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	requiring a permit to operate as a third party logistics
38	provider and a health care clinic establishment; providing
39	requirements for obtaining a permit to operate in certain
40	capacities; deleting certain permit requirements;
41	providing an exemption for a nonresident prescription drug
42	manufacturer permit; providing requirements for such
43	exemption; providing requirements for a third party
44	logistics provider permit and a health care clinic
45	establishment permit; amending and redesignating
46	provisions of ss. 499.013, and 499.014, F.S., relating to
47	such functions as provisions of that section; conforming
48	provisions and cross-references to changes made by the
49	act; amending s. 499.012, F.S.; providing that the section
50	relates to permit application requirements; providing that
51	a separate establishment permit is not required when a
52	permitted prescription drug wholesale distributor operates
53	temporary transit storage facilities for the sole purpose
54	of storage; amending the provisions to conform; amending
55	and redesignating provisions of s. 499.01, F.S., relating
56	to such functions as provisions of that section;
57	conforming provisions and cross-references to changes made
58	by the act; amending s. 499.01201, F.S.; conforming
59	provisions to changes made by the act; amending s.
60	499.0121, F.S., relating to storage and handling of
61	prescription drugs and recordkeeping; directing the
62	department to adopt rules requiring a wholesale
63	distributor to maintain pedigree papers separate and
64	distinct from other required records; deleting a
65	requirement that a person who is engaged in the wholesale
66	distribution of a prescription drug and who is not the
67	manufacturer of that drug provide a pedigree paper to the
68	person who receives the drug; deleting the department's
69	requirement to adopt rules with regard to recordkeeping by
70	affiliated groups; conforming provisions and cross-
71	references to changes made by the act; amending and
72	redesignating a provision of s. 499.013, F.S., relating to
73	such functions as a provision of that section; amending s.
74	499.01211, F.S.; conforming provisions and cross-
75	references to changes made by the act; creating s.
76	499.01212, F.S.; requiring a person who is engaged in the
77	wholesale distribution of a prescription drug to provide a
78	pedigree paper to the person who receives the drug;
79	requiring certain information in a pedigree paper;
80	requiring a wholesale distributor to maintain and make
81	available to the department certain information; providing
82	exceptions to the requirement of a pedigree paper;
83	repealing s. 499.0122, F.S., relating to medical oxygen
84	and veterinary legend drug retail establishments;
85	repealing s. 499.013, F.S., relating to manufacturers and
86	repackagers of drugs, devices, and cosmetics; amending ss.
87	499.015, 499.024, 499.028, 499.029, and 499.03, F.S.;
88	conforming provisions and cross-references to changes made
89	by the act; amending ss. 499.032 and 499.033, F.S.;
90	conforming terminology to changes made by the act;
91	amending s. 499.039, F.S.; conforming a provision and
92	cross-reference; amending ss. 499.04, F.S.; conforming
93	provisions to changes made by the act; amending s.
94	499.041, F.S.; conforming provisions to changes made by
95	the act; requiring the department to assess an annual fee
96	for a third part logistic provider permit and a health
97	care clinic establishment permit; amending s. 499.05,
98	F.S.; conforming provisions to changes made by the act;
99	requiring the department to adopt rules with regard to
100	procedures and forms relating to pedigree paper
101	requirements, alternatives to compliance with the
102	requirement of certain pedigree papers, and the return of
103	prescription drugs purchased before a specified date;
104	amending and redesignating provisions of ss. 499.013 and
105	499.0122, F.S., as provisions relating to rulemaking
106	functions of that section; amending ss. 499.051, 499.052,
107	499.055, and 499.06, F.S.; conforming provisions to
108	changes made by the act; amending s. 499.062, F.S.;
109	providing that the section relates to seizure and
110	condemnation of drugs, devices, or cosmetics; conforming a
111	provision to changes made by the act; amending and
112	redesignating ss. 499.063 and 499.064, F.S., as provisions
113	relating to such functions in that section; amending ss.
114	499.065, 499.066, 499.0661, and 499.067, F.S.; conforming
115	provisions and cross-references to changes made by the
116	act; amending ss. 409.9201, 460.403, 465.0265, 794.075,
117	895.02, and 921.0022, F.S.; conforming provisions to
118	changes made by the act; conforming cross-references to
119	changes made by the act; providing an effective date.
120
121	Be It Enacted by the Legislature of the State of Florida:
122
123	Section 1.  Section 499.002, Florida Statutes, is amended;
124	section 499.004, Florida Statutes, is redesignated as subsection
125	(2) of that section and amended; section 499.0053, Florida
126	Statutes, is redesignated as subsection (3) of that section and
127	amended; section 499.07, Florida Statutes, is redesignated as
128	subsection (4) of that section and amended; section 499.071,
129	Florida Statutes, is redesignated as subsection (5) of that
130	section and amended; and section 499.081, Florida Statutes, is
131	redesignated as subsection (6) of that section and amended, to
132	read:
133	499.002  Purpose, administration, and enforcement of and
134	exemption from this part ss. 499.001-499.081.--
135	(1)  This part is Sections 499.001-499.081 are intended to:
136	(a)(1)  Safeguard the public health and promote the public
137	welfare by protecting the public from injury by product use and
138	by merchandising deceit involving drugs, devices, and cosmetics.
139	(b)(2)  Provide uniform legislation to be administered so
140	far as practicable in conformity with the provisions of, and
141	regulations issued under the authority of, the Federal Food,
142	Drug, and Cosmetic Act and that portion of the Federal Trade
143	Commission Act which expressly prohibits the false advertisement
144	of drugs, devices, and cosmetics.
145	(c)(3)  Promote thereby uniformity of such state and
146	federal laws, and their administration and enforcement,
147	throughout the United States.
148	(2)  499.004  Administration and enforcement by
149	department.--The department of Health shall administer and
150	enforce this part ss. 499.001-499.081 to prevent fraud,
151	adulteration, misbranding, or false advertising in the
152	preparation, manufacture, repackaging, or distribution of drugs,
153	devices, and cosmetics.
154	(3)  499.0053  Power to administer oaths, take depositions,
155	and issue and serve subpoenas.--For the purpose of any
156	investigation or proceeding conducted by the department under
157	this part ss. 499.001-499.081, the department may administer
158	oaths, take depositions, issue and serve subpoenas, and compel
159	the attendance of witnesses and the production of books, papers,
160	documents, or other evidence. The department shall exercise this
161	power on its own initiative. Challenges to, and enforcement of,
162	the subpoenas and orders shall be handled as provided in s.
163	120.569.
164	(4)  499.07  Duty of prosecuting officer.--Each state
165	attorney, county attorney, or municipal attorney to whom the
166	department or its designated agent reports any violation of this
167	part ss. 499.001-499.081 shall cause appropriate proceedings to
168	be instituted in the proper courts without delay and to be
169	prosecuted in the manner required by law.
170	(5)  499.071  Issuance of warnings for minor
171	violations.--This part does Sections 499.001-499.081 do not
172	require the department to report, for the institution of
173	proceedings under this part ss. 499.001-499.081, minor
174	violations of this part ss. 499.001-499.081 when it believes
175	that the public interest will be adequately served in the
176	circumstances by a suitable written notice or warning.
177	(6)  499.081  Carriers in interstate commerce exempted from
178	ss. 499.001-499.081.--Common carriers engaged in interstate
179	commerce are not subject to this part ss. 499.001-499.081 if
180	they are engaged in the usual course of business as common
181	carriers.
182	Section 2.  Section 499.003, Florida Statutes, is amended;
183	paragraphs (a) through (f) of subsection (1) of section 499.012,
184	Florida Statutes, are redesignated as subsections (55), (56),
185	(52), and (48), paragraph (c) of subsection (48), and subsection
186	(53), respectively, of that section and amended; paragraphs (f)
187	through (j) and (l) through (m) of subsection (3) of section
188	499.029, Florida Statutes, are redesignated as subsections (25),
189	(26), (27), (35), (40), and (41), and, respectively, of that
190	section and amended; and subsection (1) of section 499.0661,
191	Florida Statutes, is redesignated as subsection (38) of that
192	section and amended, to read:
193	499.003  Definitions of terms used in this part ss.
194	499.001-499.081.--As used in this part ss. 499.001-499.081, the
195	term:
196	(1)  "Advertisement" means any representation disseminated
197	in any manner or by any means, other than by labeling, for the
198	purpose of inducing, or which is likely to induce, directly or
199	indirectly, the purchase of drugs, devices, or cosmetics.
200	(2)  "Affiliated group" means an affiliated group as
201	defined by s. 1504 of the Internal Revenue Code of 1986, as
202	amended, which is composed of chain drug entities, including at
203	least 50 retail pharmacies, warehouses, or repackagers, which
204	are members of the same affiliated group. The affiliated group
205	must disclose the names of all its members to the department.
206	(3)(2)  "Affiliated party" means:
207	(a)  A director, officer, trustee, partner, or committee
208	member of a permittee or applicant or a subsidiary or service
209	corporation of the permittee or applicant;
210	(b)  A person who, directly or indirectly, manages,
211	controls, or oversees the operation of a permittee or applicant,
212	regardless of whether such person is a partner, shareholder,
213	manager, member, officer, director, independent contractor, or
214	employee of the permittee or applicant;
215	(c)  A person who has filed or is required to file a
216	personal information statement pursuant to s. 499.012(9) s.
217	499.012(4) or is required to be identified in an application for
218	a permit or to renew a permit pursuant to s. 499.012(8) s.
219	499.012(3); or
220	(d)  The five largest natural shareholders that own at
221	least 5 percent of the permittee or applicant.
222	(4)(3)  "Applicant" means a person applying for a permit or
223	certification under this part ss. 499.001-499.081.
224	(5)(4)  "Authenticate" means to affirmatively verify upon
225	receipt before any distribution of a prescription legend drug
226	occurs that each transaction listed on the pedigree paper has
227	occurred.
228	(a)  A wholesale distributor is not required to open a
229	sealed, medical convenience kit to authenticate a pedigree paper
230	for a prescription drug contained within the kit.
231	(b)  Authentication of a prescription drug included in a
232	sealed, medical convenience kit shall be limited to verifying
233	the transaction and pedigree information received.
234	(6)(5)  "Certificate of free sale" means a document
235	prepared by the department which certifies a drug, device, or
236	cosmetic, that is registered with the department, as one that
237	can be legally sold in the state.
238	(7)  "Chain pharmacy warehouse" means a wholesale
239	distributor permitted pursuant to s. 499.01 that maintains a
240	physical location for prescription drugs that functions solely
241	as a central warehouse to perform intracompany transfers of such
242	drugs to a member of its affiliated group.
243	(8)(6)  "Closed pharmacy" means a pharmacy that is licensed
244	under chapter 465 and purchases prescription drugs for use by a
245	limited patient population and not for wholesale distribution or
246	sale to the public. The term does not include retail pharmacies.
247	(9)(7)  "Color" includes black, white, and intermediate
248	grays.
249	(10)(8)  "Color additive" means, with the exception of any
250	material that has been or hereafter is exempt under the federal
251	act, a material that:
252	(a)  Is a dye pigment, or other substance, made by a
253	process of synthesis or similar artifice, or extracted,
254	isolated, or otherwise derived, with or without intermediate or
255	final change of identity from a vegetable, animal, mineral, or
256	other source; or
257	(b)  When added or applied to a drug or cosmetic or to the
258	human body, or any part thereof, is capable alone, or through
259	reaction with other substances, of imparting color thereto;
260
261	except that the term does not include any material which has
262	been or hereafter is exempt under the federal act.
263	(11)(9)  "Compressed medical gas" means any liquefied or
264	vaporized gas that is a prescription drug, whether it is alone
265	or in combination with other gases.
266	(12)(10)  "Contraband prescription legend drug" means any
267	adulterated drug, as defined in s. 499.006, any counterfeit
268	drug, as defined in this section, and also means any
269	prescription legend drug for which a pedigree paper does not
270	exist, or for which the pedigree paper in existence has been
271	forged, counterfeited, falsely created, or contains any altered,
272	false, or misrepresented matter.
273	(13)(11)  "Cosmetic" means an article, with the exception
274	of soap, that is:
275	(a)  Intended to be rubbed, poured, sprinkled, or sprayed
276	on; introduced into; or otherwise applied to the human body or
277	any part thereof for cleansing, beautifying, promoting
278	attractiveness, or altering the appearance; or
279	(b)  Intended for use as a component of any such article;
280
281	except that the term does not include soap.
282	(14)(12)  "Counterfeit drug," "counterfeit device," or
283	"counterfeit drug, counterfeit device, or counterfeit cosmetic"
284	means a drug, device, or cosmetic which, or the container, seal,
285	or labeling of which, without authorization, bears the
286	trademark, trade name, or other identifying mark, imprint, or
287	device, or any likeness thereof, of a drug, device, or cosmetic
288	manufacturer, processor, packer, or distributor other than the
289	person that in fact manufactured, processed, packed, or
290	distributed that drug, device, or cosmetic and which thereby
291	falsely purports or is represented to be the product of, or to
292	have been packed or distributed by, that other drug, device, or
293	cosmetic manufacturer, processor, packer, or distributor.
294	(15)(13)  "Department" means the Department of Health.
295	(16)(14)  "Device" means any instrument, apparatus,
296	implement, machine, contrivance, implant, in vitro reagent, or
297	other similar or related article, including its components,
298	parts, or accessories, which is:
299	(a)  Recognized in the current edition of the United States
300	Pharmacopoeia and National Formulary, or any supplement thereof,
301	(b)  Intended for use in the diagnosis, cure, mitigation,
302	treatment, therapy, or prevention of disease in humans or other
303	animals, or
304	(c)  Intended to affect the structure or any function of
305	the body of humans or other animals,
306
307	and that which does not achieve any of its principal intended
308	purposes through chemical action within or on the body of humans
309	or other animals and which is not dependent upon being
310	metabolized for the achievement of any of its principal intended
311	purposes.
312	(17)(15)  "Distribute or distribution" or "distribution"
313	means to sell; offer to sell; give away; transfer, whether by
314	passage of title, physical movement, or both; deliver; or offer
315	to deliver. The term does not mean to administer or dispense.
316	(18)  "Drop shipment" means the sale of a prescription drug
317	from a manufacturer to a wholesale distributor, where the
318	wholesale distributor takes title to, but not possession of, the
319	prescription drug and the manufacturer of the prescription drug
320	ships the prescription drug directly to a chain pharmacy
321	warehouse or a person authorized by law to purchase prescription
322	drugs for the purpose of administering or dispensing the drug,
323	as defined in s. 465.003.
324	(16)  "Diverted from the legal channels of distribution for
325	prescription drugs" means an adulterated drug pursuant to s.
326	499.006(10).
327	(19)(17)  "Drug" means an article that is:
328	(a)  Recognized in the current edition of the United States
329	Pharmacopoeia and National Formulary, official Homeopathic
330	Pharmacopoeia of the United States, or any supplement to any of
331	those publications;
332	(b)  Intended for use in the diagnosis, cure, mitigation,
333	treatment, therapy, or prevention of disease in humans or other
334	animals;
335	(c)  Intended to affect the structure or any function of
336	the body of humans or other animals; or
337	(d)  Intended for use as a component of any article
338	specified in paragraph (a), paragraph (b), or paragraph (c), but
339	does not include devices or their components, parts, or
340	accessories.
341	(20)(18)  "Establishment" means a place of business at one
342	general physical location.
343	(21)(19)  "Federal act" means the Federal Food, Drug, and
344	Cosmetic Act, 21 U.S.C. ss. 301 et seq.; 52 Stat. 1040 et seq.
345	(22)(20)  "Freight forwarder" means a person who receives
346	prescription legend drugs which are owned by another person and
347	designated by that person for export, and exports those
348	prescription legend drugs.
349	(23)(21)  "Health care entity" means a closed pharmacy or
350	any person, organization, or business entity that provides
351	diagnostic, medical, surgical, or dental treatment or care, or
352	chronic or rehabilitative care, but does not include any
353	wholesale distributor or retail pharmacy licensed under state
354	law to deal in prescription drugs.
355	(24)(f)  "Health care facility" means a health care
356	facility licensed under chapter 395.
357	(25)(h)  "Hospice" means a corporation licensed under part
358	IV of chapter 400.
359	(26)(i)  "Hospital" means a facility as defined in s.
360	395.002 and licensed under chapter 395.
361	(27)(22)  "Immediate container" does not include package
362	liners.
363	(28)(23)  "Label" means a display of written, printed, or
364	graphic matter upon the immediate container of any drug, device,
365	or cosmetic. A requirement made by or under authority of this
366	part ss. 499.001-499.081 or rules adopted under this part those
367	sections that any word, statement, or other information appear
368	on the label is not complied with unless such word, statement,
369	or other information also appears on the outside container or
370	wrapper, if any, of the retail package of such drug, device, or
371	cosmetic or is easily legible through the outside container or
372	wrapper.
373	(29)(24)  "Labeling" means all labels and other written,
374	printed, or graphic matters:
375	(a)  Upon a drug, device, or cosmetic, or any of its
376	containers or wrappers; or
377	(b)  Accompanying or related to such drug, device, or
378	cosmetic.
379	(25)  "Legend drug," "prescription drug," or "medicinal
380	drug" means any drug, including, but not limited to, finished
381	dosage forms, or active ingredients subject to, defined by, or
382	described by s. 503(b) of the Federal Food, Drug, and Cosmetic
383	Act or s. 465.003(8), s. 499.007(12), or s. 499.0122(1)(b) or
384	(c).
385	(26)  "Legend drug label" means any display of written,
386	printed, or graphic matter upon the immediate container of any
387	legend drug prior to its dispensing to an individual patient
388	pursuant to a prescription of a practitioner authorized by law
389	to prescribe.
390	(30)(27)  "Manufacture" means the preparation, deriving,
391	compounding, propagation, processing, producing, or fabrication
392	of any drug, device, or cosmetic.
393	(31)(28)  "Manufacturer" means:
394	(a)  A person who prepares, derives, manufactures, or
395	produces a drug, device, or cosmetic.
396	(b)  The holder or holders of a New Drug Application (NDA),
397	an Abbreviated New Drug Application (ANDA), a Biologics License
398	Application (BLA), or a New Animal Drug Application (NADA),
399	provided such application has become effective or is otherwise
400	approved consistent with s. 499.023; a private label distributor
401	for whom the private label distributor's prescription drugs are
402	originally manufactured and labeled for the distributor and have
403	not been repackaged; or the distribution point for the
404	manufacturer, contract manufacturer, or private label
405	distributor whether the establishment is a member of the
406	manufacturer's affiliated group or is a contract distribution
407	site.
408
409	The term excludes pharmacies that are operating in compliance
410	with pharmacy practice standards as defined in chapter 465 and
411	rules adopted under that chapter.
412	(32)(29)  "New drug" means:
413	(a)  Any drug the composition of which is such that the
414	drug is not generally recognized, among experts qualified by
415	scientific training and experience to evaluate the safety and
416	effectiveness of drugs, as safe and effective for use under the
417	conditions prescribed, recommended, or suggested in the labeling
418	of that drug; or
419	(b)  Any drug the composition of which is such that the
420	drug, as a result of investigations to determine its safety and
421	effectiveness for use under certain conditions, has been
422	recognized for use under such conditions, but which drug has
423	not, other than in those investigations, been used to a material
424	extent or for a material time under such conditions.
425	(33)  "Normal distribution chain" means a wholesale
426	distribution of a prescription drug in which the wholesale
427	distributor or its wholly owned subsidiary purchases and
428	receives the specific unit of the prescription drug directly
429	from the manufacturer and distributes the prescription drug
430	directly, or through up to two intracompany transfers, to a
431	chain pharmacy warehouse or a person authorized by law to
432	purchase prescription drugs for the purpose of administering or
433	dispensing the drug, as defined in s. 465.003. For purposes of
434	this subsection, the term "intracompany" means any transaction
435	or transfer between any parent, division, or subsidiary wholly
436	owned by a corporate entity.
437	(34)(j)  "Nursing home" means a facility licensed under
438	part II of chapter 400.
439	(35)(30)  "Official compendium" means the current edition
440	of the official United States Pharmacopoeia and National
441	Formulary, or any supplement thereto.
442	(36)(31)  "Pedigree paper" means:
443	(a)  Effective July 1, 2006, A document in written or
444	electronic form approved by the department which contains of
445	Health and containing information required by s. 499.01212
446	regarding the sale and that records each distribution of any
447	given prescription legend drug, from sale by a pharmaceutical
448	manufacturer, through acquisition and sale by any wholesaler or
449	repackager, until final sale to a pharmacy or other person
450	administering or dispensing the drug. The information required
451	to be included on the form approved by the department pursuant
452	to this paragraph must at least detail the amount of the legend
453	drug; its dosage form and strength; its lot numbers; the name
454	and address of each owner of the legend drug and his or her
455	signature; its shipping information, including the name and
456	address of each person certifying delivery or receipt of the
457	legend drug; an invoice number, a shipping document number, or
458	another number uniquely identifying the transaction; and a
459	certification that the recipient wholesaler has authenticated
460	the pedigree papers. If the manufacturer or repackager has
461	uniquely serialized the individual legend drug unit, that
462	identifier must also be included on the form approved pursuant
463	to this paragraph. It must also include the name, address,
464	telephone number and, if available, e-mail contact information
465	of each wholesaler involved in the chain of the legend drug's
466	custody; or
467	(b)  A statement, under oath, in written or electronic
468	form, confirming that a wholesale distributor purchases and
469	receives the specific unit of the prescription drug directly
470	from the manufacturer of the prescription drug and distributes
471	the prescription drug directly, or through an intracompany
472	transfer, to a chain pharmacy warehouse or a person authorized
473	by law to purchase prescription drugs for the purpose of
474	administering or dispensing the drug, as defined in s. 465.003.
475	For purposes of this subsection, the term "chain pharmacy
476	warehouse" means a wholesale distributor permitted pursuant to
477	s. 499.01 that maintains a physical location for prescription
478	drugs that functions solely as a central warehouse to perform
479	intracompany transfers of such drugs to a member of its
480	affiliated group as described in s. 499.0121(6)(f)1.
481	1.  The information required to be included pursuant to
482	this paragraph must include:
483	a.  The following statement: "This wholesale distributor
484	purchased the specific unit of the prescription drug directly
485	from the manufacturer."
486	b.  The manufacturer's national drug code identifier and
487	the name and address of the wholesaler and the purchaser of the
488	prescription drug.
489	c.  The name of the prescription drug as it appears on the
490	label.
491	d.  The quantity, dosage form, and strength of the
492	prescription drug.
493	2.  The wholesale distributor must also maintain and make
494	available to the department, upon request, the point of origin
495	of the prescription drugs, including intracompany transfers; the
496	date of the shipment from the manufacturer to the wholesale
497	distributor; the lot numbers of such drugs; and the invoice
498	numbers from the manufacturer.
499
500	The department may adopt rules and forms relating to the
501	requirements of this subsection.
502	(37)(1)  DEFINITION.--As used in this section, the term
503	"Permittee" means any person holding a permit issued pursuant to
504	s. 499.012.
505	(38)(32)  "Person" means any individual, child, joint
506	venture, syndicate, fiduciary, partnership, corporation,
507	division of a corporation, firm, trust, business trust, company,
508	estate, public or private institution, association,
509	organization, group, city, county, city and county, political
510	subdivision of this state, other governmental agency within this
511	state, and any representative, agent, or agency of any of the
512	foregoing, or any other group or combination of the foregoing.
513	(39)(l)  "Pharmacist" means a person licensed under chapter
514	465.
515	(40)(m)  "Pharmacy" means an entity licensed under chapter
516	465.
517	(41)(33)  "Prepackaged drug product" means a drug that
518	originally was in finished packaged form sealed by a
519	manufacturer and that is placed in a properly labeled container
520	by a pharmacy or practitioner authorized to dispense pursuant to
521	chapter 465 for the purpose of dispensing in the establishment
522	in which the prepackaging occurred.
523	(42)  "Prescription drug" means a prescription, medicinal,
524	or legend drug, including, but not limited to, finished dosage
525	forms or active ingredients subject to, defined by, or described
526	by s. 503(b) of the Federal Food, Drug, and Cosmetic Act or s.
527	465.003(8), s. 499.007(13), or subsection (11), subsection (47),
528	or subsection (54).
529	(43)  "Prescription drug label" means any display of
530	written, printed, or graphic matter upon the immediate container
531	of any prescription drug prior to its dispensing to an
532	individual patient pursuant to a prescription of a practitioner
533	authorized by law to prescribe.
534	(44)(34)  "Prescription label" means any display of
535	written, printed, or graphic matter upon the immediate container
536	of any prescription legend drug dispensed pursuant to a
537	prescription of a practitioner authorized by law to prescribe.
538	(45)(35)  "Prescription medical oxygen" means oxygen USP
539	which is a drug that can only be sold on the order or
540	prescription of a practitioner authorized by law to prescribe.
541	The label of prescription medical oxygen must comply with
542	current labeling requirements for oxygen under the Federal Food,
543	Drug, and Cosmetic Act.
544	(46)(d)  "Primary wholesale distributor wholesaler" means
545	any wholesale distributor that:
546	(a)1.  Purchased 90 percent or more of the total dollar
547	volume of its purchases of prescription drugs directly from
548	manufacturers in the previous year; and
549	(b)1.2.a.  Directly purchased prescription drugs from not
550	fewer than 50 different prescription drug manufacturers in the
551	previous year; or
552	2.b.  Has, or the affiliated group, as defined in s. 1504
553	of the Internal Revenue Code, of which the wholesale distributor
554	is a member has, not fewer than 250 employees.
555	(c)(e)  For purposes of this subsection, "directly from
556	manufacturers a manufacturer" means:
557	1.  Purchases made by the wholesale distributor directly
558	from the manufacturer of prescription drugs; and
559	2.  Transfers from a member of an affiliated group, as
560	defined in s. 1504 of the Internal Revenue Code, of which the
561	wholesale distributor is a member, if:
562	a.  The affiliated group purchases 90 percent or more of
563	the total dollar volume of its purchases of prescription drugs
564	from the manufacturer in the previous year; and
565	b.  The wholesale distributor discloses to the department
566	the names of all members of the affiliated group of which the
567	wholesale distributor is a member and the affiliated group
568	agrees in writing to provide records on prescription drug
569	purchases by the members of the affiliated group not later than
570	48 hours after the department requests access to such records,
571	regardless of the location where the records are stored.
572	(47)(36)  "Proprietary drug," or "OTC drug," means a patent
573	or over-the-counter drug in its unbroken, original package,
574	which drug is sold to the public by, or under the authority of,
575	the manufacturer or primary distributor thereof, is not
576	misbranded under the provisions of this part ss. 499.001-
577	499.081, and can be purchased without a prescription.
578	(48)(37)  "Repackage" includes repacking or otherwise
579	changing the container, wrapper, or labeling to further the
580	distribution of the drug, device, or cosmetic.
581	(49)(38)  "Repackager" means a person who repackages. The
582	term excludes pharmacies that are operating in compliance with
583	pharmacy practice standards as defined in chapter 465 and rules
584	adopted under that chapter.
585	(50)(c)  "Retail pharmacy" means a community pharmacy
586	licensed under chapter 465 that purchases prescription drugs at
587	fair market prices and provides prescription services to the
588	public.
589	(51)(f)  "Secondary wholesale distributor wholesaler" means
590	a wholesale distributor that is not a primary wholesale
591	distributor wholesaler.
592	(53)(39)  "Veterinary prescription drug" means a
593	prescription legend drug intended solely for veterinary use. The
594	label of the drug must bear the statement, "Caution: Federal law
595	restricts this drug to sale by or on the order of a licensed
596	veterinarian."
597	(40)  "Veterinary prescription drug wholesaler" means any
598	person engaged in wholesale distribution of veterinary
599	prescription drugs in or into this state.
600	(54)(a)  "Wholesale distribution" means distribution of
601	prescription drugs to persons other than a consumer or patient,
602	but does not include:
603	(a)1.  Any of the following activities, which is not a
604	violation of s. 499.005(21) if such activity is conducted in
605	accordance with s. 499.01(2)(g) s. 499.014:
606	1.a.  The purchase or other acquisition by a hospital or
607	other health care entity that is a member of a group purchasing
608	organization of a prescription drug for its own use from the
609	group purchasing organization or from other hospitals or health
610	care entities that are members of that organization.
611	2.b.  The sale, purchase, or trade of a prescription drug
612	or an offer to sell, purchase, or trade a prescription drug by a
613	charitable organization described in s. 501(c)(3) of the
614	Internal Revenue Code of 1986, as amended and revised, to a
615	nonprofit affiliate of the organization to the extent otherwise
616	permitted by law.
617	3.c.  The sale, purchase, or trade of a prescription drug
618	or an offer to sell, purchase, or trade a prescription drug
619	among hospitals or other health care entities that are under
620	common control. For purposes of this subparagraph section,
621	"common control" means the power to direct or cause the
622	direction of the management and policies of a person or an
623	organization, whether by ownership of stock, by voting rights,
624	by contract, or otherwise.
625	4.d.  The sale, purchase, trade, or other transfer of a
626	prescription drug from or for any federal, state, or local
627	government agency or any entity eligible to purchase
628	prescription drugs at public health services prices pursuant to
629	Pub. L. No. 102-585, s. 602 to a contract provider or its
630	subcontractor for eligible patients of the agency or entity
631	under the following conditions:
632	a.(I)  The agency or entity must obtain written
633	authorization for the sale, purchase, trade, or other transfer
634	of a prescription drug under this subparagraph sub-subparagraph
635	from the State Surgeon General or his or her designee.
636	b.(II)  The contract provider or subcontractor must be
637	authorized by law to administer or dispense prescription drugs.
638	c.(III)  In the case of a subcontractor, the agency or
639	entity must be a party to and execute the subcontract.
640	d.(IV)  A contract provider or subcontractor must maintain
641	separate and apart from other prescription drug inventory any
642	prescription drugs of the agency or entity in its possession.
643	e.(V)  The contract provider and subcontractor must
644	maintain and produce immediately for inspection all records of
645	movement or transfer of all the prescription drugs belonging to
646	the agency or entity, including, but not limited to, the records
647	of receipt and disposition of prescription drugs. Each
648	contractor and subcontractor dispensing or administering these
649	drugs must maintain and produce records documenting the
650	dispensing or administration. Records that are required to be
651	maintained include, but are not limited to, a perpetual
652	inventory itemizing drugs received and drugs dispensed by
653	prescription number or administered by patient identifier, which
654	must be submitted to the agency or entity quarterly.
655	f.(VI)  The contract provider or subcontractor may
656	administer or dispense the prescription drugs only to the
657	eligible patients of the agency or entity or must return the
658	prescription drugs for or to the agency or entity. The contract
659	provider or subcontractor must require proof from each person
660	seeking to fill a prescription or obtain treatment that the
661	person is an eligible patient of the agency or entity and must,
662	at a minimum, maintain a copy of this proof as part of the
663	records of the contractor or subcontractor required under sub-
664	subparagraph e. sub-sub-subparagraph (V).
665	g.(VII)  In addition to the departmental inspection
666	authority set forth in s. 499.051, the establishment of the
667	contract provider and subcontractor and all records pertaining
668	to prescription drugs subject to this subparagraph sub-
669	subparagraph shall be subject to inspection by the agency or
670	entity. All records relating to prescription drugs of a
671	manufacturer under this subparagraph sub-subparagraph shall be
672	subject to audit by the manufacturer of those drugs, without
673	identifying individual patient information.
674	(b)2.  Any of the following activities, which is not a
675	violation of s. 499.005(21) if such activity is conducted in
676	accordance with rules established by the department:
677	1.a.  The sale, purchase, or trade of a prescription drug
678	among federal, state, or local government health care entities
679	that are under common control and are authorized to purchase
680	such prescription drug.
681	2.b.  The sale, purchase, or trade of a prescription drug
682	or an offer to sell, purchase, or trade a prescription drug for
683	emergency medical reasons. For purposes of this subparagraph
684	sub-subparagraph, the term "emergency medical reasons" includes
685	transfers of prescription drugs by a retail pharmacy to another
686	retail pharmacy to alleviate a temporary shortage.
687	3.c.  The transfer of a prescription drug acquired by a
688	medical director on behalf of a licensed emergency medical
689	services provider to that emergency medical services provider
690	and its transport vehicles for use in accordance with the
691	provider's license under chapter 401.
692	4.d.  The revocation of a sale or the return of a
693	prescription drug to the person's prescription drug wholesale
694	supplier.
695	5.e.  The donation of a prescription drug by a health care
696	entity to a charitable organization that has been granted an
697	exemption under s. 501(c)(3) of the Internal Revenue Code of
698	1986, as amended, and that is authorized to possess prescription
699	drugs.
700	6.f.  The transfer of a prescription drug by a person
701	authorized to purchase or receive prescription drugs to a person
702	licensed or permitted to handle reverse distributions or
703	destruction under the laws of the jurisdiction in which the
704	person handling the reverse distribution or destruction receives
705	the drug.
706	7.g.  The transfer of a prescription drug by a hospital or
707	other health care entity to a person licensed under this part
708	chapter to repackage prescription drugs for the purpose of
709	repackaging the prescription drug for use by that hospital, or
710	other health care entity and other health care entities that are
711	under common control, if ownership of the prescription drugs
712	remains with the hospital or other health care entity at all
713	times. In addition to the recordkeeping requirements of s.
714	499.0121(6), the hospital or health care entity that transfers
715	prescription drugs pursuant to this subparagraph sub-
716	subparagraph must reconcile all drugs transferred and returned
717	and resolve any discrepancies in a timely manner.
718	(c)3.  The distribution of prescription drug samples by
719	manufacturers' representatives or distributors' representatives
720	conducted in accordance with s. 499.028.
721	(d)4.  The sale, purchase, or trade of blood and blood
722	components intended for transfusion. As used in this paragraph
723	subparagraph, the term "blood" means whole blood collected from
724	a single donor and processed either for transfusion or further
725	manufacturing, and the term "blood components" means that part
726	of the blood separated by physical or mechanical means.
727	(e)5.  The lawful dispensing of a prescription drug in
728	accordance with chapter 465.
729	(f)6.  The sale, purchase, or trade of a prescription drug
730	between pharmacies as a result of a sale, transfer, merger, or
731	consolidation of all or part of the business of the pharmacies
732	from or with another pharmacy, whether accomplished as a
733	purchase and sale of stock or of business assets.
734	(54)(b)  "Wholesale distributor" means any person engaged
735	in wholesale distribution of prescription drugs in or into this
736	state, including, but not limited to, manufacturers;
737	repackagers; own-label distributors; jobbers; private-label
738	distributors; brokers; warehouses, including manufacturers' and
739	distributors' warehouses, chain drug warehouses, and wholesale
740	drug warehouses; independent wholesale drug traders; exporters;
741	retail pharmacies; and the agents thereof that conduct wholesale
742	distributions.
743	Section 3.  Subsections (4), (10), (11), (12), (14), (15),
744	(18), (19), (20), (22), (24), (28), and (29) of section 499.005,
745	Florida Statutes, are amended to read:
746	499.005  Prohibited acts.--It is unlawful for a person to
747	perform or cause the performance of any of the following acts in
748	this state:
749	(4)  The sale, distribution, purchase, trade, holding, or
750	offering of any drug, device, or cosmetic in violation of this
751	part ss. 499.001-499.081.
752	(10)  Forging; counterfeiting; simulating; falsely
753	representing any drug, device, or cosmetic; or, without the
754	authority of the manufacturer, using any mark, stamp, tag,
755	label, or other identification device authorized or required by
756	rules adopted under this part ss. 499.001-499.081.
757	(11)  The use, on the labeling of any drug or in any
758	advertisement relating to such drug, of any representation or
759	suggestion that an application of the drug is effective when it
760	is not or that the drug complies with this part ss. 499.001-
761	499.081 when it does not.
762	(12)  The possession of any drug in violation of this part
763	ss. 499.001-499.081.
764	(14)  The purchase or receipt of a prescription legend drug
765	from a person that is not authorized under this chapter to
766	distribute prescription legend drugs to that purchaser or
767	recipient.
768	(15)  The sale or transfer of a prescription legend drug to
769	a person that is not authorized under the law of the
770	jurisdiction in which the person receives the drug to purchase
771	or possess prescription legend drugs from the person selling or
772	transferring the prescription legend drug.
773	(18)  Failure to maintain records as required by this part
774	ss. 499.001-499.081 and rules adopted under this part those
775	sections.
776	(19)  Providing the department with false or fraudulent
777	records, or making false or fraudulent statements, regarding any
778	matter within the provisions of this part chapter.
779	(20)  The importation of a prescription legend drug except
780	as provided by s. 801(d) of the Federal Food, Drug, and Cosmetic
781	Act.
782	(22)  Failure to obtain a permit or registration, or
783	operating without a valid permit when a permit or registration
784	is required by this part ss. 499.001-499.081 for that activity.
785	(24)  The distribution of a prescription legend device to
786	the patient or ultimate consumer without a prescription or order
787	from a practitioner licensed by law to use or prescribe the
788	device.
789	(28)  Failure to acquire obtain or deliver pass on a
790	pedigree paper as required under this part.
791	(29)  The receipt of a prescription drug pursuant to a
792	wholesale distribution without having previously received or
793	simultaneously either first receiving a pedigree paper that was
794	attested to as accurate and complete by the wholesale
795	distributor as required under this part or complying with the
796	provisions of s. 499.0121(6)(d)5.
797	Section 4.  Section 499.0051, Florida Statutes, is amended;
798	section 499.0052, Florida Statutes, is redesignated as
799	subsection (7) of that section and amended; section 499.00535,
800	Florida Statutes, is redesignated as subsection (9) of that
801	section and amended; section 499.00545, Florida Statutes, is
802	redesignated as subsection (10) of that section and amended;
803	section 499.069, Florida Statutes, is redesignated as subsection
804	(11) of that section and amended; and section 499.0691, Florida
805	Statutes, is redesignated as subsections (12) through (15) of
806	that section and amended, to read:
807	499.0051  Criminal acts involving contraband or adulterated
808	drugs.--
809	(1)  FAILURE TO MAINTAIN OR DELIVER PEDIGREE PAPERS.--
810	(a)  A person, other than a manufacturer, engaged in the
811	wholesale distribution of prescription legend drugs who fails to
812	deliver to another person complete and accurate pedigree papers
813	concerning a prescription legend drug or contraband prescription
814	legend drug prior to, or simultaneous with, the transfer of
815	transferring the prescription legend drug or contraband
816	prescription legend drug to another person commits a felony of
817	the third degree, punishable as provided in s. 775.082, s.
818	775.083, or s. 775.084.
819	(b)  A person engaged in the wholesale distribution of
820	prescription legend drugs who fails to acquire complete and
821	accurate pedigree papers concerning a prescription legend drug
822	or contraband prescription legend drug prior to, or simultaneous
823	with, the receipt of obtaining the prescription legend drug or
824	contraband prescription legend drug from another person commits
825	a felony of the third degree, punishable as provided in s.
826	775.082, s. 775.083, or s. 775.084.
827	(c)  Any person who knowingly destroys, alters, conceals,
828	or fails to maintain complete and accurate pedigree papers
829	concerning any prescription legend drug or contraband
830	prescription legend drug in his or her possession commits a
831	felony of the third degree, punishable as provided in s.
832	775.082, s. 775.083, or s. 775.084.
833	(2)  FAILURE TO AUTHENTICATE PEDIGREE PAPERS.--Effective
834	July 1, 2006:
835	(a)  A person engaged in the wholesale distribution of
836	prescription legend drugs who is in possession of pedigree
837	papers concerning prescription legend drugs or contraband
838	prescription legend drugs and who fails to authenticate the
839	matters contained in the pedigree papers and who nevertheless
840	attempts to further distribute prescription legend drugs or
841	contraband prescription legend drugs commits a felony of the
842	third degree, punishable as provided in s. 775.082, s. 775.083,
843	or s. 775.084.
844	(b)  A person in possession of pedigree papers concerning
845	prescription legend drugs or contraband prescription legend
846	drugs who falsely swears or certifies that he or she has
847	authenticated the matters contained in the pedigree papers
848	commits a felony of the third degree, punishable as provided in
849	s. 775.082, s. 775.083, or s. 775.084.
850	(3)  KNOWING FORGERY OF PEDIGREE PAPERS.--A person who
851	knowingly forges, counterfeits, or falsely creates any pedigree
852	paper; who falsely represents any factual matter contained on
853	any pedigree paper; or who knowingly omits to record material
854	information required to be recorded in a pedigree paper, commits
855	a felony of the second degree, punishable as provided in s.
856	775.082, s. 775.083, or s. 775.084.
857	(4)  KNOWING PURCHASE OR RECEIPT OF PRESCRIPTION LEGEND
858	DRUG FROM UNAUTHORIZED PERSON.--A person who knowingly purchases
859	or receives from a person not authorized to distribute
860	prescription legend drugs under this chapter a prescription
861	legend drug in a wholesale distribution transaction commits a
862	felony of the second degree, punishable as provided in s.
863	775.082, s. 775.083, or s. 775.084.
864	(5)  KNOWING SALE OR TRANSFER OF PRESCRIPTION LEGEND DRUG
865	TO UNAUTHORIZED PERSON.--A person who knowingly sells or
866	transfers to a person not authorized to purchase or possess
867	prescription legend drugs, under the law of the jurisdiction in
868	which the person receives the drug, a prescription legend drug
869	in a wholesale distribution transaction commits a felony of the
870	second degree, punishable as provided in s. 775.082, s. 775.083,
871	or s. 775.084.
872	(6)  KNOWING SALE OR DELIVERY, OR POSSESSION WITH INTENT TO
873	SELL, CONTRABAND PRESCRIPTION LEGEND DRUGS.--A person who is
874	knowingly in actual or constructive possession of any amount of
875	contraband prescription legend drugs, who knowingly sells or
876	delivers, or who possesses with intent to sell or deliver any
877	amount of contraband prescription legend drugs, commits a felony
878	of the second degree, punishable as provided in s. 775.082, s.
879	775.083, or s. 775.084.
880	(7)499.0052  KNOWING TRAFFICKING IN CONTRABAND PRESCRIPTION
881	LEGEND DRUGS.--A person who knowingly sells, purchases,
882	manufactures, delivers, or brings into this state, or who is
883	knowingly in actual or constructive possession of any amount of
884	contraband prescription legend drugs valued at $25,000 or more
885	commits a felony of the first degree, punishable as provided in
886	s. 775.082, s. 775.083, or s. 775.084.
887	(a)  Upon conviction, each defendant shall be ordered to
888	pay a mandatory fine according to the following schedule:
889	1.(1)  If the value of contraband prescription legend drugs
890	involved is $25,000 or more, but less than $100,000, the
891	defendant shall pay a mandatory fine of $25,000. If the
892	defendant is a corporation or other person that is not a natural
893	person, it shall pay a mandatory fine of $75,000.
894	2.(2)  If the value of contraband prescription legend drugs
895	involved is $100,000 or more, but less than $250,000, the
896	defendant shall pay a mandatory fine of $100,000. If the
897	defendant is a corporation or other person that is not a natural
898	person, it shall pay a mandatory fine of $300,000.
899	3.(3)  If the value of contraband prescription legend drugs
900	involved is $250,000 or more, the defendant shall pay a
901	mandatory fine of $200,000. If the defendant is a corporation or
902	other person that is not a natural person, it shall pay a
903	mandatory fine of $600,000.
904	(b)  As used in this subsection section, the term "value"
905	means the market value of the property at the time and place of
906	the offense or, if such cannot be satisfactorily ascertained,
907	the cost of replacement of the property within a reasonable time
908	after the offense. Amounts of value of separate contraband
909	prescription legend drugs involved in distinct transactions for
910	the distribution of the contraband prescription legend drugs
911	committed pursuant to one scheme or course of conduct, whether
912	involving the same person or several persons, may be aggregated
913	in determining the punishment of the offense.
914	(8)(7)  KNOWING FORGERY OF PRESCRIPTION OR PRESCRIPTION
915	LEGEND DRUG LABELS.--A person who knowingly forges,
916	counterfeits, or falsely creates any prescription label or
917	prescription legend drug label, or who falsely represents any
918	factual matter contained on any prescription label or
919	prescription legend drug label, commits a felony of the first
920	degree, punishable as provided in s. 775.082, s. 775.083, or s.
921	775.084.
922	(9)499.00535  KNOWING Sale or purchase of contraband
923	prescription legend drugs resulting in great bodily harm.--A
924	person who knowingly sells, purchases, manufactures, delivers,
925	or brings into this state, or who is knowingly in actual or
926	constructive possession of any amount of contraband prescription
927	legend drugs, and whose acts in violation of this subsection
928	section result in great bodily harm to a person, commits a
929	felony of the first degree, as provided in s. 775.082, s.
930	775.083, or s. 775.084.
931	(10)499.00545  Knowing Sale or purchase of contraband
932	prescription legend drugs resulting in death.--A person who
933	knowingly manufactures, sells, purchases, delivers, or brings
934	into this state, or who is knowingly in actual or constructive
935	possession of any amount of contraband prescription legend
936	drugs, and whose acts in violation of this subsection section
937	result in the death of a person, commits a felony of the first
938	degree, punishable by a term of years not exceeding life, as
939	provided in s. 775.082, s. 775.083, or s. 775.084.
940	(11)499.069  Criminal punishment for violations of s.
941	499.005 related to devices and cosmetics; dissemination of false
942	advertisement.--
943	(a)(1)  Any person who violates any of the provisions of s.
944	499.005 with respect to a device or cosmetic commits a
945	misdemeanor of the second degree, punishable as provided in s.
946	775.082 or s. 775.083; but, if the violation is committed after
947	a conviction of such person under this subsection section has
948	become final, such person is guilty of a misdemeanor of the
949	first degree, punishable as provided in s. 775.082 or s. 775.083
950	or as otherwise provided in this part ss. 499.001-499.081,
951	except that any person who violates s. 499.005(8) or (10)
952	subsection (8) or subsection (10) of s. 499.005 with respect to
953	a device or cosmetic commits a felony of the third degree,
954	punishable as provided in s. 775.082, s. 775.083, or s. 775.084,
955	or as otherwise provided in this part ss. 499.001-499.081.
956	(b)(2)  A publisher, radio broadcast licensee, or agency or
957	medium for the dissemination of an advertisement, except the
958	manufacturer, wholesaler, or seller of the article to which a
959	false advertisement relates, is not liable under this subsection
960	section by reason of the dissemination by him or her of such
961	false advertisement, unless he or she has refused, on the
962	request of the department, to furnish to the department the name
963	and post office address of the manufacturer, wholesaler, seller,
964	or advertising agency that asked him or her to disseminate such
965	advertisement.
966	(12)499.0691  ADULTERATED AND MISBRANDED DRUGS; FALSE
967	ADVERTISEMENT; FAILURE TO MAINTAIN RECORDS RELATING TO DRUGS
968	Criminal punishment for violations related to drugs;
969	dissemination of false advertisement.--(1)  Any person who
970	violates any of the following provisions commits a misdemeanor
971	of the second degree, punishable as provided in s. 775.082 or s.
972	775.083; but, if the violation is committed after a conviction
973	of such person under this subsection section has become final,
974	such person commits a misdemeanor of the first degree,
975	punishable as provided in s. 775.082 or s. 775.083, or as
976	otherwise provided in this part ss. 499.001-499.081:
977	(a)  The manufacture, repackaging, sale, delivery, or
978	holding or offering for sale of any drug that is adulterated or
979	misbranded or has otherwise been rendered unfit for human or
980	animal use.
981	(b)  The adulteration or misbranding of any drug intended
982	for further distribution.
983	(c)  The receipt of any drug that is adulterated or
984	misbranded, and the delivery or proffered delivery of such drug,
985	for pay or otherwise.
986	(d)  The dissemination of any false or misleading
987	advertisement of a drug.
988	(e)  The use, on the labeling of any drug or in any
989	advertisement relating to such drug, of any representation or
990	suggestion that an application of the drug is effective when it
991	is not or that the drug complies with this part ss. 499.001-
992	499.081 when it does not.
993	(f)  The purchase or receipt of a compressed medical gas
994	from a person that is not authorized under this chapter to
995	distribute compressed medical gases.
996	(g)  Charging a dispensing fee for dispensing,
997	administering, or distributing a prescription drug sample.
998	(h)  The failure to maintain records related to a drug as
999	required by this part ss. 499.001-499.081 and rules adopted
1000	under this part those sections, except for pedigree papers,
1001	invoices, or shipping documents related to prescription legend
1002	drugs.
1003	(i)  The possession of any drug in violation of this part
1004	ss. 499.001-499.081, except if the violation relates to a
1005	deficiency in pedigree papers.
1006	(13)  REFUSAL TO ALLOW INSPECTION; SELLING, PURCHASING, OR
1007	TRADING DRUG SAMPLES; FAILURE TO MAINTAIN RECORDS RELATING TO
1008	PRESCRIPTION DRUGS.--(2)  Any person who violates any of the
1009	following provisions commits a felony of the third degree,
1010	punishable as provided in s. 775.082, s. 775.083, or s. 775.084,
1011	or as otherwise provided in this part: ss. 499.001-499.081.
1012	(a)  The refusal or constructive refusal to allow:
1013	1.  The department to enter or inspect an establishment in
1014	which drugs are manufactured, processed, repackaged, sold,
1015	brokered, or held;
1016	2.  Inspection of any record of that establishment;
1017	3.  The department to enter and inspect any vehicle that is
1018	being used to transport drugs; or
1019	4.  The department to take samples of any drug.
1020	(b)  The sale, purchase, or trade, or the offer to sell,
1021	purchase, or trade, a drug sample as defined in s. 499.028; the
1022	distribution of a drug sample in violation of s. 499.028; or the
1023	failure to otherwise comply with s. 499.028.
1024	(c)  Providing the department with false or fraudulent
1025	records, or making false or fraudulent statements, regarding any
1026	matter within the provisions of this part chapter related to a
1027	drug.
1028	(d)  The failure to receive, maintain, or provide invoices
1029	and shipping documents, other than pedigree papers, if
1030	applicable, related to the distribution of a prescription legend
1031	drug.
1032	(e)  The importation of a prescription legend drug for
1033	wholesale distribution, except as provided by s. 801(d) of the
1034	Federal Food, Drug, and Cosmetic Act.
1035	(f)  The wholesale distribution of a any prescription drug
1036	that was:
1037	1.  Purchased by a public or private hospital or other
1038	health care entity; or
1039	2.  Donated or supplied at a reduced price to a charitable
1040	organization.
1041	(g)  The failure to obtain a permit as a prescription drug
1042	wholesale distributor wholesaler when a permit is required by
1043	this part ss. 499.001-499.081 for that activity.
1044	(h)  Knowingly possessing any adulterated or misbranded
1045	prescription legend drug outside of a designated quarantine
1046	area.
1047	(i)  The purchase or sale of a prescription drug drugs for
1048	wholesale distribution in exchange for currency, as defined in
1049	s. 560.103(6).
1050	(14)  OTHER VIOLATIONS.--(3)  Any person who violates any
1051	of the following provisions commits a felony of the second
1052	degree, punishable as provided in s. 775.082, s. 775.083, or s.
1053	775.084, or as otherwise provided in this part: ss. 499.001-
1054	499.081.
1055	(a)  Knowingly manufacturing, repackaging, selling,
1056	delivering, or holding or offering for sale any drug that is
1057	adulterated or misbranded or has otherwise been rendered unfit
1058	for human or animal use.
1059	(b)  Knowingly adulterating a drug that is intended for
1060	further distribution.
1061	(c)  Knowingly receiving a drug that is adulterated and
1062	delivering or proffering delivery of such drug for pay or
1063	otherwise.
1064	(d)  Committing any act that causes a drug to be a
1065	counterfeit drug, or selling, dispensing, or knowingly holding
1066	for sale a counterfeit drug.
1067	(e)  Forging, counterfeiting, simulating, or falsely
1068	representing any drug, or, without the authority of the
1069	manufacturer, using any mark, stamp, tag, label, or other
1070	identification device authorized or required by rules adopted
1071	under this part ss. 499.001-499.081.
1072	(f)  Knowingly obtaining or attempting to obtain a
1073	prescription drug for wholesale distribution by fraud, deceit,
1074	misrepresentation, or subterfuge, or engaging in
1075	misrepresentation or fraud in the distribution of a drug.
1076	(g)  Removing a pharmacy's dispensing label from a
1077	dispensed prescription drug with the intent to further
1078	distribute the prescription drug.
1079	(h)  Knowingly distributing a prescription drug that was
1080	previously dispensed by a licensed pharmacy, unless such
1081	distribution was authorized in chapter 465 or the rules adopted
1082	under chapter 465.
1083	(15)  FALSE ADVERTISEMENT.--(4)  A publisher, radio
1084	broadcast licensee, or agency or medium for the dissemination of
1085	an advertisement, except the manufacturer, repackager, wholesale
1086	distributor wholesaler, or seller of the article to which a
1087	false advertisement relates, is not liable under subsection
1088	(12), subsection (13), or subsection (14) this section by reason
1089	of the dissemination by him or her of such false advertisement,
1090	unless he or she has refused, on the request of the department,
1091	to furnish to the department the name and post office address of
1092	the manufacturer, repackager, wholesale distributor wholesaler,
1093	seller, or advertising agency that asked him or her to
1094	disseminate such advertisement.
1095	Section 5.  Section 499.0054, Florida Statutes, is amended;
1096	section 499.0055, Florida Statutes, is redesignated as
1097	subsection (2) of that section and amended; and section
1098	499.0057, Florida Statutes, is redesignated as subsection (3) of
1099	that section and amended, to read:
1100	499.0054  Advertising and labeling of drugs, devices, and
1101	cosmetics; exemptions.--
1102	(1)  It is a violation of the Florida Drug and Cosmetic Act
1103	to perform or cause the performance of any of the following
1104	acts:
1105	(a)(1)  The dissemination of any false advertisement of any
1106	drug, device, or cosmetic. An advertisement is false if it is
1107	false or misleading in any way.
1108	(b)(2)  The distribution in commerce of any drug, device,
1109	or cosmetic, if its labeling or advertising is in violation of
1110	this part ss. 499.001-499.081.
1111	(c)(3)  The manufacturing, repackaging, packaging, selling,
1112	delivery, holding, or offering for sale of any drug, device, or
1113	cosmetic for which the advertising or labeling is false or
1114	misleading.
1115	(d)(4)  The advertising of any drug, device, or cosmetic
1116	that is adulterated or misbranded.
1117	(e)(5)  The receiving in commerce of any drug, device, or
1118	cosmetic that is falsely advertised or labeled or the delivering
1119	or proffering for delivery of any such drug, device, or
1120	cosmetic.
1121	(f)(6)  The advertising or labeling of any product
1122	containing ephedrine, a salt of ephedrine, an isomer of
1123	ephedrine, or a salt of an isomer of ephedrine, for the
1124	indication of stimulation, mental alertness, weight loss,
1125	appetite control, energy, or other indications not approved by
1126	the pertinent United States Food and Drug Administration Over-
1127	the-Counter Final or Tentative Final Monograph or approved new
1128	drug application under the federal act. In determining
1129	compliance with this requirement, the department may consider
1130	the following factors:
1131	1.(a)  The packaging of the product.
1132	2.(b)  The name and labeling of the product.
1133	3.(c)  The manner of distribution, advertising, and
1134	promotion of the product, including verbal representations at
1135	the point of sale.
1136	4.(d)  The duration, scope, and significance of abuse of
1137	the particular product.
1138	(g)(7)  The advertising of any drug or device represented
1139	to have any effect in any of the following conditions,
1140	disorders, diseases, or processes:
1141	1.(a)  Blood disorders.
1142	2.(b)  Bone or joint diseases.
1143	3.(c)  Kidney diseases or disorders.
1144	4.(d)  Cancer.
1145	5.(e)  Diabetes.
1146	6.(f)  Gall bladder diseases or disorders.
1147	7.(g)  Heart and vascular diseases.
1148	8.(h)  High blood pressure.
1149	9.(i)  Diseases or disorders of the ear or auditory
1150	apparatus, including hearing loss or deafness.
1151	10.(j)  Mental disease or mental retardation.
1152	11.(k)  Paralysis.
1153	12.(l)  Prostate gland disorders.
1154	13.(m)  Conditions of the scalp affecting hair loss.
1155	14.(n)  Baldness.
1156	15.(o)  Endocrine disorders.
1157	16.(p)  Sexual impotence.
1158	17.(q)  Tumors.
1159	18.(r)  Venereal diseases.
1160	19.(s)  Varicose ulcers.
1161	20.(t)  Breast enlargement.
1162	21.(u)  Purifying blood.
1163	22.(v)  Metabolic disorders.
1164	23.(w)  Immune system disorders or conditions affecting the
1165	immune system.
1166	24.(x)  Extension of life expectancy.
1167	25.(y)  Stress and tension.
1168	26.(z)  Brain stimulation or performance.
1169	27.(aa)  The body's natural defense mechanisms.
1170	28.(bb)  Blood flow.
1171	29.(cc)  Depression.
1172	30.(dd)  Human immunodeficiency virus or acquired immune
1173	deficiency syndrome or related disorders or conditions.
1174	(h)(8)  The representation or suggestion in labeling or
1175	advertising that an article is approved under this part ss.
1176	499.001-499.081, when such is not the case.
1177	(2)499.0055  False or misleading advertisement.--In
1178	determining whether an advertisement is false or misleading, the
1179	department shall review the representations made or suggested by
1180	statement, word, design, device, sound, or any combination
1181	thereof within the advertisement and the extent to which the
1182	advertisement fails to reveal material facts with respect to
1183	consequences that can result from the use of the drug, device,
1184	or cosmetic to which the advertisement relates under the
1185	conditions of use prescribed in the labeling or advertisement.
1186	(3)499.0057  Advertisement exemptions.--
1187	(a)(1)  An advertisement that is not prohibited under
1188	paragraph (1)(a) s. 499.0054(1) is not prohibited under
1189	paragraph (1)(g) s. 499.0054(7) if it is disseminated:
1190	1.  To the public solely to advertise the product for those
1191	indications that are safe and effective indications and the
1192	product is safe and effective for self-medication, as
1193	established by the United States Food and Drug Administration;
1194	or
1195	2.  if it is disseminated Only to members of the medical,
1196	dental, pharmaceutical, or veterinary professions or appears
1197	only in the scientific periodicals of these professions.
1198	(b)(2)  Compliance with this part ss. 499.001-499.081 and
1199	the rules adopted under this part those sections creates no
1200	legal presumption that a drug or device is safe or effective.
1201	Section 6.  Subsections (3), (10), and (11) of section
1202	499.006, Florida Statutes, are amended to read:
1203	499.006  Adulterated drug or device.--A drug or device is
1204	adulterated:
1205	(3)  If it is a drug and the methods used in, or the
1206	facilities or controls used for, its manufacture, processing,
1207	packing, or holding do not conform to, or are not operated or
1208	administered in conformity with, current good manufacturing
1209	practices to assure that the drug meets the requirements of this
1210	part ss. 499.001-499.081 and that the drug has the identity and
1211	strength, and meets the standard of quality and purity, which it
1212	purports or is represented to possess;
1213	(10)  If it is a prescription legend drug for which the
1214	required pedigree paper is nonexistent, fraudulent, or
1215	incomplete under the requirements of this part ss. 499.001-
1216	499.081 or applicable rules, or that has been purchased, held,
1217	sold, or distributed at any time by a person not authorized
1218	under federal or state law to do so; or
1219	(11)  If it is a prescription drug subject to, defined by,
1220	or described by s. 503(b) of the Federal Food, Drug, and
1221	Cosmetic Act which has been returned by a veterinarian to a
1222	limited prescription drug veterinary wholesale distributor
1223	wholesaler.
1224	Section 7.  Section 499.007, Florida Statutes, is amended
1225	to read:
1226	499.007  Misbranded drug or device.--A drug or device is
1227	misbranded:
1228	(1)  If its labeling is in any way false or misleading.
1229	(2)  Unless, If in package form, it does not bear bears a
1230	label containing:
1231	(a)  The name and place of business of the manufacturer,
1232	repackager, or distributor of the finished dosage form of the
1233	drug. For the purpose of this paragraph, the finished dosage
1234	form of a prescription medicinal drug is that form of the drug
1235	which is, or is intended to be, dispensed or administered to the
1236	patient and requires no further manufacturing or processing
1237	other than packaging, reconstitution, and labeling; and
1238	(b)  An accurate statement of the quantity of the contents
1239	in terms of weight, measure, or numerical count.; However, under
1240	this section, reasonable variations are permitted, and the
1241	department shall establish by rule exemptions for small
1242	packages.
1243	(3)  If it is an active pharmaceutical ingredient in bulk
1244	form and does not bear a label containing:
1245	(a)  The name and place of business of the manufacturer,
1246	repackager, or distributor; and
1247	(b)  An accurate statement of the quantity of the contents
1248	in terms of weight, measure, or numerical count.
1249	(4)(3)  If any word, statement, or other information
1250	required by or under this part ss. 499.001-499.081 to appear on
1251	the label or labeling is not prominently placed thereon with
1252	such conspicuousness as compared with other words, statements,
1253	designs, or devices in the labeling, and in such terms, as to
1254	render the word, statement, or other information likely to be
1255	read and understood under customary conditions of purchase and
1256	use.
1257	(5)(4)  If it is a drug and is not designated solely by a
1258	name recognized in an official compendium and, unless its label
1259	does not bear bears:
1260	(a)  The common or usual name of the drug, if any; and
1261	(b)  In case it is fabricated from two or more ingredients,
1262	the common or usual name and quantity of each active ingredient.
1263	(6)(5)  If Unless its labeling does not bear bears:
1264	(a)  Adequate directions for use; and
1265	(b)  Adequate warnings against use in those pathological
1266	conditions in which its use may be dangerous to health or
1267	against use by children if its use may be dangerous to health,
1268	or against unsafe dosage or methods or duration of
1269	administration or application, in such manner and form as are
1270	necessary for the protection of users.
1271	(7)(6)  If it purports to be a drug the name of which is
1272	recognized in the official compendium and, unless it is not
1273	packaged and labeled as prescribed therein.; However, the method
1274	of packaging may be modified with the consent of the department.
1275	(8)(7)  If it has been found by the department to be a drug
1276	liable to deterioration and, unless it is not packaged in such
1277	form and manner, and its label bears a statement of such
1278	precautions, as the department by rule requires as necessary to
1279	protect the public health. Such rule may not be established for
1280	any drug recognized in an official compendium until the
1281	department has informed the appropriate body charged with the
1282	revision of such compendium of the need for such packaging or
1283	labeling requirements and that body has failed within a
1284	reasonable time to prescribe such requirements.
1285	(9)(8)  If it is:
1286	(a)  A drug and its container or finished dosage form is so
1287	made, formed, or filled as to be misleading;
1288	(b)  An imitation of another drug; or
1289	(c)  Offered for sale under the name of another drug.
1290	(10)(9)  If it is dangerous to health when used in the
1291	dosage or with the frequency or duration prescribed,
1292	recommended, or suggested in the labeling of the drug.
1293	(11)(10)  If it is, purports to be, or is represented as a
1294	drug composed wholly or partly of insulin and, unless:
1295	(a)  it is not from a batch with respect to which a
1296	certificate has been issued pursuant to s. 506 of the federal
1297	act, which; and
1298	(b)  The certificate is in effect with respect to the drug.
1299	(12)(11)  If it is, purports to be, or is represented as a
1300	drug composed wholly or partly of any kind of antibiotic
1301	requiring certification under the federal act and unless:
1302	(a)  it is not from a batch with respect to which a
1303	certificate has been issued pursuant to s. 507 of the federal
1304	act, which; and
1305	(b)  the certificate is in effect with respect to the
1306	drug.;
1307
1308	However, this subsection does not apply to any drug or class of
1309	drugs exempted by regulations adopted under s. 507(c) or (d) of
1310	the federal act.
1311	(13)(12)  If it is a drug intended for use by humans which
1312	is a habit-forming drug or which, because of its toxicity or
1313	other potentiality for harmful effect, or the method of its use,
1314	or the collateral measures necessary to its use, is not safe for
1315	use except under the supervision of a practitioner licensed by
1316	law to administer such drugs,; or which is limited by an
1317	effective application under s. 505 of the federal act to use
1318	under the professional supervision of a practitioner licensed by
1319	law to prescribe such drug, if unless it is not dispensed only:
1320	(a)  Upon the written prescription of a practitioner
1321	licensed by law to prescribe such drug;
1322	(b)  Upon an oral prescription of such practitioner, which
1323	is reduced promptly to writing and filled by the pharmacist; or
1324	(c)  By refilling any such written or oral prescription, if
1325	such refilling is authorized by the prescriber either in the
1326	original prescription or by oral order which is reduced promptly
1327	to writing and filled by the pharmacist.
1328
1329	This subsection does not relieve any person from any requirement
1330	prescribed by law with respect to controlled substances as
1331	defined in the applicable federal and state laws.
1332	(14)(13)  If it is a drug that is subject to paragraph
1333	(13)(12)(a), and if, at any time before it is dispensed, its
1334	label does not fails to bear the statement:
1335	(a)  "Caution: Federal Law Prohibits Dispensing Without
1336	Prescription";
1337	(b)  "Rx Only";
1338	(c)  The prescription symbol followed by the word "Only";
1339	or
1340	(d)  "Caution: State Law Prohibits Dispensing Without
1341	Prescription."
1342	(15)(14)  If it is a drug that is not subject to paragraph
1343	(13)(12)(a), if at any time before it is dispensed its label
1344	bears the statement of caution required in subsection (14) (13).
1345	(16)(15)  If it is a color additive, the intended use of
1346	which in or on drugs is for the purpose of coloring only and,
1347	unless its packaging and labeling are not in conformity with the
1348	packaging and labeling requirements that apply to such color
1349	additive and are prescribed under the federal act.
1350	(17)  A drug dispensed by filling or refilling a written or
1351	oral prescription of a practitioner licensed by law to prescribe
1352	such drug is exempt from the requirements of this section,
1353	except subsections (1), (9) (8), (11) (10), and (12) (11) and
1354	the packaging requirements of subsections (7) (6) and (8) (7),
1355	if the drug bears a label that contains the name and address of
1356	the dispenser or seller, the prescription number and the date
1357	the prescription was written or filled, the name of the
1358	prescriber and the name of the patient, and the directions for
1359	use and cautionary statements. This exemption does not apply to
1360	any drug dispensed in the course of the conduct of a business of
1361	dispensing drugs pursuant to diagnosis by mail or to any drug
1362	dispensed in violation of subsection (13) (12). The department
1363	may, by rule, exempt drugs subject to s. 499.062 ss. 499.062-
1364	499.064 from subsection (13) (12) if compliance with that
1365	subsection is not necessary to protect the public health,
1366	safety, and welfare.
1367	Section 8.  Subsection (1) of section 499.008, Florida
1368	Statutes, is amended and subsection (5) is added to that section
1369	to read:
1370	499.008  Adulterated cosmetics.--A cosmetic is adulterated:
1371	(1)  If it bears or contains any poisonous or deleterious
1372	substance that is injurious to users under the conditions of use
1373	prescribed in the labeling or advertisement thereof or under
1374	such conditions of use as are customary or usual; however, this
1375	subsection does not apply to coal-tar hair dye:
1376	(a)  The label of which bears the following legend
1377	conspicuously displayed thereon: "Caution: This product contains
1378	ingredients which may cause skin irritation on certain
1379	individuals, and a preliminary test according to accompanying
1380	directions should first be made. This product must not be used
1381	for dyeing the eyelashes or eyebrows; to do so may cause
1382	blindness"; and
1383	(b)  The labeling of which bears adequate directions for
1384	such preliminary testing.
1385
1386	For the purposes of this subsection and subsection (4), the term
1387	"hair dye" does not include eyelash dyes or eyebrow dyes.
1388	(5)  For the purposes of subsections (1) and (4), the term
1389	"hair dye" does not include eyelash dyes or eyebrow dyes.
1390	Section 9.  Subsections (2), (3), and (5) of section
1391	499.009, Florida Statutes, are amended to read:
1392	499.009  Misbranded cosmetics.--A cosmetic is misbranded:
1393	(2)  Unless, If in package form, it does not bear bears a
1394	label containing:
1395	(a)  The name and place of business of the manufacturer,
1396	packer, or distributor;
1397	(b)  An accurate statement of the quantity of the contents
1398	in terms of weight, measure, or numerical count; however, under
1399	this paragraph reasonable variations are permitted, and the
1400	department shall establish by rule exemptions for small
1401	packages; and
1402	(c)  A declaration of ingredients in descending order of
1403	predominance, or as otherwise required by federal law.
1404	(3)  If any word, statement, or other information required
1405	by or under authority of this part ss. 499.001-499.081 to appear
1406	on the label or labeling is not prominently placed thereon with
1407	such conspicuousness as compared with other words, statements,
1408	designs, or devices in the labeling, and in such terms, as to
1409	render the word, statement, or other information likely to be
1410	read and understood by an individual under customary conditions
1411	of purchase and use.
1412	(5)  Unless, If it is a color additive, its packaging and
1413	labeling are not in conformity with the packaging and labeling
1414	requirements applicable to that color additive prescribed under
1415	the federal act. This subsection does not apply to packages of
1416	color additives that, with respect to their use for cosmetics,
1417	are marketed and intended for use only in or on hair dyes.
1418	Section 10.  Section 499.01, Florida Statutes, is amended;
1419	the introductory paragraph and paragraphs (a) through (h) of
1420	subsection (2) of section 499.012, Florida Statutes, are
1421	redesignated as the introductory paragraph and paragraphs (d),
1422	(n), (e), (f), (c), (i), (k), and (l), respectively, of
1423	subsection (2) of that section and amended; paragraphs (b)
1424	through (e) of subsection (2) of section 499.013, Florida
1425	Statutes, are redesignated as paragraphs (p), (o), (q), and (r),
1426	respectively, of subsection (2) of that section and amended; and
1427	section 499.014, Florida Statutes, is redesignated as paragraph
1428	(g) of subsection (2) of that section and amended, to read:
1429	499.01  Permits; applications; renewal; general
1430	requirements.--
1431	(1)  Prior to operating, a permit is required for each
1432	person and establishment that intends to operate as:
1433	(a)  A prescription drug manufacturer;
1434	(b)  A prescription drug repackager;
1435	(c)  A nonresident prescription drug manufacturer;
1436	(d)  A prescription drug wholesale distributor;
1437	(e)  An out-of-state prescription drug wholesale
1438	distributor;
1439	(f)  A retail pharmacy drug wholesale distributor;
1440	(g)  A restricted prescription drug distributor;
1441	(h)  A complimentary drug distributor;
1442	(i)  A freight forwarder;
1443	(j)  A veterinary prescription drug retail establishment;
1444	(k)  A veterinary prescription drug wholesale distributor;
1445	(l)  A limited prescription drug veterinary wholesale
1446	distributor;
1447	(m)  A medical oxygen retail establishment;
1448	(n)  A compressed medical gas wholesale distributor;
1449	(o)  A compressed medical gas manufacturer;
1450	(p)(c)  An over-the-counter drug manufacturer;
1451	(d)  A compressed medical gas manufacturer;
1452	(q)(e)  A device manufacturer;
1453	(r)(f)  A cosmetic manufacturer;
1454	(s)  A third party logistic provider; or
1455	(t)  A health care clinic establishment.
1456	(g)  A prescription drug wholesaler;
1457	(h)  A veterinary prescription drug wholesaler;
1458	(i)  A compressed medical gas wholesaler;
1459	(j)  An out-of-state prescription drug wholesaler;
1460	(k)  A nonresident prescription drug manufacturer;
1461	(l)  A freight forwarder;
1462	(m)  A retail pharmacy drug wholesaler;
1463	(n)  A veterinary legend drug retail establishment;
1464	(o)  A medical oxygen retail establishment;
1465	(p)  A complimentary drug distributor;
1466	(q)  A restricted prescription drug distributor; or
1467	(r)  A limited prescription drug veterinary wholesaler.
1468	(2)  The following types of wholesaler permits are
1469	established:
1470	(a)  Prescription drug manufacturer permit.--A prescription
1471	drug manufacturer permit is required for any person that
1472	manufactures a prescription drug in this state.
1473	1.  A person that operates an establishment permitted as a
1474	prescription drug manufacturer may engage in wholesale
1475	distribution of prescription drugs manufactured at that
1476	establishment and must comply with all the provisions of this
1477	part and the rules adopted under this part that apply to a
1478	wholesale distributor.
1479	2.  A prescription drug manufacturer must comply with all
1480	appropriate state and federal good manufacturing practices.
1481	(b)  Prescription drug repackager permit.--A prescription
1482	drug repackager permit is required for any person that
1483	repackages a prescription drug in this state.
1484	1.  A person that operates an establishment permitted as a
1485	prescription drug repackager may engage in wholesale
1486	distribution of prescription drugs repackaged at that
1487	establishment and must comply with all the provisions of this
1488	part and the rules adopted under this part that apply to a
1489	wholesale distributor.
1490	2.  A prescription drug repackager must comply with all
1491	appropriate state and federal good manufacturing practices.
1492	(c)(e)  Nonresident prescription drug manufacturer
1493	permit.--A nonresident prescription drug manufacturer permit is
1494	required for any person that is a manufacturer of prescription
1495	drugs, or the distribution point for a manufacturer of
1496	prescription drugs unless permitted as a third party logistics
1497	provider, and located outside of this state, or that is an
1498	entity to whom an approved new drug application has been issued
1499	by the United States Food and Drug Administration, or the
1500	contracted manufacturer of the approved new drug application
1501	holder, and located outside the United States, which engages in
1502	the wholesale distribution in this state of the prescription
1503	drugs it manufactures or is responsible for manufacturing. Each
1504	such manufacturer or entity must be permitted by the department
1505	and comply with all the provisions required of a wholesale
1506	distributor under this part ss. 499.001-499.081, except s.
1507	499.01212 s. 499.0121(6)(d).
1508	1.  A person that distributes prescription drugs that it
1509	did not manufacture must also obtain an out-of-state
1510	prescription drug wholesale distributor wholesaler permit
1511	pursuant to this section to engage in the wholesale distribution
1512	of the prescription drugs manufactured by another person and
1513	comply with the requirements of an out-of-state prescription
1514	drug wholesale distributor wholesaler.
1515	2.  Any such person must comply with the licensing or
1516	permitting requirements of the jurisdiction in which the
1517	establishment is located and the federal act, and any product
1518	wholesaled into this state must comply with this part ss.
1519	499.001-499.081. If a person intends to import prescription
1520	drugs from a foreign country into this state, the nonresident
1521	prescription drug manufacturer must provide to the department a
1522	list identifying each prescription drug it intends to import and
1523	document approval by the United States Food and Drug
1524	Administration for such importation.
1525	3.  A nonresident prescription drug manufacturer permit is
1526	not required for a manufacturer to distribute a prescription
1527	drug active pharmaceutical ingredient that it manufactures to a
1528	prescription drug manufacturer permitted in this state in
1529	limited quantities intended for research and development and not
1530	for resale, or human use other than lawful clinical trials and
1531	biostudies authorized and regulated by federal law. A
1532	manufacturer claiming to be exempt from the permit requirements
1533	of this subparagraph and the prescription drug manufacturer
1534	purchasing and receiving the active pharmaceutical ingredient
1535	shall comply with the recordkeeping requirements of s.
1536	499.0121(6), but not the requirements of s. 499.01212. The
1537	prescription drug manufacturer purchasing and receiving the
1538	active pharmaceutical ingredient shall maintain on file a record
1539	of the FDA registration number; the out-of-state license,
1540	permit, or registration number; and, if available, a copy of the
1541	most current FDA inspection report, for all manufacturers from
1542	whom they purchase active pharmaceutical ingredients under this
1543	section. The department shall specify by rule the allowable
1544	number of transactions within a given period of time and the
1545	amount of active pharmaceutical ingredients that qualify as
1546	limited quantities for purposes of this exemption. The failure
1547	to comply with the requirements of this subparagraph, or rules
1548	adopted by the department to administer this subparagraph, for
1549	the purchase of prescription drug active pharmaceutical
1550	ingredients is a violation of s. 499.005(14).
1551	(d)(a)  A Prescription drug wholesale distributor
1552	wholesaler's permit.--A prescription drug wholesale distributor
1553	wholesaler is a wholesale distributor that may engage in the
1554	wholesale distribution of prescription drugs. A prescription
1555	drug wholesale distributor wholesaler that applies to the
1556	department for a new permit or the renewal of a permit must
1557	submit a bond of $100,000, or other equivalent means of security
1558	acceptable to the department, such as an irrevocable letter of
1559	credit or a deposit in a trust account or financial institution,
1560	payable to the Florida Drug, Device, and Cosmetic Trust Fund.
1561	The purpose of the bond is to secure payment of any
1562	administrative penalties imposed by the department and any fees
1563	and costs incurred by the department regarding that permit which
1564	are authorized under state law and which the permittee fails to
1565	pay 30 days after the fine or costs become final. The department
1566	may make a claim against such bond or security until 1 year
1567	after the permittee's license ceases to be valid or until 60
1568	days after any administrative or legal proceeding authorized in
1569	this part ss. 499.001-499.081 which involves the permittee is
1570	concluded, including any appeal, whichever occurs later. The
1571	department may adopt rules for issuing a prescription drug
1572	wholesale distributor-broker wholesaler-broker permit to a
1573	person who engages in the wholesale distribution of prescription
1574	drugs and does not take physical possession of any prescription
1575	drugs.
1576	(e)(c)  An Out-of-state prescription drug wholesale
1577	distributor wholesaler's permit.--An out-of-state prescription
1578	drug wholesale distributor wholesaler is a wholesale distributor
1579	located outside this state which engages in the wholesale
1580	distribution of prescription drugs into this state and which
1581	must be permitted by the department and comply with all the
1582	provisions required of a wholesale distributor under this part
1583	ss. 499.001-499.081. An out-of-state prescription drug wholesale
1584	distributor wholesaler that applies to the department for a new
1585	permit or the renewal of a permit must submit a bond of
1586	$100,000, or other equivalent means of security acceptable to
1587	the department, such as an irrevocable letter of credit or a
1588	deposit in a trust account or financial institution, payable to
1589	the Florida Drug, Device, and Cosmetic Trust Fund. The purpose
1590	of the bond is to secure payment of any administrative penalties
1591	imposed by the department and any fees and costs incurred by the
1592	department regarding that permit which are authorized under
1593	state law and which the permittee fails to pay 30 days after the
1594	fine or costs become final. The department may make a claim
1595	against such bond or security until 1 year after the permittee's
1596	license ceases to be valid or until 60 days after any
1597	administrative or legal proceeding authorized in this part ss.
1598	499.001-499.081 which involves the permittee is concluded,
1599	including any appeal, whichever occurs later.
1600	1.  The out-of-state prescription drug wholesale
1601	distributor wholesaler must maintain at all times a license or
1602	permit to engage in the wholesale distribution of prescription
1603	drugs in compliance with laws of the state in which it is a
1604	resident.
1605	2.  An out-of-state prescription drug wholesale distributor
1606	wholesaler's permit is not required for an intracompany sale or
1607	transfer of a prescription drug from an out-of-state
1608	establishment that is duly licensed as a prescription drug
1609	wholesale distributor wholesaler, in its state of residence, to
1610	a licensed prescription drug wholesale distributor wholesaler in
1611	this state, if both wholesale distributors wholesalers conduct
1612	wholesale distributions of prescription drugs under the same
1613	business name. The recordkeeping requirements of ss. s.
1614	499.0121(6) and 499.01212 must be followed for this transaction.
1615	(f)(d)  A Retail pharmacy drug wholesale distributor
1616	wholesaler's permit.--A retail pharmacy drug wholesale
1617	distributor wholesaler is a retail pharmacy engaged in wholesale
1618	distribution of prescription drugs within this state under the
1619	following conditions:
1620	1.  The pharmacy must obtain a retail pharmacy drug
1621	wholesale distributor wholesaler's permit pursuant to this part
1622	ss. 499.001-499.081 and the rules adopted under this part those
1623	sections.
1624	2.  The wholesale distribution activity does not exceed 30
1625	percent of the total annual purchases of prescription drugs. If
1626	the wholesale distribution activity exceeds the 30-percent
1627	maximum, the pharmacy must obtain a prescription drug wholesale
1628	distributor wholesaler's permit.
1629	3.  The transfer of prescription drugs that appear in any
1630	schedule contained in chapter 893 is subject to chapter 893 and
1631	the federal Comprehensive Drug Abuse Prevention and Control Act
1632	of 1970.
1633	4.  The transfer is between a retail pharmacy and another
1634	retail pharmacy, or a Modified Class II institutional pharmacy,
1635	or a health care practitioner licensed in this state and
1636	authorized by law to dispense or prescribe prescription drugs.
1637	5.  All records of sales of prescription drugs subject to
1638	this section must be maintained separate and distinct from other
1639	records and comply with the recordkeeping requirements of this
1640	part ss. 499.001-499.081.
1641	(g)499.014  Restricted prescription drug distributor permit
1642	Distribution of legend drugs by hospitals, health care entities,
1643	charitable organizations, and return or destruction companies;
1644	permits, general requirements.--
1645	(1)  A restricted prescription drug distributor permit is
1646	required for any person that engages in the distribution of a
1647	prescription legend drug, which distribution is not considered
1648	"wholesale distribution" under s. 499.003(53)(a) s.
1649	499.012(1)(a)1.
1650	1.(2)  A person who engages in the receipt or distribution
1651	of a prescription legend drug in this state for the purpose of
1652	processing its return or its destruction must obtain a permit as
1653	a restricted prescription drug distributor if such person is not
1654	the person initiating the return, the prescription drug
1655	wholesale supplier of the person initiating the return, or the
1656	manufacturer of the drug.
1657	2.(3)  Storage, handling, and recordkeeping of these
1658	distributions must comply with the requirements for wholesale
1659	distributors under s. 499.0121, but not except those set forth
1660	in s. 499.01212 s. 499.0121(6)(d).
1661	3.(4)  A person who applies for a permit as a restricted
1662	prescription drug distributor, or for the renewal of such a
1663	permit, must provide to the department the information required
1664	under s. 499.012 s. 499.01.
1665	4.(5)  The department may issue permits to restricted
1666	prescription drug distributors and may adopt rules regarding the
1667	distribution of prescription drugs by hospitals, health care
1668	entities, charitable organizations, or other persons not
1669	involved in wholesale distribution, which rules are necessary
1670	for the protection of the public health, safety, and welfare.
1671	(h)  Complimentary drug distributor permit.--A
1672	complimentary drug distributor permit is required for any person
1673	that engages in the distribution of a complimentary drug,
1674	subject to the requirements of s. 499.028.
1675	(i)(f)  Freight forwarder permit.--A freight forwarder
1676	permit is required for any person that engages in the
1677	distribution of a prescription legend drug as a freight
1678	forwarder unless the person is a common carrier. The storage,
1679	handling, and recordkeeping of such distributions must comply
1680	with the requirements for wholesale distributors under s.
1681	499.0121, but not except those set forth in s. 499.01212 s.
1682	499.0121(6)(d). A freight forwarder must provide the source of
1683	the prescription legend drugs with a validated airway bill, bill
1684	of lading, or other appropriate documentation to evidence the
1685	exportation of the product.
1686	(j)  Veterinary prescription drug retail establishment
1687	permit.--A veterinary prescription drug retail establishment
1688	permit is required for any person that sells veterinary
1689	prescription drugs to the public but does not include a pharmacy
1690	licensed under chapter 465.
1691	1.  The sale to the public must be based on a valid written
1692	order from a veterinarian licensed in this state who has a valid
1693	client-veterinarian relationship with the purchaser's animal.
1694	2.  Veterinary prescription drugs may not be sold in excess
1695	of the amount clearly indicated on the order or beyond the date
1696	indicated on the order.
1697	3.  An order may not be valid for more than 1 year.
1698	4.  A veterinary prescription drug retail establishment may
1699	not purchase, sell, trade, or possess human prescription drugs
1700	or any controlled substance as defined in chapter 893.
1701	5.  A veterinary prescription drug retail establishment
1702	must sell a veterinary prescription drug in the original, sealed
1703	manufacturer's container with all labeling intact and legible.
1704	The department may adopt by rule additional labeling
1705	requirements for the sale of a veterinary prescription drug.
1706	6.  A veterinary prescription drug retail establishment
1707	must comply with all of the wholesale distribution requirements
1708	of s. 499.0121.
1709	7.  Prescription drugs sold by a veterinary prescription
1710	drug retail establishment pursuant to a practitioner's order may
1711	not be returned into the retail establishment's inventory.
1712	(k)(g)  A veterinary prescription drug wholesale
1713	distributor wholesaler permit.--A veterinary prescription drug
1714	wholesale distributor wholesaler permit is required for any
1715	person that engages in the distribution of veterinary
1716	prescription drugs in or into this state. A veterinary
1717	prescription drug wholesale distributor wholesaler that also
1718	distributes prescription drugs subject to, defined by, or
1719	described by s. 503(b) of the Federal Food, Drug, and Cosmetic
1720	Act which it did not manufacture must obtain a permit as a
1721	prescription drug wholesale distributor wholesaler, an out-of-
1722	state prescription drug wholesale distributor wholesaler, or a
1723	limited prescription drug veterinary wholesale distributor
1724	wholesaler in lieu of the veterinary prescription drug wholesale
1725	distributor wholesaler permit. A veterinary prescription drug
1726	wholesale distributor wholesaler must comply with the
1727	requirements for wholesale distributors under s. 499.0121, but
1728	not except those set forth in s. 499.01212 s. 499.0121(6)(d).
1729	(l)(h)  Limited prescription drug veterinary wholesale
1730	distributor wholesaler permit.--Unless engaging in the
1731	activities of and permitted as a prescription drug manufacturer,
1732	nonresident prescription drug manufacturer, prescription drug
1733	wholesale distributor wholesaler, or out-of-state prescription
1734	drug wholesale distributor wholesaler, a limited prescription
1735	drug veterinary wholesale distributor wholesaler permit is
1736	required for any person that engages in the distribution in or
1737	into this state of veterinary prescription drugs and
1738	prescription drugs subject to, defined by, or described by s.
1739	503(b) of the Federal Food, Drug, and Cosmetic Act under the
1740	following conditions:
1741	1.  The person is engaged in the business of wholesaling
1742	prescription and veterinary prescription legend drugs to
1743	persons:
1744	a.  Licensed as veterinarians practicing on a full-time
1745	basis;
1746	b.  Regularly and lawfully engaged in instruction in
1747	veterinary medicine;
1748	c.  Regularly and lawfully engaged in law enforcement
1749	activities;
1750	d.  For use in research not involving clinical use; or
1751	e.  For use in chemical analysis or physical testing or for
1752	purposes of instruction in law enforcement activities, research,
1753	or testing.
1754	2.  No more than 30 percent of total annual prescription
1755	drug sales may be prescription drugs approved for human use
1756	which are subject to, defined by, or described by s. 503(b) of
1757	the Federal Food, Drug, and Cosmetic Act.
1758	3.  The person does not distribute is not permitted,
1759	licensed, or otherwise authorized in any jurisdiction state to
1760	wholesale prescription drugs subject to, defined by, or
1761	described by s. 503(b) of the Federal Food, Drug, and Cosmetic
1762	Act to any person who is authorized to sell, distribute,
1763	purchase, trade, or use these drugs on or for humans.
1764	4.  A limited prescription drug veterinary wholesale
1765	distributor wholesaler that applies to the department for a new
1766	permit or the renewal of a permit must submit a bond of $20,000,
1767	or other equivalent means of security acceptable to the
1768	department, such as an irrevocable letter of credit or a deposit
1769	in a trust account or financial institution, payable to the
1770	Florida Drug, Device, and Cosmetic Trust Fund. The purpose of
1771	the bond is to secure payment of any administrative penalties
1772	imposed by the department and any fees and costs incurred by the
1773	department regarding that permit which are authorized under
1774	state law and which the permittee fails to pay 30 days after the
1775	fine or costs become final. The department may make a claim
1776	against such bond or security until 1 year after the permittee's
1777	license ceases to be valid or until 60 days after any
1778	administrative or legal proceeding authorized in this part ss.
1779	499.001-499.081 which involves the permittee is concluded,
1780	including any appeal, whichever occurs later.
1781	5.  A limited prescription drug veterinary wholesale
1782	distributor wholesaler must maintain at all times a license or
1783	permit to engage in the wholesale distribution of prescription
1784	drugs in compliance with laws of the state in which it is a
1785	resident.
1786	6.  A limited prescription drug veterinary wholesale
1787	distributor wholesaler must comply with the requirements for
1788	wholesale distributors under ss. s. 499.0121 and 499.01212,
1789	except that a limited prescription drug veterinary wholesale
1790	distributor wholesaler is not required to provide a pedigree
1791	paper as required by s. 499.01212 s. 499.0121(6)(d) upon the
1792	wholesale distribution of a prescription drug to a veterinarian.
1793	7.  A limited prescription drug veterinary wholesale
1794	distributor wholesaler may not return to inventory for
1795	subsequent wholesale distribution any prescription drug subject
1796	to, defined by, or described by s. 503(b) of the Federal Food,
1797	Drug, and Cosmetic Act which has been returned by a
1798	veterinarian.
1799	8.  An out-of-state prescription drug wholesaler's permit
1800	or A limited prescription drug veterinary wholesale distributor
1801	wholesaler permit is not required for an intracompany sale or
1802	transfer of a prescription drug from an out-of-state
1803	establishment that is duly licensed to engage in the wholesale
1804	distribution of prescription drugs in its state of residence to
1805	a licensed limited prescription drug veterinary wholesale
1806	distributor wholesaler in this state if both wholesale
1807	distributors wholesalers conduct wholesale distributions of
1808	prescription drugs under the same business name. The
1809	recordkeeping requirements of ss. s. 499.0121(6) and 499.01212
1810	must be followed for this transaction.
1811	(m)  Medical oxygen retail establishment permit.--A medical
1812	oxygen retail establishment permit is required for any person
1813	that sells medical oxygen to patients only. The sale must be
1814	based on an order from a practitioner authorized by law to
1815	prescribe. The term does not include a pharmacy licensed under
1816	chapter 465.
1817	1.  A medical oxygen retail establishment may not possess,
1818	purchase, sell, or trade any prescription drug other than
1819	medical oxygen.
1820	2.  A medical oxygen retail establishment may refill
1821	medical oxygen for an individual patient based on an order from
1822	a practitioner authorized by law to prescribe. A medical oxygen
1823	retail establishment that refills medical oxygen must comply
1824	with all appropriate state and federal good manufacturing
1825	practices.
1826	3.  A medical oxygen retail establishment must comply with
1827	all of the wholesale distribution requirements of s. 499.0121.
1828	4.  Prescription medical oxygen sold by a medical oxygen
1829	retail establishment pursuant to a practitioner's order may not
1830	be returned into the retail establishment's inventory.
1831	(n)(b)  A compressed medical gas wholesale distributor
1832	wholesaler's permit.--A compressed medical gas wholesale
1833	distributor wholesaler is a wholesale distributor that is
1834	limited to the wholesale distribution of compressed medical
1835	gases to other than the consumer or patient. The compressed
1836	medical gas must be in the original sealed container that was
1837	purchased by that wholesale distributor wholesaler. A compressed
1838	medical gas wholesale distributor wholesaler may not possess or
1839	engage in the wholesale distribution of any prescription drug
1840	other than compressed medical gases. The department shall adopt
1841	rules that govern the wholesale distribution of prescription
1842	medical oxygen for emergency use. With respect to the emergency
1843	use of prescription medical oxygen, those rules may not be
1844	inconsistent with rules and regulations of federal agencies
1845	unless the Legislature specifically directs otherwise.
1846	(o)(c)  Compressed medical gas manufacturer permit.--A
1847	compressed medical gas manufacturer manufacturer's permit is
1848	required for any person that engages in the manufacture of
1849	compressed medical gases or repackages compressed medical gases
1850	from one container to another.
1851	1.  A compressed medical gas manufacturer permittee may not
1852	manufacture or possess any prescription drug other than
1853	compressed medical gases.
1854	2.  A compressed medical gas manufacturer permittee may
1855	engage in wholesale distribution of compressed medical gases
1856	manufactured at that establishment and must comply with all the
1857	provisions of this part ss. 499.001-499.081 and the rules
1858	adopted under this part those sections that apply to a wholesale
1859	distributor.
1860	3.  A compressed medical gas manufacturer permittee must
1861	comply with all appropriate state and federal good manufacturing
1862	practices.
1863	(p)(b)  Over-the-counter drug manufacturer permit.--An
1864	over-the-counter drug manufacturer manufacturer's permit is
1865	required for any person that engages in the manufacture or
1866	repackaging of an over-the-counter drug.
1867	1.  An over-the-counter drug manufacturer permittee may not
1868	possess or purchase prescription drugs.
1869	2.  A pharmacy is exempt from obtaining an over-the-counter
1870	drug manufacturer manufacturer's permit if it is operating in
1871	compliance with pharmacy practice standards as defined in
1872	chapter 465 and the rules adopted under that chapter.
1873	3.  An over-the-counter drug manufacturer permittee must
1874	comply with all appropriate state and federal good manufacturing
1875	practices.
1876	(q)(d)  Device manufacturer permit.--A device manufacturer
1877	manufacturer's permit is required for any person that engages in
1878	the manufacture, repackaging, or assembly of medical devices for
1879	human use in this state, except that a permit is not required if
1880	the person is engaged only in manufacturing, repackaging, or
1881	assembling a medical device pursuant to a practitioner's order
1882	for a specific patient.
1883	1.  A manufacturer or repackager of medical devices in this
1884	state must comply with all appropriate state and federal good
1885	manufacturing practices and quality system rules.
1886	2.  The department shall adopt rules related to storage,
1887	handling, and recordkeeping requirements for manufacturers of
1888	medical devices for human use.
1889	(r)(e)  Cosmetic manufacturer permit.--A cosmetic
1890	manufacturer manufacturer's permit is required for any person
1891	that manufactures or repackages cosmetics in this state. A
1892	person that only labels or changes the labeling of a cosmetic
1893	but does not open the container sealed by the manufacturer of
1894	the product is exempt from obtaining a permit under this
1895	paragraph.
1896	(s)  Third party logistics provider permit.--A third party
1897	logistics provider permit is required for any person that
1898	contracts with a prescription drug wholesale distributor or
1899	prescription drug manufacturer to provide warehousing,
1900	distribution, or other logistics services on behalf of a
1901	manufacturer or wholesale distributor, but who does not take
1902	title to the prescription drug or have responsibility to direct
1903	the sale or disposition of the prescription drug. Each third
1904	party logistics provider permittee shall comply with the
1905	requirements for wholesale distributors under ss. 499.0121 and
1906	499.01212, with the exception of those wholesale distributions
1907	described in s. 499.01212(3)(a), and other rules that the
1908	department requires.
1909	(t)  Health care clinic establishment permit.--Effective
1910	January 1, 2009, a health care clinic establishment permit is
1911	required for the purchase of a prescription drug by a place of
1912	business at one general physical location owned and operated by
1913	a professional corporation or professional limited liability
1914	company described in chapter 621, or a corporation that employs
1915	a veterinarian as a qualifying practitioner. For the purpose of
1916	this paragraph, the term "qualifying practitioner" means a
1917	licensed health care practitioner defined in s. 456.001 or a
1918	veterinarian licensed under chapter 474, who is authorized under
1919	the appropriate practice act to prescribe and administer a
1920	prescription drug.
1921	1.  An establishment must provide, as part of the
1922	application required under s. 499.012, designation of a
1923	qualifying practitioner who will be responsible for complying
1924	with all legal and regulatory requirements related to the
1925	purchase, recordkeeping, storage, and handling of the
1926	prescription drugs. In addition, the designated qualifying
1927	practitioner shall be the practitioner whose name, establishment
1928	address, and license number is used on all distribution
1929	documents for prescription drugs purchased or returned by the
1930	health care clinic establishment. Upon initial appointment of a
1931	qualifying practitioner, the qualifying practitioner and the
1932	health care clinic establishment shall notify the department on
1933	a form furnished by the department within 10 days after such
1934	employment. In addition, the qualifying practitioner and health
1935	care clinic establishment shall notify the department within 10
1936	days after any subsequent change.
1937	2.  The health care clinic establishment must employ a
1938	qualifying practitioner at each establishment.
1939	3.  In addition to the remedies and penalties provided in
1940	this part, a violation of this chapter by the health care clinic
1941	establishment or qualifying practitioner constitutes grounds for
1942	discipline of the qualifying practitioner by the appropriate
1943	regulatory board.
1944	4.  The purchase of prescription drugs by the health care
1945	clinic establishment is prohibited during any period of time
1946	when the establishment does not comply with this paragraph.
1947	5.  A health care clinic establishment permit is not a
1948	pharmacy permit or otherwise subject to chapter 465. A health
1949	care clinic establishment that meets the criteria of a modified
1950	Class II institutional pharmacy under s. 465.019 is not eligible
1951	to be permitted under this paragraph.
1952	6.  This paragraph does not prohibit a qualifying
1953	practitioner from purchasing prescription drugs.
1954	Section 11.  Section 499.012, Florida Statutes, is amended
1955	and subsections (2) through (8) of section 499.01, Florida
1956	States, are redesignated as subsections (1) through (7) of that
1957	section and amended, to read:
1958	499.012  Permit application Wholesale distribution;
1959	definitions; permits; applications; general requirements.--
1960	(1)  As used in this section, the term:
1961	(2)(a)  A permit issued pursuant to this part ss. 499.001-
1962	499.081 may be issued only to a natural person who is at least
1963	18 years of age or to an applicant that is not a natural person
1964	if each person who, directly or indirectly, manages, controls,
1965	or oversees the operation of that applicant is at least 18 years
1966	of age.
1967	(b)  An establishment that is a place of residence may not
1968	receive a permit and may not operate under this part ss.
1969	499.001-499.081.
1970	(c)  A person that applies for or renews a permit to
1971	manufacture or distribute prescription legend drugs may not use
1972	a name identical to the name used by any other establishment or
1973	licensed person authorized to purchase prescription drugs in
1974	this state, except that a restricted drug distributor permit
1975	issued to a health care entity will be issued in the name in
1976	which the institutional pharmacy permit is issued and a retail
1977	pharmacy drug wholesale distributor wholesaler will be issued a
1978	permit in the name of its retail pharmacy permit.
1979	(d)  A permit for a prescription drug manufacturer,
1980	prescription drug repackager, prescription drug wholesale
1981	distributor wholesaler, limited prescription drug veterinary
1982	wholesale distributor wholesaler, or retail pharmacy drug
1983	wholesale distributor wholesaler may not be issued to the
1984	address of a health care entity or to a pharmacy licensed under
1985	chapter 465, except as provided in this paragraph. The
1986	department may issue a prescription drug manufacturer permit to
1987	an applicant at the same address as a licensed nuclear pharmacy,
1988	which is a health care entity, for the purpose of manufacturing
1989	prescription drugs used in positron emission tomography or other
1990	radiopharmaceuticals, as listed in a rule adopted by the
1991	department pursuant to this paragraph. The purpose of this
1992	exemption is to assure availability of state-of-the-art
1993	pharmaceuticals that would pose a significant danger to the
1994	public health if manufactured at a separate establishment
1995	address from the nuclear pharmacy from which the prescription
1996	drugs are dispensed. The department may also issue a retail
1997	pharmacy drug wholesale distributor wholesaler permit to the
1998	address of a community pharmacy licensed under chapter 465 which
1999	does not meet the definition of a closed pharmacy in s. 499.003.
2000	(e)  A county or municipality may not issue an occupational
2001	license for any licensing period beginning on or after October
2002	1, 2003, for any establishment that requires a permit pursuant
2003	to this part ss. 499.001-499.081, unless the establishment
2004	exhibits a current permit issued by the department for the
2005	establishment. Upon presentation of the requisite permit issued
2006	by the department, an occupational license may be issued by the
2007	municipality or county in which application is made. The
2008	department shall furnish to local agencies responsible for
2009	issuing occupational licenses a current list of all
2010	establishments licensed pursuant to this part ss. 499.001-
2011	499.081.
2012	(2)(3)  Notwithstanding subsection (6) (7), a permitted
2013	person in good standing may change the type of permit issued to
2014	that person by completing a new application for the requested
2015	permit, paying the amount of the difference in the permit fees
2016	if the fee for the new permit is more than the fee for the
2017	original permit, and meeting the applicable permitting
2018	conditions for the new permit type. The new permit expires on
2019	the expiration date of the original permit being changed;
2020	however, a new permit for a prescription drug wholesale
2021	distributor wholesaler, an out-of-state prescription drug
2022	wholesale distributor wholesaler, or a retail pharmacy drug
2023	wholesale distributor wholesaler shall expire on the expiration
2024	date of the original permit or 1 year after the date of issuance
2025	of the new permit, whichever is earlier. A refund may not be
2026	issued if the fee for the new permit is less than the fee that
2027	was paid for the original permit.
2028	(3)(4)  A written application for a permit or to renew a
2029	permit must be filed with the department on forms furnished by
2030	the department. The department shall establish, by rule, the
2031	form and content of the application to obtain or renew a permit.
2032	The applicant must submit to the department with the application
2033	a statement that swears or affirms that the information is true
2034	and correct.
2035	(4)(5)(a)  Except for a permit for a prescription drug
2036	wholesale distributor wholesaler or an out-of-state prescription
2037	drug wholesale distributor wholesaler, an application for a
2038	permit must include:
2039	1.  The name, full business address, and telephone number
2040	of the applicant;
2041	2.  All trade or business names used by the applicant;
2042	3.  The address, telephone numbers, and the names of
2043	contact persons for each facility used by the applicant for the
2044	storage, handling, and distribution of prescription drugs;
2045	4.  The type of ownership or operation, such as a
2046	partnership, corporation, or sole proprietorship; and
2047	5.  The names of the owner and the operator of the
2048	establishment, including:
2049	a.  If an individual, the name of the individual;
2050	b.  If a partnership, the name of each partner and the name
2051	of the partnership;
2052	c.  If a corporation, the name and title of each corporate
2053	officer and director, the corporate names, and the name of the
2054	state of incorporation;
2055	d.  If a sole proprietorship, the full name of the sole
2056	proprietor and the name of the business entity;
2057	e.  If a limited liability company, the name of each
2058	member, the name of each manager, the name of the limited
2059	liability company, and the name of the state in which the
2060	limited liability company was organized; and
2061	f.  Any other relevant information that the department
2062	requires.
2063	(b)  Upon approval of the application by the department and
2064	payment of the required fee, the department shall issue a permit
2065	to the applicant, if the applicant meets the requirements of
2066	this part ss. 499.001-499.081 and rules adopted under this part
2067	those sections.
2068	(c)  Any change in information required under paragraph (a)
2069	must be submitted to the department before the change occurs.
2070	(d)  The department shall consider, at a minimum, the
2071	following factors in reviewing the qualifications of persons to
2072	be permitted under this part ss. 499.001-499.081:
2073	1.  The applicant's having been found guilty, regardless of
2074	adjudication, in a court of this state or other jurisdiction, of
2075	a violation of a law that directly relates to a drug, device, or
2076	cosmetic. A plea of nolo contendere constitutes a finding of
2077	guilt for purposes of this subparagraph.
2078	2.  The applicant's having been disciplined by a regulatory
2079	agency in any state for any offense that would constitute a
2080	violation of this part ss. 499.001-499.081.
2081	3.  Any felony conviction of the applicant under a federal,
2082	state, or local law;
2083	4.  The applicant's past experience in manufacturing or
2084	distributing drugs, devices, or cosmetics;
2085	5.  The furnishing by the applicant of false or fraudulent
2086	material in any application made in connection with
2087	manufacturing or distributing drugs, devices, or cosmetics;
2088	6.  Suspension or revocation by a federal, state, or local
2089	government of any permit currently or previously held by the
2090	applicant for the manufacture or distribution of any drugs,
2091	devices, or cosmetics;
2092	7.  Compliance with permitting requirements under any
2093	previously granted permits;
2094	8.  Compliance with requirements to maintain or make
2095	available to the state permitting authority or to federal,
2096	state, or local law enforcement officials those records required
2097	under this section; and
2098	9.  Any other factors or qualifications the department
2099	considers relevant to and consistent with the public health and
2100	safety.
2101	(5)(6)  Except for a permit permits for a prescription drug
2102	wholesale distributor wholesalers or an out-of-state
2103	prescription drug wholesale distributor wholesalers:
2104	(a)  The department shall adopt rules for the biennial
2105	renewal of permits.
2106	(b)  The department shall renew a permit upon receipt of
2107	the renewal application and renewal fee if the applicant meets
2108	the requirements established under this part ss. 499.001-499.081
2109	and the rules adopted under this part those sections.
2110	(c)  A permit, unless sooner suspended or revoked,
2111	automatically expires 2 years after the last day of the
2112	anniversary month in which the permit was originally issued. A
2113	permit issued under this part ss. 499.001-499.081 may be renewed
2114	by making application for renewal on forms furnished by the
2115	department and paying the appropriate fees. If a renewal
2116	application and fee are submitted and postmarked after the
2117	expiration date of the permit, the permit may be renewed only
2118	upon payment of a late renewal delinquent fee of $100, plus the
2119	required renewal fee, not later than 60 days after the
2120	expiration date.
2121	(d)  Failure to renew a permit in accordance with this
2122	section precludes any future renewal of that permit. If a permit
2123	issued pursuant to this part section has expired and cannot be
2124	renewed, before an establishment may engage in activities that
2125	require a permit under this part ss. 499.001-499.081, the
2126	establishment must submit an application for a new permit, pay
2127	the applicable application fee, the initial permit fee, and all
2128	applicable penalties, and be issued a new permit by the
2129	department.
2130	(6)(7)  A permit issued by the department is
2131	nontransferable. Each permit is valid only for the person or
2132	governmental unit to which it is issued and is not subject to
2133	sale, assignment, or other transfer, voluntarily or
2134	involuntarily; nor is a permit valid for any establishment other
2135	than the establishment for which it was originally issued.
2136	(a)  A person permitted under this part ss. 499.001-499.081
2137	must notify the department before making a change of address.
2138	The department shall set a change of location fee not to exceed
2139	$100.
2140	(b)1.  An application for a new permit is required when a
2141	majority of the ownership or controlling interest of a permitted
2142	establishment is transferred or assigned or when a lessee agrees
2143	to undertake or provide services to the extent that legal
2144	liability for operation of the establishment will rest with the
2145	lessee. The application for the new permit must be made before
2146	the date of the sale, transfer, assignment, or lease.
2147	2.  A permittee that is authorized to distribute
2148	prescription legend drugs may transfer such drugs to the new
2149	owner or lessee under subparagraph 1. only after the new owner
2150	or lessee has been approved for a permit to distribute
2151	prescription legend drugs.
2152	(c)  If an establishment permitted under this part ss.
2153	499.001-499.081 closes, the owner must notify the department in
2154	writing before the effective date of closure and must:
2155	1.  Return the permit to the department;
2156	2.  If the permittee is authorized to distribute
2157	prescription legend drugs, indicate the disposition of such
2158	drugs, including the name, address, and inventory, and provide
2159	the name and address of a person to contact regarding access to
2160	records that are required to be maintained under this part ss.
2161	499.001-499.081. Transfer of ownership of prescription legend
2162	drugs may be made only to persons authorized to possess
2163	prescription legend drugs under this part ss. 499.001-499.081.
2164
2165	The department may revoke the permit of any person that fails to
2166	comply with the requirements of this subsection.
2167	(7)(8)  A permit must be posted in a conspicuous place on
2168	the licensed premises.
2169	(8)(3)  An application for a permit or to renew a permit
2170	for a prescription drug wholesale distributor wholesaler or an
2171	out-of-state prescription drug wholesale distributor wholesaler
2172	submitted to the department must include:
2173	(a)  The name, full business address, and telephone number
2174	of the applicant.
2175	(b)  All trade or business names used by the applicant.
2176	(c)  The address, telephone numbers, and the names of
2177	contact persons for each facility used by the applicant for the
2178	storage, handling, and distribution of prescription drugs.
2179	(d)  The type of ownership or operation, such as a
2180	partnership, corporation, or sole proprietorship.
2181	(e)  The names of the owner and the operator of the
2182	establishment, including:
2183	1.  If an individual, the name of the individual.
2184	2.  If a partnership, the name of each partner and the name
2185	of the partnership.
2186	3.  If a corporation:
2187	a.  The name, address, and title of each corporate officer
2188	and director.
2189	b.  The name and address of the corporation, resident agent
2190	of the corporation, the resident agent's address, and the
2191	corporation's state of incorporation.
2192	c.  The name and address of each shareholder of the
2193	corporation that owns 5 percent or more of the outstanding stock
2194	of the corporation.
2195	4.  If a sole proprietorship, the full name of the sole
2196	proprietor and the name of the business entity.
2197	5.  If a limited liability company:
2198	a.  The name and address of each member.
2199	b.  The name and address of each manager.
2200	c.  The name and address of the limited liability company,
2201	the resident agent of the limited liability company, and the
2202	name of the state in which the limited liability company was
2203	organized.
2204	(f)  If applicable, the name and address of each member of
2205	the affiliated group of which the applicant is a member.
2206	(g)1.  For an application for a new permit, the estimated
2207	annual dollar volume of prescription drug sales of the
2208	applicant, the estimated annual percentage of the applicant's
2209	total company sales that are prescription drugs, the applicant's
2210	estimated annual total dollar volume of purchases of
2211	prescription drugs, and the applicant's estimated annual total
2212	dollar volume of prescription drug purchases directly from
2213	manufacturers.
2214	2.  For an application to renew a permit, the total dollar
2215	volume of prescription drug sales in the previous year, the
2216	total dollar volume of prescription drug sales made in the
2217	previous 6 months, the percentage of total company sales that
2218	were prescription drugs in the previous year, the total dollar
2219	volume of purchases of prescription drugs in the previous year,
2220	and the total dollar volume of prescription drug purchases
2221	directly from manufacturers in the previous year.
2222
2223	Such portions of the information required pursuant to this
2224	paragraph which are a trade secret, as defined in s. 812.081,
2225	shall be maintained by the department as trade secret
2226	information is required to be maintained under s. 499.051.
2227	(h)  The tax year of the applicant.
2228	(i)  A copy of the deed for the property on which
2229	applicant's establishment is located, if the establishment is
2230	owned by the applicant, or a copy of the applicant's lease for
2231	the property on which applicant's establishment is located that
2232	has an original term of not less than 1 calendar year, if the
2233	establishment is not owned by the applicant.
2234	(j)  A list of all licenses and permits issued to the
2235	applicant by any other state which authorize the applicant to
2236	purchase or possess prescription drugs.
2237	(k)  The name of the manager of the establishment that is
2238	applying for the permit or to renew the permit, the next four
2239	highest ranking employees responsible for prescription drug
2240	wholesale operations for the establishment, and the name of all
2241	affiliated parties for the establishment, together with the
2242	personal information statement and fingerprints required
2243	pursuant to subsection (9) (4) for each of such persons.
2244	(l)  The name of each of the applicant's designated
2245	representatives as required by subsection (16) (11), together
2246	with the personal information statement and fingerprints
2247	required pursuant to subsection (9) (4) for each such person.
2248	(m)  For an applicant that is a secondary wholesale
2249	distributor wholesaler, each of the following:
2250	1.  A personal background information statement containing
2251	the background information and fingerprints required pursuant to
2252	subsection (9) (4) for each person named in the applicant's
2253	response to paragraphs (k) and (l) and for each affiliated party
2254	of the applicant.
2255	2.  If any of the five largest shareholders of the
2256	corporation seeking the permit is a corporation, the name,
2257	address, and title of each corporate officer and director of
2258	each such corporation; the name and address of such corporation;
2259	the name of such corporation's resident agent, such
2260	corporation's resident agent's address, and such corporation's
2261	state of its incorporation; and the name and address of each
2262	shareholder of such corporation that owns 5 percent or more of
2263	the stock of such corporation.
2264	3.  The name and address of all financial institutions in
2265	which the applicant has an account which is used to pay for the
2266	operation of the establishment or to pay for drugs purchased for
2267	the establishment, together with the names of all persons that
2268	are authorized signatories on such accounts. The portions of the
2269	information required pursuant to this subparagraph which are a
2270	trade secret, as defined in s. 812.081, shall be maintained by
2271	the department as trade secret information is required to be
2272	maintained under s. 499.051.
2273	4.  The sources of all funds and the amounts of such funds
2274	used to purchase or finance purchases of prescription drugs or
2275	to finance the premises on which the establishment is to be
2276	located.
2277	5.  If any of the funds identified in subparagraph 4. were
2278	borrowed, copies of all promissory notes or loans used to obtain
2279	such funds.
2280	(n)  Any other relevant information that the department
2281	requires, including, but not limited to, any information related
2282	to whether the applicant satisfies the definition of a primary
2283	wholesale distributor wholesaler or a secondary wholesale
2284	distributor wholesaler.
2285	(9)(4)(a)  Each person required by subsection (8) (3) to
2286	provide a personal information statement and fingerprints shall
2287	provide the following information to the department on forms
2288	prescribed by the department:
2289	1.  The person's places of residence for the past 7 years.
2290	2.  The person's date and place of birth.
2291	3.  The person's occupations, positions of employment, and
2292	offices held during the past 7 years.
2293	4.  The principal business and address of any business,
2294	corporation, or other organization in which each such office of
2295	the person was held or in which each such occupation or position
2296	of employment was carried on.
2297	5.  Whether the person has been, during the past 7 years,
2298	the subject of any proceeding for the revocation of any license
2299	and, if so, the nature of the proceeding and the disposition of
2300	the proceeding.
2301	6.  Whether, during the past 7 years, the person has been
2302	enjoined, either temporarily or permanently, by a court of
2303	competent jurisdiction from violating any federal or state law
2304	regulating the possession, control, or distribution of
2305	prescription drugs, together with details concerning any such
2306	event.
2307	7.  A description of any involvement by the person with any
2308	business, including any investments, other than the ownership of
2309	stock in a publicly traded company or mutual fund, during the
2310	past 7 years, which manufactured, administered, prescribed,
2311	distributed, or stored pharmaceutical products and any lawsuits
2312	in which such businesses were named as a party.
2313	8.  A description of any felony criminal offense of which
2314	the person, as an adult, was found guilty, regardless of whether
2315	adjudication of guilt was withheld or whether the person pled
2316	guilty or nolo contendere. A criminal offense committed in
2317	another jurisdiction which would have been a felony in this
2318	state must be reported. If the person indicates that a criminal
2319	conviction is under appeal and submits a copy of the notice of
2320	appeal of that criminal offense, the applicant must, within 15
2321	days after the disposition of the appeal, submit to the
2322	department a copy of the final written order of disposition.
2323	9.  A photograph of the person taken in the previous 30
2324	days.
2325	10.  A set of fingerprints for the person on a form and
2326	under procedures specified by the department, together with
2327	payment of an amount equal to the costs incurred by the
2328	department for the criminal record check of the person.
2329	11.  The name, address, occupation, and date and place of
2330	birth for each member of the person's immediate family who is 18
2331	years of age or older. As used in this subparagraph, the term
2332	"member of the person's immediate family" includes the person's
2333	spouse, children, parents, siblings, the spouses of the person's
2334	children, and the spouses of the person's siblings.
2335	12.  Any other relevant information that the department
2336	requires.
2337	(b)  The information required pursuant to paragraph (a)
2338	shall be provided under oath.
2339	(c)  The department shall submit the fingerprints provided
2340	by a person for initial licensure to the Department of Law
2341	Enforcement for a statewide criminal record check and for
2342	forwarding to the Federal Bureau of Investigation for a national
2343	criminal record check of the person. The department shall submit
2344	the fingerprints provided by a person as a part of a renewal
2345	application to the Department of Law Enforcement for a statewide
2346	criminal record check, and for forwarding to the Federal Bureau
2347	of Investigation for a national criminal record check, for the
2348	initial renewal of a permit after January 1, 2004; for any
2349	subsequent renewal of a permit, the department shall submit the
2350	required information for a statewide and national criminal
2351	record check of the person. Any person who as a part of an
2352	initial permit application or initial permit renewal after
2353	January 1, 2004, submits to the department a set of fingerprints
2354	required for the criminal record check required in this
2355	paragraph shall not be required to provide a subsequent set of
2356	fingerprints for a criminal record check to the department, if
2357	the person has undergone a criminal record check as a condition
2358	of the issuance of an initial permit or the initial renewal of a
2359	permit of an applicant after January 1, 2004.
2360	(10)(5)  The department may deny an application for a
2361	permit or refuse to renew a permit for a prescription drug
2362	wholesale distributor wholesaler or an out-of-state prescription
2363	drug wholesale distributor wholesaler if:
2364	(a)  The applicant has not met the requirements for the
2365	permit.
2366	(b)  The management, officers, or directors of the
2367	applicant or any affiliated party are found by the department to
2368	be incompetent or untrustworthy.
2369	(c)  The applicant is so lacking in experience in managing
2370	a wholesale distributor as to make the issuance of the proposed
2371	permit hazardous to the public health.
2372	(d)  The applicant is so lacking in experience in managing
2373	a wholesale distributor as to jeopardize the reasonable promise
2374	of successful operation of the wholesale distributor.
2375	(e)  The applicant is lacking in experience in the
2376	distribution of prescription drugs.
2377	(f)  The applicant's past experience in manufacturing or
2378	distributing prescription drugs indicates that the applicant
2379	poses a public health risk.
2380	(g)  The applicant is affiliated directly or indirectly
2381	through ownership, control, or other business relations, with
2382	any person or persons whose business operations are or have been
2383	detrimental to the public health.
2384	(h)  The applicant, or any affiliated party, has been found
2385	guilty of or has pleaded guilty or nolo contendere to any felony
2386	or crime punishable by imprisonment for 1 year or more under the
2387	laws of the United States, any state, or any other country,
2388	regardless of whether adjudication of guilt was withheld.
2389	(i)  The applicant or any affiliated party has been charged
2390	with a felony in a state or federal court and the disposition of
2391	that charge is pending during the application review or renewal
2392	review period.
2393	(j)  The applicant has furnished false or fraudulent
2394	information or material in any application made in this state or
2395	any other state in connection with obtaining a permit or license
2396	to manufacture or distribute drugs, devices, or cosmetics.
2397	(k)  That a federal, state, or local government permit
2398	currently or previously held by the applicant, or any affiliated
2399	party, for the manufacture or distribution of any drugs,
2400	devices, or cosmetics has been disciplined, suspended, or
2401	revoked and has not been reinstated.
2402	(l)  The applicant does not possess the financial or
2403	physical resources to operate in compliance with the permit
2404	being sought, this chapter, and the rules adopted under this
2405	chapter.
2406	(m)  The applicant or any affiliated party receives,
2407	directly or indirectly, financial support and assistance from a
2408	person who was an affiliated party of a permittee whose permit
2409	was subject to discipline or was suspended or revoked, other
2410	than through the ownership of stock in a publicly traded company
2411	or a mutual fund.
2412	(n)  The applicant or any affiliated party receives,
2413	directly or indirectly, financial support and assistance from a
2414	person who has been found guilty of any violation of this part
2415	ss. 499.001-499.081 or chapter 465, chapter 501, or chapter 893,
2416	any rules adopted under any of this part those sections or those
2417	chapters, any federal or state drug law, or any felony where the
2418	underlying facts related to drugs, regardless of whether the
2419	person has been pardoned, had her or his civil rights restored,
2420	or had adjudication withheld, other than through the ownership
2421	of stock in a publicly traded company or a mutual fund.
2422	(o)  The applicant for renewal of a permit under s.
2423	499.01(2)(d) paragraph (2)(a) or s. 499.01(2)(e) paragraph
2424	(2)(c)  has not actively engaged in the wholesale distribution
2425	of prescription drugs, as demonstrated by the regular and
2426	systematic distribution of prescription drugs throughout the
2427	year as evidenced by not fewer than 12 wholesale distributions
2428	in the previous year and not fewer than three wholesale
2429	distributions in the previous 6 months.
2430	(p)  Information obtained in response to s. 499.01(2)(d)
2431	paragraph (2)(a) or s. 499.01(2)(e) paragraph (2)(c)
2432	demonstrates it would not be in the best interest of the public
2433	health, safety, and welfare to issue a permit.
2434	(q)  The applicant does not possess the financial standing
2435	and business experience for the successful operation of the
2436	applicant.
2437	(r)  The applicant or any affiliated party has failed to
2438	comply with the requirements for manufacturing or distributing
2439	prescription drugs under this part ss. 499.001-499.081, similar
2440	federal laws, similar laws in other states, or the rules adopted
2441	under such laws.
2442	(11)(6)  Upon approval of the application by the department
2443	and payment of the required fee, the department shall issue or
2444	renew a prescription drug wholesale distributor wholesaler or an
2445	out-of-state prescription drug wholesale distributor wholesaler
2446	permit to the applicant.
2447	(12)(7)  For a permit permits for a prescription drug
2448	wholesale distributor wholesalers or an out-of-state
2449	prescription drug wholesale distributor wholesalers:
2450	(a)  The department shall adopt rules for the annual
2451	renewal of permits. At least 90 days before the expiration of a
2452	permit, the department shall forward a permit renewal
2453	notification and renewal application to the prescription drug
2454	wholesale distributor wholesaler or out-of-state prescription
2455	drug wholesale distributor wholesaler at the mailing address of
2456	the permitted establishment on file with the department. The
2457	permit renewal notification must state conspicuously the date on
2458	which the permit for the establishment will expire and that the
2459	establishment may not operate unless the permit for the
2460	establishment is renewed timely.
2461	(b)  A permit, unless sooner suspended or revoked,
2462	automatically expires 1 year after the last day of the
2463	anniversary month in which the permit was originally issued. A
2464	permit may be renewed by making application for renewal on forms
2465	furnished by the department and paying the appropriate fees. If
2466	a renewal application and fee are submitted and postmarked after
2467	45 days prior to the expiration date of the permit, the permit
2468	may be renewed only upon payment of a late renewal fee of $100,
2469	plus the required renewal fee. A permittee that has submitted a
2470	renewal application in accordance with this paragraph may
2471	continue to operate under its permit, unless the permit is
2472	suspended or revoked, until final disposition of the renewal
2473	application.
2474	(c)  Failure to renew a permit in accordance with this
2475	section precludes any future renewal of that permit. If a permit
2476	issued pursuant to this section has expired and cannot be
2477	renewed, before an establishment may engage in activities that
2478	require a permit under this part ss. 499.001-499.081, the
2479	establishment must submit an application for a new permit; pay
2480	the applicable application fee, initial permit fee, and all
2481	applicable penalties; and be issued a new permit by the
2482	department.
2483	(13)(8)  A person that engages in wholesale distribution of
2484	prescription drugs in this state must have a wholesale
2485	distributor's permit issued by the department, except as noted
2486	in this section. Each establishment must be separately permitted
2487	except as noted in this subsection.
2488	(a)  A separate establishment permit is not required when a
2489	permitted prescription drug wholesale distributor wholesaler
2490	consigns a prescription drug to a pharmacy that is permitted
2491	under chapter 465 and located in this state, provided that:
2492	1.  The consignor wholesale distributor wholesaler notifies
2493	the department in writing of the contract to consign
2494	prescription drugs to a pharmacy along with the identity and
2495	location of each consignee pharmacy;
2496	2.  The pharmacy maintains its permit under chapter 465;
2497	3.  The consignor wholesale distributor wholesaler, which
2498	has no legal authority to dispense prescription drugs, complies
2499	with all wholesale distribution requirements of ss. s. 499.0121
2500	and 499.01212 with respect to the consigned drugs and maintains
2501	records documenting the transfer of title or other completion of
2502	the wholesale distribution of the consigned prescription drugs;
2503	4.  The distribution of the prescription drug is otherwise
2504	lawful under this chapter and other applicable law;
2505	5.  Open packages containing prescription drugs within a
2506	pharmacy are the responsibility of the pharmacy, regardless of
2507	how the drugs are titled; and
2508	6.  The pharmacy dispenses the consigned prescription drug
2509	in accordance with the limitations of its permit under chapter
2510	465 or returns the consigned prescription drug to the consignor
2511	wholesale distributor wholesaler. In addition, a person who
2512	holds title to prescription drugs may transfer the drugs to a
2513	person permitted or licensed to handle the reverse distribution
2514	or destruction of drugs. Any other distribution by and means of
2515	the consigned prescription drug by any person, not limited to
2516	the consignor wholesale distributor wholesaler or consignee
2517	pharmacy, to any other person is prohibited.
2518	(b)  A wholesale distributor's permit is not required for
2519	the one-time transfer of title of a pharmacy's lawfully acquired
2520	prescription drug inventory by a pharmacy with a valid permit
2521	issued under chapter 465 to a consignor prescription drug
2522	wholesale distributor wholesaler, permitted under this chapter,
2523	in accordance with a written consignment agreement between the
2524	pharmacy and that wholesale distributor wholesaler if: the
2525	permitted pharmacy and the permitted prescription drug wholesale
2526	distributor wholesaler comply with all of the provisions of
2527	paragraph (a) and the prescription drugs continue to be within
2528	the permitted pharmacy's inventory for dispensing in accordance
2529	with the limitations of the pharmacy permit under chapter 465. A
2530	consignor drug wholesale distributor wholesaler may not use the
2531	pharmacy as a wholesale distributor through which it distributes
2532	the prescription legend drugs to other pharmacies. Nothing in
2533	this section is intended to prevent a wholesale drug distributor
2534	from obtaining this inventory in the event of nonpayment by the
2535	pharmacy.
2536	(c)  A separate establishment permit is not required when a
2537	permitted prescription drug wholesale distributor operates
2538	temporary transit storage facilities for the sole purpose of
2539	storage, for up to 16 hours, of a delivery of prescription drugs
2540	when the wholesale distributor was temporarily unable to
2541	complete the delivery to the recipient.
2542	(d)(c)  The department shall require information from each
2543	wholesale distributor as part of the permit and renewal of such
2544	permit, as required under s. 499.01 or this section.
2545	(14)(9)  Personnel employed in wholesale distribution must
2546	have appropriate education and experience to enable them to
2547	perform their duties in compliance with state permitting
2548	requirements.
2549	(15)(10)  The name of a permittee or establishment on a
2550	prescription drug wholesale distributor wholesaler permit or an
2551	out-of-state prescription drug wholesale distributor wholesaler
2552	permit may not include any indicia of attainment of any
2553	educational degree, any indicia that the permittee or
2554	establishment possesses a professional license, or any name or
2555	abbreviation that the department determines is likely to cause
2556	confusion or mistake or that the department determines is
2557	deceptive, including that of any other entity authorized to
2558	purchase prescription drugs.
2559	(16)(11)(a)  Each establishment that is issued an initial
2560	or renewal permit as a prescription drug wholesale distributor
2561	wholesaler or an out-of-state prescription drug wholesale
2562	distributor wholesaler must designate in writing to the
2563	department at least one natural person to serve as the
2564	designated representative of the wholesale distributor
2565	wholesaler. Such person must have an active certification as a
2566	designated representative from the department.
2567	(b)  To be certified as a designated representative, a
2568	natural person must:
2569	1.  Submit an application on a form furnished by the
2570	department and pay the appropriate fees;
2571	2.  Be at least 18 years of age;
2572	3.  Have not less than 2 years of verifiable full-time work
2573	experience in a pharmacy licensed in this state or another
2574	state, where the person's responsibilities included, but were
2575	not limited to, recordkeeping for prescription drugs, or have
2576	not less than 2 years of verifiable full-time managerial
2577	experience with a prescription drug wholesale distributor
2578	wholesaler licensed in this state or in another state;
2579	4.  Receive a passing score of at least 75 percent on an
2580	examination given by the department regarding federal laws
2581	governing distribution of prescription drugs and this part ss.
2582	499.001-499.081 and the rules adopted by the department
2583	governing the wholesale distribution of prescription drugs. This
2584	requirement shall be effective 1 year after the results of the
2585	initial examination are mailed to the persons that took the
2586	examination. The department shall offer such examinations at
2587	least four times each calendar year; and
2588	5.  Provide the department with a personal information
2589	statement and fingerprints pursuant to subsection (9)(4).
2590	(c)  The department may deny an application for
2591	certification as a designated representative or may suspend or
2592	revoke a certification of a designated representative pursuant
2593	to s. 499.067.
2594	(d)  A designated representative:
2595	1.  Must be actively involved in and aware of the actual
2596	daily operation of the wholesale distributor.
2597	2.  Must be employed full time in a managerial position by
2598	the wholesale distributor.
2599	3.  Must be physically present at the establishment during
2600	normal business hours, except for time periods when absent due
2601	to illness, family illness or death, scheduled vacation, or
2602	other authorized absence.
2603	4.  May serve as a designated representative for only one
2604	wholesale distributor at any one time.
2605	(e)  A wholesale distributor must notify the department
2606	when a designated representative leaves the employ of the
2607	wholesale distributor. Such notice must be provided to the
2608	department within 10 business days after the last day of
2609	designated representative's employment with the wholesale
2610	distributor.
2611	(f)  A wholesale distributor may not operate under a
2612	prescription drug wholesale distributor wholesaler permit or an
2613	out-of-state prescription drug wholesale distributor wholesaler
2614	permit for more than 10 business days after the designated
2615	representative leaves the employ of the wholesale distributor,
2616	unless the wholesale distributor employs another designated
2617	representative and notifies the department within 10 business
2618	days of the identity of the new designated representative.
2619	Section 12.  Section 499.01201, Florida Statutes, is
2620	amended to read:
2621	499.01201  Agency for Health Care Administration review and
2622	use of statute and rule violation or compliance
2623	data.--Notwithstanding any other provisions of law to the
2624	contrary, the Agency for Health Care Administration may not:
2625	(1)  Review or use any violation or alleged violation of s.
2626	499.0121(6) or s. 499.01212, or any rules adopted under those
2627	sections that section, as a ground for denying or withholding
2628	any payment of a Medicaid reimbursement to a pharmacy licensed
2629	under chapter 465; or
2630	(2)  Review or use compliance with s. 499.0121(6) or s.
2631	499.01212, or any rules adopted under those sections that
2632	section, as the subject of any audit of Medicaid-related records
2633	held by a pharmacy licensed under chapter 465.
2634	Section 13.  Section 499.0121, Florida Statutes, is
2635	amended, and subsection (4) of section 499.013, Florida
2636	Statutes, is redesignated as paragraph (d) of subsection (6) of
2637	that section and amended, to read:
2638	499.0121  Storage and handling of prescription drugs;
2639	recordkeeping.--The department shall adopt rules to implement
2640	this section as necessary to protect the public health, safety,
2641	and welfare. Such rules shall include, but not be limited to,
2642	requirements for the storage and handling of prescription drugs
2643	and for the establishment and maintenance of prescription drug
2644	distribution records.
2645	(1)  ESTABLISHMENTS.--An establishment at which
2646	prescription drugs are stored, warehoused, handled, held,
2647	offered, marketed, or displayed must:
2648	(a)  Be of suitable size and construction to facilitate
2649	cleaning, maintenance, and proper operations;
2650	(b)  Have storage areas designed to provide adequate
2651	lighting, ventilation, temperature, sanitation, humidity, space,
2652	equipment, and security conditions;
2653	(c)  Have a quarantine area for storage of prescription
2654	drugs that are outdated, damaged, deteriorated, misbranded, or
2655	adulterated, or that are in immediate or sealed, secondary
2656	containers that have been opened;
2657	(d)  Be maintained in a clean and orderly condition; and
2658	(e)  Be free from infestation by insects, rodents, birds,
2659	or vermin of any kind.
2660	(2)  SECURITY.--
2661	(a)  An establishment that is used for wholesale drug
2662	distribution must be secure from unauthorized entry.
2663	1.  Access from outside the premises must be kept to a
2664	minimum and be well-controlled.
2665	2.  The outside perimeter of the premises must be well-
2666	lighted.
2667	3.  Entry into areas where prescription drugs are held must
2668	be limited to authorized personnel.
2669	(b)  An establishment that is used for wholesale drug
2670	distribution must be equipped with:
2671	1.  An alarm system to detect entry after hours; however,
2672	the department may exempt by rule establishments that only hold
2673	a permit as prescription drug wholesale distributor-brokers
2674	wholesaler-brokers and establishments that only handle medical
2675	oxygen; and
2676	2.  A security system that will provide suitable protection
2677	against theft and diversion. When appropriate, the security
2678	system must provide protection against theft or diversion that
2679	is facilitated or hidden by tampering with computers or
2680	electronic records.
2681	(c)  Any vehicle that contains prescription drugs must be
2682	secure from unauthorized access to the prescription drugs in the
2683	vehicle.
2684	(3)  STORAGE.--All prescription drugs shall be stored at
2685	appropriate temperatures and under appropriate conditions in
2686	accordance with requirements, if any, in the labeling of such
2687	drugs, or with requirements in the official compendium.
2688	(a)  If no storage requirements are established for a
2689	prescription drug, the drug may be held at "controlled" room
2690	temperature, as defined in the official compendium, to help
2691	ensure that its identity, strength, quality, and purity are not
2692	adversely affected.
2693	(b)  Appropriate manual, electromechanical, or electronic
2694	temperature and humidity recording equipment, devices, or logs
2695	must be used to document proper storage of prescription drugs.
2696	(c)  The recordkeeping requirements in subsection (6) must
2697	be followed for all stored prescription drugs.
2698	(4)  EXAMINATION OF MATERIALS AND RECORDS.--
2699	(a)  Upon receipt, each outside shipping container must be
2700	visually examined for identity and to prevent the acceptance of
2701	contaminated prescription drugs that are otherwise unfit for
2702	distribution. This examination must be adequate to reveal
2703	container damage that would suggest possible contamination or
2704	other damage to the contents.
2705	(b)  Each outgoing shipment must be carefully inspected for
2706	identity of the prescription drug products and to ensure that
2707	there is no delivery of prescription drugs that have expired or
2708	been damaged in storage or held under improper conditions.
2709	(c)  The recordkeeping requirements in subsection (6) must
2710	be followed for all incoming and outgoing prescription drugs.
2711	(d)  Upon receipt, a wholesale distributor wholesaler must
2712	review records required under this section for the acquisition
2713	of prescription drugs for accuracy and completeness, considering
2714	the total facts and circumstances surrounding the transactions
2715	and the wholesale distributors involved. This includes
2716	authenticating each transaction listed on a pedigree paper, as
2717	defined in s. 499.003(35) s. 499.001(31).
2718	(5)  RETURNED, DAMAGED, OR OUTDATED PRESCRIPTION DRUGS.--
2719	(a)1.  Prescription drugs that are outdated, damaged,
2720	deteriorated, misbranded, or adulterated must be quarantined and
2721	physically separated from other prescription drugs until they
2722	are destroyed or returned to their supplier. A quarantine
2723	section must be separate and apart from other sections where
2724	prescription drugs are stored so that prescription drugs in this
2725	section are not confused with usable prescription drugs.
2726	2.  Prescription drugs must be examined at least every 12
2727	months, and drugs for which the expiration date has passed must
2728	be removed and quarantined.
2729	(b)  Any prescription drugs of which the immediate or
2730	sealed outer containers or sealed secondary containers have been
2731	opened or used must be identified as such and must be
2732	quarantined and physically separated from other prescription
2733	drugs until they are either destroyed or returned to the
2734	supplier.
2735	(c)  If the conditions under which a prescription drug has
2736	been returned cast doubt on the drug's safety, identity,
2737	strength, quality, or purity, the drug must be destroyed or
2738	returned to the supplier, unless examination, testing, or other
2739	investigation proves that the drug meets appropriate standards
2740	of safety, identity, strength, quality, and purity. In
2741	determining whether the conditions under which a drug has been
2742	returned cast doubt on the drug's safety, identity, strength,
2743	quality, or purity, the wholesale drug distributor must
2744	consider, among other things, the conditions under which the
2745	drug has been held, stored, or shipped before or during its
2746	return and the conditions of the drug and its container, carton,
2747	or labeling, as a result of storage or shipping.
2748	(d)  The recordkeeping requirements in subsection (6) must
2749	be followed for all outdated, damaged, deteriorated, misbranded,
2750	or adulterated prescription drugs.
2751	(6)  RECORDKEEPING.--The department shall adopt rules that
2752	require keeping such records of prescription drugs as are
2753	necessary for the protection of the public health.
2754	(a)  Wholesale drug distributors must establish and
2755	maintain inventories and records of all transactions regarding
2756	the receipt and distribution or other disposition of
2757	prescription drugs. These records must provide a complete audit
2758	trail from receipt to sale or other disposition, be readily
2759	retrievable for inspection, and include, at a minimum, the
2760	following information:
2761	1.  The source of the drugs, including the name and
2762	principal address of the seller or transferor, and the address
2763	of the location from which the drugs were shipped;
2764	2.  The name, principal address, and state license permit
2765	or registration number of the person authorized to purchase
2766	prescription drugs;
2767	3.  The name, strength, dosage form, and quantity of the
2768	drugs received and distributed or disposed of;
2769	4.  The dates of receipt and distribution or other
2770	disposition of the drugs; and
2771	5.  Any financial documentation supporting the transaction.
2772	(b)  Inventories and records must be made available for
2773	inspection and photocopying by authorized federal, state, or
2774	local officials for a period of 2 years following disposition of
2775	the drugs or 3 years after the creation of the records,
2776	whichever period is longer.
2777	(c)  Records described in this section that are kept at the
2778	inspection site or that can be immediately retrieved by computer
2779	or other electronic means must be readily available for
2780	authorized inspection during the retention period. Records that
2781	are kept at a central location outside of this state and that
2782	are not electronically retrievable must be made available for
2783	inspection within 2 working days after a request by an
2784	authorized official of a federal, state, or local law
2785	enforcement agency. Records that are maintained at a central
2786	location within this state must be maintained at an
2787	establishment that is permitted pursuant to this part ss.
2788	499.001-499.081 and must be readily available.
2789	(d)(4)  Each manufacturer or repackager of medical devices,
2790	over-the-counter drugs, or cosmetics must maintain records that
2791	include the name and principal address of the seller or
2792	transferor of the product, the address of the location from
2793	which the product was shipped, the date of the transaction, the
2794	name and quantity of the product involved, and the name and
2795	principal address of the person who purchased the product.
2796	(e)  A wholesale distributor must maintain pedigree papers
2797	separate and distinct from other records required under this
2798	chapter.
2799	(d)1. Effective July 1, 2006, each person who is engaged in
2800	the wholesale distribution of a prescription drug and who is not
2801	the manufacturer of that drug must, before each wholesale
2802	distribution of such drug, provide to the person who receives
2803	the drug a pedigree paper as defined in s. 499.003(31).
2804	2.  A repackager must comply with this paragraph.
2805	3.  The pedigree paper requirements in this paragraph do
2806	not apply to compressed medical gases or veterinary legend
2807	drugs.
2808	4.  Each wholesale distributor of prescription drugs must
2809	maintain separate and distinct from other required records all
2810	statements that are required under subparagraph 1.
2811	5.  Subparagraph 1. is satisfied when a wholesale
2812	distributor takes title to, but not possession of, a
2813	prescription drug and the prescription drug's manufacturer ships
2814	the prescription drug directly to a person authorized by law to
2815	purchase prescription drugs for the purpose of administering or
2816	dispensing the drug, as defined in s. 465.003, or a member of an
2817	affiliated group, as described in paragraph (f), with the
2818	exception of a repackager.
2819	a.  The wholesale distributor must deliver to the recipient
2820	of the prescription drug, within 14 days after the shipment
2821	notification from the manufacturer, an invoice and the following
2822	sworn statement: "This wholesale distributor purchased the
2823	specific unit of the prescription drug listed on the invoice
2824	directly from the manufacturer, and the specific unit of
2825	prescription drug was shipped by the manufacturer directly to a
2826	person authorized by law to administer or dispense the legend
2827	drug, as defined in s. 465.003, Florida Statutes, or a member of
2828	an affiliated group, as described in s. 499.0121(6)(f), Florida
2829	Statutes, with the exception of a repackager." The invoice must
2830	contain a unique cross-reference to the shipping document sent
2831	by the manufacturer to the recipient of the prescription drug.
2832	b.  The manufacturer of the prescription drug shipped
2833	directly to the recipient under this section must provide and
2834	the recipient of the prescription drug must acquire, within 14
2835	days after receipt of the prescription drug, a shipping document
2836	from the manufacturer that contains, at a minimum:
2837	(I)  The name and address of the manufacturer, including
2838	the point of origin of the shipment, and the names and addresses
2839	of the wholesaler and the purchaser.
2840	(II)  The name of the prescription drug as it appears on
2841	the label.
2842	(III)  The quantity, dosage form, and strength of the
2843	prescription drug.
2844	(IV)  The date of the shipment from the manufacturer.
2845	c.  The wholesale distributor must also maintain and make
2846	available to the department, upon request, the lot number of
2847	such drug if not contained in the shipping document acquired by
2848	the recipient.
2849	6.  Failure of the manufacturer to provide, the recipient
2850	to acquire, or the wholesale distributor to deliver, the
2851	documentation required under subparagraph 5. shall constitute
2852	failure to acquire or deliver a pedigree paper under s.
2853	499.0051. Forgery by the manufacturer, the recipient, or the
2854	wholesale distributor of the documentation required to be
2855	acquired or delivered under subparagraph 5. shall constitute
2856	forgery of a pedigree paper under s. 499.0051.
2857	7.  The department may, by rule, specify alternatives to
2858	compliance with subparagraph 1. for a prescription drug in the
2859	inventory of a permitted prescription drug wholesaler as of June
2860	30, 2006, and the return of a prescription drug purchased prior
2861	to July 1, 2006. The department may specify time limits for such
2862	alternatives.
2863	(7)(e)  PRESCRIPTION DRUG PURCHASE LIST.--Each wholesale
2864	distributor, except for a manufacturer, shall annually provide
2865	the department with a written list of all wholesale distributors
2866	and manufacturers from whom the wholesale distributor purchases
2867	prescription drugs. A wholesale distributor, except a
2868	manufacturer, shall notify the department not later than 10 days
2869	after any change to either list. Such portions of the
2870	information required pursuant to this subsection paragraph which
2871	are a trade secret, as defined in s. 812.081, shall be
2872	maintained by the department as trade secret information is
2873	required to be maintained under s. 499.051.
2874	(f)1.  This paragraph applies only to an affiliated group,
2875	as defined by s. 1504 of the Internal Revenue Code of 1986, as
2876	amended, which is composed of chain drug entities, including at
2877	least 50 retail pharmacies, warehouses, or repackagers, which
2878	are members of the same affiliated group, if the affiliated
2879	group:
2880	a.  Discloses to the department the names of all its
2881	members; and
2882	b.  Agrees in writing to provide records on prescription
2883	drug purchases by members of the affiliated group not later than
2884	48 hours after the department requests such records, regardless
2885	of the location where the records are stored.
2886	2.  Each warehouse within the affiliated group must comply
2887	with all applicable federal and state drug wholesale permit
2888	requirements and must purchase, receive, hold, and distribute
2889	prescription drugs only to a retail pharmacy or warehouse within
2890	the affiliated group. Such a warehouse is exempt from providing
2891	a pedigree paper in accordance with paragraph (d) to its
2892	affiliated group member warehouse or retail pharmacy, provided
2893	that:
2894	a.  Any affiliated group member that purchases or receives
2895	a prescription drug from outside the affiliated group must
2896	receive a pedigree paper if the prescription drug is distributed
2897	in or into this state and a pedigree paper is required under
2898	this section and must authenticate the documentation as required
2899	in subsection (4), regardless of whether the affiliated group
2900	member is directly subject to regulation under this chapter; and
2901	b.  The affiliated group makes available to the department
2902	on request all records related to the purchase or acquisition of
2903	prescription drugs by members of the affiliated group,
2904	regardless of the location where the records are stored, if the
2905	prescription drugs were distributed in or into this state.
2906	3.  If a repackager repackages prescription drugs solely
2907	for distribution to its affiliated group members for the
2908	exclusive distribution to and among retail pharmacies that are
2909	members of the affiliated group to which the repackager is a
2910	member:
2911	a.  The repackager must:
2912	(I)  In lieu of the written statement required by paragraph
2913	(d), for all repackaged prescription drugs distributed in or
2914	into this state, state in writing under oath with each
2915	distribution of a repackaged prescription drug to an affiliated
2916	group member warehouse or repackager: "All repackaged
2917	prescription drugs are purchased by the affiliated group
2918	directly from the manufacturer or from a prescription drug
2919	wholesaler that purchased the prescription drugs directly from
2920	the manufacturer.";
2921	(II)  Purchase all prescription drugs it repackages:
2922	(A)  Directly from the manufacturer; or
2923	(B)  From a prescription drug wholesaler that purchased the
2924	prescription drugs directly from the manufacturer; and
2925	(III)  Maintain records in accordance with this section to
2926	document that it purchased the prescription drugs directly from
2927	the manufacturer or that its prescription drug wholesale
2928	supplier purchased the prescription drugs directly from the
2929	manufacturer.
2930	b.  All members of the affiliated group must provide to
2931	agents of the department on request records of purchases by all
2932	members of the affiliated group of prescription drugs that have
2933	been repackaged, regardless of the location where the records
2934	are stored or where the repackager is located.
2935	(8)(7)  WRITTEN POLICIES AND PROCEDURES.--Wholesale drug
2936	distributors must establish, maintain, and adhere to written
2937	policies and procedures, which must be followed for the receipt,
2938	security, storage, inventory, and distribution of prescription
2939	drugs, including policies and procedures for identifying,
2940	recording, and reporting losses or thefts, and for correcting
2941	all errors and inaccuracies in inventories. Wholesale drug
2942	distributors must include in their written policies and
2943	procedures:
2944	(a)  A procedure whereby the oldest approved stock of a
2945	prescription drug product is distributed first. The procedure
2946	may permit deviation from this requirement, if the deviation is
2947	temporary and appropriate.
2948	(b)  A procedure to be followed for handling recalls and
2949	withdrawals of prescription drugs. Such procedure must be
2950	adequate to deal with recalls and withdrawals due to:
2951	1.  Any action initiated at the request of the Food and
2952	Drug Administration or any other federal, state, or local law
2953	enforcement or other government agency, including the
2954	department.
2955	2.  Any voluntary action by the manufacturer or repackager
2956	to remove defective or potentially defective drugs from the
2957	market; or
2958	3.  Any action undertaken to promote public health and
2959	safety by replacing existing merchandise with an improved
2960	product or new package design.
2961	(c)  A procedure to ensure that wholesale drug distributors
2962	prepare for, protect against, and handle any crisis that affects
2963	security or operation of any facility if a strike, fire, flood,
2964	or other natural disaster, or a local, state, or national
2965	emergency, occurs.
2966	(d)  A procedure to ensure that any outdated prescription
2967	drugs are segregated from other drugs and either returned to the
2968	manufacturer or repackager or destroyed. This procedure must
2969	provide for written documentation of the disposition of outdated
2970	prescription drugs. This documentation must be maintained for 2
2971	years after disposition of the outdated drugs.
2972	(9)(8)  RESPONSIBLE PERSONS.--Wholesale drug distributors
2973	must establish and maintain lists of officers, directors,
2974	managers, designated representatives, and other persons in
2975	charge of wholesale drug distribution, storage, and handling,
2976	including a description of their duties and a summary of their
2977	qualifications.
2978	(10)(9)  COMPLIANCE WITH FEDERAL, STATE, AND LOCAL LAW.--A
2979	wholesale drug distributor must operate in compliance with
2980	applicable federal, state, and local laws and regulations.
2981	(a)  A wholesale drug distributor must allow the department
2982	and authorized federal, state, and local officials to enter and
2983	inspect its premises and delivery vehicles, and to audit its
2984	records and written operating procedures, at reasonable times
2985	and in a reasonable manner, to the extent authorized by law.
2986	(b)  A wholesale drug distributor that deals in controlled
2987	substances must register with the Drug Enforcement
2988	Administration and must comply with all applicable state, local,
2989	and federal laws. A wholesale drug distributor that distributes
2990	any substance controlled under chapter 893 must notify the
2991	department when registering with the Drug Enforcement
2992	Administration pursuant to that chapter and must provide the
2993	department with its DEA number.
2994	(11)(10)  SALVAGING AND REPROCESSING.--A wholesale drug
2995	distributor is subject to any applicable federal, state, or
2996	local laws or regulations that relate to prescription drug
2997	product salvaging or reprocessing.
2998	(12)(11)  SHIPPING AND TRANSPORTATION.--The person
2999	responsible for shipment and transportation of a prescription
3000	drug in a wholesale distribution may use a common carrier; its
3001	own vehicle or employee acting within the scope of employment if
3002	authorized under s. 499.03 for the possession of prescription
3003	drugs in this state; or, in the case of a prescription drug
3004	intended for domestic distribution, an independent contractor
3005	who must be the agent of the authorized seller or recipient
3006	responsible for shipping and transportation as set forth in a
3007	written contract between the parties. A person selling a
3008	prescription drug for export must obtain documentation, such as
3009	a validated airway bill, bill of lading, or other appropriate
3010	documentation that the prescription drug was exported. A person
3011	responsible for shipping or transporting prescription drugs is
3012	not required to maintain documentation from a common carrier
3013	that the designated recipient received the prescription drugs;
3014	however, the person must obtain such documentation from the
3015	common carrier and make it available to the department upon
3016	request of the department.
3017	(13)(12)  DUE DILIGENCE OF SUPPLIERS.--Prior to purchasing
3018	any prescription drugs from another wholesale drug distributor,
3019	a prescription drug wholesale distributor wholesaler, an out-of-
3020	state prescription drug wholesale distributor wholesaler, or a
3021	prescription drug repackager must:
3022	(a)  Enter an agreement with the selling wholesale drug
3023	distributor by which the selling wholesale drug distributor will
3024	indemnify the purchasing wholesale drug distributor for any loss
3025	caused to the purchasing wholesale drug distributor related to
3026	the purchase of drugs from the selling wholesale drug
3027	distributor which are determined to be counterfeit or to have
3028	been distributed in violation of any federal or state law
3029	governing the distribution of drugs.
3030	(b)  Determine that the selling wholesale drug distributor
3031	has insurance coverage of not less than the greater of 1 percent
3032	of the amount of total dollar volume of the prescription drug
3033	sales reported to the department under s. 499.012(8)(g) s.
3034	499.012(3)(g) or $500,000; however the coverage need not exceed
3035	$2 million.
3036	(c)  Obtain information from the selling wholesale drug
3037	distributor, including the length of time the selling wholesale
3038	drug distributor has been licensed in this state, a copy of the
3039	selling wholesale drug distributor's licenses or permits, and
3040	background information concerning the ownership of the selling
3041	wholesale drug distributor, including the experience of the
3042	wholesale distributor in the wholesale distribution of
3043	prescription drugs.
3044	(d)  Verify that the selling wholesale drug distributor's
3045	Florida permit is valid.
3046	(e)  Inspect the selling wholesale drug distributor's
3047	licensed establishment to document that it has a policies and
3048	procedures manual relating to the distribution of drugs, the
3049	appropriate temperature controlled environment for drugs
3050	requiring temperature control, an alarm system, appropriate
3051	access restrictions, and procedures to ensure that records
3052	related to the wholesale distribution of prescription drugs are
3053	maintained as required by law:
3054	1.  Before purchasing any drug from the wholesale drug
3055	distributor, and at least once each subsequent year; or
3056	2.  Before purchasing any drug from the wholesale drug
3057	distributor, and each subsequent year obtain a complete copy of
3058	the most recent inspection report for the establishment which
3059	was prepared by the department or the regulatory authority
3060	responsible for wholesale drug distributors in the state in
3061	which the establishment is located.
3062	Section 14.  Section 499.01211, Florida Statutes, is
3063	amended to read:
3064	499.01211  Drug Wholesale Distributor Wholesaler Advisory
3065	Council.--
3066	(1)  There is created the Drug Wholesale Distributor
3067	Wholesaler Advisory Council within the department. The council
3068	shall meet at least once each calendar quarter. Staff for the
3069	council shall be provided by the department. The council shall
3070	consist of 11 members who shall serve without compensation. The
3071	council shall elect a chairperson and a vice chairperson
3072	annually.
3073	(2)  The State Surgeon General, or his or her designee, and
3074	the Secretary of Health Care Administration, or her or his
3075	designee, shall be members of the council. The State Surgeon
3076	General shall appoint nine additional members to the council who
3077	shall be appointed to a term of 4 years each, as follows:
3078	(a)  Three different persons each of whom is employed by a
3079	different prescription drug wholesale distributor wholesaler
3080	licensed under this part chapter which operates nationally and
3081	is a primary wholesale distributor wholesaler, as defined in s.
3082	499.003(46) s. 499.012(1)(d).
3083	(b)  One person employed by a prescription drug wholesale
3084	distributor wholesaler licensed under this part chapter which is
3085	a secondary wholesale distributor wholesaler, as defined in s.
3086	499.003(51) s. 499.012(1)(f).
3087	(c)  One person employed by a retail pharmacy chain located
3088	in this state.
3089	(d)  One person who is a member of the Board of Pharmacy
3090	and is a pharmacist licensed under chapter 465.
3091	(e)  One person who is a physician licensed pursuant to
3092	chapter 458 or chapter 459.
3093	(f)  One person who is an employee of a hospital licensed
3094	pursuant to chapter 395 and is a pharmacist licensed pursuant to
3095	chapter 465.
3096	(g)  One person who is an employee of a pharmaceutical
3097	manufacturer.
3098	(3)  The council shall review this part ss. 499.001-499.081
3099	and the rules adopted to administer this part ss. 499.001-
3100	499.081 annually, provide input to the department regarding all
3101	proposed rules to administer this part ss. 499.001-499.081, make
3102	recommendations to the department to improve the protection of
3103	the prescription drugs and public health, make recommendations
3104	to improve coordination with other states' regulatory agencies
3105	and the federal government concerning the wholesale distribution
3106	of drugs, and make recommendations to minimize the impact of
3107	regulation of the wholesale distribution industry while ensuring
3108	protection of the public health.
3109	Section 15.  Section 499.01212, Florida Statutes, is
3110	created to read:
3111	499.01212  Pedigree paper.--
3112	(1)  APPLICATION.--Each person who is engaged in the
3113	wholesale distribution of a prescription drug must, prior to or
3114	simultaneous with each wholesale distribution, provide a
3115	pedigree paper to the person who receives the drug.
3116	(2)  FORMAT.--A pedigree paper must contain the following
3117	information:
3118	(a)  For the wholesale distribution of a prescription drug
3119	within the normal distribution chain:
3120	1.  The following statement: "This wholesale distributor
3121	purchased the specific unit of the prescription drug directly
3122	from the manufacturer."
3123	2.  The manufacturer's national drug code identifier and
3124	the name and address of the wholesale distributor and the
3125	purchaser of the prescription drug.
3126	3.  The name of the prescription drug as it appears on the
3127	label.
3128	4.  The quantity, dosage form, and strength of the
3129	prescription drug.
3130
3131	The wholesale distributor must also maintain and make available
3132	to the department, upon request, the point of origin of the
3133	prescription drugs, including intracompany transfers, the date
3134	of the shipment from the manufacturer to the wholesale
3135	distributor, the lot numbers of such drugs, and the invoice
3136	numbers from the manufacturer.
3137	(b)  For all other wholesale distributions of prescription
3138	drugs:
3139	1.  The quantity, dosage form, and strength of the
3140	prescription drugs.
3141	2.  The lot numbers of the prescription drugs.
3142	3.  The name and address of each owner of the prescription
3143	drug and his or her signature.
3144	4.  Shipping information, including the name and address of
3145	each person certifying delivery or receipt of the prescription
3146	drug.
3147	5.  An invoice number, a shipping document number, or
3148	another number uniquely identifying the transaction.
3149	6.  A certification that the recipient wholesale
3150	distributor has authenticated the pedigree papers.
3151	7.  The unique serialization of the prescription drug, if
3152	the manufacturer or repackager has uniquely serialized the
3153	individual prescription drug unit.
3154	8.  The name, address, telephone number, and, if available,
3155	e-mail contact information of each wholesale distributor
3156	involved in the chain of the prescription drug's custody.
3157	(3)  EXCEPTIONS.--A pedigree paper is not required for:
3158	(a)  The wholesale distribution of a prescription drug by
3159	the manufacturer or by a third party logistics provider
3160	performing a wholesale distribution of a prescription drug for a
3161	manufacturer.
3162	(b)  The wholesale distribution of a prescription drug by a
3163	freight forwarder within the authority of a freight forwarder
3164	permit.
3165	(c)  The wholesale distribution of a prescription drug by a
3166	limited prescription drug veterinary wholesale distributor to a
3167	veterinarian.
3168	(d)  The wholesale distribution of a compressed medical
3169	gas.
3170	(e)  The wholesale distribution of a veterinary
3171	prescription drug.
3172	(f)  A drop shipment, provided:
3173	1.  The wholesale distributor delivers to the recipient of
3174	the prescription drug, within 14 days after the shipment
3175	notification from the manufacturer, an invoice and the following
3176	sworn statement: "This wholesale distributor purchased the
3177	specific unit of the prescription drug listed on the invoice
3178	directly from the manufacturer, and the specific unit of
3179	prescription drug was shipped by the manufacturer directly to a
3180	person authorized by law to administer or dispense the legend
3181	drug, as defined in s. 465.003, Florida Statutes, or a member of
3182	an affiliated group, with the exception of a repackager." The
3183	invoice must contain a unique cross-reference to the shipping
3184	document sent by the manufacturer to the recipient of the
3185	prescription drug.
3186	2.  The manufacturer of the prescription drug shipped
3187	directly to the recipient provides and the recipient of the
3188	prescription drug acquires, within 14 days after receipt of the
3189	prescription drug, a shipping document from the manufacturer
3190	that contains, at a minimum:
3191	a.  The name and address of the manufacturer, including the
3192	point of origin of the shipment, and the names and addresses of
3193	the wholesale distributor and the purchaser.
3194	b.  The name of the prescription drug as it appears on the
3195	label.
3196	c.  The quantity, dosage form, and strength of the
3197	prescription drug.
3198	d.  The date of the shipment from the manufacturer.
3199	3.  The wholesale distributor maintains and makes available
3200	to the department, upon request, the lot number of such drug if
3201	not contained in the shipping document acquired by the
3202	recipient.
3203
3204	Failure of the manufacturer to provide, the recipient to
3205	acquire, or the wholesale distributor to deliver the
3206	documentation required under this paragraph shall constitute
3207	failure to acquire or deliver a pedigree paper under ss.
3208	499.005(28) and 499.0051. Forgery by the manufacturer, the
3209	recipient, or the wholesale distributor of the documentation
3210	required to be acquired or delivered under this paragraph shall
3211	constitute forgery of a pedigree paper under s. 499.0051.
3212	4.  The wholesale distributor that takes title to, but not
3213	possession of, the prescription drug is not a member of the
3214	affiliated group that receives the prescription drug directly
3215	from the manufacturer.
3216	(g)  The wholesale distribution of a prescription drug by a
3217	warehouse within an affiliated group to a warehouse or retail
3218	pharmacy within its affiliated group, provided:
3219	1.  Any affiliated group member that purchases or receives
3220	a prescription drug from outside the affiliated group must
3221	receive a pedigree paper if the prescription drug is distributed
3222	in or into this state and a pedigree paper is required under
3223	this section and must authenticate the documentation as required
3224	in s. 499.0121(4), regardless of whether the affiliated group
3225	member is directly subject to regulation under this part; and
3226	2.  The affiliated group makes available, within 48 hours,
3227	to the department on request to one or more of its members all
3228	records related to the purchase or acquisition of prescription
3229	drugs by members of the affiliated group, regardless of the
3230	location where the records are stored, if the prescription drugs
3231	were distributed in or into this state.
3232	(h)  The repackaging of prescription drugs by a repackager
3233	solely for distribution to its affiliated group members for the
3234	exclusive distribution to and among retail pharmacies that are
3235	members of the affiliated group to which the repackager is a
3236	member.
3237	1.  The repackager must:
3238	a.  For all repackaged prescription drugs distributed in or
3239	into this state, state in writing under oath with each
3240	distribution of a repackaged prescription drug to an affiliated
3241	group member warehouse or repackager: "All repackaged
3242	prescription drugs are purchased by the affiliated group
3243	directly from the manufacturer or from a prescription drug
3244	wholesale distributor that purchased the prescription drugs
3245	directly from the manufacturer."
3246	b.  Purchase all prescription drugs it repackages:
3247	(I)  Directly from the manufacturer; or
3248	(II)  From a prescription drug wholesale distributor that
3249	purchased the prescription drugs directly from the manufacturer.
3250	c.  Maintain records in accordance with this section to
3251	document that it purchased the prescription drugs directly from
3252	the manufacturer or that its prescription drug wholesale
3253	supplier purchased the prescription drugs directly from the
3254	manufacturer.
3255	2.  All members of the affiliated group must provide,
3256	within 48 hours, to agents of the department on request to one
3257	or more of its members records of purchases by all members of
3258	the affiliated group of prescription drugs that have been
3259	repackaged, regardless of the location at which the records are
3260	stored or at which the repackager is located.
3261	Section 16.  Section 499.0122, Florida Statutes, is
3262	repealed.
3263	Section 17.  Section 499.013, Florida Statutes, is
3264	repealed.
3265	Section 18.  Subsections (1), (3), (4), (6), (8), and (9)
3266	of section 499.015, Florida Statutes, are amended to read:
3267	499.015  Registration of drugs, devices, and cosmetics;
3268	issuance of certificates of free sale.--
3269	(1)(a)  Except for those persons exempted from the
3270	definition of manufacturer in s. 499.003(32) s. 499.003(28), any
3271	person who manufactures, packages, repackages, labels, or
3272	relabels a drug, device, or cosmetic in this state must register
3273	such drug, device, or cosmetic biennially with the department;
3274	pay a fee in accordance with the fee schedule provided by s.
3275	499.041; and comply with this section. The registrant must list
3276	each separate and distinct drug, device, or cosmetic at the time
3277	of registration.
3278	(b)  The department may not register any product that does
3279	not comply with the Federal Food, Drug, and Cosmetic Act, as
3280	amended, or Title 21 C.F.R. Registration of a product by the
3281	department does not mean that the product does in fact comply
3282	with all provisions of the Federal Food, Drug, and Cosmetic Act,
3283	as amended.
3284	(3)  Except for those persons exempted from the definition
3285	of manufacturer in s. 499.003(31) s. 499.003(28), a person may
3286	not sell any product that he or she has failed to register in
3287	conformity with this section. Such failure to register subjects
3288	such drug, device, or cosmetic product to seizure and
3289	condemnation as provided in s. 499.062 ss. 499.062-499.064, and
3290	subjects such person to the penalties and remedies provided in
3291	this part ss. 499.001-499.081.
3292	(4)  Unless a registration is renewed, it expires 2 years
3293	after the last day of the month in which it was issued. The
3294	department may issue a stop-sale notice or order against a
3295	person that is subject to the requirements of this section and
3296	that fails to comply with this section within 31 days after the
3297	date the registration expires. The notice or order shall
3298	prohibit such person from selling or causing to be sold any
3299	drugs, devices, or cosmetics covered by this part ss. 499.001-
3300	499.081 until he or she complies with the requirements of this
3301	section.
3302	(6)  The department may issue a certificate of free sale
3303	for any product that is required to be registered under this
3304	part ss. 499.001-499.081.
3305	(8)  Notwithstanding any requirements set forth in this
3306	part ss. 499.001-499.081, a manufacturer of medical devices that
3307	is registered with the federal Food and Drug Administration is
3308	exempt from this section and s. 499.041(6) if:
3309	(a)  The manufacturer's medical devices are approved for
3310	marketing by, or listed with the federal Food and Drug
3311	Administration in accordance with federal law for commercial
3312	distribution; or
3313	(b)  The manufacturer subcontracts with a manufacturer of
3314	medical devices to manufacture components of such devices.
3315	(9)  However, the manufacturer must submit evidence of such
3316	registration, listing, or approval with its initial application
3317	for a permit to do business in this state, as required in s.
3318	499.01 s. 499.013 and any changes to such information previously
3319	submitted at the time of renewal of the permit. Evidence of
3320	approval, listing, and registration by the federal Food and Drug
3321	Administration must include:
3322	(a)  For Class II devices, a copy of the pre-market
3323	notification letter (510K);
3324	(b)  For Class III devices, a Federal Drug Administration
3325	pre-market approval number;
3326	(c)  For a manufacturer who subcontracts with a
3327	manufacturer of medical devices to manufacture components of
3328	such devices, a Federal Drug Administration registration number;
3329	or
3330	(d)  For a manufacturer of medical devices whose devices
3331	are exempt from pre-market approval by the Federal Drug
3332	Administration, a Federal Drug Administration registration
3333	number.
3334	Section 19.  Subsections (3), (5), and (6) of section
3335	499.024, Florida Statutes, are amended to read:
3336	499.024  Drug product classification.--The State Surgeon
3337	General shall adopt rules to classify drug products intended for
3338	use by humans which the United States Food and Drug
3339	Administration has not classified in the federal act or the Code
3340	of Federal Regulations.
3341	(3)  Any product that falls under the definition of drug in
3342	s. 499.003(19) definition, s. 499.003(17), may be classified
3343	under the authority of this section. This section does not
3344	subject portable emergency oxygen inhalators to classification;
3345	however, this section does not exempt any person from ss. 499.01
3346	and 499.015.
3347	(5)  The department may by rule reclassify drugs subject to
3348	this part ss. 499.001-499.081 when such classification action is
3349	necessary to protect the public health.
3350	(6)  The department may adopt rules that exempt from any
3351	labeling or packaging requirements of this part ss. 499.001-
3352	499.081 drugs classified under this section if those
3353	requirements are not necessary to protect the public health.
3354	Section 20.  Subsections (7), (12), and (15) of section
3355	499.028, Florida Statutes, are amended to read:
3356	499.028  Drug samples or complimentary drugs; starter
3357	packs; permits to distribute.--
3358	(7)  A drug manufacturer or distributor must report to the
3359	department any conviction of itself or of its assigns, agents,
3360	employees, or representatives for a violation of s. 503(c)(1) of
3361	the federal act or of this part ss. 499.001-499.081 because of
3362	the sale, purchase, or trade of a drug sample or the offer to
3363	sell, purchase, or trade a drug sample.
3364	(12)  The department may suspend or revoke a permit issued
3365	under this section, after giving notice and an opportunity to be
3366	heard pursuant to chapter 120, when:
3367	(a)  Such permit was obtained by misrepresentation or fraud
3368	or through a mistake of the department.
3369	(b)  The holder of the permit has distributed or disposed
3370	of any prescription legend drug, directly or through its agents,
3371	employees, or independent contractors, to any person not
3372	authorized to possess such drug.
3373	(c)  The holder of the permit, or its agents, employees, or
3374	independent contractors, has distributed or possessed any
3375	prescription legend drug except in the usual course of its
3376	business.
3377	(d)  The holder of the permit, or its agents, employees, or
3378	independent contractors, has distributed any prescription legend
3379	drug that is misbranded or adulterated under this part ss.
3380	499.001-499.081.
3381	(e)  The holder of the permit, or its agents, employees, or
3382	independent contractors, has distributed any prescription legend
3383	drug without written request, when a written request is required
3384	by this section.
3385	(f)  The holder of the permit has in its employ, or uses as
3386	agent or independent contractor for the purpose of distributing
3387	or disposing of drugs, any person who has:
3388	1.  Violated the requirements of this section or any rule
3389	adopted under this section.
3390	2.  Been convicted in any of the courts of this state, the
3391	United States, or any other state of a felony or any other crime
3392	involving moral turpitude or involving those drugs named or
3393	described in chapter 893.
3394	(15)  A person may not possess a prescription drug sample
3395	unless:
3396	(a)  The drug sample was prescribed to her or him as
3397	evidenced by the label required in s. 465.0276(5).
3398	(b)  She or he is the employee of a complimentary drug
3399	distributor that holds a permit issued under this part ss.
3400	499.001-499.081.
3401	(c)  She or he is a person to whom prescription drug
3402	samples may be distributed pursuant to this section.
3403	(d)  He or she is an officer or employee of a federal,
3404	state, or local government acting within the scope of his or her
3405	employment.
3406	Section 21.  Subsections (2) and (3) of section 499.029,
3407	Florida Statutes, are amended to read:
3408	499.029  Cancer Drug Donation Program.--
3409	(2)  There is created a Cancer Drug Donation Program within
3410	the department of Health for the purpose of authorizing and
3411	facilitating the donation of cancer drugs and supplies to
3412	eligible patients.
3413	(3)  As used in this section:
3414	(a)  "Cancer drug" means a prescription drug that has been
3415	approved under s. 505 of the federal Food, Drug, and Cosmetic
3416	Act and is used to treat cancer or its side effects or is used
3417	to treat the side effects of a prescription drug used to treat
3418	cancer or its side effects. "Cancer drug" does not include a
3419	substance listed in Schedule II, Schedule III, Schedule IV, or
3420	Schedule V of s. 893.03.
3421	(b)  "Closed drug delivery system" means a system in which
3422	the actual control of the unit-dose medication package is
3423	maintained by the facility rather than by the individual
3424	patient.
3425	(c)  "Department" means the Department of Health.
3426	(c)(d)  "Donor" means a patient or patient representative
3427	who donates cancer drugs or supplies needed to administer cancer
3428	drugs that have been maintained within a closed drug delivery
3429	system; health care facilities, nursing homes, hospices, or
3430	hospitals with closed drug delivery systems; or pharmacies, drug
3431	manufacturers, medical device manufacturers or suppliers, or
3432	wholesalers of drugs or supplies, in accordance with this
3433	section. "Donor" includes a physician licensed under chapter 458
3434	or chapter 459 who receives cancer drugs or supplies directly
3435	from a drug manufacturer, wholesale distributor drug wholesaler,
3436	or pharmacy.
3437	(d)(e)  "Eligible patient" means a person who the
3438	department determines is eligible to receive cancer drugs from
3439	the program.
3440	(e)(k)  "Participant facility" means a class II hospital
3441	pharmacy that has elected to participate in the program and that
3442	accepts donated cancer drugs and supplies under the rules
3443	adopted by the department for the program.
3444	(f)(n)  "Prescribing practitioner" means a physician
3445	licensed under chapter 458 or chapter 459 or any other medical
3446	professional with authority under state law to prescribe cancer
3447	medication.
3448	(o)  "Prescription drug" means a drug as defined in s.
3449	465.003(8).
3450	(g)(p)  "Program" means the Cancer Drug Donation Program
3451	created by this section.
3452	(h)(q)  "Supplies" means any supplies used in the
3453	administration of a cancer drug.
3454	Section 22.  Subsection (1) of section 499.03, Florida
3455	Statutes, is amended to read:
3456	499.03  Possession of certain drugs without prescriptions
3457	unlawful; exemptions and exceptions.--
3458	(1)  A person may not possess, or possess with intent to
3459	sell, dispense, or deliver, any habit-forming, toxic, harmful,
3460	or new drug subject to s. 499.003(32) s. 499.003(29), or
3461	prescription legend drug as defined in s. 499.003(42) s.
3462	499.003(25), unless the possession of the drug has been obtained
3463	by a valid prescription of a practitioner licensed by law to
3464	prescribe the drug. However, this section does not apply to the
3465	delivery of such drugs to persons included in any of the classes
3466	named in this subsection, or to the agents or employees of such
3467	persons, for use in the usual course of their businesses or
3468	practices or in the performance of their official duties, as the
3469	case may be; nor does this section apply to the possession of
3470	such drugs by those persons or their agents or employees for
3471	such use:
3472	(a)  A licensed pharmacist or any person under the licensed
3473	pharmacist's supervision while acting within the scope of the
3474	licensed pharmacist's practice;
3475	(b)  A licensed practitioner authorized by law to prescribe
3476	prescription legend drugs or any person under the licensed
3477	practitioner's supervision while acting within the scope of the
3478	licensed practitioner's practice;
3479	(c)  A qualified person who uses prescription legend drugs
3480	for lawful research, teaching, or testing, and not for resale;
3481	(d)  A licensed hospital or other institution that procures
3482	such drugs for lawful administration or dispensing by
3483	practitioners;
3484	(e)  An officer or employee of a federal, state, or local
3485	government; or
3486	(f)  A person that holds a valid permit issued by the
3487	department pursuant to this part ss. 499.001-499.081 which
3488	authorizes that person to possess prescription drugs.
3489	Section 23.  Section 499.032, Florida Statutes, is amended
3490	to read:
3491	499.032  Phenylalanine; prescription
3492	required.--Phenylalanine restricted formula is declared to be a
3493	prescription legend drug and may be dispensed only upon the
3494	prescription of a practitioner authorized by law to prescribe
3495	prescription medicinal drugs.
3496	Section 24.  Subsection (1) of section 499.033, Florida
3497	Statutes, is amended to read:
3498	499.033  Ephedrine; prescription required.--Ephedrine is
3499	declared to be a prescription drug.
3500	(1)  Except as provided in subsection (2), any product that
3501	contains any quantity of ephedrine, a salt of ephedrine, an
3502	optical isomer of ephedrine, or a salt of an optical isomer of
3503	ephedrine may be dispensed only upon the prescription of a duly
3504	licensed practitioner authorized by the laws of the state to
3505	prescribe prescription medicinal drugs.
3506	Section 25.  Subsections (1) and (3) of section 499.039,
3507	Florida Statutes, are amended to read:
3508	499.039  Sale, distribution, or transfer of harmful
3509	chemical substances; penalties; authority for enforcement.--It
3510	is unlawful for a person to sell, deliver, or give to a person
3511	under the age of 18 years any compound, liquid, or chemical
3512	containing toluol, hexane, trichloroethylene, acetone, toluene,
3513	ethyl acetate, methyl ethyl ketone, trichloroethane,
3514	isopropanol, methyl isobutyl ketone, ethylene glycol monomethyl
3515	ether acetate, cyclohexanone, nitrous oxide, diethyl ether,
3516	alkyl nitrites (butyl nitrite), or any similar substance for the
3517	purpose of inducing by breathing, inhaling, or ingesting a
3518	condition of intoxication or which is intended to distort or
3519	disturb the auditory, visual, or other physical or mental
3520	processes.
3521	(1)  On the first violation of this section, the department
3522	may issue a warning according to s. 499.002(5) s. 499.071, if
3523	the violation has not caused temporary or permanent physical or
3524	mental injury to the user.
3525	(3)  The department of Health shall adopt rules to
3526	implement this section.
3527	Section 26.  Section 499.04, Florida Statutes, is amended
3528	to read:
3529	499.04  Fee authority.--The department may collect fees for
3530	all drug, device, and cosmetic applications, permits, product
3531	registrations, and free-sale certificates. The total amount of
3532	fees collected from all permits, applications, product
3533	registrations, and free-sale certificates must be adequate to
3534	fund the expenses incurred by the department in carrying out
3535	this part ss. 499.001-499.081. The department shall, by rule,
3536	establish a schedule of fees that are within the ranges provided
3537	in this section and shall adjust those fees from time to time
3538	based on the costs associated with administering this part ss.
3539	499.001-499.081. The fees are payable to the department to be
3540	deposited into the Florida Drug, Device, and Cosmetic Trust Fund
3541	for the sole purpose of carrying out the provisions of this part
3542	ss. 499.001-499.081.
3543	Section 27.  Subsections (1) through (5), (8), and (10) of
3544	section 499.041, Florida Statutes, are amended to read:
3545	499.041  Schedule of fees for drug, device, and cosmetic
3546	applications and permits, product registrations, and free-sale
3547	certificates.--
3548	(1)  The department shall assess applicants requiring a
3549	manufacturing permit an annual fee within the ranges established
3550	in this section for the specific type of manufacturer.
3551	(a)  The fee for a prescription drug manufacturer
3552	manufacturer's permit may not be less than $500 or more than
3553	$750 annually.
3554	(b)  The fee for a device manufacturer manufacturer's
3555	permit may not be less than $500 or more than $600 annually.
3556	(c)  The fee for a cosmetic manufacturer manufacturer's
3557	permit may not be less than $250 or more than $400 annually.
3558	(d)  The fee for an over-the-counter drug manufacturer
3559	manufacturer's permit may not be less than $300 or more than
3560	$400 annually.
3561	(e)  The fee for a compressed medical gas manufacturer
3562	manufacturer's permit may not be less than $400 or more than
3563	$500 annually.
3564	(f)  The fee for a prescription drug repackager
3565	repackager's permit may not be less than $500 or more than $750
3566	annually.
3567	(g)  A manufacturer may not be required to pay more than
3568	one fee per establishment to obtain an additional manufacturing
3569	permit, but each manufacturer must pay the highest fee
3570	applicable to his or her operation in each establishment.
3571	(2)  The department shall assess an applicant that is
3572	required to have a wholesaling permit an annual fee within the
3573	ranges established in this section for the specific type of
3574	wholesaling.
3575	(a)  The fee for a prescription drug wholesale distributor
3576	wholesaler's permit may not be less than $300 or more than $800
3577	annually.
3578	(b)  The fee for a compressed medical gas wholesale
3579	distributor wholesaler's permit may not be less than $200 or
3580	more than $300 annually.
3581	(c)  The fee for an out-of-state prescription drug
3582	wholesale distributor wholesaler's permit may not be less than
3583	$300 or more than $800 annually.
3584	(d)  The fee for a nonresident prescription drug
3585	manufacturer manufacturer's permit may not be less than $300 or
3586	more than $500 annually.
3587	(e)  The fee for a retail pharmacy drug wholesale
3588	distributor wholesaler's permit may not be less than $35 or more
3589	than $50 annually.
3590	(f)  The fee for a freight forwarder forwarder's permit may
3591	not be less than $200 or more than $300 annually.
3592	(g)  The fee for a veterinary prescription drug wholesale
3593	distributor wholesaler's permit may not be less than $300 or
3594	more than $500 annually.
3595	(h)  The fee for a limited prescription drug veterinary
3596	wholesale distributor wholesaler's permit may not be less than
3597	$300 or more than $500 annually.
3598	(i)  The fee for a third part logistics provider permit may
3599	not be less than $200 or more than $300 annually.
3600	(3)  The department shall assess an applicant that is
3601	required to have a retail establishment permit an annual fee
3602	within the ranges established in this section for the specific
3603	type of retail establishment.
3604	(a)  The fee for a veterinary prescription legend drug
3605	retail establishment permit may not be less than $200 or more
3606	than $300 annually.
3607	(b)  The fee for a medical oxygen retail establishment
3608	permit may not be less than $200 or more than $300 annually.
3609	(c)  The fee for a health care clinic establishment permit
3610	may not be less than $125 or more than $250 annually.
3611	(4)  The department shall assess an applicant that is
3612	required to have a restricted prescription drug distributor
3613	distributor's permit an annual fee of not less than $200 or more
3614	than $300.
3615	(5)  In addition to the fee charged for a permit required
3616	by this part ss. 499.001-499.081, the department shall assess
3617	applicants an initial application fee of $150 for each new
3618	permit issued by the department which requires an onsite
3619	inspection.
3620	(8)  The department shall assess an out-of-state
3621	prescription drug wholesale distributor wholesaler applicant or
3622	permittee an onsite inspection fee of not less than $1,000 or
3623	more than $3,000 annually, to be based on the actual cost of the
3624	inspection if an onsite inspection is performed by agents of the
3625	department.
3626	(10)  The department shall assess other fees as provided in
3627	this part ss. 499.001-499.081.
3628	Section 28.  Section 499.05, Florida Statutes, is amended;
3629	subsection (3) of section 499.013, Florida Statutes, is
3630	redesignated as paragraph (k) of subsection (1) of that section
3631	and amended; paragraph (b) of subsection (2) of section
3632	499.0122, Florida Statutes, is redesignated as paragraph (l) of
3633	subsection (1) of that section and amended; and subsection (12)
3634	of section 499.012, Florida Statutes, is redesignated as
3635	paragraph (m) of subsection (1) of that section and amended, to
3636	read:
3637	499.05  Rules.--
3638	(1)  The department shall adopt rules to implement and
3639	enforce this part ss. 499.001-499.081 with respect to:
3640	(a)  The definition of terms used in this part ss. 499.001-
3641	499.081, and used in the rules adopted under this part ss.
3642	499.001-499.081, when the use of the term is not its usual and
3643	ordinary meaning.
3644	(b)  Labeling requirements for drugs, devices, and
3645	cosmetics.
3646	(c)  The establishment of fees authorized in this part ss.
3647	499.001-499.081.
3648	(d)  The identification of permits that require an initial
3649	application and onsite inspection or other prerequisites for
3650	permitting which demonstrate that the establishment and person
3651	are in compliance with the requirements of this part ss.
3652	499.001-499.081.
3653	(e)  The application processes and forms for product
3654	registration.
3655	(f)  Procedures for requesting and issuing certificates of
3656	free sale.
3657	(g)  Inspections and investigations conducted under s.
3658	499.051, and the identification of information claimed to be a
3659	trade secret and exempt from the public records law as provided
3660	in s. 499.051(7).
3661	(h)  The establishment of a range of penalties, as provided
3662	in s. 499.066 s. 499.006; requirements for notifying persons of
3663	the potential impact of a violation of this part ss. 499.001-
3664	499.081; and a process for the uncontested settlement of alleged
3665	violations.
3666	(i)  Additional conditions that qualify as an emergency
3667	medical reason under s. 499.003(53)(b)2. s. 499.012(1)(a)2.b.
3668	(j)  Procedures and forms relating to the pedigree paper
3669	requirement of s. 499.01212.
3670	(k)(3)  The department may adopt such rules as are
3671	necessary for The protection of the public health, safety, and
3672	welfare regarding good manufacturing practices that
3673	manufacturers and repackagers must follow to ensure the safety
3674	of the products.
3675	(l)(b)  The department shall adopt rules relating to
3676	Information required from each retail establishment pursuant to
3677	s. 499.012(3) s. 499.01(4), including requirements for
3678	prescriptions or orders.
3679	(m)(12)  The department may adopt rules governing The
3680	recordkeeping, storage, and handling with respect to each of the
3681	distributions of prescription drugs specified in s.
3682	499.003(53)(a)-(d) subparagraphs (1)(a)1.-4.
3683	(n)  Alternatives to compliance with s. 499.01212 for a
3684	prescription drug in the inventory of a permitted prescription
3685	drug wholesale distributor as of June 30, 2006, and the return
3686	of a prescription drug purchased prior to July 1, 2006. The
3687	department may specify time limits for such alternatives.
3688	(2)  With respect to products in interstate commerce, those
3689	rules must not be inconsistent with rules and regulations of
3690	federal agencies unless specifically otherwise directed by the
3691	Legislature.
3692	(3)  The department shall adopt rules regulating
3693	recordkeeping for and the storage, handling, and distribution of
3694	medical devices and over-the-counter drugs to protect the public
3695	from adulterated products.
3696	Section 29.  Section 499.051, Florida Statutes, is amended
3697	to read:
3698	499.051  Inspections and investigations.--
3699	(1)  The agents of the department of Health and of the
3700	Department of Law Enforcement, after they present proper
3701	identification, may inspect, monitor, and investigate any
3702	establishment permitted pursuant to this part ss. 499.001-
3703	499.081 during business hours for the purpose of enforcing this
3704	part ss. 499.001-499.081, chapters 465, 501, and 893, and the
3705	rules of the department that protect the public health, safety,
3706	and welfare.
3707	(2)  In addition to the authority set forth in subsection
3708	(1), the department and any duly designated officer or employee
3709	of the department may enter and inspect any other establishment
3710	for the purpose of determining compliance with this part ss.
3711	499.001-499.081 and rules adopted under this part those sections
3712	regarding any drug, device, or cosmetic product.
3713	(3)  Any application for a permit or product registration
3714	or for renewal of such permit or registration made pursuant to
3715	this part ss. 499.001-499.081 and rules adopted under this part
3716	those sections constitutes permission for any entry or
3717	inspection of the premises in order to verify compliance with
3718	this part those sections and rules; to discover, investigate,
3719	and determine the existence of compliance; or to elicit,
3720	receive, respond to, and resolve complaints and violations.
3721	(4)  Any application for a permit made pursuant to s.
3722	499.012 ss. 499.01 and 499.012 and rules adopted under that
3723	section those sections constitutes permission for agents of the
3724	department of Health and the Department of Law Enforcement,
3725	after presenting proper identification, to inspect, review, and
3726	copy any financial document or record related to the
3727	manufacture, repackaging, or distribution of a drug as is
3728	necessary to verify compliance with this part ss. 499.001-
3729	499.081 and the rules adopted by the department to administer
3730	this part those sections, in order to discover, investigate, and
3731	determine the existence of compliance, or to elicit, receive,
3732	respond to, and resolve complaints and violations.
3733	(5)  The authority to inspect under this section includes
3734	the authority to access, review, and copy any and all financial
3735	documents related to the activity of manufacturing, repackaging,
3736	or distributing prescription drugs.
3737	(6)  The authority to inspect under this section includes
3738	the authority to secure:
3739	(a)  Samples or specimens of any drug, device, or cosmetic;
3740	or
3741	(b)  Such other evidence as is needed for any action to
3742	enforce this part ss. 499.001-499.081 and the rules adopted
3743	under this part those sections.
3744	(7)  The complaint and all information obtained pursuant to
3745	the investigation by the department are confidential and exempt
3746	from the provisions of s. 119.07(1) and s. 24(a), Art. I of the
3747	State Constitution until the investigation and the enforcement
3748	action are completed. However, trade secret information
3749	contained therein as defined by s. 812.081(1)(c) shall remain
3750	confidential and exempt from the provisions of s. 119.07(1) and
3751	s. 24(a), Art. I of the State Constitution, as long as the
3752	information is retained by the department. This subsection does
3753	not prohibit the department from using such information for
3754	regulatory or enforcement proceedings under this chapter or from
3755	providing such information to any law enforcement agency or any
3756	other regulatory agency. However, the receiving agency shall
3757	keep such records confidential and exempt as provided in this
3758	subsection. In addition, this subsection is not intended to
3759	prevent compliance with the provisions of s. 499.01212 s.
3760	499.0121(6)(d), and the pedigree papers required in that section
3761	subsection shall not be deemed a trade secret.
3762	Section 30.  Section 499.052, Florida Statutes, is amended
3763	to read:
3764	499.052  Records of interstate shipment.--For the purpose
3765	of enforcing this part ss. 499.001-499.081, carriers engaged in
3766	interstate commerce and persons receiving drugs, devices, or
3767	cosmetics in interstate commerce must, upon the request, in the
3768	manner set out below, by an officer or employee duly designated
3769	by the department, permit the officer or employee to have access
3770	to and to copy all records showing the movement in interstate
3771	commerce of any drug, device, or cosmetic, and the quantity,
3772	shipper, and consignee thereof.
3773	Section 31.  Subsection (4) of section 499.055, Florida
3774	Statutes, is amended to read:
3775	499.055  Reports and dissemination of information by
3776	department.--
3777	(4)  The department shall publish on the department's
3778	website and update at least monthly:
3779	(a)  A list of the prescription drug wholesale distributors
3780	wholesalers, out-of-state prescription drug wholesale
3781	distributors wholesalers, and retail pharmacy drug wholesale
3782	distributors wholesalers against whom the department has
3783	initiated enforcement action pursuant to this part ss. 499.001-
3784	499.081 to suspend or revoke a permit, seek an injunction, or
3785	otherwise file an administrative complaint and the permit number
3786	of each such wholesale distributor wholesaler.
3787	(b)  A list of the prescription drug wholesale distributors
3788	wholesalers, out-of-state prescription drug wholesale
3789	distributors wholesalers, and retail pharmacy drug wholesale
3790	distributors wholesalers to which the department has issued a
3791	permit, including the date on which each permit will expire.
3792	(c)  A list of the prescription drug wholesale distributor
3793	wholesalers, out-of-state prescription drug wholesale
3794	distributor wholesalers, and retail pharmacy drug wholesale
3795	distributor wholesalers' permits that have been returned to the
3796	department, were suspended, were revoked, have expired, or were
3797	not renewed in the previous year.
3798	Section 32.  Subsections (1) and (3) of section 499.06,
3799	Florida Statutes, are amended to read:
3800	499.06  Embargoing, detaining, or destroying article or
3801	processing equipment which is in violation of law or rule.--
3802	(1)  When a duly authorized agent of the department finds,
3803	or has probable cause to believe, that any drug, device, or
3804	cosmetic is in violation of any provision of this part ss.
3805	499.001-499.081 or any rule adopted under this part such
3806	sections so as to be dangerous, unwholesome, or fraudulent
3807	within the meaning of this part ss. 499.001-499.081, she or he
3808	may issue and enforce a stop-sale, stop-use, removal, or hold
3809	order, which order gives notice that such article or processing
3810	equipment is, or is suspected of being, in violation and has
3811	been detained or embargoed, and which order warns all persons
3812	not to remove, use, or dispose of such article or processing
3813	equipment by sale or otherwise until permission for removal,
3814	use, or disposal is given by such agent or the court. It is
3815	unlawful for any person to remove, use, or dispose of such
3816	detained or embargoed article or processing equipment by sale or
3817	otherwise without such permission; and such act is a felony of
3818	the second degree, punishable as provided in s. 775.082, s.
3819	775.083, or s. 775.084.
3820	(3)  If the court finds that the detained or embargoed
3821	article or processing equipment is in violation, such article or
3822	processing equipment shall, after entry of the court order, be
3823	destroyed or made sanitary at the expense of the claimant
3824	thereof, under the supervision of such agent; and all court
3825	costs, fees, and storage and other proper expenses shall be
3826	taxed against the claimant of such article or processing
3827	equipment or her or his agent. However, when the violation can
3828	be corrected by proper labeling of the article or sanitizing of
3829	the processing equipment, and after such costs, fees, and
3830	expenses have been paid and a good and sufficient bond,
3831	conditioned that such article be so labeled or processed or such
3832	processing equipment be so sanitized, has been executed, the
3833	court may by order direct that such article or processing
3834	equipment be delivered to the claimant thereof for such
3835	labeling, processing, or sanitizing, under the supervision of an
3836	agent of the department. The expense of such supervision shall
3837	be paid by the claimant. Such bond shall be returned to the
3838	claimant of the article or processing equipment upon
3839	representation to the court by the department that the article
3840	or processing equipment is no longer in violation of this part
3841	ss. 499.001-499.081 and that the expenses of such supervision
3842	have been paid.
3843	Section 33.  Section 499.062, Florida Statutes, is amended;
3844	section 499.063, Florida Statutes, is redesignated as section
3845	(2) of that section and amended; and section 499.064, Florida
3846	Statutes, is redesignated as paragraphs (a) and (b) of
3847	subsection (2) of that section and amended, to read:
3848	499.062  Cause for Seizure and condemnation of drugs,
3849	devices, or cosmetics.--
3850	(1)  Any article of any drug, device, or cosmetic that is
3851	adulterated or misbranded under this part ss. 499.001-499.081 is
3852	subject to seizure and condemnation by the department or by its
3853	duly authorized agents designated for that purpose in regard to
3854	drugs, devices, or cosmetics.
3855	(2)499.063  Seizure; procedure; prohibition on sale or
3856	disposal of article; penalty.--Whenever a duly authorized
3857	officer or employee of the department finds cause, or has
3858	probable cause to believe that cause exists, for the seizure of
3859	any drug, device, or cosmetic, as set out in this part ss.
3860	499.001-499.081, he or she shall affix to the article a tag,
3861	stamp, or other appropriate marking, giving notice that the
3862	article is, or is suspected of being, subject to seizure under
3863	this part ss. 499.001-499.081 and that the article has been
3864	detained and seized by the department. Such officer or employee
3865	shall also warn all persons not to remove or dispose of the
3866	article, by sale or otherwise, until permission is given by the
3867	department or the court. Any person who violates this subsection
3868	section is guilty of a felony of the second degree, punishable
3869	as provided in s. 775.082, s. 775.083, or s. 775.084.
3870	(a)499.064  Condemnation and sale; release of seized
3871	article.--(1)  When any article detained or seized under this
3872	subsection s. 499.063 has been found by the department to be
3873	subject to seizure and condemnation under s. 499.063, the
3874	department shall petition the court for an order of condemnation
3875	or sale, as the court directs. The proceeds of the sale of
3876	drugs, devices, and cosmetics, less the legal costs and charges,
3877	shall be deposited into the Florida Drug, Device, and Cosmetic
3878	Trust Fund.
3879	(b)(2)  If the department finds that any article seized
3880	under this subsection s. 499.063 was not subject to seizure
3881	under that section, the department or the designated officer or
3882	employee shall remove the tag or marking.
3883	Section 34.  Section 499.065, Florida Statutes, is amended
3884	to read:
3885	499.065  Inspections; imminent danger.--
3886	(1)  Notwithstanding s. 499.051, the department shall
3887	inspect each prescription drug wholesale distributor
3888	establishment, prescription drug repackager establishment,
3889	veterinary prescription drug wholesale distributor
3890	establishment, limited prescription drug veterinary wholesale
3891	distributor wholesaler establishment, and retail pharmacy drug
3892	wholesale distributor wholesaler establishment that is required
3893	to be permitted under this part chapter as often as necessary to
3894	ensure compliance with applicable laws and rules. The department
3895	shall have the right of entry and access to these facilities at
3896	any reasonable time.
3897	(2)  To protect the public from prescription drugs that are
3898	adulterated or otherwise unfit for human or animal consumption,
3899	the department may examine, sample, seize, and stop the sale or
3900	use of prescription drugs to determine the condition of those
3901	drugs. The department may immediately seize and remove any
3902	prescription drugs if the State Surgeon General or his or her
3903	designee determines that the prescription drugs represent a
3904	threat to the public health. The owner of any property seized
3905	under this section may, within 10 days after the seizure, apply
3906	to a court of competent jurisdiction for whatever relief is
3907	appropriate. At any time after 10 days, the department may
3908	destroy the drugs as contraband.
3909	(3)  The department may determine that a prescription drug
3910	wholesale distributor establishment, prescription drug
3911	repackager establishment, veterinary prescription drug wholesale
3912	distributor establishment, limited prescription drug veterinary
3913	wholesale distributor wholesaler establishment, or retail
3914	pharmacy drug wholesale distributor wholesaler establishment
3915	that is required to be permitted under this part chapter is an
3916	imminent danger to the public health and shall require its
3917	immediate closure if the establishment fails to comply with
3918	applicable laws and rules and, because of the failure, presents
3919	an imminent threat to the public's health, safety, or welfare.
3920	Any establishment so deemed and closed shall remain closed until
3921	allowed by the department or by judicial order to reopen.
3922	(4)  For purposes of this section, a refusal to allow entry
3923	to the department for inspection at reasonable times, or a
3924	failure or refusal to provide the department with required
3925	documentation for purposes of inspection, constitutes an
3926	imminent danger to the public health.
3927	Section 35.  Subsections (1) through (4) of section
3928	499.066, Florida Statutes, are amended to read:
3929	499.066  Penalties; remedies.--In addition to other
3930	penalties and other enforcement provisions:
3931	(1)  The department may institute such suits or other legal
3932	proceedings as are required to enforce any provision of this
3933	part ss. 499.001-499.081. If it appears that a person has
3934	violated any provision of this part ss. 499.001-499.081 for
3935	which criminal prosecution is provided, the department may
3936	provide the appropriate state attorney or other prosecuting
3937	agency having jurisdiction with respect to such prosecution with
3938	the relevant information in the department's possession.
3939	(2)  If any person engaged in any activity covered by this
3940	part ss. 499.001-499.081 violates any provision of this part
3941	those sections, any rule adopted under this part those sections,
3942	or a cease and desist order as provided by this part those
3943	sections, the department may obtain an injunction in the circuit
3944	court of the county in which the violation occurred or in which
3945	the person resides or has its principal place of business, and
3946	may apply in that court for such temporary and permanent orders
3947	as the department considers necessary to restrain the person
3948	from engaging in any such activities until the person complies
3949	with this part ss. 499.001-499.081, the rules adopted under this
3950	part those sections, and the orders of the department authorized
3951	by this part those sections or to mandate compliance with this
3952	part ss. 499.001-499.081, the rules adopted under this part
3953	those sections, and any order or permit issued by the department
3954	under this part those sections.
3955	(3)  The department may impose an administrative fine, not
3956	to exceed $5,000 per violation per day, for the violation of any
3957	provision of this part ss. 499.001-499.081 or rules adopted
3958	under this part those sections. Each day a violation continues
3959	constitutes a separate violation, and each separate violation is
3960	subject to a separate fine. All amounts collected pursuant to
3961	this section shall be deposited into the Florida Drug, Device,
3962	and Cosmetic Trust Fund and are appropriated for the use of the
3963	department in administering this part ss. 499.001-499.081. In
3964	determining the amount of the fine to be levied for a violation,
3965	the department shall consider:
3966	(a)  The severity of the violation;
3967	(b)  Any actions taken by the person to correct the
3968	violation or to remedy complaints; and
3969	(c)  Any previous violations.
3970	(4)  The department shall deposit any rewards, fines, or
3971	collections that are due the department and which derive from
3972	joint enforcement activities with other state and federal
3973	agencies which relate to this part ss. 499.001-499.081, chapter
3974	893, or the federal act, into the Florida Drug, Device, and
3975	Cosmetic Trust Fund. The proceeds of those rewards, fines, and
3976	collections are appropriated for the use of the department in
3977	administering this part ss. 499.001-499.081.
3978	Section 36.  Section 499.0661, Florida Statutes, is amended
3979	to read:
3980	499.0661  Cease and desist orders; removal of certain
3981	persons.--
3982	(1)(2)  CEASE AND DESIST ORDERS.--
3983	(a)  In addition to any authority otherwise provided in
3984	this chapter, the department may issue and serve a complaint
3985	stating charges upon any permittee or upon any affiliated party,
3986	whenever the department has reasonable cause to believe that the
3987	person or individual named therein is engaging in or has engaged
3988	in conduct that is:
3989	1.  An act that demonstrates a lack of fitness or
3990	trustworthiness to engage in the business authorized under the
3991	permit issued pursuant to this part ss. 499.001-499.081, is
3992	hazardous to the public health, or constitutes business
3993	operations that are a detriment to the public health;
3994	2.  A violation of any provision of this part ss. 499.001-
3995	499.081;
3996	3.  A violation of any rule of the department;
3997	4.  A violation of any order of the department; or
3998	5.  A breach of any written agreement with the department.
3999	(b)  The complaint must contain a statement of facts and
4000	notice of opportunity for a hearing pursuant to ss. 120.569 and
4001	120.57.
4002	(c)  If a hearing is not requested within the time allowed
4003	by ss. 120.569 and 120.57, or if a hearing is held and the
4004	department finds that any of the charges are proven, the
4005	department may enter an order directing the permittee or the
4006	affiliated party named in the complaint to cease and desist from
4007	engaging in the conduct complained of and take corrective action
4008	to remedy the effects of past improper conduct and assure future
4009	compliance.
4010	(d)  A contested or default cease and desist order is
4011	effective when reduced to writing and served upon the permittee
4012	or affiliated party named therein. An uncontested cease and
4013	desist order is effective as agreed.
4014	(e)  Whenever the department finds that conduct described
4015	in paragraph (a) is likely to cause an immediate threat to the
4016	public health, it may issue an emergency cease and desist order
4017	requiring the permittee or any affiliated party to immediately
4018	cease and desist from engaging in the conduct complained of and
4019	to take corrective and remedial action. The emergency order is
4020	effective immediately upon service of a copy of the order upon
4021	the permittee or affiliated party named therein and remains
4022	effective for 90 days. If the department begins nonemergency
4023	cease and desist proceedings under this subsection, the
4024	emergency order remains effective until the conclusion of the
4025	proceedings under ss. 120.569 and 120.57.
4026	(2)(3)  REMOVAL OF AFFILIATED PARTIES BY THE DEPARTMENT.--
4027	(a)  The department may issue and serve a complaint stating
4028	charges upon any affiliated party and upon the permittee
4029	involved whenever the department has reason to believe that an
4030	affiliated party is engaging in or has engaged in conduct that
4031	constitutes:
4032	1.  An act that demonstrates a lack of fitness or
4033	trustworthiness to engage in the business authorized under the
4034	permit issued pursuant to this part ss. 499.001-499.081, is
4035	hazardous to the public health, or constitutes business
4036	operations that are a detriment to the public health;
4037	2.  A willful violation of this part ss. 499.001-499.081;
4038	however, if the violation constitutes a misdemeanor, a complaint
4039	may not be served as provided in this section until the
4040	affiliated party is notified in writing of the matter of the
4041	violation and has been afforded a reasonable period of time, as
4042	set forth in the notice, to correct the violation and has failed
4043	to do so;
4044	3.  A violation of any other law involving fraud or moral
4045	turpitude which constitutes a felony;
4046	4.  A willful violation of any rule of the department;
4047	5.  A willful violation of any order of the department; or
4048	6.  A material misrepresentation of fact, made knowingly
4049	and willfully or made with reckless disregard for the truth of
4050	the matter.
4051	(b)  The complaint must contain a statement of facts and
4052	notice of opportunity for a hearing pursuant to ss. 120.569 and
4053	120.57.
4054	(c)  If a hearing is not requested within the time allotted
4055	by ss. 120.569 and 120.57, or if a hearing is held and the
4056	department finds that any of the charges in the complaint are
4057	proven true, the department may enter an order removing the
4058	affiliated party or restricting or prohibiting participation by
4059	the person in the affairs of that permittee or of any other
4060	permittee.
4061	(d)  A contested or default order of removal, restriction,
4062	or prohibition is effective when reduced to writing and served
4063	on the permittee and the affiliated party. An uncontested order
4064	of removal, restriction, or prohibition is effective as agreed.
4065	(e)1.  The chief executive officer, designated
4066	representative, or the person holding the equivalent office, of
4067	a permittee shall promptly notify the department if she or he
4068	has actual knowledge that any affiliated party is charged with a
4069	felony in a state or federal court.
4070	2.  Whenever any affiliated party is charged with a felony
4071	in a state or federal court or with the equivalent of a felony
4072	in the courts of any foreign country with which the United
4073	States maintains diplomatic relations, and the charge alleges
4074	violation of any law involving prescription drugs,
4075	pharmaceuticals, fraud, theft, or moral turpitude, the
4076	department may enter an emergency order suspending the
4077	affiliated party or restricting or prohibiting participation by
4078	the affiliated party in the affairs of the particular permittee
4079	or of any other permittee upon service of the order upon the
4080	permittee and the affiliated party charged. The order must
4081	contain notice of opportunity for a hearing pursuant to ss.
4082	120.569 and 120.57, where the affiliated party may request a
4083	postsuspension hearing to show that continued service to or
4084	participation in the affairs of the permittee does not pose a
4085	threat to the public health or the interests of the permittee
4086	and does not threaten to impair public confidence in the
4087	permittee. In accordance with applicable departmental rules, the
4088	department shall notify the affiliated party whether the order
4089	suspending or prohibiting the person from participation in the
4090	affairs of a permittee will be rescinded or otherwise modified.
4091	The emergency order remains in effect, unless otherwise modified
4092	by the department, until the criminal charge is disposed of. The
4093	acquittal of the person charged, or the final, unappealed
4094	dismissal of all charges against the person, dissolves the
4095	emergency order but does not prohibit the department from
4096	instituting proceedings under paragraph (a). If the person
4097	charged is convicted or pleads guilty or nolo contendere,
4098	whether or not an adjudication of guilt is entered by the court,
4099	the emergency order shall become final.
4100	(f)  Any affiliated party removed pursuant to this section
4101	is not eligible for reemployment by the permittee or to be an
4102	affiliated party of any permittee except upon the written
4103	consent of the department. Any affiliated party who is removed,
4104	restricted, or prohibited from participating in the affairs of a
4105	permittee pursuant to this section may petition the department
4106	for modification or termination of the removal, restriction, or
4107	prohibition.
4108	Section 37.  Section 499.067, Florida Statutes, is amended
4109	to read:
4110	499.067  Denial, suspension, or revocation of permit,
4111	certification, or registration.--
4112	(1)(a)  The department may deny, suspend, or revoke a
4113	permit if it finds that there has been a substantial failure to
4114	comply with this part ss. 499.001-499.081 or chapter 465,
4115	chapter 501, or chapter 893, the rules adopted under this part
4116	any of those sections or those chapters, any final order of the
4117	department, or applicable federal laws or regulations or other
4118	state laws or rules governing drugs, devices, or cosmetics.
4119	(b)  The department may deny an application for a permit or
4120	certification, or suspend or revoke a permit or certification,
4121	if the department finds that:
4122	1.  The applicant is not of good moral character or that it
4123	would be a danger or not in the best interest of the public
4124	health, safety, and welfare if the applicant were issued a
4125	permit or certification.
4126	2.  The applicant has not met the requirements for the
4127	permit or certification.
4128	3.  The applicant is not eligible for a permit or
4129	certification for any of the reasons enumerated in s. 499.012 s.
4130	499.01 or s. 499.012(5).
4131	4.  The applicant, permittee, or person certified under s.
4132	499.012(16) s. 499.012(11) demonstrates any of the conditions
4133	enumerated in s. 499.012 s. 499.01 or s. 499.012(5).
4134	5.  The applicant, permittee, or person certified under s.
4135	499.012(16) s. 499.012(11) has committed any violation of ss.
4136	499.005-499.0054.
4137	(2)  The department may deny, suspend, or revoke any
4138	registration required by the provisions of this part ss.
4139	499.001-499.081 for the violation of any provision of this part
4140	ss. 499.001-499.081 or of any rules adopted under this part
4141	those sections.
4142	(3)  The department may revoke or suspend a permit:
4143	(a)  If the permit was obtained by misrepresentation or
4144	fraud or through a mistake of the department;
4145	(b)  If the permit was procured, or attempted to be
4146	procured, for any other person by making or causing to be made
4147	any false representation; or
4148	(c)  If the permittee has violated any provision of this
4149	part ss. 499.001-499.081 or rules adopted under this part those
4150	sections.
4151	(4)  If any permit issued under this part ss. 499.001-
4152	499.081 is revoked or suspended, the owner, manager, operator,
4153	or proprietor of the establishment shall cease to operate as the
4154	permit authorized, from the effective date of the suspension or
4155	revocation until the person is again registered with the
4156	department and possesses the required permit. If a permit is
4157	revoked or suspended, the owner, manager, or proprietor shall
4158	remove all signs and symbols that identify the operation as
4159	premises permitted as a drug wholesaling establishment; drug,
4160	device, or cosmetic manufacturing establishment; or retail
4161	establishment. The department shall determine the length of time
4162	for which the permit is to be suspended. If a permit is revoked,
4163	the person that owns or operates the establishment may not apply
4164	for any permit under this part ss. 499.001-499.081 for a period
4165	of 1 year after the date of the revocation. A revocation of a
4166	permit may be permanent if the department considers that to be
4167	in the best interest of the public health.
4168	(5)  The department may deny, suspend, or revoke a permit
4169	issued under this part ss. 499.001-499.081 which authorizes the
4170	permittee to purchase prescription drugs, if any owner, officer,
4171	employee, or other person who participates in administering or
4172	operating the establishment has been found guilty of any
4173	violation of this part ss. 499.001-499.081 or chapter 465,
4174	chapter 501, or chapter 893, any rules adopted under this part
4175	any of those sections or those chapters, or any federal or state
4176	drug law, regardless of whether the person has been pardoned,
4177	had her or his civil rights restored, or had adjudication
4178	withheld.
4179	(6)  The department shall deny, suspend, or revoke the
4180	permit of any person or establishment if the assignment, sale,
4181	transfer, or lease of an establishment permitted under this part
4182	ss. 499.001-499.081 will avoid an administrative penalty, civil
4183	action, or criminal prosecution.
4184	(7)  Notwithstanding s. 120.60(5), if a permittee fails to
4185	comply with s. 499.012(6) s. 499.01(7), the department may
4186	revoke the permit of the permittee and shall provide notice of
4187	the intended agency action by posting a notice at the
4188	department's headquarters and by mailing a copy of the notice of
4189	intended agency action by certified mail to the most recent
4190	mailing address on record with the department and, if the
4191	permittee is not a natural person, to the permittee's registered
4192	agent on file with the Department of State.
4193	Section 38.  Paragraph (a) of subsection (1) of section
4194	409.9201, Florida Statutes, is amended to read:
4195	409.9201  Medicaid fraud.--
4196	(1)  As used in this section, the term:
4197	(a)  "Prescription Legend drug" means any drug, including,
4198	but not limited to, finished dosage forms or active ingredients
4199	that are subject to, defined by, or described by s. 503(b) of
4200	the Federal Food, Drug, and Cosmetic Act or by s. 465.003(8), s.
4201	499.007(13) s. 499.007(12), or s. 499.003(45) or (52) s.
4202	499.0122(1)(b) or (c).
4203
4204	The value of individual items of the legend drugs or goods or
4205	services involved in distinct transactions committed during a
4206	single scheme or course of conduct, whether involving a single
4207	person or several persons, may be aggregated when determining
4208	the punishment for the offense.
4209	Section 39.  Paragraph (c) of subsection (9) of section
4210	460.403, Florida Statutes, is amended to read:
4211	460.403  Definitions.--As used in this chapter, the term:
4212	(9)
4213	(c)1.  Chiropractic physicians may adjust, manipulate, or
4214	treat the human body by manual, mechanical, electrical, or
4215	natural methods; by the use of physical means or physiotherapy,
4216	including light, heat, water, or exercise; by the use of
4217	acupuncture; or by the administration of foods, food
4218	concentrates, food extracts, and items for which a prescription
4219	is not required and may apply first aid and hygiene, but
4220	chiropractic physicians are expressly prohibited from
4221	prescribing or administering to any person any legend drug
4222	except as authorized under subparagraph 2., from performing any
4223	surgery except as stated herein, or from practicing obstetrics.
4224	2.  Notwithstanding the prohibition against prescribing and
4225	administering legend drugs under subparagraph 1., or s.
4226	499.01(2)(m) s. 499.0122, pursuant to board rule chiropractic
4227	physicians may order, store, and administer, for emergency
4228	purposes only at the chiropractic physician's office or place of
4229	business, prescription medical oxygen and may also order, store,
4230	and administer the following topical anesthetics in aerosol
4231	form:
4232	a.  Any solution consisting of 25 percent ethylchloride and
4233	75 percent dichlorodifluoromethane.
4234	b.  Any solution consisting of 15 percent
4235	dichlorodifluoromethane and 85 percent
4236	trichloromonofluoromethane.
4237
4238	However, this paragraph does not authorize a chiropractic
4239	physician to prescribe medical oxygen as defined in chapter 499.
4240	Section 40.  Subsection (3) of section 465.0265, Florida
4241	Statutes, is amended to read:
4242	465.0265  Centralized prescription filling.--
4243	(3)  The filling, delivery, and return of a prescription by
4244	one pharmacy for another pursuant to this section shall not be
4245	construed as the filling of a transferred prescription as set
4246	forth in s. 465.026 or as a wholesale distribution as set forth
4247	in s. 499.003(53) s. 499.012(1)(a).
4248	Section 41.  Section 794.075, Florida Statutes, is amended
4249	to read:
4250	794.075  Sexual predators; erectile dysfunction drugs.--
4251	(1)  A person may not possess a prescription drug, as
4252	defined in s. 499.003(42) s. 499.003(25), for the purpose of
4253	treating erectile dysfunction if the person is designated as a
4254	sexual predator under s. 775.21.
4255	(2)  A person who violates a provision of this section for
4256	the first time commits a misdemeanor of the second degree,
4257	punishable as provided in s. 775.082 or s. 775.083. A person who
4258	violates a provision of this section a second or subsequent time
4259	commits a misdemeanor of the first degree, punishable as
4260	provided in s. 775.082 or s. 775.083.
4261	Section 42.  Paragraph (a) of subsection (1) of section
4262	895.02, Florida Statutes, is amended to read:
4263	895.02  Definitions.--As used in ss. 895.01-895.08, the
4264	term:
4265	(1)  "Racketeering activity" means to commit, to attempt to
4266	commit, to conspire to commit, or to solicit, coerce, or
4267	intimidate another person to commit:
4268	(a)  Any crime that is chargeable by indictment or
4269	information under the following provisions of the Florida
4270	Statutes:
4271	1.  Section 210.18, relating to evasion of payment of
4272	cigarette taxes.
4273	2.  Section 403.727(3)(b), relating to environmental
4274	control.
4275	3.  Section 409.920 or s. 409.9201, relating to Medicaid
4276	fraud.
4277	4.  Section 414.39, relating to public assistance fraud.
4278	5.  Section 440.105 or s. 440.106, relating to workers'
4279	compensation.
4280	6.  Section 443.071(4), relating to creation of a
4281	fictitious employer scheme to commit unemployment compensation
4282	fraud.
4283	7.  Section 465.0161, relating to distribution of medicinal
4284	drugs without a permit as an Internet pharmacy.
4285	8.  Section 499.0051 Sections 499.0051, 499.0052,
4286	499.00535, 499.00545, and 499.0691, relating to crimes involving
4287	contraband and adulterated drugs.
4288	9.  Part IV of chapter 501, relating to telemarketing.
4289	10.  Chapter 517, relating to sale of securities and
4290	investor protection.
4291	11.  Section 550.235, s. 550.3551, or s. 550.3605, relating
4292	to dogracing and horseracing.
4293	12.  Chapter 550, relating to jai alai frontons.
4294	13.  Section 551.109, relating to slot machine gaming.
4295	14.  Chapter 552, relating to the manufacture,
4296	distribution, and use of explosives.
4297	15.  Chapter 560, relating to money transmitters, if the
4298	violation is punishable as a felony.
4299	16.  Chapter 562, relating to beverage law enforcement.
4300	17.  Section 624.401, relating to transacting insurance
4301	without a certificate of authority, s. 624.437(4)(c)1., relating
4302	to operating an unauthorized multiple-employer welfare
4303	arrangement, or s. 626.902(1)(b), relating to representing or
4304	aiding an unauthorized insurer.
4305	18.  Section 655.50, relating to reports of currency
4306	transactions, when such violation is punishable as a felony.
4307	19.  Chapter 687, relating to interest and usurious
4308	practices.
4309	20.  Section 721.08, s. 721.09, or s. 721.13, relating to
4310	real estate timeshare plans.
4311	21.  Chapter 782, relating to homicide.
4312	22.  Chapter 784, relating to assault and battery.
4313	23.  Chapter 787, relating to kidnapping or human
4314	trafficking.
4315	24.  Chapter 790, relating to weapons and firearms.
4316	25.  Section 796.03, s. 796.035, s. 796.04, s. 796.045, s.
4317	796.05, or s. 796.07, relating to prostitution and sex
4318	trafficking.
4319	26.  Chapter 806, relating to arson.
4320	27.  Section 810.02(2)(c), relating to specified burglary
4321	of a dwelling or structure.
4322	28.  Chapter 812, relating to theft, robbery, and related
4323	crimes.
4324	29.  Chapter 815, relating to computer-related crimes.
4325	30.  Chapter 817, relating to fraudulent practices, false
4326	pretenses, fraud generally, and credit card crimes.
4327	31.  Chapter 825, relating to abuse, neglect, or
4328	exploitation of an elderly person or disabled adult.
4329	32.  Section 827.071, relating to commercial sexual
4330	exploitation of children.
4331	33.  Chapter 831, relating to forgery and counterfeiting.
4332	34.  Chapter 832, relating to issuance of worthless checks
4333	and drafts.
4334	35.  Section 836.05, relating to extortion.
4335	36.  Chapter 837, relating to perjury.
4336	37.  Chapter 838, relating to bribery and misuse of public
4337	office.
4338	38.  Chapter 843, relating to obstruction of justice.
4339	39.  Section 847.011, s. 847.012, s. 847.013, s. 847.06, or
4340	s. 847.07, relating to obscene literature and profanity.
4341	40.  Section 849.09, s. 849.14, s. 849.15, s. 849.23, or s.
4342	849.25, relating to gambling.
4343	41.  Chapter 874, relating to criminal street gangs.
4344	42.  Chapter 893, relating to drug abuse prevention and
4345	control.
4346	43.  Chapter 896, relating to offenses related to financial
4347	transactions.
4348	44.  Sections 914.22 and 914.23, relating to tampering with
4349	a witness, victim, or informant, and retaliation against a
4350	witness, victim, or informant.
4351	45.  Sections 918.12 and 918.13, relating to tampering with
4352	jurors and evidence.
4353	Section 43.  Paragraphs (d), (f), (h), (i), and (j) of
4354	subsection (3) of section 921.0022, Florida Statutes, are
4355	amended to read:
4356	921.0022  Criminal Punishment Code; offense severity
4357	ranking chart.--
4358	(3)  OFFENSE SEVERITY RANKING CHART
4359	(d)  LEVEL 4
4360
	FloridaStatute FelonyDegree Description
4361
	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.
4362
	499.0051(1) 3rd Failure to maintain or deliver pedigree papers.
4363
	499.0051(2) 3rd Failure to authenticate pedigree papers.
4364
	499.0051(6) 2nd Knowing sale or delivery, or possession with intent to sell, contraband prescription legend drugs.
4365
	784.07(2)(b) 3rd Battery of law enforcement officer, firefighter, intake officer, etc.
4366
	784.074(1)(c) 3rd Battery of sexually violent predators facility staff.
4367
	784.075 3rd Battery on detention or commitment facility staff.
4368
	784.078 3rd Battery of facility employee by throwing, tossing, or expelling certain fluids or materials.
4369
	784.08(2)(c) 3rd Battery on a person 65 years of age or older.
4370
	784.081(3) 3rd Battery on specified official or employee.
4371
	784.082(3) 3rd Battery by detained person on visitor or other detainee.
4372
	784.083(3) 3rd Battery on code inspector.
4373
	784.085 3rd Battery of child by throwing, tossing, projecting, or expelling certain fluids or materials.
4374
	787.03(1) 3rd Interference with custody; wrongly takes minor from appointed guardian.
4375
	787.04(2) 3rd Take, entice, or remove child beyond state limits with criminal intent pending custody proceedings.
4376
	787.04(3) 3rd Carrying child beyond state lines with criminal intent to avoid producing child at custody hearing or delivering to designated person.
4377
	790.115(1) 3rd Exhibiting firearm or weapon within 1,000 feet of a school.
4378
	790.115(2)(b) 3rd Possessing electric weapon or device, destructive device, or other weapon on school property.
4379
	790.115(2)(c) 3rd Possessing firearm on school property.
4380
	800.04(7)(d) 3rd Lewd or lascivious exhibition; offender less than 18 years.
4381
	810.02(4)(a) 3rd Burglary, or attempted burglary, of an unoccupied structure; unarmed; no assault or battery.
4382
	810.02(4)(b) 3rd Burglary, or attempted burglary, of an unoccupied conveyance; unarmed; no assault or battery.
4383
	810.06 3rd Burglary; possession of tools.
4384
	810.08(2)(c) 3rd Trespass on property, armed with firearm or dangerous weapon.
4385
	812.014(2)(c)3. 3rd Grand theft, 3rd degree $10,000 or more but less than $20,000.
4386
	812.014(2)(c)4.-10. 3rd Grand theft, 3rd degree, a will, firearm, motor vehicle, livestock, etc.
4387
	812.0195(2) 3rd Dealing in stolen property by use of the Internet; property stolen $300 or more.
4388
	817.563(1) 3rd Sell or deliver substance other than controlled substance agreed upon, excluding s. 893.03(5) drugs.
4389
	817.568(2)(a) 3rd Fraudulent use of personal identification information.
4390
	817.625(2)(a) 3rd Fraudulent use of scanning device or reencoder.
4391
	828.125(1) 2nd Kill, maim, or cause great bodily harm or permanent breeding disability to any registered horse or cattle.
4392
	837.02(1) 3rd Perjury in official proceedings.
4393
	837.021(1) 3rd Make contradictory statements in official proceedings.
4394
	838.022 3rd Official misconduct.
4395
	839.13(2)(a) 3rd Falsifying records of an individual in the care and custody of a state agency.
4396
	839.13(2)(c) 3rd Falsifying records of the Department of Children and Family Services.
4397
	843.021 3rd Possession of a concealed handcuff key by a person in custody.
4398
	843.025 3rd Deprive law enforcement, correctional, or correctional probation officer of means of protection or communication.
4399
	843.15(1)(a) 3rd Failure to appear while on bail for felony (bond estreature or bond jumping).
4400
	874.05(1) 3rd Encouraging or recruiting another to join a criminal street gang.
4401
	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).
4402
	914.14(2) 3rd Witnesses accepting bribes.
4403
	914.22(1) 3rd Force, threaten, etc., witness, victim, or informant.
4404
	914.23(2) 3rd Retaliation against a witness, victim, or informant, no bodily injury.
4405
	918.12 3rd Tampering with jurors.
4406
	934.215 3rd Use of two-way communications device to facilitate commission of a crime.
4407
4408	(f)  LEVEL 6
4409
	FloridaStatute FelonyDegree Description
4410
	316.193(2)(b) 3rd Felony DUI, 4th or subsequent conviction.
4411
	499.0051(3) 2nd Knowing forgery of pedigree papers.
4412
	499.0051(4) 2nd Knowing purchase or receipt of prescription legend drug from unauthorized person.
4413
	499.0051(5) 2nd Knowing sale or transfer of prescription legend drug to unauthorized person.
4414
	775.0875(1) 3rd Taking firearm from law enforcement officer.
4415
	784.021(1)(a) 3rd Aggravated assault; deadly weapon without intent to kill.
4416
	784.021(1)(b) 3rd Aggravated assault; intent to commit felony.
4417
	784.041 3rd Felony battery; domestic battery by strangulation.
4418
	784.048(3) 3rd Aggravated stalking; credible threat.
4419
	784.048(5) 3rd Aggravated stalking of person under 16.
4420
	784.07(2)(c) 2nd Aggravated assault on law enforcement officer.
4421
	784.074(1)(b) 2nd Aggravated assault on sexually violent predators facility staff.
4422
	784.08(2)(b) 2nd Aggravated assault on a person 65 years of age or older.
4423
	784.081(2) 2nd Aggravated assault on specified official or employee.
4424
	784.082(2) 2nd Aggravated assault by detained person on visitor or other detainee.
4425
	784.083(2) 2nd Aggravated assault on code inspector.
4426
	787.02(2) 3rd False imprisonment; restraining with purpose other than those in s. 787.01.
4427
	790.115(2)(d) 2nd Discharging firearm or weapon on school property.
4428
	790.161(2) 2nd Make, possess, or throw destructive device with intent to do bodily harm or damage property.
4429
	790.164(1) 2nd False report of deadly explosive, weapon of mass destruction, or act of arson or violence to state property.
4430
	790.19 2nd Shooting or throwing deadly missiles into dwellings, vessels, or vehicles.
4431
	794.011(8)(a) 3rd Solicitation of minor to participate in sexual activity by custodial adult.
4432
	794.05(1) 2nd Unlawful sexual activity with specified minor.
4433
	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.
4434
	800.04(6)(b) 2nd Lewd or lascivious conduct; offender 18 years of age or older.
4435
	806.031(2) 2nd Arson resulting in great bodily harm to firefighter or any other person.
4436
	810.02(3)(c) 2nd Burglary of occupied structure; unarmed; no assault or battery.
4437
	812.014(2)(b)1. 2nd Property stolen $20,000 or more, but less than $100,000, grand theft in 2nd degree.
4438
	812.014(6) 2nd Theft; property stolen $3,000 or more; coordination of others.
4439
	812.015(9)(a) 2nd Retail theft; property stolen $300 or more; second or subsequent conviction.
4440
	812.015(9)(b) 2nd Retail theft; property stolen $3,000 or more; coordination of others.
4441
	812.13(2)(c) 2nd Robbery, no firearm or other weapon (strong-arm robbery).
4442
	817.034(4)(a)1. 1st Communications fraud, value greater than $50,000.
4443
	817.4821(5) 2nd Possess cloning paraphernalia with intent to create cloned cellular telephones.
4444
	825.102(1) 3rd Abuse of an elderly person or disabled adult.
4445
	825.102(3)(c) 3rd Neglect of an elderly person or disabled adult.
4446
	825.1025(3) 3rd Lewd or lascivious molestation of an elderly person or disabled adult.
4447
	825.103(2)(c) 3rd Exploiting an elderly person or disabled adult and property is valued at less than $20,000.
4448
	827.03(1) 3rd Abuse of a child.
4449
	827.03(3)(c) 3rd Neglect of a child.
4450
	827.071(2)&(3) 2nd Use or induce a child in a sexual performance, or promote or direct such performance.
4451
	836.05 2nd Threats; extortion.
4452
	836.10 2nd Written threats to kill or do bodily injury.
4453
	843.12 3rd Aids or assists person to escape.
4454
	847.0135(2) 3rd Facilitates sexual conduct of or with a minor or the visual depiction of such conduct.
4455
	914.23 2nd Retaliation against a witness, victim, or informant, with bodily injury.
4456
	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.
4457
	944.40 2nd Escapes.
4458
	944.46 3rd Harboring, concealing, aiding escaped prisoners.
4459
	944.47(1)(a)5. 2nd Introduction of contraband (firearm, weapon, or explosive) into correctional facility.
4460
	951.22(1) 3rd Intoxicating drug, firearm, or weapon introduced into county facility.
4461
4462	(h)  LEVEL 8
4463
	FloridaStatute FelonyDegree Description
4464
	316.193(3)(c)3.a. 2nd DUI manslaughter.
4465
	316.1935(4)(b) 1st Aggravated fleeing or attempted eluding with serious bodily injury or death.
4466
	327.35(3)(c)3. 2nd Vessel BUI manslaughter.
4467
	499.0051(8) 499.0051(7) 1st Knowing forgery of prescription labels or prescription legend drug labels.
4468
	499.0051(7) 499.0052 1st Knowing trafficking in contraband prescription legend drugs.
4469
	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.
4470
	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.
4471
	655.50(10)(b)2. 2nd Failure to report financial transactions totaling or exceeding $20,000, but less than $100,000 by financial institutions.
4472
	777.03(2)(a) 1st Accessory after the fact, capital felony.
4473
	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.
4474
	782.051(2) 1st Attempted felony murder while perpetrating or attempting to perpetrate a felony not enumerated in s. 782.04(3).
4475
	782.071(1)(b) 1st Committing vehicular homicide and failing to render aid or give information.
4476
	782.072(2) 1st Committing vessel homicide and failing to render aid or give information.
4477
	790.161(3) 1st Discharging a destructive device which results in bodily harm or property damage.
4478
	794.011(5) 2nd Sexual battery, victim 12 years or over, offender does not use physical force likely to cause serious injury.
4479
	794.08(3) 2nd Female genital mutilation, removal of a victim younger than 18 years of age from this state.
4480
	800.04(4) 2nd Lewd or lascivious battery.
4481
	806.01(1) 1st Maliciously damage dwelling or structure by fire or explosive, believing person in structure.
4482
	810.02(2)(a) 1st,PBL Burglary with assault or battery.
4483
	810.02(2)(b) 1st,PBL Burglary; armed with explosives or dangerous weapon.
4484
	810.02(2)(c) 1st Burglary of a dwelling or structure causing structural damage or $1,000 or more property damage.
4485
	812.014(2)(a)2. 1st Property stolen; cargo valued at $50,000 or more, grand theft in 1st degree.
4486
	812.13(2)(b) 1st Robbery with a weapon.
4487
	812.135(2)(c) 1st Home-invasion robbery, no firearm, deadly weapon, or other weapon.
4488
	817.568(6) 2nd Fraudulent use of personal identification information of an individual under the age of 18.
4489
	825.102(2) 2nd Aggravated abuse of an elderly person or disabled adult.
4490
	825.1025(2) 2nd Lewd or lascivious battery upon an elderly person or disabled adult.
4491
	825.103(2)(a) 1st Exploiting an elderly person or disabled adult and property is valued at $100,000 or more.
4492
	837.02(2) 2nd Perjury in official proceedings relating to prosecution of a capital felony.
4493
	837.021(2) 2nd Making contradictory statements in official proceedings relating to prosecution of a capital felony.
4494
	860.121(2)(c) 1st Shooting at or throwing any object in path of railroad vehicle resulting in great bodily harm.
4495
	860.16 1st Aircraft piracy.
4496
	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).
4497
	893.13(2)(b) 1st Purchase in excess of 10 grams of any substance specified in s. 893.03(1)(a) or (b).
4498
	893.13(6)(c) 1st Possess in excess of 10 grams of any substance specified in s. 893.03(1)(a) or (b).
4499
	893.135(1)(a)2. 1st Trafficking in cannabis, more than 2,000 lbs., less than 10,000 lbs.
4500
	893.135(1)(b)1.b. 1st Trafficking in cocaine, more than 200 grams, less than 400 grams.
4501
	893.135(1)(c)1.b. 1st Trafficking in illegal drugs, more than 14 grams, less than 28 grams.
4502
	893.135(1)(d)1.b. 1st Trafficking in phencyclidine, more than 200 grams, less than 400 grams.
4503
	893.135(1)(e)1.b. 1st Trafficking in methaqualone, more than 5 kilograms, less than 25 kilograms.
4504
	893.135(1)(f)1.b. 1st Trafficking in amphetamine, more than 28 grams, less than 200 grams.
4505
	893.135(1)(g)1.b. 1st Trafficking in flunitrazepam, 14 grams or more, less than 28 grams.
4506
	893.135(1)(h)1.b. 1st Trafficking in gamma-hydroxybutyric acid (GHB), 5 kilograms or more, less than 10 kilograms.
4507
	893.135(1)(j)1.b. 1st Trafficking in 1,4-Butanediol, 5 kilograms or more, less than 10 kilograms.
4508
	893.135(1)(k)2.b. 1st Trafficking in Phenethylamines, 200 grams or more, less than 400 grams.
4509
	895.03(1) 1st Use or invest proceeds derived from pattern of racketeering activity.
4510
	895.03(2) 1st Acquire or maintain through racketeering activity any interest in or control of any enterprise or real property.
4511
	895.03(3) 1st Conduct or participate in any enterprise through pattern of racketeering activity.
4512
	896.101(5)(b) 2nd Money laundering, financial transactions totaling or exceeding $20,000, but less than $100,000.
4513
	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.
4514
4515	(i)  LEVEL 9
4516
	FloridaStatute FelonyDegree Description
4517
	316.193(3)(c)3.b. 1st DUI manslaughter; failing to render aid or give information.
4518
	327.35(3)(c)3.b. 1st BUI manslaughter; failing to render aid or give information.
4519
	499.0051(9) 499.00535 1st Knowing sale or purchase of contraband prescription legend drugs resulting in great bodily harm.
4520
	560.123(8)(b)3. 1st Failure to report currency or payment instruments totaling or exceeding $100,000 by money transmitter.
4521
	560.125(5)(c) 1st Money transmitter business by unauthorized person, currency, or payment instruments totaling or exceeding $100,000.
4522
	655.50(10)(b)3. 1st Failure to report financial transactions totaling or exceeding $100,000 by financial institution.
4523
	775.0844 1st Aggravated white collar crime.
4524
	782.04(1) 1st Attempt, conspire, or solicit to commit premeditated murder.
4525
	782.04(3) 1st,PBL Accomplice to murder in connection with arson, sexual battery, robbery, burglary, and other specified felonies.
4526
	782.051(1) 1st Attempted felony murder while perpetrating or attempting to perpetrate a felony enumerated in s. 782.04(3).
4527
	782.07(2) 1st Aggravated manslaughter of an elderly person or disabled adult.
4528
	787.01(1)(a)1. 1st,PBL Kidnapping; hold for ransom or reward or as a shield or hostage.
4529
	787.01(1)(a)2. 1st,PBL Kidnapping with intent to commit or facilitate commission of any felony.
4530
	787.01(1)(a)4. 1st,PBL Kidnapping with intent to interfere with performance of any governmental or political function.
4531
	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.
4532
	790.161 1st Attempted capital destructive device offense.
4533
	790.166(2) 1st,PBL Possessing, selling, using, or attempting to use a weapon of mass destruction.
4534
	794.011(2) 1st Attempted sexual battery; victim less than 12 years of age.
4535
	794.011(2) Life Sexual battery; offender younger than 18 years and commits sexual battery on a person less than 12 years.
4536
	794.011(4) 1st Sexual battery; victim 12 years or older, certain circumstances.
4537
	794.011(8)(b) 1st Sexual battery; engage in sexual conduct with minor 12 to 18 years by person in familial or custodial authority.
4538
	794.08(2) 1st Female genital mutilation; victim younger than 18 years of age.
4539
	800.04(5)(b) Life Lewd or lascivious molestation; victim less than 12 years; offender 18 years or older.
4540
	812.13(2)(a) 1st,PBL Robbery with firearm or other deadly weapon.
4541
	812.133(2)(a) 1st,PBL Carjacking; firearm or other deadly weapon.
4542
	812.135(2)(b) 1st Home-invasion robbery with weapon.
4543
	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.
4544
	827.03(2) 1st Aggravated child abuse.
4545
	847.0145(1) 1st Selling, or otherwise transferring custody or control, of a minor.
4546
	847.0145(2) 1st Purchasing, or otherwise obtaining custody or control, of a minor.
4547
	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.
4548
	893.135 1st Attempted capital trafficking offense.
4549
	893.135(1)(a)3. 1st Trafficking in cannabis, more than 10,000 lbs.
4550
	893.135(1)(b)1.c. 1st Trafficking in cocaine, more than 400 grams, less than 150 kilograms.
4551
	893.135(1)(c)1.c. 1st Trafficking in illegal drugs, more than 28 grams, less than 30 kilograms.
4552
	893.135(1)(d)1.c. 1st Trafficking in phencyclidine, more than 400 grams.
4553
	893.135(1)(e)1.c. 1st Trafficking in methaqualone, more than 25 kilograms.
4554
	893.135(1)(f)1.c. 1st Trafficking in amphetamine, more than 200 grams.
4555
	893.135(1)(h)1.c. 1st Trafficking in gamma-hydroxybutyric acid (GHB), 10 kilograms or more.
4556
	893.135(1)(j)1.c. 1st Trafficking in 1,4-Butanediol, 10 kilograms or more.
4557
	893.135(1)(k)2.c. 1st Trafficking in Phenethylamines, 400 grams or more.
4558
	896.101(5)(c) 1st Money laundering, financial instruments totaling or exceeding $100,000.
4559
	896.104(4)(a)3. 1st Structuring transactions to evade reporting or registration requirements, financial transactions totaling or exceeding $100,000.
4560
4561	(j)  LEVEL 10
4562
	FloridaStatute FelonyDegree Description
4563
	499.0051(10) 499.00545 1st Knowing sale or purchase of contraband prescription legend drugs resulting in death.
4564
	782.04(2) 1st,PBL Unlawful killing of human; act is homicide, unpremeditated.
4565
	787.01(1)(a)3. 1st,PBL Kidnapping; inflict bodily harm upon or terrorize victim.
4566
	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.
4567
	782.07(3) 1st Aggravated manslaughter of a child.
4568
	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.
4569
	812.135(2)(a) 1st,PBL Home-invasion robbery with firearm or other deadly weapon.
4570
	876.32 1st Treason against the state.
4571
4572	Section 44.  This act shall take effect July 1, 2008.

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