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)  A separate establishment permit is not required when a
2436	permitted prescription drug wholesale distributor:
2437	1.  Operates temporary transit storage facilities for the
2438	sole purpose of storage, for a period not to exceed 12 hours, of
2439	a delivery of prescription drugs when the wholesale distributor
2440	was temporarily unable to complete the delivery to the
2441	recipient; or
2442	2.  Uses a post office box or other address for billing,
2443	payment, or other administrative purposes.
2444	(d)(c)  The department shall require information from each
2445	wholesale distributor as part of the permit and renewal of such
2446	permit, as required under s. 499.01 or this section.
2447	(14)(9)  Personnel employed in wholesale distribution must
2448	have appropriate education and experience to enable them to
2449	perform their duties in compliance with state permitting
2450	requirements.
2451	(15)(10)  The name of a permittee or establishment on a
2452	prescription drug wholesale distributor wholesaler permit or an
2453	out-of-state prescription drug wholesale distributor wholesaler
2454	permit may not include any indicia of attainment of any
2455	educational degree, any indicia that the permittee or
2456	establishment possesses a professional license, or any name or
2457	abbreviation that the department determines is likely to cause
2458	confusion or mistake or that the department determines is
2459	deceptive, including that of any other entity authorized to
2460	purchase prescription drugs.
2461	(16)(11)(a)  Each establishment that is issued an initial
2462	or renewal permit as a prescription drug wholesale distributor
2463	wholesaler or an out-of-state prescription drug wholesale
2464	distributor wholesaler must designate in writing to the
2465	department at least one natural person to serve as the
2466	designated representative of the wholesale distributor
2467	wholesaler. Such person must have an active certification as a
2468	designated representative from the department.
2469	(b)  To be certified as a designated representative, a
2470	natural person must:
2471	1.  Submit an application on a form furnished by the
2472	department and pay the appropriate fees;
2473	2.  Be at least 18 years of age;
2474	3.  Have not less than 2 years of verifiable full-time work
2475	experience in a pharmacy licensed in this state or another
2476	state, where the person's responsibilities included, but were
2477	not limited to, recordkeeping for prescription drugs, or have
2478	not less than 2 years of verifiable full-time managerial
2479	experience with a prescription drug wholesale distributor
2480	wholesaler licensed in this state or in another state;
2481	4.  Receive a passing score of at least 75 percent on an
2482	examination given by the department regarding federal laws
2483	governing distribution of prescription drugs and this part ss.
2484	499.001-499.081 and the rules adopted by the department
2485	governing the wholesale distribution of prescription drugs. This
2486	requirement shall be effective 1 year after the results of the
2487	initial examination are mailed to the persons that took the
2488	examination. The department shall offer such examinations at
2489	least four times each calendar year; and
2490	5.  Provide the department with a personal information
2491	statement and fingerprints pursuant to subsection (9)(4).
2492	(c)  The department may deny an application for
2493	certification as a designated representative or may suspend or
2494	revoke a certification of a designated representative pursuant
2495	to s. 499.067.
2496	(d)  A designated representative:
2497	1.  Must be actively involved in and aware of the actual
2498	daily operation of the wholesale distributor.
2499	2.  Must be employed full time in a managerial position by
2500	the wholesale distributor.
2501	3.  Must be physically present at the establishment during
2502	normal business hours, except for time periods when absent due
2503	to illness, family illness or death, scheduled vacation, or
2504	other authorized absence.
2505	4.  May serve as a designated representative for only one
2506	wholesale distributor at any one time.
2507	(e)  A wholesale distributor must notify the department
2508	when a designated representative leaves the employ of the
2509	wholesale distributor. Such notice must be provided to the
2510	department within 10 business days after the last day of
2511	designated representative's employment with the wholesale
2512	distributor.
2513	(f)  A wholesale distributor may not operate under a
2514	prescription drug wholesale distributor wholesaler permit or an
2515	out-of-state prescription drug wholesale distributor wholesaler
2516	permit for more than 10 business days after the designated
2517	representative leaves the employ of the wholesale distributor,
2518	unless the wholesale distributor employs another designated
2519	representative and notifies the department within 10 business
2520	days of the identity of the new designated representative.
2521	Section 12.  Section 499.01201, Florida Statutes, is
2522	amended to read:
2523	499.01201  Agency for Health Care Administration review and
2524	use of statute and rule violation or compliance
2525	data.--Notwithstanding any other provisions of law to the
2526	contrary, the Agency for Health Care Administration may not:
2527	(1)  Review or use any violation or alleged violation of s.
2528	499.0121(6) or s. 499.01212, or any rules adopted under those
2529	sections that section, as a ground for denying or withholding
2530	any payment of a Medicaid reimbursement to a pharmacy licensed
2531	under chapter 465; or
2532	(2)  Review or use compliance with s. 499.0121(6) or s.
2533	499.01212, or any rules adopted under those sections that
2534	section, as the subject of any audit of Medicaid-related records
2535	held by a pharmacy licensed under chapter 465.
2536	Section 13.  Section 499.0121, Florida Statutes, is
2537	amended, and subsection (4) of section 499.013, Florida
2538	Statutes, is redesignated as paragraph (d) of subsection (6) of
2539	that section and amended, to read:
2540	499.0121  Storage and handling of prescription drugs;
2541	recordkeeping.--The department shall adopt rules to implement
2542	this section as necessary to protect the public health, safety,
2543	and welfare. Such rules shall include, but not be limited to,
2544	requirements for the storage and handling of prescription drugs
2545	and for the establishment and maintenance of prescription drug
2546	distribution records.
2547	(1)  ESTABLISHMENTS.--An establishment at which
2548	prescription drugs are stored, warehoused, handled, held,
2549	offered, marketed, or displayed must:
2550	(a)  Be of suitable size and construction to facilitate
2551	cleaning, maintenance, and proper operations;
2552	(b)  Have storage areas designed to provide adequate
2553	lighting, ventilation, temperature, sanitation, humidity, space,
2554	equipment, and security conditions;
2555	(c)  Have a quarantine area for storage of prescription
2556	drugs that are outdated, damaged, deteriorated, misbranded, or
2557	adulterated, or that are in immediate or sealed, secondary
2558	containers that have been opened;
2559	(d)  Be maintained in a clean and orderly condition; and
2560	(e)  Be free from infestation by insects, rodents, birds,
2561	or vermin of any kind.
2562	(2)  SECURITY.--
2563	(a)  An establishment that is used for wholesale drug
2564	distribution must be secure from unauthorized entry.
2565	1.  Access from outside the premises must be kept to a
2566	minimum and be well-controlled.
2567	2.  The outside perimeter of the premises must be well-
2568	lighted.
2569	3.  Entry into areas where prescription drugs are held must
2570	be limited to authorized personnel.
2571	(b)  An establishment that is used for wholesale drug
2572	distribution must be equipped with:
2573	1.  An alarm system to detect entry after hours; however,
2574	the department may exempt by rule establishments that only hold
2575	a permit as prescription drug wholesale distributor-brokers
2576	wholesaler-brokers and establishments that only handle medical
2577	oxygen; and
2578	2.  A security system that will provide suitable protection
2579	against theft and diversion. When appropriate, the security
2580	system must provide protection against theft or diversion that
2581	is facilitated or hidden by tampering with computers or
2582	electronic records.
2583	(c)  Any vehicle that contains prescription drugs must be
2584	secure from unauthorized access to the prescription drugs in the
2585	vehicle.
2586	(3)  STORAGE.--All prescription drugs shall be stored at
2587	appropriate temperatures and under appropriate conditions in
2588	accordance with requirements, if any, in the labeling of such
2589	drugs, or with requirements in the official compendium.
2590	(a)  If no storage requirements are established for a
2591	prescription drug, the drug may be held at "controlled" room
2592	temperature, as defined in the official compendium, to help
2593	ensure that its identity, strength, quality, and purity are not
2594	adversely affected.
2595	(b)  Appropriate manual, electromechanical, or electronic
2596	temperature and humidity recording equipment, devices, or logs
2597	must be used to document proper storage of prescription drugs.
2598	(c)  The recordkeeping requirements in subsection (6) must
2599	be followed for all stored prescription drugs.
2600	(4)  EXAMINATION OF MATERIALS AND RECORDS.--
2601	(a)  Upon receipt, each outside shipping container must be
2602	visually examined for identity and to prevent the acceptance of
2603	contaminated prescription drugs that are otherwise unfit for
2604	distribution. This examination must be adequate to reveal
2605	container damage that would suggest possible contamination or
2606	other damage to the contents.
2607	(b)  Each outgoing shipment must be carefully inspected for
2608	identity of the prescription drug products and to ensure that
2609	there is no delivery of prescription drugs that have expired or
2610	been damaged in storage or held under improper conditions.
2611	(c)  The recordkeeping requirements in subsection (6) must
2612	be followed for all incoming and outgoing prescription drugs.
2613	(d)  Upon receipt, a wholesale distributor wholesaler must
2614	review records required under this section for the acquisition
2615	of prescription drugs for accuracy and completeness, considering
2616	the total facts and circumstances surrounding the transactions
2617	and the wholesale distributors involved. This includes
2618	authenticating each transaction listed on a pedigree paper, as
2619	defined in s. 499.003(37) s. 499.001(31).
2620	(5)  RETURNED, DAMAGED, OR OUTDATED PRESCRIPTION DRUGS.--
2621	(a)1.  Prescription drugs that are outdated, damaged,
2622	deteriorated, misbranded, or adulterated must be quarantined and
2623	physically separated from other prescription drugs until they
2624	are destroyed or returned to their supplier. A quarantine
2625	section must be separate and apart from other sections where
2626	prescription drugs are stored so that prescription drugs in this
2627	section are not confused with usable prescription drugs.
2628	2.  Prescription drugs must be examined at least every 12
2629	months, and drugs for which the expiration date has passed must
2630	be removed and quarantined.
2631	(b)  Any prescription drugs of which the immediate or
2632	sealed outer containers or sealed secondary containers have been
2633	opened or used must be identified as such and must be
2634	quarantined and physically separated from other prescription
2635	drugs until they are either destroyed or returned to the
2636	supplier.
2637	(c)  If the conditions under which a prescription drug has
2638	been returned cast doubt on the drug's safety, identity,
2639	strength, quality, or purity, the drug must be destroyed or
2640	returned to the supplier, unless examination, testing, or other
2641	investigation proves that the drug meets appropriate standards
2642	of safety, identity, strength, quality, and purity. In
2643	determining whether the conditions under which a drug has been
2644	returned cast doubt on the drug's safety, identity, strength,
2645	quality, or purity, the wholesale drug distributor must
2646	consider, among other things, the conditions under which the
2647	drug has been held, stored, or shipped before or during its
2648	return and the conditions of the drug and its container, carton,
2649	or labeling, as a result of storage or shipping.
2650	(d)  The recordkeeping requirements in subsection (6) must
2651	be followed for all outdated, damaged, deteriorated, misbranded,
2652	or adulterated prescription drugs.
2653	(6)  RECORDKEEPING.--The department shall adopt rules that
2654	require keeping such records of prescription drugs as are
2655	necessary for the protection of the public health.
2656	(a)  Wholesale drug distributors must establish and
2657	maintain inventories and records of all transactions regarding
2658	the receipt and distribution or other disposition of
2659	prescription drugs. These records must provide a complete audit
2660	trail from receipt to sale or other disposition, be readily
2661	retrievable for inspection, and include, at a minimum, the
2662	following information:
2663	1.  The source of the drugs, including the name and
2664	principal address of the seller or transferor, and the address
2665	of the location from which the drugs were shipped;
2666	2.  The name, principal address, and state license permit
2667	or registration number of the person authorized to purchase
2668	prescription drugs;
2669	3.  The name, strength, dosage form, and quantity of the
2670	drugs received and distributed or disposed of;
2671	4.  The dates of receipt and distribution or other
2672	disposition of the drugs; and
2673	5.  Any financial documentation supporting the transaction.
2674	(b)  Inventories and records must be made available for
2675	inspection and photocopying by authorized federal, state, or
2676	local officials for a period of 2 years following disposition of
2677	the drugs or 3 years after the creation of the records,
2678	whichever period is longer.
2679	(c)  Records described in this section that are kept at the
2680	inspection site or that can be immediately retrieved by computer
2681	or other electronic means must be readily available for
2682	authorized inspection during the retention period. Records that
2683	are kept at a central location outside of this state and that
2684	are not electronically retrievable must be made available for
2685	inspection within 2 working days after a request by an
2686	authorized official of a federal, state, or local law
2687	enforcement agency. Records that are maintained at a central
2688	location within this state must be maintained at an
2689	establishment that is permitted pursuant to this part ss.
2690	499.001-499.081 and must be readily available.
2691	(d)(4)  Each manufacturer or repackager of medical devices,
2692	over-the-counter drugs, or cosmetics must maintain records that
2693	include the name and principal address of the seller or
2694	transferor of the product, the address of the location from
2695	which the product was shipped, the date of the transaction, the
2696	name and quantity of the product involved, and the name and
2697	principal address of the person who purchased the product.
2698	(e)  A wholesale distributor must maintain pedigree papers
2699	separate and distinct from other records required under this
2700	chapter.
2701	(d)1. Effective July 1, 2006, each person who is engaged in
2702	the wholesale distribution of a prescription drug and who is not
2703	the manufacturer of that drug must, before each wholesale
2704	distribution of such drug, provide to the person who receives
2705	the drug a pedigree paper as defined in s. 499.003(31).
2706	2.  A repackager must comply with this paragraph.
2707	3.  The pedigree paper requirements in this paragraph do
2708	not apply to compressed medical gases or veterinary legend
2709	drugs.
2710	4.  Each wholesale distributor of prescription drugs must
2711	maintain separate and distinct from other required records all
2712	statements that are required under subparagraph 1.
2713	5.  Subparagraph 1. is satisfied when a wholesale
2714	distributor takes title to, but not possession of, a
2715	prescription drug and the prescription drug's manufacturer ships
2716	the prescription drug directly to a person authorized by law to
2717	purchase prescription drugs for the purpose of administering or
2718	dispensing the drug, as defined in s. 465.003, or a member of an
2719	affiliated group, as described in paragraph (f), with the
2720	exception of a repackager.
2721	a.  The wholesale distributor must deliver to the recipient
2722	of the prescription drug, within 14 days after the shipment
2723	notification from the manufacturer, an invoice and the following
2724	sworn statement: "This wholesale distributor purchased the
2725	specific unit of the prescription drug listed on the invoice
2726	directly from the manufacturer, and the specific unit of
2727	prescription drug was shipped by the manufacturer directly to a
2728	person authorized by law to administer or dispense the legend
2729	drug, as defined in s. 465.003, Florida Statutes, or a member of
2730	an affiliated group, as described in s. 499.0121(6)(f), Florida
2731	Statutes, with the exception of a repackager." The invoice must
2732	contain a unique cross-reference to the shipping document sent
2733	by the manufacturer to the recipient of the prescription drug.
2734	b.  The manufacturer of the prescription drug shipped
2735	directly to the recipient under this section must provide and
2736	the recipient of the prescription drug must acquire, within 14
2737	days after receipt of the prescription drug, a shipping document
2738	from the manufacturer that contains, at a minimum:
2739	(I)  The name and address of the manufacturer, including
2740	the point of origin of the shipment, and the names and addresses
2741	of the wholesaler and the purchaser.
2742	(II)  The name of the prescription drug as it appears on
2743	the label.
2744	(III)  The quantity, dosage form, and strength of the
2745	prescription drug.
2746	(IV)  The date of the shipment from the manufacturer.
2747	c.  The wholesale distributor must also maintain and make
2748	available to the department, upon request, the lot number of
2749	such drug if not contained in the shipping document acquired by
2750	the recipient.
2751	6.  Failure of the manufacturer to provide, the recipient
2752	to acquire, or the wholesale distributor to deliver, the
2753	documentation required under subparagraph 5. shall constitute
2754	failure to acquire or deliver a pedigree paper under s.
2755	499.0051. Forgery by the manufacturer, the recipient, or the
2756	wholesale distributor of the documentation required to be
2757	acquired or delivered under subparagraph 5. shall constitute
2758	forgery of a pedigree paper under s. 499.0051.
2759	7.  The department may, by rule, specify alternatives to
2760	compliance with subparagraph 1. for a prescription drug in the
2761	inventory of a permitted prescription drug wholesaler as of June
2762	30, 2006, and the return of a prescription drug purchased prior
2763	to July 1, 2006. The department may specify time limits for such
2764	alternatives.
2765	(7)(e)  PRESCRIPTION DRUG PURCHASE LIST.--Each wholesale
2766	distributor, except for a manufacturer, shall annually provide
2767	the department with a written list of all wholesale distributors
2768	and manufacturers from whom the wholesale distributor purchases
2769	prescription drugs. A wholesale distributor, except a
2770	manufacturer, shall notify the department not later than 10 days
2771	after any change to either list. Such portions of the
2772	information required pursuant to this subsection paragraph which
2773	are a trade secret, as defined in s. 812.081, shall be
2774	maintained by the department as trade secret information is
2775	required to be maintained under s. 499.051.
2776	(f)1.  This paragraph applies only to an affiliated group,
2777	as defined by s. 1504 of the Internal Revenue Code of 1986, as
2778	amended, which is composed of chain drug entities, including at
2779	least 50 retail pharmacies, warehouses, or repackagers, which
2780	are members of the same affiliated group, if the affiliated
2781	group:
2782	a.  Discloses to the department the names of all its
2783	members; and
2784	b.  Agrees in writing to provide records on prescription
2785	drug purchases by members of the affiliated group not later than
2786	48 hours after the department requests such records, regardless
2787	of the location where the records are stored.
2788	2.  Each warehouse within the affiliated group must comply
2789	with all applicable federal and state drug wholesale permit
2790	requirements and must purchase, receive, hold, and distribute
2791	prescription drugs only to a retail pharmacy or warehouse within
2792	the affiliated group. Such a warehouse is exempt from providing
2793	a pedigree paper in accordance with paragraph (d) to its
2794	affiliated group member warehouse or retail pharmacy, provided
2795	that:
2796	a.  Any affiliated group member that purchases or receives
2797	a prescription drug from outside the affiliated group must
2798	receive a pedigree paper if the prescription drug is distributed
2799	in or into this state and a pedigree paper is required under
2800	this section and must authenticate the documentation as required
2801	in subsection (4), regardless of whether the affiliated group
2802	member is directly subject to regulation under this chapter; and
2803	b.  The affiliated group makes available to the department
2804	on request all records related to the purchase or acquisition of
2805	prescription drugs by members of the affiliated group,
2806	regardless of the location where the records are stored, if the
2807	prescription drugs were distributed in or into this state.
2808	3.  If a repackager repackages prescription drugs solely
2809	for distribution to its affiliated group members for the
2810	exclusive distribution to and among retail pharmacies that are
2811	members of the affiliated group to which the repackager is a
2812	member:
2813	a.  The repackager must:
2814	(I)  In lieu of the written statement required by paragraph
2815	(d), for all repackaged prescription drugs distributed in or
2816	into this state, state in writing under oath with each
2817	distribution of a repackaged prescription drug to an affiliated
2818	group member warehouse or repackager: "All repackaged
2819	prescription drugs are purchased by the affiliated group
2820	directly from the manufacturer or from a prescription drug
2821	wholesaler that purchased the prescription drugs directly from
2822	the manufacturer.";
2823	(II)  Purchase all prescription drugs it repackages:
2824	(A)  Directly from the manufacturer; or
2825	(B)  From a prescription drug wholesaler that purchased the
2826	prescription drugs directly from the manufacturer; and
2827	(III)  Maintain records in accordance with this section to
2828	document that it purchased the prescription drugs directly from
2829	the manufacturer or that its prescription drug wholesale
2830	supplier purchased the prescription drugs directly from the
2831	manufacturer.
2832	b.  All members of the affiliated group must provide to
2833	agents of the department on request records of purchases by all
2834	members of the affiliated group of prescription drugs that have
2835	been repackaged, regardless of the location where the records
2836	are stored or where the repackager is located.
2837	(8)(7)  WRITTEN POLICIES AND PROCEDURES.--Wholesale drug
2838	distributors must establish, maintain, and adhere to written
2839	policies and procedures, which must be followed for the receipt,
2840	security, storage, inventory, and distribution of prescription
2841	drugs, including policies and procedures for identifying,
2842	recording, and reporting losses or thefts, and for correcting
2843	all errors and inaccuracies in inventories. Wholesale drug
2844	distributors must include in their written policies and
2845	procedures:
2846	(a)  A procedure whereby the oldest approved stock of a
2847	prescription drug product is distributed first. The procedure
2848	may permit deviation from this requirement, if the deviation is
2849	temporary and appropriate.
2850	(b)  A procedure to be followed for handling recalls and
2851	withdrawals of prescription drugs. Such procedure must be
2852	adequate to deal with recalls and withdrawals due to:
2853	1.  Any action initiated at the request of the Food and
2854	Drug Administration or any other federal, state, or local law
2855	enforcement or other government agency, including the
2856	department.
2857	2.  Any voluntary action by the manufacturer or repackager
2858	to remove defective or potentially defective drugs from the
2859	market; or
2860	3.  Any action undertaken to promote public health and
2861	safety by replacing existing merchandise with an improved
2862	product or new package design.
2863	(c)  A procedure to ensure that wholesale drug distributors
2864	prepare for, protect against, and handle any crisis that affects
2865	security or operation of any facility if a strike, fire, flood,
2866	or other natural disaster, or a local, state, or national
2867	emergency, occurs.
2868	(d)  A procedure to ensure that any outdated prescription
2869	drugs are segregated from other drugs and either returned to the
2870	manufacturer or repackager or destroyed. This procedure must
2871	provide for written documentation of the disposition of outdated
2872	prescription drugs. This documentation must be maintained for 2
2873	years after disposition of the outdated drugs.
2874	(9)(8)  RESPONSIBLE PERSONS.--Wholesale drug distributors
2875	must establish and maintain lists of officers, directors,
2876	managers, designated representatives, and other persons in
2877	charge of wholesale drug distribution, storage, and handling,
2878	including a description of their duties and a summary of their
2879	qualifications.
2880	(10)(9)  COMPLIANCE WITH FEDERAL, STATE, AND LOCAL LAW.--A
2881	wholesale drug distributor must operate in compliance with
2882	applicable federal, state, and local laws and regulations.
2883	(a)  A wholesale drug distributor must allow the department
2884	and authorized federal, state, and local officials to enter and
2885	inspect its premises and delivery vehicles, and to audit its
2886	records and written operating procedures, at reasonable times
2887	and in a reasonable manner, to the extent authorized by law.
2888	(b)  A wholesale drug distributor that deals in controlled
2889	substances must register with the Drug Enforcement
2890	Administration and must comply with all applicable state, local,
2891	and federal laws. A wholesale drug distributor that distributes
2892	any substance controlled under chapter 893 must notify the
2893	department when registering with the Drug Enforcement
2894	Administration pursuant to that chapter and must provide the
2895	department with its DEA number.
2896	(11)(10)  SALVAGING AND REPROCESSING.--A wholesale drug
2897	distributor is subject to any applicable federal, state, or
2898	local laws or regulations that relate to prescription drug
2899	product salvaging or reprocessing.
2900	(12)(11)  SHIPPING AND TRANSPORTATION.--The person
2901	responsible for shipment and transportation of a prescription
2902	drug in a wholesale distribution may use a common carrier; its
2903	own vehicle or employee acting within the scope of employment if
2904	authorized under s. 499.03 for the possession of prescription
2905	drugs in this state; or, in the case of a prescription drug
2906	intended for domestic distribution, an independent contractor
2907	who must be the agent of the authorized seller or recipient
2908	responsible for shipping and transportation as set forth in a
2909	written contract between the parties. A person selling a
2910	prescription drug for export must obtain documentation, such as
2911	a validated airway bill, bill of lading, or other appropriate
2912	documentation that the prescription drug was exported. A person
2913	responsible for shipping or transporting prescription drugs is
2914	not required to maintain documentation from a common carrier
2915	that the designated recipient received the prescription drugs;
2916	however, the person must obtain such documentation from the
2917	common carrier and make it available to the department upon
2918	request of the department.
2919	(13)(12)  DUE DILIGENCE OF SUPPLIERS.--Prior to purchasing
2920	any prescription drugs from another wholesale drug distributor,
2921	a prescription drug wholesale distributor wholesaler, an out-of-
2922	state prescription drug wholesale distributor wholesaler, or a
2923	prescription drug repackager must:
2924	(a)  Enter an agreement with the selling wholesale drug
2925	distributor by which the selling wholesale drug distributor will
2926	indemnify the purchasing wholesale drug distributor for any loss
2927	caused to the purchasing wholesale drug distributor related to
2928	the purchase of drugs from the selling wholesale drug
2929	distributor which are determined to be counterfeit or to have
2930	been distributed in violation of any federal or state law
2931	governing the distribution of drugs.
2932	(b)  Determine that the selling wholesale drug distributor
2933	has insurance coverage of not less than the greater of 1 percent
2934	of the amount of total dollar volume of the prescription drug
2935	sales reported to the department under s. 499.012(8)(g) s.
2936	499.012(3)(g) or $500,000; however the coverage need not exceed
2937	$2 million.
2938	(c)  Obtain information from the selling wholesale drug
2939	distributor, including the length of time the selling wholesale
2940	drug distributor has been licensed in this state, a copy of the
2941	selling wholesale drug distributor's licenses or permits, and
2942	background information concerning the ownership of the selling
2943	wholesale drug distributor, including the experience of the
2944	wholesale distributor in the wholesale distribution of
2945	prescription drugs.
2946	(d)  Verify that the selling wholesale drug distributor's
2947	Florida permit is valid.
2948	(e)  Inspect the selling wholesale drug distributor's
2949	licensed establishment to document that it has a policies and
2950	procedures manual relating to the distribution of drugs, the
2951	appropriate temperature controlled environment for drugs
2952	requiring temperature control, an alarm system, appropriate
2953	access restrictions, and procedures to ensure that records
2954	related to the wholesale distribution of prescription drugs are
2955	maintained as required by law:
2956	1.  Before purchasing any drug from the wholesale drug
2957	distributor, and at least once each subsequent year; or
2958	2.  Before purchasing any drug from the wholesale drug
2959	distributor, and each subsequent year obtain a complete copy of
2960	the most recent inspection report for the establishment which
2961	was prepared by the department or the regulatory authority
2962	responsible for wholesale drug distributors in the state in
2963	which the establishment is located.
2964	Section 14.  Section 499.01211, Florida Statutes, is
2965	amended to read:
2966	499.01211  Drug Wholesale Distributor Wholesaler Advisory
2967	Council.--
2968	(1)  There is created the Drug Wholesale Distributor
2969	Wholesaler Advisory Council within the department. The council
2970	shall meet at least once each calendar quarter. Staff for the
2971	council shall be provided by the department. The council shall
2972	consist of 11 members who shall serve without compensation. The
2973	council shall elect a chairperson and a vice chairperson
2974	annually.
2975	(2)  The State Surgeon General, or his or her designee, and
2976	the Secretary of Health Care Administration, or her or his
2977	designee, shall be members of the council. The State Surgeon
2978	General shall appoint nine additional members to the council who
2979	shall be appointed to a term of 4 years each, as follows:
2980	(a)  Three different persons each of whom is employed by a
2981	different prescription drug wholesale distributor wholesaler
2982	licensed under this part chapter which operates nationally and
2983	is a primary wholesale distributor wholesaler, as defined in s.
2984	499.003(48) s. 499.012(1)(d).
2985	(b)  One person employed by a prescription drug wholesale
2986	distributor wholesaler licensed under this part chapter which is
2987	a secondary wholesale distributor wholesaler, as defined in s.
2988	499.003(53) s. 499.012(1)(f).
2989	(c)  One person employed by a retail pharmacy chain located
2990	in this state.
2991	(d)  One person who is a member of the Board of Pharmacy
2992	and is a pharmacist licensed under chapter 465.
2993	(e)  One person who is a physician licensed pursuant to
2994	chapter 458 or chapter 459.
2995	(f)  One person who is an employee of a hospital licensed
2996	pursuant to chapter 395 and is a pharmacist licensed pursuant to
2997	chapter 465.
2998	(g)  One person who is an employee of a pharmaceutical
2999	manufacturer.
3000	(3)  The council shall review this part ss. 499.001-499.081
3001	and the rules adopted to administer this part ss. 499.001-
3002	499.081 annually, provide input to the department regarding all
3003	proposed rules to administer this part ss. 499.001-499.081, make
3004	recommendations to the department to improve the protection of
3005	the prescription drugs and public health, make recommendations
3006	to improve coordination with other states' regulatory agencies
3007	and the federal government concerning the wholesale distribution
3008	of drugs, and make recommendations to minimize the impact of
3009	regulation of the wholesale distribution industry while ensuring
3010	protection of the public health.
3011	Section 15.  Section 499.01212, Florida Statutes, is
3012	created to read:
3013	499.01212  Pedigree paper.--
3014	(1)  APPLICATION.--Each person who is engaged in the
3015	wholesale distribution of a prescription drug must, prior to or
3016	simultaneous with each wholesale distribution, provide a
3017	pedigree paper to the person who receives the drug.
3018	(2)  FORMAT.--A pedigree paper must contain the following
3019	information:
3020	(a)  For the wholesale distribution of a prescription drug
3021	within the normal distribution chain:
3022	1.  The following statement: "This wholesale distributor
3023	purchased the specific unit of the prescription drug directly
3024	from the manufacturer."
3025	2.  The name of the prescription drug as it appears on the
3026	label.
3027	3.  The quantity, dosage form, and strength of the
3028	prescription drug.
3029
3030	The wholesale distributor must also maintain and make available
3031	to the department, upon request, the point of origin of the
3032	prescription drugs, including intracompany transfers, the date
3033	of the shipment from the manufacturer to the wholesale
3034	distributor, the lot numbers of such drugs, and the invoice
3035	numbers from the manufacturer.
3036	(b)  For all other wholesale distributions of prescription
3037	drugs:
3038	1.  The quantity, dosage form, and strength of the
3039	prescription drugs.
3040	2.  The lot numbers of the prescription drugs.
3041	3.  The name and address of each owner of the prescription
3042	drug and his or her signature.
3043	4.  Shipping information, including the name and address of
3044	each person certifying delivery or receipt of the prescription
3045	drug.
3046	5.  An invoice number, a shipping document number, or
3047	another number uniquely identifying the transaction.
3048	6.  A certification that the recipient wholesale
3049	distributor has authenticated the pedigree papers.
3050	7.  The unique serialization of the prescription drug, if
3051	the manufacturer or repackager has uniquely serialized the
3052	individual prescription drug unit.
3053	8.  The name, address, telephone number, and, if available,
3054	e-mail contact information of each wholesale distributor
3055	involved in the chain of the prescription drug's custody.
3056	(3)  EXCEPTIONS.--A pedigree paper is not required for:
3057	(a)  The wholesale distribution of a prescription drug by
3058	the manufacturer.
3059	(b)  The wholesale distribution of a compressed medical
3060	gas.
3061	(c)  The wholesale distribution of a veterinary
3062	prescription drug.
3063	(d)  A drop shipment, provided:
3064	1.  The wholesale distributor delivers to the recipient of
3065	the prescription drug, within 14 days after the shipment
3066	notification from the manufacturer, an invoice and the following
3067	sworn statement: "This wholesale distributor purchased the
3068	specific unit of the prescription drug listed on the invoice
3069	directly from the manufacturer, and the specific unit of
3070	prescription drug was shipped by the manufacturer directly to a
3071	person authorized by law to administer or dispense the legend
3072	drug, as defined in s. 465.003, Florida Statutes, or a member of
3073	an affiliated group, with the exception of a repackager." The
3074	invoice must contain a unique cross-reference to the shipping
3075	document sent by the manufacturer to the recipient of the
3076	prescription drug.
3077	2.  The manufacturer of the prescription drug shipped
3078	directly to the recipient provides and the recipient of the
3079	prescription drug acquires, within 14 days after receipt of the
3080	prescription drug, a shipping document from the manufacturer
3081	that contains, at a minimum:
3082	a.  The name and address of the manufacturer, including the
3083	point of origin of the shipment, and the names and addresses of
3084	the wholesale distributor and the purchaser.
3085	b.  The name of the prescription drug as it appears on the
3086	label.
3087	c.  The quantity, dosage form, and strength of the
3088	prescription drug.
3089	d.  The date of the shipment from the manufacturer.
3090	3.  The wholesale distributor maintains and makes available
3091	to the department, upon request, the lot number of such drug if
3092	not contained in the shipping document acquired by the
3093	recipient.
3094
3095	Failure of the manufacturer to provide, the recipient to
3096	acquire, or the wholesale distributor to deliver the
3097	documentation required under this paragraph shall constitute
3098	failure to acquire or deliver a pedigree paper under ss.
3099	499.005(28) and 499.0051. Forgery by the manufacturer, the
3100	recipient, or the wholesale distributor of the documentation
3101	required to be acquired or delivered under this paragraph shall
3102	constitute forgery of a pedigree paper under s. 499.0051.
3103	4.  The wholesale distributor that takes title to, but not
3104	possession of, the prescription drug is not a member of the
3105	affiliated group that receives the prescription drug directly
3106	from the manufacturer.
3107	(e)  The wholesale distribution of a prescription drug by a
3108	warehouse within an affiliated group to a warehouse or retail
3109	pharmacy within its affiliated group, provided:
3110	1.  Any affiliated group member that purchases or receives
3111	a prescription drug from outside the affiliated group must
3112	receive a pedigree paper if the prescription drug is distributed
3113	in or into this state and a pedigree paper is required under
3114	this section and must authenticate the documentation as required
3115	in s. 499.0121(4), regardless of whether the affiliated group
3116	member is directly subject to regulation under this part; and
3117	2.  The affiliated group makes available, within 48 hours,
3118	to the department on request to one or more of its members all
3119	records related to the purchase or acquisition of prescription
3120	drugs by members of the affiliated group, regardless of the
3121	location where the records are stored, if the prescription drugs
3122	were distributed in or into this state.
3123	(f)  The repackaging of prescription drugs by a repackager
3124	solely for distribution to its affiliated group members for the
3125	exclusive distribution to and among retail pharmacies that are
3126	members of the affiliated group to which the repackager is a
3127	member.
3128	1.  The repackager must:
3129	a.  For all repackaged prescription drugs distributed in or
3130	into this state, state in writing under oath with each
3131	distribution of a repackaged prescription drug to an affiliated
3132	group member warehouse or repackager: "All repackaged
3133	prescription drugs are purchased by the affiliated group
3134	directly from the manufacturer or from a prescription drug
3135	wholesale distributor that purchased the prescription drugs
3136	directly from the manufacturer."
3137	b.  Purchase all prescription drugs it repackages:
3138	(I)  Directly from the manufacturer; or
3139	(II)  From a prescription drug wholesale distributor that
3140	purchased the prescription drugs directly from the manufacturer.
3141	c.  Maintain records in accordance with this section to
3142	document that it purchased the prescription drugs directly from
3143	the manufacturer or that its prescription drug wholesale
3144	supplier purchased the prescription drugs directly from the
3145	manufacturer.
3146	2.  All members of the affiliated group must provide,
3147	within 48 hours, to agents of the department on request to one
3148	or more of its members records of purchases by all members of
3149	the affiliated group of prescription drugs that have been
3150	repackaged, regardless of the location at which the records are
3151	stored or at which the repackager is located.
3152	Section 16.  Section 499.0122, Florida Statutes, is
3153	repealed.
3154	Section 17.  Section 499.013, Florida Statutes, is
3155	repealed.
3156	Section 18.  Subsections (1), (3), (4), (6), (8), and (9)
3157	of section 499.015, Florida Statutes, are amended to read:
3158	499.015  Registration of drugs, devices, and cosmetics;
3159	issuance of certificates of free sale.--
3160	(1)(a)  Except for those persons exempted from the
3161	definition of manufacturer in s. 499.003(32) s. 499.003(28), any
3162	person who manufactures, packages, repackages, labels, or
3163	relabels a drug, device, or cosmetic in this state must register
3164	such drug, device, or cosmetic biennially with the department;
3165	pay a fee in accordance with the fee schedule provided by s.
3166	499.041; and comply with this section. The registrant must list
3167	each separate and distinct drug, device, or cosmetic at the time
3168	of registration.
3169	(b)  The department may not register any product that does
3170	not comply with the Federal Food, Drug, and Cosmetic Act, as
3171	amended, or Title 21 C.F.R. Registration of a product by the
3172	department does not mean that the product does in fact comply
3173	with all provisions of the Federal Food, Drug, and Cosmetic Act,
3174	as amended.
3175	(3)  Except for those persons exempted from the definition
3176	of manufacturer in s. 499.003(32) s. 499.003(28), a person may
3177	not sell any product that he or she has failed to register in
3178	conformity with this section. Such failure to register subjects
3179	such drug, device, or cosmetic product to seizure and
3180	condemnation as provided in s. 499.062 ss. 499.062-499.064, and
3181	subjects such person to the penalties and remedies provided in
3182	this part ss. 499.001-499.081.
3183	(4)  Unless a registration is renewed, it expires 2 years
3184	after the last day of the month in which it was issued. The
3185	department may issue a stop-sale notice or order against a
3186	person that is subject to the requirements of this section and
3187	that fails to comply with this section within 31 days after the
3188	date the registration expires. The notice or order shall
3189	prohibit such person from selling or causing to be sold any
3190	drugs, devices, or cosmetics covered by this part ss. 499.001-
3191	499.081 until he or she complies with the requirements of this
3192	section.
3193	(6)  The department may issue a certificate of free sale
3194	for any product that is required to be registered under this
3195	part ss. 499.001-499.081.
3196	(8)  Notwithstanding any requirements set forth in this
3197	part ss. 499.001-499.081, a manufacturer of medical devices that
3198	is registered with the federal Food and Drug Administration is
3199	exempt from this section and s. 499.041(6) if:
3200	(a)  The manufacturer's medical devices are approved for
3201	marketing by, or listed with the federal Food and Drug
3202	Administration in accordance with federal law for commercial
3203	distribution; or
3204	(b)  The manufacturer subcontracts with a manufacturer of
3205	medical devices to manufacture components of such devices.
3206	(9)  However, the manufacturer must submit evidence of such
3207	registration, listing, or approval with its initial application
3208	for a permit to do business in this state, as required in s.
3209	499.01 s. 499.013 and any changes to such information previously
3210	submitted at the time of renewal of the permit. Evidence of
3211	approval, listing, and registration by the federal Food and Drug
3212	Administration must include:
3213	(a)  For Class II devices, a copy of the pre-market
3214	notification letter (510K);
3215	(b)  For Class III devices, a Federal Drug Administration
3216	pre-market approval number;
3217	(c)  For a manufacturer who subcontracts with a
3218	manufacturer of medical devices to manufacture components of
3219	such devices, a Federal Drug Administration registration number;
3220	or
3221	(d)  For a manufacturer of medical devices whose devices
3222	are exempt from pre-market approval by the Federal Drug
3223	Administration, a Federal Drug Administration registration
3224	number.
3225	Section 19.  Subsections (3), (5), and (6) of section
3226	499.024, Florida Statutes, are amended to read:
3227	499.024  Drug product classification.--The State Surgeon
3228	General shall adopt rules to classify drug products intended for
3229	use by humans which the United States Food and Drug
3230	Administration has not classified in the federal act or the Code
3231	of Federal Regulations.
3232	(3)  Any product that falls under the definition of drug in
3233	s. 499.003(19) definition, s. 499.003(17), may be classified
3234	under the authority of this section. This section does not
3235	subject portable emergency oxygen inhalators to classification;
3236	however, this section does not exempt any person from ss. 499.01
3237	and 499.015.
3238	(5)  The department may by rule reclassify drugs subject to
3239	this part ss. 499.001-499.081 when such classification action is
3240	necessary to protect the public health.
3241	(6)  The department may adopt rules that exempt from any
3242	labeling or packaging requirements of this part ss. 499.001-
3243	499.081 drugs classified under this section if those
3244	requirements are not necessary to protect the public health.
3245	Section 20.  Subsections (7), (12), and (15) of section
3246	499.028, Florida Statutes, are amended to read:
3247	499.028  Drug samples or complimentary drugs; starter
3248	packs; permits to distribute.--
3249	(7)  A drug manufacturer or distributor must report to the
3250	department any conviction of itself or of its assigns, agents,
3251	employees, or representatives for a violation of s. 503(c)(1) of
3252	the federal act or of this part ss. 499.001-499.081 because of
3253	the sale, purchase, or trade of a drug sample or the offer to
3254	sell, purchase, or trade a drug sample.
3255	(12)  The department may suspend or revoke a permit issued
3256	under this section, after giving notice and an opportunity to be
3257	heard pursuant to chapter 120, when:
3258	(a)  Such permit was obtained by misrepresentation or fraud
3259	or through a mistake of the department.
3260	(b)  The holder of the permit has distributed or disposed
3261	of any prescription legend drug, directly or through its agents,
3262	employees, or independent contractors, to any person not
3263	authorized to possess such drug.
3264	(c)  The holder of the permit, or its agents, employees, or
3265	independent contractors, has distributed or possessed any
3266	prescription legend drug except in the usual course of its
3267	business.
3268	(d)  The holder of the permit, or its agents, employees, or
3269	independent contractors, has distributed any prescription legend
3270	drug that is misbranded or adulterated under this part ss.
3271	499.001-499.081.
3272	(e)  The holder of the permit, or its agents, employees, or
3273	independent contractors, has distributed any prescription legend
3274	drug without written request, when a written request is required
3275	by this section.
3276	(f)  The holder of the permit has in its employ, or uses as
3277	agent or independent contractor for the purpose of distributing
3278	or disposing of drugs, any person who has:
3279	1.  Violated the requirements of this section or any rule
3280	adopted under this section.
3281	2.  Been convicted in any of the courts of this state, the
3282	United States, or any other state of a felony or any other crime
3283	involving moral turpitude or involving those drugs named or
3284	described in chapter 893.
3285	(15)  A person may not possess a prescription drug sample
3286	unless:
3287	(a)  The drug sample was prescribed to her or him as
3288	evidenced by the label required in s. 465.0276(5).
3289	(b)  She or he is the employee of a complimentary drug
3290	distributor that holds a permit issued under this part ss.
3291	499.001-499.081.
3292	(c)  She or he is a person to whom prescription drug
3293	samples may be distributed pursuant to this section.
3294	(d)  He or she is an officer or employee of a federal,
3295	state, or local government acting within the scope of his or her
3296	employment.
3297	Section 21.  Subsections (2) and (3) of section 499.029,
3298	Florida Statutes, are amended to read:
3299	499.029  Cancer Drug Donation Program.--
3300	(2)  There is created a Cancer Drug Donation Program within
3301	the department of Health for the purpose of authorizing and
3302	facilitating the donation of cancer drugs and supplies to
3303	eligible patients.
3304	(3)  As used in this section:
3305	(a)  "Cancer drug" means a prescription drug that has been
3306	approved under s. 505 of the federal Food, Drug, and Cosmetic
3307	Act and is used to treat cancer or its side effects or is used
3308	to treat the side effects of a prescription drug used to treat
3309	cancer or its side effects. "Cancer drug" does not include a
3310	substance listed in Schedule II, Schedule III, Schedule IV, or
3311	Schedule V of s. 893.03.
3312	(b)  "Closed drug delivery system" means a system in which
3313	the actual control of the unit-dose medication package is
3314	maintained by the facility rather than by the individual
3315	patient.
3316	(c)  "Department" means the Department of Health.
3317	(c)(d)  "Donor" means a patient or patient representative
3318	who donates cancer drugs or supplies needed to administer cancer
3319	drugs that have been maintained within a closed drug delivery
3320	system; health care facilities, nursing homes, hospices, or
3321	hospitals with closed drug delivery systems; or pharmacies, drug
3322	manufacturers, medical device manufacturers or suppliers, or
3323	wholesalers of drugs or supplies, in accordance with this
3324	section. "Donor" includes a physician licensed under chapter 458
3325	or chapter 459 who receives cancer drugs or supplies directly
3326	from a drug manufacturer, wholesale distributor drug wholesaler,
3327	or pharmacy.
3328	(d)(e)  "Eligible patient" means a person who the
3329	department determines is eligible to receive cancer drugs from
3330	the program.
3331	(e)(k)  "Participant facility" means a class II hospital
3332	pharmacy that has elected to participate in the program and that
3333	accepts donated cancer drugs and supplies under the rules
3334	adopted by the department for the program.
3335	(o)  "Prescription drug" means a drug as defined in s.
3336	465.003(8).
3337	(f)(p)  "Program" means the Cancer Drug Donation Program
3338	created by this section.
3339	(g)(q)  "Supplies" means any supplies used in the
3340	administration of a cancer drug.
3341	Section 22.  Subsection (1) of section 499.03, Florida
3342	Statutes, is amended to read:
3343	499.03  Possession of certain drugs without prescriptions
3344	unlawful; exemptions and exceptions.--
3345	(1)  A person may not possess, or possess with intent to
3346	sell, dispense, or deliver, any habit-forming, toxic, harmful,
3347	or new drug subject to s. 499.003(33) s. 499.003(29), or
3348	prescription legend drug as defined in s. 499.003(44) s.
3349	499.003(25), unless the possession of the drug has been obtained
3350	by a valid prescription of a practitioner licensed by law to
3351	prescribe the drug. However, this section does not apply to the
3352	delivery of such drugs to persons included in any of the classes
3353	named in this subsection, or to the agents or employees of such
3354	persons, for use in the usual course of their businesses or
3355	practices or in the performance of their official duties, as the
3356	case may be; nor does this section apply to the possession of
3357	such drugs by those persons or their agents or employees for
3358	such use:
3359	(a)  A licensed pharmacist or any person under the licensed
3360	pharmacist's supervision while acting within the scope of the
3361	licensed pharmacist's practice;
3362	(b)  A licensed practitioner authorized by law to prescribe
3363	prescription legend drugs or any person under the licensed
3364	practitioner's supervision while acting within the scope of the
3365	licensed practitioner's practice;
3366	(c)  A qualified person who uses prescription legend drugs
3367	for lawful research, teaching, or testing, and not for resale;
3368	(d)  A licensed hospital or other institution that procures
3369	such drugs for lawful administration or dispensing by
3370	practitioners;
3371	(e)  An officer or employee of a federal, state, or local
3372	government; or
3373	(f)  A person that holds a valid permit issued by the
3374	department pursuant to this part ss. 499.001-499.081 which
3375	authorizes that person to possess prescription drugs.
3376	Section 23.  Section 499.032, Florida Statutes, is amended
3377	to read:
3378	499.032  Phenylalanine; prescription
3379	required.--Phenylalanine restricted formula is declared to be a
3380	prescription legend drug and may be dispensed only upon the
3381	prescription of a practitioner authorized by law to prescribe
3382	prescription medicinal drugs.
3383	Section 24.  Subsection (1) of section 499.033, Florida
3384	Statutes, is amended to read:
3385	499.033  Ephedrine; prescription required.--Ephedrine is
3386	declared to be a prescription drug.
3387	(1)  Except as provided in subsection (2), any product that
3388	contains any quantity of ephedrine, a salt of ephedrine, an
3389	optical isomer of ephedrine, or a salt of an optical isomer of
3390	ephedrine may be dispensed only upon the prescription of a duly
3391	licensed practitioner authorized by the laws of the state to
3392	prescribe prescription medicinal drugs.
3393	Section 25.  Subsections (1) and (3) of section 499.039,
3394	Florida Statutes, are amended to read:
3395	499.039  Sale, distribution, or transfer of harmful
3396	chemical substances; penalties; authority for enforcement.--It
3397	is unlawful for a person to sell, deliver, or give to a person
3398	under the age of 18 years any compound, liquid, or chemical
3399	containing toluol, hexane, trichloroethylene, acetone, toluene,
3400	ethyl acetate, methyl ethyl ketone, trichloroethane,
3401	isopropanol, methyl isobutyl ketone, ethylene glycol monomethyl
3402	ether acetate, cyclohexanone, nitrous oxide, diethyl ether,
3403	alkyl nitrites (butyl nitrite), or any similar substance for the
3404	purpose of inducing by breathing, inhaling, or ingesting a
3405	condition of intoxication or which is intended to distort or
3406	disturb the auditory, visual, or other physical or mental
3407	processes.
3408	(1)  On the first violation of this section, the department
3409	may issue a warning according to s. 499.002(5) s. 499.071, if
3410	the violation has not caused temporary or permanent physical or
3411	mental injury to the user.
3412	(3)  The department of Health shall adopt rules to
3413	implement this section.
3414	Section 26.  Section 499.04, Florida Statutes, is amended
3415	to read:
3416	499.04  Fee authority.--The department may collect fees for
3417	all drug, device, and cosmetic applications, permits, product
3418	registrations, and free-sale certificates. The total amount of
3419	fees collected from all permits, applications, product
3420	registrations, and free-sale certificates must be adequate to
3421	fund the expenses incurred by the department in carrying out
3422	this part ss. 499.001-499.081. The department shall, by rule,
3423	establish a schedule of fees that are within the ranges provided
3424	in this section and shall adjust those fees from time to time
3425	based on the costs associated with administering this part ss.
3426	499.001-499.081. The fees are payable to the department to be
3427	deposited into the Florida Drug, Device, and Cosmetic Trust Fund
3428	for the sole purpose of carrying out the provisions of this part
3429	ss. 499.001-499.081.
3430	Section 27.  Subsections (1) through (5), (8), and (10) of
3431	section 499.041, Florida Statutes, are amended to read:
3432	499.041  Schedule of fees for drug, device, and cosmetic
3433	applications and permits, product registrations, and free-sale
3434	certificates.--
3435	(1)  The department shall assess applicants requiring a
3436	manufacturing permit an annual fee within the ranges established
3437	in this section for the specific type of manufacturer.
3438	(a)  The fee for a prescription drug manufacturer
3439	manufacturer's permit may not be less than $500 or more than
3440	$750 annually.
3441	(b)  The fee for a device manufacturer manufacturer's
3442	permit may not be less than $500 or more than $600 annually.
3443	(c)  The fee for a cosmetic manufacturer manufacturer's
3444	permit may not be less than $250 or more than $400 annually.
3445	(d)  The fee for an over-the-counter drug manufacturer
3446	manufacturer's permit may not be less than $300 or more than
3447	$400 annually.
3448	(e)  The fee for a compressed medical gas manufacturer
3449	manufacturer's permit may not be less than $400 or more than
3450	$500 annually.
3451	(f)  The fee for a prescription drug repackager
3452	repackager's permit may not be less than $500 or more than $750
3453	annually.
3454	(g)  A manufacturer may not be required to pay more than
3455	one fee per establishment to obtain an additional manufacturing
3456	permit, but each manufacturer must pay the highest fee
3457	applicable to his or her operation in each establishment.
3458	(2)  The department shall assess an applicant that is
3459	required to have a wholesaling permit an annual fee within the
3460	ranges established in this section for the specific type of
3461	wholesaling.
3462	(a)  The fee for a prescription drug wholesale distributor
3463	wholesaler's permit may not be less than $300 or more than $800
3464	annually.
3465	(b)  The fee for a compressed medical gas wholesale
3466	distributor wholesaler's permit may not be less than $200 or
3467	more than $300 annually.
3468	(c)  The fee for an out-of-state prescription drug
3469	wholesale distributor wholesaler's permit may not be less than
3470	$300 or more than $800 annually.
3471	(d)  The fee for a nonresident prescription drug
3472	manufacturer manufacturer's permit may not be less than $300 or
3473	more than $500 annually.
3474	(e)  The fee for a retail pharmacy drug wholesale
3475	distributor wholesaler's permit may not be less than $35 or more
3476	than $50 annually.
3477	(f)  The fee for a freight forwarder forwarder's permit may
3478	not be less than $200 or more than $300 annually.
3479	(g)  The fee for a veterinary prescription drug wholesale
3480	distributor wholesaler's permit may not be less than $300 or
3481	more than $500 annually.
3482	(h)  The fee for a limited prescription drug veterinary
3483	wholesale distributor wholesaler's permit may not be less than
3484	$300 or more than $500 annually.
3485	(3)  The department shall assess an applicant that is
3486	required to have a retail establishment permit an annual fee
3487	within the ranges established in this section for the specific
3488	type of retail establishment.
3489	(a)  The fee for a veterinary prescription legend drug
3490	retail establishment permit may not be less than $200 or more
3491	than $300 annually.
3492	(b)  The fee for a medical oxygen retail establishment
3493	permit may not be less than $200 or more than $300 annually.
3494	(4)  The department shall assess an applicant that is
3495	required to have a restricted prescription drug distributor
3496	distributor's permit an annual fee of not less than $200 or more
3497	than $300.
3498	(5)  In addition to the fee charged for a permit required
3499	by this part ss. 499.001-499.081, the department shall assess
3500	applicants an initial application fee of $150 for each new
3501	permit issued by the department which requires an onsite
3502	inspection.
3503	(8)  The department shall assess an out-of-state
3504	prescription drug wholesale distributor wholesaler applicant or
3505	permittee an onsite inspection fee of not less than $1,000 or
3506	more than $3,000 annually, to be based on the actual cost of the
3507	inspection if an onsite inspection is performed by agents of the
3508	department.
3509	(10)  The department shall assess other fees as provided in
3510	this part ss. 499.001-499.081.
3511	Section 28.  Section 499.05, Florida Statutes, is amended;
3512	subsection (3) of section 499.013, Florida Statutes, is
3513	redesignated as paragraph (k) of subsection (1) of that section
3514	and amended; paragraph (b) of subsection (2) of section
3515	499.0122, Florida Statutes, is redesignated as paragraph (l) of
3516	subsection (1) of that section and amended; and subsection (12)
3517	of section 499.012, Florida Statutes, is redesignated as
3518	paragraph (m) of subsection (1) of that section and amended, to
3519	read:
3520	499.05  Rules.--
3521	(1)  The department shall adopt rules to implement and
3522	enforce this part ss. 499.001-499.081 with respect to:
3523	(a)  The definition of terms used in this part ss. 499.001-
3524	499.081, and used in the rules adopted under this part ss.
3525	499.001-499.081, when the use of the term is not its usual and
3526	ordinary meaning.
3527	(b)  Labeling requirements for drugs, devices, and
3528	cosmetics.
3529	(c)  The establishment of fees authorized in this part ss.
3530	499.001-499.081.
3531	(d)  The identification of permits that require an initial
3532	application and onsite inspection or other prerequisites for
3533	permitting which demonstrate that the establishment and person
3534	are in compliance with the requirements of this part ss.
3535	499.001-499.081.
3536	(e)  The application processes and forms for product
3537	registration.
3538	(f)  Procedures for requesting and issuing certificates of
3539	free sale.
3540	(g)  Inspections and investigations conducted under s.
3541	499.051, and the identification of information claimed to be a
3542	trade secret and exempt from the public records law as provided
3543	in s. 499.051(7).
3544	(h)  The establishment of a range of penalties, as provided
3545	in s. 499.066 s. 499.006; requirements for notifying persons of
3546	the potential impact of a violation of this part ss. 499.001-
3547	499.081; and a process for the uncontested settlement of alleged
3548	violations.
3549	(i)  Additional conditions that qualify as an emergency
3550	medical reason under s. 499.003(55)(b)2. s. 499.012(1)(a)2.b.
3551	(j)  Procedures and forms relating to the pedigree paper
3552	requirement of s. 499.01212.
3553	(k)(3)  The department may adopt such rules as are
3554	necessary for The protection of the public health, safety, and
3555	welfare regarding good manufacturing practices that
3556	manufacturers and repackagers must follow to ensure the safety
3557	of the products.
3558	(l)(b)  The department shall adopt rules relating to
3559	Information required from each retail establishment pursuant to
3560	s. 499.012(3) s. 499.01(4), including requirements for
3561	prescriptions or orders.
3562	(m)(12)  The department may adopt rules governing The
3563	recordkeeping, storage, and handling with respect to each of the
3564	distributions of prescription drugs specified in s.
3565	499.003(55)(a)-(d) subparagraphs (1)(a)1.-4.
3566	(n)  Alternatives to compliance with s. 499.01212 for a
3567	prescription drug in the inventory of a permitted prescription
3568	drug wholesale distributor as of June 30, 2006, and the return
3569	of a prescription drug purchased prior to July 1, 2006. The
3570	department may specify time limits for such alternatives.
3571	(2)  With respect to products in interstate commerce, those
3572	rules must not be inconsistent with rules and regulations of
3573	federal agencies unless specifically otherwise directed by the
3574	Legislature.
3575	(3)  The department shall adopt rules regulating
3576	recordkeeping for and the storage, handling, and distribution of
3577	medical devices and over-the-counter drugs to protect the public
3578	from adulterated products.
3579	Section 29.  Section 499.051, Florida Statutes, is amended
3580	to read:
3581	499.051  Inspections and investigations.--
3582	(1)  The agents of the department of Health and of the
3583	Department of Law Enforcement, after they present proper
3584	identification, may inspect, monitor, and investigate any
3585	establishment permitted pursuant to this part ss. 499.001-
3586	499.081 during business hours for the purpose of enforcing this
3587	part ss. 499.001-499.081, chapters 465, 501, and 893, and the
3588	rules of the department that protect the public health, safety,
3589	and welfare.
3590	(2)  In addition to the authority set forth in subsection
3591	(1), the department and any duly designated officer or employee
3592	of the department may enter and inspect any other establishment
3593	for the purpose of determining compliance with this part ss.
3594	499.001-499.081 and rules adopted under this part those sections
3595	regarding any drug, device, or cosmetic product.
3596	(3)  Any application for a permit or product registration
3597	or for renewal of such permit or registration made pursuant to
3598	this part ss. 499.001-499.081 and rules adopted under this part
3599	those sections constitutes permission for any entry or
3600	inspection of the premises in order to verify compliance with
3601	this part those sections and rules; to discover, investigate,
3602	and determine the existence of compliance; or to elicit,
3603	receive, respond to, and resolve complaints and violations.
3604	(4)  Any application for a permit made pursuant to s.
3605	499.012 ss. 499.01 and 499.012 and rules adopted under that
3606	section those sections constitutes permission for agents of the
3607	department of Health and the Department of Law Enforcement,
3608	after presenting proper identification, to inspect, review, and
3609	copy any financial document or record related to the
3610	manufacture, repackaging, or distribution of a drug as is
3611	necessary to verify compliance with this part ss. 499.001-
3612	499.081 and the rules adopted by the department to administer
3613	this part those sections, in order to discover, investigate, and
3614	determine the existence of compliance, or to elicit, receive,
3615	respond to, and resolve complaints and violations.
3616	(5)  The authority to inspect under this section includes
3617	the authority to access, review, and copy any and all financial
3618	documents related to the activity of manufacturing, repackaging,
3619	or distributing prescription drugs.
3620	(6)  The authority to inspect under this section includes
3621	the authority to secure:
3622	(a)  Samples or specimens of any drug, device, or cosmetic;
3623	or
3624	(b)  Such other evidence as is needed for any action to
3625	enforce this part ss. 499.001-499.081 and the rules adopted
3626	under this part those sections.
3627	(7)  The complaint and all information obtained pursuant to
3628	the investigation by the department are confidential and exempt
3629	from the provisions of s. 119.07(1) and s. 24(a), Art. I of the
3630	State Constitution until the investigation and the enforcement
3631	action are completed. However, trade secret information
3632	contained therein as defined by s. 812.081(1)(c) shall remain
3633	confidential and exempt from the provisions of s. 119.07(1) and
3634	s. 24(a), Art. I of the State Constitution, as long as the
3635	information is retained by the department. This subsection does
3636	not prohibit the department from using such information for
3637	regulatory or enforcement proceedings under this chapter or from
3638	providing such information to any law enforcement agency or any
3639	other regulatory agency. However, the receiving agency shall
3640	keep such records confidential and exempt as provided in this
3641	subsection. In addition, this subsection is not intended to
3642	prevent compliance with the provisions of s. 499.01212 s.
3643	499.0121(6)(d), and the pedigree papers required in that section
3644	subsection shall not be deemed a trade secret.
3645	Section 30.  Section 499.052, Florida Statutes, is amended
3646	to read:
3647	499.052  Records of interstate shipment.--For the purpose
3648	of enforcing this part ss. 499.001-499.081, carriers engaged in
3649	interstate commerce and persons receiving drugs, devices, or
3650	cosmetics in interstate commerce must, upon the request, in the
3651	manner set out below, by an officer or employee duly designated
3652	by the department, permit the officer or employee to have access
3653	to and to copy all records showing the movement in interstate
3654	commerce of any drug, device, or cosmetic, and the quantity,
3655	shipper, and consignee thereof.
3656	Section 31.  Subsection (4) of section 499.055, Florida
3657	Statutes, is amended to read:
3658	499.055  Reports and dissemination of information by
3659	department.--
3660	(4)  The department shall publish on the department's
3661	website and update at least monthly:
3662	(a)  A list of the prescription drug wholesale distributors
3663	wholesalers, out-of-state prescription drug wholesale
3664	distributors wholesalers, and retail pharmacy drug wholesale
3665	distributors wholesalers against whom the department has
3666	initiated enforcement action pursuant to this part ss. 499.001-
3667	499.081 to suspend or revoke a permit, seek an injunction, or
3668	otherwise file an administrative complaint and the permit number
3669	of each such wholesale distributor wholesaler.
3670	(b)  A list of the prescription drug wholesale distributors
3671	wholesalers, out-of-state prescription drug wholesale
3672	distributors wholesalers, and retail pharmacy drug wholesale
3673	distributors wholesalers to which the department has issued a
3674	permit, including the date on which each permit will expire.
3675	(c)  A list of the prescription drug wholesale distributor
3676	wholesalers, out-of-state prescription drug wholesale
3677	distributor wholesalers, and retail pharmacy drug wholesale
3678	distributor wholesalers' permits that have been returned to the
3679	department, were suspended, were revoked, have expired, or were
3680	not renewed in the previous year.
3681	Section 32.  Subsections (1) and (3) of section 499.06,
3682	Florida Statutes, are amended to read:
3683	499.06  Embargoing, detaining, or destroying article or
3684	processing equipment which is in violation of law or rule.--
3685	(1)  When a duly authorized agent of the department finds,
3686	or has probable cause to believe, that any drug, device, or
3687	cosmetic is in violation of any provision of this part ss.
3688	499.001-499.081 or any rule adopted under this part such
3689	sections so as to be dangerous, unwholesome, or fraudulent
3690	within the meaning of this part ss. 499.001-499.081, she or he
3691	may issue and enforce a stop-sale, stop-use, removal, or hold
3692	order, which order gives notice that such article or processing
3693	equipment is, or is suspected of being, in violation and has
3694	been detained or embargoed, and which order warns all persons
3695	not to remove, use, or dispose of such article or processing
3696	equipment by sale or otherwise until permission for removal,
3697	use, or disposal is given by such agent or the court. It is
3698	unlawful for any person to remove, use, or dispose of such
3699	detained or embargoed article or processing equipment by sale or
3700	otherwise without such permission; and such act is a felony of
3701	the second degree, punishable as provided in s. 775.082, s.
3702	775.083, or s. 775.084.
3703	(3)  If the court finds that the detained or embargoed
3704	article or processing equipment is in violation, such article or
3705	processing equipment shall, after entry of the court order, be
3706	destroyed or made sanitary at the expense of the claimant
3707	thereof, under the supervision of such agent; and all court
3708	costs, fees, and storage and other proper expenses shall be
3709	taxed against the claimant of such article or processing
3710	equipment or her or his agent. However, when the violation can
3711	be corrected by proper labeling of the article or sanitizing of
3712	the processing equipment, and after such costs, fees, and
3713	expenses have been paid and a good and sufficient bond,
3714	conditioned that such article be so labeled or processed or such
3715	processing equipment be so sanitized, has been executed, the
3716	court may by order direct that such article or processing
3717	equipment be delivered to the claimant thereof for such
3718	labeling, processing, or sanitizing, under the supervision of an
3719	agent of the department. The expense of such supervision shall
3720	be paid by the claimant. Such bond shall be returned to the
3721	claimant of the article or processing equipment upon
3722	representation to the court by the department that the article
3723	or processing equipment is no longer in violation of this part
3724	ss. 499.001-499.081 and that the expenses of such supervision
3725	have been paid.
3726	Section 33.  Section 499.062, Florida Statutes, is amended;
3727	section 499.063, Florida Statutes, is redesignated as section
3728	(2) of that section and amended; and section 499.064, Florida
3729	Statutes, is redesignated as paragraphs (a) and (b) of
3730	subsection (2) of that section and amended, to read:
3731	499.062  Cause for Seizure and condemnation of drugs,
3732	devices, or cosmetics.--
3733	(1)  Any article of any drug, device, or cosmetic that is
3734	adulterated or misbranded under this part ss. 499.001-499.081 is
3735	subject to seizure and condemnation by the department or by its
3736	duly authorized agents designated for that purpose in regard to
3737	drugs, devices, or cosmetics.
3738	(2)499.063  Seizure; procedure; prohibition on sale or
3739	disposal of article; penalty.--Whenever a duly authorized
3740	officer or employee of the department finds cause, or has
3741	probable cause to believe that cause exists, for the seizure of
3742	any drug, device, or cosmetic, as set out in this part ss.
3743	499.001-499.081, he or she shall affix to the article a tag,
3744	stamp, or other appropriate marking, giving notice that the
3745	article is, or is suspected of being, subject to seizure under
3746	this part ss. 499.001-499.081 and that the article has been
3747	detained and seized by the department. Such officer or employee
3748	shall also warn all persons not to remove or dispose of the
3749	article, by sale or otherwise, until permission is given by the
3750	department or the court. Any person who violates this subsection
3751	section is guilty of a felony of the second degree, punishable
3752	as provided in s. 775.082, s. 775.083, or s. 775.084.
3753	(a)499.064  Condemnation and sale; release of seized
3754	article.--(1)  When any article detained or seized under this
3755	subsection s. 499.063 has been found by the department to be
3756	subject to seizure and condemnation under s. 499.063, the
3757	department shall petition the court for an order of condemnation
3758	or sale, as the court directs. The proceeds of the sale of
3759	drugs, devices, and cosmetics, less the legal costs and charges,
3760	shall be deposited into the Florida Drug, Device, and Cosmetic
3761	Trust Fund.
3762	(b)(2)  If the department finds that any article seized
3763	under this subsection s. 499.063 was not subject to seizure
3764	under that section, the department or the designated officer or
3765	employee shall remove the tag or marking.
3766	Section 34.  Section 499.065, Florida Statutes, is amended
3767	to read:
3768	499.065  Inspections; imminent danger.--
3769	(1)  Notwithstanding s. 499.051, the department shall
3770	inspect each prescription drug wholesale distributor
3771	establishment, prescription drug repackager establishment,
3772	veterinary prescription drug wholesale distributor
3773	establishment, limited prescription drug veterinary wholesale
3774	distributor wholesaler establishment, and retail pharmacy drug
3775	wholesale distributor wholesaler establishment that is required
3776	to be permitted under this part chapter as often as necessary to
3777	ensure compliance with applicable laws and rules. The department
3778	shall have the right of entry and access to these facilities at
3779	any reasonable time.
3780	(2)  To protect the public from prescription drugs that are
3781	adulterated or otherwise unfit for human or animal consumption,
3782	the department may examine, sample, seize, and stop the sale or
3783	use of prescription drugs to determine the condition of those
3784	drugs. The department may immediately seize and remove any
3785	prescription drugs if the State Surgeon General or his or her
3786	designee determines that the prescription drugs represent a
3787	threat to the public health. The owner of any property seized
3788	under this section may, within 10 days after the seizure, apply
3789	to a court of competent jurisdiction for whatever relief is
3790	appropriate. At any time after 10 days, the department may
3791	destroy the drugs as contraband.
3792	(3)  The department may determine that a prescription drug
3793	wholesale distributor establishment, prescription drug
3794	repackager establishment, veterinary prescription drug wholesale
3795	distributor establishment, limited prescription drug veterinary
3796	wholesale distributor wholesaler establishment, or retail
3797	pharmacy drug wholesale distributor wholesaler establishment
3798	that is required to be permitted under this part chapter is an
3799	imminent danger to the public health and shall require its
3800	immediate closure if the establishment fails to comply with
3801	applicable laws and rules and, because of the failure, presents
3802	an imminent threat to the public's health, safety, or welfare.
3803	Any establishment so deemed and closed shall remain closed until
3804	allowed by the department or by judicial order to reopen.
3805	(4)  For purposes of this section, a refusal to allow entry
3806	to the department for inspection at reasonable times, or a
3807	failure or refusal to provide the department with required
3808	documentation for purposes of inspection, constitutes an
3809	imminent danger to the public health.
3810	Section 35.  Subsections (1) through (4) of section
3811	499.066, Florida Statutes, are amended to read:
3812	499.066  Penalties; remedies.--In addition to other
3813	penalties and other enforcement provisions:
3814	(1)  The department may institute such suits or other legal
3815	proceedings as are required to enforce any provision of this
3816	part ss. 499.001-499.081. If it appears that a person has
3817	violated any provision of this part ss. 499.001-499.081 for
3818	which criminal prosecution is provided, the department may
3819	provide the appropriate state attorney or other prosecuting
3820	agency having jurisdiction with respect to such prosecution with
3821	the relevant information in the department's possession.
3822	(2)  If any person engaged in any activity covered by this
3823	part ss. 499.001-499.081 violates any provision of this part
3824	those sections, any rule adopted under this part those sections,
3825	or a cease and desist order as provided by this part those
3826	sections, the department may obtain an injunction in the circuit
3827	court of the county in which the violation occurred or in which
3828	the person resides or has its principal place of business, and
3829	may apply in that court for such temporary and permanent orders
3830	as the department considers necessary to restrain the person
3831	from engaging in any such activities until the person complies
3832	with this part ss. 499.001-499.081, the rules adopted under this
3833	part those sections, and the orders of the department authorized
3834	by this part those sections or to mandate compliance with this
3835	part ss. 499.001-499.081, the rules adopted under this part
3836	those sections, and any order or permit issued by the department
3837	under this part those sections.
3838	(3)  The department may impose an administrative fine, not
3839	to exceed $5,000 per violation per day, for the violation of any
3840	provision of this part ss. 499.001-499.081 or rules adopted
3841	under this part those sections. Each day a violation continues
3842	constitutes a separate violation, and each separate violation is
3843	subject to a separate fine. All amounts collected pursuant to
3844	this section shall be deposited into the Florida Drug, Device,
3845	and Cosmetic Trust Fund and are appropriated for the use of the
3846	department in administering this part ss. 499.001-499.081. In
3847	determining the amount of the fine to be levied for a violation,
3848	the department shall consider:
3849	(a)  The severity of the violation;
3850	(b)  Any actions taken by the person to correct the
3851	violation or to remedy complaints; and
3852	(c)  Any previous violations.
3853	(4)  The department shall deposit any rewards, fines, or
3854	collections that are due the department and which derive from
3855	joint enforcement activities with other state and federal
3856	agencies which relate to this part ss. 499.001-499.081, chapter
3857	893, or the federal act, into the Florida Drug, Device, and
3858	Cosmetic Trust Fund. The proceeds of those rewards, fines, and
3859	collections are appropriated for the use of the department in
3860	administering this part ss. 499.001-499.081.
3861	Section 36.  Section 499.0661, Florida Statutes, is amended
3862	to read:
3863	499.0661  Cease and desist orders; removal of certain
3864	persons.--
3865	(1)(2)  CEASE AND DESIST ORDERS.--
3866	(a)  In addition to any authority otherwise provided in
3867	this chapter, the department may issue and serve a complaint
3868	stating charges upon any permittee or upon any affiliated party,
3869	whenever the department has reasonable cause to believe that the
3870	person or individual named therein is engaging in or has engaged
3871	in conduct that is:
3872	1.  An act that demonstrates a lack of fitness or
3873	trustworthiness to engage in the business authorized under the
3874	permit issued pursuant to this part ss. 499.001-499.081, is
3875	hazardous to the public health, or constitutes business
3876	operations that are a detriment to the public health;
3877	2.  A violation of any provision of this part ss. 499.001-
3878	499.081;
3879	3.  A violation of any rule of the department;
3880	4.  A violation of any order of the department; or
3881	5.  A breach of any written agreement with the department.
3882	(b)  The complaint must contain a statement of facts and
3883	notice of opportunity for a hearing pursuant to ss. 120.569 and
3884	120.57.
3885	(c)  If a hearing is not requested within the time allowed
3886	by ss. 120.569 and 120.57, or if a hearing is held and the
3887	department finds that any of the charges are proven, the
3888	department may enter an order directing the permittee or the
3889	affiliated party named in the complaint to cease and desist from
3890	engaging in the conduct complained of and take corrective action
3891	to remedy the effects of past improper conduct and assure future
3892	compliance.
3893	(d)  A contested or default cease and desist order is
3894	effective when reduced to writing and served upon the permittee
3895	or affiliated party named therein. An uncontested cease and
3896	desist order is effective as agreed.
3897	(e)  Whenever the department finds that conduct described
3898	in paragraph (a) is likely to cause an immediate threat to the
3899	public health, it may issue an emergency cease and desist order
3900	requiring the permittee or any affiliated party to immediately
3901	cease and desist from engaging in the conduct complained of and
3902	to take corrective and remedial action. The emergency order is
3903	effective immediately upon service of a copy of the order upon
3904	the permittee or affiliated party named therein and remains
3905	effective for 90 days. If the department begins nonemergency
3906	cease and desist proceedings under this subsection, the
3907	emergency order remains effective until the conclusion of the
3908	proceedings under ss. 120.569 and 120.57.
3909	(2)(3)  REMOVAL OF AFFILIATED PARTIES BY THE DEPARTMENT.--
3910	(a)  The department may issue and serve a complaint stating
3911	charges upon any affiliated party and upon the permittee
3912	involved whenever the department has reason to believe that an
3913	affiliated party is engaging in or has engaged in conduct that
3914	constitutes:
3915	1.  An act that demonstrates a lack of fitness or
3916	trustworthiness to engage in the business authorized under the
3917	permit issued pursuant to this part ss. 499.001-499.081, is
3918	hazardous to the public health, or constitutes business
3919	operations that are a detriment to the public health;
3920	2.  A willful violation of this part ss. 499.001-499.081;
3921	however, if the violation constitutes a misdemeanor, a complaint
3922	may not be served as provided in this section until the
3923	affiliated party is notified in writing of the matter of the
3924	violation and has been afforded a reasonable period of time, as
3925	set forth in the notice, to correct the violation and has failed
3926	to do so;
3927	3.  A violation of any other law involving fraud or moral
3928	turpitude which constitutes a felony;
3929	4.  A willful violation of any rule of the department;
3930	5.  A willful violation of any order of the department; or
3931	6.  A material misrepresentation of fact, made knowingly
3932	and willfully or made with reckless disregard for the truth of
3933	the matter.
3934	(b)  The complaint must contain a statement of facts and
3935	notice of opportunity for a hearing pursuant to ss. 120.569 and
3936	120.57.
3937	(c)  If a hearing is not requested within the time allotted
3938	by ss. 120.569 and 120.57, or if a hearing is held and the
3939	department finds that any of the charges in the complaint are
3940	proven true, the department may enter an order removing the
3941	affiliated party or restricting or prohibiting participation by
3942	the person in the affairs of that permittee or of any other
3943	permittee.
3944	(d)  A contested or default order of removal, restriction,
3945	or prohibition is effective when reduced to writing and served
3946	on the permittee and the affiliated party. An uncontested order
3947	of removal, restriction, or prohibition is effective as agreed.
3948	(e)1.  The chief executive officer, designated
3949	representative, or the person holding the equivalent office, of
3950	a permittee shall promptly notify the department if she or he
3951	has actual knowledge that any affiliated party is charged with a
3952	felony in a state or federal court.
3953	2.  Whenever any affiliated party is charged with a felony
3954	in a state or federal court or with the equivalent of a felony
3955	in the courts of any foreign country with which the United
3956	States maintains diplomatic relations, and the charge alleges
3957	violation of any law involving prescription drugs,
3958	pharmaceuticals, fraud, theft, or moral turpitude, the
3959	department may enter an emergency order suspending the
3960	affiliated party or restricting or prohibiting participation by
3961	the affiliated party in the affairs of the particular permittee
3962	or of any other permittee upon service of the order upon the
3963	permittee and the affiliated party charged. The order must
3964	contain notice of opportunity for a hearing pursuant to ss.
3965	120.569 and 120.57, where the affiliated party may request a
3966	postsuspension hearing to show that continued service to or
3967	participation in the affairs of the permittee does not pose a
3968	threat to the public health or the interests of the permittee
3969	and does not threaten to impair public confidence in the
3970	permittee. In accordance with applicable departmental rules, the
3971	department shall notify the affiliated party whether the order
3972	suspending or prohibiting the person from participation in the
3973	affairs of a permittee will be rescinded or otherwise modified.
3974	The emergency order remains in effect, unless otherwise modified
3975	by the department, until the criminal charge is disposed of. The
3976	acquittal of the person charged, or the final, unappealed
3977	dismissal of all charges against the person, dissolves the
3978	emergency order but does not prohibit the department from
3979	instituting proceedings under paragraph (a). If the person
3980	charged is convicted or pleads guilty or nolo contendere,
3981	whether or not an adjudication of guilt is entered by the court,
3982	the emergency order shall become final.
3983	(f)  Any affiliated party removed pursuant to this section
3984	is not eligible for reemployment by the permittee or to be an
3985	affiliated party of any permittee except upon the written
3986	consent of the department. Any affiliated party who is removed,
3987	restricted, or prohibited from participating in the affairs of a
3988	permittee pursuant to this section may petition the department
3989	for modification or termination of the removal, restriction, or
3990	prohibition.
3991	Section 37.  Section 499.067, Florida Statutes, is amended
3992	to read:
3993	499.067  Denial, suspension, or revocation of permit,
3994	certification, or registration.--
3995	(1)(a)  The department may deny, suspend, or revoke a
3996	permit if it finds that there has been a substantial failure to
3997	comply with this part ss. 499.001-499.081 or chapter 465,
3998	chapter 501, or chapter 893, the rules adopted under this part
3999	any of those sections or those chapters, any final order of the
4000	department, or applicable federal laws or regulations or other
4001	state laws or rules governing drugs, devices, or cosmetics.
4002	(b)  The department may deny an application for a permit or
4003	certification, or suspend or revoke a permit or certification,
4004	if the department finds that:
4005	1.  The applicant is not of good moral character or that it
4006	would be a danger or not in the best interest of the public
4007	health, safety, and welfare if the applicant were issued a
4008	permit or certification.
4009	2.  The applicant has not met the requirements for the
4010	permit or certification.
4011	3.  The applicant is not eligible for a permit or
4012	certification for any of the reasons enumerated in s. 499.012 s.
4013	499.01 or s. 499.012(5).
4014	4.  The applicant, permittee, or person certified under s.
4015	499.012(16) s. 499.012(11) demonstrates any of the conditions
4016	enumerated in s. 499.012 s. 499.01 or s. 499.012(5).
4017	5.  The applicant, permittee, or person certified under s.
4018	499.012(16) s. 499.012(11) has committed any violation of ss.
4019	499.005-499.0054.
4020	(2)  The department may deny, suspend, or revoke any
4021	registration required by the provisions of this part ss.
4022	499.001-499.081 for the violation of any provision of this part
4023	ss. 499.001-499.081 or of any rules adopted under this part
4024	those sections.
4025	(3)  The department may revoke or suspend a permit:
4026	(a)  If the permit was obtained by misrepresentation or
4027	fraud or through a mistake of the department;
4028	(b)  If the permit was procured, or attempted to be
4029	procured, for any other person by making or causing to be made
4030	any false representation; or
4031	(c)  If the permittee has violated any provision of this
4032	part ss. 499.001-499.081 or rules adopted under this part those
4033	sections.
4034	(4)  If any permit issued under this part ss. 499.001-
4035	499.081 is revoked or suspended, the owner, manager, operator,
4036	or proprietor of the establishment shall cease to operate as the
4037	permit authorized, from the effective date of the suspension or
4038	revocation until the person is again registered with the
4039	department and possesses the required permit. If a permit is
4040	revoked or suspended, the owner, manager, or proprietor shall
4041	remove all signs and symbols that identify the operation as
4042	premises permitted as a drug wholesaling establishment; drug,
4043	device, or cosmetic manufacturing establishment; or retail
4044	establishment. The department shall determine the length of time
4045	for which the permit is to be suspended. If a permit is revoked,
4046	the person that owns or operates the establishment may not apply
4047	for any permit under this part ss. 499.001-499.081 for a period
4048	of 1 year after the date of the revocation. A revocation of a
4049	permit may be permanent if the department considers that to be
4050	in the best interest of the public health.
4051	(5)  The department may deny, suspend, or revoke a permit
4052	issued under this part ss. 499.001-499.081 which authorizes the
4053	permittee to purchase prescription drugs, if any owner, officer,
4054	employee, or other person who participates in administering or
4055	operating the establishment has been found guilty of any
4056	violation of this part ss. 499.001-499.081 or chapter 465,
4057	chapter 501, or chapter 893, any rules adopted under this part
4058	any of those sections or those chapters, or any federal or state
4059	drug law, regardless of whether the person has been pardoned,
4060	had her or his civil rights restored, or had adjudication
4061	withheld.
4062	(6)  The department shall deny, suspend, or revoke the
4063	permit of any person or establishment if the assignment, sale,
4064	transfer, or lease of an establishment permitted under this part
4065	ss. 499.001-499.081 will avoid an administrative penalty, civil
4066	action, or criminal prosecution.
4067	(7)  Notwithstanding s. 120.60(5), if a permittee fails to
4068	comply with s. 499.012(6) s. 499.01(7), the department may
4069	revoke the permit of the permittee and shall provide notice of
4070	the intended agency action by posting a notice at the
4071	department's headquarters and by mailing a copy of the notice of
4072	intended agency action by certified mail to the most recent
4073	mailing address on record with the department and, if the
4074	permittee is not a natural person, to the permittee's registered
4075	agent on file with the Department of State.
4076	Section 38.  Paragraph (a) of subsection (1) of section
4077	409.9201, Florida Statutes, is amended to read:
4078	409.9201  Medicaid fraud.--
4079	(1)  As used in this section, the term:
4080	(a)  "Legend drug" means any drug, including, but not
4081	limited to, finished dosage forms or active ingredients that are
4082	subject to, defined by, or described by s. 503(b) of the Federal
4083	Food, Drug, and Cosmetic Act or by s. 465.003(8), s. 499.007(13)
4084	s. 499.007(12), or s. 499.003(47) or (54) s. 499.0122(1)(b) or
4085	(c).
4086
4087	The value of individual items of the legend drugs or goods or
4088	services involved in distinct transactions committed during a
4089	single scheme or course of conduct, whether involving a single
4090	person or several persons, may be aggregated when determining
4091	the punishment for the offense.
4092	Section 39.  Paragraph (c) of subsection (9) of section
4093	460.403, Florida Statutes, is amended to read:
4094	460.403  Definitions.--As used in this chapter, the term:
4095	(9)
4096	(c)1.  Chiropractic physicians may adjust, manipulate, or
4097	treat the human body by manual, mechanical, electrical, or
4098	natural methods; by the use of physical means or physiotherapy,
4099	including light, heat, water, or exercise; by the use of
4100	acupuncture; or by the administration of foods, food
4101	concentrates, food extracts, and items for which a prescription
4102	is not required and may apply first aid and hygiene, but
4103	chiropractic physicians are expressly prohibited from
4104	prescribing or administering to any person any legend drug
4105	except as authorized under subparagraph 2., from performing any
4106	surgery except as stated herein, or from practicing obstetrics.
4107	2.  Notwithstanding the prohibition against prescribing and
4108	administering legend drugs under subparagraph 1., or s.
4109	499.01(2)(m) s. 499.0122, pursuant to board rule chiropractic
4110	physicians may order, store, and administer, for emergency
4111	purposes only at the chiropractic physician's office or place of
4112	business, prescription medical oxygen and may also order, store,
4113	and administer the following topical anesthetics in aerosol
4114	form:
4115	a.  Any solution consisting of 25 percent ethylchloride and
4116	75 percent dichlorodifluoromethane.
4117	b.  Any solution consisting of 15 percent
4118	dichlorodifluoromethane and 85 percent
4119	trichloromonofluoromethane.
4120
4121	However, this paragraph does not authorize a chiropractic
4122	physician to prescribe medical oxygen as defined in chapter 499.
4123	Section 40.  Subsection (3) of section 465.0265, Florida
4124	Statutes, is amended to read:
4125	465.0265  Centralized prescription filling.--
4126	(3)  The filling, delivery, and return of a prescription by
4127	one pharmacy for another pursuant to this section shall not be
4128	construed as the filling of a transferred prescription as set
4129	forth in s. 465.026 or as a wholesale distribution as set forth
4130	in s. 499.003(55) s. 499.012(1)(a).
4131	Section 41.  Section 794.075, Florida Statutes, is amended
4132	to read:
4133	794.075  Sexual predators; erectile dysfunction drugs.--
4134	(1)  A person may not possess a prescription drug, as
4135	defined in s. 499.003(44) s. 499.003(25), for the purpose of
4136	treating erectile dysfunction if the person is designated as a
4137	sexual predator under s. 775.21.
4138	(2)  A person who violates a provision of this section for
4139	the first time commits a misdemeanor of the second degree,
4140	punishable as provided in s. 775.082 or s. 775.083. A person who
4141	violates a provision of this section a second or subsequent time
4142	commits a misdemeanor of the first degree, punishable as
4143	provided in s. 775.082 or s. 775.083.
4144	Section 42.  Paragraph (a) of subsection (1) of section
4145	895.02, Florida Statutes, is amended to read:
4146	895.02  Definitions.--As used in ss. 895.01-895.08, the
4147	term:
4148	(1)  "Racketeering activity" means to commit, to attempt to
4149	commit, to conspire to commit, or to solicit, coerce, or
4150	intimidate another person to commit:
4151	(a)  Any crime that is chargeable by indictment or
4152	information under the following provisions of the Florida
4153	Statutes:
4154	1.  Section 210.18, relating to evasion of payment of
4155	cigarette taxes.
4156	2.  Section 403.727(3)(b), relating to environmental
4157	control.
4158	3.  Section 409.920 or s. 409.9201, relating to Medicaid
4159	fraud.
4160	4.  Section 414.39, relating to public assistance fraud.
4161	5.  Section 440.105 or s. 440.106, relating to workers'
4162	compensation.
4163	6.  Section 443.071(4), relating to creation of a
4164	fictitious employer scheme to commit unemployment compensation
4165	fraud.
4166	7.  Section 465.0161, relating to distribution of medicinal
4167	drugs without a permit as an Internet pharmacy.
4168	8.  Section 499.0051 Sections 499.0051, 499.0052,
4169	499.00535, 499.00545, and 499.0691, relating to crimes involving
4170	contraband and adulterated drugs.
4171	9.  Part IV of chapter 501, relating to telemarketing.
4172	10.  Chapter 517, relating to sale of securities and
4173	investor protection.
4174	11.  Section 550.235, s. 550.3551, or s. 550.3605, relating
4175	to dogracing and horseracing.
4176	12.  Chapter 550, relating to jai alai frontons.
4177	13.  Section 551.109, relating to slot machine gaming.
4178	14.  Chapter 552, relating to the manufacture,
4179	distribution, and use of explosives.
4180	15.  Chapter 560, relating to money transmitters, if the
4181	violation is punishable as a felony.
4182	16.  Chapter 562, relating to beverage law enforcement.
4183	17.  Section 624.401, relating to transacting insurance
4184	without a certificate of authority, s. 624.437(4)(c)1., relating
4185	to operating an unauthorized multiple-employer welfare
4186	arrangement, or s. 626.902(1)(b), relating to representing or
4187	aiding an unauthorized insurer.
4188	18.  Section 655.50, relating to reports of currency
4189	transactions, when such violation is punishable as a felony.
4190	19.  Chapter 687, relating to interest and usurious
4191	practices.
4192	20.  Section 721.08, s. 721.09, or s. 721.13, relating to
4193	real estate timeshare plans.
4194	21.  Chapter 782, relating to homicide.
4195	22.  Chapter 784, relating to assault and battery.
4196	23.  Chapter 787, relating to kidnapping or human
4197	trafficking.
4198	24.  Chapter 790, relating to weapons and firearms.
4199	25.  Section 796.03, s. 796.035, s. 796.04, s. 796.045, s.
4200	796.05, or s. 796.07, relating to prostitution and sex
4201	trafficking.
4202	26.  Chapter 806, relating to arson.
4203	27.  Section 810.02(2)(c), relating to specified burglary
4204	of a dwelling or structure.
4205	28.  Chapter 812, relating to theft, robbery, and related
4206	crimes.
4207	29.  Chapter 815, relating to computer-related crimes.
4208	30.  Chapter 817, relating to fraudulent practices, false
4209	pretenses, fraud generally, and credit card crimes.
4210	31.  Chapter 825, relating to abuse, neglect, or
4211	exploitation of an elderly person or disabled adult.
4212	32.  Section 827.071, relating to commercial sexual
4213	exploitation of children.
4214	33.  Chapter 831, relating to forgery and counterfeiting.
4215	34.  Chapter 832, relating to issuance of worthless checks
4216	and drafts.
4217	35.  Section 836.05, relating to extortion.
4218	36.  Chapter 837, relating to perjury.
4219	37.  Chapter 838, relating to bribery and misuse of public
4220	office.
4221	38.  Chapter 843, relating to obstruction of justice.
4222	39.  Section 847.011, s. 847.012, s. 847.013, s. 847.06, or
4223	s. 847.07, relating to obscene literature and profanity.
4224	40.  Section 849.09, s. 849.14, s. 849.15, s. 849.23, or s.
4225	849.25, relating to gambling.
4226	41.  Chapter 874, relating to criminal street gangs.
4227	42.  Chapter 893, relating to drug abuse prevention and
4228	control.
4229	43.  Chapter 896, relating to offenses related to financial
4230	transactions.
4231	44.  Sections 914.22 and 914.23, relating to tampering with
4232	a witness, victim, or informant, and retaliation against a
4233	witness, victim, or informant.
4234	45.  Sections 918.12 and 918.13, relating to tampering with
4235	jurors and evidence.
4236	Section 43.  Paragraphs (d), (f), (h), (i), and (j) of
4237	subsection (3) of section 921.0022, Florida Statutes, are
4238	amended to read:
4239	921.0022  Criminal Punishment Code; offense severity
4240	ranking chart.--
4241	(3)  OFFENSE SEVERITY RANKING CHART
4242	(d)  LEVEL 4
4243
	FloridaStatute FelonyDegree Description
4244
	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.
4245
	499.0051(1) 3rd Failure to maintain or deliver pedigree papers.
4246
	499.0051(2) 3rd Failure to authenticate pedigree papers.
4247
	499.0051(6) 2nd Knowing sale or delivery, or possession with intent to sell, contraband prescription legend drugs.
4248
	784.07(2)(b) 3rd Battery of law enforcement officer, firefighter, intake officer, etc.
4249
	784.074(1)(c) 3rd Battery of sexually violent predators facility staff.
4250
	784.075 3rd Battery on detention or commitment facility staff.
4251
	784.078 3rd Battery of facility employee by throwing, tossing, or expelling certain fluids or materials.
4252
	784.08(2)(c) 3rd Battery on a person 65 years of age or older.
4253
	784.081(3) 3rd Battery on specified official or employee.
4254
	784.082(3) 3rd Battery by detained person on visitor or other detainee.
4255
	784.083(3) 3rd Battery on code inspector.
4256
	784.085 3rd Battery of child by throwing, tossing, projecting, or expelling certain fluids or materials.
4257
	787.03(1) 3rd Interference with custody; wrongly takes minor from appointed guardian.
4258
	787.04(2) 3rd Take, entice, or remove child beyond state limits with criminal intent pending custody proceedings.
4259
	787.04(3) 3rd Carrying child beyond state lines with criminal intent to avoid producing child at custody hearing or delivering to designated person.
4260
	790.115(1) 3rd Exhibiting firearm or weapon within 1,000 feet of a school.
4261
	790.115(2)(b) 3rd Possessing electric weapon or device, destructive device, or other weapon on school property.
4262
	790.115(2)(c) 3rd Possessing firearm on school property.
4263
	800.04(7)(d) 3rd Lewd or lascivious exhibition; offender less than 18 years.
4264
	810.02(4)(a) 3rd Burglary, or attempted burglary, of an unoccupied structure; unarmed; no assault or battery.
4265
	810.02(4)(b) 3rd Burglary, or attempted burglary, of an unoccupied conveyance; unarmed; no assault or battery.
4266
	810.06 3rd Burglary; possession of tools.
4267
	810.08(2)(c) 3rd Trespass on property, armed with firearm or dangerous weapon.
4268
	812.014(2)(c)3. 3rd Grand theft, 3rd degree $10,000 or more but less than $20,000.
4269
	812.014(2)(c)4.-10. 3rd Grand theft, 3rd degree, a will, firearm, motor vehicle, livestock, etc.
4270
	812.0195(2) 3rd Dealing in stolen property by use of the Internet; property stolen $300 or more.
4271
	817.563(1) 3rd Sell or deliver substance other than controlled substance agreed upon, excluding s. 893.03(5) drugs.
4272
	817.568(2)(a) 3rd Fraudulent use of personal identification information.
4273
	817.625(2)(a) 3rd Fraudulent use of scanning device or reencoder.
4274
	828.125(1) 2nd Kill, maim, or cause great bodily harm or permanent breeding disability to any registered horse or cattle.
4275
	837.02(1) 3rd Perjury in official proceedings.
4276
	837.021(1) 3rd Make contradictory statements in official proceedings.
4277
	838.022 3rd Official misconduct.
4278
	839.13(2)(a) 3rd Falsifying records of an individual in the care and custody of a state agency.
4279
	839.13(2)(c) 3rd Falsifying records of the Department of Children and Family Services.
4280
	843.021 3rd Possession of a concealed handcuff key by a person in custody.
4281
	843.025 3rd Deprive law enforcement, correctional, or correctional probation officer of means of protection or communication.
4282
	843.15(1)(a) 3rd Failure to appear while on bail for felony (bond estreature or bond jumping).
4283
	874.05(1) 3rd Encouraging or recruiting another to join a criminal street gang.
4284
	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).
4285
	914.14(2) 3rd Witnesses accepting bribes.
4286
	914.22(1) 3rd Force, threaten, etc., witness, victim, or informant.
4287
	914.23(2) 3rd Retaliation against a witness, victim, or informant, no bodily injury.
4288
	918.12 3rd Tampering with jurors.
4289
	934.215 3rd Use of two-way communications device to facilitate commission of a crime.
4290
4291	(f)  LEVEL 6
4292
	FloridaStatute FelonyDegree Description
4293
	316.193(2)(b) 3rd Felony DUI, 4th or subsequent conviction.
4294
	499.0051(3) 2nd Knowing forgery of pedigree papers.
4295
	499.0051(4) 2nd Knowing purchase or receipt of prescription legend drug from unauthorized person.
4296
	499.0051(5) 2nd Knowing sale or transfer of prescription legend drug to unauthorized person.
4297
	775.0875(1) 3rd Taking firearm from law enforcement officer.
4298
	784.021(1)(a) 3rd Aggravated assault; deadly weapon without intent to kill.
4299
	784.021(1)(b) 3rd Aggravated assault; intent to commit felony.
4300
	784.041 3rd Felony battery; domestic battery by strangulation.
4301
	784.048(3) 3rd Aggravated stalking; credible threat.
4302
	784.048(5) 3rd Aggravated stalking of person under 16.
4303
	784.07(2)(c) 2nd Aggravated assault on law enforcement officer.
4304
	784.074(1)(b) 2nd Aggravated assault on sexually violent predators facility staff.
4305
	784.08(2)(b) 2nd Aggravated assault on a person 65 years of age or older.
4306
	784.081(2) 2nd Aggravated assault on specified official or employee.
4307
	784.082(2) 2nd Aggravated assault by detained person on visitor or other detainee.
4308
	784.083(2) 2nd Aggravated assault on code inspector.
4309
	787.02(2) 3rd False imprisonment; restraining with purpose other than those in s. 787.01.
4310
	790.115(2)(d) 2nd Discharging firearm or weapon on school property.
4311
	790.161(2) 2nd Make, possess, or throw destructive device with intent to do bodily harm or damage property.
4312
	790.164(1) 2nd False report of deadly explosive, weapon of mass destruction, or act of arson or violence to state property.
4313
	790.19 2nd Shooting or throwing deadly missiles into dwellings, vessels, or vehicles.
4314
	794.011(8)(a) 3rd Solicitation of minor to participate in sexual activity by custodial adult.
4315
	794.05(1) 2nd Unlawful sexual activity with specified minor.
4316
	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.
4317
	800.04(6)(b) 2nd Lewd or lascivious conduct; offender 18 years of age or older.
4318
	806.031(2) 2nd Arson resulting in great bodily harm to firefighter or any other person.
4319
	810.02(3)(c) 2nd Burglary of occupied structure; unarmed; no assault or battery.
4320
	812.014(2)(b)1. 2nd Property stolen $20,000 or more, but less than $100,000, grand theft in 2nd degree.
4321
	812.014(6) 2nd Theft; property stolen $3,000 or more; coordination of others.
4322
	812.015(9)(a) 2nd Retail theft; property stolen $300 or more; second or subsequent conviction.
4323
	812.015(9)(b) 2nd Retail theft; property stolen $3,000 or more; coordination of others.
4324
	812.13(2)(c) 2nd Robbery, no firearm or other weapon (strong-arm robbery).
4325
	817.034(4)(a)1. 1st Communications fraud, value greater than $50,000.
4326
	817.4821(5) 2nd Possess cloning paraphernalia with intent to create cloned cellular telephones.
4327
	825.102(1) 3rd Abuse of an elderly person or disabled adult.
4328
	825.102(3)(c) 3rd Neglect of an elderly person or disabled adult.
4329
	825.1025(3) 3rd Lewd or lascivious molestation of an elderly person or disabled adult.
4330
	825.103(2)(c) 3rd Exploiting an elderly person or disabled adult and property is valued at less than $20,000.
4331
	827.03(1) 3rd Abuse of a child.
4332
	827.03(3)(c) 3rd Neglect of a child.
4333
	827.071(2)&(3) 2nd Use or induce a child in a sexual performance, or promote or direct such performance.
4334
	836.05 2nd Threats; extortion.
4335
	836.10 2nd Written threats to kill or do bodily injury.
4336
	843.12 3rd Aids or assists person to escape.
4337
	847.0135(2) 3rd Facilitates sexual conduct of or with a minor or the visual depiction of such conduct.
4338
	914.23 2nd Retaliation against a witness, victim, or informant, with bodily injury.
4339
	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.
4340
	944.40 2nd Escapes.
4341
	944.46 3rd Harboring, concealing, aiding escaped prisoners.
4342
	944.47(1)(a)5. 2nd Introduction of contraband (firearm, weapon, or explosive) into correctional facility.
4343
	951.22(1) 3rd Intoxicating drug, firearm, or weapon introduced into county facility.
4344
4345	(h)  LEVEL 8
4346
	FloridaStatute FelonyDegree Description
4347
	316.193(3)(c)3.a. 2nd DUI manslaughter.
4348
	316.1935(4)(b) 1st Aggravated fleeing or attempted eluding with serious bodily injury or death.
4349
	327.35(3)(c)3. 2nd Vessel BUI manslaughter.
4350
	499.0051(8) 499.0051(7) 1st Knowing forgery of prescription labels or prescription legend drug labels.
4351
	499.0051(7) 499.0052 1st Knowing trafficking in contraband prescription legend drugs.
4352
	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.
4353
	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.
4354
	655.50(10)(b)2. 2nd Failure to report financial transactions totaling or exceeding $20,000, but less than $100,000 by financial institutions.
4355
	777.03(2)(a) 1st Accessory after the fact, capital felony.
4356
	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.
4357
	782.051(2) 1st Attempted felony murder while perpetrating or attempting to perpetrate a felony not enumerated in s. 782.04(3).
4358
	782.071(1)(b) 1st Committing vehicular homicide and failing to render aid or give information.
4359
	782.072(2) 1st Committing vessel homicide and failing to render aid or give information.
4360
	790.161(3) 1st Discharging a destructive device which results in bodily harm or property damage.
4361
	794.011(5) 2nd Sexual battery, victim 12 years or over, offender does not use physical force likely to cause serious injury.
4362
	794.08(3) 2nd Female genital mutilation, removal of a victim younger than 18 years of age from this state.
4363
	800.04(4) 2nd Lewd or lascivious battery.
4364
	806.01(1) 1st Maliciously damage dwelling or structure by fire or explosive, believing person in structure.
4365
	810.02(2)(a) 1st,PBL Burglary with assault or battery.
4366
	810.02(2)(b) 1st,PBL Burglary; armed with explosives or dangerous weapon.
4367
	810.02(2)(c) 1st Burglary of a dwelling or structure causing structural damage or $1,000 or more property damage.
4368
	812.014(2)(a)2. 1st Property stolen; cargo valued at $50,000 or more, grand theft in 1st degree.
4369
	812.13(2)(b) 1st Robbery with a weapon.
4370
	812.135(2)(c) 1st Home-invasion robbery, no firearm, deadly weapon, or other weapon.
4371
	817.568(6) 2nd Fraudulent use of personal identification information of an individual under the age of 18.
4372
	825.102(2) 2nd Aggravated abuse of an elderly person or disabled adult.
4373
	825.1025(2) 2nd Lewd or lascivious battery upon an elderly person or disabled adult.
4374
	825.103(2)(a) 1st Exploiting an elderly person or disabled adult and property is valued at $100,000 or more.
4375
	837.02(2) 2nd Perjury in official proceedings relating to prosecution of a capital felony.
4376
	837.021(2) 2nd Making contradictory statements in official proceedings relating to prosecution of a capital felony.
4377
	860.121(2)(c) 1st Shooting at or throwing any object in path of railroad vehicle resulting in great bodily harm.
4378
	860.16 1st Aircraft piracy.
4379
	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).
4380
	893.13(2)(b) 1st Purchase in excess of 10 grams of any substance specified in s. 893.03(1)(a) or (b).
4381
	893.13(6)(c) 1st Possess in excess of 10 grams of any substance specified in s. 893.03(1)(a) or (b).
4382
	893.135(1)(a)2. 1st Trafficking in cannabis, more than 2,000 lbs., less than 10,000 lbs.
4383
	893.135(1)(b)1.b. 1st Trafficking in cocaine, more than 200 grams, less than 400 grams.
4384
	893.135(1)(c)1.b. 1st Trafficking in illegal drugs, more than 14 grams, less than 28 grams.
4385
	893.135(1)(d)1.b. 1st Trafficking in phencyclidine, more than 200 grams, less than 400 grams.
4386
	893.135(1)(e)1.b. 1st Trafficking in methaqualone, more than 5 kilograms, less than 25 kilograms.
4387
	893.135(1)(f)1.b. 1st Trafficking in amphetamine, more than 28 grams, less than 200 grams.
4388
	893.135(1)(g)1.b. 1st Trafficking in flunitrazepam, 14 grams or more, less than 28 grams.
4389
	893.135(1)(h)1.b. 1st Trafficking in gamma-hydroxybutyric acid (GHB), 5 kilograms or more, less than 10 kilograms.
4390
	893.135(1)(j)1.b. 1st Trafficking in 1,4-Butanediol, 5 kilograms or more, less than 10 kilograms.
4391
	893.135(1)(k)2.b. 1st Trafficking in Phenethylamines, 200 grams or more, less than 400 grams.
4392
	895.03(1) 1st Use or invest proceeds derived from pattern of racketeering activity.
4393
	895.03(2) 1st Acquire or maintain through racketeering activity any interest in or control of any enterprise or real property.
4394
	895.03(3) 1st Conduct or participate in any enterprise through pattern of racketeering activity.
4395
	896.101(5)(b) 2nd Money laundering, financial transactions totaling or exceeding $20,000, but less than $100,000.
4396
	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.
4397
4398	(i)  LEVEL 9
4399
	FloridaStatute FelonyDegree Description
4400
	316.193(3)(c)3.b. 1st DUI manslaughter; failing to render aid or give information.
4401
	327.35(3)(c)3.b. 1st BUI manslaughter; failing to render aid or give information.
4402
	499.0051(9) 499.00535 1st Knowing sale or purchase of contraband prescription legend drugs resulting in great bodily harm.
4403
	560.123(8)(b)3. 1st Failure to report currency or payment instruments totaling or exceeding $100,000 by money transmitter.
4404
	560.125(5)(c) 1st Money transmitter business by unauthorized person, currency, or payment instruments totaling or exceeding $100,000.
4405
	655.50(10)(b)3. 1st Failure to report financial transactions totaling or exceeding $100,000 by financial institution.
4406
	775.0844 1st Aggravated white collar crime.
4407
	782.04(1) 1st Attempt, conspire, or solicit to commit premeditated murder.
4408
	782.04(3) 1st,PBL Accomplice to murder in connection with arson, sexual battery, robbery, burglary, and other specified felonies.
4409
	782.051(1) 1st Attempted felony murder while perpetrating or attempting to perpetrate a felony enumerated in s. 782.04(3).
4410
	782.07(2) 1st Aggravated manslaughter of an elderly person or disabled adult.
4411
	787.01(1)(a)1. 1st,PBL Kidnapping; hold for ransom or reward or as a shield or hostage.
4412
	787.01(1)(a)2. 1st,PBL Kidnapping with intent to commit or facilitate commission of any felony.
4413
	787.01(1)(a)4. 1st,PBL Kidnapping with intent to interfere with performance of any governmental or political function.
4414
	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.
4415
	790.161 1st Attempted capital destructive device offense.
4416
	790.166(2) 1st,PBL Possessing, selling, using, or attempting to use a weapon of mass destruction.
4417
	794.011(2) 1st Attempted sexual battery; victim less than 12 years of age.
4418
	794.011(2) Life Sexual battery; offender younger than 18 years and commits sexual battery on a person less than 12 years.
4419
	794.011(4) 1st Sexual battery; victim 12 years or older, certain circumstances.
4420
	794.011(8)(b) 1st Sexual battery; engage in sexual conduct with minor 12 to 18 years by person in familial or custodial authority.
4421
	794.08(2) 1st Female genital mutilation; victim younger than 18 years of age.
4422
	800.04(5)(b) Life Lewd or lascivious molestation; victim less than 12 years; offender 18 years or older.
4423
	812.13(2)(a) 1st,PBL Robbery with firearm or other deadly weapon.
4424
	812.133(2)(a) 1st,PBL Carjacking; firearm or other deadly weapon.
4425
	812.135(2)(b) 1st Home-invasion robbery with weapon.
4426
	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.
4427
	827.03(2) 1st Aggravated child abuse.
4428
	847.0145(1) 1st Selling, or otherwise transferring custody or control, of a minor.
4429
	847.0145(2) 1st Purchasing, or otherwise obtaining custody or control, of a minor.
4430
	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.
4431
	893.135 1st Attempted capital trafficking offense.
4432
	893.135(1)(a)3. 1st Trafficking in cannabis, more than 10,000 lbs.
4433
	893.135(1)(b)1.c. 1st Trafficking in cocaine, more than 400 grams, less than 150 kilograms.
4434
	893.135(1)(c)1.c. 1st Trafficking in illegal drugs, more than 28 grams, less than 30 kilograms.
4435
	893.135(1)(d)1.c. 1st Trafficking in phencyclidine, more than 400 grams.
4436
	893.135(1)(e)1.c. 1st Trafficking in methaqualone, more than 25 kilograms.
4437
	893.135(1)(f)1.c. 1st Trafficking in amphetamine, more than 200 grams.
4438
	893.135(1)(h)1.c. 1st Trafficking in gamma-hydroxybutyric acid (GHB), 10 kilograms or more.
4439
	893.135(1)(j)1.c. 1st Trafficking in 1,4-Butanediol, 10 kilograms or more.
4440
	893.135(1)(k)2.c. 1st Trafficking in Phenethylamines, 400 grams or more.
4441
	896.101(5)(c) 1st Money laundering, financial instruments totaling or exceeding $100,000.
4442
	896.104(4)(a)3. 1st Structuring transactions to evade reporting or registration requirements, financial transactions totaling or exceeding $100,000.
4443
4444	(j)  LEVEL 10
4445
	FloridaStatute FelonyDegree Description
4446
	499.0051(10) 499.00545 1st Knowing sale or purchase of contraband prescription legend drugs resulting in death.
4447
	782.04(2) 1st,PBL Unlawful killing of human; act is homicide, unpremeditated.
4448
	787.01(1)(a)3. 1st,PBL Kidnapping; inflict bodily harm upon or terrorize victim.
4449
	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.
4450
	782.07(3) 1st Aggravated manslaughter of a child.
4451
	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.
4452
	812.135(2)(a) 1st,PBL Home-invasion robbery with firearm or other deadly weapon.
4453
	876.32 1st Treason against the state.
4454
4455	Section 44.  This act shall take effect July 1, 2008.

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