indirectly
2966
through ownership, control, or other business relations, with any
2967
person or persons whose business operations are or have been
2968
detrimental to the public health.
2969
(h) The applicant, or any affiliated party, has been found
2970
guilty of or has pleaded guilty or nolo contendere to any felony
2971
or crime punishable by imprisonment for 1 year or more under the
2972
laws of the United States, any state, or any other country,
2973
regardless of whether adjudication of guilt was withheld.
2974
(i) The applicant or any affiliated party has been charged
2975
with a felony in a state or federal court and the disposition of
2976
that charge is pending during the application review or renewal
2977
review period.
2978
(j) The applicant has furnished false or fraudulent
2979
information or material in any application made in this state or
2980
any other state in connection with obtaining a permit or license
2981
to manufacture or distribute drugs, devices, or cosmetics.
2982
(k) That a federal, state, or local government permit
2983
currently or previously held by the applicant, or any affiliated
2984
party, for the manufacture or distribution of any drugs, devices,
2985
or cosmetics has been disciplined, suspended, or revoked and has
2986
not been reinstated.
2987
(l) The applicant does not possess the financial or
2988
physical resources to operate in compliance with the permit being
2989
sought, this chapter, and the rules adopted under this chapter.
2990
(m) The applicant or any affiliated party receives,
2991
directly or indirectly, financial support and assistance from a
2992
person who was an affiliated party of a permittee whose permit
2993
was subject to discipline or was suspended or revoked, other than
2994
through the ownership of stock in a publicly traded company or a
2995
mutual fund.
2996
(n) The applicant or any affiliated party receives,
2997
directly or indirectly, financial support and assistance from a
2998
person who has been found guilty of any violation of this part
3000
any rules adopted under any of this part or those sections or
3001
chapters, any federal or state drug law, or any felony where the
3002
underlying facts related to drugs, regardless of whether the
3003
person has been pardoned, had her or his civil rights restored,
3004
or had adjudication withheld, other than through the ownership of
3005
stock in a publicly traded company or a mutual fund.
3006
(o) The applicant for renewal of a permit under s.
3008
has not actively engaged in the wholesale distribution of
3009
prescription drugs, as demonstrated by the regular and systematic
3010
distribution of prescription drugs throughout the year as
3011
evidenced by not fewer than 12 wholesale distributions in the
3012
previous year and not fewer than three wholesale distributions in
3013
the previous 6 months.
3014
(p) Information obtained in response to s. 499.01(2)(d)
3015
paragraph (2)(a) or s. 499.01(2)(e) paragraph (2)(c) demonstrates
3016
it would not be in the best interest of the public health,
3017
safety, and welfare to issue a permit.
3018
(q) The applicant does not possess the financial standing
3019
and business experience for the successful operation of the
3020
applicant.
3021
(r) The applicant or any affiliated party has failed to
3022
comply with the requirements for manufacturing or distributing
3024
federal laws, similar laws in other states, or the rules adopted
3025
under such laws.
3026
(11)(6) Upon approval of the application by the department
3027
and payment of the required fee, the department shall issue or
3028
renew a prescription drug wholesaler or an out-of-state
3029
prescription drug wholesaler permit to the applicant.
3030
(12)(7) For a permit permits for a prescription drug
3031
wholesale distributor wholesalers or an out-of-state prescription
3032
drug wholesale distributor wholesalers:
3033
(a) The department shall adopt rules for the annual renewal
3034
of permits. At least 90 days before the expiration of a permit,
3035
the department shall forward a permit renewal notification and
3036
renewal application to the prescription drug wholesale
3037
distributor wholesaler or out-of-state prescription drug
3038
wholesale distributor wholesaler at the mailing address of the
3039
permitted establishment on file with the department. The permit
3040
renewal notification must state conspicuously the date on which
3041
the permit for the establishment will expire and that the
3042
establishment may not operate unless the permit for the
3043
establishment is renewed timely.
3044
(b) A permit, unless sooner suspended or revoked,
3045
automatically expires 1 year after the last day of the
3046
anniversary month in which the permit was originally issued. A
3047
permit may be renewed by making application for renewal on forms
3048
furnished by the department and paying the appropriate fees. If a
3049
renewal application and fee are submitted and postmarked after 45
3050
days prior to the expiration date of the permit, the permit may
3051
be renewed only upon payment of a late renewal fee of $100, plus
3052
the required renewal fee. A permittee that has submitted a
3053
renewal application in accordance with this paragraph may
3054
continue to operate under its permit, unless the permit is
3055
suspended or revoked, until final disposition of the renewal
3056
application.
3057
(c) Failure to renew a permit in accordance with this
3058
section precludes any future renewal of that permit. If a permit
3059
issued pursuant to this section has expired and cannot be
3060
renewed, before an establishment may engage in activities that
3062
establishment must submit an application for a new permit; pay
3063
the applicable application fee, initial permit fee, and all
3064
applicable penalties; and be issued a new permit by the
3065
department.
3066
(13)(8) A person that engages in wholesale distribution of
3067
prescription drugs in this state must have a wholesale
3068
distributor's permit issued by the department, except as noted in
3069
this section. Each establishment must be separately permitted
3070
except as noted in this subsection.
3071
(a) A separate establishment permit is not required when a
3072
permitted prescription drug wholesale distributor wholesaler
3073
consigns a prescription drug to a pharmacy that is permitted
3074
under chapter 465 and located in this state, provided that:
3075
1. The consignor wholesale distributor wholesaler notifies
3076
the department in writing of the contract to consign prescription
3077
drugs to a pharmacy along with the identity and location of each
3078
consignee pharmacy;
3079
2. The pharmacy maintains its permit under chapter 465;
3080
3. The consignor wholesale distributor wholesaler, which
3081
has no legal authority to dispense prescription drugs, complies
3082
with all wholesale distribution requirements of s. 499.0121 and
3083
s. 499.01213 with respect to the consigned drugs and maintains
3084
records documenting the transfer of title or other completion of
3085
the wholesale distribution of the consigned prescription drugs;
3086
4. The distribution of the prescription drug is otherwise
3087
lawful under this chapter and other applicable law;
3088
5. Open packages containing prescription drugs within a
3089
pharmacy are the responsibility of the pharmacy, regardless of
3090
how the drugs are titled; and
3091
6. The pharmacy dispenses the consigned prescription drug
3092
in accordance with the limitations of its permit under chapter
3093
465 or returns the consigned prescription drug to the consignor
3094
wholesale distributor wholesaler. In addition, a person who holds
3095
title to prescription drugs may transfer the drugs to a person
3096
permitted or licensed to handle the reverse distribution or
3097
destruction of drugs. Any other distribution by and means of the
3098
consigned prescription drug by any person, not limited to the
3099
consignor wholesaler or consignee pharmacy, to any other person
3100
is prohibited.
3101
(b) A wholesale distributor's permit is not required for
3102
the one-time transfer of title of a pharmacy's lawfully acquired
3103
prescription drug inventory by a pharmacy with a valid permit
3104
issued under chapter 465 to a consignor prescription drug
3105
wholesale distributor wholesaler, permitted under this chapter,
3106
in accordance with a written consignment agreement between the
3107
pharmacy and that wholesale distributor wholesaler if: the
3108
permitted pharmacy and the permitted prescription drug wholesale
3109
distributor wholesaler comply with all of the provisions of
3110
paragraph (a) and the prescription drugs continue to be within
3111
the permitted pharmacy's inventory for dispensing in accordance
3112
with the limitations of the pharmacy permit under chapter 465. A
3113
consignor drug wholesale distributor wholesaler may not use the
3114
pharmacy as a wholesale distributor through which it distributes
3115
the prescription legend drugs to other pharmacies. Nothing in
3116
this section is intended to prevent a wholesale drug distributor
3117
from obtaining this inventory in the event of nonpayment by the
3118
pharmacy.
3119
(c) The department shall require information from each
3120
wholesale distributor as part of the permit and renewal of such
3121
permit, as required under s. 499.01 or this section.
3122
(14)(9) Personnel employed in wholesale distribution must
3123
have appropriate education and experience to enable them to
3124
perform their duties in compliance with state permitting
3125
requirements.
3126
(15)(10) The name of a permittee or establishment on a
3127
prescription drug wholesale distributor wholesaler permit or an
3128
out-of-state prescription drug wholesale distributor wholesaler
3129
permit may not include any indicia of attainment of any
3130
educational degree, any indicia that the permittee or
3131
establishment possesses a professional license, or any name or
3132
abbreviation that the department determines is likely to cause
3133
confusion or mistake or that the department determines is
3134
deceptive, including that of any other entity authorized to
3135
purchase prescription drugs.
3136
(16)(11)(a) Each establishment that is issued an initial or
3137
renewal permit as a prescription drug wholesale distributor
3138
wholesaler or an out-of-state prescription drug wholesale
3139
distributor wholesaler must designate in writing to the
3140
department at least one natural person to serve as the designated
3141
representative of the wholesale distributor wholesaler. Such
3142
person must have an active certification as a designated
3143
representative from the department.
3144
(b) To be certified as a designated representative, a
3145
natural person must:
3146
1. Submit an application on a form furnished by the
3147
department and pay the appropriate fees;
3148
2. Be at least 18 years of age;
3149
3. Have not less than 2 years of verifiable full-time work
3150
experience in a pharmacy licensed in this state or another state,
3151
where the person's responsibilities included, but were not
3152
limited to, recordkeeping for prescription drugs, or have not
3153
less than 2 years of verifiable full-time managerial experience
3154
with a prescription drug wholesale distributor wholesaler
3155
licensed in this state or in another state;
3156
4. Receive a passing score of at least 75 percent on an
3157
examination given by the department regarding federal laws
3158
governing distribution of prescription drugs and this part ss.
3160
the wholesale distribution of prescription drugs. This
3161
requirement shall be effective 1 year after the results of the
3162
initial examination are mailed to the persons that took the
3163
examination. The department shall offer such examinations at
3164
least four times each calendar year; and
3165
5. Provide the department with a personal information
3166
statement and fingerprints pursuant to subsection (9) (4).
3167
(c) The department may deny an application for
3168
certification as a designated representative or may suspend or
3169
revoke a certification of a designated representative pursuant to
3170
s. 499.067.
3171
(d) A designated representative:
3172
1. Must be actively involved in and aware of the actual
3173
daily operation of the wholesale distributor.
3174
2. Must be employed full time in a managerial position by
3175
the wholesale distributor.
3176
3. Must be physically present at the establishment during
3177
normal business hours, except for time periods when absent due to
3178
illness, family illness or death, scheduled vacation, or other
3179
authorized absence.
3180
4. May serve as a designated representative for only one
3181
wholesale distributor at any one time.
3182
(e) A wholesale distributor must notify the department when
3183
a designated representative leaves the employ of the wholesale
3184
distributor. Such notice must be provided to the department
3185
within 10 business days after the last day of designated
3186
representative's employment with the wholesale distributor.
3187
(f) A wholesale distributor may not operate under a
3188
prescription drug wholesale distributor wholesaler permit or an
3189
out-of-state prescription drug wholesale distributor wholesaler
3190
permit for more than 10 business days after the designated
3191
representative leaves the employ of the wholesale distributor,
3192
unless the wholesale distributor employs another designated
3193
representative and notifies the department within 10 business
3194
days of the identity of the new designated representative.
3195
(12) The department may adopt rules governing the
3196
recordkeeping, storage, and handling with respect to each of the
3197
distributions of prescription drugs specified in subparagraphs
3198
(1)(a)1.-4.
3199
Section 20. Section 499.01201, Florida Statutes, is amended
3200
to read:
3201
499.01201 Agency for Health Care Administration review and
3202
use of statute and rule violation or compliance
3203
data.--Notwithstanding any other provisions of law to the
3204
contrary, the Agency for Health Care Administration may not:
3205
(1) Review or use any violation or alleged violation of s.
3207
sections that section, as a ground for denying or withholding any
3208
payment of a Medicaid reimbursement to a pharmacy licensed under
3209
chapter 465; or
3210
(2) Review or use compliance with s. 499.0121(6) or s.
3211
499.01213, or any rules adopted under those sections that
3212
section, as the subject of any audit of Medicaid-related records
3213
held by a pharmacy licensed under chapter 465.
3214
Section 21. Section 499.0121, Florida Statutes, is amended
3215
to read:
3216
499.0121 Storage and handling of prescription drugs;
3217
recordkeeping.--The department shall adopt rules to implement
3218
this section as necessary to protect the public health, safety,
3219
and welfare. Such rules shall include, but not be limited to,
3220
requirements for the storage and handling of prescription drugs
3221
and for the establishment and maintenance of prescription drug
3222
distribution records.
3223
(1) ESTABLISHMENTS.--An establishment at which prescription
3224
drugs are stored, warehoused, handled, held, offered, marketed,
3225
or displayed must:
3226
(a) Be of suitable size and construction to facilitate
3227
cleaning, maintenance, and proper operations;
3228
(b) Have storage areas designed to provide adequate
3229
lighting, ventilation, temperature, sanitation, humidity, space,
3230
equipment, and security conditions;
3231
(c) Have a quarantine area for storage of prescription
3232
drugs that are outdated, damaged, deteriorated, misbranded, or
3233
adulterated, or that are in immediate or sealed, secondary
3234
containers that have been opened;
3235
(d) Be maintained in a clean and orderly condition; and
3236
(e) Be free from infestation by insects, rodents, birds, or
3237
vermin of any kind.
3238
(2) SECURITY.--
3239
(a) An establishment that is used for wholesale drug
3240
distribution must be secure from unauthorized entry.
3241
1. Access from outside the premises must be kept to a
3242
minimum and be well-controlled.
3243
2. The outside perimeter of the premises must be well-
3244
lighted.
3245
3. Entry into areas where prescription drugs are held must
3246
be limited to authorized personnel.
3247
(b) An establishment that is used for wholesale drug
3248
distribution must be equipped with:
3249
1. An alarm system to detect entry after hours; however,
3250
the department may exempt by rule establishments that only hold a
3251
permit as prescription drug wholesaler distributor-brokers
3252
wholesaler-brokers and establishments that only handle medical
3253
oxygen; and
3254
2. A security system that will provide suitable protection
3255
against theft and diversion. When appropriate, the security
3256
system must provide protection against theft or diversion that is
3257
facilitated or hidden by tampering with computers or electronic
3258
records.
3259
(c) Any vehicle that contains prescription drugs must be
3260
secure from unauthorized access to the prescription drugs in the
3261
vehicle.
3262
(3) STORAGE.--All prescription drugs shall be stored at
3263
appropriate temperatures and under appropriate conditions in
3264
accordance with requirements, if any, in the labeling of such
3265
drugs, or with requirements in the official compendium.
3266
(a) If no storage requirements are established for a
3267
prescription drug, the drug may be held at "controlled" room
3268
temperature, as defined in the official compendium, to help
3269
ensure that its identity, strength, quality, and purity are not
3270
adversely affected.
3271
(b) Appropriate manual, electromechanical, or electronic
3272
temperature and humidity recording equipment, devices, or logs
3273
must be used to document proper storage of prescription drugs.
3274
(c) The recordkeeping requirements in subsection (6) must
3275
be followed for all stored prescription drugs.
3276
(4) EXAMINATION OF MATERIALS AND RECORDS.--
3277
(a) Upon receipt, each outside shipping container must be
3278
visually examined for identity and to prevent the acceptance of
3279
contaminated prescription drugs that are otherwise unfit for
3280
distribution. This examination must be adequate to reveal
3281
container damage that would suggest possible contamination or
3282
other damage to the contents.
3283
(b) Each outgoing shipment must be carefully inspected for
3284
identity of the prescription drug products and to ensure that
3285
there is no delivery of prescription drugs that have expired or
3286
been damaged in storage or held under improper conditions.
3287
(c) The recordkeeping requirements in subsection (6) must
3288
be followed for all incoming and outgoing prescription drugs.
3289
(d) Upon receipt, a wholesale distributor wholesaler must
3290
review records required under this section for the acquisition of
3291
prescription drugs for accuracy and completeness, considering the
3292
total facts and circumstances surrounding the transactions and
3293
the wholesale distributors involved. This includes authenticating
3294
each transaction listed on a pedigree paper, as defined in s.
3296
(5) RETURNED, DAMAGED, OR OUTDATED PRESCRIPTION DRUGS.--
3297
(a)1. Prescription drugs that are outdated, damaged,
3298
deteriorated, misbranded, or adulterated must be quarantined and
3299
physically separated from other prescription drugs until they are
3300
destroyed or returned to their supplier. A quarantine section
3301
must be separate and apart from other sections where prescription
3302
drugs are stored so that prescription drugs in this section are
3303
not confused with usable prescription drugs.
3304
2. Prescription drugs must be examined at least every 12
3305
months, and drugs for which the expiration date has passed must
3306
be removed and quarantined.
3307
(b) Any prescription drugs of which the immediate or sealed
3308
outer containers or sealed secondary containers have been opened
3309
or used must be identified as such and must be quarantined and
3310
physically separated from other prescription drugs until they are
3311
either destroyed or returned to the supplier.
3312
(c) If the conditions under which a prescription drug has
3313
been returned cast doubt on the drug's safety, identity,
3314
strength, quality, or purity, the drug must be destroyed or
3315
returned to the supplier, unless examination, testing, or other
3316
investigation proves that the drug meets appropriate standards of
3317
safety, identity, strength, quality, and purity. In determining
3318
whether the conditions under which a drug has been returned cast
3319
doubt on the drug's safety, identity, strength, quality, or
3320
purity, the wholesale drug distributor must consider, among other
3321
things, the conditions under which the drug has been held,
3322
stored, or shipped before or during its return and the conditions
3323
of the drug and its container, carton, or labeling, as a result
3324
of storage or shipping.
3325
(d) The recordkeeping requirements in subsection (6) must
3326
be followed for all outdated, damaged, deteriorated, misbranded,
3327
or adulterated prescription drugs.
3328
(6) RECORDKEEPING.--The department shall adopt rules that
3329
require keeping such records of prescription drugs as are
3330
necessary for the protection of the public health.
3331
(a) Wholesale drug distributors must establish and maintain
3332
inventories and records of all transactions regarding the receipt
3333
and distribution or other disposition of prescription drugs.
3334
These records must provide a complete audit trail from receipt to
3335
sale or other disposition, be readily retrievable for inspection,
3336
and include, at a minimum, the following information:
3337
1. The source of the drugs, including the name and
3338
principal address of the seller or transferor, and the address of
3339
the location from which the drugs were shipped;
3340
2. The name, principal address, and state license permit or
3341
registration number of the person authorized to purchase
3342
prescription drugs;
3343
3. The name, strength, dosage form, and quantity of the
3344
drugs received and distributed or disposed of;
3345
4. The dates of receipt and distribution or other
3346
disposition of the drugs; and
3347
5. Any financial documentation supporting the transaction.
3348
(b) Inventories and records must be made available for
3349
inspection and photocopying by authorized federal, state, or
3350
local officials for a period of 2 years following disposition of
3351
the drugs or 3 years after the creation of the records, whichever
3352
period is longer.
3353
(c) Records described in this section that are kept at the
3354
inspection site or that can be immediately retrieved by computer
3355
or other electronic means must be readily available for
3356
authorized inspection during the retention period. Records that
3357
are kept at a central location outside of this state and that are
3358
not electronically retrievable must be made available for
3359
inspection within 2 working days after a request by an authorized
3360
official of a federal, state, or local law enforcement agency.
3361
Records that are maintained at a central location within this
3362
state must be maintained at an establishment that is permitted
3364
available.
3365
(d) Each manufacturer or repackager of medical devices,
3366
over-the-counter drugs, or cosmetics must maintain records that
3367
include the name and principal address of the seller or
3368
transferor of the product, the address of the location from which
3369
the product was shipped, the date of the transaction, the name
3370
and quantity of the product involved, and the name and principal
3371
address of the person who purchased the product.
3372
(e) A wholesale distributor must maintain pedigree papers
3373
separate and distinct from other records required under this
3374
chapter.
3375
(d)1. Effective July 1, 2006, each person who is engaged in
3376
the wholesale distribution of a prescription drug and who is not
3377
the manufacturer of that drug must, before each wholesale
3378
distribution of such drug, provide to the person who receives the
3379
drug a pedigree paper as defined in s. 499.003(31).
3380
2. A repackager must comply with this paragraph.
3381
3. The pedigree paper requirements in this paragraph do not
3382
apply to compressed medical gases or veterinary legend drugs.
3383
4. Each wholesale distributor of prescription drugs must
3384
maintain separate and distinct from other required records all
3385
statements that are required under subparagraph 1.
3386
5. Subparagraph 1. is satisfied when a wholesale
3387
distributor takes title to, but not possession of, a prescription
3388
drug and the prescription drug's manufacturer ships the
3389
prescription drug directly to a person authorized by law to
3390
purchase prescription drugs for the purpose of administering or
3391
dispensing the drug, as defined in s. 465.003, or a member of an
3392
affiliated group, as described in paragraph (f), with the
3393
exception of a repackager.
3394
a. The wholesale distributor must deliver to the recipient
3395
of the prescription drug, within 14 days after the shipment
3396
notification from the manufacturer, an invoice and the following
3397
sworn statement: "This wholesale distributor purchased the
3398
specific unit of the prescription drug listed on the invoice
3399
directly from the manufacturer, and the specific unit of
3400
prescription drug was shipped by the manufacturer directly to a
3401
person authorized by law to administer or dispense the legend
3402
drug, as defined in s. 465.003, Florida Statutes, or a member of
3403
an affiliated group, as described in s. 499.0121(6)(f), Florida
3404
Statutes, with the exception of a repackager." The invoice must
3405
contain a unique cross-reference to the shipping document sent by
3406
the manufacturer to the recipient of the prescription drug.
3407
b. The manufacturer of the prescription drug shipped
3408
directly to the recipient under this section must provide and the
3409
recipient of the prescription drug must acquire, within 14 days
3410
after receipt of the prescription drug, a shipping document from
3411
the manufacturer that contains, at a minimum:
3412
(I) The name and address of the manufacturer, including the
3413
point of origin of the shipment, and the names and addresses of
3414
the wholesaler and the purchaser.
3415
(II) The name of the prescription drug as it appears on the
3416
label.
3417
(III) The quantity, dosage form, and strength of the
3418
prescription drug.
3419
(IV) The date of the shipment from the manufacturer.
3420
c. The wholesale distributor must also maintain and make
3421
available to the department, upon request, the lot number of such
3422
drug if not contained in the shipping document acquired by the
3423
recipient.
3424
6. Failure of the manufacturer to provide, the recipient to
3425
acquire, or the wholesale distributor to deliver, the
3426
documentation required under subparagraph 5. shall constitute
3427
failure to acquire or deliver a pedigree paper under s. 499.0051.
3428
Forgery by the manufacturer, the recipient, or the wholesale
3429
distributor of the documentation required to be acquired or
3430
delivered under subparagraph 5. shall constitute forgery of a
3431
pedigree paper under s. 499.0051.
3432
7. The department may, by rule, specify alternatives to
3433
compliance with subparagraph 1. for a prescription drug in the
3434
inventory of a permitted prescription drug wholesaler as of June
3435
30, 2006, and the return of a prescription drug purchased prior
3436
to July 1, 2006. The department may specify time limits for such
3437
alternatives.
3438
(7)(e) NOTIFICATION REQUIRED.--Each wholesale distributor,
3439
except for a manufacturer, shall annually provide the department
3440
with a written list of all wholesale distributors and
3441
manufacturers from whom the wholesale distributor purchases
3442
prescription drugs. A wholesale distributor, except a
3443
manufacturer, shall notify the department not later than 10 days
3444
after any change to either list. Such portions of the information
3445
required pursuant to this paragraph which are a trade secret, as
3446
defined in s. 812.081, shall be maintained by the department as
3447
trade secret information is required to be maintained under s.
3448
3449
(f)1. This paragraph applies only to an affiliated group,
3450
as defined by s. 1504 of the Internal Revenue Code of 1986, as
3451
amended, which is composed of chain drug entities, including at
3452
least 50 retail pharmacies, warehouses, or repackagers, which are
3453
members of the same affiliated group, if the affiliated group:
3454
a. Discloses to the department the names of all its
3455
members; and
3456
b. Agrees in writing to provide records on prescription
3457
drug purchases by members of the affiliated group not later than
3458
48 hours after the department requests such records, regardless
3459
of the location where the records are stored.
3460
2. Each warehouse within the affiliated group must comply
3461
with all applicable federal and state drug wholesale permit
3462
requirements and must purchase, receive, hold, and distribute
3463
prescription drugs only to a retail pharmacy or warehouse within
3464
the affiliated group. Such a warehouse is exempt from providing a
3465
pedigree paper in accordance with paragraph (d) to its affiliated
3466
group member warehouse or retail pharmacy, provided that:
3467
a. Any affiliated group member that purchases or receives a
3468
prescription drug from outside the affiliated group must receive
3469
a pedigree paper if the prescription drug is distributed in or
3470
into this state and a pedigree paper is required under this
3471
section and must authenticate the documentation as required in
3472
subsection (4), regardless of whether the affiliated group member
3473
is directly subject to regulation under this chapter; and
3474
b. The affiliated group makes available to the department
3475
on request all records related to the purchase or acquisition of
3476
prescription drugs by members of the affiliated group, regardless
3477
of the location where the records are stored, if the prescription
3478
drugs were distributed in or into this state.
3479
3. If a repackager repackages prescription drugs solely for
3480
distribution to its affiliated group members for the exclusive
3481
distribution to and among retail pharmacies that are members of
3482
the affiliated group to which the repackager is a member:
3483
a. The repackager must:
3484
(I) In lieu of the written statement required by paragraph
3485
(d), for all repackaged prescription drugs distributed in or into
3486
this state, state in writing under oath with each distribution of
3487
a repackaged prescription drug to an affiliated group member
3488
warehouse or repackager: "All repackaged prescription drugs are
3489
purchased by the affiliated group directly from the manufacturer
3490
or from a prescription drug wholesaler that purchased the
3491
prescription drugs directly from the manufacturer.";
3492
(II) Purchase all prescription drugs it repackages:
3493
(A) Directly from the manufacturer; or
3494
(B) From a prescription drug wholesaler that purchased the
3495
prescription drugs directly from the manufacturer; and
3496
(III) Maintain records in accordance with this section to
3497
document that it purchased the prescription drugs directly from
3498
the manufacturer or that its prescription drug wholesale supplier
3499
purchased the prescription drugs directly from the manufacturer.
3500
b. All members of the affiliated group must provide to
3501
agents of the department on request records of purchases by all
3502
members of the affiliated group of prescription drugs that have
3503
been repackaged, regardless of the location where the records are
3504
stored or where the repackager is located.
3505
(8)(7) WRITTEN POLICIES AND PROCEDURES.--Wholesale drug
3506
distributors must establish, maintain, and adhere to written
3507
policies and procedures, which must be followed for the receipt,
3508
security, storage, inventory, and distribution of prescription
3509
drugs, including policies and procedures for identifying,
3510
recording, and reporting losses or thefts, and for correcting all
3511
errors and inaccuracies in inventories. Wholesale drug
3512
distributors must include in their written policies and
3513
procedures:
3514
(a) A procedure whereby the oldest approved stock of a
3515
prescription drug product is distributed first. The procedure may
3516
permit deviation from this requirement, if the deviation is
3517
temporary and appropriate.
3518
(b) A procedure to be followed for handling recalls and
3519
withdrawals of prescription drugs. Such procedure must be
3520
adequate to deal with recalls and withdrawals due to:
3521
1. Any action initiated at the request of the Food and Drug
3522
Administration or any other federal, state, or local law
3523
enforcement or other government agency, including the department.
3524
2. Any voluntary action by the manufacturer or repackager
3525
to remove defective or potentially defective drugs from the
3526
market; or
3527
3. Any action undertaken to promote public health and
3528
safety by replacing existing merchandise with an improved product
3529
or new package design.
3530
(c) A procedure to ensure that wholesale drug distributors
3531
prepare for, protect against, and handle any crisis that affects
3532
security or operation of any facility if a strike, fire, flood,
3533
or other natural disaster, or a local, state, or national
3534
emergency, occurs.
3535
(d) A procedure to ensure that any outdated prescription
3536
drugs are segregated from other drugs and either returned to the
3537
manufacturer or repackager or destroyed. This procedure must
3538
provide for written documentation of the disposition of outdated
3539
prescription drugs. This documentation must be maintained for 2
3540
years after disposition of the outdated drugs.
3541
(9)(8) RESPONSIBLE PERSONS.--Wholesale drug distributors
3542
must establish and maintain lists of officers, directors,
3543
managers, designated representatives, and other persons in charge
3544
of wholesale drug distribution, storage, and handling, including
3545
a description of their duties and a summary of their
3546
qualifications.
3547
(10)(9) COMPLIANCE WITH FEDERAL, STATE, AND LOCAL LAW.--A
3548
wholesale drug distributor must operate in compliance with
3549
applicable federal, state, and local laws and regulations.
3550
(a) A wholesale drug distributor must allow the department
3551
and authorized federal, state, and local officials to enter and
3552
inspect its premises and delivery vehicles, and to audit its
3553
records and written operating procedures, at reasonable times and
3554
in a reasonable manner, to the extent authorized by law.
3555
(b) A wholesale drug distributor that deals in controlled
3556
substances must register with the Drug Enforcement Administration
3557
and must comply with all applicable state, local, and federal
3558
laws. A wholesale drug distributor that distributes any substance
3559
controlled under chapter 893 must notify the department when
3560
registering with the Drug Enforcement Administration pursuant to
3561
that chapter and must provide the department with its DEA number.
3562
(11)(10) SALVAGING AND REPROCESSING.--A wholesale drug
3563
distributor is subject to any applicable federal, state, or local
3564
laws or regulations that relate to prescription drug product
3565
salvaging or reprocessing.
3566
(12)(11) SHIPPING AND TRANSPORTATION.--The person
3567
responsible for shipment and transportation of a prescription
3568
drug in a wholesale distribution may use a common carrier; its
3569
own vehicle or employee acting within the scope of employment if
3570
authorized under s. 499.03 for the possession of prescription
3571
drugs in this state; or, in the case of a prescription drug
3572
intended for domestic distribution, an independent contractor who
3573
must be the agent of the authorized seller or recipient
3574
responsible for shipping and transportation as set forth in a
3575
written contract between the parties. A person selling a
3576
prescription drug for export must obtain documentation, such as a
3577
validated airway bill, bill of lading, or other appropriate
3578
documentation that the prescription drug was exported. A person
3579
responsible for shipping or transporting prescription drugs is
3580
not required to maintain documentation from a common carrier that
3581
the designated recipient received the prescription drugs;
3582
however, the person must obtain such documentation from the
3583
common carrier and make it available to the department upon
3584
request of the department.
3585
(13)(12) DUE DILIGENCE OF SUPPLIERS.--Prior to purchasing
3586
any prescription drugs from another wholesale drug distributor, a
3587
prescription drug wholesale distributor wholesaler, an out-of-
3588
state prescription drug wholesale distributor wholesaler, or a
3589
prescription drug repackager must:
3590
(a) Enter an agreement with the selling wholesale drug
3591
distributor by which the selling wholesale drug distributor will
3592
indemnify the purchasing wholesale drug distributor for any loss
3593
caused to the purchasing wholesale drug distributor related to
3594
the purchase of drugs from the selling wholesale drug distributor
3595
which are determined to be counterfeit or to have been
3596
distributed in violation of any federal or state law governing
3597
the distribution of drugs.
3598
(b) Determine that the selling wholesale drug distributor
3599
has insurance coverage of not less than the greater of 1 percent
3600
of the amount of total dollar volume of the prescription drug
3601
sales reported to the department under s. 499.012(8)(g) s.
3602
499.012(3)(g) or $500,000; however the coverage need not exceed
3603
$2 million.
3604
(c) Obtain information from the selling wholesale drug
3605
distributor, including the length of time the selling wholesale
3606
drug distributor has been licensed in this state, a copy of the
3607
selling wholesale drug distributor's licenses or permits, and
3608
background information concerning the ownership of the selling
3609
wholesale drug distributor, including the experience of the
3610
wholesale distributor in the wholesale distribution of
3611
prescription drugs.
3612
(d) Verify that the selling wholesale drug distributor's
3613
Florida permit is valid.
3614
(e) Inspect the selling wholesale drug distributor's
3615
licensed establishment to document that it has a policies and
3616
procedures manual relating to the distribution of drugs, the
3617
appropriate temperature controlled environment for drugs
3618
requiring temperature control, an alarm system, appropriate
3619
access restrictions, and procedures to ensure that records
3620
related to the wholesale distribution of prescription drugs are
3621
maintained as required by law:
3622
1. Before purchasing any drug from the wholesale drug
3623
distributor, and at least once each subsequent year; or
3624
2. Before purchasing any drug from the wholesale drug
3625
distributor, and each subsequent year obtain a complete copy of
3626
the most recent inspection report for the establishment which was
3627
prepared by the department or the regulatory authority
3628
responsible for wholesale drug distributors in the state in which
3629
the establishment is located.
3630
Section 22. Section 499.01211, Florida Statutes, is amended
3631
to read:
3632
499.01211 Drug Wholesaler Advisory Council.--
3633
(1) There is created the Drug Wholesaler Advisory Council
3634
within the department. The council shall meet at least once each
3635
calendar quarter. Staff for the council shall be provided by the
3636
department. The council shall consist of 11 members who shall
3637
serve without compensation. The council shall elect a chairperson
3638
and a vice chairperson annually.
3639
(2) The State Surgeon General, or his or her designee, and
3640
the Secretary of Health Care Administration, or her or his
3641
designee, shall be members of the council. The State Surgeon
3642
General shall appoint nine additional members to the council who
3643
shall be appointed to a term of 4 years each, as follows:
3644
(a) Three different persons each of whom is employed by a
3645
different prescription drug wholesaler licensed under this
3646
chapter which operates nationally and is a primary wholesale
3647
distributor wholesaler, as defined in s. 499.003(52) s.
3648
499.012(1)(d).
3649
(b) One person employed by a prescription drug wholesaler
3650
licensed under this chapter which is a secondary wholesale
3651
distributor wholesaler, as defined in s. 499.003(58) s.
3652
499.012(1)(f).
3653
(c) One person employed by a retail pharmacy chain located
3654
in this state.
3655
(d) One person who is a member of the Board of Pharmacy and
3656
is a pharmacist licensed under chapter 465.
3657
(e) One person who is a physician licensed pursuant to
3658
chapter 458 or chapter 459.
3659
(f) One person who is an employee of a hospital licensed
3660
pursuant to chapter 395 and is a pharmacist licensed pursuant to
3661
chapter 465.
3662
(g) One person who is an employee of a pharmaceutical
3663
manufacturer.
3666
annually, provide input to the department regarding all proposed
3668
recommendations to the department to improve the protection of
3669
the prescription drugs and public health, make recommendations to
3670
improve coordination with other states' regulatory agencies and
3671
the federal government concerning the wholesale distribution of
3672
drugs, and make recommendations to minimize the impact of
3673
regulation of the wholesale distribution industry while ensuring
3674
protection of the public health.
3675
Section 23. Section 499.01213, Florida Statutes, is created
3676
to read:
3677
499.01213 Pedigree paper.--
3678
(1) APPLICATION.--Each person who is engaged in the
3679
wholesale distribution of a prescription drug, with the exception
3680
of the manufacturer of the prescription drug, must, before each
3681
wholesale distribution of such drug, provide to the person who
3682
receives the drug a pedigree paper.
3683
(2) FORMAT.--A pedigree paper must contain the following
3684
information:
3685
(a) For the wholesale distribution of a prescription drug
3686
within the normal distribution chain:
3687
1. The following statement, under oath, which may be
3688
included on the invoice for the transaction and does not require
3689
a signature: "This wholesale distributor purchased the specific
3690
unit of the prescription drug directly from the manufacturer."
3691
2. The manufacturer's national drug code identifier and the
3692
name and address of the wholesale distributor and the purchaser
3693
of the prescription drug.
3694
3. The name of the prescription drug as it appears on the
3695
label.
3696
4. The quantity, dosage form, and strength of the
3697
prescription drug.
3698
3699
The wholesale distributor must also maintain and make available
3700
to the department, upon request, the point of origin of the
3701
prescription drug, including intracompany transfers; the date of
3702
the shipment from the manufacturer to the wholesale distributor;
3703
the lot numbers of such drug; and the invoice numbers from the
3704
manufacturer.
3705
(b) For all other wholesale distributions of prescription
3706
drugs:
3707
1. The quantity, dosage form, and strength of the
3708
prescription drug.
3709
2. The lot numbers of the prescription drug.
3710
3. The name and address of each owner of the prescription
3711
drug and his or her signature.
3712
4. The shipping information, including the name and address
3713
of each person certifying delivery or receipt of the prescription
3714
drug.
3715
5. An invoice number, a shipping document number, or
3716
another number uniquely identifying the transaction.
3717
6. A certification that the recipient wholesale distributor
3718
has authenticated the pedigree papers.
3719
7. The unique serialization of the prescription drug, if
3720
the manufacturer or repackager has uniquely serialized the
3721
individual prescription drug unit.
3722
8. The name, address, telephone number and, if available,
3723
e-mail contact information of each wholesale distributor involved
3724
in the chain of the prescription drug's custody.
3725
(3) EXCEPTIONS.--A pedigree paper is not required for:
3726
(a) The wholesale distribution of a compressed medical gas.
3727
(b) The wholesale distribution of a veterinary prescription
3728
drug.
3729
(c) A drop shipment, provided that:
3730
1. The wholesale distributor delivers to the recipient of
3731
the prescription drug, within 14 days after the shipment
3732
notification from the manufacturer, an invoice and the following
3733
sworn statement: "This wholesale distributor purchased the
3734
specific unit of the prescription drug listed on the invoice
3735
directly from the manufacturer, and the specific unit of
3736
prescription drug was shipped by the manufacturer directly to a
3737
person authorized by law to administer or dispense the legend
3738
drug, as defined in s. 465.003, or a member of an affiliated
3739
group, with the exception of a repackager." The invoice must
3740
contain a unique cross-reference to the shipping document sent by
3741
the manufacturer to the recipient of the prescription drug.
3742
2. The manufacturer of the prescription drug shipped
3743
directly to the recipient provides, and the recipient of the
3744
prescription drug acquires, within 14 days after receipt of the
3745
prescription drug, a shipping document from the manufacturer that
3746
contains, at a minimum:
3747
a. The name and address of the manufacturer, including the
3748
point of origin of the shipment, and the names and addresses of
3749
the wholesaler and the purchaser.
3750
b. The name of the prescription drug as it appears on the
3751
label.
3752
c. The quantity, dosage form, and strength of the
3753
prescription drug.
3754
d. The date of the shipment from the manufacturer.
3755
3. The wholesale distributor maintains and makes available
3756
to the department, upon request, the lot number of such drug if
3757
not contained in the shipping document acquired by the recipient.
3758
3759
Failure of the manufacturer to provide, the recipient to acquire,
3760
or the wholesale distributor to deliver the documentation
3761
required under paragraph (c),including manufacturer notification
3762
to the wholesaler, shall constitute failure to acquire or deliver
3764
the manufacturer, the recipient, or the wholesale distributor of
3765
the documentation required to be acquired or delivered under
3766
subparagraph (2)(b)5. shall constitute forgery of a pedigree
3767
paper under s. 499.0051.
3768
4. The wholesale distributor that takes title to, but not
3769
possession of, the prescription drug is not a member of the
3770
affiliated group that receives the prescription drug directly
3771
from the manufacturer.
3772
(d) The wholesale distribution of a prescription drug by a
3773
warehouse within an affiliated group to a warehouse or retail
3774
pharmacy within its affiliated group, provided that:
3775
1. Any affiliated group member that purchases or receives a
3776
prescription drug from outside the affiliated group must receive
3777
a pedigree paper if the prescription drug is distributed in or
3778
into this state and a pedigree paper is required under this
3779
section and must authenticate the documentation as required in s.
3780
499.0121(4), regardless of whether the affiliated group member is
3781
directly subject to regulation under this chapter; and
3782
2. The affiliated group makes available to the department
3783
on request all records related to the purchase or acquisition of
3784
prescription drugs by members of the affiliated group, regardless
3785
of the location where the records are stored, if the prescription
3786
drugs were distributed in or into this state.
3787
(e) The repackaging of prescription drugs by a repackager
3788
solely for distribution to its affiliated group members for the
3789
exclusive distribution to and among retail pharmacies that are
3790
members of the affiliated group to which the repackager is a
3791
member.
3792
1. The repackager must:
3793
a. For all repackaged prescription drugs distributed in or
3794
into this state, state in writing under oath with each
3795
distribution of a repackaged prescription drug to an affiliated
3796
group member warehouse or repackager: "All repackaged
3797
prescription drugs are purchased by the affiliated group directly
3798
from the manufacturer or from a prescription drug wholesale
3799
distributor that purchased the prescription drugs directly from
3800
the manufacturer."
3801
b. Purchase all prescription drugs it repackages:
3802
(I) Directly from the manufacturer; or
3803
(II) From a prescription drug wholesaler that purchased the
3804
prescription drugs directly from the manufacturer; and
3805
c. Maintain records in accordance with this section to
3806
document that it purchased the prescription drugs directly from
3807
the manufacturer or that its prescription drug wholesale supplier
3808
purchased the prescription drugs directly from the manufacturer.
3809
2. All members of the affiliated group must provide to
3810
agents of the department on request records of purchases by all
3811
members of the affiliated group of prescription drugs that have
3812
been repackaged, regardless of the location where the records are
3813
stored or where the repackager is located.
3814
Section 24. Section 499.0122, Florida Statutes, is
3815
repealed.
3816
Section 25. Section 499.013, Florida Statutes, is repealed.
3817
Section 26. Section 499.014, Florida Statutes, is repealed.
3818
Section 27. Subsections (1), (3), (4), (6), and (8) of
3819
section 499.015, Florida Statutes, are amended to read:
3820
499.015 Registration of drugs, devices, and cosmetics;
3821
issuance of certificates of free sale.--
3822
(1)(a) Except for those persons exempted from the
3824
person who manufactures, packages, repackages, labels, or
3825
relabels a drug, device, or cosmetic in this state must register
3826
such drug, device, or cosmetic biennially with the department;
3827
pay a fee in accordance with the fee schedule provided by s.
3828
499.041; and comply with this section. The registrant must list
3829
each separate and distinct drug, device, or cosmetic at the time
3830
of registration.
3831
(b) The department may not register any product that does
3832
not comply with the Federal Food, Drug, and Cosmetic Act, as
3833
amended, or Title 21 C.F.R. Registration of a product by the
3834
department does not mean that the product does in fact comply
3835
with all provisions of the Federal Food, Drug, and Cosmetic Act,
3836
as amended.
3837
(3) Except for those persons exempted from the definition
3839
not sell any product that he or she has failed to register in
3840
conformity with this section. Such failure to register subjects
3841
such drug, device, or cosmetic product to seizure and
3843
such person to the penalties and remedies provided in this part
3845
(4) Unless a registration is renewed, it expires 2 years
3846
after the last day of the month in which it was issued. The
3847
department may issue a stop-sale notice or order against a person
3848
that is subject to the requirements of this section and that
3849
fails to comply with this section within 31 days after the date
3850
the registration expires. The notice or order shall prohibit such
3851
person from selling or causing to be sold any drugs, devices, or
3853
she complies with the requirements of this section.
3854
(6) The department may issue a certificate of free sale for
3855
any product that is required to be registered under this part ss.
3857
(8) Notwithstanding any requirements set forth in this part
3859
registered with the federal Food and Drug Administration is
3860
exempt from this section and s. 499.041(6) if:
3861
(a) The manufacturer's medical devices are approved for
3862
marketing by, or listed with the federal Food and Drug
3863
Administration in accordance with federal law for commercial
3864
distribution; or
3865
(b) The manufacturer subcontracts with a manufacturer of
3866
medical devices to manufacture components of such devices.
3867
Section 28. Subsections (3), (5), and (6) of section
3868
499.024, Florida Statutes, are amended to read:
3869
499.024 Drug product classification.--The State Surgeon
3870
General shall adopt rules to classify drug products intended for
3871
use by humans which the United States Food and Drug
3872
Administration has not classified in the federal act or the Code
3873
of Federal Regulations.
3874
(3) Any product that falls under the definition of drug
3876
under the authority of this section. This section does not
3877
subject portable emergency oxygen inhalators to classification;
3878
however, this section does not exempt any person from ss. 499.01
3879
and 499.015.
3880
(5) The department may by rule reclassify drugs subject to
3882
necessary to protect the public health.
3883
(6) The department may adopt rules that exempt from any
3884
labeling or packaging requirements of this part ss. 499.001-
3885
499.081 drugs classified under this section if those requirements
3886
are not necessary to protect the public health.
3887
Section 29. Subsections (7), (12), and (15) of section
3888
499.028, Florida Statutes, are amended to read:
3889
499.028 Drug samples or complimentary drugs; starter packs;
3890
permits to distribute.--
3891
(7) A drug manufacturer or distributor must report to the
3892
department any conviction of itself or of its assigns, agents,
3893
employees, or representatives for a violation of s. 503(c)(1) of
3895
the sale, purchase, or trade of a drug sample or the offer to
3896
sell, purchase, or trade a drug sample.
3897
(12) The department may suspend or revoke a permit issued
3898
under this section, after giving notice and an opportunity to be
3899
heard pursuant to chapter 120, when:
3900
(a) Such permit was obtained by misrepresentation or fraud
3901
or through a mistake of the department.
3902
(b) The holder of the permit has distributed or disposed of
3903
any prescription legend drug, directly or through its agents,
3904
employees, or independent contractors, to any person not
3905
authorized to possess such drug.
3906
(c) The holder of the permit, or its agents, employees, or
3907
independent contractors, has distributed or possessed any
3908
prescription legend drug except in the usual course of its
3909
business.
3910
(d) The holder of the permit, or its agents, employees, or
3911
independent contractors, has distributed any prescription legend
3912
drug that is misbranded or adulterated under this part ss.
3914
(e) The holder of the permit, or its agents, employees, or
3915
independent contractors, has distributed any prescription legend
3916
drug without written request, when a written request is required
3917
by this section.
3918
(f) The holder of the permit has in its employ, or uses as
3919
agent or independent contractor for the purpose of distributing
3920
or disposing of drugs, any person who has:
3921
1. Violated the requirements of this section or any rule
3922
adopted under this section.
3923
2. Been convicted in any of the courts of this state, the
3924
United States, or any other state of a felony or any other crime
3925
involving moral turpitude or involving those drugs named or
3926
described in chapter 893.
3927
(15) A person may not possess a prescription drug sample
3928
unless:
3929
(a) The drug sample was prescribed to her or him as
3930
evidenced by the label required in s. 465.0276(5).
3931
(b) She or he is the employee of a complimentary drug
3932
distributor that holds a permit issued under this part ss.
3934
(c) She or he is a person to whom prescription drug samples
3935
may be distributed pursuant to this section.
3936
(d) He or she is an officer or employee of a federal,
3937
state, or local government acting within the scope of his or her
3938
employment.
3939
Section 30. Subsections (2) and (3) of section 499.029,
3940
Florida Statutes, are amended to read:
3941
499.029 Cancer Drug Donation Program.--
3942
(2) There is created a Cancer Drug Donation Program within
3943
the department of Health for the purpose of authorizing and
3944
facilitating the donation of cancer drugs and supplies to
3945
eligible patients.
3946
(3) As used in this section:
3947
(a) "Cancer drug" means a prescription drug that has been
3948
approved under s. 505 of the federal Food, Drug, and Cosmetic Act
3949
and is used to treat cancer or its side effects or is used to
3950
treat the side effects of a prescription drug used to treat
3951
cancer or its side effects. "Cancer drug" does not include a
3952
substance listed in Schedule II, Schedule III, Schedule IV, or
3953
Schedule V of s. 893.03.
3954
(b) "Closed drug delivery system" means a system in which
3955
the actual control of the unit-dose medication package is
3956
maintained by the facility rather than by the individual patient.
3957
(c) "Department" means the Department of Health.
3958
(c)(d) "Donor" means a patient or patient representative
3959
who donates cancer drugs or supplies needed to administer cancer
3960
drugs that have been maintained within a closed drug delivery
3961
system; health care facilities, nursing homes, hospices, or
3962
hospitals with closed drug delivery systems; or pharmacies, drug
3963
manufacturers, medical device manufacturers or suppliers, or
3964
wholesalers of drugs or supplies, in accordance with this
3965
section. "Donor" includes a physician licensed under chapter 458
3966
or chapter 459 who receives cancer drugs or supplies directly
3967
from a drug manufacturer, drug wholesaler, or pharmacy.
3968
(d)(e) "Eligible patient" means a person who the department
3969
determines is eligible to receive cancer drugs from the program.
3970
(e)(f) "Health care facility" means a health care facility
3971
licensed under chapter 395.
3972
(f)(g) "Health care clinic" means a health care clinic
3973
licensed under part X of chapter 400.
3974
(g)(h) "Hospice" means a corporation licensed under part IV
3975
of chapter 400.
3976
(h)(i) "Hospital" means a facility as defined in s. 395.002
3977
and licensed under chapter 395.
3978
(i)(j) "Nursing home" means a facility licensed under part
3979
II of chapter 400.
3980
(j)(k) "Participant facility" means a class II hospital
3981
pharmacy that has elected to participate in the program and that
3982
accepts donated cancer drugs and supplies under the rules adopted
3983
by the department for the program.
3984
(k)(l) "Pharmacist" means a person licensed under chapter
3985
465.
3986
(l)(m) "Pharmacy" means an entity licensed under chapter
3987
465.
3988
(m)(n) "Prescribing practitioner" means a physician
3989
licensed under chapter 458 or any other medical professional with
3990
authority under state law to prescribe cancer medication.
3991
(o) "Prescription drug" means a drug as defined in s.
3992
465.003(8).
3993
(n)(p) "Program" means the Cancer Drug Donation Program
3994
created by this section.
3995
(o)(q) "Supplies" means any supplies used in the
3996
administration of a cancer drug.
3997
Section 31. Subsection (1) of section 499.03, Florida
3998
Statutes, is amended to read:
3999
499.03 Possession of certain drugs without prescriptions
4000
unlawful; exemptions and exceptions.--
4001
(1) A person may not possess, or possess with intent to
4002
sell, dispense, or deliver, any habit-forming, toxic, harmful, or
4004
prescription legend drug as defined in s. 499.003(48) s.
4005
499.003(25), unless the possession of the drug has been obtained
4006
by a valid prescription of a practitioner licensed by law to
4007
prescribe the drug. However, this section does not apply to the
4008
delivery of such drugs to persons included in any of the classes
4009
named in this subsection, or to the agents or employees of such
4010
persons, for use in the usual course of their businesses or
4011
practices or in the performance of their official duties, as the
4012
case may be; nor does this section apply to the possession of
4013
such drugs by those persons or their agents or employees for such
4014
use:
4015
(a) A licensed pharmacist or any person under the licensed
4016
pharmacist's supervision while acting within the scope of the
4017
licensed pharmacist's practice;
4018
(b) A licensed practitioner authorized by law to prescribe
4019
prescription legend drugs or any person under the licensed
4020
practitioner's supervision while acting within the scope of the
4021
licensed practitioner's practice;
4022
(c) A qualified person who uses prescription legend drugs
4023
for lawful research, teaching, or testing, and not for resale;
4024
(d) A licensed hospital or other institution that procures
4025
such drugs for lawful administration or dispensing by
4026
practitioners;
4027
(e) An officer or employee of a federal, state, or local
4028
government; or
4029
(f) A person that holds a valid permit issued by the
4031
authorizes that person to possess prescription drugs.
4032
Section 32. Section 499.032, Florida Statutes, is amended
4033
to read:
4034
499.032 Phenylalanine; prescription
4035
required.--Phenylalanine restricted formula is declared to be a
4036
prescription legend drug and may be dispensed only upon the
4037
prescription of a practitioner authorized by law to prescribe
4038
prescription medicinal drugs.
4039
Section 33. Subsection (1) of section 499.033, Florida
4040
Statutes, is amended to read:
4041
499.033 Ephedrine; prescription required.--Ephedrine is
4042
declared to be a prescription drug.
4043
(1) Except as provided in subsection (2), any product that
4044
contains any quantity of ephedrine, a salt of ephedrine, an
4045
optical isomer of ephedrine, or a salt of an optical isomer of
4046
ephedrine may be dispensed only upon the prescription of a duly
4047
licensed practitioner authorized by the laws of the state to
4048
prescribe prescription medicinal drugs.
4049
Section 34. Subsections (1) and (3) of section 499.039,
4050
Florida Statutes, is amended to read:
4051
499.039 Sale, distribution, or transfer of harmful chemical
4052
substances; penalties; authority for enforcement.--It is unlawful
4053
for a person to sell, deliver, or give to a person under the age
4054
of 18 years any compound, liquid, or chemical containing toluol,
4055
hexane, trichloroethylene, acetone, toluene, ethyl acetate,
4056
methyl ethyl ketone, trichloroethane, isopropanol, methyl
4057
isobutyl ketone, ethylene glycol monomethyl ether acetate,
4058
cyclohexanone, nitrous oxide, diethyl ether, alkyl nitrites
4059
(butyl nitrite), or any similar substance for the purpose of
4060
inducing by breathing, inhaling, or ingesting a condition of
4061
intoxication or which is intended to distort or disturb the
4062
auditory, visual, or other physical or mental processes.
4063
(1) On the first violation of this section, the department
4065
violation has not caused temporary or permanent physical or
4066
mental injury to the user.
4067
(3) The department of Health shall adopt rules to implement
4068
this section.
4069
Section 35. Section 499.04, Florida Statutes, is amended to
4070
read:
4071
499.04 Fee authority.--The department may collect fees for
4072
all drug, device, and cosmetic applications, permits, product
4073
registrations, and free-sale certificates. The total amount of
4074
fees collected from all permits, applications, product
4075
registrations, and free-sale certificates must be adequate to
4076
fund the expenses incurred by the department in carrying out this
4078
establish a schedule of fees that are within the ranges provided
4079
in this section and shall adjust those fees from time to time
4080
based on the costs associated with administering this part ss.
4082
deposited into the Florida Drug, Device, and Cosmetic Trust Fund
4083
for the sole purpose of carrying out the provisions of this part
4085
Section 36. Section 499.041, Florida Statutes, is amended
4086
to read:
4087
499.041 Schedule of fees for drug, device, and cosmetic
4088
applications and permits, product registrations, and free-sale
4089
certificates.--
4090
(1) The department shall assess applicants requiring a
4091
manufacturing permit an annual fee within the ranges established
4092
in this section for the specific type of manufacturer.
4093
(a) The fee for a prescription drug manufacturer
4094
manufacturer's permit may not be less than $500 or more than $750
4095
annually.
4096
(b) The fee for a device manufacturer manufacturer's permit
4097
may not be less than $500 or more than $600 annually.
4098
(c) The fee for a cosmetic manufacturer manufacturer's
4099
permit may not be less than $250 or more than $400 annually.
4100
(d) The fee for an over-the-counter drug manufacturer
4101
manufacturer's permit may not be less than $300 or more than $400
4102
annually.
4103
(e) The fee for a compressed medical gas manufacturer
4104
manufacturer's permit may not be less than $400 or more than $500
4105
annually.
4106
(f) The fee for a prescription drug repackager repackager's
4107
permit may not be less than $500 or more than $750 annually.
4108
(g) A manufacturer may not be required to pay more than one
4109
fee per establishment to obtain an additional manufacturing
4110
permit, but each manufacturer must pay the highest fee applicable
4111
to his or her operation in each establishment.
4112
(2) The department shall assess an applicant that is
4113
required to have a wholesaling permit an annual fee within the
4114
ranges established in this section for the specific type of
4115
wholesaling.
4116
(a) The fee for a prescription drug wholesale distributor
4117
wholesaler's permit may not be less than $300 or more than $800
4118
annually.
4119
(b) The fee for a compressed medical gas wholesale
4120
distributor wholesaler's permit may not be less than $200 or more
4121
than $300 annually.
4122
(c) The fee for an out-of-state prescription drug wholesale
4123
distributor wholesaler's permit may not be less than $300 or more
4124
than $800 annually.
4125
(d) The fee for a nonresident prescription drug
4126
manufacturer manufacturer's permit may not be less than $300 or
4127
more than $500 annually.
4128
(e) The fee for a retail pharmacy wholesale distributor
4129
wholesaler's permit may not be less than $35 or more than $50
4130
annually.
4131
(f) The fee for a freight forwarder forwarder's permit may
4132
not be less than $200 or more than $300 annually.
4133
(g) The fee for a veterinary prescription drug wholesaler
4134
distributor wholesaler's permit may not be less than $300 or more
4135
than $500 annually.
4136
(h) The fee for a limited prescription drug veterinary
4137
wholesaler's permit may not be less than $300 or more than $500
4138
annually.
4139
(3) The department shall assess an applicant that is
4140
required to have a retail establishment permit an annual fee
4141
within the ranges established in this section for the specific
4142
type of retail establishment.
4143
(a) The fee for a veterinary prescription legend drug
4144
retail establishment permit may not be less than $200 or more
4145
than $300 annually.
4146
(b) The fee for a medical oxygen retail establishment
4147
permit may not be less than $200 or more than $300 annually.
4148
(4) The department shall assess an applicant that is
4149
required to have a restricted prescription drug distributor
4150
distributor's permit an annual fee of not less than $200 or more
4151
than $300.
4152
(5) In addition to the fee charged for a permit required by
4154
applicants an initial application fee of $150 for each new permit
4155
issued by the department which requires an onsite inspection.
4156
(6) A person that is required to register drugs, devices,
4157
or cosmetic products under s. 499.015 shall pay an annual product
4158
registration fee of not less than $5 or more than $15 for each
4159
separate and distinct product in package form. The registration
4160
fee is in addition to the fee charged for a free-sale
4161
certificate.
4162
(7) The department shall assess an applicant that requests
4163
a free-sale certificate a fee of $25. A fee of $2 will be charged
4164
for each signature copy of a free-sale certificate that is
4165
obtained at the same time the free-sale certificate is issued.
4166
(8) The department shall assess an out-of-state
4167
prescription drug wholesale distributor wholesaler applicant or
4168
permittee an onsite inspection fee of not less than $1,000 or
4169
more than $3,000 annually, to be based on the actual cost of the
4170
inspection if an onsite inspection is performed by agents of the
4171
department.
4172
(9) The department shall assess each person applying for
4173
certification as a designated representative a fee of $150, plus
4174
the cost of processing the criminal history record check.
4175
(10) The department shall assess other fees as provided in
4177
Section 37. Section 499.05, Florida Statutes, is amended to
4178
read:
4179
499.05 Rules.--
4180
(1) The department shall adopt rules to implement and
4182
(a) The definition of terms used in this part ss. 499.001-
4183
499.081, and used in the rules adopted under this part ss.
4185
ordinary meaning.
4186
(b) Labeling requirements for drugs, devices, and
4187
cosmetics.
4188
(c) The establishment of fees authorized in this part ss.
4190
(d) The identification of permits that require an initial
4191
application and onsite inspection or other prerequisites for
4192
permitting which demonstrate that the establishment and person
4193
are in compliance with the requirements of this part ss. 499.001-
4194
4195
(e) The application processes and forms for product
4196
registration.
4197
(f) Procedures for requesting and issuing certificates of
4198
free sale.
4199
(g) Inspections and investigations conducted under s.
4200
499.051, and the identification of information claimed to be a
4201
trade secret and exempt from the public records law as provided
4202
in s. 499.051(7).
4203
(h) The establishment of a range of penalties, as provided
4205
the potential impact of a violation of this part ss. 499.001-
4206
499.081; and a process for the uncontested settlement of alleged
4207
violations.
4208
(i) Additional conditions that qualify as an emergency
4210
(j) Procedures and forms relating to the pedigree paper
4211
requirements of s. 499.01213.
4212
(k) The protection of the public health, safety, and
4213
welfare regarding good manufacturing practices that manufacturers
4214
and repackagers must follow to ensure the safety of the products.
4215
(l) Information required from each retail establishment
4216
pursuant to s. 499.012(3), including requirements for
4217
prescriptions or orders.
4218
(m) The recordkeeping, storage, and handling with respect
4219
to each of the distributions of prescription drugs specified in
4220
s. 499.003(60)(a)-(d).
4221
(n) Alternatives to compliance with s. 499.01213 for a
4222
prescription drug in the inventory of a permitted prescription
4223
drug wholesale distributor as of June 30, 2006, and the return of
4224
a prescription drug purchased prior to July 1, 2006. The
4225
department may specify time limits for such alternatives.
4226
(2) With respect to products in interstate commerce, those
4227
rules must not be inconsistent with rules and regulations of
4228
federal agencies unless specifically otherwise directed by the
4229
Legislature.
4230
(3) The department shall adopt rules regulating
4231
recordkeeping for and the storage, handling, and distribution of
4232
medical devices and over-the-counter drugs to protect the public
4233
from adulterated products.
4234
Section 38. Section 499.051, Florida Statutes, is amended
4235
to read:
4236
499.051 Inspections and investigations.--
4237
(1) The agents of the Department of Health and of the
4238
Department of Law Enforcement, after they present proper
4239
identification, may inspect, monitor, and investigate any
4241
during business hours for the purpose of enforcing this part ss.
4243
department that protect the public health, safety, and welfare.
4244
(2) In addition to the authority set forth in subsection
4245
(1), the department and any duly designated officer or employee
4246
of the department may enter and inspect any other establishment
4247
for the purpose of determining compliance with this part ss.
4249
regarding any drug, device, or cosmetic product.
4250
(3) Any application for a permit or product registration or
4251
for renewal of such permit or registration made pursuant to this
4253
sections constitutes permission for any entry or inspection of
4254
the premises in order to verify compliance with this part those
4255
sections and rules; to discover, investigate, and determine the
4256
existence of compliance; or to elicit, receive, respond to, and
4257
resolve complaints and violations.
4258
(4) Any application for a permit made pursuant to s. ss.
4260
sections constitutes permission for agents of the department of
4261
Health and the Department of Law Enforcement, after presenting
4262
proper identification, to inspect, review, and copy any financial
4263
document or record related to the manufacture, repackaging, or
4264
distribution of a drug as is necessary to verify compliance with
4266
department to administer this part those sections, in order to
4267
discover, investigate, and determine the existence of compliance,
4268
or to elicit, receive, respond to, and resolve complaints and
4269
violations.
4270
(5) The authority to inspect under this section includes
4271
the authority to access, review, and copy any and all financial
4272
documents related to the activity of manufacturing, repackaging,
4273
or distributing prescription drugs.
4274
(6) The authority to inspect under this section includes
4275
the authority to secure:
4276
(a) Samples or specimens of any drug, device, or cosmetic;
4277
or
4278
(b) Such other evidence as is needed for any action to
4280
this part those sections.
4281
(7) The complaint and all information obtained pursuant to
4282
the investigation by the department are confidential and exempt
4283
from the provisions of s. 119.07(1) and s. 24(a), Art. I of the
4284
State Constitution until the investigation and the enforcement
4285
action are completed. However, trade secret information contained
4286
therein as defined by s. 812.081(1)(c) shall remain confidential
4287
and exempt from the provisions of s. 119.07(1) and s. 24(a), Art.
4288
I of the State Constitution, as long as the information is
4289
retained by the department. This subsection does not prohibit the
4290
department from using such information for regulatory or
4291
enforcement proceedings under this chapter or from providing such
4292
information to any law enforcement agency or any other regulatory
4293
agency. However, the receiving agency shall keep such records
4294
confidential and exempt as provided in this subsection. In
4295
addition, this subsection is not intended to prevent compliance
4297
pedigree papers required in that subsection shall not be deemed a
4298
trade secret.
4299
Section 39. Section 499.052, Florida Statutes, is amended
4300
to read:
4301
499.052 Records of interstate shipment.--For the purpose of
4303
interstate commerce and persons receiving drugs, devices, or
4304
cosmetics in interstate commerce must, upon the request, in the
4305
manner set out below, by an officer or employee duly designated
4306
by the department, permit the officer or employee to have access
4307
to and to copy all records showing the movement in interstate
4308
commerce of any drug, device, or cosmetic, and the quantity,
4309
shipper, and consignee thereof.
4310
Section 40. Subsection (4) of section 499.055, Florida
4311
Statutes, is amended to read:
4312
499.055 Reports and dissemination of information by
4313
department.--
4314
(4) The department shall publish on the department's
4315
website and update at least monthly:
4316
(a) A list of the prescription drug wholesale distributors
4317
wholesalers, out-of-state prescription drug wholesale
4318
distributors wholesalers, and retail pharmacy drug wholesale
4319
distributors wholesalers against whom the department has
4320
initiated enforcement action pursuant to this part ss. 499.001-
4321
499.081 to suspend or revoke a permit, seek an injunction, or
4322
otherwise file an administrative complaint and the permit number
4323
of each such wholesale distributor wholesaler.
4324
(b) A list of the prescription drug wholesale distributors
4325
wholesalers, out-of-state prescription drug wholesale
4326
distributors wholesalers, and retail pharmacy drug wholesale
4327
distributors wholesalers to which the department has issued a
4328
permit, including the date on which each permit will expire.
4329
(c) A list of the prescription drug wholesale distributors'
4330
wholesalers, out-of-state prescription drug wholesale
4331
distributors' wholesalers, and retail pharmacy drug wholesale
4332
distributors' wholesalers' permits that have been returned to the
4333
department, were suspended, were revoked, have expired, or were
4334
not renewed in the previous year.
4335
Section 41. Subsections (1) and (3) of section 499.06,
4336
Florida Statutes, are amended to read:
4337
499.06 Embargoing, detaining, or destroying article or
4338
processing equipment which is in violation of law or rule.--
4339
(1) When a duly authorized agent of the department finds,
4340
or has probable cause to believe, that any drug, device, or
4341
cosmetic is in violation of any provision of this part ss.
4343
so as to be dangerous, unwholesome, or fraudulent within the
4345
enforce a stop-sale, stop-use, removal, or hold order, which
4346
order gives notice that such article or processing equipment is,
4347
or is suspected of being, in violation and has been detained or
4348
embargoed, and which order warns all persons not to remove, use,
4349
or dispose of such article or processing equipment by sale or
4350
otherwise until permission for removal, use, or disposal is given
4351
by such agent or the court. It is unlawful for any person to
4352
remove, use, or dispose of such detained or embargoed article or
4353
processing equipment by sale or otherwise without such
4354
permission; and such act is a felony of the second degree,
4356
(3) If the court finds that the detained or embargoed
4357
article or processing equipment is in violation, such article or
4358
processing equipment shall, after entry of the court order, be
4359
destroyed or made sanitary at the expense of the claimant
4360
thereof, under the supervision of such agent; and all court
4361
costs, fees, and storage and other proper expenses shall be taxed
4362
against the claimant of such article or processing equipment or
4363
her or his agent. However, when the violation can be corrected by
4364
proper labeling of the article or sanitizing of the processing
4365
equipment, and after such costs, fees, and expenses have been
4366
paid and a good and sufficient bond, conditioned that such
4367
article be so labeled or processed or such processing equipment
4368
be so sanitized, has been executed, the court may by order direct
4369
that such article or processing equipment be delivered to the
4370
claimant thereof for such labeling, processing, or sanitizing,
4371
under the supervision of an agent of the department. The expense
4372
of such supervision shall be paid by the claimant. Such bond
4373
shall be returned to the claimant of the article or processing
4374
equipment upon representation to the court by the department that
4375
the article or processing equipment is no longer in violation of
4377
supervision have been paid.
4378
Section 42. Section 499.062, Florida Statutes, is amended
4379
to read:
4380
499.062 Cause for Seizure and condemnation of drugs,
4381
devices, or cosmetics.--
4382
(1) Any article of any drug, device, or cosmetic that is
4384
subject to seizure and condemnation by the department or by its
4385
duly authorized agents designated for that purpose in regard to
4386
drugs, devices, or cosmetics.
4387
(2) Whenever a duly authorized officer or employee of the
4388
department finds cause, or has probable cause to believe that
4389
cause exists, for the seizure of any drug, device, or cosmetic,
4390
as set out in this part, he or she shall affix to the article a
4391
tag, stamp, or other appropriate marking, giving notice that the
4392
article is, or is suspected of being, subject to seizure under
4393
this part and that the article has been detained and seized by
4394
the department. Such officer or employee shall also warn all
4395
persons not to remove or dispose of the article, by sale or
4396
otherwise, until permission is given by the department or the
4397
court. Any person who violates this subsection is guilty of a
4398
felony of the second degree, punishable as provided in s.
4400
(a) When any article detained or seized under this
4401
subsection has been found by the department to be subject to
4402
seizure and condemnation, the department shall petition the court
4403
for an order of condemnation or sale, as the court directs. The
4404
proceeds of the sale of drugs, devices, and cosmetics, less the
4405
legal costs and charges, shall be deposited into the Florida
4406
Drug, Device, and Cosmetic Trust Fund.
4407
(b) If the department finds that any article seized under
4408
this subsection was not subject to seizure under that section,
4409
the department or the designated officer or employee shall remove
4410
the tag or marking.
4411
Section 43. Section 499.063, Florida Statutes, is repealed.
4412
Section 44. Section 499.064, Florida Statutes, is repealed.
4413
Section 45. Section 499.065, Florida Statutes, is amended
4414
to read:
4415
499.065 Inspections; imminent danger.--
4416
(1) Notwithstanding s. 499.051, the department shall
4417
inspect each prescription drug wholesale distributor
4418
establishment, prescription drug repackager establishment,
4419
veterinary prescription drug wholesale distributor establishment,
4420
limited prescription drug veterinary wholesale distributor
4421
wholesaler establishment, and retail pharmacy drug wholesale
4422
distributor wholesaler establishment that is required to be
4423
permitted under this part chapter as often as necessary to ensure
4424
compliance with applicable laws and rules. The department shall
4425
have the right of entry and access to these facilities at any
4426
reasonable time.
4427
(2) To protect the public from prescription drugs that are
4428
adulterated or otherwise unfit for human or animal consumption,
4429
the department may examine, sample, seize, and stop the sale or
4430
use of prescription drugs to determine the condition of those
4431
drugs. The department may immediately seize and remove any
4432
prescription drugs if the State Surgeon General or his or her
4433
designee determines that the prescription drugs represent a
4434
threat to the public health. The owner of any property seized
4435
under this section may, within 10 days after the seizure, apply
4436
to a court of competent jurisdiction for whatever relief is
4437
appropriate. At any time after 10 days, the department may
4438
destroy the drugs as contraband.
4439
(3) The department may determine that a prescription drug
4440
wholesale distributor establishment, prescription drug repackager
4441
establishment, veterinary prescription drug wholesale distributor
4442
establishment, limited prescription drug veterinary wholesale
4443
distributor wholesaler establishment, or retail pharmacy drug
4444
wholesale distributor wholesaler establishment that is required
4445
to be permitted under this part chapter is an imminent danger to
4446
the public health and shall require its immediate closure if the
4447
establishment fails to comply with applicable laws and rules and,
4448
because of the failure, presents an imminent threat to the
4449
public's health, safety, or welfare. Any establishment so deemed
4450
and closed shall remain closed until allowed by the department or
4451
by judicial order to reopen.
4452
4453
For purposes of this section, a refusal to allow entry to the
4454
department for inspection at reasonable times, or a failure or
4455
refusal to provide the department with required documentation for
4456
purposes of inspection, constitutes an imminent danger to the
4457
public health.
4458
Section 46. Subsections (1), (2), (3), and (4) of section
4459
499.066, Florida Statutes, are amended to read:
4460
499.066 Penalties; remedies.--In addition to other
4461
penalties and other enforcement provisions:
4462
(1) The department may institute such suits or other legal
4463
proceedings as are required to enforce any provision of this part
4466
prosecution is provided, the department may provide the
4467
appropriate state attorney or other prosecuting agency having
4468
jurisdiction with respect to such prosecution with the relevant
4469
information in the department's possession.
4470
(2) If any person engaged in any activity covered by this
4472
those sections, any rule adopted under this part those sections,
4473
or a cease and desist order as provided by this part those
4474
sections, the department may obtain an injunction in the circuit
4475
court of the county in which the violation occurred or in which
4476
the person resides or has its principal place of business, and
4477
may apply in that court for such temporary and permanent orders
4478
as the department considers necessary to restrain the person from
4479
engaging in any such activities until the person complies with
4481
those sections, and the orders of the department authorized by
4482
this part those sections or to mandate compliance with this part
4484
sections, and any order or permit issued by the department under
4485
this part those sections.
4486
(3) The department may impose an administrative fine, not
4487
to exceed $5,000 per violation per day, for the violation of any
4489
this part those sections. Each day a violation continues
4490
constitutes a separate violation, and each separate violation is
4491
subject to a separate fine. All amounts collected pursuant to
4492
this section shall be deposited into the Florida Drug, Device,
4493
and Cosmetic Trust Fund and are appropriated for the use of the
4495
determining the amount of the fine to be levied for a violation,
4496
the department shall consider:
4497
(a) The severity of the violation;
4498
(b) Any actions taken by the person to correct the
4499
violation or to remedy complaints; and
4500
(c) Any previous violations.
4501
(4) The department shall deposit any rewards, fines, or
4502
collections that are due the department and which derive from
4503
joint enforcement activities with other state and federal
4505
893, or the federal act, into the Florida Drug, Device, and
4506
Cosmetic Trust Fund. The proceeds of those rewards, fines, and
4507
collections are appropriated for the use of the department in
4509
Section 47. Section 499.0661, Florida Statutes, is amended
4510
to read:
4511
499.0661 Cease and desist orders; removal of certain
4512
persons.--
4513
(1) DEFINITION.--As used in this section, the term
4514
"permittee" means any person holding a permit issued pursuant to
4515
s. 499.012.
4516
(1)(2) CEASE AND DESIST ORDERS.--
4517
(a) In addition to any authority otherwise provided in this
4518
chapter, the department may issue and serve a complaint stating
4519
charges upon any permittee or upon any affiliated party, whenever
4520
the department has reasonable cause to believe that the person or
4521
individual named therein is engaging in or has engaged in conduct
4522
that is:
4523
1. An act that demonstrates a lack of fitness or
4524
trustworthiness to engage in the business authorized under the
4526
hazardous to the public health, or constitutes business
4527
operations that are a detriment to the public health;
4528
2. A violation of any provision of this part ss. 499.001-
4529
4530
3. A violation of any rule of the department;
4531
4. A violation of any order of the department; or
4532
5. A breach of any written agreement with the department.
4533
(b) The complaint must contain a statement of facts and
4534
notice of opportunity for a hearing pursuant to ss. 120.569 and
4535
4536
(c) If a hearing is not requested within the time allowed
4538
department finds that any of the charges are proven, the
4539
department may enter an order directing the permittee or the
4540
affiliated party named in the complaint to cease and desist from
4541
engaging in the conduct complained of and take corrective action
4542
to remedy the effects of past improper conduct and assure future
4543
compliance.
4544
(d) A contested or default cease and desist order is
4545
effective when reduced to writing and served upon the permittee
4546
or affiliated party named therein. An uncontested cease and
4547
desist order is effective as agreed.
4548
(e) Whenever the department finds that conduct described in
4549
paragraph (a) is likely to cause an immediate threat to the
4550
public health, it may issue an emergency cease and desist order
4551
requiring the permittee or any affiliated party to immediately
4552
cease and desist from engaging in the conduct complained of and
4553
to take corrective and remedial action. The emergency order is
4554
effective immediately upon service of a copy of the order upon
4555
the permittee or affiliated party named therein and remains
4556
effective for 90 days. If the department begins nonemergency
4557
cease and desist proceedings under this subsection, the emergency
4558
order remains effective until the conclusion of the proceedings
4560
(2)(3) REMOVAL OF AFFILIATED PARTIES BY THE DEPARTMENT.--
4561
(a) The department may issue and serve a complaint stating
4562
charges upon any affiliated party and upon the permittee involved
4563
whenever the department has reason to believe that an affiliated
4564
party is engaging in or has engaged in conduct that constitutes:
4565
1. An act that demonstrates a lack of fitness or
4566
trustworthiness to engage in the business authorized under the
4568
hazardous to the public health, or constitutes business
4569
operations that are a detriment to the public health;
4571
however, if the violation constitutes a misdemeanor, a complaint
4572
may not be served as provided in this section until the
4573
affiliated party is notified in writing of the matter of the
4574
violation and has been afforded a reasonable period of time, as
4575
set forth in the notice, to correct the violation and has failed
4576
to do so;
4577
3. A violation of any other law involving fraud or moral
4578
turpitude which constitutes a felony;
4579
4. A willful violation of any rule of the department;
4580
5. A willful violation of any order of the department; or
4581
6. A material misrepresentation of fact, made knowingly and
4582
willfully or made with reckless disregard for the truth of the
4583
matter.
4584
(b) The complaint must contain a statement of facts and
4585
notice of opportunity for a hearing pursuant to ss. 120.569 and
4586
4587
(c) If a hearing is not requested within the time allotted
4589
department finds that any of the charges in the complaint are
4590
proven true, the department may enter an order removing the
4591
affiliated party or restricting or prohibiting participation by
4592
the person in the affairs of that permittee or of any other
4593
permittee.
4594
(d) A contested or default order of removal, restriction,
4595
or prohibition is effective when reduced to writing and served on
4596
the permittee and the affiliated party. An uncontested order of
4597
removal, restriction, or prohibition is effective as agreed.
4598
(e)1. The chief executive officer, designated
4599
representative, or the person holding the equivalent office, of a
4600
permittee shall promptly notify the department if she or he has
4601
actual knowledge that any affiliated party is charged with a
4602
felony in a state or federal court.
4603
2. Whenever any affiliated party is charged with a felony
4604
in a state or federal court or with the equivalent of a felony in
4605
the courts of any foreign country with which the United States
4606
maintains diplomatic relations, and the charge alleges violation
4607
of any law involving prescription drugs, pharmaceuticals, fraud,
4608
theft, or moral turpitude, the department may enter an emergency
4609
order suspending the affiliated party or restricting or
4610
prohibiting participation by the affiliated party in the affairs
4611
of the particular permittee or of any other permittee upon
4612
service of the order upon the permittee and the affiliated party
4613
charged. The order must contain notice of opportunity for a
4615
party may request a postsuspension hearing to show that continued
4616
service to or participation in the affairs of the permittee does
4617
not pose a threat to the public health or the interests of the
4618
permittee and does not threaten to impair public confidence in
4619
the permittee. In accordance with applicable departmental rules,
4620
the department shall notify the affiliated party whether the
4621
order suspending or prohibiting the person from participation in
4622
the affairs of a permittee will be rescinded or otherwise
4623
modified. The emergency order remains in effect, unless otherwise
4624
modified by the department, until the criminal charge is disposed
4625
of. The acquittal of the person charged, or the final, unappealed
4626
dismissal of all charges against the person, dissolves the
4627
emergency order but does not prohibit the department from
4628
instituting proceedings under paragraph (a). If the person
4629
charged is convicted or pleads guilty or nolo contendere, whether
4630
or not an adjudication of guilt is entered by the court, the
4631
emergency order shall become final.
4632
(f) Any affiliated party removed pursuant to this section
4633
is not eligible for reemployment by the permittee or to be an
4634
affiliated party of any permittee except upon the written consent
4635
of the department. Any affiliated party who is removed,
4636
restricted, or prohibited from participating in the affairs of a
4637
permittee pursuant to this section may petition the department
4638
for modification or termination of the removal, restriction, or
4639
prohibition.
4640
Section 48. Section 499.067, Florida Statutes, is amended
4641
to read:
4642
499.067 Denial, suspension, or revocation of permit,
4643
certification, or registration.--
4644
(1)(a) The department may deny, suspend, or revoke a permit
4645
if it finds that there has been a substantial failure to comply
4647
or chapter 893, the rules adopted under this part any of those
4648
sections or those chapters, any final order of the department, or
4649
applicable federal laws or regulations or other state laws or
4650
rules governing drugs, devices, or cosmetics.
4651
(b) The department may deny an application for a permit or
4652
certification, or suspend or revoke a permit or certification, if
4653
the department finds that:
4654
1. The applicant is not of good moral character or that it
4655
would be a danger or not in the best interest of the public
4656
health, safety, and welfare if the applicant were issued a permit
4657
or certification.
4658
2. The applicant has not met the requirements for the
4659
permit or certification.
4660
3. The applicant is not eligible for a permit or
4661
certification for any of the reasons enumerated in s. 499.012 s.
4663
4. The applicant, permittee, or person certified under s.
4666
5. The applicant, permittee, or person certified under s.
4669
(2) The department may deny, suspend, or revoke any
4670
registration required by the provisions of this part ss. 499.001-
4671
499.081 for the violation of any provision of this part ss.
4673
sections.
4674
(3) The department may revoke or suspend a permit:
4675
(a) If the permit was obtained by misrepresentation or
4676
fraud or through a mistake of the department;
4677
(b) If the permit was procured, or attempted to be
4678
procured, for any other person by making or causing to be made
4679
any false representation; or
4680
(c) If the permittee has violated any provision of this
4682
sections.
4683
(4) If any permit issued under this part ss. 499.001-
4684
499.081 is revoked or suspended, the owner, manager, operator, or
4685
proprietor of the establishment shall cease to operate as the
4686
permit authorized, from the effective date of the suspension or
4687
revocation until the person is again registered with the
4688
department and possesses the required permit. If a permit is
4689
revoked or suspended, the owner, manager, or proprietor shall
4690
remove all signs and symbols that identify the operation as
4691
premises permitted as a drug wholesaling establishment; drug,
4692
device, or cosmetic manufacturing establishment; or retail
4693
establishment. The department shall determine the length of time
4694
for which the permit is to be suspended. If a permit is revoked,
4695
the person that owns or operates the establishment may not apply
4697
of 1 year after the date of the revocation. A revocation of a
4698
permit may be permanent if the department considers that to be in
4699
the best interest of the public health.
4700
(5) The department may deny, suspend, or revoke a permit
4702
permittee to purchase prescription drugs, if any owner, officer,
4703
employee, or other person who participates in administering or
4704
operating the establishment has been found guilty of any
4706
chapter 501, or chapter 893, any rules adopted under this part
4707
any of those sections or those chapters, or any federal or state
4708
drug law, regardless of whether the person has been pardoned, had
4709
her or his civil rights restored, or had adjudication withheld.
4710
(6) The department shall deny, suspend, or revoke the
4711
permit of any person or establishment if the assignment, sale,
4712
transfer, or lease of an establishment permitted under this part
4714
action, or criminal prosecution.
4715
(7) Notwithstanding s. 120.60(5), if a permittee fails to
4717
the permit of the permittee and shall provide notice of the
4718
intended agency action by posting a notice at the department's
4719
headquarters and by mailing a copy of the notice of intended
4720
agency action by certified mail to the most recent mailing
4721
address on record with the department and, if the permittee is
4722
not a natural person, to the permittee's registered agent on file
4723
with the Department of State.
4724
Section 49. Section 499.069, Florida Statutes, is repealed.
4725
Section 50. Section 499.0691, Florida Statutes, is
4726
repealed.
4727
Section 51. Section 499.07, Florida Statutes, is repealed.
4728
Section 52. Section 499.071, Florida Statutes, is repealed.
4729
Section 53. Section 499.081, Florida Statutes, is repealed.
4730
Section 54. Paragraph (a) of subsection (1) of section
4731
895.02, Florida Statutes, is amended to read:
4733
term:
4734
(1) "Racketeering activity" means to commit, to attempt to
4735
commit, to conspire to commit, or to solicit, coerce, or
4736
intimidate another person to commit:
4737
(a) Any crime that is chargeable by indictment or
4738
information under the following provisions of the Florida
4739
Statutes:
4740
1. Section 210.18, relating to evasion of payment of
4741
cigarette taxes.
4742
2. Section 403.727(3)(b), relating to environmental
4743
control.
4745
fraud.
4746
4. Section 414.39, relating to public assistance fraud.
4748
compensation.
4749
6. Section 443.071(4), relating to creation of a fictitious
4750
employer scheme to commit unemployment compensation fraud.
4751
7. Section 465.0161, relating to distribution of medicinal
4752
drugs without a permit as an Internet pharmacy.
4755
prescription contraband and adulterated drugs.
4756
9. Part IV of chapter 501, relating to telemarketing.
4757
10. Chapter 517, relating to sale of securities and
4758
investor protection.
4760
to dogracing and horseracing.
4761
12. Chapter 550, relating to jai alai frontons.
4762
13. Section 551.109, relating to slot machine gaming.
4763
14. Chapter 552, relating to the manufacture, distribution,
4764
and use of explosives.
4765
15. Chapter 560, relating to money transmitters, if the
4766
violation is punishable as a felony.
4767
16. Chapter 562, relating to beverage law enforcement.
4768
17. Section 624.401, relating to transacting insurance
4769
without a certificate of authority, s. 624.437(4)(c)1., relating
4770
to operating an unauthorized multiple-employer welfare
4771
arrangement, or s. 626.902(1)(b), relating to representing or
4772
aiding an unauthorized insurer.
4773
18. Section 655.50, relating to reports of currency
4774
transactions, when such violation is punishable as a felony.
4775
19. Chapter 687, relating to interest and usurious
4776
practices.
4778
real estate timeshare plans.
4779
21. Chapter 782, relating to homicide.
4780
22. Chapter 784, relating to assault and battery.
4781
23. Chapter 787, relating to kidnapping or human
4782
trafficking.
4783
24. Chapter 790, relating to weapons and firearms.
4786
trafficking.
4787
26. Chapter 806, relating to arson.
4788
27. Section 810.02(2)(c), relating to specified burglary of
4789
a dwelling or structure.
4790
28. Chapter 812, relating to theft, robbery, and related
4791
crimes.
4792
29. Chapter 815, relating to computer-related crimes.
4793
30. Chapter 817, relating to fraudulent practices, false
4794
pretenses, fraud generally, and credit card crimes.
4795
31. Chapter 825, relating to abuse, neglect, or
4796
exploitation of an elderly person or disabled adult.
4797
32. Section 827.071, relating to commercial sexual
4798
exploitation of children.
4799
33. Chapter 831, relating to forgery and counterfeiting.
4800
34. Chapter 832, relating to issuance of worthless checks
4801
and drafts.
4802
35. Section 836.05, relating to extortion.
4803
36. Chapter 837, relating to perjury.
4804
37. Chapter 838, relating to bribery and misuse of public
4805
office.
4806
38. Chapter 843, relating to obstruction of justice.
4808
s. 847.07, relating to obscene literature and profanity.
4810
849.25, relating to gambling.
4811
41. Chapter 874, relating to criminal street gangs.
4812
42. Chapter 893, relating to drug abuse prevention and
4813
control.
4814
43. Chapter 896, relating to offenses related to financial
4815
transactions.
4817
a witness, victim, or informant, and retaliation against a
4818
witness, victim, or informant.
4820
jurors and evidence.
4821
Section 55. Paragraphs (d), (h), (i), and (j) of subsection
4822
(3) of section 921.0022, Florida Statutes, are amended to read:
4823
921.0022 Criminal Punishment Code; offense severity ranking
4824
chart.--
4825
(3) OFFENSE SEVERITY RANKING CHART
4826
(d) LEVEL 4
4827
| FloridaStatute | FelonyDegree | Description |
4828
| 316.1935(3)(a) | 2nd | Driving at high speed or with wanton disregard for safety while fleeing or attempting to elude law enforcement officer who is in a patrol vehicle with siren and lights activated. |
4829
| 499.0051(1) | 3rd | Failure to maintain or deliver pedigree papers. |
4830
| 499.0051(2) | 3rd | Failure to authenticate pedigree papers. |
4831
| 499.0051(6) | 2nd | Sale or delivery, or possession with intent to sell, contraband prescription legend drugs. |
4832
| 784.07(2)(b) | 3rd | Battery of law enforcement officer, firefighter, intake officer, etc. |
4833
| 784.074(1)(c) | 3rd | Battery of sexually violent predators facility staff. |
4834
| 784.075 | 3rd | Battery on detention or commitment facility staff. |
4835
| 784.078 | 3rd | Battery of facility employee by throwing, tossing, or expelling certain fluids or materials. |
4836
| 784.08(2)(c) | 3rd | Battery on a person 65 years of age or older. |
4837
| 784.081(3) | 3rd | Battery on specified official or employee. |
4838
| 784.082(3) | 3rd | Battery by detained person on visitor or other detainee. |
4839
| 784.083(3) | 3rd | Battery on code inspector. |
4840
| 784.085 | 3rd | Battery of child by throwing, tossing, projecting, or expelling certain fluids or materials. |
4841
| 787.03(1) | 3rd | Interference with custody; wrongly takes minor from appointed guardian. |
4842
| 787.04(2) | 3rd | Take, entice, or remove child beyond state limits with criminal intent pending custody proceedings. |
4843
| 787.04(3) | 3rd | Carrying child beyond state lines with criminal intent to avoid producing child at custody hearing or delivering to designated person. |
4844
| 790.115(1) | 3rd | Exhibiting firearm or weapon within 1,000 feet of a school. |
4845
| 790.115(2)(b) | 3rd | Possessing electric weapon or device, destructive device, or other weapon on school property. |
4846
| 790.115(2)(c) | 3rd | Possessing firearm on school property. |
4847
| 800.04(7)(d) | 3rd | Lewd or lascivious exhibition; offender less than 18 years. |
4848
| 810.02(4)(a) | 3rd | Burglary, or attempted burglary, of an unoccupied structure; unarmed; no assault or battery. |
4849
| 810.02(4)(b) | 3rd | Burglary, or attempted burglary, of an unoccupied conveyance; unarmed; no assault or battery. |
4850
| 810.06 | 3rd | Burglary; possession of tools. |
4851
| 810.08(2)(c) | 3rd | Trespass on property, armed with firearm or dangerous weapon. |
4852
| 812.014(2)(c)3. | 3rd | Grand theft, 3rd degree $10,000 or more but less than $20,000. |
4853
| 812.014(2)(c)4.-10. | 3rd | Grand theft, 3rd degree, a will, firearm, motor vehicle, livestock, etc. |
4854
| 812.0195(2) | 3rd | Dealing in stolen property by use of the Internet; property stolen $300 or more. |
4855
| 817.563(1) | 3rd | Sell or deliver substance other than controlled substance agreed upon, excluding s. 893.03(5) drugs. |
4856
| 817.568(2)(a) | 3rd | Fraudulent use of personal identification information. |
4857
| 817.625(2)(a) | 3rd | Fraudulent use of scanning device or reencoder. |
4858
| 828.125(1) | 2nd | Kill, maim, or cause great bodily harm or permanent breeding disability to any registered horse or cattle. |
4859
| 837.02(1) | 3rd | Perjury in official proceedings. |
4860
| 837.021(1) | 3rd | Make contradictory statements in official proceedings. |
4861
| 838.022 | 3rd | Official misconduct. |
4862
| 839.13(2)(a) | 3rd | Falsifying records of an individual in the care and custody of a state agency. |
4863
| 839.13(2)(c) | 3rd | Falsifying records of the Department of Children and Family Services. |
4864
| 843.021 | 3rd | Possession of a concealed handcuff key by a person in custody. |
4865
| 843.025 | 3rd | Deprive law enforcement, correctional, or correctional probation officer of means of protection or communication. |
4866
| 843.15(1)(a) | 3rd | Failure to appear while on bail for felony (bond estreature or bond jumping). |
4867
| 874.05(1) | 3rd | Encouraging or recruiting another to join a criminal street gang. |
4868
| 893.13(2)(a)1. | 2nd | Purchase of cocaine (or other s. 893.03(1)(a), (b), or (d), (2)(a), (2)(b), or (2)(c)4. drugs). |
4869
| 914.14(2) | 3rd | Witnesses accepting bribes. |
4870
| 914.22(1) | 3rd | Force, threaten, etc., witness, victim, or informant. |
4871
| 914.23(2) | 3rd | Retaliation against a witness, victim, or informant, no bodily injury. |
4872
| 918.12 | 3rd | Tampering with jurors. |
4873
| 934.215 | 3rd | Use of two-way communications device to facilitate commission of a crime. |
4874
4875
4876
(h) LEVEL 8
4877
| FloridaStatute | FelonyDegree | Description |
4878
| 316.193(3)(c)3.a. | 2nd | DUI manslaughter. |
4879
| 316.1935(4)(b) | 1st | Aggravated fleeing or attempted eluding with serious bodily injury or death. |
4880
| 327.35(3)(c)3. | 2nd | Vessel BUI manslaughter. |
4881
4882
4883
| 560.123(8)(b)2. | 2nd | Failure to report currency or payment instruments totaling or exceeding $20,000, but less than $100,000 by money transmitter. |
4884
| 560.125(5)(b) | 2nd | Money transmitter business by unauthorized person, currency or payment instruments totaling or exceeding $20,000, but less than $100,000. |
4885
| 655.50(10)(b)2. | 2nd | Failure to report financial transactions totaling or exceeding $20,000, but less than $100,000 by financial institutions. |
4886
| 777.03(2)(a) | 1st | Accessory after the fact, capital felony. |
4887
| 782.04(4) | 2nd | Killing of human without design when engaged in act or attempt of any felony other than arson, sexual battery, robbery, burglary, kidnapping, aircraft piracy, or unlawfully discharging bomb. |
4888
| 782.051(2) | 1st | Attempted felony murder while perpetrating or attempting to perpetrate a felony not enumerated in s. 782.04(3). |
4889
| 782.071(1)(b) | 1st | Committing vehicular homicide and failing to render aid or give information. |
4890
| 782.072(2) | 1st | Committing vessel homicide and failing to render aid or give information. |
4891
| 790.161(3) | 1st | Discharging a destructive device which results in bodily harm or property damage. |
4892
| 794.011(5) | 2nd | Sexual battery, victim 12 years or over, offender does not use physical force likely to cause serious injury. |
4893
| 794.08(3) | 2nd | Female genital mutilation, removal of a victim younger than 18 years of age from this state. |
4894
| 800.04(4) | 2nd | Lewd or lascivious battery. |
4895
| 806.01(1) | 1st | Maliciously damage dwelling or structure by fire or explosive, believing person in structure. |
4896
| 810.02(2)(a) | 1st,PBL | Burglary with assault or battery. |
4897
| 810.02(2)(b) | 1st,PBL | Burglary; armed with explosives or dangerous weapon. |
4898
| 810.02(2)(c) | 1st | Burglary of a dwelling or structure causing structural damage or $1,000 or more property damage. |
4899
| 812.014(2)(a)2. | 1st | Property stolen; cargo valued at $50,000 or more, grand theft in 1st degree. |
4900
| 812.13(2)(b) | 1st | Robbery with a weapon. |
4901
| 812.135(2)(c) | 1st | Home-invasion robbery, no firearm, deadly weapon, or other weapon. |
4902
| 817.568(6) | 2nd | Fraudulent use of personal identification information of an individual under the age of 18. |
4903
| 825.102(2) | 2nd | Aggravated abuse of an elderly person or disabled adult. |
4904
| 825.1025(2) | 2nd | Lewd or lascivious battery upon an elderly person or disabled adult. |
4905
| 825.103(2)(a) | 1st | Exploiting an elderly person or disabled adult and property is valued at $100,000 or more. |
4906
| 837.02(2) | 2nd | Perjury in official proceedings relating to prosecution of a capital felony. |
4907
| 837.021(2) | 2nd | Making contradictory statements in official proceedings relating to prosecution of a capital felony. |
4908
| 860.121(2)(c) | 1st | Shooting at or throwing any object in path of railroad vehicle resulting in great bodily harm. |
4909
| 860.16 | 1st | Aircraft piracy. |
4910
| 893.13(1)(b) | 1st | Sell or deliver in excess of 10 grams of any substance specified in s. 893.03(1)(a) or (b). |
4911
4912
4913
| 893.135(1)(a)2. | 1st | Trafficking in cannabis, more than 2,000 lbs., less than 10,000 lbs. |
4914
| 893.135(1)(b)1.b. | 1st | Trafficking in cocaine, more than 200 grams, less than 400 grams. |
4915
| 893.135(1)(c)1.b. | 1st | Trafficking in illegal drugs, more than 14 grams, less than 28 grams. |
4916
| 893.135(1)(d)1.b. | 1st | Trafficking in phencyclidine, more than 200 grams, less than 400 grams. |
4917
| 893.135(1)(e)1.b. | 1st | Trafficking in methaqualone, more than 5 kilograms, less than 25 kilograms. |
4918
| 893.135(1)(f)1.b. | 1st | Trafficking in amphetamine, more than 28 grams, less than 200 grams. |
4919
| 893.135(1)(g)1.b. | 1st | Trafficking in flunitrazepam, 14 grams or more, less than 28 grams. |
4920
| 893.135(1)(h)1.b. | 1st | Trafficking in gamma-hydroxybutyric acid (GHB), 5 kilograms or more, less than 10 kilograms. |
4921
| 893.135(1)(j)1.b. | 1st | Trafficking in 1,4-Butanediol, 5 kilograms or more, less than 10 kilograms. |
4922
| 893.135(1)(k)2.b. | 1st | Trafficking in Phenethylamines, 200 grams or more, less than 400 grams. |
4923
| 895.03(1) | 1st | Use or invest proceeds derived from pattern of racketeering activity. |
4924
| 895.03(2) | 1st | Acquire or maintain through racketeering activity any interest in or control of any enterprise or real property. |
4925
| 895.03(3) | 1st | Conduct or participate in any enterprise through pattern of racketeering activity. |
4926
| 896.101(5)(b) | 2nd | Money laundering, financial transactions totaling or exceeding $20,000, but less than $100,000. |
4927
| 896.104(4)(a)2. | 2nd | Structuring transactions to evade reporting or registration requirements, financial transactions totaling or exceeding $20,000 but less than $100,000. |
4928
4929
4930
(i) LEVEL 9
4931
| FloridaStatute | FelonyDegree | Description |
4932
| 316.193(3)(c)3.b. | 1st | DUI manslaughter; failing to render aid or give information. |
4933
| 327.35(3)(c)3.b. | 1st | BUI manslaughter; failing to render aid or give information. |
4934
| 499.0051(9) 499.00535 | 1st | Sale or purchase of contraband prescription legend drugs resulting in great bodily harm. |
4935
| 560.123(8)(b)3. | 1st | Failure to report currency or payment instruments totaling or exceeding $100,000 by money transmitter. |
4936
| 560.125(5)(c) | 1st | Money transmitter business by unauthorized person, currency, or payment instruments totaling or exceeding $100,000. |
4937
| 655.50(10)(b)3. | 1st | Failure to report financial transactions totaling or exceeding $100,000 by financial institution. |
4938
| 775.0844 | 1st | Aggravated white collar crime. |
4939
| 782.04(1) | 1st | Attempt, conspire, or solicit to commit premeditated murder. |
4940
| 782.04(3) | 1st,PBL | Accomplice to murder in connection with arson, sexual battery, robbery, burglary, and other specified felonies. |
4941
| 782.051(1) | 1st | Attempted felony murder while perpetrating or attempting to perpetrate a felony enumerated in s. 782.04(3). |
4942
| 782.07(2) | 1st | Aggravated manslaughter of an elderly person or disabled adult. |
4943
| 787.01(1)(a)1. | 1st,PBL | Kidnapping; hold for ransom or reward or as a shield or hostage. |
4944
| 787.01(1)(a)2. | 1st,PBL | Kidnapping with intent to commit or facilitate commission of any felony. |
4945
| 787.01(1)(a)4. | 1st,PBL | Kidnapping with intent to interfere with performance of any governmental or political function. |
4946
| 787.02(3)(a) | 1st | False imprisonment; child under age 13; perpetrator also commits aggravated child abuse, sexual battery, or lewd or lascivious battery, molestation, conduct, or exhibition. |
4947
| 790.161 | 1st | Attempted capital destructive device offense. |
4948
| 790.166(2) | 1st,PBL | Possessing, selling, using, or attempting to use a weapon of mass destruction. |
4949
| 794.011(2) | 1st | Attempted sexual battery; victim less than 12 years of age. |
4950
| 794.011(2) | Life | Sexual battery; offender younger than 18 years and commits sexual battery on a person less than 12 years. |
4951
| 794.011(4) | 1st | Sexual battery; victim 12 years or older, certain circumstances. |
4952
| 794.011(8)(b) | 1st | Sexual battery; engage in sexual conduct with minor 12 to 18 years by person in familial or custodial authority. |
4953
| 794.08(2) | 1st | Female genital mutilation; victim younger than 18 years of age. |
4954
| 800.04(5)(b) | Life | Lewd or lascivious molestation; victim less than 12 years; offender 18 years or older. |
4955
| 812.13(2)(a) | 1st,PBL | Robbery with firearm or other deadly weapon. |
4956
| 812.133(2)(a) | 1st,PBL | Carjacking; firearm or other deadly weapon. |
4957
| 812.135(2)(b) | 1st | Home-invasion robbery with weapon. |
4958
| 817.568(7) | 2nd,PBL | Fraudulent use of personal identification information of an individual under the age of 18 by his or her parent, legal guardian, or person exercising custodial authority. |
4959
| 827.03(2) | 1st | Aggravated child abuse. |
4960
| 847.0145(1) | 1st | Selling, or otherwise transferring custody or control, of a minor. |
4961
| 847.0145(2) | 1st | Purchasing, or otherwise obtaining custody or control, of a minor. |
4962
| 859.01 | 1st | Poisoning or introducing bacteria, radioactive materials, viruses, or chemical compounds into food, drink, medicine, or water with intent to kill or injure another person. |
4963
| 893.135 | 1st | Attempted capital trafficking offense. |
4964
| 893.135(1)(a)3. | 1st | Trafficking in cannabis, more than 10,000 lbs. |
4965
| 893.135(1)(b)1.c. | 1st | Trafficking in cocaine, more than 400 grams, less than 150 kilograms. |
4966
| 893.135(1)(c)1.c. | 1st | Trafficking in illegal drugs, more than 28 grams, less than 30 kilograms. |
4967
| 893.135(1)(d)1.c. | 1st | Trafficking in phencyclidine, more than 400 grams. |
4968
| 893.135(1)(e)1.c. | 1st | Trafficking in methaqualone, more than 25 kilograms. |
4969
| 893.135(1)(f)1.c. | 1st | Trafficking in amphetamine, more than 200 grams. |
4970
| 893.135(1)(h)1.c. | 1st | Trafficking in gamma-hydroxybutyric acid (GHB), 10 kilograms or more. |
4971
| 893.135(1)(j)1.c. | 1st | Trafficking in 1,4-Butanediol, 10 kilograms or more. |
4972
| 893.135(1)(k)2.c. | 1st | Trafficking in Phenethylamines, 400 grams or more. |
4973
| 896.101(5)(c) | 1st | Money laundering, financial instruments totaling or exceeding $100,000. |
4974
| 896.104(4)(a)3. | 1st | Structuring transactions to evade reporting or registration requirements, financial transactions totaling or exceeding $100,000. |
4975
4976
4977
(j) LEVEL 10
4978
| FloridaStatute | FelonyDegree | Description |
4979
| 499.0051(10) 499.00545 | 1st | Sale or purchase of contraband prescription legend drugs resulting in death. |
4980
| 782.04(2) | 1st,PBL | Unlawful killing of human; act is homicide, unpremeditated. |
4981
| 787.01(1)(a)3. | 1st,PBL | Kidnapping; inflict bodily harm upon or terrorize victim. |
4982
| 787.01(3)(a) | Life | Kidnapping; child under age 13, perpetrator also commits aggravated child abuse, sexual battery, or lewd or lascivious battery, molestation, conduct, or exhibition. |
4983
| 782.07(3) | 1st | Aggravated manslaughter of a child. |
4984
| 794.011(3) | Life | Sexual battery; victim 12 years or older, offender uses or threatens to use deadly weapon or physical force to cause serious injury. |
4985
| 812.135(2)(a) | 1st,PBL | Home-invasion robbery with firearm or other deadly weapon. |
4986
| 876.32 | 1st | Treason against the state. |
4987
4988
Section 56. This act shall take effect July 1, 2008.
CODING: Words stricken are deletions; words underlined are additions.