HB 7049

1	A bill to be entitled
2	An act relating to drugs, devices, and cosmetics; amending
3	and reorganizing provisions in part I of ch. 499, F.S.;
4	amending s. 499.002, F.S.; expanding the provisions of the
5	section to include administration and enforcement of,
6	exemptions from, and purpose of the part; amending and
7	redesignating ss. 499.004, 499.0053, 499.07, 499.071, and
8	499.081, F.S., as provisions in that section relating to
9	such functions to conform; amending s. 499.003, F.S.;
10	revising and providing definitions; amending and
11	redesignating provisions in ss. 499.012, 499.029, and
12	499.0661, F.S., relating to definitions, as provisions of
13	that section; amending s. 499.005, F.S.; conforming
14	provisions to changes made by the act, including the
15	substitution of the term "prescription drug" for the term
16	"legend drug"; amending s. 499.0051, F.S.; substituting
17	the term "prescription drug" for the term "legend drug"
18	with regard to criminal acts; consolidating criminal act
19	provisions of part I of ch. 499, F.S.; amending and
20	redesignating ss. 499.0052, 499.00535, 499.00545, 499.069,
21	and 499.0691, F.S., as criminal offense provisions in that
22	section; providing penalties; conforming provisions to
23	changes made by the act; amending s. 499.0054, F.S.,
24	relating to advertising and labeling of drugs, devices,
25	and cosmetics to include certain exemptions; amending and
26	redesignating ss. 499.0055 and 499.0057, F.S., as
27	provisions relating to those functions in that section;
28	amending s. 499.006, F.S.; conforming provisions to
29	changes made by the act; amending s. 499.007, F.S.;
30	conforming provisions to changes made by the act;
31	providing that a drug or device is misbranded if it is an
32	active pharmaceutical ingredient in bulk form and does not
33	bear a label containing certain information; amending ss.
34	499.008 and 499.009, F.S.; conforming provisions to
35	changes made by the act; amending s. 499.01, F.S.;
36	providing that the section relates only to permits;
37	providing requirements for obtaining a permit to operate
38	in certain capacities; deleting certain permit
39	requirements; amending and redesignating provisions of ss.
40	499.012, 499.013, and 499.014, F.S., relating to such
41	functions as provisions of that section; conforming
42	provisions and cross-references to changes made by the
43	act; amending s. 499.012, F.S.; providing that the section
44	relates to permit application requirements; amending the
45	provisions to conform; amending and redesignating
46	provisions of s. 499.01, F.S., relating to such functions
47	as provisions of that section; conforming provisions and
48	cross-references to changes made by the act; amending s.
49	499.01201, F.S.; conforming provisions to changes made by
50	the act; amending s. 499.0121, F.S., relating to storage
51	and handling of prescription drugs and recordkeeping;
52	directing the department to adopt rules requiring a
53	wholesale distributor to maintain pedigree papers separate
54	and distinct from other required records; deleting a
55	requirement that a person who is engaged in the wholesale
56	distribution of a prescription drug and who is not the
57	manufacturer of that drug provide a pedigree paper to the
58	person who receives the drug; deleting the department's
59	requirement to adopt rules with regard to recordkeeping by
60	affiliated groups; conforming provisions and cross-
61	references to changes made by the act; amending and
62	redesignating a provision of s. 499.013, F.S., relating to
63	such functions as a provision of that section; amending s.
64	499.01211, F.S.; conforming provisions and cross-
65	references to changes made by the act; creating s.
66	499.01212, F.S.; requiring a person who is engaged in the
67	wholesale distribution of a prescription drug to provide a
68	pedigree paper to the person who receives the drug;
69	requiring certain information in a pedigree paper;
70	requiring a wholesale distributor to maintain and make
71	available to the department certain information; providing
72	exceptions to the requirement of a pedigree paper;
73	repealing s. 499.0122, F.S., relating to medical oxygen
74	and veterinary legend drug retail establishments;
75	repealing s. 499.013, F.S., relating to manufacturers and
76	repackagers of drugs, devices, and cosmetics; amending ss.
77	499.015, 499.024, 499.028, 499.029, and 499.03, F.S.;
78	conforming provisions and cross-references to changes made
79	by the act; amending ss. 499.032 and 499.033, F.S.;
80	conforming terminology to changes made by the act;
81	amending s. 499.039, F.S.; conforming a provision and
82	cross-reference; amending ss. 499.04 and 499.041, F.S.;
83	conforming provisions to changes made by the act; amending
84	s. 499.05, F.S.; conforming provisions to changes made by
85	the act; requiring the department to adopt rules with
86	regard to procedures and forms relating to pedigree paper
87	requirements, alternatives to compliance with the
88	requirement of certain pedigree papers, and the return of
89	prescription drugs purchased before a specified date;
90	amending and redesignating provisions of ss. 499.013 and
91	499.0122, F.S., as provisions relating to rulemaking
92	functions of that section; amending ss. 499.051, 499.052,
93	499.055, and 499.06, F.S.; conforming provisions to
94	changes made by the act; amending s. 499.062, F.S.;
95	providing that the section relates to seizure and
96	condemnation of drugs, devices, or cosmetics; conforming a
97	provision to changes made by the act; amending and
98	redesignating ss. 499.063 and 499.064, F.S., as provisions
99	relating to such functions in that section; amending ss.
100	499.065, 499.066, 499.0661, and 499.067, F.S.; conforming
101	provisions and cross-references to changes made by the
102	act; amending ss. 409.9201, 460.403, 465.0265, 794.075,
103	895.02, and 921.0022, F.S.; conforming cross-references to
104	changes made by the act; providing an effective date.
105
106	Be It Enacted by the Legislature of the State of Florida:
107
108	Section 1.  Section 499.002, Florida Statutes, is amended;
109	section 499.004, Florida Statutes, is redesignated as subsection
110	(2) of that section and amended; section 499.0053, Florida
111	Statutes, is redesignated as subsection (3) of that section and
112	amended; section 499.07, Florida Statutes, is redesignated as
113	subsection (4) of that section and amended; section 499.071,
114	Florida Statutes, is redesignated as subsection (5) of that
115	section and amended; and section 499.081, Florida Statutes, is
116	redesignated as subsection (6) of that section and amended, to
117	read:
118	499.002  Purpose, administration, and enforcement of and
119	exemption from this part ss. 499.001-499.081.--
120	(1)  This part is Sections 499.001-499.081 are intended to:
121	(a)(1)  Safeguard the public health and promote the public
122	welfare by protecting the public from injury by product use and
123	by merchandising deceit involving drugs, devices, and cosmetics.
124	(b)(2)  Provide uniform legislation to be administered so
125	far as practicable in conformity with the provisions of, and
126	regulations issued under the authority of, the Federal Food,
127	Drug, and Cosmetic Act and that portion of the Federal Trade
128	Commission Act which expressly prohibits the false advertisement
129	of drugs, devices, and cosmetics.
130	(c)(3)  Promote thereby uniformity of such state and
131	federal laws, and their administration and enforcement,
132	throughout the United States.
133	(2)  499.004  Administration and enforcement by
134	department.--The department of Health shall administer and
135	enforce this part ss. 499.001-499.081 to prevent fraud,
136	adulteration, misbranding, or false advertising in the
137	preparation, manufacture, repackaging, or distribution of drugs,
138	devices, and cosmetics.
139	(3)  499.0053  Power to administer oaths, take depositions,
140	and issue and serve subpoenas.--For the purpose of any
141	investigation or proceeding conducted by the department under
142	this part ss. 499.001-499.081, the department may administer
143	oaths, take depositions, issue and serve subpoenas, and compel
144	the attendance of witnesses and the production of books, papers,
145	documents, or other evidence. The department shall exercise this
146	power on its own initiative. Challenges to, and enforcement of,
147	the subpoenas and orders shall be handled as provided in s.
148	120.569.
149	(4)  499.07  Duty of prosecuting officer.--Each state
150	attorney, county attorney, or municipal attorney to whom the
151	department or its designated agent reports any violation of this
152	part ss. 499.001-499.081 shall cause appropriate proceedings to
153	be instituted in the proper courts without delay and to be
154	prosecuted in the manner required by law.
155	(5)  499.071  Issuance of warnings for minor
156	violations.--This part does Sections 499.001-499.081 do not
157	require the department to report, for the institution of
158	proceedings under this part ss. 499.001-499.081, minor
159	violations of this part ss. 499.001-499.081 when it believes
160	that the public interest will be adequately served in the
161	circumstances by a suitable written notice or warning.
162	(6)  499.081  Carriers in interstate commerce exempted from
163	ss. 499.001-499.081.--Carriers engaged in interstate commerce
164	are not subject to this part ss. 499.001-499.081 if they are
165	engaged in the usual course of business as carriers.
166	Section 2.  Section 499.003, Florida Statutes, is amended;
167	paragraphs (a) through (f) of subsection (1) of section 499.012,
168	Florida Statutes, are redesignated as subsections (55), (56),
169	(52), and (48), paragraph (c) of subsection (48), and subsection
170	(53), respectively, of that section and amended; paragraphs (f)
171	through (j) and (l) through (n) of subsection (3) of section
172	499.029, Florida Statutes, are redesignated as subsections (25),
173	(23), (26), (27), (35), (40), (41), and (43), respectively, of
174	that section and amended; and subsection (1) of section
175	499.0661, Florida Statutes, is redesignated as subsection (38)
176	of that section and amended, to read:
177	499.003  Definitions of terms used in this part ss.
178	499.001-499.081.--As used in this part ss. 499.001-499.081, the
179	term:
180	(1)  "Advertisement" means any representation disseminated
181	in any manner or by any means, other than by labeling, for the
182	purpose of inducing, or which is likely to induce, directly or
183	indirectly, the purchase of drugs, devices, or cosmetics.
184	(2)  "Affiliated group" means an affiliated group as
185	defined by s. 1504 of the Internal Revenue Code of 1986, as
186	amended, which is composed of chain drug entities, including at
187	least 50 retail pharmacies, warehouses, or repackagers, which
188	are members of the same affiliated group. The affiliated group
189	must disclose the names of all its members to the department.
190	(3)(2)  "Affiliated party" means:
191	(a)  A director, officer, trustee, partner, or committee
192	member of a permittee or applicant or a subsidiary or service
193	corporation of the permittee or applicant;
194	(b)  A person who, directly or indirectly, manages,
195	controls, or oversees the operation of a permittee or applicant,
196	regardless of whether such person is a partner, shareholder,
197	manager, member, officer, director, independent contractor, or
198	employee of the permittee or applicant;
199	(c)  A person who has filed or is required to file a
200	personal information statement pursuant to s. 499.012(9) s.
201	499.012(4) or is required to be identified in an application for
202	a permit or to renew a permit pursuant to s. 499.012(8) s.
203	499.012(3); or
204	(d)  The five largest natural shareholders that own at
205	least 5 percent of the permittee or applicant.
206	(4)(3)  "Applicant" means a person applying for a permit or
207	certification under this part ss. 499.001-499.081.
208	(5)(4)  "Authenticate" means to affirmatively verify upon
209	receipt before any distribution of a prescription legend drug
210	occurs that each transaction listed on the pedigree paper has
211	occurred. A wholesale distributor is not required to open a
212	sealed, medical convenience kit to authenticate a pedigree paper
213	for a prescription drug contained within the kit.
214	(6)(5)  "Certificate of free sale" means a document
215	prepared by the department which certifies a drug, device, or
216	cosmetic, that is registered with the department, as one that
217	can be legally sold in the state.
218	(7)  "Chain pharmacy warehouse" means a wholesale
219	distributor permitted pursuant to s. 499.01 that maintains a
220	physical location for prescription drugs that functions solely
221	as a central warehouse to perform intracompany transfers of such
222	drugs to a member of its affiliated group.
223	(8)(6)  "Closed pharmacy" means a pharmacy that is licensed
224	under chapter 465 and purchases prescription drugs for use by a
225	limited patient population and not for wholesale distribution or
226	sale to the public. The term does not include retail pharmacies.
227	(9)(7)  "Color" includes black, white, and intermediate
228	grays.
229	(10)(8)  "Color additive" means, with the exception of any
230	material that has been or hereafter is exempt under the federal
231	act, a material that:
232	(a)  Is a dye pigment, or other substance, made by a
233	process of synthesis or similar artifice, or extracted,
234	isolated, or otherwise derived, with or without intermediate or
235	final change of identity from a vegetable, animal, mineral, or
236	other source; or
237	(b)  When added or applied to a drug or cosmetic or to the
238	human body, or any part thereof, is capable alone, or through
239	reaction with other substances, of imparting color thereto;
240
241	except that the term does not include any material which has
242	been or hereafter is exempt under the federal act.
243	(11)(9)  "Compressed medical gas" means any liquefied or
244	vaporized gas that is a prescription drug, whether it is alone
245	or in combination with other gases.
246	(12)(10)  "Contraband prescription legend drug" means any
247	adulterated drug, as defined in s. 499.006, any counterfeit
248	drug, as defined in this section, and also means any
249	prescription legend drug for which a pedigree paper does not
250	exist, or for which the pedigree paper in existence has been
251	forged, counterfeited, falsely created, or contains any altered,
252	false, or misrepresented matter.
253	(13)(11)  "Cosmetic" means an article, with the exception
254	of soap, that is:
255	(a)  Intended to be rubbed, poured, sprinkled, or sprayed
256	on; introduced into; or otherwise applied to the human body or
257	any part thereof for cleansing, beautifying, promoting
258	attractiveness, or altering the appearance; or
259	(b)  Intended for use as a component of any such article;
260
261	except that the term does not include soap.
262	(14)(12)  "Counterfeit drug," "counterfeit device," or
263	"counterfeit drug, counterfeit device, or counterfeit cosmetic"
264	means a drug, device, or cosmetic which, or the container, seal,
265	or labeling of which, without authorization, bears the
266	trademark, trade name, or other identifying mark, imprint, or
267	device, or any likeness thereof, of a drug, device, or cosmetic
268	manufacturer, processor, packer, or distributor other than the
269	person that in fact manufactured, processed, packed, or
270	distributed that drug, device, or cosmetic and which thereby
271	falsely purports or is represented to be the product of, or to
272	have been packed or distributed by, that other drug, device, or
273	cosmetic manufacturer, processor, packer, or distributor.
274	(15)(13)  "Department" means the Department of Health.
275	(16)(14)  "Device" means any instrument, apparatus,
276	implement, machine, contrivance, implant, in vitro reagent, or
277	other similar or related article, including its components,
278	parts, or accessories, which is:
279	(a)  Recognized in the current edition of the United States
280	Pharmacopoeia and National Formulary, or any supplement thereof,
281	(b)  Intended for use in the diagnosis, cure, mitigation,
282	treatment, therapy, or prevention of disease in humans or other
283	animals, or
284	(c)  Intended to affect the structure or any function of
285	the body of humans or other animals,
286
287	and that which does not achieve any of its principal intended
288	purposes through chemical action within or on the body of humans
289	or other animals and which is not dependent upon being
290	metabolized for the achievement of any of its principal intended
291	purposes.
292	(17)(15)  "Distribute or distribution" or "distribution"
293	means to sell; offer to sell; give away; transfer, whether by
294	passage of title, physical movement, or both; deliver; or offer
295	to deliver. The term does not mean to administer or dispense.
296	(18)  "Drop shipment" means the sale of a prescription drug
297	from a manufacturer to a wholesale distributor, where the
298	wholesale distributor takes title to, but not possession of, the
299	prescription drug and the manufacturer of the prescription drug
300	ships the prescription drug directly to a chain pharmacy
301	warehouse or a person authorized by law to purchase prescription
302	drugs for the purpose of administering or dispensing the drug,
303	as defined in s. 465.003.
304	(16)  "Diverted from the legal channels of distribution for
305	prescription drugs" means an adulterated drug pursuant to s.
306	499.006(10).
307	(19)(17)  "Drug" means an article that is:
308	(a)  Recognized in the current edition of the United States
309	Pharmacopoeia and National Formulary, official Homeopathic
310	Pharmacopoeia of the United States, or any supplement to any of
311	those publications;
312	(b)  Intended for use in the diagnosis, cure, mitigation,
313	treatment, therapy, or prevention of disease in humans or other
314	animals;
315	(c)  Intended to affect the structure or any function of
316	the body of humans or other animals; or
317	(d)  Intended for use as a component of any article
318	specified in paragraph (a), paragraph (b), or paragraph (c), but
319	does not include devices or their components, parts, or
320	accessories.
321	(20)(18)  "Establishment" means a place of business at one
322	general physical location.
323	(21)(19)  "Federal act" means the Federal Food, Drug, and
324	Cosmetic Act, 21 U.S.C. ss. 301 et seq.; 52 Stat. 1040 et seq.
325	(22)(20)  "Freight forwarder" means a person who receives
326	prescription legend drugs which are owned by another person and
327	designated by that person for export, and exports those
328	prescription legend drugs.
329	(23)(g)  "Health care clinic" means a health care clinic
330	licensed under part X of chapter 400.
331	(24)(21)  "Health care entity" means a closed pharmacy or
332	any person, organization, or business entity that provides
333	diagnostic, medical, surgical, or dental treatment or care, or
334	chronic or rehabilitative care, but does not include any
335	wholesale distributor or retail pharmacy licensed under state
336	law to deal in prescription drugs.
337	(25)(f)  "Health care facility" means a health care
338	facility licensed under chapter 395.
339	(26)(h)  "Hospice" means a corporation licensed under part
340	IV of chapter 400.
341	(27)(i)  "Hospital" means a facility as defined in s.
342	395.002 and licensed under chapter 395.
343	(28)(22)  "Immediate container" does not include package
344	liners.
345	(29)(23)  "Label" means a display of written, printed, or
346	graphic matter upon the immediate container of any drug, device,
347	or cosmetic. A requirement made by or under authority of this
348	part ss. 499.001-499.081 or rules adopted under this part those
349	sections that any word, statement, or other information appear
350	on the label is not complied with unless such word, statement,
351	or other information also appears on the outside container or
352	wrapper, if any, of the retail package of such drug, device, or
353	cosmetic or is easily legible through the outside container or
354	wrapper.
355	(30)(24)  "Labeling" means all labels and other written,
356	printed, or graphic matters:
357	(a)  Upon a drug, device, or cosmetic, or any of its
358	containers or wrappers; or
359	(b)  Accompanying or related to such drug, device, or
360	cosmetic.
361	(25)  "Legend drug," "prescription drug," or "medicinal
362	drug" means any drug, including, but not limited to, finished
363	dosage forms, or active ingredients subject to, defined by, or
364	described by s. 503(b) of the Federal Food, Drug, and Cosmetic
365	Act or s. 465.003(8), s. 499.007(12), or s. 499.0122(1)(b) or
366	(c).
367	(26)  "Legend drug label" means any display of written,
368	printed, or graphic matter upon the immediate container of any
369	legend drug prior to its dispensing to an individual patient
370	pursuant to a prescription of a practitioner authorized by law
371	to prescribe.
372	(31)(27)  "Manufacture" means the preparation, deriving,
373	compounding, propagation, processing, producing, or fabrication
374	of any drug, device, or cosmetic.
375	(32)(28)  "Manufacturer" means:
376	(a)  A person who prepares, derives, manufactures, or
377	produces a drug, device, or cosmetic.
378	(b)  The holder or holders of a New Drug Application (NDA),
379	an Abbreviated New Drug Application (ANDA), a Biologics License
380	Application (BLA), or a New Animal Drug Application (NADA),
381	provided such application has become effective or is otherwise
382	approved consistent with s. 499.023; a private label distributor
383	for whom the private label distributor's prescription drugs are
384	originally manufactured and labeled for the distributor and have
385	not been repackaged; or the distribution point for the
386	manufacturer, contract manufacturer, or private label
387	distributor whether the establishment is a member of the
388	manufacturer's affiliated group or is a contract distribution
389	site.
390
391	The term excludes pharmacies that are operating in compliance
392	with pharmacy practice standards as defined in chapter 465 and
393	rules adopted under that chapter.
394	(33)(29)  "New drug" means:
395	(a)  Any drug the composition of which is such that the
396	drug is not generally recognized, among experts qualified by
397	scientific training and experience to evaluate the safety and
398	effectiveness of drugs, as safe and effective for use under the
399	conditions prescribed, recommended, or suggested in the labeling
400	of that drug; or
401	(b)  Any drug the composition of which is such that the
402	drug, as a result of investigations to determine its safety and
403	effectiveness for use under certain conditions, has been
404	recognized for use under such conditions, but which drug has
405	not, other than in those investigations, been used to a material
406	extent or for a material time under such conditions.
407	(34)  "Normal distribution chain" means a wholesale
408	distribution of a prescription drug in which the wholesale
409	distributor purchases and receives the specific unit of the
410	prescription drug directly from the manufacturer and distributes
411	the prescription drug directly, or through one or more
412	intracompany transfers, to a chain pharmacy warehouse or a
413	person authorized by law to purchase prescription drugs for the
414	purpose of administering or dispensing the drug, as defined in
415	s. 465.003. For purposes of this subsection, the term
416	"intracompany" means any transaction or transfer between any
417	parent, division, or subsidiary wholly owned by a corporate
418	entity.
419	(35)(j)  "Nursing home" means a facility licensed under
420	part II of chapter 400.
421	(36)(30)  "Official compendium" means the current edition
422	of the official United States Pharmacopoeia and National
423	Formulary, or any supplement thereto.
424	(37)(31)  "Pedigree paper" means:
425	(a)  Effective July 1, 2006, a document in written or
426	electronic form approved by the department that contains of
427	Health and containing information required by s. 499.01212
428	regarding the sale and that records each distribution of any
429	given prescription legend drug, from sale by a pharmaceutical
430	manufacturer, through acquisition and sale by any wholesaler or
431	repackager, until final sale to a pharmacy or other person
432	administering or dispensing the drug. The information required
433	to be included on the form approved by the department pursuant
434	to this paragraph must at least detail the amount of the legend
435	drug; its dosage form and strength; its lot numbers; the name
436	and address of each owner of the legend drug and his or her
437	signature; its shipping information, including the name and
438	address of each person certifying delivery or receipt of the
439	legend drug; an invoice number, a shipping document number, or
440	another number uniquely identifying the transaction; and a
441	certification that the recipient wholesaler has authenticated
442	the pedigree papers. If the manufacturer or repackager has
443	uniquely serialized the individual legend drug unit, that
444	identifier must also be included on the form approved pursuant
445	to this paragraph. It must also include the name, address,
446	telephone number and, if available, e-mail contact information
447	of each wholesaler involved in the chain of the legend drug's
448	custody; or
449	(b)  A statement, under oath, in written or electronic
450	form, confirming that a wholesale distributor purchases and
451	receives the specific unit of the prescription drug directly
452	from the manufacturer of the prescription drug and distributes
453	the prescription drug directly, or through an intracompany
454	transfer, to a chain pharmacy warehouse or a person authorized
455	by law to purchase prescription drugs for the purpose of
456	administering or dispensing the drug, as defined in s. 465.003.
457	For purposes of this subsection, the term "chain pharmacy
458	warehouse" means a wholesale distributor permitted pursuant to
459	s. 499.01 that maintains a physical location for prescription
460	drugs that functions solely as a central warehouse to perform
461	intracompany transfers of such drugs to a member of its
462	affiliated group as described in s. 499.0121(6)(f)1.
463	1.  The information required to be included pursuant to
464	this paragraph must include:
465	a.  The following statement: "This wholesale distributor
466	purchased the specific unit of the prescription drug directly
467	from the manufacturer."
468	b.  The manufacturer's national drug code identifier and
469	the name and address of the wholesaler and the purchaser of the
470	prescription drug.
471	c.  The name of the prescription drug as it appears on the
472	label.
473	d.  The quantity, dosage form, and strength of the
474	prescription drug.
475	2.  The wholesale distributor must also maintain and make
476	available to the department, upon request, the point of origin
477	of the prescription drugs, including intracompany transfers; the
478	date of the shipment from the manufacturer to the wholesale
479	distributor; the lot numbers of such drugs; and the invoice
480	numbers from the manufacturer.
481
482	The department may adopt rules and forms relating to the
483	requirements of this subsection.
484	(38)(1)  DEFINITION.--As used in this section, the term
485	"Permittee" means any person holding a permit issued pursuant to
486	s. 499.012.
487	(39)(32)  "Person" means any individual, child, joint
488	venture, syndicate, fiduciary, partnership, corporation,
489	division of a corporation, firm, trust, business trust, company,
490	estate, public or private institution, association,
491	organization, group, city, county, city and county, political
492	subdivision of this state, other governmental agency within this
493	state, and any representative, agent, or agency of any of the
494	foregoing, or any other group or combination of the foregoing.
495	(40)(l)  "Pharmacist" means a person licensed under chapter
496	465.
497	(4l)(m)  "Pharmacy" means an entity licensed under chapter
498	465.
499	(42)(33)  "Prepackaged drug product" means a drug that
500	originally was in finished packaged form sealed by a
501	manufacturer and that is placed in a properly labeled container
502	by a pharmacy or practitioner authorized to dispense pursuant to
503	chapter 465 for the purpose of dispensing in the establishment
504	in which the prepackaging occurred.
505	(43)(n)  "Prescribing practitioner" means a physician
506	licensed under chapter 458 or chapter 459 or any other medical
507	professional with authority under state law to prescribe cancer
508	medication.
509	(44)  "Prescription drug" means a prescription, medicinal,
510	or legend drug, including, but not limited to, finished dosage
511	forms or active ingredients subject to, defined by, or described
512	by s. 503(b) of the Federal Food, Drug, and Cosmetic Act or s.
513	465.003(8), s. 499.007(13), or subsection (11), subsection (47),
514	or subsection (54).
515	(45)  "Prescription drug label" means any display of
516	written, printed, or graphic matter upon the immediate container
517	of any prescription drug prior to its dispensing to an
518	individual patient pursuant to a prescription of a practitioner
519	authorized by law to prescribe.
520	(46)(34)  "Prescription label" means any display of
521	written, printed, or graphic matter upon the immediate container
522	of any prescription legend drug dispensed pursuant to a
523	prescription of a practitioner authorized by law to prescribe.
524	(47)(35)  "Prescription medical oxygen" means oxygen USP
525	which is a drug that can only be sold on the order or
526	prescription of a practitioner authorized by law to prescribe.
527	The label of prescription medical oxygen must comply with
528	current labeling requirements for oxygen under the Federal Food,
529	Drug, and Cosmetic Act.
530	(48)(d)  "Primary wholesale distributor wholesaler" means
531	any wholesale distributor that:
532	(a)1.  Purchased 90 percent or more of the total dollar
533	volume of its purchases of prescription drugs directly from
534	manufacturers in the previous year; and
535	(b)1.2.a.  Directly purchased prescription drugs from not
536	fewer than 50 different prescription drug manufacturers in the
537	previous year; or
538	2.b.  Has, or the affiliated group, as defined in s. 1504
539	of the Internal Revenue Code, of which the wholesale distributor
540	is a member has, not fewer than 250 employees.
541	(c)(e)  For purposes of this subsection, "directly from
542	manufacturers a manufacturer" means:
543	1.  Purchases made by the wholesale distributor directly
544	from the manufacturer of prescription drugs; and
545	2.  Transfers from a member of an affiliated group, as
546	defined in s. 1504 of the Internal Revenue Code, of which the
547	wholesale distributor is a member, if:
548	a.  The affiliated group purchases 90 percent or more of
549	the total dollar volume of its purchases of prescription drugs
550	from the manufacturer in the previous year; and
551	b.  The wholesale distributor discloses to the department
552	the names of all members of the affiliated group of which the
553	wholesale distributor is a member and the affiliated group
554	agrees in writing to provide records on prescription drug
555	purchases by the members of the affiliated group not later than
556	48 hours after the department requests access to such records,
557	regardless of the location where the records are stored.
558	(49)(36)  "Proprietary drug," or "OTC drug," means a patent
559	or over-the-counter drug in its unbroken, original package,
560	which drug is sold to the public by, or under the authority of,
561	the manufacturer or primary distributor thereof, is not
562	misbranded under the provisions of this part ss. 499.001-
563	499.081, and can be purchased without a prescription.
564	(50)(37)  "Repackage" includes repacking or otherwise
565	changing the container, wrapper, or labeling to further the
566	distribution of the drug, device, or cosmetic.
567	(51)(38)  "Repackager" means a person who repackages. The
568	term excludes pharmacies that are operating in compliance with
569	pharmacy practice standards as defined in chapter 465 and rules
570	adopted under that chapter.
571	(52)(c)  "Retail pharmacy" means a community pharmacy
572	licensed under chapter 465 that purchases prescription drugs at
573	fair market prices and provides prescription services to the
574	public.
575	(53)(f)  "Secondary wholesale distributor wholesaler" means
576	a wholesale distributor that is not a primary wholesale
577	distributor wholesaler.
578	(54)(39)  "Veterinary prescription drug" means a
579	prescription legend drug intended solely for veterinary use. The
580	label of the drug must bear the statement, "Caution: Federal law
581	restricts this drug to sale by or on the order of a licensed
582	veterinarian."
583	(40)  "Veterinary prescription drug wholesaler" means any
584	person engaged in wholesale distribution of veterinary
585	prescription drugs in or into this state.
586	(55)(a)  "Wholesale distribution" means distribution of
587	prescription drugs to persons other than a consumer or patient,
588	but does not include:
589	(a)1.  Any of the following activities, which is not a
590	violation of s. 499.005(21) if such activity is conducted in
591	accordance with s. 499.01(2)(g) s. 499.014:
592	1.a.  The purchase or other acquisition by a hospital or
593	other health care entity that is a member of a group purchasing
594	organization of a prescription drug for its own use from the
595	group purchasing organization or from other hospitals or health
596	care entities that are members of that organization.
597	2.b.  The sale, purchase, or trade of a prescription drug
598	or an offer to sell, purchase, or trade a prescription drug by a
599	charitable organization described in s. 501(c)(3) of the
600	Internal Revenue Code of 1986, as amended and revised, to a
601	nonprofit affiliate of the organization to the extent otherwise
602	permitted by law.
603	3.c.  The sale, purchase, or trade of a prescription drug
604	or an offer to sell, purchase, or trade a prescription drug
605	among hospitals or other health care entities that are under
606	common control. For purposes of this subparagraph section,
607	"common control" means the power to direct or cause the
608	direction of the management and policies of a person or an
609	organization, whether by ownership of stock, by voting rights,
610	by contract, or otherwise.
611	4.d.  The sale, purchase, trade, or other transfer of a
612	prescription drug from or for any federal, state, or local
613	government agency or any entity eligible to purchase
614	prescription drugs at public health services prices pursuant to
615	Pub. L. No. 102-585, s. 602 to a contract provider or its
616	subcontractor for eligible patients of the agency or entity
617	under the following conditions:
618	a.(I)  The agency or entity must obtain written
619	authorization for the sale, purchase, trade, or other transfer
620	of a prescription drug under this subparagraph sub-subparagraph
621	from the State Surgeon General or his or her designee.
622	b.(II)  The contract provider or subcontractor must be
623	authorized by law to administer or dispense prescription drugs.
624	c.(III)  In the case of a subcontractor, the agency or
625	entity must be a party to and execute the subcontract.
626	d.(IV)  A contract provider or subcontractor must maintain
627	separate and apart from other prescription drug inventory any
628	prescription drugs of the agency or entity in its possession.
629	e.(V)  The contract provider and subcontractor must
630	maintain and produce immediately for inspection all records of
631	movement or transfer of all the prescription drugs belonging to
632	the agency or entity, including, but not limited to, the records
633	of receipt and disposition of prescription drugs. Each
634	contractor and subcontractor dispensing or administering these
635	drugs must maintain and produce records documenting the
636	dispensing or administration. Records that are required to be
637	maintained include, but are not limited to, a perpetual
638	inventory itemizing drugs received and drugs dispensed by
639	prescription number or administered by patient identifier, which
640	must be submitted to the agency or entity quarterly.
641	f.(VI)  The contract provider or subcontractor may
642	administer or dispense the prescription drugs only to the
643	eligible patients of the agency or entity or must return the
644	prescription drugs for or to the agency or entity. The contract
645	provider or subcontractor must require proof from each person
646	seeking to fill a prescription or obtain treatment that the
647	person is an eligible patient of the agency or entity and must,
648	at a minimum, maintain a copy of this proof as part of the
649	records of the contractor or subcontractor required under sub-
650	subparagraph e. sub-sub-subparagraph (V).
651	g.(VII)  In addition to the departmental inspection
652	authority set forth in s. 499.051, the establishment of the
653	contract provider and subcontractor and all records pertaining
654	to prescription drugs subject to this subparagraph sub-
655	subparagraph shall be subject to inspection by the agency or
656	entity. All records relating to prescription drugs of a
657	manufacturer under this subparagraph sub-subparagraph shall be
658	subject to audit by the manufacturer of those drugs, without
659	identifying individual patient information.
660	(b)2.  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 rules established by the department:
663	1.a.  The sale, purchase, or trade of a prescription drug
664	among federal, state, or local government health care entities
665	that are under common control and are authorized to purchase
666	such prescription drug.
667	2.b.  The sale, purchase, or trade of a prescription drug
668	or an offer to sell, purchase, or trade a prescription drug for
669	emergency medical reasons. For purposes of this subparagraph
670	sub-subparagraph, the term "emergency medical reasons" includes
671	transfers of prescription drugs by a retail pharmacy to another
672	retail pharmacy to alleviate a temporary shortage.
673	3.c.  The transfer of a prescription drug acquired by a
674	medical director on behalf of a licensed emergency medical
675	services provider to that emergency medical services provider
676	and its transport vehicles for use in accordance with the
677	provider's license under chapter 401.
678	4.d.  The revocation of a sale or the return of a
679	prescription drug to the person's prescription drug wholesale
680	supplier.
681	5.e.  The donation of a prescription drug by a health care
682	entity to a charitable organization that has been granted an
683	exemption under s. 501(c)(3) of the Internal Revenue Code of
684	1986, as amended, and that is authorized to possess prescription
685	drugs.
686	6.f.  The transfer of a prescription drug by a person
687	authorized to purchase or receive prescription drugs to a person
688	licensed or permitted to handle reverse distributions or
689	destruction under the laws of the jurisdiction in which the
690	person handling the reverse distribution or destruction receives
691	the drug.
692	7.g.  The transfer of a prescription drug by a hospital or
693	other health care entity to a person licensed under this part
694	chapter to repackage prescription drugs for the purpose of
695	repackaging the prescription drug for use by that hospital, or
696	other health care entity and other health care entities that are
697	under common control, if ownership of the prescription drugs
698	remains with the hospital or other health care entity at all
699	times. In addition to the recordkeeping requirements of s.
700	499.0121(6), the hospital or health care entity that transfers
701	prescription drugs pursuant to this subparagraph sub-
702	subparagraph must reconcile all drugs transferred and returned
703	and resolve any discrepancies in a timely manner.
704	(c)3.  The distribution of prescription drug samples by
705	manufacturers' representatives or distributors' representatives
706	conducted in accordance with s. 499.028.
707	(d)4.  The sale, purchase, or trade of blood and blood
708	components intended for transfusion. As used in this paragraph
709	subparagraph, the term "blood" means whole blood collected from
710	a single donor and processed either for transfusion or further
711	manufacturing, and the term "blood components" means that part
712	of the blood separated by physical or mechanical means.
713	(e)5.  The lawful dispensing of a prescription drug in
714	accordance with chapter 465.
715	(f)6.  The sale, purchase, or trade of a prescription drug
716	between pharmacies as a result of a sale, transfer, merger, or
717	consolidation of all or part of the business of the pharmacies
718	from or with another pharmacy, whether accomplished as a
719	purchase and sale of stock or of business assets.
720	(56)(b)  "Wholesale distributor" means any person engaged
721	in wholesale distribution of prescription drugs in or into this
722	state, including, but not limited to, manufacturers;
723	repackagers; own-label distributors; jobbers; private-label
724	distributors; brokers; warehouses, including manufacturers' and
725	distributors' warehouses, chain drug warehouses, and wholesale
726	drug warehouses; independent wholesale drug traders; exporters;
727	retail pharmacies; and the agents thereof that conduct wholesale
728	distributions.
729	Section 3.  Subsections (4), (10), (11), (12), (14), (15),
730	(18), (19), (20), (22), (24), (28), and (29) of section 499.005,
731	Florida Statutes, are amended to read:
732	499.005  Prohibited acts.--It is unlawful for a person to
733	perform or cause the performance of any of the following acts in
734	this state:
735	(4)  The sale, distribution, purchase, trade, holding, or
736	offering of any drug, device, or cosmetic in violation of this
737	part ss. 499.001-499.081.
738	(10)  Forging; counterfeiting; simulating; falsely
739	representing any drug, device, or cosmetic; or, without the
740	authority of the manufacturer, using any mark, stamp, tag,
741	label, or other identification device authorized or required by
742	rules adopted under this part ss. 499.001-499.081.
743	(11)  The use, on the labeling of any drug or in any
744	advertisement relating to such drug, of any representation or
745	suggestion that an application of the drug is effective when it
746	is not or that the drug complies with this part ss. 499.001-
747	499.081 when it does not.
748	(12)  The possession of any drug in violation of this part
749	ss. 499.001-499.081.
750	(14)  The purchase or receipt of a prescription legend drug
751	from a person that is not authorized under this chapter to
752	distribute prescription legend drugs to that purchaser or
753	recipient.
754	(15)  The sale or transfer of a prescription legend drug to
755	a person that is not authorized under the law of the
756	jurisdiction in which the person receives the drug to purchase
757	or possess prescription legend drugs from the person selling or
758	transferring the prescription legend drug.
759	(18)  Failure to maintain records as required by this part
760	ss. 499.001-499.081 and rules adopted under this part those
761	sections.
762	(19)  Providing the department with false or fraudulent
763	records, or making false or fraudulent statements, regarding any
764	matter within the provisions of this part chapter.
765	(20)  The importation of a prescription legend drug except
766	as provided by s. 801(d) of the Federal Food, Drug, and Cosmetic
767	Act.
768	(22)  Failure to obtain a permit or registration, or
769	operating without a valid permit when a permit or registration
770	is required by this part ss. 499.001-499.081 for that activity.
771	(24)  The distribution of a prescription legend device to
772	the patient or ultimate consumer without a prescription or order
773	from a practitioner licensed by law to use or prescribe the
774	device.
775	(28)  Failure to acquire obtain or deliver pass on a
776	pedigree paper as required under this part.
777	(29)  The receipt of a prescription drug pursuant to a
778	wholesale distribution without having previously received or
779	simultaneously either first receiving a pedigree paper that was
780	attested to as accurate and complete by the wholesale
781	distributor as required under this part or complying with the
782	provisions of s. 499.0121(6)(d)5.
783	Section 4.  Section 499.0051, Florida Statutes, is amended;
784	section 499.0052, Florida Statutes, is redesignated as
785	subsection (7) of that section and amended; section 499.00535,
786	Florida Statutes, is redesignated as subsection (9) of that
787	section and amended; section 499.00545, Florida Statutes, is
788	redesignated as subsection (10) of that section and amended;
789	section 499.069, Florida Statutes, is redesignated as subsection
790	(11) of that section and amended; and section 499.0691, Florida
791	Statutes, is redesignated as subsections (12) through (15) of
792	that section and amended, to read:
793	499.0051  Criminal acts involving contraband or adulterated
794	drugs.--
795	(1)  FAILURE TO MAINTAIN OR DELIVER PEDIGREE PAPERS.--
796	(a)  A person, other than a manufacturer, engaged in the
797	wholesale distribution of prescription legend drugs who fails to
798	deliver to another person complete and accurate pedigree papers
799	concerning a prescription legend drug or contraband prescription
800	legend drug prior to, or simultaneous with, the transfer of
801	transferring the prescription legend drug or contraband
802	prescription legend drug to another person commits a felony of
803	the third degree, punishable as provided in s. 775.082, s.
804	775.083, or s. 775.084.
805	(b)  A person engaged in the wholesale distribution of
806	prescription legend drugs who fails to acquire complete and
807	accurate pedigree papers concerning a prescription legend drug
808	or contraband prescription legend drug prior to, or simultaneous
809	with, the receipt of obtaining the prescription legend drug or
810	contraband prescription legend drug from another person commits
811	a felony of the third degree, punishable as provided in s.
812	775.082, s. 775.083, or s. 775.084.
813	(c)  Any person who knowingly destroys, alters, conceals,
814	or fails to maintain complete and accurate pedigree papers
815	concerning any prescription legend drug or contraband
816	prescription legend drug in his or her possession commits a
817	felony of the third degree, punishable as provided in s.
818	775.082, s. 775.083, or s. 775.084.
819	(2)  FAILURE TO AUTHENTICATE PEDIGREE PAPERS.--Effective
820	July 1, 2006:
821	(a)  A person engaged in the wholesale distribution of
822	prescription legend drugs who is in possession of pedigree
823	papers concerning prescription legend drugs or contraband
824	prescription legend drugs and who fails to authenticate the
825	matters contained in the pedigree papers and who nevertheless
826	attempts to further distribute prescription legend drugs or
827	contraband prescription legend drugs commits a felony of the
828	third degree, punishable as provided in s. 775.082, s. 775.083,
829	or s. 775.084.
830	(b)  A person in possession of pedigree papers concerning
831	prescription legend drugs or contraband prescription legend
832	drugs who falsely swears or certifies that he or she has
833	authenticated the matters contained in the pedigree papers
834	commits a felony of the third degree, punishable as provided in
835	s. 775.082, s. 775.083, or s. 775.084.
836	(3)  KNOWING FORGERY OF PEDIGREE PAPERS.--A person who
837	knowingly forges, counterfeits, or falsely creates any pedigree
838	paper; who falsely represents any factual matter contained on
839	any pedigree paper; or who knowingly omits to record material
840	information required to be recorded in a pedigree paper, commits
841	a felony of the second degree, punishable as provided in s.
842	775.082, s. 775.083, or s. 775.084.
843	(4)  KNOWING PURCHASE OR RECEIPT OF PRESCRIPTION LEGEND
844	DRUG FROM UNAUTHORIZED PERSON.--A person who knowingly purchases
845	or receives from a person not authorized to distribute
846	prescription legend drugs under this chapter a prescription
847	legend drug in a wholesale distribution transaction commits a
848	felony of the second degree, punishable as provided in s.
849	775.082, s. 775.083, or s. 775.084.
850	(5)  KNOWING SALE OR TRANSFER OF PRESCRIPTION LEGEND DRUG
851	TO UNAUTHORIZED PERSON.--A person who knowingly sells or
852	transfers to a person not authorized to purchase or possess
853	prescription legend drugs, under the law of the jurisdiction in
854	which the person receives the drug, a prescription legend drug
855	in a wholesale distribution transaction commits a felony of the
856	second degree, punishable as provided in s. 775.082, s. 775.083,
857	or s. 775.084.
858	(6)  KNOWING SALE OR DELIVERY, OR POSSESSION WITH INTENT TO
859	SELL, CONTRABAND PRESCRIPTION LEGEND DRUGS.--A person who is
860	knowingly in actual or constructive possession of any amount of
861	contraband prescription legend drugs, who knowingly sells or
862	delivers, or who possesses with intent to sell or deliver any
863	amount of contraband prescription legend drugs, commits a felony
864	of the second degree, punishable as provided in s. 775.082, s.
865	775.083, or s. 775.084.
866	(7)499.0052  KNOWING TRAFFICKING IN CONTRABAND PRESCRIPTION
867	LEGEND DRUGS.--A person who knowingly sells, purchases,
868	manufactures, delivers, or brings into this state, or who is
869	knowingly in actual or constructive possession of any amount of
870	contraband prescription legend drugs valued at $25,000 or more
871	commits a felony of the first degree, punishable as provided in
872	s. 775.082, s. 775.083, or s. 775.084.
873	(a)  Upon conviction, each defendant shall be ordered to
874	pay a mandatory fine according to the following schedule:
875	1.(1)  If the value of contraband prescription legend drugs
876	involved is $25,000 or more, but less than $100,000, the
877	defendant shall pay a mandatory fine of $25,000. If the
878	defendant is a corporation or other person that is not a natural
879	person, it shall pay a mandatory fine of $75,000.
880	2.(2)  If the value of contraband prescription legend drugs
881	involved is $100,000 or more, but less than $250,000, the
882	defendant shall pay a mandatory fine of $100,000. If the
883	defendant is a corporation or other person that is not a natural
884	person, it shall pay a mandatory fine of $300,000.
885	3.(3)  If the value of contraband prescription legend drugs
886	involved is $250,000 or more, the defendant shall pay a
887	mandatory fine of $200,000. If the defendant is a corporation or
888	other person that is not a natural person, it shall pay a
889	mandatory fine of $600,000.
890	(b)  As used in this subsection section, the term "value"
891	means the market value of the property at the time and place of
892	the offense or, if such cannot be satisfactorily ascertained,
893	the cost of replacement of the property within a reasonable time
894	after the offense. Amounts of value of separate contraband
895	prescription legend drugs involved in distinct transactions for
896	the distribution of the contraband prescription legend drugs
897	committed pursuant to one scheme or course of conduct, whether
898	involving the same person or several persons, may be aggregated
899	in determining the punishment of the offense.
900	(8)(7)  KNOWING FORGERY OF PRESCRIPTION OR PRESCRIPTION
901	LEGEND DRUG LABELS.--A person who knowingly forges,
902	counterfeits, or falsely creates any prescription label or
903	prescription legend drug label, or who falsely represents any
904	factual matter contained on any prescription label or
905	prescription legend drug label, commits a felony of the first
906	degree, punishable as provided in s. 775.082, s. 775.083, or s.
907	775.084.
908	(9)499.00535  KNOWING SALE OR PURCHASE OF CONTRABAND
909	PRESCRIPTION LEGEND DRUGS RESULTING IN GREAT BODILY HARM.--A
910	person who knowingly sells, purchases, manufactures, delivers,
911	or brings into this state, or who is knowingly in actual or
912	constructive possession of any amount of contraband prescription
913	legend drugs, and whose acts in violation of this subsection
914	section result in great bodily harm to a person, commits a
915	felony of the first degree, as provided in s. 775.082, s.
916	775.083, or s. 775.084.
917	(10)499.00545  KNOWING SALE OR PURCHASE OF CONTRABAND
918	PRESCRIPTION LEGEND DRUGS RESULTING IN DEATH.--A person who
919	knowingly manufactures, sells, purchases, delivers, or brings
920	into this state, or who is knowingly in actual or constructive
921	possession of any amount of contraband prescription legend
922	drugs, and whose acts in violation of this subsection section
923	result in the death of a person, commits a felony of the first
924	degree, punishable by a term of years not exceeding life, as
925	provided in s. 775.082, s. 775.083, or s. 775.084.
926	(11)499.069  CRIMINAL PUNISHMENT FOR VIOLATIONS OF S.
927	499.005 RELATED TO DEVICES AND COSMETICS; DISSEMINATION OF FALSE
928	ADVERTISEMENT.--
929	(a)(1)  Any person who violates any of the provisions of s.
930	499.005 with respect to a device or cosmetic commits a
931	misdemeanor of the second degree, punishable as provided in s.
932	775.082 or s. 775.083; but, if the violation is committed after
933	a conviction of such person under this subsection section has
934	become final, such person is guilty of a misdemeanor of the
935	first degree, punishable as provided in s. 775.082 or s. 775.083
936	or as otherwise provided in this part ss. 499.001-499.081,
937	except that any person who violates s. 499.005(8) or (10)
938	subsection (8) or subsection (10) of s. 499.005 with respect to
939	a device or cosmetic commits a felony of the third degree,
940	punishable as provided in s. 775.082, s. 775.083, or s. 775.084,
941	or as otherwise provided in this part ss. 499.001-499.081.
942	(b)(2)  A publisher, radio broadcast licensee, or agency or
943	medium for the dissemination of an advertisement, except the
944	manufacturer, wholesaler, or seller of the article to which a
945	false advertisement relates, is not liable under this subsection
946	section by reason of the dissemination by him or her of such
947	false advertisement, unless he or she has refused, on the
948	request of the department, to furnish to the department the name
949	and post office address of the manufacturer, wholesaler, seller,
950	or advertising agency that asked him or her to disseminate such
951	advertisement.
952	(12)499.0691  ADULTERATED AND MISBRANDED DRUGS; FALSE
953	ADVERTISEMENT; FAILURE TO MAINTAIN RECORDS RELATING TO DRUGS
954	Criminal punishment for violations related to drugs;
955	dissemination of false advertisement.--(1)  Any person who
956	violates any of the following provisions commits a misdemeanor
957	of the second degree, punishable as provided in s. 775.082 or s.
958	775.083; but, if the violation is committed after a conviction
959	of such person under this subsection section has become final,
960	such person commits a misdemeanor of the first degree,
961	punishable as provided in s. 775.082 or s. 775.083, or as
962	otherwise provided in this part ss. 499.001-499.081:
963	(a)  The manufacture, repackaging, sale, delivery, or
964	holding or offering for sale of any drug that is adulterated or
965	misbranded or has otherwise been rendered unfit for human or
966	animal use.
967	(b)  The adulteration or misbranding of any drug intended
968	for further distribution.
969	(c)  The receipt of any drug that is adulterated or
970	misbranded, and the delivery or proffered delivery of such drug,
971	for pay or otherwise.
972	(d)  The dissemination of any false or misleading
973	advertisement of a drug.
974	(e)  The use, on the labeling of any drug or in any
975	advertisement relating to such drug, of any representation or
976	suggestion that an application of the drug is effective when it
977	is not or that the drug complies with this part ss. 499.001-
978	499.081 when it does not.
979	(f)  The purchase or receipt of a compressed medical gas
980	from a person that is not authorized under this chapter to
981	distribute compressed medical gases.
982	(g)  Charging a dispensing fee for dispensing,
983	administering, or distributing a prescription drug sample.
984	(h)  The failure to maintain records related to a drug as
985	required by this part ss. 499.001-499.081 and rules adopted
986	under this part those sections, except for pedigree papers,
987	invoices, or shipping documents related to prescription legend
988	drugs.
989	(i)  The possession of any drug in violation of this part
990	ss. 499.001-499.081, except if the violation relates to a
991	deficiency in pedigree papers.
992	(13)  REFUSAL TO ALLOW INSPECTION; SELLING, PURCHASING, OR
993	TRADING DRUG SAMPLES; FAILURE TO MAINTAIN RECORDS RELATING TO
994	PRESCRIPTION DRUGS.--(2)  Any person who violates any of the
995	following provisions commits a felony of the third degree,
996	punishable as provided in s. 775.082, s. 775.083, or s. 775.084,
997	or as otherwise provided in this part: ss. 499.001-499.081.
998	(a)  The refusal or constructive refusal to allow:
999	1.  The department to enter or inspect an establishment in
1000	which drugs are manufactured, processed, repackaged, sold,
1001	brokered, or held;
1002	2.  Inspection of any record of that establishment;
1003	3.  The department to enter and inspect any vehicle that is
1004	being used to transport drugs; or
1005	4.  The department to take samples of any drug.
1006	(b)  The sale, purchase, or trade, or the offer to sell,
1007	purchase, or trade, a drug sample as defined in s. 499.028; the
1008	distribution of a drug sample in violation of s. 499.028; or the
1009	failure to otherwise comply with s. 499.028.
1010	(c)  Providing the department with false or fraudulent
1011	records, or making false or fraudulent statements, regarding any
1012	matter within the provisions of this part chapter related to a
1013	drug.
1014	(d)  The failure to receive, maintain, or provide invoices
1015	and shipping documents, other than pedigree papers, if
1016	applicable, related to the distribution of a prescription legend
1017	drug.
1018	(e)  The importation of a prescription legend drug for
1019	wholesale distribution, except as provided by s. 801(d) of the
1020	Federal Food, Drug, and Cosmetic Act.
1021	(f)  The wholesale distribution of a any prescription drug
1022	that was:
1023	1.  Purchased by a public or private hospital or other
1024	health care entity; or
1025	2.  Donated or supplied at a reduced price to a charitable
1026	organization.
1027	(g)  The failure to obtain a permit as a prescription drug
1028	wholesale distributor wholesaler when a permit is required by
1029	this part ss. 499.001-499.081 for that activity.
1030	(h)  Knowingly possessing any adulterated or misbranded
1031	prescription legend drug outside of a designated quarantine
1032	area.
1033	(i)  The purchase or sale of a prescription drug drugs for
1034	wholesale distribution in exchange for currency, as defined in
1035	s. 560.103(6).
1036	(14)  OTHER VIOLATIONS.--(3)  Any person who violates any
1037	of the following provisions commits a felony of the second
1038	degree, punishable as provided in s. 775.082, s. 775.083, or s.
1039	775.084, or as otherwise provided in this part: ss. 499.001-
1040	499.081.
1041	(a)  Knowingly manufacturing, repackaging, selling,
1042	delivering, or holding or offering for sale any drug that is
1043	adulterated or misbranded or has otherwise been rendered unfit
1044	for human or animal use.
1045	(b)  Knowingly adulterating a drug that is intended for
1046	further distribution.
1047	(c)  Knowingly receiving a drug that is adulterated and
1048	delivering or proffering delivery of such drug for pay or
1049	otherwise.
1050	(d)  Committing any act that causes a drug to be a
1051	counterfeit drug, or selling, dispensing, or knowingly holding
1052	for sale a counterfeit drug.
1053	(e)  Forging, counterfeiting, simulating, or falsely
1054	representing any drug, or, without the authority of the
1055	manufacturer, using any mark, stamp, tag, label, or other
1056	identification device authorized or required by rules adopted
1057	under this part ss. 499.001-499.081.
1058	(f)  Knowingly obtaining or attempting to obtain a
1059	prescription drug for wholesale distribution by fraud, deceit,
1060	misrepresentation, or subterfuge, or engaging in
1061	misrepresentation or fraud in the distribution of a drug.
1062	(g)  Removing a pharmacy's dispensing label from a
1063	dispensed prescription drug with the intent to further
1064	distribute the prescription drug.
1065	(h)  Knowingly distributing a prescription drug that was
1066	previously dispensed by a licensed pharmacy, unless such
1067	distribution was authorized in chapter 465 or the rules adopted
1068	under chapter 465.
1069	(15)  FALSE ADVERTISEMENT.--(4)  A publisher, radio
1070	broadcast licensee, or agency or medium for the dissemination of
1071	an advertisement, except the manufacturer, repackager, wholesale
1072	distributor wholesaler, or seller of the article to which a
1073	false advertisement relates, is not liable under subsection
1074	(12), subsection (13), or subsection (14) this section by reason
1075	of the dissemination by him or her of such false advertisement,
1076	unless he or she has refused, on the request of the department,
1077	to furnish to the department the name and post office address of
1078	the manufacturer, repackager, wholesale distributor wholesaler,
1079	seller, or advertising agency that asked him or her to
1080	disseminate such advertisement.
1081	Section 5.  Section 499.0054, Florida Statutes, is amended;
1082	section 499.0055, Florida Statutes, is redesignated as
1083	subsection (2) of that section and amended; and section
1084	499.0057, Florida Statutes, is redesignated as subsection (3) of
1085	that section and amended, to read:
1086	499.0054  Advertising and labeling of drugs, devices, and
1087	cosmetics; exemptions.--
1088	(1)  It is a violation of the Florida Drug and Cosmetic Act
1089	to perform or cause the performance of any of the following
1090	acts:
1091	(a)(1)  The dissemination of any false advertisement of any
1092	drug, device, or cosmetic. An advertisement is false if it is
1093	false or misleading in any way.
1094	(b)(2)  The distribution in commerce of any drug, device,
1095	or cosmetic, if its labeling or advertising is in violation of
1096	this part ss. 499.001-499.081.
1097	(c)(3)  The manufacturing, repackaging, packaging, selling,
1098	delivery, holding, or offering for sale of any drug, device, or
1099	cosmetic for which the advertising or labeling is false or
1100	misleading.
1101	(d)(4)  The advertising of any drug, device, or cosmetic
1102	that is adulterated or misbranded.
1103	(e)(5)  The receiving in commerce of any drug, device, or
1104	cosmetic that is falsely advertised or labeled or the delivering
1105	or proffering for delivery of any such drug, device, or
1106	cosmetic.
1107	(f)(6)  The advertising or labeling of any product
1108	containing ephedrine, a salt of ephedrine, an isomer of
1109	ephedrine, or a salt of an isomer of ephedrine, for the
1110	indication of stimulation, mental alertness, weight loss,
1111	appetite control, energy, or other indications not approved by
1112	the pertinent United States Food and Drug Administration Over-
1113	the-Counter Final or Tentative Final Monograph or approved new
1114	drug application under the federal act. In determining
1115	compliance with this requirement, the department may consider
1116	the following factors:
1117	1.(a)  The packaging of the product.
1118	2.(b)  The name and labeling of the product.
1119	3.(c)  The manner of distribution, advertising, and
1120	promotion of the product, including verbal representations at
1121	the point of sale.
1122	4.(d)  The duration, scope, and significance of abuse of
1123	the particular product.
1124	(g)(7)  The advertising of any drug or device represented
1125	to have any effect in any of the following conditions,
1126	disorders, diseases, or processes:
1127	1.(a)  Blood disorders.
1128	2.(b)  Bone or joint diseases.
1129	3.(c)  Kidney diseases or disorders.
1130	4.(d)  Cancer.
1131	5.(e)  Diabetes.
1132	6.(f)  Gall bladder diseases or disorders.
1133	7.(g)  Heart and vascular diseases.
1134	8.(h)  High blood pressure.
1135	9.(i)  Diseases or disorders of the ear or auditory
1136	apparatus, including hearing loss or deafness.
1137	10.(j)  Mental disease or mental retardation.
1138	11.(k)  Paralysis.
1139	12.(l)  Prostate gland disorders.
1140	13.(m)  Conditions of the scalp affecting hair loss.
1141	14.(n)  Baldness.
1142	15.(o)  Endocrine disorders.
1143	16.(p)  Sexual impotence.
1144	17.(q)  Tumors.
1145	18.(r)  Venereal diseases.
1146	19.(s)  Varicose ulcers.
1147	20.(t)  Breast enlargement.
1148	21.(u)  Purifying blood.
1149	22.(v)  Metabolic disorders.
1150	23.(w)  Immune system disorders or conditions affecting the
1151	immune system.
1152	24.(x)  Extension of life expectancy.
1153	25.(y)  Stress and tension.
1154	26.(z)  Brain stimulation or performance.
1155	27.(aa)  The body's natural defense mechanisms.
1156	28.(bb)  Blood flow.
1157	29.(cc)  Depression.
1158	30.(dd)  Human immunodeficiency virus or acquired immune
1159	deficiency syndrome or related disorders or conditions.
1160	(h)(8)  The representation or suggestion in labeling or
1161	advertising that an article is approved under this part ss.
1162	499.001-499.081, when such is not the case.
1163	(2)499.0055  False or misleading advertisement.--In
1164	determining whether an advertisement is false or misleading, the
1165	department shall review the representations made or suggested by
1166	statement, word, design, device, sound, or any combination
1167	thereof within the advertisement and the extent to which the
1168	advertisement fails to reveal material facts with respect to
1169	consequences that can result from the use of the drug, device,
1170	or cosmetic to which the advertisement relates under the
1171	conditions of use prescribed in the labeling or advertisement.
1172	(3)499.0057  Advertisement exemptions.--
1173	(a)(1)  An advertisement that is not prohibited under
1174	paragraph (1)(a) s. 499.0054(1) is not prohibited under
1175	paragraph (1)(g) s. 499.0054(7) if it is disseminated:
1176	1.  To the public solely to advertise the product for those
1177	indications that are safe and effective indications and the
1178	product is safe and effective for self-medication, as
1179	established by the United States Food and Drug Administration;
1180	or
1181	2.  if it is disseminated Only to members of the medical,
1182	dental, pharmaceutical, or veterinary professions or appears
1183	only in the scientific periodicals of these professions.
1184	(b)(2)  Compliance with this part ss. 499.001-499.081 and
1185	the rules adopted under this part those sections creates no
1186	legal presumption that a drug or device is safe or effective.
1187	Section 6.  Subsections (3), (10), and (11) of section
1188	499.006, Florida Statutes, are amended to read:
1189	499.006  Adulterated drug or device.--A drug or device is
1190	adulterated:
1191	(3)  If it is a drug and the methods used in, or the
1192	facilities or controls used for, its manufacture, processing,
1193	packing, or holding do not conform to, or are not operated or
1194	administered in conformity with, current good manufacturing
1195	practices to assure that the drug meets the requirements of this
1196	part ss. 499.001-499.081 and that the drug has the identity and
1197	strength, and meets the standard of quality and purity, which it
1198	purports or is represented to possess;
1199	(10)  If it is a prescription legend drug for which the
1200	required pedigree paper is nonexistent, fraudulent, or
1201	incomplete under the requirements of this part ss. 499.001-
1202	499.081 or applicable rules, or that has been purchased, held,
1203	sold, or distributed at any time by a person not authorized
1204	under federal or state law to do so; or
1205	(11)  If it is a prescription drug subject to, defined by,
1206	or described by s. 503(b) of the Federal Food, Drug, and
1207	Cosmetic Act which has been returned by a veterinarian to a
1208	limited prescription drug veterinary wholesale distributor
1209	wholesaler.
1210	Section 7.  Section 499.007, Florida Statutes, is amended
1211	to read:
1212	499.007  Misbranded drug or device.--A drug or device is
1213	misbranded:
1214	(1)  If its labeling is in any way false or misleading.
1215	(2)  Unless, If in package form, it does not bear bears a
1216	label containing:
1217	(a)  The name and place of business of the manufacturer,
1218	repackager, or distributor of the finished dosage form of the
1219	drug. For the purpose of this paragraph, the finished dosage
1220	form of a prescription medicinal drug is that form of the drug
1221	which is, or is intended to be, dispensed or administered to the
1222	patient and requires no further manufacturing or processing
1223	other than packaging, reconstitution, and labeling; and
1224	(b)  An accurate statement of the quantity of the contents
1225	in terms of weight, measure, or numerical count.; However, under
1226	this section, reasonable variations are permitted, and the
1227	department shall establish by rule exemptions for small
1228	packages.
1229	(3)  If it is an active pharmaceutical ingredient in bulk
1230	form and does not bear a label containing:
1231	(a)  The name and place of business of the manufacturer,
1232	repackager, or distributor; and
1233	(b)  An accurate statement of the quantity of the contents
1234	in terms of weight, measure, or numerical count.
1235	(4)(3)  If any word, statement, or other information
1236	required by or under this part ss. 499.001-499.081 to appear on
1237	the label or labeling is not prominently placed thereon with
1238	such conspicuousness as compared with other words, statements,
1239	designs, or devices in the labeling, and in such terms, as to
1240	render the word, statement, or other information likely to be
1241	read and understood under customary conditions of purchase and
1242	use.
1243	(5)(4)  If it is a drug and is not designated solely by a
1244	name recognized in an official compendium and, unless its label
1245	does not bear bears:
1246	(a)  The common or usual name of the drug, if any; and
1247	(b)  In case it is fabricated from two or more ingredients,
1248	the common or usual name and quantity of each active ingredient.
1249	(6)(5)  If Unless its labeling does not bear bears:
1250	(a)  Adequate directions for use; and
1251	(b)  Adequate warnings against use in those pathological
1252	conditions in which its use may be dangerous to health or
1253	against use by children if its use may be dangerous to health,
1254	or against unsafe dosage or methods or duration of
1255	administration or application, in such manner and form as are
1256	necessary for the protection of users.
1257	(7)(6)  If it purports to be a drug the name of which is
1258	recognized in the official compendium and, unless it is not
1259	packaged and labeled as prescribed therein.; However, the method
1260	of packaging may be modified with the consent of the department.
1261	(8)(7)  If it has been found by the department to be a drug
1262	liable to deterioration and, unless it is not packaged in such
1263	form and manner, and its label bears a statement of such
1264	precautions, as the department by rule requires as necessary to
1265	protect the public health. Such rule may not be established for
1266	any drug recognized in an official compendium until the
1267	department has informed the appropriate body charged with the
1268	revision of such compendium of the need for such packaging or
1269	labeling requirements and that body has failed within a
1270	reasonable time to prescribe such requirements.
1271	(9)(8)  If it is:
1272	(a)  A drug and its container or finished dosage form is so
1273	made, formed, or filled as to be misleading;
1274	(b)  An imitation of another drug; or
1275	(c)  Offered for sale under the name of another drug.
1276	(10)(9)  If it is dangerous to health when used in the
1277	dosage or with the frequency or duration prescribed,
1278	recommended, or suggested in the labeling of the drug.
1279	(11)(10)  If it is, purports to be, or is represented as a
1280	drug composed wholly or partly of insulin and, unless:
1281	(a)  it is not from a batch with respect to which a
1282	certificate has been issued pursuant to s. 506 of the federal
1283	act, which; and
1284	(b)  The certificate is in effect with respect to the drug.
1285	(12)(11)  If it is, purports to be, or is represented as a
1286	drug composed wholly or partly of any kind of antibiotic
1287	requiring certification under the federal act and unless:
1288	(a)  it is not from a batch with respect to which a
1289	certificate has been issued pursuant to s. 507 of the federal
1290	act, which; and
1291	(b)  the certificate is in effect with respect to the
1292	drug.;
1293
1294	However, this subsection does not apply to any drug or class of
1295	drugs exempted by regulations adopted under s. 507(c) or (d) of
1296	the federal act.
1297	(13)(12)  If it is a drug intended for use by humans which
1298	is a habit-forming drug or which, because of its toxicity or
1299	other potentiality for harmful effect, or the method of its use,
1300	or the collateral measures necessary to its use, is not safe for
1301	use except under the supervision of a practitioner licensed by
1302	law to administer such drugs,; or which is limited by an
1303	effective application under s. 505 of the federal act to use
1304	under the professional supervision of a practitioner licensed by
1305	law to prescribe such drug, if unless it is not dispensed only:
1306	(a)  Upon the written prescription of a practitioner
1307	licensed by law to prescribe such drug;
1308	(b)  Upon an oral prescription of such practitioner, which
1309	is reduced promptly to writing and filled by the pharmacist; or
1310	(c)  By refilling any such written or oral prescription, if
1311	such refilling is authorized by the prescriber either in the
1312	original prescription or by oral order which is reduced promptly
1313	to writing and filled by the pharmacist.
1314
1315	This subsection does not relieve any person from any requirement
1316	prescribed by law with respect to controlled substances as
1317	defined in the applicable federal and state laws.
1318	(14)(13)  If it is a drug that is subject to paragraph
1319	(13)(12)(a), and if, at any time before it is dispensed, its
1320	label does not fails to bear the statement:
1321	(a)  "Caution: Federal Law Prohibits Dispensing Without
1322	Prescription";
1323	(b)  "Rx Only";
1324	(c)  The prescription symbol followed by the word "Only";
1325	or
1326	(d)  "Caution: State Law Prohibits Dispensing Without
1327	Prescription."
1328	(15)(14)  If it is a drug that is not subject to paragraph
1329	(13)(12)(a), if at any time before it is dispensed its label
1330	bears the statement of caution required in subsection (14) (13).
1331	(16)(15)  If it is a color additive, the intended use of
1332	which in or on drugs is for the purpose of coloring only and,
1333	unless its packaging and labeling are not in conformity with the
1334	packaging and labeling requirements that apply to such color
1335	additive and are prescribed under the federal act.
1336	(17)  A drug dispensed by filling or refilling a written or
1337	oral prescription of a practitioner licensed by law to prescribe
1338	such drug is exempt from the requirements of this section,
1339	except subsections (1), (9) (8), (11) (10), and (12) (11) and
1340	the packaging requirements of subsections (7) (6) and (8) (7),
1341	if the drug bears a label that contains the name and address of
1342	the dispenser or seller, the prescription number and the date
1343	the prescription was written or filled, the name of the
1344	prescriber and the name of the patient, and the directions for
1345	use and cautionary statements. This exemption does not apply to
1346	any drug dispensed in the course of the conduct of a business of
1347	dispensing drugs pursuant to diagnosis by mail or to any drug
1348	dispensed in violation of subsection (13) (12). The department
1349	may, by rule, exempt drugs subject to s. 499.062 ss. 499.062-
1350	499.064 from subsection (13) (12) if compliance with that
1351	subsection is not necessary to protect the public health,
1352	safety, and welfare.
1353	Section 8.  Subsection (1) of section 499.008, Florida
1354	Statutes, is amended and subsection (5) is added to that section
1355	to read:
1356	499.008  Adulterated cosmetics.--A cosmetic is adulterated:
1357	(1)  If it bears or contains any poisonous or deleterious
1358	substance that is injurious to users under the conditions of use
1359	prescribed in the labeling or advertisement thereof or under
1360	such conditions of use as are customary or usual; however, this
1361	subsection does not apply to coal-tar hair dye:
1362	(a)  The label of which bears the following legend
1363	conspicuously displayed thereon: "Caution: This product contains
1364	ingredients which may cause skin irritation on certain
1365	individuals, and a preliminary test according to accompanying
1366	directions should first be made. This product must not be used
1367	for dyeing the eyelashes or eyebrows; to do so may cause
1368	blindness"; and
1369	(b)  The labeling of which bears adequate directions for
1370	such preliminary testing.
1371
1372	For the purposes of this subsection and subsection (4), the term
1373	"hair dye" does not include eyelash dyes or eyebrow dyes.
1374	(5)  For the purposes of subsections (1) and (4), the term
1375	"hair dye" does not include eyelash dyes or eyebrow dyes.
1376	Section 9.  Subsections (2), (3), and (5) of section
1377	499.009, Florida Statutes, are amended to read:
1378	499.009  Misbranded cosmetics.--A cosmetic is misbranded:
1379	(2)  Unless, If in package form, it does not bear bears a
1380	label containing:
1381	(a)  The name and place of business of the manufacturer,
1382	packer, or distributor;
1383	(b)  An accurate statement of the quantity of the contents
1384	in terms of weight, measure, or numerical count; however, under
1385	this paragraph reasonable variations are permitted, and the
1386	department shall establish by rule exemptions for small
1387	packages; and
1388	(c)  A declaration of ingredients in descending order of
1389	predominance, or as otherwise required by federal law.
1390	(3)  If any word, statement, or other information required
1391	by or under authority of this part ss. 499.001-499.081 to appear
1392	on the label or labeling is not prominently placed thereon with
1393	such conspicuousness as compared with other words, statements,
1394	designs, or devices in the labeling, and in such terms, as to
1395	render the word, statement, or other information likely to be
1396	read and understood by an individual under customary conditions
1397	of purchase and use.
1398	(5)  Unless, If it is a color additive, its packaging and
1399	labeling are not in conformity with the packaging and labeling
1400	requirements applicable to that color additive prescribed under
1401	the federal act. This subsection does not apply to packages of
1402	color additives that, with respect to their use for cosmetics,
1403	are marketed and intended for use only in or on hair dyes.
1404	Section 10.  Section 499.01, Florida Statutes, is amended;
1405	the introductory paragraph and paragraphs (a) through (h) of
1406	subsection (2) of section 499.012, Florida Statutes, are
1407	redesignated as the introductory paragraph and paragraphs (d),
1408	(n), (e), (f), (c), (i), (k), and (l), respectively, of
1409	subsection (2) of that section and amended; paragraphs (b)
1410	through (e) of subsection (2) of section 499.013, Florida
1411	Statutes, are redesignated as paragraphs (p), (o), (q), and (r),
1412	respectively, of subsection (2) of that section and amended; and
1413	section 499.014, Florida Statutes, is redesignated as paragraph
1414	(g) of subsection (2) of that section and amended, to read:
1415	499.01  Permits; applications; renewal; general
1416	requirements.--
1417	(1)  Prior to operating, a permit is required for each
1418	person and establishment that intends to operate as:
1419	(a)  A prescription drug manufacturer;
1420	(b)  A prescription drug repackager;
1421	(c)  A nonresident prescription drug manufacturer;
1422	(d)  A prescription drug wholesale distributor;
1423	(e)  An out-of-state prescription drug wholesale
1424	distributor;
1425	(f)  A retail pharmacy drug wholesale distributor;
1426	(g)  A restricted prescription drug distributor;
1427	(h)  A complimentary drug distributor;
1428	(i)  A freight forwarder;
1429	(j)  A veterinary prescription drug retail establishment;
1430	(k)  A veterinary prescription drug wholesale distributor;
1431	(l)  A limited prescription drug veterinary wholesale
1432	distributor;
1433	(m)  A medical oxygen retail establishment;
1434	(n)  A compressed medical gas wholesale distributor;
1435	(o)  A compressed medical gas manufacturer;
1436	(p)(c)  An over-the-counter drug manufacturer;
1437	(d)  A compressed medical gas manufacturer;
1438	(q)(e)  A device manufacturer; or
1439	(r)(f)  A cosmetic manufacturer.;
1440	(g)  A prescription drug wholesaler;
1441	(h)  A veterinary prescription drug wholesaler;
1442	(i)  A compressed medical gas wholesaler;
1443	(j)  An out-of-state prescription drug wholesaler;
1444	(k)  A nonresident prescription drug manufacturer;
1445	(l)  A freight forwarder;
1446	(m)  A retail pharmacy drug wholesaler;
1447	(n)  A veterinary legend drug retail establishment;
1448	(o)  A medical oxygen retail establishment;
1449	(p)  A complimentary drug distributor;
1450	(q)  A restricted prescription drug distributor; or
1451	(r)  A limited prescription drug veterinary wholesaler.
1452	(2)  The following types of wholesaler permits are
1453	established:
1454	(a)  Prescription drug manufacturer permit.--A prescription
1455	drug manufacturer permit is required for any person that
1456	manufactures a prescription drug in this state.
1457	1.  A person that operates an establishment permitted as a
1458	prescription drug manufacturer may engage in wholesale
1459	distribution of prescription drugs manufactured at that
1460	establishment and must comply with all the provisions of this
1461	part and the rules adopted under this part that apply to a
1462	wholesale distributor.
1463	2.  A prescription drug manufacturer must comply with all
1464	appropriate state and federal good manufacturing practices.
1465	(b)  Prescription drug repackager permit.--A prescription
1466	drug repackager permit is required for any person that
1467	repackages a prescription drug in this state.
1468	1.  A person that operates an establishment permitted as a
1469	prescription drug repackager may engage in wholesale
1470	distribution of prescription drugs repackaged at that
1471	establishment and must comply with all the provisions of this
1472	part and the rules adopted under this part that apply to a
1473	wholesale distributor.
1474	2.  A prescription drug repackager must comply with all
1475	appropriate state and federal good manufacturing practices.
1476	(c)(e)  Nonresident prescription drug manufacturer
1477	permit.--A nonresident prescription drug manufacturer permit is
1478	required for any person that is a manufacturer of prescription
1479	drugs, or the distribution point for a manufacturer of
1480	prescription drugs, and located outside of this state, or that
1481	is an entity to whom an approved new drug application has been
1482	issued by the United States Food and Drug Administration, or the
1483	contracted manufacturer of the approved new drug application
1484	holder, and located outside the United States, which engages in
1485	the wholesale distribution in this state of the prescription
1486	drugs it manufactures or is responsible for manufacturing. Each
1487	such manufacturer or entity must be permitted by the department
1488	and comply with all the provisions required of a wholesale
1489	distributor under this part ss. 499.001-499.081, except s.
1490	499.01212 s. 499.0121(6)(d).
1491	1.  A person that distributes prescription drugs that it
1492	did not manufacture must also obtain an out-of-state
1493	prescription drug wholesale distributor wholesaler permit
1494	pursuant to this section to engage in the wholesale distribution
1495	of the prescription drugs manufactured by another person and
1496	comply with the requirements of an out-of-state prescription
1497	drug wholesale distributor wholesaler.
1498	2.  Any such person must comply with the licensing or
1499	permitting requirements of the jurisdiction in which the
1500	establishment is located and the federal act, and any product
1501	wholesaled into this state must comply with this part ss.
1502	499.001-499.081. If a person intends to import prescription
1503	drugs from a foreign country into this state, the nonresident
1504	prescription drug manufacturer must provide to the department a
1505	list identifying each prescription drug it intends to import and
1506	document approval by the United States Food and Drug
1507	Administration for such importation.
1508	(d)(a)  A Prescription drug wholesale distributor
1509	wholesaler's permit.--A prescription drug wholesale distributor
1510	wholesaler is a wholesale distributor that may engage in the
1511	wholesale distribution of prescription drugs. A prescription
1512	drug wholesale distributor wholesaler that applies to the
1513	department for a new permit or the renewal of a permit must
1514	submit a bond of $100,000, or other equivalent means of security
1515	acceptable to the department, such as an irrevocable letter of
1516	credit or a deposit in a trust account or financial institution,
1517	payable to the Florida Drug, Device, and Cosmetic Trust Fund.
1518	The purpose of the bond is to secure payment of any
1519	administrative penalties imposed by the department and any fees
1520	and costs incurred by the department regarding that permit which
1521	are authorized under state law and which the permittee fails to
1522	pay 30 days after the fine or costs become final. The department
1523	may make a claim against such bond or security until 1 year
1524	after the permittee's license ceases to be valid or until 60
1525	days after any administrative or legal proceeding authorized in
1526	this part ss. 499.001-499.081 which involves the permittee is
1527	concluded, including any appeal, whichever occurs later. The
1528	department may adopt rules for issuing a prescription drug
1529	wholesale distributor-broker wholesaler-broker permit to a
1530	person who engages in the wholesale distribution of prescription
1531	drugs and does not take physical possession of any prescription
1532	drugs.
1533	(e)(c)  An Out-of-state prescription drug wholesale
1534	distributor wholesaler's permit.--An out-of-state prescription
1535	drug wholesale distributor wholesaler is a wholesale distributor
1536	located outside this state which engages in the wholesale
1537	distribution of prescription drugs into this state and which
1538	must be permitted by the department and comply with all the
1539	provisions required of a wholesale distributor under this part
1540	ss. 499.001-499.081. An out-of-state prescription drug wholesale
1541	distributor wholesaler that applies to the department for a new
1542	permit or the renewal of a permit must submit a bond of
1543	$100,000, or other equivalent means of security acceptable to
1544	the department, such as an irrevocable letter of credit or a
1545	deposit in a trust account or financial institution, payable to
1546	the Florida Drug, Device, and Cosmetic Trust Fund. The purpose
1547	of the bond is to secure payment of any administrative penalties
1548	imposed by the department and any fees and costs incurred by the
1549	department regarding that permit which are authorized under
1550	state law and which the permittee fails to pay 30 days after the
1551	fine or costs become final. The department may make a claim
1552	against such bond or security until 1 year after the permittee's
1553	license ceases to be valid or until 60 days after any
1554	administrative or legal proceeding authorized in this part ss.
1555	499.001-499.081 which involves the permittee is concluded,
1556	including any appeal, whichever occurs later.
1557	1.  The out-of-state prescription drug wholesale
1558	distributor wholesaler must maintain at all times a license or
1559	permit to engage in the wholesale distribution of prescription
1560	drugs in compliance with laws of the state in which it is a
1561	resident.
1562	2.  An out-of-state prescription drug wholesale distributor
1563	wholesaler's permit is not required for an intracompany sale or
1564	transfer of a prescription drug from an out-of-state
1565	establishment that is duly licensed as a prescription drug
1566	wholesale distributor wholesaler, in its state of residence, to
1567	a licensed prescription drug wholesale distributor wholesaler in
1568	this state, if both wholesale distributors wholesalers conduct
1569	wholesale distributions of prescription drugs under the same
1570	business name. The recordkeeping requirements of ss. s.
1571	499.0121(6) and 499.01212 must be followed for this transaction.
1572	(f)(d)  A Retail pharmacy drug wholesale distributor
1573	wholesaler's permit.--A retail pharmacy drug wholesale
1574	distributor wholesaler is a retail pharmacy engaged in wholesale
1575	distribution of prescription drugs within this state under the
1576	following conditions:
1577	1.  The pharmacy must obtain a retail pharmacy drug
1578	wholesale distributor wholesaler's permit pursuant to this part
1579	ss. 499.001-499.081 and the rules adopted under this part those
1580	sections.
1581	2.  The wholesale distribution activity does not exceed 30
1582	percent of the total annual purchases of prescription drugs. If
1583	the wholesale distribution activity exceeds the 30-percent
1584	maximum, the pharmacy must obtain a prescription drug wholesale
1585	distributor wholesaler's permit.
1586	3.  The transfer of prescription drugs that appear in any
1587	schedule contained in chapter 893 is subject to chapter 893 and
1588	the federal Comprehensive Drug Abuse Prevention and Control Act
1589	of 1970.
1590	4.  The transfer is between a retail pharmacy and another
1591	retail pharmacy, or a Modified Class II institutional pharmacy,
1592	or a health care practitioner licensed in this state and
1593	authorized by law to dispense or prescribe prescription drugs.
1594	5.  All records of sales of prescription drugs subject to
1595	this section must be maintained separate and distinct from other
1596	records and comply with the recordkeeping requirements of this
1597	part ss. 499.001-499.081.
1598	(g)499.014  Restricted prescription drug distributor permit
1599	Distribution of legend drugs by hospitals, health care entities,
1600	charitable organizations, and return or destruction companies;
1601	permits, general requirements.--
1602	(1)  A restricted prescription drug distributor permit is
1603	required for any person that engages in the distribution of a
1604	prescription legend drug, which distribution is not considered
1605	"wholesale distribution" under s. 499.003(55)(a) s.
1606	499.012(1)(a)1.
1607	1.(2)  A person who engages in the receipt or distribution
1608	of a prescription legend drug in this state for the purpose of
1609	processing its return or its destruction must obtain a permit as
1610	a restricted prescription drug distributor if such person is not
1611	the person initiating the return, the prescription drug
1612	wholesale supplier of the person initiating the return, or the
1613	manufacturer of the drug.
1614	2.(3)  Storage, handling, and recordkeeping of these
1615	distributions must comply with the requirements for wholesale
1616	distributors under s. 499.0121, but not except those set forth
1617	in s. 499.01212 s. 499.0121(6)(d).
1618	3.(4)  A person who applies for a permit as a restricted
1619	prescription drug distributor, or for the renewal of such a
1620	permit, must provide to the department the information required
1621	under s. 499.012 s. 499.01.
1622	4.(5)  The department may issue permits to restricted
1623	prescription drug distributors and may adopt rules regarding the
1624	distribution of prescription drugs by hospitals, health care
1625	entities, charitable organizations, or other persons not
1626	involved in wholesale distribution, which rules are necessary
1627	for the protection of the public health, safety, and welfare.
1628	(h)  Complimentary drug distributor permit.--A
1629	complimentary drug distributor permit is required for any person
1630	that engages in the distribution of a complimentary drug,
1631	subject to the requirements of s. 499.028.
1632	(i)(f)  Freight forwarder permit.--A freight forwarder
1633	permit is required for any person that engages in the
1634	distribution of a prescription legend drug as a freight
1635	forwarder unless the person is a common carrier. The storage,
1636	handling, and recordkeeping of such distributions must comply
1637	with the requirements for wholesale distributors under s.
1638	499.0121, but not except those set forth in s. 499.01212 s.
1639	499.0121(6)(d). A freight forwarder must provide the source of
1640	the prescription legend drugs with a validated airway bill, bill
1641	of lading, or other appropriate documentation to evidence the
1642	exportation of the product.
1643	(j)  Veterinary prescription drug retail establishment
1644	permit.--A veterinary prescription drug retail establishment
1645	permit is required for any person that sells veterinary
1646	prescription drugs to the public but does not include a pharmacy
1647	licensed under chapter 465.
1648	1.  The sale to the public must be based on a valid written
1649	order from a veterinarian licensed in this state who has a valid
1650	client-veterinarian relationship with the purchaser's animal.
1651	2.  Veterinary prescription drugs may not be sold in excess
1652	of the amount clearly indicated on the order or beyond the date
1653	indicated on the order.
1654	3.  An order may not be valid for more than 1 year.
1655	4.  A veterinary prescription drug retail establishment may
1656	not purchase, sell, trade, or possess human prescription drugs
1657	or any controlled substance as defined in chapter 893.
1658	5.  A veterinary prescription drug retail establishment
1659	must sell a veterinary prescription drug in the original, sealed
1660	manufacturer's container with all labeling intact and legible.
1661	The department may adopt by rule additional labeling
1662	requirements for the sale of a veterinary prescription drug.
1663	6.  A veterinary prescription drug retail establishment
1664	must comply with all of the wholesale distribution requirements
1665	of s. 499.0121.
1666	7.  Prescription drugs sold by a veterinary prescription
1667	drug retail establishment pursuant to a practitioner's order may
1668	not be returned into the retail establishment's inventory.
1669	(k)(g)  A veterinary prescription drug wholesale
1670	distributor wholesaler permit.--A veterinary prescription drug
1671	wholesale distributor wholesaler permit is required for any
1672	person that engages in the distribution of veterinary
1673	prescription drugs in or into this state. A veterinary
1674	prescription drug wholesale distributor wholesaler that also
1675	distributes prescription drugs subject to, defined by, or
1676	described by s. 503(b) of the Federal Food, Drug, and Cosmetic
1677	Act which it did not manufacture must obtain a permit as a
1678	prescription drug wholesale distributor wholesaler, an out-of-
1679	state prescription drug wholesale distributor wholesaler, or a
1680	limited prescription drug veterinary wholesale distributor
1681	wholesaler in lieu of the veterinary prescription drug wholesale
1682	distributor wholesaler permit. A veterinary prescription drug
1683	wholesale distributor wholesaler must comply with the
1684	requirements for wholesale distributors under s. 499.0121, but
1685	not except those set forth in s. 499.01212 s. 499.0121(6)(d).
1686	(l)(h)  Limited prescription drug veterinary wholesale
1687	distributor wholesaler permit.--Unless engaging in the
1688	activities of and permitted as a prescription drug manufacturer,
1689	nonresident prescription drug manufacturer, prescription drug
1690	wholesale distributor wholesaler, or out-of-state prescription
1691	drug wholesale distributor wholesaler, a limited prescription
1692	drug veterinary wholesale distributor wholesaler permit is
1693	required for any person that engages in the distribution in or
1694	into this state of veterinary prescription drugs and
1695	prescription drugs subject to, defined by, or described by s.
1696	503(b) of the Federal Food, Drug, and Cosmetic Act under the
1697	following conditions:
1698	1.  The person is engaged in the business of wholesaling
1699	prescription and veterinary prescription legend drugs to
1700	persons:
1701	a.  Licensed as veterinarians practicing on a full-time
1702	basis;
1703	b.  Regularly and lawfully engaged in instruction in
1704	veterinary medicine;
1705	c.  Regularly and lawfully engaged in law enforcement
1706	activities;
1707	d.  For use in research not involving clinical use; or
1708	e.  For use in chemical analysis or physical testing or for
1709	purposes of instruction in law enforcement activities, research,
1710	or testing.
1711	2.  No more than 30 percent of total annual prescription
1712	drug sales may be prescription drugs approved for human use
1713	which are subject to, defined by, or described by s. 503(b) of
1714	the Federal Food, Drug, and Cosmetic Act.
1715	3.  The person does not distribute is not permitted,
1716	licensed, or otherwise authorized in any jurisdiction state to
1717	wholesale prescription drugs subject to, defined by, or
1718	described by s. 503(b) of the Federal Food, Drug, and Cosmetic
1719	Act to any person who is authorized to sell, distribute,
1720	purchase, trade, or use these drugs on or for humans.
1721	4.  A limited prescription drug veterinary wholesale
1722	distributor wholesaler that applies to the department for a new
1723	permit or the renewal of a permit must submit a bond of $20,000,
1724	or other equivalent means of security acceptable to the
1725	department, such as an irrevocable letter of credit or a deposit
1726	in a trust account or financial institution, payable to the
1727	Florida Drug, Device, and Cosmetic Trust Fund. The purpose of
1728	the bond is to secure payment of any administrative penalties
1729	imposed by the department and any fees and costs incurred by the
1730	department regarding that permit which are authorized under
1731	state law and which the permittee fails to pay 30 days after the
1732	fine or costs become final. The department may make a claim
1733	against such bond or security until 1 year after the permittee's
1734	license ceases to be valid or until 60 days after any
1735	administrative or legal proceeding authorized in this part ss.
1736	499.001-499.081 which involves the permittee is concluded,
1737	including any appeal, whichever occurs later.
1738	5.  A limited prescription drug veterinary wholesale
1739	distributor wholesaler must maintain at all times a license or
1740	permit to engage in the wholesale distribution of prescription
1741	drugs in compliance with laws of the state in which it is a
1742	resident.
1743	6.  A limited prescription drug veterinary wholesale
1744	distributor wholesaler must comply with the requirements for
1745	wholesale distributors under ss. s. 499.0121 and 499.01212,
1746	except that a limited prescription drug veterinary wholesale
1747	distributor wholesaler is not required to provide a pedigree
1748	paper as required by s. 499.01212 s. 499.0121(6)(d) upon the
1749	wholesale distribution of a prescription drug to a veterinarian.
1750	7.  A limited prescription drug veterinary wholesale
1751	distributor wholesaler may not return to inventory for
1752	subsequent wholesale distribution any prescription drug subject
1753	to, defined by, or described by s. 503(b) of the Federal Food,
1754	Drug, and Cosmetic Act which has been returned by a
1755	veterinarian.
1756	8.  An out-of-state prescription drug wholesaler's permit
1757	or A limited prescription drug veterinary wholesale distributor
1758	wholesaler permit is not required for an intracompany sale or
1759	transfer of a prescription drug from an out-of-state
1760	establishment that is duly licensed to engage in the wholesale
1761	distribution of prescription drugs in its state of residence to
1762	a licensed limited prescription drug veterinary wholesale
1763	distributor wholesaler in this state if both wholesale
1764	distributors wholesalers conduct wholesale distributions of
1765	prescription drugs under the same business name. The
1766	recordkeeping requirements of ss. s. 499.0121(6) and 499.01212
1767	must be followed for this transaction.
1768	(m)  Medical oxygen retail establishment permit.--A medical
1769	oxygen retail establishment permit is required for any person
1770	that sells medical oxygen to patients only. The sale must be
1771	based on an order from a practitioner authorized by law to
1772	prescribe. The term does not include a pharmacy licensed under
1773	chapter 465.
1774	1.  A medical oxygen retail establishment may not possess,
1775	purchase, sell, or trade any prescription drug other than
1776	medical oxygen.
1777	2.  A medical oxygen retail establishment may refill
1778	medical oxygen for an individual patient based on an order from
1779	a practitioner authorized by law to prescribe. A medical oxygen
1780	retail establishment that refills medical oxygen must comply
1781	with all appropriate state and federal good manufacturing
1782	practices.
1783	3.  A medical oxygen retail establishment must comply with
1784	all of the wholesale distribution requirements of s. 499.0121.
1785	4.  Prescription medical oxygen sold by a medical oxygen
1786	retail establishment pursuant to a practitioner's order may not
1787	be returned into the retail establishment's inventory.
1788	(n)(b)  A compressed medical gas wholesale distributor
1789	wholesaler's permit.--A compressed medical gas wholesale
1790	distributor wholesaler is a wholesale distributor that is
1791	limited to the wholesale distribution of compressed medical
1792	gases to other than the consumer or patient. The compressed
1793	medical gas must be in the original sealed container that was
1794	purchased by that wholesale distributor wholesaler. A compressed
1795	medical gas wholesale distributor wholesaler may not possess or
1796	engage in the wholesale distribution of any prescription drug
1797	other than compressed medical gases. The department shall adopt
1798	rules that govern the wholesale distribution of prescription
1799	medical oxygen for emergency use. With respect to the emergency
1800	use of prescription medical oxygen, those rules may not be
1801	inconsistent with rules and regulations of federal agencies
1802	unless the Legislature specifically directs otherwise.
1803	(o)(c)  Compressed medical gas manufacturer permit.--A
1804	compressed medical gas manufacturer manufacturer's permit is
1805	required for any person that engages in the manufacture of
1806	compressed medical gases or repackages compressed medical gases
1807	from one container to another.
1808	1.  A compressed medical gas manufacturer permittee may not
1809	manufacture or possess any prescription drug other than
1810	compressed medical gases.
1811	2.  A compressed medical gas manufacturer permittee may
1812	engage in wholesale distribution of compressed medical gases
1813	manufactured at that establishment and must comply with all the
1814	provisions of this part ss. 499.001-499.081 and the rules
1815	adopted under this part those sections that apply to a wholesale
1816	distributor.
1817	3.  A compressed medical gas manufacturer permittee must
1818	comply with all appropriate state and federal good manufacturing
1819	practices.
1820	(p)(b)  Over-the-counter drug manufacturer permit.--An
1821	over-the-counter drug manufacturer manufacturer's permit is
1822	required for any person that engages in the manufacture or
1823	repackaging of an over-the-counter drug.
1824	1.  An over-the-counter drug manufacturer permittee may not
1825	possess or purchase prescription drugs.
1826	2.  A pharmacy is exempt from obtaining an over-the-counter
1827	drug manufacturer manufacturer's permit if it is operating in
1828	compliance with pharmacy practice standards as defined in
1829	chapter 465 and the rules adopted under that chapter.
1830	3.  An over-the-counter drug manufacturer permittee must
1831	comply with all appropriate state and federal good manufacturing
1832	practices.
1833	(q)(d)  Device manufacturer permit.--A device manufacturer
1834	manufacturer's permit is required for any person that engages in
1835	the manufacture, repackaging, or assembly of medical devices for
1836	human use in this state, except that a permit is not required if
1837	the person is engaged only in manufacturing, repackaging, or
1838	assembling a medical device pursuant to a practitioner's order
1839	for a specific patient.
1840	1.  A manufacturer or repackager of medical devices in this
1841	state must comply with all appropriate state and federal good
1842	manufacturing practices and quality system rules.
1843	2.  The department shall adopt rules related to storage,
1844	handling, and recordkeeping requirements for manufacturers of
1845	medical devices for human use.
1846	(r)(e)  Cosmetic manufacturer permit.--A cosmetic
1847	manufacturer manufacturer's permit is required for any person
1848	that manufactures or repackages cosmetics in this state. A
1849	person that only labels or changes the labeling of a cosmetic
1850	but does not open the container sealed by the manufacturer of
1851	the product is exempt from obtaining a permit under this
1852	paragraph.
1853	Section 11.  Section 499.012, Florida Statutes, is amended
1854	and subsections (2) through (8) of section 499.01, Florida
1855	States, are redesignated as subsections (1) through (7) of that
1856	section and amended, to read:
1857	499.012  Permit application Wholesale distribution;
1858	definitions; permits; applications; general requirements.--
1859	(1)  As used in this section, the term:
1860	(2)(a)  A permit issued pursuant to this part ss. 499.001-
1861	499.081 may be issued only to a natural person who is at least
1862	18 years of age or to an applicant that is not a natural person
1863	if each person who, directly or indirectly, manages, controls,
1864	or oversees the operation of that applicant is at least 18 years
1865	of age.
1866	(b)  An establishment that is a place of residence may not
1867	receive a permit and may not operate under this part ss.
1868	499.001-499.081.
1869	(c)  A person that applies for or renews a permit to
1870	manufacture or distribute prescription legend drugs may not use
1871	a name identical to the name used by any other establishment or
1872	licensed person authorized to purchase prescription drugs in
1873	this state, except that a restricted drug distributor permit
1874	issued to a health care entity will be issued in the name in
1875	which the institutional pharmacy permit is issued and a retail
1876	pharmacy drug wholesale distributor wholesaler will be issued a
1877	permit in the name of its retail pharmacy permit.
1878	(d)  A permit for a prescription drug manufacturer,
1879	prescription drug repackager, prescription drug wholesale
1880	distributor wholesaler, limited prescription drug veterinary
1881	wholesale distributor wholesaler, or retail pharmacy drug
1882	wholesale distributor wholesaler may not be issued to the
1883	address of a health care entity or to a pharmacy licensed under
1884	chapter 465, except as provided in this paragraph. The
1885	department may issue a prescription drug manufacturer permit to
1886	an applicant at the same address as a licensed nuclear pharmacy,
1887	which is a health care entity, for the purpose of manufacturing
1888	prescription drugs used in positron emission tomography or other
1889	radiopharmaceuticals, as listed in a rule adopted by the
1890	department pursuant to this paragraph. The purpose of this
1891	exemption is to assure availability of state-of-the-art
1892	pharmaceuticals that would pose a significant danger to the
1893	public health if manufactured at a separate establishment
1894	address from the nuclear pharmacy from which the prescription
1895	drugs are dispensed. The department may also issue a retail
1896	pharmacy drug wholesale distributor wholesaler permit to the
1897	address of a community pharmacy licensed under chapter 465 which
1898	does not meet the definition of a closed pharmacy in s. 499.003.
1899	(e)  A county or municipality may not issue an occupational
1900	license for any licensing period beginning on or after October
1901	1, 2003, for any establishment that requires a permit pursuant
1902	to this part ss. 499.001-499.081, unless the establishment
1903	exhibits a current permit issued by the department for the
1904	establishment. Upon presentation of the requisite permit issued
1905	by the department, an occupational license may be issued by the
1906	municipality or county in which application is made. The
1907	department shall furnish to local agencies responsible for
1908	issuing occupational licenses a current list of all
1909	establishments licensed pursuant to this part ss. 499.001-
1910	499.081.
1911	(2)(3)  Notwithstanding subsection (6) (7), a permitted
1912	person in good standing may change the type of permit issued to
1913	that person by completing a new application for the requested
1914	permit, paying the amount of the difference in the permit fees
1915	if the fee for the new permit is more than the fee for the
1916	original permit, and meeting the applicable permitting
1917	conditions for the new permit type. The new permit expires on
1918	the expiration date of the original permit being changed;
1919	however, a new permit for a prescription drug wholesale
1920	distributor wholesaler, an out-of-state prescription drug
1921	wholesale distributor wholesaler, or a retail pharmacy drug
1922	wholesale distributor wholesaler shall expire on the expiration
1923	date of the original permit or 1 year after the date of issuance
1924	of the new permit, whichever is earlier. A refund may not be
1925	issued if the fee for the new permit is less than the fee that
1926	was paid for the original permit.
1927	(3)(4)  A written application for a permit or to renew a
1928	permit must be filed with the department on forms furnished by
1929	the department. The department shall establish, by rule, the
1930	form and content of the application to obtain or renew a permit.
1931	The applicant must submit to the department with the application
1932	a statement that swears or affirms that the information is true
1933	and correct.
1934	(4)(5)(a)  Except for a permit for a prescription drug
1935	wholesale distributor wholesaler or an out-of-state prescription
1936	drug wholesale distributor wholesaler, an application for a
1937	permit must include:
1938	1.  The name, full business address, and telephone number
1939	of the applicant;
1940	2.  All trade or business names used by the applicant;
1941	3.  The address, telephone numbers, and the names of
1942	contact persons for each facility used by the applicant for the
1943	storage, handling, and distribution of prescription drugs;
1944	4.  The type of ownership or operation, such as a
1945	partnership, corporation, or sole proprietorship; and
1946	5.  The names of the owner and the operator of the
1947	establishment, including:
1948	a.  If an individual, the name of the individual;
1949	b.  If a partnership, the name of each partner and the name
1950	of the partnership;
1951	c.  If a corporation, the name and title of each corporate
1952	officer and director, the corporate names, and the name of the
1953	state of incorporation;
1954	d.  If a sole proprietorship, the full name of the sole
1955	proprietor and the name of the business entity;
1956	e.  If a limited liability company, the name of each
1957	member, the name of each manager, the name of the limited
1958	liability company, and the name of the state in which the
1959	limited liability company was organized; and
1960	f.  Any other relevant information that the department
1961	requires.
1962	(b)  Upon approval of the application by the department and
1963	payment of the required fee, the department shall issue a permit
1964	to the applicant, if the applicant meets the requirements of
1965	this part ss. 499.001-499.081 and rules adopted under this part
1966	those sections.
1967	(c)  Any change in information required under paragraph (a)
1968	must be submitted to the department before the change occurs.
1969	(d)  The department shall consider, at a minimum, the
1970	following factors in reviewing the qualifications of persons to
1971	be permitted under this part ss. 499.001-499.081:
1972	1.  The applicant's having been found guilty, regardless of
1973	adjudication, in a court of this state or other jurisdiction, of
1974	a violation of a law that directly relates to a drug, device, or
1975	cosmetic. A plea of nolo contendere constitutes a finding of
1976	guilt for purposes of this subparagraph.
1977	2.  The applicant's having been disciplined by a regulatory
1978	agency in any state for any offense that would constitute a
1979	violation of this part ss. 499.001-499.081.
1980	3.  Any felony conviction of the applicant under a federal,
1981	state, or local law;
1982	4.  The applicant's past experience in manufacturing or
1983	distributing drugs, devices, or cosmetics;
1984	5.  The furnishing by the applicant of false or fraudulent
1985	material in any application made in connection with
1986	manufacturing or distributing drugs, devices, or cosmetics;
1987	6.  Suspension or revocation by a federal, state, or local
1988	government of any permit currently or previously held by the
1989	applicant for the manufacture or distribution of any drugs,
1990	devices, or cosmetics;
1991	7.  Compliance with permitting requirements under any
1992	previously granted permits;
1993	8.  Compliance with requirements to maintain or make
1994	available to the state permitting authority or to federal,
1995	state, or local law enforcement officials those records required
1996	under this section; and
1997	9.  Any other factors or qualifications the department
1998	considers relevant to and consistent with the public health and
1999	safety.
2000	(5)(6)  Except for a permit permits for a prescription drug
2001	wholesale distributor wholesalers or an out-of-state
2002	prescription drug wholesale distributor wholesalers:
2003	(a)  The department shall adopt rules for the biennial
2004	renewal of permits.
2005	(b)  The department shall renew a permit upon receipt of
2006	the renewal application and renewal fee if the applicant meets
2007	the requirements established under this part ss. 499.001-499.081
2008	and the rules adopted under this part those sections.
2009	(c)  A permit, unless sooner suspended or revoked,
2010	automatically expires 2 years after the last day of the
2011	anniversary month in which the permit was originally issued. A
2012	permit issued under this part ss. 499.001-499.081 may be renewed
2013	by making application for renewal on forms furnished by the
2014	department and paying the appropriate fees. If a renewal
2015	application and fee are submitted and postmarked after the
2016	expiration date of the permit, the permit may be renewed only
2017	upon payment of a late renewal delinquent fee of $100, plus the
2018	required renewal fee, not later than 60 days after the
2019	expiration date.
2020	(d)  Failure to renew a permit in accordance with this
2021	section precludes any future renewal of that permit. If a permit
2022	issued pursuant to this part section has expired and cannot be
2023	renewed, before an establishment may engage in activities that
2024	require a permit under this part ss. 499.001-499.081, the
2025	establishment must submit an application for a new permit, pay
2026	the applicable application fee, the initial permit fee, and all
2027	applicable penalties, and be issued a new permit by the
2028	department.
2029	(6)(7)  A permit issued by the department is
2030	nontransferable. Each permit is valid only for the person or
2031	governmental unit to which it is issued and is not subject to
2032	sale, assignment, or other transfer, voluntarily or
2033	involuntarily; nor is a permit valid for any establishment other
2034	than the establishment for which it was originally issued.
2035	(a)  A person permitted under this part ss. 499.001-499.081
2036	must notify the department before making a change of address.
2037	The department shall set a change of location fee not to exceed
2038	$100.
2039	(b)1.  An application for a new permit is required when a
2040	majority of the ownership or controlling interest of a permitted
2041	establishment is transferred or assigned or when a lessee agrees
2042	to undertake or provide services to the extent that legal
2043	liability for operation of the establishment will rest with the
2044	lessee. The application for the new permit must be made before
2045	the date of the sale, transfer, assignment, or lease.
2046	2.  A permittee that is authorized to distribute
2047	prescription legend drugs may transfer such drugs to the new
2048	owner or lessee under subparagraph 1. only after the new owner
2049	or lessee has been approved for a permit to distribute
2050	prescription legend drugs.
2051	(c)  If an establishment permitted under this part ss.
2052	499.001-499.081 closes, the owner must notify the department in
2053	writing before the effective date of closure and must:
2054	1.  Return the permit to the department;
2055	2.  If the permittee is authorized to distribute
2056	prescription legend drugs, indicate the disposition of such
2057	drugs, including the name, address, and inventory, and provide
2058	the name and address of a person to contact regarding access to
2059	records that are required to be maintained under this part ss.
2060	499.001-499.081. Transfer of ownership of prescription legend
2061	drugs may be made only to persons authorized to possess
2062	prescription legend drugs under this part ss. 499.001-499.081.
2063
2064	The department may revoke the permit of any person that fails to
2065	comply with the requirements of this subsection.
2066	(7)(8)  A permit must be posted in a conspicuous place on
2067	the licensed premises.
2068	(8)(3)  An application for a permit or to renew a permit
2069	for a prescription drug wholesale distributor wholesaler or an
2070	out-of-state prescription drug wholesale distributor wholesaler
2071	submitted to the department must include:
2072	(a)  The name, full business address, and telephone number
2073	of the applicant.
2074	(b)  All trade or business names used by the applicant.
2075	(c)  The address, telephone numbers, and the names of
2076	contact persons for each facility used by the applicant for the
2077	storage, handling, and distribution of prescription drugs.
2078	(d)  The type of ownership or operation, such as a
2079	partnership, corporation, or sole proprietorship.
2080	(e)  The names of the owner and the operator of the
2081	establishment, including:
2082	1.  If an individual, the name of the individual.
2083	2.  If a partnership, the name of each partner and the name
2084	of the partnership.
2085	3.  If a corporation:
2086	a.  The name, address, and title of each corporate officer
2087	and director.
2088	b.  The name and address of the corporation, resident agent
2089	of the corporation, the resident agent's address, and the
2090	corporation's state of incorporation.
2091	c.  The name and address of each shareholder of the
2092	corporation that owns 5 percent or more of the outstanding stock
2093	of the corporation.
2094	4.  If a sole proprietorship, the full name of the sole
2095	proprietor and the name of the business entity.
2096	5.  If a limited liability company:
2097	a.  The name and address of each member.
2098	b.  The name and address of each manager.
2099	c.  The name and address of the limited liability company,
2100	the resident agent of the limited liability company, and the
2101	name of the state in which the limited liability company was
2102	organized.
2103	(f)  If applicable, the name and address of each member of
2104	the affiliated group of which the applicant is a member.
2105	(g)1.  For an application for a new permit, the estimated
2106	annual dollar volume of prescription drug sales of the
2107	applicant, the estimated annual percentage of the applicant's
2108	total company sales that are prescription drugs, the applicant's
2109	estimated annual total dollar volume of purchases of
2110	prescription drugs, and the applicant's estimated annual total
2111	dollar volume of prescription drug purchases directly from
2112	manufacturers.
2113	2.  For an application to renew a permit, the total dollar
2114	volume of prescription drug sales in the previous year, the
2115	total dollar volume of prescription drug sales made in the
2116	previous 6 months, the percentage of total company sales that
2117	were prescription drugs in the previous year, the total dollar
2118	volume of purchases of prescription drugs in the previous year,
2119	and the total dollar volume of prescription drug purchases
2120	directly from manufacturers in the previous year.
2121
2122	Such portions of the information required pursuant to this
2123	paragraph which are a trade secret, as defined in s. 812.081,
2124	shall be maintained by the department as trade secret
2125	information is required to be maintained under s. 499.051.
2126	(h)  The tax year of the applicant.
2127	(i)  A copy of the deed for the property on which
2128	applicant's establishment is located, if the establishment is
2129	owned by the applicant, or a copy of the applicant's lease for
2130	the property on which applicant's establishment is located that
2131	has an original term of not less than 1 calendar year, if the
2132	establishment is not owned by the applicant.
2133	(j)  A list of all licenses and permits issued to the
2134	applicant by any other state which authorize the applicant to
2135	purchase or possess prescription drugs.
2136	(k)  The name of the manager of the establishment that is
2137	applying for the permit or to renew the permit, the next four
2138	highest ranking employees responsible for prescription drug
2139	wholesale operations for the establishment, and the name of all
2140	affiliated parties for the establishment, together with the
2141	personal information statement and fingerprints required
2142	pursuant to subsection (9) (4) for each of such persons.
2143	(l)  The name of each of the applicant's designated
2144	representatives as required by subsection (16) (11), together
2145	with the personal information statement and fingerprints
2146	required pursuant to subsection (9) (4) for each such person.
2147	(m)  For an applicant that is a secondary wholesale
2148	distributor wholesaler, each of the following:
2149	1.  A personal background information statement containing
2150	the background information and fingerprints required pursuant to
2151	subsection (9) (4) for each person named in the applicant's
2152	response to paragraphs (k) and (l) and for each affiliated party
2153	of the applicant.
2154	2.  If any of the five largest shareholders of the
2155	corporation seeking the permit is a corporation, the name,
2156	address, and title of each corporate officer and director of
2157	each such corporation; the name and address of such corporation;
2158	the name of such corporation's resident agent, such
2159	corporation's resident agent's address, and such corporation's
2160	state of its incorporation; and the name and address of each
2161	shareholder of such corporation that owns 5 percent or more of
2162	the stock of such corporation.
2163	3.  The name and address of all financial institutions in
2164	which the applicant has an account which is used to pay for the
2165	operation of the establishment or to pay for drugs purchased for
2166	the establishment, together with the names of all persons that
2167	are authorized signatories on such accounts. The portions of the
2168	information required pursuant to this subparagraph which are a
2169	trade secret, as defined in s. 812.081, shall be maintained by
2170	the department as trade secret information is required to be
2171	maintained under s. 499.051.
2172	4.  The sources of all funds and the amounts of such funds
2173	used to purchase or finance purchases of prescription drugs or
2174	to finance the premises on which the establishment is to be
2175	located.
2176	5.  If any of the funds identified in subparagraph 4. were
2177	borrowed, copies of all promissory notes or loans used to obtain
2178	such funds.
2179	(n)  Any other relevant information that the department
2180	requires, including, but not limited to, any information related
2181	to whether the applicant satisfies the definition of a primary
2182	wholesale distributor wholesaler or a secondary wholesale
2183	distributor wholesaler.
2184	(9)(4)(a)  Each person required by subsection (8) (3) to
2185	provide a personal information statement and fingerprints shall
2186	provide the following information to the department on forms
2187	prescribed by the department:
2188	1.  The person's places of residence for the past 7 years.
2189	2.  The person's date and place of birth.
2190	3.  The person's occupations, positions of employment, and
2191	offices held during the past 7 years.
2192	4.  The principal business and address of any business,
2193	corporation, or other organization in which each such office of
2194	the person was held or in which each such occupation or position
2195	of employment was carried on.
2196	5.  Whether the person has been, during the past 7 years,
2197	the subject of any proceeding for the revocation of any license
2198	and, if so, the nature of the proceeding and the disposition of
2199	the proceeding.
2200	6.  Whether, during the past 7 years, the person has been
2201	enjoined, either temporarily or permanently, by a court of
2202	competent jurisdiction from violating any federal or state law
2203	regulating the possession, control, or distribution of
2204	prescription drugs, together with details concerning any such
2205	event.
2206	7.  A description of any involvement by the person with any
2207	business, including any investments, other than the ownership of
2208	stock in a publicly traded company or mutual fund, during the
2209	past 7 years, which manufactured, administered, prescribed,
2210	distributed, or stored pharmaceutical products and any lawsuits
2211	in which such businesses were named as a party.
2212	8.  A description of any felony criminal offense of which
2213	the person, as an adult, was found guilty, regardless of whether
2214	adjudication of guilt was withheld or whether the person pled
2215	guilty or nolo contendere. A criminal offense committed in
2216	another jurisdiction which would have been a felony in this
2217	state must be reported. If the person indicates that a criminal
2218	conviction is under appeal and submits a copy of the notice of
2219	appeal of that criminal offense, the applicant must, within 15
2220	days after the disposition of the appeal, submit to the
2221	department a copy of the final written order of disposition.
2222	9.  A photograph of the person taken in the previous 30
2223	days.
2224	10.  A set of fingerprints for the person on a form and
2225	under procedures specified by the department, together with
2226	payment of an amount equal to the costs incurred by the
2227	department for the criminal record check of the person.
2228	11.  The name, address, occupation, and date and place of
2229	birth for each member of the person's immediate family who is 18
2230	years of age or older. As used in this subparagraph, the term
2231	"member of the person's immediate family" includes the person's
2232	spouse, children, parents, siblings, the spouses of the person's
2233	children, and the spouses of the person's siblings.
2234	12.  Any other relevant information that the department
2235	requires.
2236	(b)  The information required pursuant to paragraph (a)
2237	shall be provided under oath.
2238	(c)  The department shall submit the fingerprints provided
2239	by a person for initial licensure to the Department of Law
2240	Enforcement for a statewide criminal record check and for
2241	forwarding to the Federal Bureau of Investigation for a national
2242	criminal record check of the person. The department shall submit
2243	the fingerprints provided by a person as a part of a renewal
2244	application to the Department of Law Enforcement for a statewide
2245	criminal record check, and for forwarding to the Federal Bureau
2246	of Investigation for a national criminal record check, for the
2247	initial renewal of a permit after January 1, 2004; for any
2248	subsequent renewal of a permit, the department shall submit the
2249	required information for a statewide and national criminal
2250	record check of the person. Any person who as a part of an
2251	initial permit application or initial permit renewal after
2252	January 1, 2004, submits to the department a set of fingerprints
2253	required for the criminal record check required in this
2254	paragraph shall not be required to provide a subsequent set of
2255	fingerprints for a criminal record check to the department, if
2256	the person has undergone a criminal record check as a condition
2257	of the issuance of an initial permit or the initial renewal of a
2258	permit of an applicant after January 1, 2004.
2259	(10)(5)  The department may deny an application for a
2260	permit or refuse to renew a permit for a prescription drug
2261	wholesale distributor wholesaler or an out-of-state prescription
2262	drug wholesale distributor wholesaler if:
2263	(a)  The applicant has not met the requirements for the
2264	permit.
2265	(b)  The management, officers, or directors of the
2266	applicant or any affiliated party are found by the department to
2267	be incompetent or untrustworthy.
2268	(c)  The applicant is so lacking in experience in managing
2269	a wholesale distributor as to make the issuance of the proposed
2270	permit hazardous to the public health.
2271	(d)  The applicant is so lacking in experience in managing
2272	a wholesale distributor as to jeopardize the reasonable promise
2273	of successful operation of the wholesale distributor.
2274	(e)  The applicant is lacking in experience in the
2275	distribution of prescription drugs.
2276	(f)  The applicant's past experience in manufacturing or
2277	distributing prescription drugs indicates that the applicant
2278	poses a public health risk.
2279	(g)  The applicant is affiliated directly or indirectly
2280	through ownership, control, or other business relations, with
2281	any person or persons whose business operations are or have been
2282	detrimental to the public health.
2283	(h)  The applicant, or any affiliated party, has been found
2284	guilty of or has pleaded guilty or nolo contendere to any felony
2285	or crime punishable by imprisonment for 1 year or more under the
2286	laws of the United States, any state, or any other country,
2287	regardless of whether adjudication of guilt was withheld.
2288	(i)  The applicant or any affiliated party has been charged
2289	with a felony in a state or federal court and the disposition of
2290	that charge is pending during the application review or renewal
2291	review period.
2292	(j)  The applicant has furnished false or fraudulent
2293	information or material in any application made in this state or
2294	any other state in connection with obtaining a permit or license
2295	to manufacture or distribute drugs, devices, or cosmetics.
2296	(k)  That a federal, state, or local government permit
2297	currently or previously held by the applicant, or any affiliated
2298	party, for the manufacture or distribution of any drugs,
2299	devices, or cosmetics has been disciplined, suspended, or
2300	revoked and has not been reinstated.
2301	(l)  The applicant does not possess the financial or
2302	physical resources to operate in compliance with the permit
2303	being sought, this chapter, and the rules adopted under this
2304	chapter.
2305	(m)  The applicant or any affiliated party receives,
2306	directly or indirectly, financial support and assistance from a
2307	person who was an affiliated party of a permittee whose permit
2308	was subject to discipline or was suspended or revoked, other
2309	than through the ownership of stock in a publicly traded company
2310	or a mutual fund.
2311	(n)  The applicant or any affiliated party receives,
2312	directly or indirectly, financial support and assistance from a
2313	person who has been found guilty of any violation of this part
2314	ss. 499.001-499.081 or chapter 465, chapter 501, or chapter 893,
2315	any rules adopted under any of this part those sections or those
2316	chapters, any federal or state drug law, or any felony where the
2317	underlying facts related to drugs, regardless of whether the
2318	person has been pardoned, had her or his civil rights restored,
2319	or had adjudication withheld, other than through the ownership
2320	of stock in a publicly traded company or a mutual fund.
2321	(o)  The applicant for renewal of a permit under s.
2322	499.01(2)(d) paragraph (2)(a) or s. 499.01(2)(e) paragraph
2323	(2)(c)  has not actively engaged in the wholesale distribution
2324	of prescription drugs, as demonstrated by the regular and
2325	systematic distribution of prescription drugs throughout the
2326	year as evidenced by not fewer than 12 wholesale distributions
2327	in the previous year and not fewer than three wholesale
2328	distributions in the previous 6 months.
2329	(p)  Information obtained in response to s. 499.01(2)(d)
2330	paragraph (2)(a) or s. 499.01(2)(e) paragraph (2)(c)
2331	demonstrates it would not be in the best interest of the public
2332	health, safety, and welfare to issue a permit.
2333	(q)  The applicant does not possess the financial standing
2334	and business experience for the successful operation of the
2335	applicant.
2336	(r)  The applicant or any affiliated party has failed to
2337	comply with the requirements for manufacturing or distributing
2338	prescription drugs under this part ss. 499.001-499.081, similar
2339	federal laws, similar laws in other states, or the rules adopted
2340	under such laws.
2341	(11)(6)  Upon approval of the application by the department
2342	and payment of the required fee, the department shall issue or
2343	renew a prescription drug wholesale distributor wholesaler or an
2344	out-of-state prescription drug wholesale distributor wholesaler
2345	permit to the applicant.
2346	(12)(7)  For a permit permits for a prescription drug
2347	wholesale distributor wholesalers or an out-of-state
2348	prescription drug wholesale distributor wholesalers:
2349	(a)  The department shall adopt rules for the annual
2350	renewal of permits. At least 90 days before the expiration of a
2351	permit, the department shall forward a permit renewal
2352	notification and renewal application to the prescription drug
2353	wholesale distributor wholesaler or out-of-state prescription
2354	drug wholesale distributor wholesaler at the mailing address of
2355	the permitted establishment on file with the department. The
2356	permit renewal notification must state conspicuously the date on
2357	which the permit for the establishment will expire and that the
2358	establishment may not operate unless the permit for the
2359	establishment is renewed timely.
2360	(b)  A permit, unless sooner suspended or revoked,
2361	automatically expires 1 year after the last day of the
2362	anniversary month in which the permit was originally issued. A
2363	permit may be renewed by making application for renewal on forms
2364	furnished by the department and paying the appropriate fees. If
2365	a renewal application and fee are submitted and postmarked after
2366	45 days prior to the expiration date of the permit, the permit
2367	may be renewed only upon payment of a late renewal fee of $100,
2368	plus the required renewal fee. A permittee that has submitted a
2369	renewal application in accordance with this paragraph may
2370	continue to operate under its permit, unless the permit is
2371	suspended or revoked, until final disposition of the renewal
2372	application.
2373	(c)  Failure to renew a permit in accordance with this
2374	section precludes any future renewal of that permit. If a permit
2375	issued pursuant to this section has expired and cannot be
2376	renewed, before an establishment may engage in activities that
2377	require a permit under this part ss. 499.001-499.081, the
2378	establishment must submit an application for a new permit; pay
2379	the applicable application fee, initial permit fee, and all
2380	applicable penalties; and be issued a new permit by the
2381	department.
2382	(13)(8)  A person that engages in wholesale distribution of
2383	prescription drugs in this state must have a wholesale
2384	distributor's permit issued by the department, except as noted
2385	in this section. Each establishment must be separately permitted
2386	except as noted in this subsection.
2387	(a)  A separate establishment permit is not required when a
2388	permitted prescription drug wholesale distributor wholesaler
2389	consigns a prescription drug to a pharmacy that is permitted
2390	under chapter 465 and located in this state, provided that:
2391	1.  The consignor wholesale distributor wholesaler notifies
2392	the department in writing of the contract to consign
2393	prescription drugs to a pharmacy along with the identity and
2394	location of each consignee pharmacy;
2395	2.  The pharmacy maintains its permit under chapter 465;
2396	3.  The consignor wholesale distributor wholesaler, which
2397	has no legal authority to dispense prescription drugs, complies
2398	with all wholesale distribution requirements of ss. s. 499.0121
2399	and 499.01212 with respect to the consigned drugs and maintains
2400	records documenting the transfer of title or other completion of
2401	the wholesale distribution of the consigned prescription drugs;
2402	4.  The distribution of the prescription drug is otherwise
2403	lawful under this chapter and other applicable law;
2404	5.  Open packages containing prescription drugs within a
2405	pharmacy are the responsibility of the pharmacy, regardless of
2406	how the drugs are titled; and
2407	6.  The pharmacy dispenses the consigned prescription drug
2408	in accordance with the limitations of its permit under chapter
2409	465 or returns the consigned prescription drug to the consignor
2410	wholesale distributor wholesaler. In addition, a person who
2411	holds title to prescription drugs may transfer the drugs to a
2412	person permitted or licensed to handle the reverse distribution
2413	or destruction of drugs. Any other distribution by and means of
2414	the consigned prescription drug by any person, not limited to
2415	the consignor wholesale distributor wholesaler or consignee
2416	pharmacy, to any other person is prohibited.
2417	(b)  A wholesale distributor's permit is not required for
2418	the one-time transfer of title of a pharmacy's lawfully acquired
2419	prescription drug inventory by a pharmacy with a valid permit
2420	issued under chapter 465 to a consignor prescription drug
2421	wholesale distributor wholesaler, permitted under this chapter,
2422	in accordance with a written consignment agreement between the
2423	pharmacy and that wholesale distributor wholesaler if: the
2424	permitted pharmacy and the permitted prescription drug wholesale
2425	distributor wholesaler comply with all of the provisions of
2426	paragraph (a) and the prescription drugs continue to be within
2427	the permitted pharmacy's inventory for dispensing in accordance
2428	with the limitations of the pharmacy permit under chapter 465. A
2429	consignor drug wholesale distributor wholesaler may not use the
2430	pharmacy as a wholesale distributor through which it distributes
2431	the prescription legend drugs to other pharmacies. Nothing in
2432	this section is intended to prevent a wholesale drug distributor
2433	from obtaining this inventory in the event of nonpayment by the
2434	pharmacy.
2435	(c)  The department shall require information from each
2436	wholesale distributor as part of the permit and renewal of such
2437	permit, as required under s. 499.01 or this section.
2438	(14)(9)  Personnel employed in wholesale distribution must
2439	have appropriate education and experience to enable them to
2440	perform their duties in compliance with state permitting
2441	requirements.
2442	(15)(10)  The name of a permittee or establishment on a
2443	prescription drug wholesale distributor wholesaler permit or an
2444	out-of-state prescription drug wholesale distributor wholesaler
2445	permit may not include any indicia of attainment of any
2446	educational degree, any indicia that the permittee or
2447	establishment possesses a professional license, or any name or
2448	abbreviation that the department determines is likely to cause
2449	confusion or mistake or that the department determines is
2450	deceptive, including that of any other entity authorized to
2451	purchase prescription drugs.
2452	(16)(11)(a)  Each establishment that is issued an initial
2453	or renewal permit as a prescription drug wholesale distributor
2454	wholesaler or an out-of-state prescription drug wholesale
2455	distributor wholesaler must designate in writing to the
2456	department at least one natural person to serve as the
2457	designated representative of the wholesale distributor
2458	wholesaler. Such person must have an active certification as a
2459	designated representative from the department.
2460	(b)  To be certified as a designated representative, a
2461	natural person must:
2462	1.  Submit an application on a form furnished by the
2463	department and pay the appropriate fees;
2464	2.  Be at least 18 years of age;
2465	3.  Have not less than 2 years of verifiable full-time work
2466	experience in a pharmacy licensed in this state or another
2467	state, where the person's responsibilities included, but were
2468	not limited to, recordkeeping for prescription drugs, or have
2469	not less than 2 years of verifiable full-time managerial
2470	experience with a prescription drug wholesale distributor
2471	wholesaler licensed in this state or in another state;
2472	4.  Receive a passing score of at least 75 percent on an
2473	examination given by the department regarding federal laws
2474	governing distribution of prescription drugs and this part ss.
2475	499.001-499.081 and the rules adopted by the department
2476	governing the wholesale distribution of prescription drugs. This
2477	requirement shall be effective 1 year after the results of the
2478	initial examination are mailed to the persons that took the
2479	examination. The department shall offer such examinations at
2480	least four times each calendar year; and
2481	5.  Provide the department with a personal information
2482	statement and fingerprints pursuant to subsection (9)(4).
2483	(c)  The department may deny an application for
2484	certification as a designated representative or may suspend or
2485	revoke a certification of a designated representative pursuant
2486	to s. 499.067.
2487	(d)  A designated representative:
2488	1.  Must be actively involved in and aware of the actual
2489	daily operation of the wholesale distributor.
2490	2.  Must be employed full time in a managerial position by
2491	the wholesale distributor.
2492	3.  Must be physically present at the establishment during
2493	normal business hours, except for time periods when absent due
2494	to illness, family illness or death, scheduled vacation, or
2495	other authorized absence.
2496	4.  May serve as a designated representative for only one
2497	wholesale distributor at any one time.
2498	(e)  A wholesale distributor must notify the department
2499	when a designated representative leaves the employ of the
2500	wholesale distributor. Such notice must be provided to the
2501	department within 10 business days after the last day of
2502	designated representative's employment with the wholesale
2503	distributor.
2504	(f)  A wholesale distributor may not operate under a
2505	prescription drug wholesale distributor wholesaler permit or an
2506	out-of-state prescription drug wholesale distributor wholesaler
2507	permit for more than 10 business days after the designated
2508	representative leaves the employ of the wholesale distributor,
2509	unless the wholesale distributor employs another designated
2510	representative and notifies the department within 10 business
2511	days of the identity of the new designated representative.
2512	Section 12.  Section 499.01201, Florida Statutes, is
2513	amended to read:
2514	499.01201  Agency for Health Care Administration review and
2515	use of statute and rule violation or compliance
2516	data.--Notwithstanding any other provisions of law to the
2517	contrary, the Agency for Health Care Administration may not:
2518	(1)  Review or use any violation or alleged violation of s.
2519	499.0121(6) or s. 499.01212, or any rules adopted under those
2520	sections that section, as a ground for denying or withholding
2521	any payment of a Medicaid reimbursement to a pharmacy licensed
2522	under chapter 465; or
2523	(2)  Review or use compliance with s. 499.0121(6) or s.
2524	499.01212, or any rules adopted under those sections that
2525	section, as the subject of any audit of Medicaid-related records
2526	held by a pharmacy licensed under chapter 465.
2527	Section 13.  Section 499.0121, Florida Statutes, is
2528	amended, and subsection (4) of section 499.013, Florida
2529	Statutes, is redesignated as paragraph (d) of subsection (6) of
2530	that section and amended, to read:
2531	499.0121  Storage and handling of prescription drugs;
2532	recordkeeping.--The department shall adopt rules to implement
2533	this section as necessary to protect the public health, safety,
2534	and welfare. Such rules shall include, but not be limited to,
2535	requirements for the storage and handling of prescription drugs
2536	and for the establishment and maintenance of prescription drug
2537	distribution records.
2538	(1)  ESTABLISHMENTS.--An establishment at which
2539	prescription drugs are stored, warehoused, handled, held,
2540	offered, marketed, or displayed must:
2541	(a)  Be of suitable size and construction to facilitate
2542	cleaning, maintenance, and proper operations;
2543	(b)  Have storage areas designed to provide adequate
2544	lighting, ventilation, temperature, sanitation, humidity, space,
2545	equipment, and security conditions;
2546	(c)  Have a quarantine area for storage of prescription
2547	drugs that are outdated, damaged, deteriorated, misbranded, or
2548	adulterated, or that are in immediate or sealed, secondary
2549	containers that have been opened;
2550	(d)  Be maintained in a clean and orderly condition; and
2551	(e)  Be free from infestation by insects, rodents, birds,
2552	or vermin of any kind.
2553	(2)  SECURITY.--
2554	(a)  An establishment that is used for wholesale drug
2555	distribution must be secure from unauthorized entry.
2556	1.  Access from outside the premises must be kept to a
2557	minimum and be well-controlled.
2558	2.  The outside perimeter of the premises must be well-
2559	lighted.
2560	3.  Entry into areas where prescription drugs are held must
2561	be limited to authorized personnel.
2562	(b)  An establishment that is used for wholesale drug
2563	distribution must be equipped with:
2564	1.  An alarm system to detect entry after hours; however,
2565	the department may exempt by rule establishments that only hold
2566	a permit as prescription drug wholesale distributor-brokers
2567	wholesaler-brokers and establishments that only handle medical
2568	oxygen; and
2569	2.  A security system that will provide suitable protection
2570	against theft and diversion. When appropriate, the security
2571	system must provide protection against theft or diversion that
2572	is facilitated or hidden by tampering with computers or
2573	electronic records.
2574	(c)  Any vehicle that contains prescription drugs must be
2575	secure from unauthorized access to the prescription drugs in the
2576	vehicle.
2577	(3)  STORAGE.--All prescription drugs shall be stored at
2578	appropriate temperatures and under appropriate conditions in
2579	accordance with requirements, if any, in the labeling of such
2580	drugs, or with requirements in the official compendium.
2581	(a)  If no storage requirements are established for a
2582	prescription drug, the drug may be held at "controlled" room
2583	temperature, as defined in the official compendium, to help
2584	ensure that its identity, strength, quality, and purity are not
2585	adversely affected.
2586	(b)  Appropriate manual, electromechanical, or electronic
2587	temperature and humidity recording equipment, devices, or logs
2588	must be used to document proper storage of prescription drugs.
2589	(c)  The recordkeeping requirements in subsection (6) must
2590	be followed for all stored prescription drugs.
2591	(4)  EXAMINATION OF MATERIALS AND RECORDS.--
2592	(a)  Upon receipt, each outside shipping container must be
2593	visually examined for identity and to prevent the acceptance of
2594	contaminated prescription drugs that are otherwise unfit for
2595	distribution. This examination must be adequate to reveal
2596	container damage that would suggest possible contamination or
2597	other damage to the contents.
2598	(b)  Each outgoing shipment must be carefully inspected for
2599	identity of the prescription drug products and to ensure that
2600	there is no delivery of prescription drugs that have expired or
2601	been damaged in storage or held under improper conditions.
2602	(c)  The recordkeeping requirements in subsection (6) must
2603	be followed for all incoming and outgoing prescription drugs.
2604	(d)  Upon receipt, a wholesale distributor wholesaler must
2605	review records required under this section for the acquisition
2606	of prescription drugs for accuracy and completeness, considering
2607	the total facts and circumstances surrounding the transactions
2608	and the wholesale distributors involved. This includes
2609	authenticating each transaction listed on a pedigree paper, as
2610	defined in s. 499.003(37) s. 499.001(31).
2611	(5)  RETURNED, DAMAGED, OR OUTDATED PRESCRIPTION DRUGS.--
2612	(a)1.  Prescription drugs that are outdated, damaged,
2613	deteriorated, misbranded, or adulterated must be quarantined and
2614	physically separated from other prescription drugs until they
2615	are destroyed or returned to their supplier. A quarantine
2616	section must be separate and apart from other sections where
2617	prescription drugs are stored so that prescription drugs in this
2618	section are not confused with usable prescription drugs.
2619	2.  Prescription drugs must be examined at least every 12
2620	months, and drugs for which the expiration date has passed must
2621	be removed and quarantined.
2622	(b)  Any prescription drugs of which the immediate or
2623	sealed outer containers or sealed secondary containers have been
2624	opened or used must be identified as such and must be
2625	quarantined and physically separated from other prescription
2626	drugs until they are either destroyed or returned to the
2627	supplier.
2628	(c)  If the conditions under which a prescription drug has
2629	been returned cast doubt on the drug's safety, identity,
2630	strength, quality, or purity, the drug must be destroyed or
2631	returned to the supplier, unless examination, testing, or other
2632	investigation proves that the drug meets appropriate standards
2633	of safety, identity, strength, quality, and purity. In
2634	determining whether the conditions under which a drug has been
2635	returned cast doubt on the drug's safety, identity, strength,
2636	quality, or purity, the wholesale drug distributor must
2637	consider, among other things, the conditions under which the
2638	drug has been held, stored, or shipped before or during its
2639	return and the conditions of the drug and its container, carton,
2640	or labeling, as a result of storage or shipping.
2641	(d)  The recordkeeping requirements in subsection (6) must
2642	be followed for all outdated, damaged, deteriorated, misbranded,
2643	or adulterated prescription drugs.
2644	(6)  RECORDKEEPING.--The department shall adopt rules that
2645	require keeping such records of prescription drugs as are
2646	necessary for the protection of the public health.
2647	(a)  Wholesale drug distributors must establish and
2648	maintain inventories and records of all transactions regarding
2649	the receipt and distribution or other disposition of
2650	prescription drugs. These records must provide a complete audit
2651	trail from receipt to sale or other disposition, be readily
2652	retrievable for inspection, and include, at a minimum, the
2653	following information:
2654	1.  The source of the drugs, including the name and
2655	principal address of the seller or transferor, and the address
2656	of the location from which the drugs were shipped;
2657	2.  The name, principal address, and state license permit
2658	or registration number of the person authorized to purchase
2659	prescription drugs;
2660	3.  The name, strength, dosage form, and quantity of the
2661	drugs received and distributed or disposed of;
2662	4.  The dates of receipt and distribution or other
2663	disposition of the drugs; and
2664	5.  Any financial documentation supporting the transaction.
2665	(b)  Inventories and records must be made available for
2666	inspection and photocopying by authorized federal, state, or
2667	local officials for a period of 2 years following disposition of
2668	the drugs or 3 years after the creation of the records,
2669	whichever period is longer.
2670	(c)  Records described in this section that are kept at the
2671	inspection site or that can be immediately retrieved by computer
2672	or other electronic means must be readily available for
2673	authorized inspection during the retention period. Records that
2674	are kept at a central location outside of this state and that
2675	are not electronically retrievable must be made available for
2676	inspection within 2 working days after a request by an
2677	authorized official of a federal, state, or local law
2678	enforcement agency. Records that are maintained at a central
2679	location within this state must be maintained at an
2680	establishment that is permitted pursuant to this part ss.
2681	499.001-499.081 and must be readily available.
2682	(d)(4)  Each manufacturer or repackager of medical devices,
2683	over-the-counter drugs, or cosmetics must maintain records that
2684	include the name and principal address of the seller or
2685	transferor of the product, the address of the location from
2686	which the product was shipped, the date of the transaction, the
2687	name and quantity of the product involved, and the name and
2688	principal address of the person who purchased the product.
2689	(e)  A wholesale distributor must maintain pedigree papers
2690	separate and distinct from other records required under this
2691	chapter.
2692	(d)1. Effective July 1, 2006, each person who is engaged in
2693	the wholesale distribution of a prescription drug and who is not
2694	the manufacturer of that drug must, before each wholesale
2695	distribution of such drug, provide to the person who receives
2696	the drug a pedigree paper as defined in s. 499.003(31).
2697	2.  A repackager must comply with this paragraph.
2698	3.  The pedigree paper requirements in this paragraph do
2699	not apply to compressed medical gases or veterinary legend
2700	drugs.
2701	4.  Each wholesale distributor of prescription drugs must
2702	maintain separate and distinct from other required records all
2703	statements that are required under subparagraph 1.
2704	5.  Subparagraph 1. is satisfied when a wholesale
2705	distributor takes title to, but not possession of, a
2706	prescription drug and the prescription drug's manufacturer ships
2707	the prescription drug directly to a person authorized by law to
2708	purchase prescription drugs for the purpose of administering or
2709	dispensing the drug, as defined in s. 465.003, or a member of an
2710	affiliated group, as described in paragraph (f), with the
2711	exception of a repackager.
2712	a.  The wholesale distributor must deliver to the recipient
2713	of the prescription drug, within 14 days after the shipment
2714	notification from the manufacturer, an invoice and the following
2715	sworn statement: "This wholesale distributor purchased the
2716	specific unit of the prescription drug listed on the invoice
2717	directly from the manufacturer, and the specific unit of
2718	prescription drug was shipped by the manufacturer directly to a
2719	person authorized by law to administer or dispense the legend
2720	drug, as defined in s. 465.003, Florida Statutes, or a member of
2721	an affiliated group, as described in s. 499.0121(6)(f), Florida
2722	Statutes, with the exception of a repackager." The invoice must
2723	contain a unique cross-reference to the shipping document sent
2724	by the manufacturer to the recipient of the prescription drug.
2725	b.  The manufacturer of the prescription drug shipped
2726	directly to the recipient under this section must provide and
2727	the recipient of the prescription drug must acquire, within 14
2728	days after receipt of the prescription drug, a shipping document
2729	from the manufacturer that contains, at a minimum:
2730	(I)  The name and address of the manufacturer, including
2731	the point of origin of the shipment, and the names and addresses
2732	of the wholesaler and the purchaser.
2733	(II)  The name of the prescription drug as it appears on
2734	the label.
2735	(III)  The quantity, dosage form, and strength of the
2736	prescription drug.
2737	(IV)  The date of the shipment from the manufacturer.
2738	c.  The wholesale distributor must also maintain and make
2739	available to the department, upon request, the lot number of
2740	such drug if not contained in the shipping document acquired by
2741	the recipient.
2742	6.  Failure of the manufacturer to provide, the recipient
2743	to acquire, or the wholesale distributor to deliver, the
2744	documentation required under subparagraph 5. shall constitute
2745	failure to acquire or deliver a pedigree paper under s.
2746	499.0051. Forgery by the manufacturer, the recipient, or the
2747	wholesale distributor of the documentation required to be
2748	acquired or delivered under subparagraph 5. shall constitute
2749	forgery of a pedigree paper under s. 499.0051.
2750	7.  The department may, by rule, specify alternatives to
2751	compliance with subparagraph 1. for a prescription drug in the
2752	inventory of a permitted prescription drug wholesaler as of June
2753	30, 2006, and the return of a prescription drug purchased prior
2754	to July 1, 2006. The department may specify time limits for such
2755	alternatives.
2756	(7)(e)  PRESCRIPTION DRUG PURCHASE LIST.--Each wholesale
2757	distributor, except for a manufacturer, shall annually provide
2758	the department with a written list of all wholesale distributors
2759	and manufacturers from whom the wholesale distributor purchases
2760	prescription drugs. A wholesale distributor, except a
2761	manufacturer, shall notify the department not later than 10 days
2762	after any change to either list. Such portions of the
2763	information required pursuant to this subsection paragraph which
2764	are a trade secret, as defined in s. 812.081, shall be
2765	maintained by the department as trade secret information is
2766	required to be maintained under s. 499.051.
2767	(f)1.  This paragraph applies only to an affiliated group,
2768	as defined by s. 1504 of the Internal Revenue Code of 1986, as
2769	amended, which is composed of chain drug entities, including at
2770	least 50 retail pharmacies, warehouses, or repackagers, which
2771	are members of the same affiliated group, if the affiliated
2772	group:
2773	a.  Discloses to the department the names of all its
2774	members; and
2775	b.  Agrees in writing to provide records on prescription
2776	drug purchases by members of the affiliated group not later than
2777	48 hours after the department requests such records, regardless
2778	of the location where the records are stored.
2779	2.  Each warehouse within the affiliated group must comply
2780	with all applicable federal and state drug wholesale permit
2781	requirements and must purchase, receive, hold, and distribute
2782	prescription drugs only to a retail pharmacy or warehouse within
2783	the affiliated group. Such a warehouse is exempt from providing
2784	a pedigree paper in accordance with paragraph (d) to its
2785	affiliated group member warehouse or retail pharmacy, provided
2786	that:
2787	a.  Any affiliated group member that purchases or receives
2788	a prescription drug from outside the affiliated group must
2789	receive a pedigree paper if the prescription drug is distributed
2790	in or into this state and a pedigree paper is required under
2791	this section and must authenticate the documentation as required
2792	in subsection (4), regardless of whether the affiliated group
2793	member is directly subject to regulation under this chapter; and
2794	b.  The affiliated group makes available to the department
2795	on request all records related to the purchase or acquisition of
2796	prescription drugs by members of the affiliated group,
2797	regardless of the location where the records are stored, if the
2798	prescription drugs were distributed in or into this state.
2799	3.  If a repackager repackages prescription drugs solely
2800	for distribution to its affiliated group members for the
2801	exclusive distribution to and among retail pharmacies that are
2802	members of the affiliated group to which the repackager is a
2803	member:
2804	a.  The repackager must:
2805	(I)  In lieu of the written statement required by paragraph
2806	(d), for all repackaged prescription drugs distributed in or
2807	into this state, state in writing under oath with each
2808	distribution of a repackaged prescription drug to an affiliated
2809	group member warehouse or repackager: "All repackaged
2810	prescription drugs are purchased by the affiliated group
2811	directly from the manufacturer or from a prescription drug
2812	wholesaler that purchased the prescription drugs directly from
2813	the manufacturer.";
2814	(II)  Purchase all prescription drugs it repackages:
2815	(A)  Directly from the manufacturer; or
2816	(B)  From a prescription drug wholesaler that purchased the
2817	prescription drugs directly from the manufacturer; and
2818	(III)  Maintain records in accordance with this section to
2819	document that it purchased the prescription drugs directly from
2820	the manufacturer or that its prescription drug wholesale
2821	supplier purchased the prescription drugs directly from the
2822	manufacturer.
2823	b.  All members of the affiliated group must provide to
2824	agents of the department on request records of purchases by all
2825	members of the affiliated group of prescription drugs that have
2826	been repackaged, regardless of the location where the records
2827	are stored or where the repackager is located.
2828	(8)(7)  WRITTEN POLICIES AND PROCEDURES.--Wholesale drug
2829	distributors must establish, maintain, and adhere to written
2830	policies and procedures, which must be followed for the receipt,
2831	security, storage, inventory, and distribution of prescription
2832	drugs, including policies and procedures for identifying,
2833	recording, and reporting losses or thefts, and for correcting
2834	all errors and inaccuracies in inventories. Wholesale drug
2835	distributors must include in their written policies and
2836	procedures:
2837	(a)  A procedure whereby the oldest approved stock of a
2838	prescription drug product is distributed first. The procedure
2839	may permit deviation from this requirement, if the deviation is
2840	temporary and appropriate.
2841	(b)  A procedure to be followed for handling recalls and
2842	withdrawals of prescription drugs. Such procedure must be
2843	adequate to deal with recalls and withdrawals due to:
2844	1.  Any action initiated at the request of the Food and
2845	Drug Administration or any other federal, state, or local law
2846	enforcement or other government agency, including the
2847	department.
2848	2.  Any voluntary action by the manufacturer or repackager
2849	to remove defective or potentially defective drugs from the
2850	market; or
2851	3.  Any action undertaken to promote public health and
2852	safety by replacing existing merchandise with an improved
2853	product or new package design.
2854	(c)  A procedure to ensure that wholesale drug distributors
2855	prepare for, protect against, and handle any crisis that affects
2856	security or operation of any facility if a strike, fire, flood,
2857	or other natural disaster, or a local, state, or national
2858	emergency, occurs.
2859	(d)  A procedure to ensure that any outdated prescription
2860	drugs are segregated from other drugs and either returned to the
2861	manufacturer or repackager or destroyed. This procedure must
2862	provide for written documentation of the disposition of outdated
2863	prescription drugs. This documentation must be maintained for 2
2864	years after disposition of the outdated drugs.
2865	(9)(8)  RESPONSIBLE PERSONS.--Wholesale drug distributors
2866	must establish and maintain lists of officers, directors,
2867	managers, designated representatives, and other persons in
2868	charge of wholesale drug distribution, storage, and handling,
2869	including a description of their duties and a summary of their
2870	qualifications.
2871	(10)(9)  COMPLIANCE WITH FEDERAL, STATE, AND LOCAL LAW.--A
2872	wholesale drug distributor must operate in compliance with
2873	applicable federal, state, and local laws and regulations.
2874	(a)  A wholesale drug distributor must allow the department
2875	and authorized federal, state, and local officials to enter and
2876	inspect its premises and delivery vehicles, and to audit its
2877	records and written operating procedures, at reasonable times
2878	and in a reasonable manner, to the extent authorized by law.
2879	(b)  A wholesale drug distributor that deals in controlled
2880	substances must register with the Drug Enforcement
2881	Administration and must comply with all applicable state, local,
2882	and federal laws. A wholesale drug distributor that distributes
2883	any substance controlled under chapter 893 must notify the
2884	department when registering with the Drug Enforcement
2885	Administration pursuant to that chapter and must provide the
2886	department with its DEA number.
2887	(11)(10)  SALVAGING AND REPROCESSING.--A wholesale drug
2888	distributor is subject to any applicable federal, state, or
2889	local laws or regulations that relate to prescription drug
2890	product salvaging or reprocessing.
2891	(12)(11)  SHIPPING AND TRANSPORTATION.--The person
2892	responsible for shipment and transportation of a prescription
2893	drug in a wholesale distribution may use a common carrier; its
2894	own vehicle or employee acting within the scope of employment if
2895	authorized under s. 499.03 for the possession of prescription
2896	drugs in this state; or, in the case of a prescription drug
2897	intended for domestic distribution, an independent contractor
2898	who must be the agent of the authorized seller or recipient
2899	responsible for shipping and transportation as set forth in a
2900	written contract between the parties. A person selling a
2901	prescription drug for export must obtain documentation, such as
2902	a validated airway bill, bill of lading, or other appropriate
2903	documentation that the prescription drug was exported. A person
2904	responsible for shipping or transporting prescription drugs is
2905	not required to maintain documentation from a common carrier
2906	that the designated recipient received the prescription drugs;
2907	however, the person must obtain such documentation from the
2908	common carrier and make it available to the department upon
2909	request of the department.
2910	(13)(12)  DUE DILIGENCE OF SUPPLIERS.--Prior to purchasing
2911	any prescription drugs from another wholesale drug distributor,
2912	a prescription drug wholesale distributor wholesaler, an out-of-
2913	state prescription drug wholesale distributor wholesaler, or a
2914	prescription drug repackager must:
2915	(a)  Enter an agreement with the selling wholesale drug
2916	distributor by which the selling wholesale drug distributor will
2917	indemnify the purchasing wholesale drug distributor for any loss
2918	caused to the purchasing wholesale drug distributor related to
2919	the purchase of drugs from the selling wholesale drug
2920	distributor which are determined to be counterfeit or to have
2921	been distributed in violation of any federal or state law
2922	governing the distribution of drugs.
2923	(b)  Determine that the selling wholesale drug distributor
2924	has insurance coverage of not less than the greater of 1 percent
2925	of the amount of total dollar volume of the prescription drug
2926	sales reported to the department under s. 499.012(8)(g) s.
2927	499.012(3)(g) or $500,000; however the coverage need not exceed
2928	$2 million.
2929	(c)  Obtain information from the selling wholesale drug
2930	distributor, including the length of time the selling wholesale
2931	drug distributor has been licensed in this state, a copy of the
2932	selling wholesale drug distributor's licenses or permits, and
2933	background information concerning the ownership of the selling
2934	wholesale drug distributor, including the experience of the
2935	wholesale distributor in the wholesale distribution of
2936	prescription drugs.
2937	(d)  Verify that the selling wholesale drug distributor's
2938	Florida permit is valid.
2939	(e)  Inspect the selling wholesale drug distributor's
2940	licensed establishment to document that it has a policies and
2941	procedures manual relating to the distribution of drugs, the
2942	appropriate temperature controlled environment for drugs
2943	requiring temperature control, an alarm system, appropriate
2944	access restrictions, and procedures to ensure that records
2945	related to the wholesale distribution of prescription drugs are
2946	maintained as required by law:
2947	1.  Before purchasing any drug from the wholesale drug
2948	distributor, and at least once each subsequent year; or
2949	2.  Before purchasing any drug from the wholesale drug
2950	distributor, and each subsequent year obtain a complete copy of
2951	the most recent inspection report for the establishment which
2952	was prepared by the department or the regulatory authority
2953	responsible for wholesale drug distributors in the state in
2954	which the establishment is located.
2955	Section 14.  Section 499.01211, Florida Statutes, is
2956	amended to read:
2957	499.01211  Drug Wholesale Distributor Wholesaler Advisory
2958	Council.--
2959	(1)  There is created the Drug Wholesale Distributor
2960	Wholesaler Advisory Council within the department. The council
2961	shall meet at least once each calendar quarter. Staff for the
2962	council shall be provided by the department. The council shall
2963	consist of 11 members who shall serve without compensation. The
2964	council shall elect a chairperson and a vice chairperson
2965	annually.
2966	(2)  The State Surgeon General, or his or her designee, and
2967	the Secretary of Health Care Administration, or her or his
2968	designee, shall be members of the council. The State Surgeon
2969	General shall appoint nine additional members to the council who
2970	shall be appointed to a term of 4 years each, as follows:
2971	(a)  Three different persons each of whom is employed by a
2972	different prescription drug wholesale distributor wholesaler
2973	licensed under this part chapter which operates nationally and
2974	is a primary wholesale distributor wholesaler, as defined in s.
2975	499.003(48) s. 499.012(1)(d).
2976	(b)  One person employed by a prescription drug wholesale
2977	distributor wholesaler licensed under this part chapter which is
2978	a secondary wholesale distributor wholesaler, as defined in s.
2979	499.003(53) s. 499.012(1)(f).
2980	(c)  One person employed by a retail pharmacy chain located
2981	in this state.
2982	(d)  One person who is a member of the Board of Pharmacy
2983	and is a pharmacist licensed under chapter 465.
2984	(e)  One person who is a physician licensed pursuant to
2985	chapter 458 or chapter 459.
2986	(f)  One person who is an employee of a hospital licensed
2987	pursuant to chapter 395 and is a pharmacist licensed pursuant to
2988	chapter 465.
2989	(g)  One person who is an employee of a pharmaceutical
2990	manufacturer.
2991	(3)  The council shall review this part ss. 499.001-499.081
2992	and the rules adopted to administer this part ss. 499.001-
2993	499.081 annually, provide input to the department regarding all
2994	proposed rules to administer this part ss. 499.001-499.081, make
2995	recommendations to the department to improve the protection of
2996	the prescription drugs and public health, make recommendations
2997	to improve coordination with other states' regulatory agencies
2998	and the federal government concerning the wholesale distribution
2999	of drugs, and make recommendations to minimize the impact of
3000	regulation of the wholesale distribution industry while ensuring
3001	protection of the public health.
3002	Section 15.  Section 499.01212, Florida Statutes, is
3003	created to read:
3004	499.01212  Pedigree paper.--
3005	(1)  APPLICATION.--Each person who is engaged in the
3006	wholesale distribution of a prescription drug must, prior to or
3007	simultaneous with each wholesale distribution, provide a
3008	pedigree paper to the person who receives the drug.
3009	(2)  FORMAT.--A pedigree paper must contain the following
3010	information:
3011	(a)  For the wholesale distribution of a prescription drug
3012	within the normal distribution chain:
3013	1.  The following statement: "This wholesale distributor
3014	purchased the specific unit of the prescription drug directly
3015	from the manufacturer."
3016	2.  The name of the prescription drug as it appears on the
3017	label.
3018	3.  The quantity, dosage form, and strength of the
3019	prescription drug.
3020
3021	The wholesale distributor must also maintain and make available
3022	to the department, upon request, the point of origin of the
3023	prescription drugs, including intracompany transfers, the date
3024	of the shipment from the manufacturer to the wholesale
3025	distributor, the lot numbers of such drugs, and the invoice
3026	numbers from the manufacturer.
3027	(b)  For all other wholesale distributions of prescription
3028	drugs:
3029	1.  The quantity, dosage form, and strength of the
3030	prescription drugs.
3031	2.  The lot numbers of the prescription drugs.
3032	3.  The name and address of each owner of the prescription
3033	drug and his or her signature.
3034	4.  Shipping information, including the name and address of
3035	each person certifying delivery or receipt of the prescription
3036	drug.
3037	5.  An invoice number, a shipping document number, or
3038	another number uniquely identifying the transaction.
3039	6.  A certification that the recipient wholesale
3040	distributor has authenticated the pedigree papers.
3041	7.  The unique serialization of the prescription drug, if
3042	the manufacturer or repackager has uniquely serialized the
3043	individual prescription drug unit.
3044	8.  The name, address, telephone number, and, if available,
3045	e-mail contact information of each wholesale distributor
3046	involved in the chain of the prescription drug's custody.
3047	(3)  EXCEPTIONS.--A pedigree paper is not required for:
3048	(a)  The wholesale distribution of a prescription drug by
3049	the manufacturer.
3050	(b)  The wholesale distribution of a compressed medical
3051	gas.
3052	(c)  The wholesale distribution of a veterinary
3053	prescription drug.
3054	(d)  A drop shipment, provided:
3055	1.  The wholesale distributor delivers to the recipient of
3056	the prescription drug, within 14 days after the shipment
3057	notification from the manufacturer, an invoice and the following
3058	sworn statement: "This wholesale distributor purchased the
3059	specific unit of the prescription drug listed on the invoice
3060	directly from the manufacturer, and the specific unit of
3061	prescription drug was shipped by the manufacturer directly to a
3062	person authorized by law to administer or dispense the legend
3063	drug, as defined in s. 465.003, Florida Statutes, or a member of
3064	an affiliated group, with the exception of a repackager." The
3065	invoice must contain a unique cross-reference to the shipping
3066	document sent by the manufacturer to the recipient of the
3067	prescription drug.
3068	2.  The manufacturer of the prescription drug shipped
3069	directly to the recipient provides and the recipient of the
3070	prescription drug acquires, within 14 days after receipt of the
3071	prescription drug, a shipping document from the manufacturer
3072	that contains, at a minimum:
3073	a.  The name and address of the manufacturer, including the
3074	point of origin of the shipment, and the names and addresses of
3075	the wholesale distributor and the purchaser.
3076	b.  The name of the prescription drug as it appears on the
3077	label.
3078	c.  The quantity, dosage form, and strength of the
3079	prescription drug.
3080	d.  The date of the shipment from the manufacturer.
3081	3.  The wholesale distributor maintains and makes available
3082	to the department, upon request, the lot number of such drug if
3083	not contained in the shipping document acquired by the
3084	recipient.
3085
3086	Failure of the manufacturer to provide, the recipient to
3087	acquire, or the wholesale distributor to deliver the
3088	documentation required under this paragraph shall constitute
3089	failure to acquire or deliver a pedigree paper under ss.
3090	499.005(28) and 499.0051. Forgery by the manufacturer, the
3091	recipient, or the wholesale distributor of the documentation
3092	required to be acquired or delivered under this paragraph shall
3093	constitute forgery of a pedigree paper under s. 499.0051.
3094	4.  The wholesale distributor that takes title to, but not
3095	possession of, the prescription drug is not a member of the
3096	affiliated group that receives the prescription drug directly
3097	from the manufacturer.
3098	(e)  The wholesale distribution of a prescription drug by a
3099	warehouse within an affiliated group to a warehouse or retail
3100	pharmacy within its affiliated group, provided:
3101	1.  Any affiliated group member that purchases or receives
3102	a prescription drug from outside the affiliated group must
3103	receive a pedigree paper if the prescription drug is distributed
3104	in or into this state and a pedigree paper is required under
3105	this section and must authenticate the documentation as required
3106	in s. 499.0121(4), regardless of whether the affiliated group
3107	member is directly subject to regulation under this part; and
3108	2.  The affiliated group makes available, within 48 hours,
3109	to the department on request to one or more of its members all
3110	records related to the purchase or acquisition of prescription
3111	drugs by members of the affiliated group, regardless of the
3112	location where the records are stored, if the prescription drugs
3113	were distributed in or into this state.
3114	(f)  The repackaging of prescription drugs by a repackager
3115	solely for distribution to its affiliated group members for the
3116	exclusive distribution to and among retail pharmacies that are
3117	members of the affiliated group to which the repackager is a
3118	member.
3119	1.  The repackager must:
3120	a.  For all repackaged prescription drugs distributed in or
3121	into this state, state in writing under oath with each
3122	distribution of a repackaged prescription drug to an affiliated
3123	group member warehouse or repackager: "All repackaged
3124	prescription drugs are purchased by the affiliated group
3125	directly from the manufacturer or from a prescription drug
3126	wholesale distributor that purchased the prescription drugs
3127	directly from the manufacturer."
3128	b.  Purchase all prescription drugs it repackages:
3129	(I)  Directly from the manufacturer; or
3130	(II)  From a prescription drug wholesale distributor that
3131	purchased the prescription drugs directly from the manufacturer.
3132	c.  Maintain records in accordance with this section to
3133	document that it purchased the prescription drugs directly from
3134	the manufacturer or that its prescription drug wholesale
3135	supplier purchased the prescription drugs directly from the
3136	manufacturer.
3137	2.  All members of the affiliated group must provide,
3138	within 48 hours, to agents of the department on request to one
3139	or more of its members records of purchases by all members of
3140	the affiliated group of prescription drugs that have been
3141	repackaged, regardless of the location at which the records are
3142	stored or at which the repackager is located.
3143	Section 16.  Section 499.0122, Florida Statutes, is
3144	repealed.
3145	Section 17.  Section 499.013, Florida Statutes, is
3146	repealed.
3147	Section 18.  Subsections (1), (3), (4), (6), (8), and (9)
3148	of section 499.015, Florida Statutes, are amended to read:
3149	499.015  Registration of drugs, devices, and cosmetics;
3150	issuance of certificates of free sale.--
3151	(1)(a)  Except for those persons exempted from the
3152	definition of manufacturer in s. 499.003(32) s. 499.003(28), any
3153	person who manufactures, packages, repackages, labels, or
3154	relabels a drug, device, or cosmetic in this state must register
3155	such drug, device, or cosmetic biennially with the department;
3156	pay a fee in accordance with the fee schedule provided by s.
3157	499.041; and comply with this section. The registrant must list
3158	each separate and distinct drug, device, or cosmetic at the time
3159	of registration.
3160	(b)  The department may not register any product that does
3161	not comply with the Federal Food, Drug, and Cosmetic Act, as
3162	amended, or Title 21 C.F.R. Registration of a product by the
3163	department does not mean that the product does in fact comply
3164	with all provisions of the Federal Food, Drug, and Cosmetic Act,
3165	as amended.
3166	(3)  Except for those persons exempted from the definition
3167	of manufacturer in s. 499.003(32) s. 499.003(28), a person may
3168	not sell any product that he or she has failed to register in
3169	conformity with this section. Such failure to register subjects
3170	such drug, device, or cosmetic product to seizure and
3171	condemnation as provided in s. 499.062 ss. 499.062-499.064, and
3172	subjects such person to the penalties and remedies provided in
3173	this part ss. 499.001-499.081.
3174	(4)  Unless a registration is renewed, it expires 2 years
3175	after the last day of the month in which it was issued. The
3176	department may issue a stop-sale notice or order against a
3177	person that is subject to the requirements of this section and
3178	that fails to comply with this section within 31 days after the
3179	date the registration expires. The notice or order shall
3180	prohibit such person from selling or causing to be sold any
3181	drugs, devices, or cosmetics covered by this part ss. 499.001-
3182	499.081 until he or she complies with the requirements of this
3183	section.
3184	(6)  The department may issue a certificate of free sale
3185	for any product that is required to be registered under this
3186	part ss. 499.001-499.081.
3187	(8)  Notwithstanding any requirements set forth in this
3188	part ss. 499.001-499.081, a manufacturer of medical devices that
3189	is registered with the federal Food and Drug Administration is
3190	exempt from this section and s. 499.041(6) if:
3191	(a)  The manufacturer's medical devices are approved for
3192	marketing by, or listed with the federal Food and Drug
3193	Administration in accordance with federal law for commercial
3194	distribution; or
3195	(b)  The manufacturer subcontracts with a manufacturer of
3196	medical devices to manufacture components of such devices.
3197	(9)  However, the manufacturer must submit evidence of such
3198	registration, listing, or approval with its initial application
3199	for a permit to do business in this state, as required in s.
3200	499.01 s. 499.013 and any changes to such information previously
3201	submitted at the time of renewal of the permit. Evidence of
3202	approval, listing, and registration by the federal Food and Drug
3203	Administration must include:
3204	(a)  For Class II devices, a copy of the pre-market
3205	notification letter (510K);
3206	(b)  For Class III devices, a Federal Drug Administration
3207	pre-market approval number;
3208	(c)  For a manufacturer who subcontracts with a
3209	manufacturer of medical devices to manufacture components of
3210	such devices, a Federal Drug Administration registration number;
3211	or
3212	(d)  For a manufacturer of medical devices whose devices
3213	are exempt from pre-market approval by the Federal Drug
3214	Administration, a Federal Drug Administration registration
3215	number.
3216	Section 19.  Subsections (3), (5), and (6) of section
3217	499.024, Florida Statutes, are amended to read:
3218	499.024  Drug product classification.--The State Surgeon
3219	General shall adopt rules to classify drug products intended for
3220	use by humans which the United States Food and Drug
3221	Administration has not classified in the federal act or the Code
3222	of Federal Regulations.
3223	(3)  Any product that falls under the definition of drug in
3224	s. 499.003(19) definition, s. 499.003(17), may be classified
3225	under the authority of this section. This section does not
3226	subject portable emergency oxygen inhalators to classification;
3227	however, this section does not exempt any person from ss. 499.01
3228	and 499.015.
3229	(5)  The department may by rule reclassify drugs subject to
3230	this part ss. 499.001-499.081 when such classification action is
3231	necessary to protect the public health.
3232	(6)  The department may adopt rules that exempt from any
3233	labeling or packaging requirements of this part ss. 499.001-
3234	499.081 drugs classified under this section if those
3235	requirements are not necessary to protect the public health.
3236	Section 20.  Subsections (7), (12), and (15) of section
3237	499.028, Florida Statutes, are amended to read:
3238	499.028  Drug samples or complimentary drugs; starter
3239	packs; permits to distribute.--
3240	(7)  A drug manufacturer or distributor must report to the
3241	department any conviction of itself or of its assigns, agents,
3242	employees, or representatives for a violation of s. 503(c)(1) of
3243	the federal act or of this part ss. 499.001-499.081 because of
3244	the sale, purchase, or trade of a drug sample or the offer to
3245	sell, purchase, or trade a drug sample.
3246	(12)  The department may suspend or revoke a permit issued
3247	under this section, after giving notice and an opportunity to be
3248	heard pursuant to chapter 120, when:
3249	(a)  Such permit was obtained by misrepresentation or fraud
3250	or through a mistake of the department.
3251	(b)  The holder of the permit has distributed or disposed
3252	of any prescription legend drug, directly or through its agents,
3253	employees, or independent contractors, to any person not
3254	authorized to possess such drug.
3255	(c)  The holder of the permit, or its agents, employees, or
3256	independent contractors, has distributed or possessed any
3257	prescription legend drug except in the usual course of its
3258	business.
3259	(d)  The holder of the permit, or its agents, employees, or
3260	independent contractors, has distributed any prescription legend
3261	drug that is misbranded or adulterated under this part ss.
3262	499.001-499.081.
3263	(e)  The holder of the permit, or its agents, employees, or
3264	independent contractors, has distributed any prescription legend
3265	drug without written request, when a written request is required
3266	by this section.
3267	(f)  The holder of the permit has in its employ, or uses as
3268	agent or independent contractor for the purpose of distributing
3269	or disposing of drugs, any person who has:
3270	1.  Violated the requirements of this section or any rule
3271	adopted under this section.
3272	2.  Been convicted in any of the courts of this state, the
3273	United States, or any other state of a felony or any other crime
3274	involving moral turpitude or involving those drugs named or
3275	described in chapter 893.
3276	(15)  A person may not possess a prescription drug sample
3277	unless:
3278	(a)  The drug sample was prescribed to her or him as
3279	evidenced by the label required in s. 465.0276(5).
3280	(b)  She or he is the employee of a complimentary drug
3281	distributor that holds a permit issued under this part ss.
3282	499.001-499.081.
3283	(c)  She or he is a person to whom prescription drug
3284	samples may be distributed pursuant to this section.
3285	(d)  He or she is an officer or employee of a federal,
3286	state, or local government acting within the scope of his or her
3287	employment.
3288	Section 21.  Subsections (2) and (3) of section 499.029,
3289	Florida Statutes, are amended to read:
3290	499.029  Cancer Drug Donation Program.--
3291	(2)  There is created a Cancer Drug Donation Program within
3292	the department of Health for the purpose of authorizing and
3293	facilitating the donation of cancer drugs and supplies to
3294	eligible patients.
3295	(3)  As used in this section:
3296	(a)  "Cancer drug" means a prescription drug that has been
3297	approved under s. 505 of the federal Food, Drug, and Cosmetic
3298	Act and is used to treat cancer or its side effects or is used
3299	to treat the side effects of a prescription drug used to treat
3300	cancer or its side effects. "Cancer drug" does not include a
3301	substance listed in Schedule II, Schedule III, Schedule IV, or
3302	Schedule V of s. 893.03.
3303	(b)  "Closed drug delivery system" means a system in which
3304	the actual control of the unit-dose medication package is
3305	maintained by the facility rather than by the individual
3306	patient.
3307	(c)  "Department" means the Department of Health.
3308	(c)(d)  "Donor" means a patient or patient representative
3309	who donates cancer drugs or supplies needed to administer cancer
3310	drugs that have been maintained within a closed drug delivery
3311	system; health care facilities, nursing homes, hospices, or
3312	hospitals with closed drug delivery systems; or pharmacies, drug
3313	manufacturers, medical device manufacturers or suppliers, or
3314	wholesalers of drugs or supplies, in accordance with this
3315	section. "Donor" includes a physician licensed under chapter 458
3316	or chapter 459 who receives cancer drugs or supplies directly
3317	from a drug manufacturer, wholesale distributor drug wholesaler,
3318	or pharmacy.
3319	(d)(e)  "Eligible patient" means a person who the
3320	department determines is eligible to receive cancer drugs from
3321	the program.
3322	(e)(k)  "Participant facility" means a class II hospital
3323	pharmacy that has elected to participate in the program and that
3324	accepts donated cancer drugs and supplies under the rules
3325	adopted by the department for the program.
3326	(o)  "Prescription drug" means a drug as defined in s.
3327	465.003(8).
3328	(f)(p)  "Program" means the Cancer Drug Donation Program
3329	created by this section.
3330	(g)(q)  "Supplies" means any supplies used in the
3331	administration of a cancer drug.
3332	Section 22.  Subsection (1) of section 499.03, Florida
3333	Statutes, is amended to read:
3334	499.03  Possession of certain drugs without prescriptions
3335	unlawful; exemptions and exceptions.--
3336	(1)  A person may not possess, or possess with intent to
3337	sell, dispense, or deliver, any habit-forming, toxic, harmful,
3338	or new drug subject to s. 499.003(33) s. 499.003(29), or
3339	prescription legend drug as defined in s. 499.003(44) s.
3340	499.003(25), unless the possession of the drug has been obtained
3341	by a valid prescription of a practitioner licensed by law to
3342	prescribe the drug. However, this section does not apply to the
3343	delivery of such drugs to persons included in any of the classes
3344	named in this subsection, or to the agents or employees of such
3345	persons, for use in the usual course of their businesses or
3346	practices or in the performance of their official duties, as the
3347	case may be; nor does this section apply to the possession of
3348	such drugs by those persons or their agents or employees for
3349	such use:
3350	(a)  A licensed pharmacist or any person under the licensed
3351	pharmacist's supervision while acting within the scope of the
3352	licensed pharmacist's practice;
3353	(b)  A licensed practitioner authorized by law to prescribe
3354	prescription legend drugs or any person under the licensed
3355	practitioner's supervision while acting within the scope of the
3356	licensed practitioner's practice;
3357	(c)  A qualified person who uses prescription legend drugs
3358	for lawful research, teaching, or testing, and not for resale;
3359	(d)  A licensed hospital or other institution that procures
3360	such drugs for lawful administration or dispensing by
3361	practitioners;
3362	(e)  An officer or employee of a federal, state, or local
3363	government; or
3364	(f)  A person that holds a valid permit issued by the
3365	department pursuant to this part ss. 499.001-499.081 which
3366	authorizes that person to possess prescription drugs.
3367	Section 23.  Section 499.032, Florida Statutes, is amended
3368	to read:
3369	499.032  Phenylalanine; prescription
3370	required.--Phenylalanine restricted formula is declared to be a
3371	prescription legend drug and may be dispensed only upon the
3372	prescription of a practitioner authorized by law to prescribe
3373	prescription medicinal drugs.
3374	Section 24.  Subsection (1) of section 499.033, Florida
3375	Statutes, is amended to read:
3376	499.033  Ephedrine; prescription required.--Ephedrine is
3377	declared to be a prescription drug.
3378	(1)  Except as provided in subsection (2), any product that
3379	contains any quantity of ephedrine, a salt of ephedrine, an
3380	optical isomer of ephedrine, or a salt of an optical isomer of
3381	ephedrine may be dispensed only upon the prescription of a duly
3382	licensed practitioner authorized by the laws of the state to
3383	prescribe prescription medicinal drugs.
3384	Section 25.  Subsections (1) and (3) of section 499.039,
3385	Florida Statutes, are amended to read:
3386	499.039  Sale, distribution, or transfer of harmful
3387	chemical substances; penalties; authority for enforcement.--It
3388	is unlawful for a person to sell, deliver, or give to a person
3389	under the age of 18 years any compound, liquid, or chemical
3390	containing toluol, hexane, trichloroethylene, acetone, toluene,
3391	ethyl acetate, methyl ethyl ketone, trichloroethane,
3392	isopropanol, methyl isobutyl ketone, ethylene glycol monomethyl
3393	ether acetate, cyclohexanone, nitrous oxide, diethyl ether,
3394	alkyl nitrites (butyl nitrite), or any similar substance for the
3395	purpose of inducing by breathing, inhaling, or ingesting a
3396	condition of intoxication or which is intended to distort or
3397	disturb the auditory, visual, or other physical or mental
3398	processes.
3399	(1)  On the first violation of this section, the department
3400	may issue a warning according to s. 499.002(5) s. 499.071, if
3401	the violation has not caused temporary or permanent physical or
3402	mental injury to the user.
3403	(3)  The department of Health shall adopt rules to
3404	implement this section.
3405	Section 26.  Section 499.04, Florida Statutes, is amended
3406	to read:
3407	499.04  Fee authority.--The department may collect fees for
3408	all drug, device, and cosmetic applications, permits, product
3409	registrations, and free-sale certificates. The total amount of
3410	fees collected from all permits, applications, product
3411	registrations, and free-sale certificates must be adequate to
3412	fund the expenses incurred by the department in carrying out
3413	this part ss. 499.001-499.081. The department shall, by rule,
3414	establish a schedule of fees that are within the ranges provided
3415	in this section and shall adjust those fees from time to time
3416	based on the costs associated with administering this part ss.
3417	499.001-499.081. The fees are payable to the department to be
3418	deposited into the Florida Drug, Device, and Cosmetic Trust Fund
3419	for the sole purpose of carrying out the provisions of this part
3420	ss. 499.001-499.081.
3421	Section 27.  Subsections (1) through (5), (8), and (10) of
3422	section 499.041, Florida Statutes, are amended to read:
3423	499.041  Schedule of fees for drug, device, and cosmetic
3424	applications and permits, product registrations, and free-sale
3425	certificates.--
3426	(1)  The department shall assess applicants requiring a
3427	manufacturing permit an annual fee within the ranges established
3428	in this section for the specific type of manufacturer.
3429	(a)  The fee for a prescription drug manufacturer
3430	manufacturer's permit may not be less than $500 or more than
3431	$750 annually.
3432	(b)  The fee for a device manufacturer manufacturer's
3433	permit may not be less than $500 or more than $600 annually.
3434	(c)  The fee for a cosmetic manufacturer manufacturer's
3435	permit may not be less than $250 or more than $400 annually.
3436	(d)  The fee for an over-the-counter drug manufacturer
3437	manufacturer's permit may not be less than $300 or more than
3438	$400 annually.
3439	(e)  The fee for a compressed medical gas manufacturer
3440	manufacturer's permit may not be less than $400 or more than
3441	$500 annually.
3442	(f)  The fee for a prescription drug repackager
3443	repackager's permit may not be less than $500 or more than $750
3444	annually.
3445	(g)  A manufacturer may not be required to pay more than
3446	one fee per establishment to obtain an additional manufacturing
3447	permit, but each manufacturer must pay the highest fee
3448	applicable to his or her operation in each establishment.
3449	(2)  The department shall assess an applicant that is
3450	required to have a wholesaling permit an annual fee within the
3451	ranges established in this section for the specific type of
3452	wholesaling.
3453	(a)  The fee for a prescription drug wholesale distributor
3454	wholesaler's permit may not be less than $300 or more than $800
3455	annually.
3456	(b)  The fee for a compressed medical gas wholesale
3457	distributor wholesaler's permit may not be less than $200 or
3458	more than $300 annually.
3459	(c)  The fee for an out-of-state prescription drug
3460	wholesale distributor wholesaler's permit may not be less than
3461	$300 or more than $800 annually.
3462	(d)  The fee for a nonresident prescription drug
3463	manufacturer manufacturer's permit may not be less than $300 or
3464	more than $500 annually.
3465	(e)  The fee for a retail pharmacy drug wholesale
3466	distributor wholesaler's permit may not be less than $35 or more
3467	than $50 annually.
3468	(f)  The fee for a freight forwarder forwarder's permit may
3469	not be less than $200 or more than $300 annually.
3470	(g)  The fee for a veterinary prescription drug wholesale
3471	distributor wholesaler's permit may not be less than $300 or
3472	more than $500 annually.
3473	(h)  The fee for a limited prescription drug veterinary
3474	wholesale distributor wholesaler's permit may not be less than
3475	$300 or more than $500 annually.
3476	(3)  The department shall assess an applicant that is
3477	required to have a retail establishment permit an annual fee
3478	within the ranges established in this section for the specific
3479	type of retail establishment.
3480	(a)  The fee for a veterinary prescription legend drug
3481	retail establishment permit may not be less than $200 or more
3482	than $300 annually.
3483	(b)  The fee for a medical oxygen retail establishment
3484	permit may not be less than $200 or more than $300 annually.
3485	(4)  The department shall assess an applicant that is
3486	required to have a restricted prescription drug distributor
3487	distributor's permit an annual fee of not less than $200 or more
3488	than $300.
3489	(5)  In addition to the fee charged for a permit required
3490	by this part ss. 499.001-499.081, the department shall assess
3491	applicants an initial application fee of $150 for each new
3492	permit issued by the department which requires an onsite
3493	inspection.
3494	(8)  The department shall assess an out-of-state
3495	prescription drug wholesale distributor wholesaler applicant or
3496	permittee an onsite inspection fee of not less than $1,000 or
3497	more than $3,000 annually, to be based on the actual cost of the
3498	inspection if an onsite inspection is performed by agents of the
3499	department.
3500	(10)  The department shall assess other fees as provided in
3501	this part ss. 499.001-499.081.
3502	Section 28.  Section 499.05, Florida Statutes, is amended;
3503	subsection (3) of section 499.013, Florida Statutes, is
3504	redesignated as paragraph (k) of subsection (1) of that section
3505	and amended; paragraph (b) of subsection (2) of section
3506	499.0122, Florida Statutes, is redesignated as paragraph (l) of
3507	subsection (1) of that section and amended; and subsection (12)
3508	of section 499.012, Florida Statutes, is redesignated as
3509	paragraph (m) of subsection (1) of that section and amended, to
3510	read:
3511	499.05  Rules.--
3512	(1)  The department shall adopt rules to implement and
3513	enforce this part ss. 499.001-499.081 with respect to:
3514	(a)  The definition of terms used in this part ss. 499.001-
3515	499.081, and used in the rules adopted under this part ss.
3516	499.001-499.081, when the use of the term is not its usual and
3517	ordinary meaning.
3518	(b)  Labeling requirements for drugs, devices, and
3519	cosmetics.
3520	(c)  The establishment of fees authorized in this part ss.
3521	499.001-499.081.
3522	(d)  The identification of permits that require an initial
3523	application and onsite inspection or other prerequisites for
3524	permitting which demonstrate that the establishment and person
3525	are in compliance with the requirements of this part ss.
3526	499.001-499.081.
3527	(e)  The application processes and forms for product
3528	registration.
3529	(f)  Procedures for requesting and issuing certificates of
3530	free sale.
3531	(g)  Inspections and investigations conducted under s.
3532	499.051, and the identification of information claimed to be a
3533	trade secret and exempt from the public records law as provided
3534	in s. 499.051(7).
3535	(h)  The establishment of a range of penalties, as provided
3536	in s. 499.066 s. 499.006; requirements for notifying persons of
3537	the potential impact of a violation of this part ss. 499.001-
3538	499.081; and a process for the uncontested settlement of alleged
3539	violations.
3540	(i)  Additional conditions that qualify as an emergency
3541	medical reason under s. 499.003(55)(b)2. s. 499.012(1)(a)2.b.
3542	(j)  Procedures and forms relating to the pedigree paper
3543	requirement of s. 499.01212.
3544	(k)(3)  The department may adopt such rules as are
3545	necessary for The protection of the public health, safety, and
3546	welfare regarding good manufacturing practices that
3547	manufacturers and repackagers must follow to ensure the safety
3548	of the products.
3549	(l)(b)  The department shall adopt rules relating to
3550	Information required from each retail establishment pursuant to
3551	s. 499.012(3) s. 499.01(4), including requirements for
3552	prescriptions or orders.
3553	(m)(12)  The department may adopt rules governing The
3554	recordkeeping, storage, and handling with respect to each of the
3555	distributions of prescription drugs specified in s.
3556	499.003(55)(a)-(d) subparagraphs (1)(a)1.-4.
3557	(n)  Alternatives to compliance with s. 499.01212 for a
3558	prescription drug in the inventory of a permitted prescription
3559	drug wholesale distributor as of June 30, 2006, and the return
3560	of a prescription drug purchased prior to July 1, 2006. The
3561	department may specify time limits for such alternatives.
3562	(2)  With respect to products in interstate commerce, those
3563	rules must not be inconsistent with rules and regulations of
3564	federal agencies unless specifically otherwise directed by the
3565	Legislature.
3566	(3)  The department shall adopt rules regulating
3567	recordkeeping for and the storage, handling, and distribution of
3568	medical devices and over-the-counter drugs to protect the public
3569	from adulterated products.
3570	Section 29.  Section 499.051, Florida Statutes, is amended
3571	to read:
3572	499.051  Inspections and investigations.--
3573	(1)  The agents of the department of Health and of the
3574	Department of Law Enforcement, after they present proper
3575	identification, may inspect, monitor, and investigate any
3576	establishment permitted pursuant to this part ss. 499.001-
3577	499.081 during business hours for the purpose of enforcing this
3578	part ss. 499.001-499.081, chapters 465, 501, and 893, and the
3579	rules of the department that protect the public health, safety,
3580	and welfare.
3581	(2)  In addition to the authority set forth in subsection
3582	(1), the department and any duly designated officer or employee
3583	of the department may enter and inspect any other establishment
3584	for the purpose of determining compliance with this part ss.
3585	499.001-499.081 and rules adopted under this part those sections
3586	regarding any drug, device, or cosmetic product.
3587	(3)  Any application for a permit or product registration
3588	or for renewal of such permit or registration made pursuant to
3589	this part ss. 499.001-499.081 and rules adopted under this part
3590	those sections constitutes permission for any entry or
3591	inspection of the premises in order to verify compliance with
3592	this part those sections and rules; to discover, investigate,
3593	and determine the existence of compliance; or to elicit,
3594	receive, respond to, and resolve complaints and violations.
3595	(4)  Any application for a permit made pursuant to s.
3596	499.012 ss. 499.01 and 499.012 and rules adopted under that
3597	section those sections constitutes permission for agents of the
3598	department of Health and the Department of Law Enforcement,
3599	after presenting proper identification, to inspect, review, and
3600	copy any financial document or record related to the
3601	manufacture, repackaging, or distribution of a drug as is
3602	necessary to verify compliance with this part ss. 499.001-
3603	499.081 and the rules adopted by the department to administer
3604	this part those sections, in order to discover, investigate, and
3605	determine the existence of compliance, or to elicit, receive,
3606	respond to, and resolve complaints and violations.
3607	(5)  The authority to inspect under this section includes
3608	the authority to access, review, and copy any and all financial
3609	documents related to the activity of manufacturing, repackaging,
3610	or distributing prescription drugs.
3611	(6)  The authority to inspect under this section includes
3612	the authority to secure:
3613	(a)  Samples or specimens of any drug, device, or cosmetic;
3614	or
3615	(b)  Such other evidence as is needed for any action to
3616	enforce this part ss. 499.001-499.081 and the rules adopted
3617	under this part those sections.
3618	(7)  The complaint and all information obtained pursuant to
3619	the investigation by the department are confidential and exempt
3620	from the provisions of s. 119.07(1) and s. 24(a), Art. I of the
3621	State Constitution until the investigation and the enforcement
3622	action are completed. However, trade secret information
3623	contained therein as defined by s. 812.081(1)(c) shall remain
3624	confidential and exempt from the provisions of s. 119.07(1) and
3625	s. 24(a), Art. I of the State Constitution, as long as the
3626	information is retained by the department. This subsection does
3627	not prohibit the department from using such information for
3628	regulatory or enforcement proceedings under this chapter or from
3629	providing such information to any law enforcement agency or any
3630	other regulatory agency. However, the receiving agency shall
3631	keep such records confidential and exempt as provided in this
3632	subsection. In addition, this subsection is not intended to
3633	prevent compliance with the provisions of s. 499.01212 s.
3634	499.0121(6)(d), and the pedigree papers required in that section
3635	subsection shall not be deemed a trade secret.
3636	Section 30.  Section 499.052, Florida Statutes, is amended
3637	to read:
3638	499.052  Records of interstate shipment.--For the purpose
3639	of enforcing this part ss. 499.001-499.081, carriers engaged in
3640	interstate commerce and persons receiving drugs, devices, or
3641	cosmetics in interstate commerce must, upon the request, in the
3642	manner set out below, by an officer or employee duly designated
3643	by the department, permit the officer or employee to have access
3644	to and to copy all records showing the movement in interstate
3645	commerce of any drug, device, or cosmetic, and the quantity,
3646	shipper, and consignee thereof.
3647	Section 31.  Subsection (4) of section 499.055, Florida
3648	Statutes, is amended to read:
3649	499.055  Reports and dissemination of information by
3650	department.--
3651	(4)  The department shall publish on the department's
3652	website and update at least monthly:
3653	(a)  A list of the prescription drug wholesale distributors
3654	wholesalers, out-of-state prescription drug wholesale
3655	distributors wholesalers, and retail pharmacy drug wholesale
3656	distributors wholesalers against whom the department has
3657	initiated enforcement action pursuant to this part ss. 499.001-
3658	499.081 to suspend or revoke a permit, seek an injunction, or
3659	otherwise file an administrative complaint and the permit number
3660	of each such wholesale distributor wholesaler.
3661	(b)  A list of the prescription drug wholesale distributors
3662	wholesalers, out-of-state prescription drug wholesale
3663	distributors wholesalers, and retail pharmacy drug wholesale
3664	distributors wholesalers to which the department has issued a
3665	permit, including the date on which each permit will expire.
3666	(c)  A list of the prescription drug wholesale distributor
3667	wholesalers, out-of-state prescription drug wholesale
3668	distributor wholesalers, and retail pharmacy drug wholesale
3669	distributor wholesalers' permits that have been returned to the
3670	department, were suspended, were revoked, have expired, or were
3671	not renewed in the previous year.
3672	Section 32.  Subsections (1) and (3) of section 499.06,
3673	Florida Statutes, are amended to read:
3674	499.06  Embargoing, detaining, or destroying article or
3675	processing equipment which is in violation of law or rule.--
3676	(1)  When a duly authorized agent of the department finds,
3677	or has probable cause to believe, that any drug, device, or
3678	cosmetic is in violation of any provision of this part ss.
3679	499.001-499.081 or any rule adopted under this part such
3680	sections so as to be dangerous, unwholesome, or fraudulent
3681	within the meaning of this part ss. 499.001-499.081, she or he
3682	may issue and enforce a stop-sale, stop-use, removal, or hold
3683	order, which order gives notice that such article or processing
3684	equipment is, or is suspected of being, in violation and has
3685	been detained or embargoed, and which order warns all persons
3686	not to remove, use, or dispose of such article or processing
3687	equipment by sale or otherwise until permission for removal,
3688	use, or disposal is given by such agent or the court. It is
3689	unlawful for any person to remove, use, or dispose of such
3690	detained or embargoed article or processing equipment by sale or
3691	otherwise without such permission; and such act is a felony of
3692	the second degree, punishable as provided in s. 775.082, s.
3693	775.083, or s. 775.084.
3694	(3)  If the court finds that the detained or embargoed
3695	article or processing equipment is in violation, such article or
3696	processing equipment shall, after entry of the court order, be
3697	destroyed or made sanitary at the expense of the claimant
3698	thereof, under the supervision of such agent; and all court
3699	costs, fees, and storage and other proper expenses shall be
3700	taxed against the claimant of such article or processing
3701	equipment or her or his agent. However, when the violation can
3702	be corrected by proper labeling of the article or sanitizing of
3703	the processing equipment, and after such costs, fees, and
3704	expenses have been paid and a good and sufficient bond,
3705	conditioned that such article be so labeled or processed or such
3706	processing equipment be so sanitized, has been executed, the
3707	court may by order direct that such article or processing
3708	equipment be delivered to the claimant thereof for such
3709	labeling, processing, or sanitizing, under the supervision of an
3710	agent of the department. The expense of such supervision shall
3711	be paid by the claimant. Such bond shall be returned to the
3712	claimant of the article or processing equipment upon
3713	representation to the court by the department that the article
3714	or processing equipment is no longer in violation of this part
3715	ss. 499.001-499.081 and that the expenses of such supervision
3716	have been paid.
3717	Section 33.  Section 499.062, Florida Statutes, is amended;
3718	section 499.063, Florida Statutes, is redesignated as section
3719	(2) of that section and amended; and section 499.064, Florida
3720	Statutes, is redesignated as paragraphs (a) and (b) of
3721	subsection (2) of that section and amended, to read:
3722	499.062  Cause for Seizure and condemnation of drugs,
3723	devices, or cosmetics.--
3724	(1)  Any article of any drug, device, or cosmetic that is
3725	adulterated or misbranded under this part ss. 499.001-499.081 is
3726	subject to seizure and condemnation by the department or by its
3727	duly authorized agents designated for that purpose in regard to
3728	drugs, devices, or cosmetics.
3729	(2)499.063  Seizure; procedure; prohibition on sale or
3730	disposal of article; penalty.--Whenever a duly authorized
3731	officer or employee of the department finds cause, or has
3732	probable cause to believe that cause exists, for the seizure of
3733	any drug, device, or cosmetic, as set out in this part ss.
3734	499.001-499.081, he or she shall affix to the article a tag,
3735	stamp, or other appropriate marking, giving notice that the
3736	article is, or is suspected of being, subject to seizure under
3737	this part ss. 499.001-499.081 and that the article has been
3738	detained and seized by the department. Such officer or employee
3739	shall also warn all persons not to remove or dispose of the
3740	article, by sale or otherwise, until permission is given by the
3741	department or the court. Any person who violates this subsection
3742	section is guilty of a felony of the second degree, punishable
3743	as provided in s. 775.082, s. 775.083, or s. 775.084.
3744	(a)499.064  Condemnation and sale; release of seized
3745	article.--(1)  When any article detained or seized under this
3746	subsection s. 499.063 has been found by the department to be
3747	subject to seizure and condemnation under s. 499.063, the
3748	department shall petition the court for an order of condemnation
3749	or sale, as the court directs. The proceeds of the sale of
3750	drugs, devices, and cosmetics, less the legal costs and charges,
3751	shall be deposited into the Florida Drug, Device, and Cosmetic
3752	Trust Fund.
3753	(b)(2)  If the department finds that any article seized
3754	under this subsection s. 499.063 was not subject to seizure
3755	under that section, the department or the designated officer or
3756	employee shall remove the tag or marking.
3757	Section 34.  Section 499.065, Florida Statutes, is amended
3758	to read:
3759	499.065  Inspections; imminent danger.--
3760	(1)  Notwithstanding s. 499.051, the department shall
3761	inspect each prescription drug wholesale distributor
3762	establishment, prescription drug repackager establishment,
3763	veterinary prescription drug wholesale distributor
3764	establishment, limited prescription drug veterinary wholesale
3765	distributor wholesaler establishment, and retail pharmacy drug
3766	wholesale distributor wholesaler establishment that is required
3767	to be permitted under this part chapter as often as necessary to
3768	ensure compliance with applicable laws and rules. The department
3769	shall have the right of entry and access to these facilities at
3770	any reasonable time.
3771	(2)  To protect the public from prescription drugs that are
3772	adulterated or otherwise unfit for human or animal consumption,
3773	the department may examine, sample, seize, and stop the sale or
3774	use of prescription drugs to determine the condition of those
3775	drugs. The department may immediately seize and remove any
3776	prescription drugs if the State Surgeon General or his or her
3777	designee determines that the prescription drugs represent a
3778	threat to the public health. The owner of any property seized
3779	under this section may, within 10 days after the seizure, apply
3780	to a court of competent jurisdiction for whatever relief is
3781	appropriate. At any time after 10 days, the department may
3782	destroy the drugs as contraband.
3783	(3)  The department may determine that a prescription drug
3784	wholesale distributor establishment, prescription drug
3785	repackager establishment, veterinary prescription drug wholesale
3786	distributor establishment, limited prescription drug veterinary
3787	wholesale distributor wholesaler establishment, or retail
3788	pharmacy drug wholesale distributor wholesaler establishment
3789	that is required to be permitted under this part chapter is an
3790	imminent danger to the public health and shall require its
3791	immediate closure if the establishment fails to comply with
3792	applicable laws and rules and, because of the failure, presents
3793	an imminent threat to the public's health, safety, or welfare.
3794	Any establishment so deemed and closed shall remain closed until
3795	allowed by the department or by judicial order to reopen.
3796	(4)  For purposes of this section, a refusal to allow entry
3797	to the department for inspection at reasonable times, or a
3798	failure or refusal to provide the department with required
3799	documentation for purposes of inspection, constitutes an
3800	imminent danger to the public health.
3801	Section 35.  Subsections (1) through (4) of section
3802	499.066, Florida Statutes, are amended to read:
3803	499.066  Penalties; remedies.--In addition to other
3804	penalties and other enforcement provisions:
3805	(1)  The department may institute such suits or other legal
3806	proceedings as are required to enforce any provision of this
3807	part ss. 499.001-499.081. If it appears that a person has
3808	violated any provision of this part ss. 499.001-499.081 for
3809	which criminal prosecution is provided, the department may
3810	provide the appropriate state attorney or other prosecuting
3811	agency having jurisdiction with respect to such prosecution with
3812	the relevant information in the department's possession.
3813	(2)  If any person engaged in any activity covered by this
3814	part ss. 499.001-499.081 violates any provision of this part
3815	those sections, any rule adopted under this part those sections,
3816	or a cease and desist order as provided by this part those
3817	sections, the department may obtain an injunction in the circuit
3818	court of the county in which the violation occurred or in which
3819	the person resides or has its principal place of business, and
3820	may apply in that court for such temporary and permanent orders
3821	as the department considers necessary to restrain the person
3822	from engaging in any such activities until the person complies
3823	with this part ss. 499.001-499.081, the rules adopted under this
3824	part those sections, and the orders of the department authorized
3825	by this part those sections or to mandate compliance with this
3826	part ss. 499.001-499.081, the rules adopted under this part
3827	those sections, and any order or permit issued by the department
3828	under this part those sections.
3829	(3)  The department may impose an administrative fine, not
3830	to exceed $5,000 per violation per day, for the violation of any
3831	provision of this part ss. 499.001-499.081 or rules adopted
3832	under this part those sections. Each day a violation continues
3833	constitutes a separate violation, and each separate violation is
3834	subject to a separate fine. All amounts collected pursuant to
3835	this section shall be deposited into the Florida Drug, Device,
3836	and Cosmetic Trust Fund and are appropriated for the use of the
3837	department in administering this part ss. 499.001-499.081. In
3838	determining the amount of the fine to be levied for a violation,
3839	the department shall consider:
3840	(a)  The severity of the violation;
3841	(b)  Any actions taken by the person to correct the
3842	violation or to remedy complaints; and
3843	(c)  Any previous violations.
3844	(4)  The department shall deposit any rewards, fines, or
3845	collections that are due the department and which derive from
3846	joint enforcement activities with other state and federal
3847	agencies which relate to this part ss. 499.001-499.081, chapter
3848	893, or the federal act, into the Florida Drug, Device, and
3849	Cosmetic Trust Fund. The proceeds of those rewards, fines, and
3850	collections are appropriated for the use of the department in
3851	administering this part ss. 499.001-499.081.
3852	Section 36.  Section 499.0661, Florida Statutes, is amended
3853	to read:
3854	499.0661  Cease and desist orders; removal of certain
3855	persons.--
3856	(1)(2)  CEASE AND DESIST ORDERS.--
3857	(a)  In addition to any authority otherwise provided in
3858	this chapter, the department may issue and serve a complaint
3859	stating charges upon any permittee or upon any affiliated party,
3860	whenever the department has reasonable cause to believe that the
3861	person or individual named therein is engaging in or has engaged
3862	in conduct that is:
3863	1.  An act that demonstrates a lack of fitness or
3864	trustworthiness to engage in the business authorized under the
3865	permit issued pursuant to this part ss. 499.001-499.081, is
3866	hazardous to the public health, or constitutes business
3867	operations that are a detriment to the public health;
3868	2.  A violation of any provision of this part ss. 499.001-
3869	499.081;
3870	3.  A violation of any rule of the department;
3871	4.  A violation of any order of the department; or
3872	5.  A breach of any written agreement with the department.
3873	(b)  The complaint must contain a statement of facts and
3874	notice of opportunity for a hearing pursuant to ss. 120.569 and
3875	120.57.
3876	(c)  If a hearing is not requested within the time allowed
3877	by ss. 120.569 and 120.57, or if a hearing is held and the
3878	department finds that any of the charges are proven, the
3879	department may enter an order directing the permittee or the
3880	affiliated party named in the complaint to cease and desist from
3881	engaging in the conduct complained of and take corrective action
3882	to remedy the effects of past improper conduct and assure future
3883	compliance.
3884	(d)  A contested or default cease and desist order is
3885	effective when reduced to writing and served upon the permittee
3886	or affiliated party named therein. An uncontested cease and
3887	desist order is effective as agreed.
3888	(e)  Whenever the department finds that conduct described
3889	in paragraph (a) is likely to cause an immediate threat to the
3890	public health, it may issue an emergency cease and desist order
3891	requiring the permittee or any affiliated party to immediately
3892	cease and desist from engaging in the conduct complained of and
3893	to take corrective and remedial action. The emergency order is
3894	effective immediately upon service of a copy of the order upon
3895	the permittee or affiliated party named therein and remains
3896	effective for 90 days. If the department begins nonemergency
3897	cease and desist proceedings under this subsection, the
3898	emergency order remains effective until the conclusion of the
3899	proceedings under ss. 120.569 and 120.57.
3900	(2)(3)  REMOVAL OF AFFILIATED PARTIES BY THE DEPARTMENT.--
3901	(a)  The department may issue and serve a complaint stating
3902	charges upon any affiliated party and upon the permittee
3903	involved whenever the department has reason to believe that an
3904	affiliated party is engaging in or has engaged in conduct that
3905	constitutes:
3906	1.  An act that demonstrates a lack of fitness or
3907	trustworthiness to engage in the business authorized under the
3908	permit issued pursuant to this part ss. 499.001-499.081, is
3909	hazardous to the public health, or constitutes business
3910	operations that are a detriment to the public health;
3911	2.  A willful violation of this part ss. 499.001-499.081;
3912	however, if the violation constitutes a misdemeanor, a complaint
3913	may not be served as provided in this section until the
3914	affiliated party is notified in writing of the matter of the
3915	violation and has been afforded a reasonable period of time, as
3916	set forth in the notice, to correct the violation and has failed
3917	to do so;
3918	3.  A violation of any other law involving fraud or moral
3919	turpitude which constitutes a felony;
3920	4.  A willful violation of any rule of the department;
3921	5.  A willful violation of any order of the department; or
3922	6.  A material misrepresentation of fact, made knowingly
3923	and willfully or made with reckless disregard for the truth of
3924	the matter.
3925	(b)  The complaint must contain a statement of facts and
3926	notice of opportunity for a hearing pursuant to ss. 120.569 and
3927	120.57.
3928	(c)  If a hearing is not requested within the time allotted
3929	by ss. 120.569 and 120.57, or if a hearing is held and the
3930	department finds that any of the charges in the complaint are
3931	proven true, the department may enter an order removing the
3932	affiliated party or restricting or prohibiting participation by
3933	the person in the affairs of that permittee or of any other
3934	permittee.
3935	(d)  A contested or default order of removal, restriction,
3936	or prohibition is effective when reduced to writing and served
3937	on the permittee and the affiliated party. An uncontested order
3938	of removal, restriction, or prohibition is effective as agreed.
3939	(e)1.  The chief executive officer, designated
3940	representative, or the person holding the equivalent office, of
3941	a permittee shall promptly notify the department if she or he
3942	has actual knowledge that any affiliated party is charged with a
3943	felony in a state or federal court.
3944	2.  Whenever any affiliated party is charged with a felony
3945	in a state or federal court or with the equivalent of a felony
3946	in the courts of any foreign country with which the United
3947	States maintains diplomatic relations, and the charge alleges
3948	violation of any law involving prescription drugs,
3949	pharmaceuticals, fraud, theft, or moral turpitude, the
3950	department may enter an emergency order suspending the
3951	affiliated party or restricting or prohibiting participation by
3952	the affiliated party in the affairs of the particular permittee
3953	or of any other permittee upon service of the order upon the
3954	permittee and the affiliated party charged. The order must
3955	contain notice of opportunity for a hearing pursuant to ss.
3956	120.569 and 120.57, where the affiliated party may request a
3957	postsuspension hearing to show that continued service to or
3958	participation in the affairs of the permittee does not pose a
3959	threat to the public health or the interests of the permittee
3960	and does not threaten to impair public confidence in the
3961	permittee. In accordance with applicable departmental rules, the
3962	department shall notify the affiliated party whether the order
3963	suspending or prohibiting the person from participation in the
3964	affairs of a permittee will be rescinded or otherwise modified.
3965	The emergency order remains in effect, unless otherwise modified
3966	by the department, until the criminal charge is disposed of. The
3967	acquittal of the person charged, or the final, unappealed
3968	dismissal of all charges against the person, dissolves the
3969	emergency order but does not prohibit the department from
3970	instituting proceedings under paragraph (a). If the person
3971	charged is convicted or pleads guilty or nolo contendere,
3972	whether or not an adjudication of guilt is entered by the court,
3973	the emergency order shall become final.
3974	(f)  Any affiliated party removed pursuant to this section
3975	is not eligible for reemployment by the permittee or to be an
3976	affiliated party of any permittee except upon the written
3977	consent of the department. Any affiliated party who is removed,
3978	restricted, or prohibited from participating in the affairs of a
3979	permittee pursuant to this section may petition the department
3980	for modification or termination of the removal, restriction, or
3981	prohibition.
3982	Section 37.  Section 499.067, Florida Statutes, is amended
3983	to read:
3984	499.067  Denial, suspension, or revocation of permit,
3985	certification, or registration.--
3986	(1)(a)  The department may deny, suspend, or revoke a
3987	permit if it finds that there has been a substantial failure to
3988	comply with this part ss. 499.001-499.081 or chapter 465,
3989	chapter 501, or chapter 893, the rules adopted under this part
3990	any of those sections or those chapters, any final order of the
3991	department, or applicable federal laws or regulations or other
3992	state laws or rules governing drugs, devices, or cosmetics.
3993	(b)  The department may deny an application for a permit or
3994	certification, or suspend or revoke a permit or certification,
3995	if the department finds that:
3996	1.  The applicant is not of good moral character or that it
3997	would be a danger or not in the best interest of the public
3998	health, safety, and welfare if the applicant were issued a
3999	permit or certification.
4000	2.  The applicant has not met the requirements for the
4001	permit or certification.
4002	3.  The applicant is not eligible for a permit or
4003	certification for any of the reasons enumerated in s. 499.012 s.
4004	499.01 or s. 499.012(5).
4005	4.  The applicant, permittee, or person certified under s.
4006	499.012(16) s. 499.012(11) demonstrates any of the conditions
4007	enumerated in s. 499.012 s. 499.01 or s. 499.012(5).
4008	5.  The applicant, permittee, or person certified under s.
4009	499.012(16) s. 499.012(11) has committed any violation of ss.
4010	499.005-499.0054.
4011	(2)  The department may deny, suspend, or revoke any
4012	registration required by the provisions of this part ss.
4013	499.001-499.081 for the violation of any provision of this part
4014	ss. 499.001-499.081 or of any rules adopted under this part
4015	those sections.
4016	(3)  The department may revoke or suspend a permit:
4017	(a)  If the permit was obtained by misrepresentation or
4018	fraud or through a mistake of the department;
4019	(b)  If the permit was procured, or attempted to be
4020	procured, for any other person by making or causing to be made
4021	any false representation; or
4022	(c)  If the permittee has violated any provision of this
4023	part ss. 499.001-499.081 or rules adopted under this part those
4024	sections.
4025	(4)  If any permit issued under this part ss. 499.001-
4026	499.081 is revoked or suspended, the owner, manager, operator,
4027	or proprietor of the establishment shall cease to operate as the
4028	permit authorized, from the effective date of the suspension or
4029	revocation until the person is again registered with the
4030	department and possesses the required permit. If a permit is
4031	revoked or suspended, the owner, manager, or proprietor shall
4032	remove all signs and symbols that identify the operation as
4033	premises permitted as a drug wholesaling establishment; drug,
4034	device, or cosmetic manufacturing establishment; or retail
4035	establishment. The department shall determine the length of time
4036	for which the permit is to be suspended. If a permit is revoked,
4037	the person that owns or operates the establishment may not apply
4038	for any permit under this part ss. 499.001-499.081 for a period
4039	of 1 year after the date of the revocation. A revocation of a
4040	permit may be permanent if the department considers that to be
4041	in the best interest of the public health.
4042	(5)  The department may deny, suspend, or revoke a permit
4043	issued under this part ss. 499.001-499.081 which authorizes the
4044	permittee to purchase prescription drugs, if any owner, officer,
4045	employee, or other person who participates in administering or
4046	operating the establishment has been found guilty of any
4047	violation of this part ss. 499.001-499.081 or chapter 465,
4048	chapter 501, or chapter 893, any rules adopted under this part
4049	any of those sections or those chapters, or any federal or state
4050	drug law, regardless of whether the person has been pardoned,
4051	had her or his civil rights restored, or had adjudication
4052	withheld.
4053	(6)  The department shall deny, suspend, or revoke the
4054	permit of any person or establishment if the assignment, sale,
4055	transfer, or lease of an establishment permitted under this part
4056	ss. 499.001-499.081 will avoid an administrative penalty, civil
4057	action, or criminal prosecution.
4058	(7)  Notwithstanding s. 120.60(5), if a permittee fails to
4059	comply with s. 499.012(6) s. 499.01(7), the department may
4060	revoke the permit of the permittee and shall provide notice of
4061	the intended agency action by posting a notice at the
4062	department's headquarters and by mailing a copy of the notice of
4063	intended agency action by certified mail to the most recent
4064	mailing address on record with the department and, if the
4065	permittee is not a natural person, to the permittee's registered
4066	agent on file with the Department of State.
4067	Section 38.  Paragraph (a) of subsection (1) of section
4068	409.9201, Florida Statutes, is amended to read:
4069	409.9201  Medicaid fraud.--
4070	(1)  As used in this section, the term:
4071	(a)  "Legend drug" means any drug, including, but not
4072	limited to, finished dosage forms or active ingredients that are
4073	subject to, defined by, or described by s. 503(b) of the Federal
4074	Food, Drug, and Cosmetic Act or by s. 465.003(8), s. 499.007(13)
4075	s. 499.007(12), or s. 499.003(47) or (54) s. 499.0122(1)(b) or
4076	(c).
4077
4078	The value of individual items of the legend drugs or goods or
4079	services involved in distinct transactions committed during a
4080	single scheme or course of conduct, whether involving a single
4081	person or several persons, may be aggregated when determining
4082	the punishment for the offense.
4083	Section 39.  Paragraph (c) of subsection (9) of section
4084	460.403, Florida Statutes, is amended to read:
4085	460.403  Definitions.--As used in this chapter, the term:
4086	(9)
4087	(c)1.  Chiropractic physicians may adjust, manipulate, or
4088	treat the human body by manual, mechanical, electrical, or
4089	natural methods; by the use of physical means or physiotherapy,
4090	including light, heat, water, or exercise; by the use of
4091	acupuncture; or by the administration of foods, food
4092	concentrates, food extracts, and items for which a prescription
4093	is not required and may apply first aid and hygiene, but
4094	chiropractic physicians are expressly prohibited from
4095	prescribing or administering to any person any legend drug
4096	except as authorized under subparagraph 2., from performing any
4097	surgery except as stated herein, or from practicing obstetrics.
4098	2.  Notwithstanding the prohibition against prescribing and
4099	administering legend drugs under subparagraph 1., or s.
4100	499.01(2)(m) s. 499.0122, pursuant to board rule chiropractic
4101	physicians may order, store, and administer, for emergency
4102	purposes only at the chiropractic physician's office or place of
4103	business, prescription medical oxygen and may also order, store,
4104	and administer the following topical anesthetics in aerosol
4105	form:
4106	a.  Any solution consisting of 25 percent ethylchloride and
4107	75 percent dichlorodifluoromethane.
4108	b.  Any solution consisting of 15 percent
4109	dichlorodifluoromethane and 85 percent
4110	trichloromonofluoromethane.
4111
4112	However, this paragraph does not authorize a chiropractic
4113	physician to prescribe medical oxygen as defined in chapter 499.
4114	Section 40.  Subsection (3) of section 465.0265, Florida
4115	Statutes, is amended to read:
4116	465.0265  Centralized prescription filling.--
4117	(3)  The filling, delivery, and return of a prescription by
4118	one pharmacy for another pursuant to this section shall not be
4119	construed as the filling of a transferred prescription as set
4120	forth in s. 465.026 or as a wholesale distribution as set forth
4121	in s. 499.003(55) s. 499.012(1)(a).
4122	Section 41.  Section 794.075, Florida Statutes, is amended
4123	to read:
4124	794.075  Sexual predators; erectile dysfunction drugs.--
4125	(1)  A person may not possess a prescription drug, as
4126	defined in s. 499.003(44) s. 499.003(25), for the purpose of
4127	treating erectile dysfunction if the person is designated as a
4128	sexual predator under s. 775.21.
4129	(2)  A person who violates a provision of this section for
4130	the first time commits a misdemeanor of the second degree,
4131	punishable as provided in s. 775.082 or s. 775.083. A person who
4132	violates a provision of this section a second or subsequent time
4133	commits a misdemeanor of the first degree, punishable as
4134	provided in s. 775.082 or s. 775.083.
4135	Section 42.  Paragraph (a) of subsection (1) of section
4136	895.02, Florida Statutes, is amended to read:
4137	895.02  Definitions.--As used in ss. 895.01-895.08, the
4138	term:
4139	(1)  "Racketeering activity" means to commit, to attempt to
4140	commit, to conspire to commit, or to solicit, coerce, or
4141	intimidate another person to commit:
4142	(a)  Any crime that is chargeable by indictment or
4143	information under the following provisions of the Florida
4144	Statutes:
4145	1.  Section 210.18, relating to evasion of payment of
4146	cigarette taxes.
4147	2.  Section 403.727(3)(b), relating to environmental
4148	control.
4149	3.  Section 409.920 or s. 409.9201, relating to Medicaid
4150	fraud.
4151	4.  Section 414.39, relating to public assistance fraud.
4152	5.  Section 440.105 or s. 440.106, relating to workers'
4153	compensation.
4154	6.  Section 443.071(4), relating to creation of a
4155	fictitious employer scheme to commit unemployment compensation
4156	fraud.
4157	7.  Section 465.0161, relating to distribution of medicinal
4158	drugs without a permit as an Internet pharmacy.
4159	8.  Section 499.0051 Sections 499.0051, 499.0052,
4160	499.00535, 499.00545, and 499.0691, relating to crimes involving
4161	contraband and adulterated drugs.
4162	9.  Part IV of chapter 501, relating to telemarketing.
4163	10.  Chapter 517, relating to sale of securities and
4164	investor protection.
4165	11.  Section 550.235, s. 550.3551, or s. 550.3605, relating
4166	to dogracing and horseracing.
4167	12.  Chapter 550, relating to jai alai frontons.
4168	13.  Section 551.109, relating to slot machine gaming.
4169	14.  Chapter 552, relating to the manufacture,
4170	distribution, and use of explosives.
4171	15.  Chapter 560, relating to money transmitters, if the
4172	violation is punishable as a felony.
4173	16.  Chapter 562, relating to beverage law enforcement.
4174	17.  Section 624.401, relating to transacting insurance
4175	without a certificate of authority, s. 624.437(4)(c)1., relating
4176	to operating an unauthorized multiple-employer welfare
4177	arrangement, or s. 626.902(1)(b), relating to representing or
4178	aiding an unauthorized insurer.
4179	18.  Section 655.50, relating to reports of currency
4180	transactions, when such violation is punishable as a felony.
4181	19.  Chapter 687, relating to interest and usurious
4182	practices.
4183	20.  Section 721.08, s. 721.09, or s. 721.13, relating to
4184	real estate timeshare plans.
4185	21.  Chapter 782, relating to homicide.
4186	22.  Chapter 784, relating to assault and battery.
4187	23.  Chapter 787, relating to kidnapping or human
4188	trafficking.
4189	24.  Chapter 790, relating to weapons and firearms.
4190	25.  Section 796.03, s. 796.035, s. 796.04, s. 796.045, s.
4191	796.05, or s. 796.07, relating to prostitution and sex
4192	trafficking.
4193	26.  Chapter 806, relating to arson.
4194	27.  Section 810.02(2)(c), relating to specified burglary
4195	of a dwelling or structure.
4196	28.  Chapter 812, relating to theft, robbery, and related
4197	crimes.
4198	29.  Chapter 815, relating to computer-related crimes.
4199	30.  Chapter 817, relating to fraudulent practices, false
4200	pretenses, fraud generally, and credit card crimes.
4201	31.  Chapter 825, relating to abuse, neglect, or
4202	exploitation of an elderly person or disabled adult.
4203	32.  Section 827.071, relating to commercial sexual
4204	exploitation of children.
4205	33.  Chapter 831, relating to forgery and counterfeiting.
4206	34.  Chapter 832, relating to issuance of worthless checks
4207	and drafts.
4208	35.  Section 836.05, relating to extortion.
4209	36.  Chapter 837, relating to perjury.
4210	37.  Chapter 838, relating to bribery and misuse of public
4211	office.
4212	38.  Chapter 843, relating to obstruction of justice.
4213	39.  Section 847.011, s. 847.012, s. 847.013, s. 847.06, or
4214	s. 847.07, relating to obscene literature and profanity.
4215	40.  Section 849.09, s. 849.14, s. 849.15, s. 849.23, or s.
4216	849.25, relating to gambling.
4217	41.  Chapter 874, relating to criminal street gangs.
4218	42.  Chapter 893, relating to drug abuse prevention and
4219	control.
4220	43.  Chapter 896, relating to offenses related to financial
4221	transactions.
4222	44.  Sections 914.22 and 914.23, relating to tampering with
4223	a witness, victim, or informant, and retaliation against a
4224	witness, victim, or informant.
4225	45.  Sections 918.12 and 918.13, relating to tampering with
4226	jurors and evidence.
4227	Section 43.  Paragraphs (d), (f), (h), (i), and (j) of
4228	subsection (3) of section 921.0022, Florida Statutes, are
4229	amended to read:
4230	921.0022  Criminal Punishment Code; offense severity
4231	ranking chart.--
4232	(3)  OFFENSE SEVERITY RANKING CHART
4233	(d)  LEVEL 4
4234
	FloridaStatute FelonyDegree Description
4235
	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.
4236
	499.0051(1) 3rd Failure to maintain or deliver pedigree papers.
4237
	499.0051(2) 3rd Failure to authenticate pedigree papers.
4238
	499.0051(6) 2nd Knowing sale or delivery, or possession with intent to sell, contraband prescription legend drugs.
4239
	784.07(2)(b) 3rd Battery of law enforcement officer, firefighter, intake officer, etc.
4240
	784.074(1)(c) 3rd Battery of sexually violent predators facility staff.
4241
	784.075 3rd Battery on detention or commitment facility staff.
4242
	784.078 3rd Battery of facility employee by throwing, tossing, or expelling certain fluids or materials.
4243
	784.08(2)(c) 3rd Battery on a person 65 years of age or older.
4244
	784.081(3) 3rd Battery on specified official or employee.
4245
	784.082(3) 3rd Battery by detained person on visitor or other detainee.
4246
	784.083(3) 3rd Battery on code inspector.
4247
	784.085 3rd Battery of child by throwing, tossing, projecting, or expelling certain fluids or materials.
4248
	787.03(1) 3rd Interference with custody; wrongly takes minor from appointed guardian.
4249
	787.04(2) 3rd Take, entice, or remove child beyond state limits with criminal intent pending custody proceedings.
4250
	787.04(3) 3rd Carrying child beyond state lines with criminal intent to avoid producing child at custody hearing or delivering to designated person.
4251
	790.115(1) 3rd Exhibiting firearm or weapon within 1,000 feet of a school.
4252
	790.115(2)(b) 3rd Possessing electric weapon or device, destructive device, or other weapon on school property.
4253
	790.115(2)(c) 3rd Possessing firearm on school property.
4254
	800.04(7)(d) 3rd Lewd or lascivious exhibition; offender less than 18 years.
4255
	810.02(4)(a) 3rd Burglary, or attempted burglary, of an unoccupied structure; unarmed; no assault or battery.
4256
	810.02(4)(b) 3rd Burglary, or attempted burglary, of an unoccupied conveyance; unarmed; no assault or battery.
4257
	810.06 3rd Burglary; possession of tools.
4258
	810.08(2)(c) 3rd Trespass on property, armed with firearm or dangerous weapon.
4259
	812.014(2)(c)3. 3rd Grand theft, 3rd degree $10,000 or more but less than $20,000.
4260
	812.014(2)(c)4.-10. 3rd Grand theft, 3rd degree, a will, firearm, motor vehicle, livestock, etc.
4261
	812.0195(2) 3rd Dealing in stolen property by use of the Internet; property stolen $300 or more.
4262
	817.563(1) 3rd Sell or deliver substance other than controlled substance agreed upon, excluding s. 893.03(5) drugs.
4263
	817.568(2)(a) 3rd Fraudulent use of personal identification information.
4264
	817.625(2)(a) 3rd Fraudulent use of scanning device or reencoder.
4265
	828.125(1) 2nd Kill, maim, or cause great bodily harm or permanent breeding disability to any registered horse or cattle.
4266
	837.02(1) 3rd Perjury in official proceedings.
4267
	837.021(1) 3rd Make contradictory statements in official proceedings.
4268
	838.022 3rd Official misconduct.
4269
	839.13(2)(a) 3rd Falsifying records of an individual in the care and custody of a state agency.
4270
	839.13(2)(c) 3rd Falsifying records of the Department of Children and Family Services.
4271
	843.021 3rd Possession of a concealed handcuff key by a person in custody.
4272
	843.025 3rd Deprive law enforcement, correctional, or correctional probation officer of means of protection or communication.
4273
	843.15(1)(a) 3rd Failure to appear while on bail for felony (bond estreature or bond jumping).
4274
	874.05(1) 3rd Encouraging or recruiting another to join a criminal street gang.
4275
	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).
4276
	914.14(2) 3rd Witnesses accepting bribes.
4277
	914.22(1) 3rd Force, threaten, etc., witness, victim, or informant.
4278
	914.23(2) 3rd Retaliation against a witness, victim, or informant, no bodily injury.
4279
	918.12 3rd Tampering with jurors.
4280
	934.215 3rd Use of two-way communications device to facilitate commission of a crime.
4281
4282	(f)  LEVEL 6
4283
	FloridaStatute FelonyDegree Description
4284
	316.193(2)(b) 3rd Felony DUI, 4th or subsequent conviction.
4285
	499.0051(3) 2nd Knowing forgery of pedigree papers.
4286
	499.0051(4) 2nd Knowing purchase or receipt of prescription legend drug from unauthorized person.
4287
	499.0051(5) 2nd Knowing sale or transfer of prescription legend drug to unauthorized person.
4288
	775.0875(1) 3rd Taking firearm from law enforcement officer.
4289
	784.021(1)(a) 3rd Aggravated assault; deadly weapon without intent to kill.
4290
	784.021(1)(b) 3rd Aggravated assault; intent to commit felony.
4291
	784.041 3rd Felony battery; domestic battery by strangulation.
4292
	784.048(3) 3rd Aggravated stalking; credible threat.
4293
	784.048(5) 3rd Aggravated stalking of person under 16.
4294
	784.07(2)(c) 2nd Aggravated assault on law enforcement officer.
4295
	784.074(1)(b) 2nd Aggravated assault on sexually violent predators facility staff.
4296
	784.08(2)(b) 2nd Aggravated assault on a person 65 years of age or older.
4297
	784.081(2) 2nd Aggravated assault on specified official or employee.
4298
	784.082(2) 2nd Aggravated assault by detained person on visitor or other detainee.
4299
	784.083(2) 2nd Aggravated assault on code inspector.
4300
	787.02(2) 3rd False imprisonment; restraining with purpose other than those in s. 787.01.
4301
	790.115(2)(d) 2nd Discharging firearm or weapon on school property.
4302
	790.161(2) 2nd Make, possess, or throw destructive device with intent to do bodily harm or damage property.
4303
	790.164(1) 2nd False report of deadly explosive, weapon of mass destruction, or act of arson or violence to state property.
4304
	790.19 2nd Shooting or throwing deadly missiles into dwellings, vessels, or vehicles.
4305
	794.011(8)(a) 3rd Solicitation of minor to participate in sexual activity by custodial adult.
4306
	794.05(1) 2nd Unlawful sexual activity with specified minor.
4307
	800.04(5)(d) 3rd Lewd or lascivious molestation; victim 12 years of age or older but less than 16 years; offender less than 18 years.
4308
	800.04(6)(b) 2nd Lewd or lascivious conduct; offender 18 years of age or older.
4309
	806.031(2) 2nd Arson resulting in great bodily harm to firefighter or any other person.
4310
	810.02(3)(c) 2nd Burglary of occupied structure; unarmed; no assault or battery.
4311
	812.014(2)(b)1. 2nd Property stolen $20,000 or more, but less than $100,000, grand theft in 2nd degree.
4312
	812.014(6) 2nd Theft; property stolen $3,000 or more; coordination of others.
4313
	812.015(9)(a) 2nd Retail theft; property stolen $300 or more; second or subsequent conviction.
4314
	812.015(9)(b) 2nd Retail theft; property stolen $3,000 or more; coordination of others.
4315
	812.13(2)(c) 2nd Robbery, no firearm or other weapon (strong-arm robbery).
4316
	817.034(4)(a)1. 1st Communications fraud, value greater than $50,000.
4317
	817.4821(5) 2nd Possess cloning paraphernalia with intent to create cloned cellular telephones.
4318
	825.102(1) 3rd Abuse of an elderly person or disabled adult.
4319
	825.102(3)(c) 3rd Neglect of an elderly person or disabled adult.
4320
	825.1025(3) 3rd Lewd or lascivious molestation of an elderly person or disabled adult.
4321
	825.103(2)(c) 3rd Exploiting an elderly person or disabled adult and property is valued at less than $20,000.
4322
	827.03(1) 3rd Abuse of a child.
4323
	827.03(3)(c) 3rd Neglect of a child.
4324
	827.071(2)&(3) 2nd Use or induce a child in a sexual performance, or promote or direct such performance.
4325
	836.05 2nd Threats; extortion.
4326
	836.10 2nd Written threats to kill or do bodily injury.
4327
	843.12 3rd Aids or assists person to escape.
4328
	847.0135(2) 3rd Facilitates sexual conduct of or with a minor or the visual depiction of such conduct.
4329
	914.23 2nd Retaliation against a witness, victim, or informant, with bodily injury.
4330
	944.35(3)(a)2. 3rd Committing malicious battery upon or inflicting cruel or inhuman treatment on an inmate or offender on community supervision, resulting in great bodily harm.
4331
	944.40 2nd Escapes.
4332
	944.46 3rd Harboring, concealing, aiding escaped prisoners.
4333
	944.47(1)(a)5. 2nd Introduction of contraband (firearm, weapon, or explosive) into correctional facility.
4334
	951.22(1) 3rd Intoxicating drug, firearm, or weapon introduced into county facility.
4335
4336	(h)  LEVEL 8
4337
	FloridaStatute FelonyDegree Description
4338
	316.193(3)(c)3.a. 2nd DUI manslaughter.
4339
	316.1935(4)(b) 1st Aggravated fleeing or attempted eluding with serious bodily injury or death.
4340
	327.35(3)(c)3. 2nd Vessel BUI manslaughter.
4341
	499.0051(8) 499.0051(7) 1st Knowing forgery of prescription labels or prescription legend drug labels.
4342
	499.0051(7) 499.0052 1st Knowing trafficking in contraband prescription legend drugs.
4343
	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.
4344
	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.
4345
	655.50(10)(b)2. 2nd Failure to report financial transactions totaling or exceeding $20,000, but less than $100,000 by financial institutions.
4346
	777.03(2)(a) 1st Accessory after the fact, capital felony.
4347
	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.
4348
	782.051(2) 1st Attempted felony murder while perpetrating or attempting to perpetrate a felony not enumerated in s. 782.04(3).
4349
	782.071(1)(b) 1st Committing vehicular homicide and failing to render aid or give information.
4350
	782.072(2) 1st Committing vessel homicide and failing to render aid or give information.
4351
	790.161(3) 1st Discharging a destructive device which results in bodily harm or property damage.
4352
	794.011(5) 2nd Sexual battery, victim 12 years or over, offender does not use physical force likely to cause serious injury.
4353
	794.08(3) 2nd Female genital mutilation, removal of a victim younger than 18 years of age from this state.
4354
	800.04(4) 2nd Lewd or lascivious battery.
4355
	806.01(1) 1st Maliciously damage dwelling or structure by fire or explosive, believing person in structure.
4356
	810.02(2)(a) 1st,PBL Burglary with assault or battery.
4357
	810.02(2)(b) 1st,PBL Burglary; armed with explosives or dangerous weapon.
4358
	810.02(2)(c) 1st Burglary of a dwelling or structure causing structural damage or $1,000 or more property damage.
4359
	812.014(2)(a)2. 1st Property stolen; cargo valued at $50,000 or more, grand theft in 1st degree.
4360
	812.13(2)(b) 1st Robbery with a weapon.
4361
	812.135(2)(c) 1st Home-invasion robbery, no firearm, deadly weapon, or other weapon.
4362
	817.568(6) 2nd Fraudulent use of personal identification information of an individual under the age of 18.
4363
	825.102(2) 2nd Aggravated abuse of an elderly person or disabled adult.
4364
	825.1025(2) 2nd Lewd or lascivious battery upon an elderly person or disabled adult.
4365
	825.103(2)(a) 1st Exploiting an elderly person or disabled adult and property is valued at $100,000 or more.
4366
	837.02(2) 2nd Perjury in official proceedings relating to prosecution of a capital felony.
4367
	837.021(2) 2nd Making contradictory statements in official proceedings relating to prosecution of a capital felony.
4368
	860.121(2)(c) 1st Shooting at or throwing any object in path of railroad vehicle resulting in great bodily harm.
4369
	860.16 1st Aircraft piracy.
4370
	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).
4371
	893.13(2)(b) 1st Purchase in excess of 10 grams of any substance specified in s. 893.03(1)(a) or (b).
4372
	893.13(6)(c) 1st Possess in excess of 10 grams of any substance specified in s. 893.03(1)(a) or (b).
4373
	893.135(1)(a)2. 1st Trafficking in cannabis, more than 2,000 lbs., less than 10,000 lbs.
4374
	893.135(1)(b)1.b. 1st Trafficking in cocaine, more than 200 grams, less than 400 grams.
4375
	893.135(1)(c)1.b. 1st Trafficking in illegal drugs, more than 14 grams, less than 28 grams.
4376
	893.135(1)(d)1.b. 1st Trafficking in phencyclidine, more than 200 grams, less than 400 grams.
4377
	893.135(1)(e)1.b. 1st Trafficking in methaqualone, more than 5 kilograms, less than 25 kilograms.
4378
	893.135(1)(f)1.b. 1st Trafficking in amphetamine, more than 28 grams, less than 200 grams.
4379
	893.135(1)(g)1.b. 1st Trafficking in flunitrazepam, 14 grams or more, less than 28 grams.
4380
	893.135(1)(h)1.b. 1st Trafficking in gamma-hydroxybutyric acid (GHB), 5 kilograms or more, less than 10 kilograms.
4381
	893.135(1)(j)1.b. 1st Trafficking in 1,4-Butanediol, 5 kilograms or more, less than 10 kilograms.
4382
	893.135(1)(k)2.b. 1st Trafficking in Phenethylamines, 200 grams or more, less than 400 grams.
4383
	895.03(1) 1st Use or invest proceeds derived from pattern of racketeering activity.
4384
	895.03(2) 1st Acquire or maintain through racketeering activity any interest in or control of any enterprise or real property.
4385
	895.03(3) 1st Conduct or participate in any enterprise through pattern of racketeering activity.
4386
	896.101(5)(b) 2nd Money laundering, financial transactions totaling or exceeding $20,000, but less than $100,000.
4387
	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.
4388
4389	(i)  LEVEL 9
4390
	FloridaStatute FelonyDegree Description
4391
	316.193(3)(c)3.b. 1st DUI manslaughter; failing to render aid or give information.
4392
	327.35(3)(c)3.b. 1st BUI manslaughter; failing to render aid or give information.
4393
	499.0051(9) 499.00535 1st Knowing sale or purchase of contraband prescription legend drugs resulting in great bodily harm.
4394
	560.123(8)(b)3. 1st Failure to report currency or payment instruments totaling or exceeding $100,000 by money transmitter.
4395
	560.125(5)(c) 1st Money transmitter business by unauthorized person, currency, or payment instruments totaling or exceeding $100,000.
4396
	655.50(10)(b)3. 1st Failure to report financial transactions totaling or exceeding $100,000 by financial institution.
4397
	775.0844 1st Aggravated white collar crime.
4398
	782.04(1) 1st Attempt, conspire, or solicit to commit premeditated murder.
4399
	782.04(3) 1st,PBL Accomplice to murder in connection with arson, sexual battery, robbery, burglary, and other specified felonies.
4400
	782.051(1) 1st Attempted felony murder while perpetrating or attempting to perpetrate a felony enumerated in s. 782.04(3).
4401
	782.07(2) 1st Aggravated manslaughter of an elderly person or disabled adult.
4402
	787.01(1)(a)1. 1st,PBL Kidnapping; hold for ransom or reward or as a shield or hostage.
4403
	787.01(1)(a)2. 1st,PBL Kidnapping with intent to commit or facilitate commission of any felony.
4404
	787.01(1)(a)4. 1st,PBL Kidnapping with intent to interfere with performance of any governmental or political function.
4405
	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.
4406
	790.161 1st Attempted capital destructive device offense.
4407
	790.166(2) 1st,PBL Possessing, selling, using, or attempting to use a weapon of mass destruction.
4408
	794.011(2) 1st Attempted sexual battery; victim less than 12 years of age.
4409
	794.011(2) Life Sexual battery; offender younger than 18 years and commits sexual battery on a person less than 12 years.
4410
	794.011(4) 1st Sexual battery; victim 12 years or older, certain circumstances.
4411
	794.011(8)(b) 1st Sexual battery; engage in sexual conduct with minor 12 to 18 years by person in familial or custodial authority.
4412
	794.08(2) 1st Female genital mutilation; victim younger than 18 years of age.
4413
	800.04(5)(b) Life Lewd or lascivious molestation; victim less than 12 years; offender 18 years or older.
4414
	812.13(2)(a) 1st,PBL Robbery with firearm or other deadly weapon.
4415
	812.133(2)(a) 1st,PBL Carjacking; firearm or other deadly weapon.
4416
	812.135(2)(b) 1st Home-invasion robbery with weapon.
4417
	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.
4418
	827.03(2) 1st Aggravated child abuse.
4419
	847.0145(1) 1st Selling, or otherwise transferring custody or control, of a minor.
4420
	847.0145(2) 1st Purchasing, or otherwise obtaining custody or control, of a minor.
4421
	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.
4422
	893.135 1st Attempted capital trafficking offense.
4423
	893.135(1)(a)3. 1st Trafficking in cannabis, more than 10,000 lbs.
4424
	893.135(1)(b)1.c. 1st Trafficking in cocaine, more than 400 grams, less than 150 kilograms.
4425
	893.135(1)(c)1.c. 1st Trafficking in illegal drugs, more than 28 grams, less than 30 kilograms.
4426
	893.135(1)(d)1.c. 1st Trafficking in phencyclidine, more than 400 grams.
4427
	893.135(1)(e)1.c. 1st Trafficking in methaqualone, more than 25 kilograms.
4428
	893.135(1)(f)1.c. 1st Trafficking in amphetamine, more than 200 grams.
4429
	893.135(1)(h)1.c. 1st Trafficking in gamma-hydroxybutyric acid (GHB), 10 kilograms or more.
4430
	893.135(1)(j)1.c. 1st Trafficking in 1,4-Butanediol, 10 kilograms or more.
4431
	893.135(1)(k)2.c. 1st Trafficking in Phenethylamines, 400 grams or more.
4432
	896.101(5)(c) 1st Money laundering, financial instruments totaling or exceeding $100,000.
4433
	896.104(4)(a)3. 1st Structuring transactions to evade reporting or registration requirements, financial transactions totaling or exceeding $100,000.
4434
4435	(j)  LEVEL 10
4436
	FloridaStatute FelonyDegree Description
4437
	499.0051(10) 499.00545 1st Knowing sale or purchase of contraband prescription legend drugs resulting in death.
4438
	782.04(2) 1st,PBL Unlawful killing of human; act is homicide, unpremeditated.
4439
	787.01(1)(a)3. 1st,PBL Kidnapping; inflict bodily harm upon or terrorize victim.
4440
	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.
4441
	782.07(3) 1st Aggravated manslaughter of a child.
4442
	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.
4443
	812.135(2)(a) 1st,PBL Home-invasion robbery with firearm or other deadly weapon.
4444
	876.32 1st Treason against the state.
4445
4446	Section 44.  This act shall take effect July 1, 2008.

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