HB 1481 2003
1	CHAMBER ACTION
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6	The Committee on Health Care recommends the following:
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8	Committee Substitute
9	Remove the entire bill and insert:
10	A bill to be entitled
11	An act relating to the distribution of prescription drugs;
12	providing a popular name; providing legislative findings
13	and intent with respect to a report by the Seventeenth
14	Statewide Grand Jury; amending s. 499.003, F.S.; defining
15	additional terms, including the terms "contraband legend
16	drug," "pedigree paper," and "repackager"; amending s.
17	499.005, F.S.; prohibiting the purchase or sale of
18	prescription drugs in wholesale distribution in exchange
19	for currency; clarifying provisions prohibiting the
20	transfer of legend drugs from or to any person not
21	authorized to possess such drugs; prohibiting additional
22	acts concerning the distribution of prescription drugs;
23	creating s. 499.0051, F.S.; providing that failure to
24	maintain or deliver pedigree papers, failure to
25	authenticate pedigree papers, forgery of pedigree papers,
26	purchase of legend drugs from an unlicensed person, sale
27	of legend drugs to an unlicensed person, possession or
28	sale of contraband legend drugs and possession with intent
29	to sell or deliver contraband legend drugs, and forgery of
30	prescription labels or legend drug labels are felony
31	offenses; providing penalties; creating s. 499.0052, F.S.;
32	providing that trafficking in contraband legend drugs is a
33	felony offense; providing penalties; providing enhanced
34	penalties if the defendant is a corporation or not a
35	natural person; creating s. 499.00523, F.S.; providing
36	that the sale or purchase of a contraband legend drug
37	resulting in great bodily harm is a first-degree felony;
38	creating s. 499.00525, F.S.; providing that the sale or
39	purchase of a contraband legend drug resulting in death is
40	a first-degree felony; amending s. 499.006, F.S.;
41	providing that a legend drug that is unaccompanied by a
42	proper pedigree paper or that has been in the possession
43	of an unauthorized person is an adulterated drug; amending
44	s. 499.007, F.S.; revising labeling requirements to
45	conform to federal law; amending s. 499.01, F.S.;
46	authorizing issuance of prescription drug manufacturer
47	permits to the addresses of certain pharmacies;
48	prohibiting issuance of local occupational licenses to
49	establishments not exhibiting a current permit; providing
50	expiration dates for prescription drug wholesaler permits
51	and out-of-state prescription drug wholesaler permits;
52	requiring that prescription drug repackagers, nonresident
53	prescription drug manufacturers, and freight forwarders
54	obtain a permit from the Department of Health in order to
55	do business; revising application requirements; providing
56	for revocation of permit for failure to comply with
57	requirements prohibiting transfer of a permit; amending s.
58	499.012, F.S.; excluding the transfer of prescription
59	drugs within a hospital from the definition of wholesale
60	distribution; providing bond requirements for prescription
61	drug wholesalers and out-of-state prescription drug
62	wholesalers; deleting provisions authorizing the
63	department to grant out-of-state wholesalers reciprocity;
64	requiring freight forwarders and nonresident prescription
65	drug manufacturers to obtain a permit; providing
66	requirements; providing requirements for the permitting of
67	prescription drug wholesalers, out-of-state prescription
68	drug wholesalers, and retail pharmacy drug wholesalers;
69	requiring prescription drug wholesalers and out-of-state
70	prescription drug wholesalers to designate a
71	representative; providing criteria for designation as a
72	representative; amending s. 499.0121, F.S.; requiring
73	pedigree papers for the transfer and sale of legend drugs;
74	providing documentation requirements for the shipment of
75	prescription drugs; providing requirements for wholesale
76	drug distributors with respect to the exercise of due
77	diligence; creating s. 499.01211, F.S.; creating the Drug
78	Wholesaler Advisory Council within the Department of
79	Health; providing for membership of the council and terms
80	of office; requiring the council to review rules and make
81	recommendations to the secretary of the department;
82	amending s. 499.0122, F.S.; conforming cross references;
83	amending s. 499.013, F.S.; providing requirements for
84	repackagers of drugs, devices, and cosmetics; requiring
85	that a repackager obtain a permit from the department;
86	amending s. 499.014, F.S.; specifying that certain
87	restricted distributors are exempt from the requirements
88	concerning pedigree papers; amending ss. 499.015, 499.024,
89	and 499.03, F.S.; conforming cross references; amending s.
90	499.041, F.S.; revising the schedule of fees for permits;
91	amending s. 499.05, F.S.; conforming a cross reference;
92	amending s. 499.051, F.S.; extending the authority of the
93	Department of Health to inspect pharmacies and retail
94	pharmacy wholesalers; authorizing the department and the
95	Department of Law Enforcement to inspect certain financial
96	documents and records; amending s. 499.055, F.S.;
97	requiring the Department of Health to establish a website
98	listing certain wholesaler permitholders and pending
99	enforcement actions; creating s. 499.065, F.S.;
100	authorizing the department to enter and inspect all
101	permitted facilities at any reasonable time; authorizing
102	the department to seize and destroy prescription drugs
103	representing a threat to public health; authorizing the
104	department to close facilities that represent an imminent
105	danger to public health; amending s. 499.066, F.S.;
106	providing for enforcement actions by the department;
107	creating s. 499.0661, F.S.; providing for the department
108	to issue cease and desist orders; providing for the
109	department to order the removal of certain persons from
110	involvement with certain drug wholesalers; amending s.
111	499.067, F.S.; specifying additional grounds for denial of
112	a permit or certification; amending s. 499.069, F.S.;
113	revising certain penalty provisions; creating s. 499.0691,
114	F.S.; providing criminal penalties for violations related
115	to drugs or false advertisement; amending s. 921.0022,
116	F.S., relating to the offense severity ranking chart of
117	the Criminal Punishment Code; conforming provisions to
118	changes made by the act; amending s. 895.02, F.S.;
119	including certain violations of part I of ch. 499, F.S.,
120	within the definition of racketeering activity; amending
121	ss. 16.56 and 905.34, F.S.; authorizing criminal
122	violations of part I of ch. 499, F.S., to be prosecuted by
123	the Office of Statewide Prosecution and heard by a
124	statewide grand jury; providing for severability;
125	providing effective dates.
126
127	Be It Enacted by the Legislature of the State of Florida:
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129	Section 1. This act shall be known by the popular name the
130	"Prescription Drug Protection Act."
131	Section 2. Legislative findings and intent.--Based on the
132	report of the Seventeenth Statewide Grand Jury in its First
133	Interim Report, the Legislature finds that prescription drugs
134	brought into the state by wholesalers are being relabeled and
135	falsely represented as being of a higher dosage by other
136	wholesalers in order to charge higher prices for those drugs and
137	that counterfeit substances labeled as genuine pharmaceuticals
138	are being distributed, thereby causing an extreme danger that
139	persons eventually receiving the drugs by prescription are
140	receiving ineffective drugs in nontherapeutic doses, or even
141	receiving dangerous or unwholesome substances, with the result
142	that the health and well-being of the public is at risk. The
143	Statewide Grand Jury also found that the lack of an effective
144	pedigree paper requirement has resulted in the inability of
145	prescription drug users to have confidence in the purity and
146	efficacy of the drugs they use. The Statewide Grand Jury further
147	noted that present laws do not allow effective criminal
148	prosecution of persons involved in such false representations.
149	It is the intent of the Legislature that the statutory changes
150	and recommendations outlined in the Statewide Grand Jury's
151	report be implemented as provided by this act.
152	Section 3. Section 499.003, Florida Statutes, is amended
153	to read:
154	499.003 Definitions of terms used in ss. 499.001-
155	499.081.--As used in ss. 499.001-499.081, the term:
156	(1) "Advertisement" means any representation disseminated
157	in any manner or by any means, other than by labeling, for the
158	purpose of inducing, or which is likely to induce, directly or
159	indirectly, the purchase of drugs, devices, or cosmetics.
160	(2) "Affiliated party" means:
161	(a) A director, officer, trustee, partner, or committee
162	member of a permittee or applicant or a subsidiary or service
163	corporation of the permittee or applicant;
164	(b) A person who, directly or indirectly, manages,
165	controls, or oversees the operation of a permittee or applicant,
166	regardless of whether such person is a partner, shareholder,
167	manager, member, officer, director, independent contractor, or
168	employee of the permittee or applicant;
169	(c) A person who has filed or is required to file a
170	personal information statement pursuant to s. 499.012(4) or is
171	required to be identified in an application for a permit or to
172	renew a permit pursuant to s. 499.012(3); or
173	(d) The five largest natural shareholders that own at
174	least 5 percent of the permittee or applicant.
175	(3) "Applicant" means a person applying for a permit or
176	certification under ss. 499.001-499.081.
177	(4) "Authenticate" means to affirmatively verify before
178	any distribution of a legend drug occurs that each transaction
179	listed on the pedigree paper has occurred.
180	(5)(2)"Certificate of free sale" means a document
181	prepared by the department which certifies a drug, device, or
182	cosmetic, that is registered with the department, as one that
183	can be legally sold in the state.
184	(6)(3)"Closed pharmacy" means a pharmacy that is licensed
185	under chapter 465 and purchases prescription drugs for use by a
186	limited patient population and not for wholesale distribution or
187	sale to the public. The term does not include retail
188	pharmacies.
189	(7)(4)"Color" includes black, white, and intermediate
190	grays.
191	(8)(5)"Color additive" means a material that:
192	(a) Is a dye pigment, or other substance, made by a
193	process of synthesis or similar artifice, or extracted,
194	isolated, or otherwise derived, with or without intermediate or
195	final change of identity from a vegetable, animal, mineral, or
196	other source; or
197	(b) When added or applied to a drug or cosmetic or to the
198	human body, or any part thereof, is capable alone, or through
199	reaction with other substances, of imparting color thereto;
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201	except that the term does not include any material which has
202	been or hereafter is exempt under the federal act.
203	(9)(6)"Compressed medical gas" means any liquefied or
204	vaporized gas that is a prescription drug, whether it is alone
205	or in combination with other gases.
206	(10) "Contraband legend drug" means any:
207	(a) Adulterated drug, as defined in s. 499.006;
208	(b) Counterfeit drug, as defined in this section; or
209	(c) Legend drug for which a pedigree paper does not exist
210	or for which the pedigree paper in existence has been forged,
211	counterfeited, falsely created or contains any altered, false,
212	or misrepresented matter.
213	(11)(7)"Cosmetic" means an article that is:
214	(a) Intended to be rubbed, poured, sprinkled, or sprayed
215	on; introduced into; or otherwise applied to the human body or
216	any part thereof for cleansing, beautifying, promoting
217	attractiveness, or altering the appearance; or
218	(b) Intended for use as a component of any such article;
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220	except that the term does not include soap.
221	(12)(8)"Counterfeit drug, counterfeit device, or
222	counterfeit cosmetic" means a drug, device, or cosmetic which,
223	or the container, seal, or labeling of which, without
224	authorization, bears the trademark, trade name, or other
225	identifying mark, imprint, or device, or any likeness thereof,
226	of a drug, device, or cosmetic manufacturer, processor, packer,
227	or distributor other than the person that in fact manufactured,
228	processed, packed, or distributed that drug, device, or cosmetic
229	and which thereby falsely purports or is represented to be the
230	product of, or to have been packed or distributed by, that other
231	drug, device, or cosmetic manufacturer, processor, packer, or
232	distributor.
233	(13)(9)"Department" means the Department of Health.
234	(14)(10)"Device" means any instrument, apparatus,
235	implement, machine, contrivance, implant, in vitro reagent, or
236	other similar or related article, including its components,
237	parts, or accessories, which is:
238	(a) Recognized in the current edition of the United States
239	Pharmacopoeia and National Formulary, or any supplement thereof,
240	(b) Intended for use in the diagnosis, cure, mitigation,
241	treatment, therapy, or prevention of disease in humans or other
242	animals, or
243	(c) Intended to affect the structure or any function of
244	the body of humans or other animals,
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246	and which does not achieve any of its principal intended
247	purposes through chemical action within or on the body of humans
248	or other animals and which is not dependent upon being
249	metabolized for the achievement of any of its principal intended
250	purposes.
251	(15)(11) "Distribute" or "distribution" means to sell;
252	offer to sell; give away; transfer, whether by passage of title,
253	physical movement, or both; deliver; or offer to deliver. The
254	term does not mean to administer or dispense.
255	(16) "Diverted from the legal channels of distribution for
256	prescription drugs" means an adulterated drug pursuant to s.
257	499.006(10).
258	(17)(12)"Drug" means an article that is:
259	(a) Recognized in the current edition of the United States
260	Pharmacopoeia and National Formulary, official Homeopathic
261	Pharmacopoeia of the United States, or any supplement to any of
262	those publications;
263	(b) Intended for use in the diagnosis, cure, mitigation,
264	treatment, therapy, or prevention of disease in humans or other
265	animals;
266	(c) Intended to affect the structure or any function of
267	the body of humans or other animals; or
268	(d) Intended for use as a component of any article
269	specified in paragraph (a), paragraph (b), or paragraph (c), but
270	does not include devices or their components, parts, or
271	accessories.
272	(18)(13)"Establishment" means a place of business at one
273	general physical location.
274	(19)(14)"Federal act" means the Federal Food, Drug, and
275	Cosmetic Act, 21 U.S.C. ss. 301 et seq.; 52 Stat. 1040 et seq.
276	(20) "Freight forwarder" means a person who receives
277	legend drugs which are owned by another person and designated by
278	that person for export, and exports those legend drugs.
279	(21)(15)"Health care entity" means a closed pharmacy or
280	any person, organization, or business entity that provides
281	diagnostic, medical, surgical, or dental treatment or care, or
282	chronic or rehabilitative care, but does not include any
283	wholesale distributor or retail pharmacy licensed under state
284	law to deal in prescription drugs.
285	(22)(16)"Immediate container" does not include package
286	liners.
287	(23)(17)"Label" means a display of written, printed, or
288	graphic matter upon the immediate container of any drug, device,
289	or cosmetic. A requirement made by or under authority of ss.
290	499.001-499.081 or rules adopted under those sections that any
291	word, statement, or other information appear on the label is not
292	complied with unless such word, statement, or other information
293	also appears on the outside container or wrapper, if any, of the
294	retail package of such drug, device, or cosmetic or is easily
295	legible through the outside container or wrapper.
296	(24)(18)"Labeling" means all labels and other written,
297	printed, or graphic matters:
298	(a) Upon a drug, device, or cosmetic, or any of its
299	containers or wrappers; or
300	(b) Accompanying or related to such drug, device, or
301	cosmetic.
302	(25)(19)"Legend drug," "prescription drug," or "medicinal
303	drug" means any drug, including, but not limited to, finished
304	dosage forms, or active ingredients subject to, defined by, or
305	described by s. 503(b) of the Federal Food, Drug, and Cosmetic
306	Act or s. 465.003(8), s. 499.007(12), or s. 499.0122(1)(b) or
307	(c).
308	(26) "Legend drug label" means any display of written,
309	printed, or graphic matter upon the immediate container of any
310	legend drug prior to its dispensing to an individual patient
311	pursuant to a prescription of a practitioner authorized by law
312	to prescribe.
313	(27)(20)"Manufacture" means the preparation, deriving,
314	compounding, propagation, processing, producing, or fabrication
315	of any drug, device, or cosmetic. The term includes repackaging
316	or otherwise changing the container, wrapper, or labeling to
317	further the distribution of the drug, device, or cosmetic.
318	(28)(21)"Manufacturer" means a person who prepares,
319	derives, manufactures, or produces a drug, device, or cosmetic.
320	The term excludes pharmacies that are operating in compliance
321	with pharmacy practice standards as defined in chapter 465 and
322	rules adopted under that chapter.
323	(29)(22)"New drug" means:
324	(a) Any drug the composition of which is such that the
325	drug is not generally recognized, among experts qualified by
326	scientific training and experience to evaluate the safety and
327	effectiveness of drugs, as safe and effective for use under the
328	conditions prescribed, recommended, or suggested in the labeling
329	of that drug; or
330	(b) Any drug the composition of which is such that the
331	drug, as a result of investigations to determine its safety and
332	effectiveness for use under certain conditions, has been
333	recognized for use under such conditions, but which drug has
334	not, other than in those investigations, been used to a material
335	extent or for a material time under such conditions.
336	(30)(23)"Official compendium" means the current edition
337	of the official United States Pharmacopoeia and National
338	Formulary, or any supplement thereto.
339	(31) "Pedigree paper" means:
340	(a) A document required pursuant to s. 499.0121(6)(d) or
341	(e); or
342	(b) Effective July 1, 2006, a document in a form approved
343	by the department and containing information that records each
344	distribution of any given legend drug, from sale by a
345	pharmaceutical manufacturer, through acquisition and sale by any
346	wholesaler or repackager, until final sale to a pharmacy or
347	other person administering or dispensing the drug. The
348	information required to be included on a legend drug's pedigree
349	paper must at least detail the amount of the legend drug, its
350	dosage form and strength, its lot numbers, the name and address
351	of each owner of the legend drug and his or her signature, its
352	shipping information, including the name and address of each
353	person certifying delivery or receipt of the legend drug, and a
354	certification that the recipient has authenticated the pedigree
355	papers. It must also include the name, address, telephone number
356	and, if available, e-mail contact information of each wholesaler
357	involved in the chain of the legend drug's custody. The
358	department shall adopt rules and a form relating to the
359	requirements of this paragraph no later than 90 days after the
360	effective date of this act.
361	(32)(24)"Person" means any individual, child, joint
362	venture, syndicate, fiduciary, partnership, corporation,
363	division of a corporation, firm, trust, business trust, company,
364	estate, public or private institution, association,
365	organization, group, city, county, city and county, political
366	subdivision of this state, other governmental agency within this
367	state, and any representative, agent, or agency of any of the
368	foregoing, or any other group or combination of the foregoing.
369	(33)(25)"Prepackaged drug product" means a drug that
370	originally was in finished packaged form sealed by a
371	manufacturer and that is placed in a properly labeled container
372	by a pharmacy or practitioner authorized to dispense pursuant to
373	chapter 465 for the purpose of dispensing in the establishment
374	in which the prepackaging occurred.
375	(34) "Prescription label" means any display of written,
376	printed, or graphic matter upon the immediate container of any
377	legend drug dispensed pursuant to a prescription of a
378	practitioner authorized by law to prescribe.
379	(35)(26)"Prescription medical oxygen" means oxygen USP
380	which is a drug that can only be sold on the order or
381	prescription of a practitioner authorized by law to prescribe.
382	The label of prescription medical oxygen must comply with
383	current labeling requirements for oxygen under the Federal Food,
384	Drug, and Cosmetic Act.
385	(36)(27)"Proprietary drug," or "OTC drug," means a patent
386	or over-the-counter drug in its unbroken, original package,
387	which drug is sold to the public by, or under the authority of,
388	the manufacturer or primary distributor thereof, is not
389	misbranded under the provisions of ss. 499.001-499.081, and can
390	be purchased without a prescription.
391	(37) "Repackage" includes repacking or otherwise changing
392	the container, wrapper, or labeling to further the distribution
393	of a drug, device, or cosmetic.
394	(38) "Repackager" means a person who repackages. The term
395	excludes pharmacies that are operating in compliance with
396	pharmacy practice standards as defined in chapter 465 and rules
397	adopted under that chapter.
398	(39)(28)"Veterinary prescription drug" means a legend
399	drug intended solely for veterinary use. The label of the drug
400	must bear the statement, "Caution: Federal law restricts this
401	drug to sale by or on the order of a licensed veterinarian."
402	Section 4. Section 499.005, Florida Statutes, is amended
403	to read:
404	499.005 Prohibited acts.--It is unlawful for a personto
405	perform or cause the performance of any of the following acts in
406	this state:
407	(1) The manufacture, repackaging, sale, delivery, or
408	holding or offering for sale of any drug, device, or cosmetic
409	that is adulterated or misbranded or has otherwise been rendered
410	unfit for human or animal use.
411	(2) The adulteration or misbranding of any drug, device,
412	or cosmetic.
413	(3) The receipt of any drug, device, or cosmetic that is
414	adulterated or misbranded, and the delivery or proffered
415	delivery of such drug, device, or cosmetic, for pay or
416	otherwise.
417	(4) The sale, distribution, purchase, trade, holding, or
418	offering of any drug, device, or cosmetic in violation of ss.
419	499.001-499.081.
420	(5) The dissemination of any false or misleading
421	advertisement of a drug, device, or cosmetic.
422	(6) The refusal or constructive refusal:
423	(a) To allow the department to enter or inspect an
424	establishment in which drugs, devices, or cosmetics are
425	manufactured, processed, repackaged, sold, brokered, or held;
426	(b) To allow inspection of any record of that
427	establishment;
428	(c) To allow the department to enter and inspect any
429	vehicle that is being used to transport drugs, devices, or
430	cosmetics; or
431	(d) To allow the department to take samples of any drug,
432	device, or cosmetic.
433	(7) The purchase or sale of prescription drugs for
434	wholesale distribution in exchange for currency, as defined in
435	s. 560.103(6).The giving of a false guaranty or false
436	undertaking with respect to a drug, device, or cosmetic, except
437	by a person who relied on a guaranty or undertaking to the same
438	effect signed by, and containing the name and address of, the
439	person residing in this state from whom she or he received in
440	good faith the drug, device, or cosmetic.
441	(8) Committing any act that causes a drug, device, or
442	cosmetic to be a counterfeit drug, device, or cosmetic; or
443	selling, dispensing, or holding for sale a counterfeit drug,
444	device, or cosmetic.
445	(9) The alteration, mutilation, destruction, obliteration,
446	or removal of the whole or any part of the labeling of a drug,
447	device, or cosmetic, or the doing of any other act with respect
448	to a drug, device, or cosmetic, if the act is done while the
449	drug, device, or cosmetic is held for sale and the act results
450	in the drug, device, or cosmetic being misbranded.
451	(10) Forging; counterfeiting; simulating; falsely
452	representing any drug, device, or cosmetic; or, without the
453	authority of the manufacturer, using any mark, stamp, tag,
454	label, or other identification device authorized or required by
455	rules adopted under ss. 499.001-499.081.
456	(11) The use, on the labeling of any drug or in any
457	advertisement relating to such drug, of any representation or
458	suggestion that an application of the drug is effective when it
459	is not or that the drug complies with ss. 499.001-499.081 when
460	it does not.
461	(12) The possession of any drug in violation of ss.
462	499.001-499.081.
463	(13) The sale, delivery, holding, or offering for sale of
464	any self-testing kits designed to tell persons their status
465	concerning human immunodeficiency virus or acquired immune
466	deficiency syndrome or related disorders or conditions. This
467	prohibition shall not apply to home access HIV test kits
468	approved for distribution and sale by the United States Food and
469	Drug Administration.
470	(14) The purchase or receipt of a legend drug from a
471	person that is not authorized under this chapter to distribute
472	legend drugs to that purchaser or recipient.
473	(15) The sale or transfer of a legend drug to a person
474	that is not authorized under the law of the jurisdiction in
475	which the person receives the drug to purchase or possess legend
476	drugs from the person selling or transferring the legend drug.
477	(16) The purchase or receipt of a compressed medical gas
478	from a person that is not authorized under this chapter to
479	distribute compressed medical gases.
480	(17) The sale, purchase, or trade, or the offer to sell,
481	purchase, or trade, a drug sample as defined in s. 499.028; the
482	distribution of a drug sample in violation of s. 499.028; or the
483	failure to otherwise comply with s. 499.028.
484	(18) Failure to maintain records as required by ss.
485	499.001-499.081 and rules adopted under those sections.
486	(19) Providing the department with false or fraudulent
487	records, or making false or fraudulent statements, regarding any
488	matter within the provisions of this chapter.
489	(20) The importation of a legend drug except as provided
490	by s. 801(d) of the Federal Food, Drug, and Cosmetic Act.
491	(21) The wholesale distribution of any prescription drug
492	that was:
493	(a) Purchased by a public or private hospital or other
494	health care entity; or
495	(b) Donated or supplied at a reduced price to a charitable
496	organization.
497	(22) Failure to obtain a permit or registration, or
498	operating without a valid permit when a permit or registration
499	is required by ss. 499.001-499.081 for that activity.
500	(23) Obtaining or attempting to obtain a prescription drug
501	or device by fraud, deceit, misrepresentation or subterfuge, or
502	engaging in misrepresentation or fraud in the distribution of a
503	drug or device.
504	(24) The distribution of a legend device to the patient or
505	ultimate consumer without a prescription or order from a
506	practitioner licensed by law to use or prescribe the device.
507	(25) Charging a dispensing fee for dispensing,
508	administering, or distributing a prescription drug sample.
509	(26) Removing a pharmacy's dispensing label from a
510	dispensed prescription drug with the intent to further
511	distribute the prescription drug.
512	(27) Distributing a prescription drug that was previously
513	dispensed by a licensed pharmacy, unless such distribution was
514	authorized in chapter 465 or the rules adopted under chapter
515	465.
516	(28) Failure to obtain or pass on a pedigree paper.
517	(29) The receipt of a prescription drug pursuant to a
518	wholesale distribution without first receiving a pedigree paper
519	that was attested to as accurate and complete by the wholesale
520	distributor.
521	Section 5. Section 499.0051, Florida Statutes, is created
522	to read:
523	499.0051 Criminal acts involving contraband or adulterated
524	drugs.--
525	(1) FAILURE TO MAINTAIN OR DELIVER PEDIGREE PAPERS.--
526	(a) A person, other than a manufacturer, engaged in the
527	wholesale distribution of legend drugs who fails to deliver to
528	another person complete and accurate pedigree papers concerning
529	a legend drug or contraband legend drug prior to transferring
530	the legend drug or contraband legend drug to another person
531	commits a felony of the third degree, punishable as provided in
532	s. 775.082, s. 775.083, or s. 775.084.
533	(b) A person engaged in the wholesale distribution of
534	legend drugs who fails to acquire complete and accurate pedigree
535	papers concerning a legend drug or contraband legend drug prior
536	to obtaining the legend drug or contraband legend drug from
537	another person commits a felony of the third degree, punishable
538	as provided in s. 775.082, s. 775.083, or s. 775.084.
539	(c) Any person who knowingly destroys, alters, conceals,
540	or fails to maintain complete and accurate pedigree papers
541	concerning any legend drug or contraband legend drug in his or
542	her possession commits a felony of the third degree, punishable
543	as provided in s. 775.082, s. 775.083, or s. 775.084.
544	(2) FAILURE TO AUTHENTICATE PEDIGREE PAPERS.--
545	(a)1. A person engaged in the wholesale distribution of
546	legend drugs who is in possession of documents required under s.
547	499.0121(6)(e) and who fails to authenticate the matters
548	contained in the documents and who nevertheless attempts to
549	further distribute legend drugs or contraband legend drugs
550	commits a felony of the third degree, punishable as provided in
551	s. 775.082, s. 775.083, or s. 775.084.
552	2. A person in possession of documents required under s.
553	499.0121(6)(e) who falsely swears or certifies that he or she
554	has authenticated the matters contained in the documents commits
555	a felony of the third degree, punishable as provided in s.
556	775.082, s. 775.083, or s. 775.084.
557	3. This paragraph expires July 1, 2006.
558	(b) Effective July 1, 2006:
559	1. A person engaged in the wholesale distribution of
560	legend drugs who is in possession of pedigree papers concerning
561	legend drugs or contraband legend drugs and who fails to
562	authenticate the matters contained in the pedigree papers and
563	who nevertheless attempts to further distribute legend drugs or
564	contraband legend drug commits a felony of the third degree,
565	punishable as provided in s. 775.082, s. 775.083, or s. 775.084.
566	2. A person in possession of pedigree papers concerning
567	legend drugs or contraband legend drugs who falsely swears or
568	certifies that he or she has authenticated the matters contained
569	in the pedigree papers commits a felony of the third degree,
570	punishable as provided in s. 775.082, s. 775.083, or s. 775.084.
571	(3) FORGERY OF PEDIGREE PAPERS.--A person who knowingly
572	forges, counterfeits, or falsely creates any pedigree paper; who
573	falsely represents any factual matter contained on any pedigree
574	paper; or who knowingly omits to record material information
575	required to be recorded in a pedigree paper, commits a felony of
576	the second degree, punishable as provided in s. 775.082, s.
577	775.083, or s. 775.084.
578	(4) PURCHASE OR RECEIPT OF LEGEND DRUG FROM UNAUTHORIZED
579	PERSON.--A person who knowingly purchases or receives from a
580	person not authorized to distribute legend drugs under this
581	chapter a legend drug in a wholesale distribution transaction
582	commits a felony of the second degree, punishable as provided in
583	s. 775.082, s. 775.083, or s. 775.084.
584	(5) SALE OR TRANSFER OF LEGEND DRUG TO UNAUTHORIZED
585	PERSON.--A person who knowingly sells or transfers to a person
586	not authorized to purchase or possess legend drugs, under the
587	law of the jurisdiction in which the person receives the drug, a
588	legend drug in a wholesale distribution transaction commits a
589	felony of the second degree, punishable as provided in s.
590	775.082, s. 775.083, or s. 775.084.
591	(6) SALE OR DELIVERY, OR POSSESSION WITH INTENT TO SELL,
592	CONTRABAND LEGEND DRUGS.--A person who is knowingly in actual or
593	constructive possession of any amount of contraband legend
594	drugs, who knowingly sells or delivers, or who possesses with
595	intent to sell or deliver any amount of contraband legend drugs,
596	commits a felony of the second degree, punishable as provided in
597	s. 775.082, s. 775.083, or s. 775.084.
598	(7) FORGERY OF PRESCRIPTION OR LEGEND DRUG LABELS.--A
599	person who knowingly forges, counterfeits, or falsely creates
600	any prescription label or legend drug label, or who falsely
601	represents any factual matter contained on any prescription
602	label or legend drug label, commits a felony of the first
603	degree, punishable as provided in s. 775.082, s. 775.083, or s.
604	775.084.
605	Section 6. Section 499.0052, Florida Statutes, is created
606	to read:
607	499.0052 Trafficking in contraband legend drugs.--A person
608	who knowingly sells, purchases, manufactures, delivers, or
609	brings into this state, or who is knowingly in actual or
610	constructive possession of, any amount of contraband legend
611	drugs valued at $25,000 or more commits a felony of the first
612	degree, punishable as provided in s. 775.082, s. 775.083, or s.
613	775.084. Upon conviction, each defendant shall be ordered to pay
614	a mandatory fine according to the following schedule:
615	(1) If the value of contraband legend drugs involved is
616	$25,000 or more, but less than $100,000, the defendant shall pay
617	a mandatory fine of $25,000. If the defendant is a corporation
618	or other person that is not a natural person, it shall pay a
619	mandatory fine of $75,000.
620	(2) If the value of contraband legend drugs involved is
621	$100,000 or more, but less than $250,000, the defendant shall
622	pay a mandatory fine of $100,000. If the defendant is a
623	corporation or other person that is not a natural person, it
624	shall pay a mandatory fine of $300,000.
625	(3) If the value of contraband legend drugs involved is
626	$250,000 or more, the defendant shall pay a mandatory fine of
627	$200,000. If the defendant is a corporation or other person that
628	is not a natural person, it shall pay a mandatory fine of
629	$600,000.
630
631	As used in this section, the term "value" means the market value
632	of the property at the time and place of the offense or, if such
633	cannot be satisfactorily ascertained, the cost of replacement of
634	the property within a reasonable time after the offense. Amounts
635	of value of separate contraband legend drugs involved in
636	distinct transactions for the distribution of the contraband
637	legend drugs committed pursuant to one scheme or course of
638	conduct, whether involving the same person or several persons,
639	may be aggregated in determining the punishment of the offense.
640	Section 7. Section 499.00523, Florida Statutes, is created
641	to read:
642	499.00523 Sale or purchase of contraband legend drugs
643	resulting in great bodily harm.--A person who knowingly sells,
644	purchases, manufactures, delivers, or brings into this state, or
645	who is knowingly in actual or constructive possession of, any
646	amount of contraband legend drugs, and whose acts in violation
647	of this section result in great bodily harm to a person, commits
648	a felony of the first degree, punishable as provided in s.
649	775.082, s. 775.083, or s. 775.084.
650	Section 8. Section 499.00525, Florida Statutes, is created
651	to read:
652	499.00525 Sale or purchase of contraband legend drugs
653	resulting in death.--A person who knowingly manufactures, sells,
654	purchases, delivers, or brings into this state, or who is
655	knowingly in actual or constructive possession of, any amount of
656	contraband legend drugs, and whose acts in violation of this
657	section result in the death of a person, commits a felony of the
658	first degree, punishable by a term of years not exceeding life,
659	as provided in s. 775.082, s. 775.083, or s. 775.084.
660	Section 9. Section 499.006, Florida Statutes, is amended
661	to read:
662	499.006 Adulterated drug or device.--A drug or device is
663	adulterated:
664	(1) If it consists in whole or in part of any filthy,
665	putrid, or decomposed substance;
666	(2) If it has been produced, prepared, packed, or held
667	under conditions whereby it could have been contaminated with
668	filth or rendered injurious to health;
669	(3) If it is a drug and the methods used in, or the
670	facilities or controls used for, its manufacture, processing,
671	packing, or holding do not conform to, or are not operated or
672	administered in conformity with, current good manufacturing
673	practices to assure that the drug meets the requirements of ss.
674	499.001-499.081 and that the drug has the identity and strength,
675	and meets the standard of quality and purity, which it purports
676	or is represented to possess;
677	(4) If it is a drug and its container is composed, in
678	whole or in part, of any poisonous or deleterious substance
679	which could render the contents injurious to health;
680	(5) If it is a drug and it bears or contains, for the
681	purpose of coloring only, a color additive that is unsafe within
682	the meaning of the federal act; or, if it is a color additive,
683	the intended use of which in or on drugs is for the purpose of
684	coloring only, and it is unsafe within the meaning of the
685	federal act;
686	(6) If it purports to be, or is represented as, a drug the
687	name of which is recognized in the official compendium, and its
688	strength differs from, or its quality or purity falls below, the
689	standard set forth in such compendium. The determination as to
690	strength, quality, or purity must be made in accordance with the
691	tests or methods of assay set forth in such compendium, or, when
692	such tests or methods of assay are absent or inadequate, in
693	accordance with those tests or methods of assay prescribed under
694	authority of the federal act. A drug defined in the official
695	compendium is not adulterated under this subsection merely
696	because it differs from the standard of strength, quality, or
697	purity set forth for that drug in such compendium if its
698	difference in strength, quality, or purity from such standard is
699	plainly stated on its label;
700	(7) If it is not subject to subsection (6) and its
701	strength differs from, or its purity or quality falls below the
702	standard of, that which it purports or is represented to
703	possess; or
704	(8) If it is a drug:
705	(a) With which any substance has been mixed or packed so
706	as to reduce the quality or strength of the drug; or
707	(b) For which any substance has been substituted wholly or
708	in part;.
709	(9) If it is a drug or device for which the expiration
710	date has passed; or.
711	(10) If it is a legend drug for which the required
712	pedigree paper is nonexistent, fraudulent, or incomplete under
713	the requirements of ss. 499.001-499.081 or applicable rules or
714	that has been purchased, held, sold, or distributed at any time
715	by a person not authorized under federal or state law to do so.
716	Section 10. Subsection (2) of section 499.007, Florida
717	Statutes, is amended to read:
718	499.007 Misbranded drug or device.--A drug or device is
719	misbranded:
720	(2) Unless, if in package form, it bears a label
721	containing:
722	(a) The name and place of business of the manufacturer,
723	repackager, or distributor; in addition, for a medicinal drug,
724	as defined in s. 499.003, the label must contain the name and
725	place of business of the manufacturerof the finished dosage
726	form of the drug. For the purpose of this paragraph, the
727	finished dosage form of a medicinal drug is that form of the
728	drug which is, or is intended to be, dispensed or administered
729	to the patient and requires no further manufacturing or
730	processing other than packaging, reconstitution, and labeling;
731	and
732	(b) An accurate statement of the quantity of the contents
733	in terms of weight, measure, or numerical count; however, under
734	this section, reasonable variations are permitted, and the
735	department shall establish by rule exemptions for small
736	packages.
737	Section 11. Subsections (1) and (3) of section 499.01,
738	Florida Statutes, are amended to read:
739	499.01 Permits; applications; renewal; general
740	requirements.--
741	(1) Any person that is required under ss. 499.001-499.081
742	to have a permit must apply to the department on forms furnished
743	by the department.
744	(a) A permit issued pursuant to ss. 499.001-499.081 may be
745	issued only to a natural personan individualwho is at least 18
746	years of age or to an applicant that is not a natural person if
747	each person who, directly or indirectly, manages, controls, or
748	oversees the operation of that applicanta corporation that is
749	registered pursuant to chapter 607 or chapter 617 and each
750	officer of whichis at least 18 years of age.
751	(b) An establishment that is a place of residence may not
752	receive a permit and may not operate under ss. 499.001-499.081.
753	(c) A person that applies for or renews a permit to
754	manufacture or distribute legend drugs may not use a name
755	identical to the name used by any other establishment or
756	licensed person authorized to purchase prescription drugs in
757	this state, except that a restricted drug distributor permit
758	issued to a health care entity will be issued in the name in
759	which the institutional pharmacy permit is issued and a retail
760	pharmacy drug wholesaler will be issued a permit in the name of
761	its retail pharmacy permit.
762	(d) A permit is required for each establishment that
763	operates as a:
764	1. Prescription drug manufacturer;
765	2. Over-the-counter drug manufacturer;
766	3. Compressed medical gas manufacturer;
767	4. Device manufacturer;
768	5. Cosmetic manufacturer;
769	6. Prescription drug wholesaler;
770	7. Compressed medical gas wholesaler;
771	8. Out-of-state prescription drug wholesaler;
772	9. Retail pharmacy drug wholesaler;
773	10. Veterinary legend drug retail establishment;
774	11. Medical oxygen retail establishment;
775	12. Complimentary drug distributor; or
776	13. Restricted prescription drug distributor.
777	(e) A permit for a prescription drug manufacturer,
778	prescription drug wholesaler, or retail pharmacy wholesaler may
779	not be issued to the address of a health care entity or to a
780	pharmacy licensed under chapter 465, except as provided in this
781	paragraph. The department may issue a prescription drug
782	manufacturer's permit to an applicant at the same address as a
783	licensed nuclear pharmacy, which is a health care entity, for
784	the purpose of manufacturing prescription drugs used in positron
785	emission tomography or other radiopharmaceuticals, as listed in
786	a rule adopted by the department pursuant to this paragraph. The
787	purpose of this exemption is to ensure availability of state-of-
788	the-art pharmaceuticals that would pose a significant danger to
789	the public health if manufactured at a separate establishment
790	address from the nuclear pharmacy from which the prescription
791	drugs are dispensed. The department may also issue a retail
792	pharmacy wholesaler permit to the address of a community
793	pharmacy licensed under chapter 465 which does not meet the
794	definition of a closed pharmacy in s. 499.003.
795	(f) A county or municipality may not issue an occupational
796	license for any licensing period beginning on or after October
797	1, 2003, for any establishment that requires a permit pursuant
798	to ss. 499.001-499.081, unless the establishment exhibits a
799	current permit issued by the department for the establishment.
800	Upon presentation of the requisite permit issued by the
801	department, an occupational license may be issued by the
802	municipality or county in which application is made. The
803	department shall furnish to local agencies responsible for
804	issuing occupational licenses a current list of all
805	establishments licensed pursuant to ss. 499.001-499.081.
806	(g)(f)Notwithstanding subsection (4), a permitted person
807	in good standing may change the type of permit issued to that
808	person by completing a new application for the requested permit,
809	paying the amount of the difference in the permit fees if the
810	fee for the new permit is more than the fee for the original
811	permit, and meeting the applicable permitting conditions for the
812	new permit type. The new permit expires on the expiration date
813	of the original permit being changed; however, a new permit for
814	a prescription drug wholesaler and an out-of-state prescription
815	drug wholesaler shall expire on the expiration date of the
816	original permit or 1 year after the date of issuance of the new
817	permit, whichever is earlier. A refund may not be issued if the
818	biennial fee for the new permit is less than the fee that was
819	paid for the original permit for which a fee was paid.
820	(3) The department shall adopt rules for the biennial
821	renewal of permits.
822	(a) The department shall renew a permit upon receipt of
823	the renewal application and renewal fee if the applicant meets
824	the requirements established under ss. 499.001-499.081 and the
825	rules adopted under those sections.
826	(b) A permit, unless sooner suspended or revoked,
827	automatically expires 2 years after the last day of the
828	anniversary month in which the permit was originally issued;
829	except that a prescription drug wholesaler permit or an out-of-
830	state prescription drug wholesaler permit issued from July 1,
831	2003, through December 31, 2003, shall expire 1 year after the
832	last day of the anniversary month in which the permit was
833	issued. Any valid prescription drug wholesaler or out-of-state
834	prescription drug wholesaler permit issued by the department on
835	or before June 30, 2003, with an expiration date between January
836	1, 2005, and June 30, 2005, shall automatically expire 1 year
837	prior to the expiration date stated on the permit. A permittee
838	that submits a renewal application for a permit with a stated
839	expiration date between January 1, 2005, and June 30, 2005,
840	shall receive a credit of one-half of the permit fee paid when
841	the application for the expiring permit was submitted. Any valid
842	prescription drug wholesaler or out-of-state prescription drug
843	wholesaler permit issued by the department on or before June 30,
844	2003, with an expiration date between July 1, 2004, and December
845	31, 2004, shall automatically expire 6 months prior to the
846	expiration date stated on the permit. A permittee that submits a
847	renewal application for a permit with a stated expiration date
848	between July 1, 2004, and December 31, 2004, shall receive a
849	credit of one-fourth of the permit fee paid when the application
850	for the expiring permit was submitted. A permittee whose permit
851	expiration date was accelerated in this paragraph may request a
852	pro rata refund equivalent to the credit available for
853	submission of a renewal application if the permittee does not
854	submit a renewal application. A permit issued under ss. 499.001-
855	499.081 maymustbe renewed by making application for renewal on
856	forms furnished by the department and paying the appropriate
857	fees. If a renewal application and fee are notsubmitted and
858	postmarked afterbythe expiration date of the permit, the
859	permit may be renewedreinstated only upon payment of a late
860	renewal delinquent fee of $100, plus the required renewal fee,
861	not later thanwithin60 days after the expiration date.
862	(c) Failure to renew a permit in accordance with this
863	section precludes any future renewal of that permit. If a permit
864	issued pursuant to this section has expired and cannot be
865	renewed, before an establishment may engage in activities that
866	require a permit under ss. 499.001-499.081, the establishment
867	must submit an application for a new permit, pay the applicable
868	application fee, the initial permit fee, and all applicable
869	penalties, and be issued a new permit by the department.
870	Continuing to engage in activities that require a permit under
871	ss. 499.001-499.081 requires a new permit application and
872	payment of an application fee, initial permit fee, and
873	applicable penalties.
874	Section 12. Effective January 1, 2004, section 499.01,
875	Florida Statutes, as amended by this act, is amended to read:
876	499.01 Permits; applications; renewal; general
877	requirements.--
878	(1) Prior to operating, a permit is required for each
879	person and establishment that intends to operate as:
880	(a) A prescription drug manufacturer;
881	(b) A prescription drug repackager;
882	(c) An over-the-counter drug manufacturer;
883	(d) A compressed medical gas manufacturer;
884	(e) A device manufacturer;
885	(f) A cosmetic manufacturer;
886	(g) A prescription drug wholesaler;
887	(h) A compressed medical gas wholesaler;
888	(i) An out-of-state prescription drug wholesaler;
889	(j) A nonresident prescription drug manufacturer;
890	(k) A freight forwarder;
891	(l) A retail pharmacy drug wholesaler;
892	(m) A veterinary legend drug retail establishment;
893	(n) A medical oxygen retail establishment;
894	(o) A complimentary drug distributor; or
895	(p) A restricted prescription drug distributor.
896	(1) Any person that is required under ss. 499.001-499.081
897	to have a permit must apply to the department on forms furnished
898	by the department.
899	(2)(a) A permit issued pursuant to ss. 499.001-499.081 may
900	be issued only to a natural person who is at least 18 years of
901	age or to an applicant that is not a natural person if each
902	person who, directly or indirectly, manages, controls, or
903	oversees the operation of that applicant is at least 18 years of
904	age.
905	(b) An establishment that is a place of residence may not
906	receive a permit and may not operate under ss. 499.001-499.081.
907	(c) A person that applies for or renews a permit to
908	manufacture or distribute legend drugs may not use a name
909	identical to the name used by any other establishment or
910	licensed person authorized to purchase prescription drugs in
911	this state, except that a restricted drug distributor permit
912	issued to a health care entity will be issued in the name in
913	which the institutional pharmacy permit is issued and a retail
914	pharmacy drug wholesaler will be issued a permit in the name of
915	its retail pharmacy permit.
916	(d) A permit is required for each establishment that
917	operates as a:
918	1. Prescription drug manufacturer;
919	2. Over-the-counter drug manufacturer;
920	3. Compressed medical gas manufacturer;
921	4. Device manufacturer;
922	5. Cosmetic manufacturer;
923	6. Prescription drug wholesaler;
924	7. Compressed medical gas wholesaler;
925	8. Out-of-state prescription drug wholesaler;
926	9. Retail pharmacy drug wholesaler;
927	10. Veterinary legend drug retail establishment;
928	11. Medical oxygen retail establishment;
929	12. Complimentary drug distributor; or
930	13. Restricted prescription drug distributor.
931	(d)(e) A permit for a prescription drug manufacturer,
932	prescription drug repackager,prescription drug wholesaler, or
933	retail pharmacy wholesaler may not be issued to the address of a
934	health care entity or to a pharmacy licensed under chapter 465,
935	except as provided in this paragraph. The department may issue a
936	prescription drug manufacturer's permit to an applicant at the
937	same address as a licensed nuclear pharmacy, which is a health
938	care entity, for the purpose of manufacturing prescription drugs
939	used in positron emission tomography or other
940	radiopharmaceuticals, as listed in a rule adopted by the
941	department pursuant to this paragraph. The purpose of this
942	exemption is to assure availability of state-of-the-art
943	pharmaceuticals that would pose a significant danger to the
944	public health if manufactured at a separate establishment
945	address from the nuclear pharmacy from which the prescription
946	drugs are dispensed. The department may also issue a retail
947	pharmacy wholesaler permit to the address of a community
948	pharmacy licensed under chapter 465 which does not meet the
949	definition of a closed pharmacy in s. 499.003.
950	(e)(f)A county or municipality may not issue an
951	occupational license for any licensing period beginning on or
952	after October 1, 2003, for any establishment that requires a
953	permit pursuant to ss. 499.001-499.081, unless the establishment
954	exhibits a current permit issued by the department for the
955	establishment. Upon presentation of the requisite permit issued
956	by the department, an occupational license may be issued by the
957	municipality or county in which application is made. The
958	department shall furnish to local agencies responsible for
959	issuing occupational licenses a current list of all
960	establishments licensed pursuant to ss. 499.001-499.081.
961	(3)(g) Notwithstanding subsection (7)(4), a permitted
962	person in good standing may change the type of permit issued to
963	that person by completing a new application for the requested
964	permit, paying the amount of the difference in the permit fees
965	if the fee for the new permit is more than the fee for the
966	original permit, and meeting the applicable permitting
967	conditions for the new permit type. The new permit expires on
968	the expiration date of the original permit being changed;
969	however, a new permit for a prescription drug wholesaler, an
970	out-of-state prescription drug wholesaler, or a retail pharmacy
971	drug wholesaler shall expire on the expiration date of the
972	original permit or 1 year after the date of issuance of the new
973	permit, whichever is earlier. A refund may not be issued if the
974	fee for the new permit is less than the fee that was paid for
975	the original permit.
976	(4)(2)A written application for a permit or to renew a
977	permit must be filed with the department on forms furnished by
978	the department.The department shall establish, by rule, the
979	form and content of the application to obtain or renew a permit.
980	The applicant must submit to the department with the application
981	a statement that swears or affirms that the information is true
982	and correct.
983	(5)(a) Except for a permit for a prescription drug
984	wholesaler or an out-of-state prescription drug wholesaler, an
985	application for a permit must includeInformation that an
986	applicant must provide includes, but need not be limited to:
987	1. The name, full business address, and telephone number
988	of the applicant;
989	2. All trade or business names used by the applicant;
990	3. The address, telephone numbers, and the names of
991	contact persons for each facility used by the applicant for the
992	storage, handling, and distribution of prescription drugs;
993	4. The type of ownership or operation, such as a
994	partnership, corporation, or sole proprietorship; and
995	5. The names of the owner and the operator of the
996	establishment, including:
997	a. If an individual, the name of the individual;
998	b. If a partnership, the name of each partner and the name
999	of the partnership;
1000	c. If a corporation, the name and title of each corporate
1001	officer and director, the corporate names, and the name of the
1002	state of incorporation;
1003	d. If a sole proprietorship, the full name of the sole
1004	proprietor and the name of the business entity; and
1005	e. If a limited liability company, the name of each
1006	member, the name of each manager, the name of the limited
1007	liability company, and the name of the state in which the
1008	limited liability company was organized; and
1009	f.e.Any other relevant information that the department
1010	requires.
1011	(b) Upon approval of the application by the department and
1012	payment of the required fee, the department shall issue a permit
1013	to the applicant, if the applicant meets the requirements of ss.
1014	499.001-499.081 and rules adopted under those sections.
1015	(c) Any change in information required under paragraph (a)
1016	must be submitted to the department before the change occurs.
1017	(d) The department shall consider, at a minimum, the
1018	following factors in reviewing the qualifications of persons to
1019	be permitted under ss. 499.001-499.081:
1020	1. The applicant's having been found guilty, regardless of
1021	adjudication, in a court of this state or other jurisdiction, of
1022	a violation of a law that directly relates to a drug, device, or
1023	cosmetic. A plea of nolo contendere constitutes a finding of
1024	guilt for purposes of this subparagraph.
1025	2. The applicant's having been disciplined by a regulatory
1026	agency in any state for any offense that would constitute a
1027	violation of ss. 499.001-499.081.
1028	3. Any felony conviction of the applicant under a federal,
1029	state, or local law;
1030	4. The applicant's past experience in manufacturing or
1031	distributing drugs, devices, or cosmetics;
1032	5. The furnishing by the applicant of false or fraudulent
1033	material in any application made in connection with
1034	manufacturing or distributing drugs, devices, or cosmetics;
1035	6. Suspension or revocation by a federal, state, or local
1036	government of any permit currently or previously held by the
1037	applicant for the manufacture or distribution of any drugs,
1038	devices, or cosmetics;
1039	7. Compliance with permitting requirements under any
1040	previously granted permits;
1041	8. Compliance with requirements to maintain or make
1042	available to the state permitting authority or to federal,
1043	state, or local law enforcement officials those records required
1044	under this section; and
1045	9. Any other factors or qualifications the department
1046	considers relevant to and consistent with the public health and
1047	safety.
1048	(6) Except for permits for prescription drug wholesalers
1049	or out-of-state prescription drug wholesalers:
1050	(a)(3)The department shall adopt rules for the biennial
1051	renewal of permits.
1052	(b)(a)The department shall renew a permit upon receipt of
1053	the renewal application and renewal fee if the applicant meets
1054	the requirements established under ss. 499.001-499.081 and the
1055	rules adopted under those sections.
1056	(c)(b)A permit, unless sooner suspended or revoked,
1057	automatically expires 2 years after the last day of the
1058	anniversary month in which the permit was originally issued;
1059	except that a prescription drug wholesaler permit and an out-of-
1060	state prescription drug wholesaler permit, issued from July 1,
1061	2003, through December 31, 2003, shall expire 1 year after the
1062	last day of the anniversary month in which the permit was
1063	issued. Any valid prescription drug wholesaler or out-of-state
1064	prescription drug wholesaler permit issued by the department on
1065	or before June 30, 2003, with an expiration date between January
1066	1, 2005, and June 30, 2005, shall automatically expire 1 year
1067	prior to the expiration date stated on the permit. A permittee
1068	that submits a renewal application for a permit with a stated
1069	expiration date between January 1, 2005, and June 30, 2005,
1070	shall receive a credit of one-half of the permit fee paid when
1071	the application for the expiring permit was submitted. Any valid
1072	prescription drug wholesaler or out-of-state prescription drug
1073	wholesaler permit issued by the department on or before June 30,
1074	2003, with an expiration date between July 1, 2004, and December
1075	31, 2004, shall automatically expire 6 months prior to the
1076	expiration date stated on the permit. A permittee that submits a
1077	renewal application for a permit with a stated expiration date
1078	between July 1, 2004, and December 31, 2004, shall receive a
1079	credit of one-fourth of the permit fee paid when the application
1080	for the expiring permit was submitted. A permittee whose permit
1081	expiration date was accelerated in this paragraph may request a
1082	pro rata refund equivalent to the credit available for
1083	submission of a renewal application if the permittee does not
1084	submit a renewal application.A permit issued under ss. 499.001-
1085	499.081 may be renewed by making application for renewal on
1086	forms furnished by the department and paying the appropriate
1087	fees. If a renewal application and fee are submitted and
1088	postmarked after the expiration date of the permit, the permit
1089	may be renewed only upon payment of a late renewal delinquent
1090	fee of $100, plus the required renewal fee, not later than 60
1091	days after the expiration date.
1092	(d)(c)Failure to renew a permit in accordance with this
1093	section precludes any future renewal of that permit. If a permit
1094	issued pursuant to this section has expired and cannot be
1095	renewed, before an establishment may engage in activities that
1096	require a permit under ss. 499.001-499.081, the establishment
1097	must submit an application for a new permit, pay the applicable
1098	application fee, the initial permit fee, and all applicable
1099	penalties, and be issued a new permit by the department.
1100	(7)(4)A permit issued by the department is
1101	nontransferable. Each permit is valid only for the person or
1102	governmental unit to which it is issued and is not subject to
1103	sale, assignment, or other transfer, voluntarily or
1104	involuntarily; nor is a permit valid for any establishment other
1105	than the establishment for which it was originally issued.
1106	(a) A person permitted under ss. 499.001-499.081 must
1107	notify the department before making a change of address. The
1108	department shall set a change of location fee not to exceed
1109	$100.
1110	(b)1. An application for a new permit is required when a
1111	majority of the ownership or controlling interest of a permitted
1112	establishment is transferred or assigned or when a lessee agrees
1113	to undertake or provide services to the extent that legal
1114	liability for operation of the establishment will rest with the
1115	lessee. The application for the new permit must be made before
1116	the date of the sale, transfer, assignment, or lease.
1117	2. A permittee that is authorized to distribute legend
1118	drugs may transfer such drugs to the new owner or lessee under
1119	subparagraph 1. only after the new owner or lessee has been
1120	approved for a permit to distribute legend drugs.
1121	(c) The department shall deny, suspend, or revoke the
1122	permit of any person or establishment if the assignment, sale,
1123	transfer, or lease of an establishment permitted under ss.
1124	499.001-499.081 will avoid an administrative penalty, civil
1125	action, or criminal prosecution.
1126	(c)(d)If an establishment permitted under ss. 499.001-
1127	499.081 closes, the owner must notify the department in writing
1128	before the effective date of closure and must:
1129	1. Return the permit to the department;
1130	2. If the permittee is authorized to distribute legend
1131	drugs, indicate the disposition of such drugs, including the
1132	name, address, and inventory, and provide the name and address
1133	of a person to contact regarding access to records that are
1134	required to be maintained under ss. 499.001-499.081. Transfer
1135	of ownership of legend drugs may be made only to persons
1136	authorized to possess legend drugs under ss. 499.001-499.081.
1137
1138	The department may revoke the permit of any person that fails to
1139	comply with the requirements of this subsection.
1140	(8)(5)A permit must be posted in a conspicuous place on
1141	the licensed premise.
1142	Section 13. Section 499.012, Florida Statutes, is amended
1143	to read:
1144	499.012 Wholesale distribution; definitions; permits;
1145	applications;general requirements.--
1146	(1) As used in this section, the term:
1147	(a) "Wholesale distribution" means distribution of
1148	prescription drugs to persons other than a consumer or patient,
1149	but does not include:
1150	1. Any of the following activities, which is not a
1151	violation of s. 499.005(21) if such activity is conducted in
1152	accordance with s. 499.014:
1153	a. The purchase or other acquisition by a hospital or
1154	other health care entity that is a member of a group purchasing
1155	organization of a prescription drug for its own use from the
1156	group purchasing organization or from other hospitals or health
1157	care entities that are members of that organization.
1158	b. The sale, purchase, or trade of a prescription drug or
1159	an offer to sell, purchase, or trade a prescription drug by a
1160	charitable organization described in s. 501(c)(3) of the
1161	Internal Revenue Code of 1986, as amended and revised, to a
1162	nonprofit affiliate of the organization to the extent otherwise
1163	permitted by law.
1164	c. The sale, purchase, or trade of a prescription drug or
1165	an offer to sell, purchase, or trade a prescription drug among
1166	hospitals or other health care entities that are under common
1167	control. For purposes of this section, "common control" means
1168	the power to direct or cause the direction of the management and
1169	policies of a person or an organization, whether by ownership of
1170	stock, by voting rights, by contract, or otherwise.
1171	d. The sale, purchase, trade, or other transfer of a
1172	prescription drug from or for any federal, state, or local
1173	government agency or any entity eligible to purchase
1174	prescription drugs at public health services prices pursuant to
1175	Pub. L. No. 102-585, s. 602 to a contract provider or its
1176	subcontractor for eligible patients of the agency or entity
1177	under the following conditions:
1178	(I) The agency or entity must obtain written authorization
1179	for the sale, purchase, trade, or other transfer of a
1180	prescription drug under this sub-subparagraph from the Secretary
1181	of Health or his or her designee.
1182	(II) The contract provider or subcontractor must be
1183	authorized by law to administer or dispense prescription drugs.
1184	(III) In the case of a subcontractor, the agency or entity
1185	must be a party to and execute the subcontract.
1186	(IV) A contract provider or subcontractor must maintain
1187	separate and apart from other prescription drug inventory any
1188	prescription drugs of the agency or entity in its possession.
1189	(V) The contract provider and subcontractor must maintain
1190	and produce immediately for inspection all records of movement
1191	or transfer of all the prescription drugs belonging to the
1192	agency or entity, including, but not limited to, the records of
1193	receipt and disposition of prescription drugs. Each contractor
1194	and subcontractor dispensing or administering these drugs must
1195	maintain and produce records documenting the dispensing or
1196	administration. Records that are required to be maintained
1197	include, but are not limited to, a perpetual inventory itemizing
1198	drugs received and drugs dispensed by prescription number or
1199	administered by patient identifier, which must be submitted to
1200	the agency or entity quarterly.
1201	(VI) The contract provider or subcontractor may administer
1202	or dispense the prescription drugs only to the eligible patients
1203	of the agency or entity or must return the prescription drugs
1204	for or to the agency or entity. The contract provider or
1205	subcontractor must require proof from each person seeking to
1206	fill a prescription or obtain treatment that the person is an
1207	eligible patient of the agency or entity and must, at a minimum,
1208	maintain a copy of this proof as part of the records of the
1209	contractor or subcontractor required under sub-sub-subparagraph
1210	(V).
1211	(VII) In addition to the departmental inspection authority
1212	set forth in s. 499.051, the establishment of the contract
1213	provider and subcontractor and all records pertaining to
1214	prescription drugs subject to this sub-subparagraph shall be
1215	subject to inspection by the agency or entity. All records
1216	relating to prescription drugs of a manufacturer under this sub-
1217	subparagraph shall be subject to audit by the manufacturer of
1218	those drugs, without identifying individual patient information.
1219	2. Any of the following activities, which is not a
1220	violation of s. 499.005(21) if such activity is conducted in
1221	accordance with rules established by the department:
1222	a. The sale, purchase, or trade of a prescription drug
1223	among federal, state, or local government health care entities
1224	that are under common control and are authorized to purchase
1225	such prescription drug.
1226	b. The sale, purchase, or trade of a prescription drug or
1227	an offer to sell, purchase, or trade a prescription drug for
1228	emergency medical reasons. For purposes of this sub-
1229	subparagraph, the term "emergency medical reasons" includes
1230	transfers of prescription drugs by a retail pharmacy to another
1231	retail pharmacy to alleviate a temporary shortage.
1232	c. The transfer of a prescription drug acquired by a
1233	medical director on behalf of a licensed emergency medical
1234	services provider to that emergency medical services provider
1235	and its transport vehicles for use in accordance with the
1236	provider's license under chapter 401.
1237	d. The revocation of a sale or the return of a
1238	prescription drug to the person's prescription drug wholesale
1239	supplier.
1240	e. The donation of a prescription drug by a health care
1241	entity to a charitable organization that has been granted an
1242	exemption under s. 501(c)(3) of the Internal Revenue Code of
1243	1986, as amended, and that is authorized to possess prescription
1244	drugs.
1245	f. The transfer of a prescription drug by a person
1246	authorized to purchase or receive prescription drugs to a person
1247	licensed or permitted to handle reverse distributions or
1248	destruction under the laws of the jurisdiction in which the
1249	person handling the reverse distribution or destruction receives
1250	the drug.
1251	g. The transfer of a prescription drug by a hospital or
1252	other health care entity to a person licensed under this chapter
1253	to repackage prescription drugs for the purpose of repackaging
1254	the prescription drug for use by that hospital, or other health
1255	care entity and other health care entities that are under common
1256	control, if ownership of the prescription drugs remains with the
1257	hospital or other health care entity at all times. In addition
1258	to the recordkeeping requirements of s. 499.0121(6), the
1259	hospital or health care entity that transfers prescription drugs
1260	pursuant to this sub-subparagraph must reconcile all drugs
1261	transferred and returned and resolve any discrepancies in a
1262	timely manner.
1263	3. The distribution of prescription drug samples by
1264	manufacturers' representatives or distributors' representatives
1265	conducted in accordance with s. 499.028.
1266	4. The sale, purchase, or trade of blood and blood
1267	components intended for transfusion. As used in this
1268	subparagraph, the term "blood" means whole blood collected from
1269	a single donor and processed either for transfusion or further
1270	manufacturing, and the term "blood components" means that part
1271	of the blood separated by physical or mechanical means.
1272	5. The lawful dispensing of a prescription drug in
1273	accordance with chapter 465.
1274	(b) "Wholesale distributor" means any person engaged in
1275	wholesale distribution of prescription drugs in or into this
1276	state, including, but not limited to, manufacturers; repackagers
1277	repackers; own-label distributors; jobbers; private-label
1278	distributors; brokers; warehouses, including manufacturers' and
1279	distributors' warehouses, chain drug warehouses, and wholesale
1280	drug warehouses; independent wholesale drug traders; exporters;
1281	retail pharmacies; and the agents thereof that conduct wholesale
1282	distributions.
1283	(c) "Retail pharmacy" means a community pharmacy licensed
1284	under chapter 465 that purchases prescription drugs at fair
1285	market prices and provides prescription services to the public.
1286	(d) "Primary wholesaler" means any wholesale distributor
1287	that:
1288	1. Purchased 90 percent or more of the total dollar volume
1289	of its purchases of prescription drugs directly from
1290	manufacturers in the previous year; and
1291	2.a. Directly purchased prescription drugs from not fewer
1292	than 50 different prescription drug manufacturers in the
1293	previous year; or
1294	b. Has, or the affiliated group, as defined in s. 1504 of
1295	the Internal Revenue Code, of which the wholesale distributor is
1296	a member has, not fewer than 250 employees.
1297	(e) "Directly from a manufacturer" means:
1298	1. Purchases made by the wholesale distributor directly
1299	from the manufacturer of prescription drugs; and
1300	2. Transfers from a member of an affiliated group, as
1301	defined in s. 1504 of the Internal Revenue Code, of which the
1302	wholesale distributor is a member, if:
1303	a. The affiliated group purchases 90 percent or more of
1304	the total dollar volume of its purchases of prescription drugs
1305	from manufacturers in the previous year; or
1306	b. The wholesale distributor discloses to the department
1307	the names of all members of the affiliated group of which the
1308	wholesale distributor is a member and the affiliated group
1309	agrees in writing to provide records on prescription drug
1310	purchases by the members of the affiliated group not later than
1311	48 hours after the department requests access to such records,
1312	regardless of the location where the records are stored.
1313	(f) "Secondary wholesaler" means a wholesale distributor
1314	that is not a primary wholesaler.
1315	(2) The following types of wholesaler permits are
1316	established:
1317	(a) A prescription drug wholesaler's permit. A
1318	prescription drug wholesaler is a wholesale distributor that may
1319	engage in the wholesale distribution of prescription drugs. A
1320	prescription drug wholesaler that applies to the department for
1321	a new permit or the renewal of a permit after July 1, 2003
1322	January 1, 1993, must submit a bond of $100,000, or other
1323	equivalent means of security acceptable to the department, such
1324	as an irrevocable letter of credit or a deposit in a trust
1325	account or financial institution$200, payable to the Florida
1326	Drug, Device, and Cosmetic Trust Fund. The purpose of the bond
1327	is to secure payment of any administrative penalties imposed by
1328	the department and any fees and costs incurred by the department
1329	regarding that permit which are authorized under state law and
1330	which the permittee fails to pay 30 days after the fine or costs
1331	become final. The department may make a claim against such bond
1332	or security until 1 year after the permittee's license ceases to
1333	be valid or until 60 days after any administrative or legal
1334	proceeding authorized in ss. 499.001-499.081 which involves the
1335	permittee is concluded, including any appeal, whichever occurs
1336	later.This bond will be refunded to the permittee when the
1337	permit is returned to the department and the permittee ceases to
1338	function as a business. A permittee that fails to notify the
1339	department before changing the address of the business, fails to
1340	notify the department before closing the business, or fails to
1341	notify the department before a change of ownership forfeits its
1342	bond.The department may adopt rules for issuing a prescription
1343	drug wholesaler-broker permit to a person who engages in the
1344	wholesale distribution of prescription drugs and does not take
1345	physical possession of any prescription drugs.
1346	(b) A compressed medical gas wholesaler's permit. A
1347	compressed medical gas wholesaler is a wholesale distributor
1348	that is limited to the wholesale distribution of compressed
1349	medical gases to other than the consumer or patient. The
1350	compressed medical gas must be in the original sealed container
1351	that was purchased by that wholesaler. A compressed medical gas
1352	wholesaler may not possess or engage in the wholesale
1353	distribution of any prescription drug other than compressed
1354	medical gases. The department shall adopt rules that govern the
1355	wholesale distribution of prescription medical oxygen for
1356	emergency use. With respect to the emergency use of prescription
1357	medical oxygen, those rules may not be inconsistent with rules
1358	and regulations of federal agencies unless the Legislature
1359	specifically directs otherwise.
1360	(c) An out-of-state prescription drug wholesaler's permit.
1361	An out-of-state prescription drug wholesaler is a wholesale
1362	distributor located outside this state which engages in the
1363	wholesale distribution of prescription drugs into this state and
1364	which must be permitted by the department and comply with all
1365	the provisions required of a wholesale distributor under ss.
1366	499.001-499.081. An out-of-state prescription drug wholesaler
1367	that applies to the department for a new permit or the renewal
1368	of a permit after July 1, 2003, must submit a bond of $100,000,
1369	or other equivalent means of security acceptable to the
1370	department, such as an irrevocable letter of credit or a deposit
1371	in a trust account or financial institution, payable to the
1372	Florida Drug, Device, and Cosmetic Trust Fund. The purpose of
1373	the bond is to secure payment of any administrative penalties
1374	imposed by the department and any fees and costs incurred by the
1375	department regarding that permit which are authorized under
1376	state law and which the permittee fails to pay 30 days after the
1377	fine or costs become final. The department may make a claim
1378	against such bond or security until 1 year after the permittee's
1379	license ceases to be valid or until 60 days after any
1380	administrative or legal proceeding authorized in ss. 499.001-
1381	499.081 which involves the permittee is concluded, including any
1382	appeal, whichever occurs later.
1383	1. The out-of-state drug wholesaler must maintain at all
1384	times a license or permit to engage in the wholesale
1385	distribution of prescription drugs in compliance with laws of
1386	the state in which it is a resident.
1387	2. An out-of-state prescription drug wholesaler's permit
1388	is not required for an intracompany sale or transfer of a
1389	prescription drug from an out-of-state establishment that is
1390	duly licensed as a prescription drug wholesaler, in its state of
1391	residence, to a licensed prescription drug wholesaler in this
1392	state, if both wholesalers conduct wholesale distributions of
1393	prescription drugs under the same business nameare under common
1394	control. The recordkeeping requirements of s. 499.0121(6) must
1395	be followed for this transaction.
1396	3. The department may adopt rules that allow out-of-state
1397	drug wholesalers to obtain a drug wholesale permit on the basis
1398	of reciprocity to the extent that an out-of-state drug
1399	wholesaler:
1400	a. Possesses a valid permit granted by another state that
1401	has requirements comparable to those that a drug wholesaler in
1402	this state must meet as prerequisites to obtaining a permit
1403	under the laws of this state.
1404	b. Can show that the other state from which the wholesaler
1405	holds a permit would extend reciprocal treatment under its own
1406	laws to a drug wholesaler of this state.
1407	(d) A retail pharmacy wholesaler's permit. A retail
1408	pharmacy wholesaler is a retail pharmacy engaged in wholesale
1409	distribution of prescription drugs within this state under the
1410	following conditions:
1411	1. The pharmacy must obtain a retail pharmacy wholesaler's
1412	permit pursuant to ss. 499.001-499.081 and the rules adopted
1413	under those sections.
1414	2. The wholesale distribution activity does not exceed 30
1415	percent of the total annual purchases of prescription drugs. If
1416	the wholesale distribution activity exceeds the 30-percent
1417	maximum, the pharmacy must obtain a prescription drug
1418	wholesaler's permit.
1419	3. The transfer of prescription drugs that appear in any
1420	schedule contained in chapter 893 is subject to chapter 893 and
1421	the federal Comprehensive Drug Abuse Prevention and Control Act
1422	of 1970.
1423	4. The transfer is between a retail pharmacy and another
1424	retail pharmacy, or a Modified Class II institutional pharmacy,
1425	or a health care practitioner licensed in this state and
1426	authorized by law to dispense or prescribe prescription drugs.
1427	5. All records of sales of prescription drugs subject to
1428	this section must be maintained separate and distinct from other
1429	records and comply with the recordkeeping requirements of ss.
1430	499.001-499.081.
1431	(3) A person that engages in wholesale distribution of
1432	prescription drugs in this state must have a wholesale
1433	distributor's permit issued by the department, except as noted
1434	in this section. Each establishment must be separately permitted
1435	except as noted in this subsection.
1436	(a) A separate establishment permit is not required when a
1437	permitted prescription drug wholesaler consigns a prescription
1438	drug to a pharmacy that is permitted under chapter 465 and
1439	located in this state, provided that:
1440	1. The consignor wholesaler notifies the department in
1441	writing of the contract to consign prescription drugs to a
1442	pharmacy along with the identity and location of each consignee
1443	pharmacy;
1444	2. The pharmacy maintains its permit under chapter 465;
1445	3. The consignor wholesaler, which has no legal authority
1446	to dispense prescription drugs, complies with all wholesale
1447	distribution requirements of s. 499.0121 with respect to the
1448	consigned drugs and maintains records documenting the transfer
1449	of title or other completion of the wholesale distribution of
1450	the consigned prescription drugs;
1451	4. The distribution of the prescription drug is otherwise
1452	lawful under this chapter and other applicable law;
1453	5. Open packages containing prescription drugs within a
1454	pharmacy are the responsibility of the pharmacy, regardless of
1455	how the drugs are titled; and
1456	6. The pharmacy dispenses the consigned prescription drug
1457	in accordance with the limitations of its permit under chapter
1458	465 or returns the consigned prescription drug to the consignor
1459	wholesaler. In addition, a person who holds title to
1460	prescription drugs may transfer the drugs to a person permitted
1461	or licensed to handle the reverse distribution or destruction of
1462	drugs. Any other distribution by and means of the consigned
1463	prescription drug by any person, not limited to the consignor
1464	wholesaler or consignee pharmacy, to any other person is
1465	prohibited.
1466	(b) A wholesale distributor's permit is not required for
1467	the one-time transfer of title of a pharmacy's lawfully acquired
1468	prescription drug inventory by a pharmacy with a valid permit
1469	issued under chapter 465 to a consignor prescription drug
1470	wholesaler, permitted under this chapter, in accordance with a
1471	written consignment agreement between the pharmacy and that
1472	wholesaler if: the permitted pharmacy and the permitted
1473	prescription drug wholesaler comply with all of the provisions
1474	of paragraph (a) and the prescription drugs continue to be
1475	within the permitted pharmacy's inventory for dispensing in
1476	accordance with the limitations of the pharmacy permit under
1477	chapter 465. A consignor drug wholesaler may not use the
1478	pharmacy as a wholesale distributor through which it distributes
1479	the legend drugs to other pharmacies. Nothing in this section is
1480	intended to prevent a wholesale drug distributor from obtaining
1481	this inventory in the event of nonpayment by the pharmacy.
1482	(c) The department shall require information from each
1483	wholesale distributor as part of the permit and renewal of such
1484	permit, as required under s. 499.01.
1485	(4) Personnel employed in wholesale distribution must have
1486	appropriate education and experience to enable them to perform
1487	their duties in compliance with state permitting requirements.
1488	(5) The department may adopt rules governing the
1489	recordkeeping, storage, and handling with respect to each of the
1490	distributions of prescription drugs specified in subparagraphs
1491	(1)(a)1.-4.
1492	Section 14. Effective January 1, 2004, section 499.012,
1493	Florida Statutes, as amended by this act, is amended to read:
1494	499.012 Wholesale distribution; definitions; permits;
1495	applications; general requirements.--
1496	(1) As used in this section, the term:
1497	(a) "Wholesale distribution" means distribution of
1498	prescription drugs to persons other than a consumer or patient,
1499	but does not include:
1500	1. Any of the following activities, which is not a
1501	violation of s. 499.005(21) if such activity is conducted in
1502	accordance with s. 499.014:
1503	a. The purchase or other acquisition by a hospital or
1504	other health care entity that is a member of a group purchasing
1505	organization of a prescription drug for its own use from the
1506	group purchasing organization or from other hospitals or health
1507	care entities that are members of that organization.
1508	b. The sale, purchase, or trade of a prescription drug or
1509	an offer to sell, purchase, or trade a prescription drug by a
1510	charitable organization described in s. 501(c)(3) of the
1511	Internal Revenue Code of 1986, as amended and revised, to a
1512	nonprofit affiliate of the organization to the extent otherwise
1513	permitted by law.
1514	c. The sale, purchase, or trade of a prescription drug or
1515	an offer to sell, purchase, or trade a prescription drug among
1516	hospitals or other health care entities that are under common
1517	control. For purposes of this section, "common control" means
1518	the power to direct or cause the direction of the management and
1519	policies of a person or an organization, whether by ownership of
1520	stock, by voting rights, by contract, or otherwise.
1521	d. The sale, purchase, trade, or other transfer of a
1522	prescription drug from or for any federal, state, or local
1523	government agency or any entity eligible to purchase
1524	prescription drugs at public health services prices pursuant to
1525	Pub. L. No. 102-585, s. 602 to a contract provider or its
1526	subcontractor for eligible patients of the agency or entity
1527	under the following conditions:
1528	(I) The agency or entity must obtain written authorization
1529	for the sale, purchase, trade, or other transfer of a
1530	prescription drug under this sub-subparagraph from the Secretary
1531	of Health or his or her designee.
1532	(II) The contract provider or subcontractor must be
1533	authorized by law to administer or dispense prescription drugs.
1534	(III) In the case of a subcontractor, the agency or entity
1535	must be a party to and execute the subcontract.
1536	(IV) A contract provider or subcontractor must maintain
1537	separate and apart from other prescription drug inventory any
1538	prescription drugs of the agency or entity in its possession.
1539	(V) The contract provider and subcontractor must maintain
1540	and produce immediately for inspection all records of movement
1541	or transfer of all the prescription drugs belonging to the
1542	agency or entity, including, but not limited to, the records of
1543	receipt and disposition of prescription drugs. Each contractor
1544	and subcontractor dispensing or administering these drugs must
1545	maintain and produce records documenting the dispensing or
1546	administration. Records that are required to be maintained
1547	include, but are not limited to, a perpetual inventory itemizing
1548	drugs received and drugs dispensed by prescription number or
1549	administered by patient identifier, which must be submitted to
1550	the agency or entity quarterly.
1551	(VI) The contract provider or subcontractor may administer
1552	or dispense the prescription drugs only to the eligible patients
1553	of the agency or entity or must return the prescription drugs
1554	for or to the agency or entity. The contract provider or
1555	subcontractor must require proof from each person seeking to
1556	fill a prescription or obtain treatment that the person is an
1557	eligible patient of the agency or entity and must, at a minimum,
1558	maintain a copy of this proof as part of the records of the
1559	contractor or subcontractor required under sub-sub-subparagraph
1560	(V).
1561	(VII) In addition to the departmental inspection authority
1562	set forth in s. 499.051, the establishment of the contract
1563	provider and subcontractor and all records pertaining to
1564	prescription drugs subject to this sub-subparagraph shall be
1565	subject to inspection by the agency or entity. All records
1566	relating to prescription drugs of a manufacturer under this sub-
1567	subparagraph shall be subject to audit by the manufacturer of
1568	those drugs, without identifying individual patient information.
1569	2. Any of the following activities, which is not a
1570	violation of s. 499.005(21) if such activity is conducted in
1571	accordance with rules established by the department:
1572	a. The sale, purchase, or trade of a prescription drug
1573	among federal, state, or local government health care entities
1574	that are under common control and are authorized to purchase
1575	such prescription drug.
1576	b. The sale, purchase, or trade of a prescription drug or
1577	an offer to sell, purchase, or trade a prescription drug for
1578	emergency medical reasons. For purposes of this sub-
1579	subparagraph, the term "emergency medical reasons" includes
1580	transfers of prescription drugs by a retail pharmacy to another
1581	retail pharmacy to alleviate a temporary shortage.
1582	c. The transfer of a prescription drug acquired by a
1583	medical director on behalf of a licensed emergency medical
1584	services provider to that emergency medical services provider
1585	and its transport vehicles for use in accordance with the
1586	provider's license under chapter 401.
1587	d. The revocation of a sale or the return of a
1588	prescription drug to the person's prescription drug wholesale
1589	supplier.
1590	e. The donation of a prescription drug by a health care
1591	entity to a charitable organization that has been granted an
1592	exemption under s. 501(c)(3) of the Internal Revenue Code of
1593	1986, as amended, and that is authorized to possess prescription
1594	drugs.
1595	f. The transfer of a prescription drug by a person
1596	authorized to purchase or receive prescription drugs to a person
1597	licensed or permitted to handle reverse distributions or
1598	destruction under the laws of the jurisdiction in which the
1599	person handling the reverse distribution or destruction receives
1600	the drug.
1601	g. The transfer of a prescription drug by a hospital or
1602	other health care entity to a person licensed under this chapter
1603	to repackage prescription drugs for the purpose of repackaging
1604	the prescription drug for use by that hospital, or other health
1605	care entity and other health care entities that are under common
1606	control, if ownership of the prescription drugs remains with the
1607	hospital or other health care entity at all times. In addition
1608	to the recordkeeping requirements of s. 499.0121(6), the
1609	hospital or health care entity that transfers prescription drugs
1610	pursuant to this sub-subparagraph must reconcile all drugs
1611	transferred and returned and resolve any discrepancies in a
1612	timely manner.
1613	3. The distribution of prescription drug samples by
1614	manufacturers' representatives or distributors' representatives
1615	conducted in accordance with s. 499.028.
1616	4. The sale, purchase, or trade of blood and blood
1617	components intended for transfusion. As used in this
1618	subparagraph, the term "blood" means whole blood collected from
1619	a single donor and processed either for transfusion or further
1620	manufacturing, and the term "blood components" means that part
1621	of the blood separated by physical or mechanical means.
1622	5. The lawful dispensing of a prescription drug in
1623	accordance with chapter 465.
1624	(b) "Wholesale distributor" means any person engaged in
1625	wholesale distribution of prescription drugs in or into this
1626	state, including, but not limited to, manufacturers;
1627	repackagers; own-label distributors; jobbers; private-label
1628	distributors; brokers; warehouses, including manufacturers' and
1629	distributors' warehouses, chain drug warehouses, and wholesale
1630	drug warehouses; independent wholesale drug traders; exporters;
1631	retail pharmacies; and the agents thereof that conduct wholesale
1632	distributions.
1633	(c) "Retail pharmacy" means a community pharmacy licensed
1634	under chapter 465 that purchases prescription drugs at fair
1635	market prices and provides prescription services to the public.
1636	(d) "Primary wholesaler" means any wholesale distributor
1637	that:
1638	1. Purchased 90 percent or more of the total dollar volume
1639	of its purchases of prescription drugs directly from
1640	manufacturers in the previous year; and
1641	2.a. Directly purchased prescription drugs from not fewer
1642	than 50 different prescription drug manufacturers in the
1643	previous year; or
1644	b. Has, or the affiliated group, as defined in s. 1504 of
1645	the Internal Revenue Code, of which the wholesale distributor is
1646	a member has, not fewer than 250 employees.
1647	(e) "Directly from a manufacturer" means:
1648	1. Purchases made by the wholesale distributor directly
1649	from the manufacturer of prescription drugs; and
1650	2. Transfers from a member of an affiliated group, as
1651	defined in s. 1504 of the Internal Revenue Code, of which the
1652	wholesale distributor is a member, if:
1653	a. The affiliated group purchases 90 percent or more of
1654	the total dollar volume of its purchases of prescription drugs
1655	from manufacturers in the previous year; or
1656	b. The wholesale distributor discloses to the department
1657	the names of all members of the affiliated group of which the
1658	wholesale distributor is a member and the affiliated group
1659	agrees in writing to provide records on prescription drug
1660	purchases by the members of the affiliated group not later than
1661	48 hours after the department requests access to such records,
1662	regardless of the location where the records are stored.
1663	(f) "Secondary wholesaler" means a wholesale distributor
1664	that is not a primary wholesaler.
1665	(2) The following types of wholesaler permits are
1666	established:
1667	(a) A prescription drug wholesaler's permit. A
1668	prescription drug wholesaler is a wholesale distributor that may
1669	engage in the wholesale distribution of prescription drugs. A
1670	prescription drug wholesaler that applies to the department for
1671	a new permit or the renewal of a permit after July 1, 2003, must
1672	submit a bond of $100,000, or other equivalent means of security
1673	acceptable to the department, such as an irrevocable letter of
1674	credit or a deposit in a trust account or financial institution,
1675	payable to the Florida Drug, Device, and Cosmetic Trust Fund.
1676	The purpose of the bond is to secure payment of any
1677	administrative penalties imposed by the department and any fees
1678	and costs incurred by the department regarding that permit which
1679	are authorized under state law and which the permittee fails to
1680	pay 30 days after the fine or costs become final. The department
1681	may make a claim against such bond or security until 1 year
1682	after the permittee's license ceases to be valid or until 60
1683	days after any administrative or legal proceeding authorized in
1684	ss. 499.001-499.081 which involves the permittee is concluded,
1685	including any appeal, whichever occurs later. The department may
1686	adopt rules for issuing a prescription drug wholesaler-broker
1687	permit to a person who engages in the wholesale distribution of
1688	prescription drugs and does not take physical possession of any
1689	prescription drugs.
1690	(b) A compressed medical gas wholesaler's permit. A
1691	compressed medical gas wholesaler is a wholesale distributor
1692	that is limited to the wholesale distribution of compressed
1693	medical gases to other than the consumer or patient. The
1694	compressed medical gas must be in the original sealed container
1695	that was purchased by that wholesaler. A compressed medical gas
1696	wholesaler may not possess or engage in the wholesale
1697	distribution of any prescription drug other than compressed
1698	medical gases. The department shall adopt rules that govern the
1699	wholesale distribution of prescription medical oxygen for
1700	emergency use. With respect to the emergency use of prescription
1701	medical oxygen, those rules may not be inconsistent with rules
1702	and regulations of federal agencies unless the Legislature
1703	specifically directs otherwise.
1704	(c) An out-of-state prescription drug wholesaler's permit.
1705	An out-of-state prescription drug wholesaler is a wholesale
1706	distributor located outside this state which engages in the
1707	wholesale distribution of prescription drugs into this state and
1708	which must be permitted by the department and comply with all
1709	the provisions required of a wholesale distributor under ss.
1710	499.001-499.081. An out-of-state prescription drug wholesaler
1711	that applies to the department for a new permit or the renewal
1712	of a permit after July 1, 2003, must submit a bond of $100,000,
1713	or other equivalent means of security acceptable to the
1714	department, such as an irrevocable letter of credit or a deposit
1715	in a trust account or financial institution, payable to the
1716	Florida Drug, Device, and Cosmetic Trust Fund. The purpose of
1717	the bond is to secure payment of any administrative penalties
1718	imposed by the department and any fees and costs incurred by the
1719	department regarding that permit which are authorized under
1720	state law and which the permittee fails to pay 30 days after the
1721	fine or costs become final. The department may make a claim
1722	against such bond or security until 1 year after the permittee's
1723	license ceases to be valid or until 60 days after any
1724	administrative or legal proceeding authorized in ss. 499.001-
1725	499.081 which involves the permittee is concluded, including any
1726	appeal, whichever occurs later.
1727	1. The out-of-state drug wholesaler must maintain at all
1728	times a license or permit to engage in the wholesale
1729	distribution of prescription drugs in compliance with laws of
1730	the state in which it is a resident.
1731	2. An out-of-state prescription drug wholesaler's permit
1732	is not required for an intracompany sale or transfer of a
1733	prescription drug from an out-of-state establishment that is
1734	duly licensed as a prescription drug wholesaler, in its state of
1735	residence, to a licensed prescription drug wholesaler in this
1736	state, if both wholesalers conduct wholesale distributions of
1737	prescription drugs under the same business name. The
1738	recordkeeping requirements of s. 499.0121(6) must be followed
1739	for this transaction.
1740	(d) A retail pharmacy wholesaler's permit. A retail
1741	pharmacy wholesaler is a retail pharmacy engaged in wholesale
1742	distribution of prescription drugs within this state under the
1743	following conditions:
1744	1. The pharmacy must obtain a retail pharmacy wholesaler's
1745	permit pursuant to ss. 499.001-499.081 and the rules adopted
1746	under those sections.
1747	2. The wholesale distribution activity does not exceed 30
1748	percent of the total annual purchases of prescription drugs. If
1749	the wholesale distribution activity exceeds the 30-percent
1750	maximum, the pharmacy must obtain a prescription drug
1751	wholesaler's permit.
1752	3. The transfer of prescription drugs that appear in any
1753	schedule contained in chapter 893 is subject to chapter 893 and
1754	the federal Comprehensive Drug Abuse Prevention and Control Act
1755	of 1970.
1756	4. The transfer is between a retail pharmacy and another
1757	retail pharmacy, or a Modified Class II institutional pharmacy,
1758	or a health care practitioner licensed in this state and
1759	authorized by law to dispense or prescribe prescription drugs.
1760	5. All records of sales of prescription drugs subject to
1761	this section must be maintained separate and distinct from other
1762	records and comply with the recordkeeping requirements of ss.
1763	499.001-499.081.
1764	(e) A nonresident prescription drug manufacturer's permit.
1765	A nonresident prescription drug manufacturer's permit is
1766	required for any person that is a manufacturer of prescription
1767	drugs, or the distribution point for a manufacturer of
1768	prescription drugs, and located outside of this state, or that
1769	is an entity to whom an approved new drug application has been
1770	issued by the United States Food and Drug Administration, or the
1771	contracted manufacturer of the approved new drug application
1772	holder, and located outside the United States, which engages in
1773	the wholesale distribution in this state of the prescription
1774	drugs it manufactures or is responsible for manufacturing. Each
1775	such manufacturer or entity must be permitted by the department
1776	and comply with all the provisions required of a wholesale
1777	distributor under ss. 499.001-499.081, except s. 499.0121(6)(d).
1778	1. A person that distributes prescription drugs that it
1779	did not manufacture must also obtain an out-of-state
1780	prescription drug wholesaler permit pursuant this section to
1781	engage in the wholesale distribution of the prescription drugs
1782	manufactured by another person and comply with the requirements
1783	of an out-of-state prescription drug wholesaler.
1784	2. Any such person must comply with the licensing or
1785	permitting requirements of the jurisdiction in which the
1786	establishment is located and the federal act, and any product
1787	wholesaled into this state must comply with ss. 499.001-499.081.
1788	If a person intends to import prescription drugs from a foreign
1789	country into this state, the nonresident prescription drug
1790	manufacturer must provide to the department a list identifying
1791	each prescription drug it intends to import and document
1792	approval by the United States Food and Drug Administration for
1793	such importation.
1794	(f) A freight forwarder's permit. A freight forwarder's
1795	permit is required for any person that engages in the
1796	distribution of a legend drug as a freight forwarder unless the
1797	person is a common carrier. The storage, handling, and
1798	recordkeeping of such distributions must comply with the
1799	requirements for wholesale distributors under s. 499.0121,
1800	except those set forth in s. 499.0121(6)(d), (e), or (f). A
1801	freight forwarder must provide the source of the legend drugs
1802	with a validated airway bill, bill of lading, or other
1803	appropriate documentation to evidence the exportation of the
1804	product.
1805	(3) An application for a permit or to renew a permit for a
1806	prescription drug wholesaler or an out-of-state prescription
1807	drug wholesaler submitted to the department must include:
1808	(a) The name, full business address, and telephone number
1809	of the applicant.
1810	(b) All trade or business names used by the applicant.
1811	(c) The address, telephone numbers, and names of contact
1812	persons for each facility used by the applicant for the storage,
1813	handling, and distribution of prescription drugs.
1814	(d) The type of ownership or operation, such as a
1815	partnership, corporation, or sole proprietorship.
1816	(e) The names of the owner and the operator of the
1817	establishment, including:
1818	1. If an individual, the name of the individual.
1819	2. If a partnership, the name of each partner and the name
1820	of the partnership.
1821	3. If a corporation:
1822	a. The name, address, and title of each corporate officer
1823	and director.
1824	b. The name and address of the corporation, resident agent
1825	of the corporation, the resident agent's address, and the
1826	corporation's state of incorporation.
1827	c. The name and address of each shareholder of the
1828	corporation that owns 5 percent or more of the outstanding stock
1829	of the corporation.
1830	4. If a sole proprietorship, the full name of the sole
1831	proprietor and the name of the business entity.
1832	5. If a limited liability company:
1833	a. The name and address of each member.
1834	b. The name and address of each manager.
1835	c. The name and address of the limited liability company,
1836	the resident agent of the limited liability company, and the
1837	name of the state in which the limited liability company was
1838	organized.
1839	(f) If applicable, the name and address of each member of
1840	the affiliated group, as defined in s. 1504 of the Internal
1841	Revenue Code, of which the applicant is a member.
1842	(g)1. For an application for a new permit, the estimated
1843	annual dollar volume of prescription drug sales of the
1844	applicant, the estimated annual percentage of the applicant's
1845	total company sales that are prescription drugs, the applicant's
1846	estimated annual total dollar volume of purchases of
1847	prescription drugs, and the applicant's estimated annual total
1848	dollar volume of prescription drug purchases directly from
1849	manufacturers.
1850	2. For an application to renew a permit, the total dollar
1851	volume of prescription drug sales in the previous year, the
1852	total dollar volume of prescription drug sales made in the
1853	previous 6 months, the percentage of total company sales that
1854	were prescription drugs in the previous year, the total dollar
1855	volume of purchases of prescription drugs in the previous year,
1856	and the total dollar volume of prescription drug purchases
1857	directly from manufacturers in the previous year.
1858
1859	Such portions of the information required pursuant to this
1860	paragraph which are a trade secret, as defined in s. 812.081,
1861	shall be maintained by the department as trade secret
1862	information is required to be maintained under s. 499.051.
1863	(h) The tax year of the applicant.
1864	(i) A copy of the deed for the property on which
1865	applicant's establishment is located, if the establishment is
1866	owned by the applicant, or a copy of the applicant's lease for
1867	the property on which applicant's establishment is located that
1868	has an original term of not less than 1 calendar year, if the
1869	establishment is not owned by the applicant.
1870	(j) A list of all licenses and permits issued to the
1871	applicant by any other state which authorize the applicant to
1872	purchase or possess prescription drugs.
1873	(k) The name of the manager of the establishment that is
1874	applying for the permit or to renew the permit, the next four
1875	highest ranking employees responsible for prescription drug
1876	wholesale operations for the establishment, and the name of all
1877	affiliated parties for the establishment, together with the
1878	personal information statement and fingerprints required
1879	pursuant to subsection (4) for each such person.
1880	(l) The name of each of the applicant's designated
1881	representatives as required by subsection (11), together with
1882	the personal information statement and fingerprints required
1883	pursuant to subsection (4) for each such person.
1884	(m) For an applicant that is a secondary wholesaler, each
1885	of the following:
1886	1. A personal background information statement containing
1887	the background information and fingerprints required pursuant to
1888	subsection (4) for each person named in the applicant's response
1889	to paragraphs (k) and (l) and for each affiliated party of the
1890	applicant.
1891	2. If any of the five largest shareholders of the
1892	corporation seeking the permit is a corporation, the name,
1893	address, and title of each corporate officer and director of
1894	each such corporation; the name and address of such corporation;
1895	the name of such corporation's resident agent, such
1896	corporation's resident agent's address, and such corporation's
1897	state of its incorporation; and the name and address of each
1898	shareholder of such corporation that owns 5 percent or more of
1899	the stock of such corporation.
1900	3. The name and address of all financial institutions in
1901	which the applicant has an account which is used to pay for the
1902	operation of the establishment or to pay for drugs purchased for
1903	the establishment, together with the names of all persons that
1904	are authorized signatories on such accounts. Any portions of the
1905	information required pursuant to this subparagraph which are a
1906	trade secret, as defined in s. 812.081, shall be maintained by
1907	the department as trade secret information is required to be
1908	maintained under s. 499.051.
1909	4. The sources of all funds and the amounts of such funds
1910	used to purchase or finance purchases of prescription drugs or
1911	to finance the premises on which the establishment is to be
1912	located.
1913	5. If any of the funds identified in subparagraph 4. were
1914	borrowed, copies of all promissory notes or loans used to obtain
1915	such funds.
1916	(n) Any other relevant information that the department
1917	requires, including, but not limited to, any information related
1918	to whether the applicant satisfies the definition of a primary
1919	wholesaler or a secondary wholesaler.
1920	(4)(a) Each person required under subsection (3) to
1921	provide a personal information statement and fingerprints
1922	pursuant to this subsection shall provide the following
1923	information to the department on forms prescribed by the
1924	department:
1925	1. The person's places of residence for the past 7 years.
1926	2. The person's date and place of birth.
1927	3. The person's occupations, positions of employment, and
1928	offices held during the past 7 years.
1929	4. The principal business and address of any business,
1930	corporation, or other organization in which each such office of
1931	the person was held or in which each such occupation or position
1932	of employment was carried on.
1933	5. Whether the person has been, during the past 7 years,
1934	the subject of any proceeding for the revocation of any license
1935	and, if so, the nature of the proceeding and the disposition of
1936	the proceeding.
1937	6. Whether, during the past 7 years, the person has been
1938	enjoined, either temporarily or permanently, by a court of
1939	competent jurisdiction from violating any federal or state law
1940	regulating the possession, control, or distribution of
1941	prescription drugs, together with details concerning any such
1942	event.
1943	7. A description of any involvement by the person with any
1944	business, including any investments, other than the ownership of
1945	stock in a publicly traded company or mutual fund, during the
1946	past 7 years, which manufactured, administered, prescribed,
1947	distributed, or stored pharmaceutical products and any lawsuits
1948	in which such businesses were named as a party.
1949	8. A description of any felony criminal offense of which
1950	the person, as an adult, was found guilty, regardless of whether
1951	adjudication of guilt was withheld or whether the person pled
1952	guilty or nolo contendere. A criminal offense committed in
1953	another jurisdiction which would have been a felony in this
1954	state must be reported. If the person indicates that a criminal
1955	conviction is under appeal and submits a copy of the notice of
1956	appeal of that criminal offense, the applicant must, within 15
1957	days after the disposition of the appeal, submit to the
1958	department a copy of the final written order of disposition.
1959	9. A photograph of the person taken in the previous 30
1960	days.
1961	10. A set of fingerprints of the person on a form and
1962	under procedures specified by the department, together with
1963	payment of an amount equal to the costs incurred by the
1964	department for the criminal record check of the person.
1965	11. The name, address, occupation, and date and place of
1966	birth for each member of the person's immediate family who is 18
1967	years of age or older. As used in this subparagraph, the term
1968	"member of the person's immediate family" includes the person's
1969	spouse, children, parents, siblings, the spouses of the person's
1970	children, and the spouses of the person's siblings.
1971	12. Any other relevant information that the department
1972	requires.
1973	(b) The information required pursuant to paragraph (a)
1974	shall be provided under oath.
1975	(c) The department shall submit the fingerprints provided
1976	by a person for initial licensure to the Department of Law
1977	Enforcement for a statewide criminal record check and for
1978	forwarding to the Federal Bureau of Investigation for a national
1979	criminal record check of the person. The department shall submit
1980	the fingerprints provided by a person as a part of a renewal
1981	application to the Department of Law Enforcement for a statewide
1982	criminal record check, and for forwarding to the Federal Bureau
1983	of Investigation for a national criminal record check, for the
1984	initial renewal of a permit after January 1, 2004; for any
1985	subsequent renewal of a permit, the department shall submit the
1986	required information for a statewide and national criminal
1987	record check of the person. Any person who, as a part of an
1988	initial permit application or initial permit renewal after
1989	January 1, 2004, submits to the department a set of fingerprints
1990	required for the criminal record check required in this
1991	paragraph shall not be required to provide a subsequent set of
1992	fingerprints for a criminal record check to the department, if
1993	the person has undergone a criminal record check as a condition
1994	of the issuance of an initial permit or the initial renewal of a
1995	permit of an applicant after January 1, 2004.
1996	(5) The department may deny an application for a permit or
1997	refuse to renew a permit for a prescription drug wholesaler or
1998	an out-of-state prescription drug wholesaler if:
1999	(a) The applicant has not met the requirements for the
2000	permit.
2001	(b) The management, officers, or directors of the
2002	applicant or any affiliated party are found by the department to
2003	be incompetent or untrustworthy.
2004	(c) The applicant is so lacking in experience in managing
2005	a wholesale distributor as to make the issuance of the proposed
2006	permit hazardous to the public health.
2007	(d) The applicant is so lacking in experience in managing
2008	a wholesale distributor as to jeopardize the reasonable promise
2009	of successful operation of the wholesale distributor.
2010	(e) The applicant is lacking in experience in the
2011	distribution of prescription drugs.
2012	(f) The applicant's past experience in manufacturing or
2013	distributing prescription drugs indicates that the applicant
2014	poses a public health risk.
2015	(g) The applicant is affiliated directly or indirectly
2016	through ownership, control, or other business relations, with
2017	any person or persons whose business operations are or have been
2018	detrimental to the public health.
2019	(h) The applicant, or any affiliated party, has been found
2020	guilty of or has pleaded guilty or nolo contendere to any felony
2021	or crime punishable by imprisonment for 1 year or more under the
2022	laws of the United States, any state, or any other country,
2023	regardless of whether adjudication of guilt was withheld.
2024	(i) The applicant or any affiliated party has been charged
2025	with a felony in a state or federal court and the disposition of
2026	that charge is pending during the application review or renewal
2027	review period.
2028	(j) The applicant has furnished false or fraudulent
2029	information or material in any application made in this state or
2030	any other state in connection with obtaining a permit or license
2031	to manufacture or distribute drugs, devices, or cosmetics.
2032	(k) That a federal, state, or local government permit
2033	currently or previously held by the applicant, or any affiliated
2034	party, for the manufacture or distribution of any drugs,
2035	devices, or cosmetics has been disciplined, suspended, or
2036	revoked and has not been reinstated.
2037	(l) The applicant does not possess the financial or
2038	physical resources to operate in compliance with the permit
2039	being sought, this chapter, and the rules adopted under this
2040	chapter.
2041	(m) The applicant or any affiliated party receives,
2042	directly or indirectly, financial support and assistance from a
2043	person who was an affiliated party of a permittee whose permit
2044	was subject to discipline or was suspended or revoked, other
2045	than through the ownership of stock in a publicly traded company
2046	or a mutual fund.
2047	(n) The applicant or any affiliated party receives,
2048	directly or indirectly, financial support and assistance from a
2049	person who has been found guilty of any violation of ss.
2050	499.001-499.081 or chapter 465, chapter 501, or chapter 893, any
2051	rules adopted under any of those sections or chapters, any
2052	federal or state drug law, or any felony where the underlying
2053	facts related to drugs, regardless of whether the person has
2054	been pardoned, had her or his civil rights restored, or had
2055	adjudication withheld, other than through the ownership of stock
2056	in a publicly traded company or a mutual fund.
2057	(o) The applicant for renewal of a permit under paragraph
2058	(2)(a) or paragraph (2)(c) has not actively engaged in the
2059	wholesale distribution of prescription drugs, as demonstrated by
2060	the regular and systematic distribution of prescription drugs
2061	throughout the year as evidenced by not fewer than 12 wholesale
2062	distributions in the previous year and not fewer than three
2063	wholesale distributions in the previous 6 months.
2064	(p) Information obtained in response to subsection (3) or
2065	subsection (4) demonstrates it would not be in the best interest
2066	of the public health, safety, and welfare to issue a permit.
2067	(q) The applicant does not possess the financial standing
2068	and business experience for the successful operation of the
2069	applicant's business.
2070	(r) The applicant or any affiliated party has failed to
2071	comply with the requirements for manufacturing or distributing
2072	prescription drugs under ss. 499.001-499.081, similar federal
2073	laws, similar laws in other states, or the rules adopted under
2074	such laws.
2075	(6) Upon approval of the application by the department and
2076	payment of the required fee, the department shall issue or renew
2077	a prescription drug wholesaler or an out-of-state prescription
2078	drug wholesaler permit to the applicant.
2079	(7) For permits for prescription drug wholesalers or out-
2080	of-state prescription drug wholesalers:
2081	(a) The department shall adopt rules for the annual
2082	renewal of permits. At least 90 days before the expiration of a
2083	permit, the department shall forward a permit renewal
2084	notification and renewal application to the prescription drug
2085	wholesaler or out-of-state prescription drug wholesaler at the
2086	mailing address of the permitted establishment on file with the
2087	department. The permit renewal notification must state
2088	conspicuously the date on which the permit for the establishment
2089	will expire and that the establishment may not operate unless
2090	the permit for the establishment is renewed timely.
2091	(b) A permit, unless sooner suspended or revoked,
2092	automatically expires 1 year after the last day of the
2093	anniversary month in which the permit was originally issued. A
2094	permit may be renewed by making application for renewal on forms
2095	furnished by the department and paying the appropriate fees. If
2096	a renewal application and fee are submitted and postmarked after
2097	the 45th day prior to the expiration date of the permit, the
2098	permit may be renewed only upon payment of a late renewal fee of
2099	$100, plus the required renewal fee. A permittee that has
2100	submitted a renewal application in accordance with this
2101	paragraph may continue to operate under its permit, unless the
2102	permit is suspended or revoked, until final disposition of the
2103	renewal application.
2104	(c) Failure to renew a permit in accordance with this
2105	section precludes any future renewal of that permit. If a permit
2106	issued pursuant to this section has expired and cannot be
2107	renewed, before an establishment may engage in activities that
2108	require a permit under ss. 499.001-499.081, the establishment
2109	must submit an application for a new permit; pay the applicable
2110	application fee, initial permit fee, and all applicable
2111	penalties; and be issued a new permit by the department.
2112	(8)(3)A person that engages in wholesale distribution of
2113	prescription drugs in this state must have a wholesale
2114	distributor's permit issued by the department, except as noted
2115	in this section. Each establishment must be separately permitted
2116	except as noted in this subsection.
2117	(a) A separate establishment permit is not required when a
2118	permitted prescription drug wholesaler consigns a prescription
2119	drug to a pharmacy that is permitted under chapter 465 and
2120	located in this state, provided that:
2121	1. The consignor wholesaler notifies the department in
2122	writing of the contract to consign prescription drugs to a
2123	pharmacy along with the identity and location of each consignee
2124	pharmacy;
2125	2. The pharmacy maintains its permit under chapter 465;
2126	3. The consignor wholesaler, which has no legal authority
2127	to dispense prescription drugs, complies with all wholesale
2128	distribution requirements of s. 499.0121 with respect to the
2129	consigned drugs and maintains records documenting the transfer
2130	of title or other completion of the wholesale distribution of
2131	the consigned prescription drugs;
2132	4. The distribution of the prescription drug is otherwise
2133	lawful under this chapter and other applicable law;
2134	5. Open packages containing prescription drugs within a
2135	pharmacy are the responsibility of the pharmacy, regardless of
2136	how the drugs are titled; and
2137	6. The pharmacy dispenses the consigned prescription drug
2138	in accordance with the limitations of its permit under chapter
2139	465 or returns the consigned prescription drug to the consignor
2140	wholesaler. In addition, a person who holds title to
2141	prescription drugs may transfer the drugs to a person permitted
2142	or licensed to handle the reverse distribution or destruction of
2143	drugs. Any other distribution by and means of the consigned
2144	prescription drug by any person, not limited to the consignor
2145	wholesaler or consignee pharmacy, to any other person is
2146	prohibited.
2147	(b) A wholesale distributor's permit is not required for
2148	the one-time transfer of title of a pharmacy's lawfully acquired
2149	prescription drug inventory by a pharmacy with a valid permit
2150	issued under chapter 465 to a consignor prescription drug
2151	wholesaler, permitted under this chapter, in accordance with a
2152	written consignment agreement between the pharmacy and that
2153	wholesaler if: the permitted pharmacy and the permitted
2154	prescription drug wholesaler comply with all of the provisions
2155	of paragraph (a) and the prescription drugs continue to be
2156	within the permitted pharmacy's inventory for dispensing in
2157	accordance with the limitations of the pharmacy permit under
2158	chapter 465. A consignor drug wholesaler may not use the
2159	pharmacy as a wholesale distributor through which it distributes
2160	the legend drugs to other pharmacies. Nothing in this section is
2161	intended to prevent a wholesale drug distributor from obtaining
2162	this inventory in the event of nonpayment by the pharmacy.
2163	(c) The department shall require information from each
2164	wholesale distributor as part of the permit and renewal of such
2165	permit, as required under s. 499.01 or s. 499.012.
2166	(9)(4)Personnel employed in wholesale distribution must
2167	have appropriate education and experience to enable them to
2168	perform their duties in compliance with state permitting
2169	requirements.
2170	(10) The name of a permittee or establishment on a
2171	prescription drug wholesaler permit or an out-of-state
2172	prescription drug wholesaler permit may not include any indicia
2173	of attainment of any educational degree, any indicia that the
2174	permittee or establishment possesses a professional license, or
2175	any name or abbreviation that the department determines is
2176	likely to cause confusion or mistake or that the department
2177	determines is deceptive, including that of any other entity
2178	authorized to purchase prescription drugs.
2179	(11)(a) Each establishment that is issued an initial or
2180	renewal permit as a prescription drug wholesaler or an out-of-
2181	state prescription drug wholesaler must designate in writing to
2182	the department at least one natural person to serve as the
2183	designated representative of the wholesaler. Such person must
2184	have an active certification as a designated representative from
2185	the department.
2186	(b) To be certified as a designated representative, a
2187	natural person must:
2188	1. Submit an application on a form furnished by the
2189	department and pay the appropriate fees;
2190	2. Be at least 18 years of age;
2191	3. Have not less than 2 years of verifiable full-time work
2192	experience in a pharmacy licensed in this state or another
2193	state, where the person's responsibilities included, but were
2194	not limited to, recordkeeping for prescription drugs, or have
2195	not less than 2 years of verifiable full-time managerial
2196	experience with a prescription drug wholesaler licensed in this
2197	state or in another state;
2198	4. Receive a passing score of at least 75 percent on an
2199	examination given by the department regarding federal laws
2200	governing distribution of prescription drugs and ss. 499.001-
2201	499.081 and the rules adopted by the department governing the
2202	wholesale distribution of prescription drugs. This requirement
2203	shall be effective 1 year after the results of the initial
2204	examination are mailed to the persons that took the examination.
2205	The department shall offer such examinations at least four times
2206	each calendar year; and
2207	5. Provide the department with a personal information
2208	statement and fingerprints pursuant to subsection (4).
2209	(c) The department may deny an application for
2210	certification as a designated representative or may suspend or
2211	revoke a certification of a designated representative pursuant
2212	to s. 499.067.
2213	(d) A designated representative:
2214	1. Must be actively involved in and aware of the actual
2215	daily operation of the wholesale distributor.
2216	2. Must be employed full time in a managerial position by
2217	the wholesale distributor.
2218	3. Must be physically present at the establishment during
2219	normal business hours, except for time periods when absent due
2220	to illness, family illness or death, scheduled vacation, or
2221	other authorized absence.
2222	4. May serve as a designated representative for only one
2223	wholesale distributor at any one time.
2224	(e) A wholesale distributor must notify the department
2225	when a designated representative leaves the employ of the
2226	wholesale distributor. Such notice must be provided to the
2227	department within 10 business days after the last day of
2228	designated representative's employment with the wholesale
2229	distributor.
2230	(f) A wholesale distributor may not operate under a
2231	prescription drug wholesaler permit or an out-of-state
2232	prescription drug wholesaler permit for more than 10 business
2233	days after the designated representative leaves the employ of
2234	the wholesale distributor, unless the wholesale distributor
2235	employs another designated representative and notifies the
2236	department within 10 business days of the identity of the new
2237	designated representative.
2238	(12)(5)The department may adopt rules governing the
2239	recordkeeping, storage, and handling with respect to each of the
2240	distributions of prescription drugs specified in subparagraphs
2241	(1)(a)1.-4.
2242	Section 15. Subsections (4), (6), (7), and (8) of section
2243	499.0121, Florida Statutes, are amended, and subsection (11) is
2244	added to said section, to read:
2245	499.0121 Storage and handling of prescription drugs;
2246	recordkeeping.--The department shall adopt rules to implement
2247	this section as necessary to protect the public health, safety,
2248	and welfare. Such rules shall include, but not be limited to,
2249	requirements for the storage and handling of prescription drugs
2250	and for the establishment and maintenance of prescription drug
2251	distribution records.
2252	(4) EXAMINATION OF MATERIALS AND RECORDS.--
2253	(a) Upon receipt, each outside shipping container must be
2254	visually examined for identity and to prevent the acceptance of
2255	contaminated prescription drugs that are otherwise unfit for
2256	distribution. This examination must be adequate to reveal
2257	container damage that would suggest possible contamination or
2258	other damage to the contents.
2259	(b) Each outgoing shipment must be carefully inspected for
2260	identity of the prescription drug products and to ensure that
2261	there is no delivery of prescription drugs that have expired or
2262	been damaged in storage or held under improper conditions.
2263	(c) The recordkeeping requirements in subsection (6) must
2264	be followed for all incoming and outgoing prescription drugs.
2265	(d) Upon receipt, a wholesaler must review records
2266	required under this section for the acquisition of prescription
2267	drugs for accuracy and completeness, considering the total facts
2268	and circumstances surrounding the transactions and the wholesale
2269	distributors involved. This includes authenticating each
2270	transaction listed on a pedigree paper, as defined in s.
2271	499.003(31).
2272	(6) RECORDKEEPING.--The department shall adopt rules that
2273	require keeping such records of prescription drugs as are
2274	necessary for the protection of the public health.
2275	(a) Wholesale drug distributors must establish and
2276	maintain inventories and records of all transactions regarding
2277	the receipt and distribution or other disposition of
2278	prescription drugs. These records must provide a complete audit
2279	trail from receipt to sale or other disposition, be readily
2280	retrievable for inspection, and include, at a minimum, the
2281	following information:
2282	1. The source of the drugs, including the name and
2283	principal address of the seller or transferor, and the address
2284	of the location from which the drugs were shipped.;
2285	2. The name, principal address, and state license permit
2286	or registration number of the person authorized to purchase
2287	prescription drugs.;
2288	3. The name, strength, dosage form, and quantity of the
2289	drugs received and distributed or disposed of.; and
2290	4. The dates of receipt and distribution or other
2291	disposition of the drugs.
2292	5. Any financial documentation supporting the transaction.
2293	(b) Inventories and records must be made available for
2294	inspection and photocopying by authorized federal, state, or
2295	local officials for a period of 2 years following disposition of
2296	the drugs or 3 years after the creation of the records,
2297	whichever period is longer.
2298	(c) Records described in this section that are kept at the
2299	inspection site or that can be immediately retrieved by computer
2300	or other electronic means must be readily available for
2301	authorized inspection during the retention period. Records that
2302	are kept at a central location outside of this state and that
2303	are not electronically retrievable must be made available for
2304	inspection within 2 working days after a request by an
2305	authorized official of a federal, state, or local law
2306	enforcement agency. Records that are maintained at a central
2307	location within this state must be maintained at an
2308	establishment that is permitted pursuant to ss. 499.001-499.081
2309	and must be readily available.
2310	(d)1. Each person who is engaged in the wholesale
2311	distribution of a prescription drug, and who is not an
2312	authorized distributor of record for the drug manufacturer's
2313	productsof such drug, must provide to each wholesale
2314	distributor of such drug, before the sale is made to such
2315	wholesale distributor, a written statement under oath
2316	identifying each previous sale of the drug back to the last
2317	authorized distributor of record, the lot number of the drug,
2318	and the sales invoice number of the invoice evidencing the sale
2319	of the drug. The written statement identifying all sales of
2320	such drug must accompany the drug for each subsequent wholesale
2321	distribution of the drug to the nextawholesale distributor.
2322	The department shall adopt rules relating to the requirements of
2323	this written statement. This subparagraph does not apply to a
2324	manufacturer unless the manufacturer is performing the
2325	manufacturing operation of repackaging prescription drugs.
2326	2. Each wholesale distributor of prescription drugs must
2327	maintain separate and distinct from other required records all
2328	statements that are required under subparagraph 1. and paragraph
2329	(e).
2330	3. Each manufacturer of a prescription drug sold in this
2331	state must maintain at its corporate offices a current list of
2332	authorized distributors of recordand must make such list
2333	available to the department upon request.
2334	4. Each manufacturer shall file a written list of all of
2335	the manufacturer's authorized distributors of record with the
2336	department. A manufacturer shall notify the department not later
2337	than 10 days after any change to the list. The department shall
2338	publish a list of all authorized distributors of record on its
2339	website.
2340	5.For the purposes of this subsection, the term
2341	"authorized distributors of record" means a wholesale
2342	distributorthose distributors with whom a manufacturer has
2343	established an ongoing relationship to distribute the
2344	manufacturer's products. Effective March 1, 2004, an ongoing
2345	relationship is deemed to exist when a wholesale distributor,
2346	including any affiliated group, as defined in s. 1504 of the
2347	Internal Revenue Code, of which the wholesale distributor is a
2348	member:
2349	a. Is listed on the manufacturer's current list of
2350	authorized distributors of record.
2351	b. Annually purchases not less than 90 percent of all of
2352	its purchases of a manufacturer's prescription drug products,
2353	based on dollar volume, directly from the manufacturer and has
2354	total annual prescription drug sales of $100 million or more.
2355	c. Has reported to the department pursuant to s.
2356	499.012(3)(g)2. that the wholesale distributor has total annual
2357	prescription drug sales of $100 million or more, and has a
2358	verifiable account number issued by the manufacturer authorizing
2359	the wholesale distributor to purchase the manufacturer's drug
2360	products directly from that manufacturer and that wholesale
2361	distributor makes not fewer than 12 purchases of that
2362	manufacturer's drug products directly from the manufacturer
2363	using said verifiable account number in 12 months. The
2364	provisions of this sub-subparagraph apply with respect to a
2365	manufacturer that fails to file a copy of the manufacturer's
2366	list of authorized distributors of record with the department by
2367	July 1, 2003, that files a list of authorized distributors of
2368	record that contains fewer than five wholesale distributors
2369	permitted in this state, excluding the wholesale distributors
2370	described in sub-subparagraph b., or that, as a result of
2371	changes to the list of authorized distributors of record filed
2372	with the department, has fewer than five wholesale distributors
2373	permitted in this state as authorized distributors of record,
2374	excluding the wholesale distributors described in sub-
2375	subparagraph b.
2376
2377	A wholesale distributor that satisfies the requirements of sub-
2378	subparagraph b. or sub-subparagraph c. shall submit to the
2379	department documentation substantiating its qualification
2380	pursuant to sub-subparagraph b. or sub-subparagraph c. The
2381	department shall add those wholesale distributors that the
2382	department has determined have met the requirements of sub-
2383	subparagraph b. or sub-subparagraph c. to the list of authorized
2384	distributors of record on the department's website.
2385	6. This paragraph expires July 1, 2006.
2386	(e)1. Notwithstanding paragraph (d), each person who is
2387	engaged in the wholesale distribution of a specified drug must
2388	provide to each wholesale distributor of such specified drug:
2389	a. Upon any sale, a written statement that:
2390	(I) If the establishment is not a member of an affiliated
2391	group, as defined in s. 1504 of the Internal Revenue Code: "This
2392	establishment purchased the specific unit of the specified drug
2393	directly from the manufacturer"; or
2394	(II) If the establishment is a member of an affiliated
2395	group, as defined in s. 1504 of the Internal Revenue Code: "This
2396	establishment or a member of my affiliated group purchased the
2397	specific unit of the specified drug directly from the
2398	manufacturer"; or
2399	b. Before the wholesale distribution, a written statement,
2400	under oath, that identifies each previous sale of the specific
2401	unit of the specified drug back to the manufacturer of the
2402	specified drug, the lot number of the specific unit of the
2403	specified prescription drug, and the sales invoice number of the
2404	invoice evidencing each previous sale of the specific unit of
2405	the specified drug. The written statement identifying all sales
2406	of such specific unit of the specified drug must accompany the
2407	specific unit of the specified drug for each subsequent
2408	wholesale distribution of the specific unit of the specified
2409	drug to a wholesale distributor.
2410
2411	The department shall adopt rules to administer the requirements
2412	of these written statements.
2413	2. As used in this paragraph, the term "specified drug"
2414	means a specific prescription drug on the list of drugs adopted
2415	by the department by rule.
2416	3.a. A drug may be placed on the list of specified drugs
2417	if the department has seized or issued a stop sale notice on the
2418	prescription drug because of the adulteration, counterfeiting,
2419	or diversion of the prescription drug from the legal channels of
2420	distribution for prescription drugs, or the United States Food
2421	and Drug Administration, a manufacturer, a wholesale
2422	distributor, a law enforcement agency, or a government agency
2423	responsible for regulating the sale or distribution of
2424	prescription drugs in another state has notified the department
2425	in writing or through a website operated by one of said entities
2426	that the prescription drug has been adulterated, counterfeit or
2427	diverted from the legal channels of distribution for
2428	prescription drugs; and the prescription drug satisfies one of
2429	the following criteria:
2430	(I) The prescription drug is included among the top 150
2431	prescription drugs for which the state has incurred the highest
2432	amount of Medicaid claims in the most recently ended state
2433	fiscal year;
2434	(II) The prescription drug is available for normal
2435	prescription use in dosages or strengths that have a wholesale
2436	cost $200 or more;
2437	(III) The prescription drug is used extensively for
2438	patients with human immunodeficiency virus, acquired immune
2439	deficiency syndrome, cancer, or other serious, life threatening
2440	conditions, where drug nonresponsiveness would not be considered
2441	to be medically unusual;
2442	(IV) The prescription drug is an injectable drug;
2443	(V) The prescription drug is subject to a special, limited
2444	distribution process and is not generally sold to wholesale
2445	distributors by the manufacturer of the prescription drug;
2446	(VI) The department has found not less than five instances
2447	where statements required pursuant to paragraph (d) for the
2448	prescription drug were not passed on other than because of
2449	unintentional oversight, or have been passed on by or to a
2450	wholesale distributor and such statements were fraudulent; or
2451	(VII) A shipment of a prescription drug has been reported
2452	to a law enforcement agency as having been stolen or as missing.
2453	b. A prescription drug may be placed on the list of
2454	specified drugs if the prescription drug satisfies any three of
2455	the seven criteria set forth in sub-sub-subparagraphs (I)-(VII).
2456	However, a prescription drug may not be included on the list of
2457	specified drugs if the prescription drug is unlikely to be
2458	counterfeited or diverted from the legal channels of
2459	distribution for prescription drugs.
2460	c. Before the department begins the rulemaking process to
2461	place a drug on the list of specified drugs, except when the
2462	department files a rule under the procedure specified in sub-
2463	subparagraph e., the Drug Wholesaler Advisory Council created in
2464	s. 499.01211 shall consider whether a prescription drug should
2465	be included on or added to the list of specified drugs using the
2466	criteria enumerated in sub-subparagraph a. or sub-subparagraph
2467	b. and provide a written recommendation adopted by majority vote
2468	to the secretary of the department concerning each such drug.
2469	This paragraph does not apply to any list of prescription drugs
2470	on which the department has begun rulemaking prior to this
2471	paragraph becoming law.
2472	d. When a prescription drug is added to the list of
2473	specified drugs, the requirements of this paragraph shall be
2474	effective as to the prescription drug beginning 60 days after
2475	the effective date of the rule adding the prescription drug to
2476	the list, except when the department files a rule under the
2477	procedure specified in sub-subparagraph e.
2478	e.(I) Notwithstanding chapter 120, if the Attorney General
2479	or Statewide Prosecutor certifies to the secretary of the
2480	department that a prescription drug should be added to the list
2481	of specified drugs by emergency rule, the department may proceed
2482	to add such drug to the list of specified drugs and the
2483	emergency rule shall be effective for a period of one year from
2484	the date on which the emergency rule is filed, if the department
2485	begins the rulemaking process to adopt a permanent rule to place
2486	the drug on the list of specified drugs not later than 90 days
2487	after the date on which the emergency rule was filed. An
2488	emergency rule adding a drug to the list of specified drugs may
2489	not be renewed.
2490	(II) A prescription drug may be placed on the list of
2491	specified drugs through the procedure provided in this sub-
2492	subparagraph when:
2493	(A) The prescription drug satisfies any two of the
2494	criteria specified in sub-subparagraph a. or sub-subparagraph
2495	b.; or
2496	(B) The prescription drug satisfies any one of the
2497	criteria specified in sub-subparagraph a. or sub-subparagraph b.
2498	if the prescription drug has not yet become available for
2499	wholesale distribution or has been available for wholesale
2500	distribution for not more than 60 days.
2501	(III) Notwithstanding chapter 120, any emergency rule that
2502	places a prescription drug on the list of specified drugs may be
2503	challenged as being an invalid exercise of the delegated
2504	legislative authority only if the department lacks any
2505	substantial competent evidence that the prescription drug
2506	satisfied the criteria required pursuant to sub-sub-subparagraph
2507	(I) or sub-sub-subparagraph (II). Not later than 7 days after
2508	any request by any person, the department shall provide such
2509	person with the substantial competent evidence that justifies
2510	the department's adoption of an emergency rule placing a
2511	prescription drug on the list of specified drugs.
2512	(IV) The department shall notify all prescription drug
2513	wholesalers and out-of-state-prescription drug wholesalers by
2514	electronic means, facsimile, or United States mail and on the
2515	bureau's website when any emergency rule is adopted which places
2516	a prescription drug on the list of specified drugs. Not later
2517	than 7 days after the department adopts an emergency rule
2518	placing a prescription drug on the list of specified drugs,
2519	wholesalers shall provide the department with the lot numbers
2520	and quantities of such prescription drug which the wholesaler
2521	owns or has in transit on the date that the department adopted
2522	the emergency rule placing the prescription drug on the list of
2523	specified drugs.
2524	(V) The requirements of subparagraph 1. do not apply to
2525	those lot numbers and quantities of a prescription drug which
2526	are included on a report filed pursuant to sub-sub-subparagraph
2527	(IV), and paragraph (6)(d) shall apply to those lot numbers and
2528	quantities of the prescription drug. In addition to the
2529	requirements of paragraph (6)(d), any wholesale distributor
2530	selling a prescription drug included on a report filed pursuant
2531	to sub-sub-subparagraph (IV) shall provide any wholesaler
2532	purchasing the prescription drugs with a statement under oath
2533	that the prescription drugs are among those included on a report
2534	filed pursuant to sub-sub-subparagraph (IV) and with a copy of
2535	the report filed by the wholesale distributor with the
2536	department for those prescription drugs.
2537	f. Not less than annually, the council and department
2538	shall evaluate whether each prescription drug included on the
2539	list of specified drugs should remain on the list. In
2540	determining whether a prescription drug should remain on the
2541	list of specified drugs, the council and department shall
2542	consider:
2543	(I) The availability of generic forms of the drug.
2544	(II) Changes in the price of the drug since the
2545	prescription drug was placed on the list.
2546	(III) The current status of the drug that caused the
2547	department to place the prescription drug on the list of
2548	specified drugs.
2549
2550	The council shall provide a written recommendation adopted by
2551	majority vote to the secretary of the department concerning each
2552	drug that the council recommends be removed from the list of
2553	specified drugs.
2554	4. This paragraph does not apply to a manufacturer;
2555	however, a repackager must comply with this paragraph.
2556	5. This paragraph expires July 1, 2006.
2557	(f)1. Effective July 1, 2006, each person who is engaged
2558	in the wholesale distribution of a prescription drug and who is
2559	not the manufacturer of that drug must, before each wholesale
2560	distribution of such drug, provide to the person who receives
2561	the drug a pedigree paper as defined in s. 499.003(31).
2562	2. A repackager must comply with this paragraph.
2563	3. The department may by rule exempt compressed medical
2564	gases and veterinary prescription drugs from the pedigree paper
2565	requirements in this paragraph.
2566	4. Each wholesale distributor of prescription drugs must
2567	maintain separate and distinct from other required records all
2568	statements that are required under subparagraph 1.
2569	5. In order to verify compliance with subparagraph (d)1.,
2570	each manufacturer of a prescription drug sold in this state must
2571	make available upon request distribution documentation related
2572	to its sales of prescription drugs, regardless of whether the
2573	prescription drug was sold directly by the manufacturer to a
2574	person in Florida.
2575	(g) Each wholesale distributor, except for a manufacturer,
2576	shall annually provide the department with a written list of all
2577	wholesale distributors and manufacturers from whom the wholesale
2578	distributor purchases prescription drugs. A wholesale
2579	distributor, except a manufacturer, shall notify the department
2580	not later than 10 days after any change to either list. Such
2581	portions of the information required pursuant to this paragraph
2582	which are a trade secret, as defined in s. 812.081, shall be
2583	maintained by the department as trade secret information is
2584	required to be maintained under s. 499.051.
2585	(7) WRITTEN POLICIES AND PROCEDURES.--Wholesale drug
2586	distributors must establish, maintain, and adhere to written
2587	policies and procedures, which must be followed for the receipt,
2588	security, storage, inventory, and distribution of prescription
2589	drugs, including policies and procedures for identifying,
2590	recording, and reporting losses or thefts, and for correcting
2591	all errors and inaccuracies in inventories. Wholesale drug
2592	distributors must include in their written policies and
2593	procedures:
2594	(a) A procedure whereby the oldest approved stock of a
2595	prescription drug product is distributed first. The procedure
2596	may permit deviation from this requirement, if the deviation is
2597	temporary and appropriate.
2598	(b) A procedure to be followed for handling recalls and
2599	withdrawals of prescription drugs. Such procedure must be
2600	adequate to deal with recalls and withdrawals due to:
2601	1. Any action initiated at the request of the Food and
2602	Drug Administration or any other federal, state, or local law
2603	enforcement or other government agency, including the
2604	department.
2605	2. Any voluntary action by the manufacturer or repackager
2606	to remove defective or potentially defective drugs from the
2607	market; or
2608	3. Any action undertaken to promote public health and
2609	safety by replacing existing merchandise with an improved
2610	product or new package design.
2611	(c) A procedure to ensure that wholesale drug distributors
2612	prepare for, protect against, and handle any crisis that affects
2613	security or operation of any facility if a strike, fire, flood,
2614	or other natural disaster, or a local, state, or national
2615	emergency, occurs.
2616	(d) A procedure to ensure that any outdated prescription
2617	drugs are segregated from other drugs and either returned to the
2618	manufacturer or repackageror destroyed. This procedure must
2619	provide for written documentation of the disposition of outdated
2620	prescription drugs. This documentation must be maintained for 2
2621	years after disposition of the outdated drugs.
2622	(8) RESPONSIBLE PERSONS.--Wholesale drug distributors must
2623	establish and maintain lists of officers, directors, managers,
2624	designated representatives,and other persons in charge of
2625	wholesale drug distribution, storage, and handling, including a
2626	description of their duties and a summary of their
2627	qualifications.
2628	(11) SHIPPING AND TRANSPORTATION.--The person responsible
2629	for shipment and transportation of a prescription drug in a
2630	wholesale distribution may use a common carrier; its own vehicle
2631	or employee acting within the scope of employment if authorized
2632	under s. 499.03 for the possession of prescription drugs in this
2633	state; or, in the case of a prescription drug intended for
2634	domestic distribution, an independent contractor who must be the
2635	agent of the authorized seller or recipient responsible for
2636	shipping and transportation as set forth in a written contract
2637	between the parties. A person selling a prescription drug for
2638	export must obtain documentation, such as a validated airway
2639	bill, bill of lading, or other appropriate documentation that
2640	the prescription drug was exported. A person responsible for
2641	shipping or transporting prescription drugs is not required to
2642	maintain documentation from a common carrier that the designated
2643	recipient received the prescription drugs; however, the person
2644	must obtain such documentation from the common carrier and make
2645	it available to the department upon request of the department.
2646	Section 16. Effective January 1, 2004, subsection (12) is
2647	added to section 499.0121, Florida Statutes, to read:
2648	499.0121 Storage and handling of prescription drugs;
2649	recordkeeping.--The department shall adopt rules to implement
2650	this section as necessary to protect the public health, safety,
2651	and welfare. Such rules shall include, but not be limited to,
2652	requirements for the storage and handling of prescription drugs
2653	and for the establishment and maintenance of prescription drug
2654	distribution records.
2655	(12) DUE DILIGENCE OF SUPPLIERS.--Prior to purchasing any
2656	prescription drugs from another wholesale drug distributor, a
2657	wholesale drug distributor must:
2658	(a) Enter an agreement with the selling wholesale drug
2659	distributor by which the selling wholesale drug distributor will
2660	indemnify the purchasing wholesale drug distributor for any loss
2661	caused to the purchasing wholesale drug distributor related to
2662	the purchase of drugs from the selling wholesale drug
2663	distributor which are determined to be counterfeit or to have
2664	been distributed in violation of any federal or state law
2665	governing the distribution of drugs.
2666	(b) Determine that the selling wholesale drug distributor
2667	has insurance coverage of not less than the greater of 1 percent
2668	of the amount of total dollar volume of the prescription drug
2669	sales reported to the department pursuant to s. 499.012(3)(g) or
2670	$500,000; however the coverage need not exceed $2 million.
2671	(c) Obtain information from the selling wholesale drug
2672	distributor, including the length of time the selling wholesale
2673	drug distributor has been licensed in this state, a copy of the
2674	selling wholesale drug distributor's licenses or permits, and
2675	background information concerning the ownership of the selling
2676	wholesale drug distributor, including the experience of the
2677	wholesale distributor in the wholesale distribution of
2678	prescription drugs.
2679	(d) Verify that the selling wholesale drug distributor's
2680	Florida permit is valid.
2681	(e) Inspect the selling wholesale drug distributor's
2682	licensed establishment to document that it has a policies and
2683	procedures manual relating to the distribution of drugs, the
2684	appropriate temperature controlled environment for drugs
2685	requiring temperature control, an alarm system, appropriate
2686	access restrictions, and procedures to ensure that records
2687	related to the wholesale distribution of prescription drugs are
2688	maintained as required by law:
2689	1. Before purchasing any drug from the wholesale drug
2690	distributor, and at least once each subsequent year; or
2691	2. Before purchasing any drug from the wholesale drug
2692	distributor, and each subsequent year obtain a complete copy of
2693	the most recent inspection report for the establishment which
2694	was prepared by the department or the regulatory authority
2695	responsible for wholesale drug distributors in the state in
2696	which the establishment is located.
2697	Section 17. Section 499.01211, Florida Statutes, is
2698	created to read:
2699	499.01211 Drug Wholesaler Advisory Council.--
2700	(1) There is created the Drug Wholesaler Advisory Council
2701	within the department. The council shall meet at least once each
2702	calendar quarter. Staff for the council shall be provided by the
2703	department. The council shall consist of 11 members who shall
2704	serve without compensation. The council shall elect a
2705	chairperson and a vice chairperson annually.
2706	(2) The secretary of the department, or his or her
2707	designee, and the Secretary of Health Care Administration, or
2708	her or his designee, shall be members of the council. The
2709	Secretary of Health shall appoint nine additional members to the
2710	council who shall be appointed to a term of 4 years each, as
2711	follows:
2712	(a) Three different persons each of whom is employed by a
2713	different prescription drug wholesaler licensed under this
2714	chapter which operates nationally and is a primary wholesaler,
2715	as defined in s. 499.012 (1)(d).
2716	(b) One person employed by a prescription drug wholesaler
2717	licensed under this chapter which is a secondary wholesaler, as
2718	defined in s. 499.012(1)(f).
2719	(c) One person employed by a retail pharmacy chain located
2720	in this state.
2721	(d) One person who is a member of the Board of Pharmacy
2722	and is a pharmacist licensed under chapter 465.
2723	(e) One person who is a physician licensed pursuant to
2724	chapter 458 or 459.
2725	(f) One person who is an employee of a hospital licensed
2726	pursuant to chapter 395 and is a pharmacist licensed pursuant to
2727	chapter 465.
2728	(g) One person who is an employee of a pharmaceutical
2729	manufacturer.
2730	(3) The council shall review ss. 499.001-499.081 and the
2731	rules adopted to administer ss. 499.001-499.081 annually,
2732	provide input to the department regarding all proposed rules to
2733	administer ss. 499.001-499.081, make written recommendation to
2734	the secretary of the department regarding the listing of all
2735	specified drugs pursuant to s. 499.0121(6)(e), make
2736	recommendations to the department to improve the protection of
2737	the prescription drugs and public health, make recommendations
2738	to improve coordination with other states' regulatory agencies
2739	and the federal government concerning the wholesale distribution
2740	of drugs, and make recommendations to minimize the impact of
2741	regulation of the wholesale distribution industry while ensuring
2742	protection of the public health.
2743	Section 18. Effective January 1, 2004, paragraph (b) of
2744	subsection (2) of section 499.0122, Florida Statutes, is amended
2745	to read:
2746	499.0122 Medical oxygen and veterinary legend drug retail
2747	establishments; definitions, permits, general requirements.--
2748	(2)
2749	(b) The department shall adopt rules relating to
2750	information required from each retail establishment pursuant to
2751	s. 499.01(4) and (5)(2), including requirements for
2752	prescriptions or orders.
2753	Section 19. Paragraph (c) of subsection (2) of section
2754	499.0122, Florida Statutes, is amended to read:
2755	499.0122 Medical oxygen and veterinary legend drug retail
2756	establishments; definitions, permits, general requirements.--
2757	(2)
2758	(c) A retail establishment must comply with all of the
2759	wholesale distribution requirements of s. 499.0121 except those
2760	set forth in s. 499.0121(6)(d), (e), and (f).
2761	Section 20. Effective January 1, 2004, section 499.013,
2762	Florida Statutes, is amended to read:
2763	499.013 Manufacturers and repackagersof drugs, devices,
2764	and cosmetics; definitions, permits, and general requirements.--
2765	(1) As used in this section, the termsterm "manufacture"
2766	and "repackage" havehas the meaning as inassigned to it under
2767	s. 499.003. A pharmacy is exempt from these definitionsthis
2768	definitionif it is operating in compliance with pharmacy
2769	practice standards as defined in chapter 465 and the rules
2770	adopted under that chapter.
2771	(2) Any person that engages in the manufacture or
2772	repackagingof drugs, devices, or cosmetics in this state must
2773	first obtain one of the following permits and may engage only in
2774	the activity allowed under that permit:
2775	(a) A prescription drug manufacturer's permit is required
2776	for any person that manufactures a prescription drug in this
2777	state. A prescription drug repackager's permit is required for
2778	any person that repackages a prescription drug in this state.
2779	1. A person that operates an establishment permitted as a
2780	prescription drug manufacturer or prescription drug repackager
2781	may engage in wholesale distribution of prescription drugs
2782	manufactured or repackagedat that establishment and must comply
2783	with all the provisions of ss. 499.001-499.081 and the rules
2784	adopted under those sections that apply to a wholesale
2785	distributor.
2786	2. A prescription drug manufacturer permittee or
2787	prescription drug repackagermust comply with all appropriate
2788	state and federal good manufacturing practices.
2789	(b) An over-the-counter drug manufacturer's permit is
2790	required for any person that engages in the manufacture or
2791	repackagingof an over-the-counter drug.
2792	1. An over-the-counter drug manufacturer permittee may not
2793	possess or purchase prescription drugs.
2794	2. A pharmacy is exempt from obtaining an over-the-counter
2795	drug manufacturer's permit if it is operating in compliance with
2796	pharmacy practice standards as defined in chapter 465 and the
2797	rules adopted under that chapter.
2798	3. An over-the-counter drug manufacturer permittee must
2799	comply with all appropriate state and federal good manufacturing
2800	practices.
2801	(c) A compressed medical gas manufacturer's permit is
2802	required for any person that engages in the manufacture of
2803	compressed medical gases or repackages compressed medical gases
2804	from one container to another.
2805	1. A compressed medical gas manufacturer permittee may not
2806	manufacture or possess any prescription drug other than
2807	compressed medical gases.
2808	2. A compressed medical gas manufacturer permittee may
2809	engage in wholesale distribution of compressed medical gases
2810	manufactured at that establishment and must comply with all the
2811	provisions of ss. 499.001-499.081 and the rules adopted under
2812	those sections that apply to a wholesale distributor.
2813	3. A compressed medical gas manufacturer permittee must
2814	comply with all appropriate state and federal good manufacturing
2815	practices.
2816	(d) A device manufacturer's permit is required for any
2817	person that engages in the manufacture, repackaging,or assembly
2818	of medical devices for human use in this state, except that a
2819	permit is not required if the person is engaged only in
2820	manufacturing, repackaging,or assembling a medical device
2821	pursuant to a practitioner's order for a specific patient.
2822	1. A manufacturer or repackagerof medical devices in this
2823	state must comply with all appropriate state and federal good
2824	manufacturing practices and quality system rules.
2825	2. The department shall adopt rules related to storage,
2826	handling, and recordkeeping requirements for manufacturers of
2827	medical devices for human use.
2828	(e) A cosmetic manufacturer's permit is required for any
2829	person that manufactures or repackagescosmetics in this state.
2830	A person that only labels or changes the labeling of a cosmetic
2831	but does not open the container sealed by the manufacturer of
2832	the product is exempt from obtaining a permit under this
2833	paragraph.
2834	(3) The department may adopt such rules as are necessary
2835	for the protection of the public health, safety, and welfare
2836	regarding good manufacturing practices that manufacturers and
2837	repackagersmust follow to ensure the safety of the products.
2838	(4) Each manufacturer or repackagerof medical devices,
2839	over-the-counter drugs, or cosmetics must maintain records that
2840	include the name and principal address of the seller or
2841	transferor of the product, the address of the location from
2842	which the product was shipped, the date of the transaction, the
2843	name and quantity of the product involved, and the name and
2844	principal address of the person who purchased the product.
2845	Section 21. Subsection (3) of section 499.014, Florida
2846	Statutes, is amended to read:
2847	499.014 Distribution of legend drugs by hospitals, health
2848	care entities, charitable organizations, and return or
2849	destruction companies; permits, general requirements.--
2850	(3) Storage,andhandling, and recordkeeping of these
2851	distributions must comply with the requirements for wholesale
2852	distributors under s. 499.0121, except those set forth in s.
2853	499.0121(6)(d), (e), and (f).
2854	Section 22. Paragraph (a) of subsection (1) and subsection
2855	(3) of section 499.015, Florida Statutes, are amended to read:
2856	499.015 Registration of drugs, devices, and cosmetics;
2857	issuance of certificates of free sale.--
2858	(1)(a) Except for those persons exempted from the
2859	definition in s. 499.003(28)(21), any person who manufactures,
2860	packages, repackages, labels, or relabels a drug, device, or
2861	cosmetic in this state must register such drug, device, or
2862	cosmetic biennially with the department; pay a fee in accordance
2863	with the fee schedule provided by s. 499.041; and comply with
2864	this section. The registrant must list each separate and
2865	distinct drug, device, or cosmetic at the time of registration.
2866	(3) Except for those persons exempted from the definition
2867	in s. 499.003(28)(21), a person may not sell any product that he
2868	or she has failed to register in conformity with this section.
2869	Such failure to register subjects such drug, device, or cosmetic
2870	product to seizure and condemnation as provided in ss. 499.062-
2871	499.064, and subjects such person to the penalties and remedies
2872	provided in ss. 499.001-499.081.
2873	Section 23. Subsection (3) of section 499.024, Florida
2874	Statutes, is amended to read:
2875	499.024 Drug product classification.--The secretary shall
2876	adopt rules to classify drug products intended for use by humans
2877	which the United States Food and Drug Administration has not
2878	classified in the federal act or the Code of Federal
2879	Regulations.
2880	(3) Any product that falls under the drug definition, s.
2881	499.003(17)(12), may be classified under the authority of this
2882	section. This section does not subject portable emergency oxygen
2883	inhalators to classification; however, this section does not
2884	exempt any person from ss. 499.01 and 499.015.
2885	Section 24. Subsection (1) of section 499.03, Florida
2886	Statutes, is amended to read:
2887	499.03 Possession of new drugs or legend drugs without
2888	prescriptions unlawful; exemptions and exceptions.--
2889	(1) A person may not possess, or possess with intent to
2890	sell, dispense, or deliver, any habit-forming, toxic, harmful,
2891	or new drug subject to s. 499.003(29)(22), or legend drug as
2892	defined in s. 499.003(25)(19), unless the possession of the drug
2893	has been obtained by a valid prescription of a practitioner
2894	licensed by law to prescribe the drug. However, this section
2895	does not apply to the delivery of such drugs to persons included
2896	in any of the classes named in this subsection, or to the agents
2897	or employees of such persons, for use in the usual course of
2898	their businesses or practices or in the performance of their
2899	official duties, as the case may be; nor does this section apply
2900	to the possession of such drugs by those persons or their agents
2901	or employees for such use:
2902	(a) A licensed pharmacist or any person under the licensed
2903	pharmacist's supervision while acting within the scope of the
2904	licensed pharmacist's practice;
2905	(b) A licensed practitioner authorized by law to prescribe
2906	legend drugs or any person under the licensed practitioner's
2907	supervision while acting within the scope of the licensed
2908	practitioner's practice;
2909	(c) A qualified person who uses legend drugs for lawful
2910	research, teaching, or testing, and not for resale;
2911	(d) A licensed hospital or other institution that procures
2912	such drugs for lawful administration or dispensing by
2913	practitioners;
2914	(e) An officer or employee of a federal, state, or local
2915	government; or
2916	(f) A person that holds a valid permit issued by the
2917	department pursuant to ss. 499.001-499.081 which authorizes that
2918	person to possess prescription drugs.
2919	Section 25. Section 499.041, Florida Statutes, is amended
2920	to read:
2921	499.041 Schedule of fees for drug, device, and cosmetic
2922	applications and permits, product registrations, and free-sale
2923	certificates.--
2924	(1) The department shall assess applicants requiring a
2925	manufacturing permit an annual fee within the ranges established
2926	in this section for the specific type of manufacturer.
2927	(a) The fee for a prescription drug manufacturer's permit
2928	may not be less than $500 or more than $750$600annually.
2929	(b) The fee for a device manufacturer's permit may not be
2930	less than $500 or more than $600 annually.
2931	(c) The fee for a cosmetic manufacturer's permit may not
2932	be less than $250 or more than $400 annually.
2933	(d) The fee for an over-the-counter drug manufacturer's
2934	permit may not be less than $300 or more than $400 annually.
2935	(e) The fee for a compressed medical gas manufacturer's
2936	permit may not be less than $400 or more than $500 annually.
2937	(f) The fee for a prescription drug repackager's permit
2938	may not be less than $500 or more than $750 annually.
2939	(g)(f)A manufacturer may not be required to pay more than
2940	one fee per establishment to obtain an additional manufacturing
2941	permit, but each manufacturer must pay the highest fee
2942	applicable to his or her operation in each establishment.
2943	(2) The department shall assess an applicant that is
2944	required to have a wholesaling permit an annual fee within the
2945	ranges established in this section for the specific type of
2946	wholesaling.
2947	(a) The fee for a prescription drug wholesaler's permit
2948	may not be less than $300 or more than $800$400 annually.;
2949	(b) The fee for a compressed medical gas wholesaler's
2950	permit may not be less than $200 or more than $300 annually.;
2951	(c) The fee for an out-of-state prescription drug
2952	wholesaler's permit may not be less than $300$200 or more than
2953	$800$300 annually.;
2954	(d) The fee for a nonresident prescription drug
2955	manufacturer's permit may not be less than $300 or more than
2956	$500 annually.
2957	(e)(d)The fee for a retail pharmacy wholesaler's permit
2958	may not be less than $35 or more than $50 annually.
2959	(f) The fee for a freight forwarder's permit may not be
2960	less than $200 or more than $300 annually.
2961	(3) The department shall assess an applicant that is
2962	required to have a retail establishment permit an annual fee
2963	within the ranges established in this section for the specific
2964	type of retail establishment.
2965	(a) The fee for a veterinary legend drug retail
2966	establishment permit may not be less than $200 or more than $300
2967	annually.;
2968	(b) The fee for a medical oxygen retail establishment
2969	permit may not be less than $200 or more than $300 annually.
2970	(4) The department shall assess an applicant that is
2971	required to have a restricted prescription drug distributor's
2972	permit an annual fee of not less than $200 or more than $300.
2973	(5) In addition to the fee charged for a permit required
2974	by ss. 499.001-499.081, beginning January 1, 1993,the
2975	department shall assess applicants an initial application fee of
2976	$150 for each new permit issued by the department which requires
2977	an onsite inspection.
2978	(6) A person that is required to register drugs, devices,
2979	or cosmetic products under s. 499.015 shall pay an annual
2980	product registration fee of not less than $5 or more than $15
2981	for each separate and distinct product in package form. The
2982	registration fee is in addition to the fee charged for a free-
2983	sale certificate.
2984	(7) The department shall assess an applicant that requests
2985	a free-sale certificate a fee of $25. A fee of $2 will be
2986	charged for each signature copy of a free-sale certificate that
2987	is obtained at the same time the free-sale certificate is
2988	issued.
2989	(8) The department shall assess an out-of-state
2990	prescription drug wholesaler applicant or permittee an on-site
2991	inspection fee of not less than $1,000 or more than $3,000
2992	annually, to be based on the actual cost of the inspection if an
2993	on-site inspection is performed by agents of the department.
2994	(9) The department shall assess each person applying for
2995	certification as a designated representative a fee of $150, plus
2996	the cost of processing the criminal history record check.
2997	(10)(8)The department shall assess other fees as provided
2998	in ss. 499.001-499.081.
2999	Section 26. Paragraph (g) of subsection (1) of section
3000	499.05, Florida Statutes, is amended to read:
3001	499.05 Rules.--
3002	(1) The department shall adopt rules to implement and
3003	enforce ss. 499.001-499.081 with respect to:
3004	(g) Inspections and investigations conducted under s.
3005	499.051, and the identification of information claimed to be a
3006	trade secret and exempt from the public records law as provided
3007	in s. 499.051(7)(5).
3008	Section 27. Subsection (2) and present subsection (5) of
3009	section 499.051, Florida Statutes, are amended, present
3010	subsections (4) and (5) of said section are redesignated as
3011	subsections (6) and (7), respectively, and new subsections (4)
3012	and (5) are added to said section, to read:
3013	499.051 Inspections and investigations.--
3014	(2) In addition to the authority set forth in subsection
3015	(1), the department and any duly designated officer or employee
3016	of the department may enter and inspect any other establishment
3017	for the purpose of determining compliance with ss. 499.001-
3018	499.081 and rules adopted under those sections regarding any
3019	drug, device, or cosmetic product. The authority to enter and
3020	inspect does not extend to the practice of the profession of
3021	pharmacy, as defined in chapter 465 and the rules adopted under
3022	that chapter, in a pharmacy permitted under chapter 465. The
3023	Department of Business and Professional Regulation shall conduct
3024	routine inspections of retail pharmacy wholesalers at the time
3025	of the regular pharmacy permit inspection and shall send the
3026	inspection report regarding drug wholesale activity to the
3027	Department of Health.
3028	(4) Any application for a permit made pursuant to ss.
3029	499.01 and 499.012 and rules adopted under those sections
3030	constitutes permission for agents of the Department of Health
3031	and the Department of Law Enforcement, after presenting proper
3032	identification, to inspect, review, and copy any financial
3033	document or record related to the manufacture, repackaging, or
3034	distribution of a drug as is necessary to verify compliance with
3035	ss. 499.001-499.081 and the rules adopted by the department to
3036	administer those sections, in order to discover, investigate,
3037	and determine the existence of compliance or to elicit, receive,
3038	respond to, and resolve complaints and violations.
3039	(5) The authority to inspect under this section includes
3040	the authority to access, review, and copy any and all financial
3041	documents related to the activity of manufacturing, repackaging,
3042	or distributing prescription drugs.
3043	(7)(5)The complaint and all information obtained pursuant
3044	to the investigation by the department are confidential and
3045	exempt from the provisions of s. 119.07(1) and s. 24(a), Art. I
3046	of the State Constitution until the investigation and the
3047	enforcement action are completed. However, trade secret
3048	information contained therein as defined by s. 812.081(1)(c)
3049	shall remain confidential and exempt from the provisions of s.
3050	119.07(1) and s. 24(a), Art. I of the State Constitution, as
3051	long as the information is retained by the department. This
3052	subsection does not prohibit the department from using such
3053	information for regulatory or enforcement proceedings under this
3054	chapter or from providing such information to any law
3055	enforcement agency or any other regulatory agency. However, the
3056	receiving agency shall keep such records confidential and exempt
3057	as provided in this subsection. In addition, this subsection is
3058	not intended to prevent compliance with the provisions of s.
3059	499.0121(6)(d), (e), and (f),and the pedigree papers required
3060	in those paragraphsthat subsectionshall not be deemed a trade
3061	secret.
3062	Section 28. Subsection (4) is added to section 499.055,
3063	Florida Statutes, to read:
3064	499.055 Reports and dissemination of information by
3065	department.--
3066	(4) The department shall publish on the department's
3067	website and update at least monthly:
3068	(a) A list of the prescription drug wholesalers, out-of-
3069	state prescription drug wholesalers, and retail pharmacy drug
3070	wholesalers against whom the department has initiated
3071	enforcement action pursuant to 499.001-499.081 to suspend or
3072	revoke a permit, seek an injunction, or otherwise file an
3073	administrative complaint and the permit number of each such
3074	wholesaler.
3075	(b) A list of the prescription drug wholesalers, out-of-
3076	state prescription drug wholesalers, and retail pharmacy drug
3077	wholesalers to which the department has issued a permit,
3078	including the date on which each permit will expire.
3079	(c) A list of the prescription drug wholesalers, out-of-
3080	state prescription drug wholesalers, and retail pharmacy drug
3081	wholesalers' permits that have been returned to the department,
3082	were suspended, were revoked, have expired, or were not renewed
3083	in the previous year.
3084	Section 29. Section 499.065, Florida Statutes, is created
3085	to read:
3086	499.065 Imminent danger.--
3087	(1) Notwithstanding s. 499.051, the department shall
3088	inspect each prescription drug wholesale establishment,
3089	prescription drug repackager establishment, and retail pharmacy
3090	drug wholesaler establishment that is required to be permitted
3091	under this chapter as often as necessary to ensure compliance
3092	with applicable laws and rules. The department shall have the
3093	right of entry and access to these facilities at any reasonable
3094	time.
3095	(2) To protect the public from prescription drugs that are
3096	adulterated or otherwise unfit for human consumption, the
3097	department may examine, sample, seize, and stop the sale or use
3098	of prescription drugs to determine the condition of those drugs.
3099	The department may immediately seize and remove any prescription
3100	drugs if the Secretary of Health or his or her designee
3101	determines that such prescription drugs represent a threat to
3102	the public health. The owner of any property seized under this
3103	section may, within 10 days after the seizure, apply to a court
3104	of competent jurisdiction for whatever relief is appropriate. At
3105	any time after 10 days, the department may destroy the drugs as
3106	contraband.
3107	(3) The department may determine that a prescription drug
3108	wholesale establishment, prescription drug repackager
3109	establishment, or retail pharmacy drug wholesaler establishment
3110	that is required to be permitted under this chapter is an
3111	imminent danger to the public health and require its immediate
3112	closure if such establishment fails to comply with applicable
3113	laws and rules and, because of such failure, presents an
3114	imminent threat to the public's health, safety, or welfare. Any
3115	establishment so deemed and closed shall remain closed until
3116	allowed by the department or by judicial order to reopen.
3117
3118	For purposes of this section, a refusal to allow entry to the
3119	department for inspection at reasonable times or a failure or
3120	refusal to provide the department with required documentation
3121	for purposes of inspection constitutes an imminent danger to the
3122	public health.
3123	Section 30. Subsection (1) of section 499.066, Florida
3124	Statutes, is amended, and subsection (7) is added to said
3125	section, to read:
3126	499.066 Penalties; remedies.--In addition to other
3127	penalties and other enforcement provisions:
3128	(1) The department may institute such suits or other legal
3129	proceedings as are required to enforce any provision of ss.
3130	499.001-499.081. If it appears that a person has violated any
3131	provision of ss. 499.001-499.081 for which criminal prosecution
3132	is provided, the department may provide the appropriate state
3133	attorney or other prosecuting agency having jurisdiction with
3134	respect to such prosecution with the relevant information in the
3135	department's possession.When the department believes that any
3136	person has violated ss. 499.001-499.081 or any rules adopted
3137	pursuant to those sections, it may issue and deliver an order to
3138	cease and desist from such violation.
3139	(7) Resignation or termination of an affiliated party does
3140	not affect the department's jurisdiction or discretion to
3141	proceed with action to suspend or revoke a permit or to impose
3142	other penalties or enforcement actions authorized by law.
3143	Section 31. Section 499.0661, Florida Statutes, is created
3144	to read:
3145	499.0661 Cease and desist orders; removal of certain
3146	persons.--
3147	(1) DEFINITION.--As used in this section, the term
3148	"permittee" means any person holding a permit issued pursuant to
3149	s. 499.012.
3150	(2) CEASE AND DESIST ORDERS.--
3151	(a) In addition to any authority otherwise provided in
3152	this chapter, the department may issue and serve a complaint
3153	stating charges upon any permittee or upon any affiliated party,
3154	whenever the department has reasonable cause to believe that the
3155	person or individual named therein is engaging in or has engaged
3156	in conduct that is:
3157	1. An act that demonstrates a lack of fitness or
3158	trustworthiness to engage in the business authorized under the
3159	permit issued pursuant to ss. 499.001-499.081, is hazardous to
3160	the public health, or constitutes business operations that are a
3161	detriment to the public health;
3162	2. A violation of any provision of ss. 499.001-499.081;
3163	3. A violation of any rule of the department;
3164	4. A violation of any order of the department; or
3165	5. A breach of any written agreement with the department.
3166	(b) The complaint must contain a statement of facts and
3167	notice of opportunity for a hearing pursuant to ss. 120.569 and
3168	120.57.
3169	(c) If a hearing is not requested within the time allowed
3170	by ss. 120.569 and 120.57, or if a hearing is held and the
3171	department finds that any of the charges are proven, the
3172	department may enter an order directing the permittee or the
3173	affiliated party named in the complaint to cease and desist from
3174	engaging in the conduct complained of and take corrective action
3175	to remedy the effects of past improper conduct and ensure future
3176	compliance.
3177	(d) A contested or default cease and desist order is
3178	effective when reduced to writing and served upon the permittee
3179	or affiliated party named therein. An uncontested cease and
3180	desist order is effective as agreed.
3181	(e) Whenever the department finds that conduct described
3182	in paragraph (a) is likely to cause an immediate threat to the
3183	public health, it may issue an emergency cease and desist order
3184	requiring the permittee or any affiliated party to immediately
3185	cease and desist from engaging in the conduct complained of and
3186	to take corrective and remedial action. The emergency order is
3187	effective immediately upon service of a copy of the order upon
3188	the permittee or affiliated party named therein and remains
3189	effective for 90 days. If the department begins nonemergency
3190	cease and desist proceedings under this subsection, the
3191	emergency order remains effective until the conclusion of the
3192	proceedings under ss. 120.569 and 120.57.
3193	(3) REMOVAL OF AFFILIATED PARTIES BY THE DEPARTMENT.--
3194	(a) The department may issue and serve a complaint stating
3195	charges upon any affiliated party and upon the permittee
3196	involved whenever the department has reason to believe that an
3197	affiliated party is engaging in or has engaged in conduct that
3198	constitutes:
3199	1. An act that demonstrates a lack of fitness or
3200	trustworthiness to engage in the business authorized under the
3201	permit issued pursuant to ss. 499.001-499.081, is hazardous to
3202	the public health, or constitutes business operations that are a
3203	detriment to the public health;
3204	2. A willful violation of ss. 499.001-499.081; however, if
3205	the violation constitutes a misdemeanor, a complaint may not be
3206	served as provided in this section until the affiliated party is
3207	notified in writing of the matter of the violation and has been
3208	afforded a reasonable period of time, as set forth in the
3209	notice, to correct the violation and has failed to do so;
3210	3. A violation of any other law involving fraud or moral
3211	turpitude which constitutes a felony;
3212	4. A willful violation of any rule of the department;
3213	5. A willful violation of any order of the department; or
3214	6. A material misrepresentation of fact, made knowingly
3215	and willfully or made with reckless disregard for the truth of
3216	the matter.
3217	(b) The complaint must contain a statement of facts and
3218	notice of opportunity for a hearing pursuant to ss. 120.569 and
3219	120.57.
3220	(c) If a hearing is not requested within the time allotted
3221	by ss. 120.569 and 120.57, or if a hearing is held and the
3222	department finds that any of the charges in the complaint are
3223	proven true, the department may enter an order removing the
3224	affiliated party or restricting or prohibiting participation by
3225	the person in the affairs of that permittee or of any other
3226	permittee.
3227	(d) A contested or default order of removal, restriction,
3228	or prohibition is effective when reduced to writing and served
3229	on the permittee and the affiliated party. An uncontested order
3230	of removal, restriction, or prohibition is effective as agreed.
3231	(e)1. The chief executive officer, designated
3232	representative, or the person holding the equivalent office, of
3233	a permittee shall promptly notify the department if she or he
3234	has actual knowledge that any affiliated party is charged with a
3235	felony in a state or federal court.
3236	2. Whenever any affiliated party is charged with a felony
3237	in a state or federal court or with the equivalent of a felony
3238	in the courts of any foreign country with which the United
3239	States maintains diplomatic relations, and the charge alleges
3240	violation of any law involving prescription drugs,
3241	pharmaceuticals, fraud, theft, or moral turpitude, the
3242	department may enter an emergency order suspending the
3243	affiliated party or restricting or prohibiting participation by
3244	the affiliated party in the affairs of the particular permittee
3245	or of any other permittee upon service of the order upon the
3246	permittee and the affiliated party charged. The order must
3247	contain notice of opportunity for a hearing pursuant to ss.
3248	120.569 and 120.57, where the affiliated party may request a
3249	postsuspension hearing to show that continued service to or
3250	participation in the affairs of the permittee does not pose a
3251	threat to the public health or the interests of the permittee
3252	and does not threaten to impair public confidence in the
3253	permittee. In accordance with applicable departmental rules, the
3254	department shall notify the affiliated party whether the order
3255	suspending or prohibiting the person from participation in the
3256	affairs of a permittee will be rescinded or otherwise modified.
3257	The emergency order remains in effect, unless otherwise modified
3258	by the department, until the criminal charge is disposed of. The
3259	acquittal of the person charged, or the final, unappealed
3260	dismissal of all charges against the person, dissolves the
3261	emergency order, but does not prohibit the department from
3262	instituting proceedings under paragraph (a). If the person
3263	charged is convicted or pleads guilty or nolo contendere,
3264	whether or not an adjudication of guilt is entered by the court,
3265	the emergency order shall become final.
3266	(f) Any affiliated party removed pursuant to this section
3267	is not eligible for reemployment by the permittee or to be an
3268	affiliated party of any permittee except upon the written
3269	consent of the department. Any affiliated party who is removed,
3270	restricted, or prohibited from participating in the affairs of a
3271	permittee pursuant to this section may petition the department
3272	for modification or termination of the removal, restriction, or
3273	prohibition.
3274	Section 32. Effective January 1, 2004, subsection (1) of
3275	section 499.067, Florida Statutes, is amended, and subsections
3276	(6) and (7) are added to said section, to read:
3277	499.067 Denial, suspension, or revocation of permit,
3278	certification,or registration.--
3279	(1)(a) The department may deny, suspend, or revoke a
3280	permit if it finds that there has been a substantial failure to
3281	comply with ss. 499.001-499.081 or chapter 465, chapter 501, or
3282	chapter 893, the rules adopted under any of those sections or
3283	chapters, any final order of the department, or applicable
3284	federal laws or regulations or other state laws or rules
3285	governing drugs, devices, or cosmetics.
3286	(b) The department may deny an application for a permit or
3287	certification, or suspend or revoke a permit or certification,
3288	if the department findsit is shown that:
3289	1.The applicant is not of good moral character or that it
3290	would be a danger or not in the best interest of the public
3291	health, safety, and welfare if the applicant were issued a
3292	permit or certification.
3293	2. The applicant has not met the requirements for the
3294	permit or certification.
3295	3. The applicant is not eligible for a permit or
3296	certification for any of the reasons enumerated in s. 499.01 or
3297	s. 499.012(5).
3298	4. The applicant, permittee, or person certified under s.
3299	499.012(11) demonstrates any of the conditions enumerated in s.
3300	499.01 or s. 499.012(5).
3301	5. The applicant, permittee, or person certified under s.
3302	499.012(11) has committed any violation of ss. 499.005-
3303	499.00525.
3304	(6) The department shall deny, suspend, or revoke the
3305	permit of any person or establishment if the assignment, sale,
3306	transfer, or lease of an establishment permitted under ss.
3307	499.001-499.081 will avoid an administrative penalty, civil
3308	action, or criminal prosecution.
3309	(7) Notwithstanding s. 120.60(5), if a permittee fails to
3310	comply with s. 499.01(7), the department may revoke the permit
3311	of the permittee and shall provide notice of the intended agency
3312	action by posting a notice at the department's headquarters and
3313	by mailing a copy of the notice of intended agency action by
3314	certified mail to the most recent mailing address on record with
3315	the department and, if the permittee is not a natural person, to
3316	the permittee's registered agent on file with the Department of
3317	State.
3318	Section 33. Section 499.069, Florida Statutes, is amended
3319	to read:
3320	499.069 Criminal punishment for violations of s. 499.005
3321	related to devices and cosmetics; dissemination of false
3322	advertisement.--
3323	(1) Any person who violates any of the provisions of s.
3324	499.005 with respect to a device or cosmetic commitsis guilty
3325	ofa misdemeanor of the second degree, punishable as provided in
3326	s. 775.082 or s. 775.083; but, if the violation is committed
3327	after a conviction of such person under this section has become
3328	final, such person is guilty of a misdemeanor of the first
3329	degree, punishable as provided in s. 775.082 or s. 775.083 or as
3330	otherwise provided in ss. 499.001-499.081, except that any
3331	person who violates subsection (8) or, subsection (10),
3332	subsection (14), subsection (15), or subsection (17)of s.
3333	499.005 with respect to a device or cosmetic commitsis guilty
3334	ofa felony of the third degree, punishable as provided in s.
3335	775.082, s. 775.083, or s. 775.084, or as otherwise provided in
3336	ss. 499.001-499.081.
3337	(2) A person is not subject to the penalties of subsection
3338	(1) for having violated any of the provisions of s. 499.005 if
3339	he or she establishes a guaranty or undertaking, which guaranty
3340	or undertaking is signed by and contains the name and address of
3341	the person residing in the state, or the manufacturer, from whom
3342	he or she received the article in good faith, to the effect that
3343	such article is not adulterated or misbranded within the meaning
3344	of ss. 499.001-499.081, citing such sections.
3345	(2)(3)A publisher, radio broadcast licensee, or agency or
3346	medium for the dissemination of an advertisement, except the
3347	manufacturer, wholesaler, or seller of the article to which a
3348	false advertisement relates, is not liable under this section by
3349	reason of the dissemination by him or her of such false
3350	advertisement, unless he or she has refused, on the request of
3351	the department, to furnish to the department the name and post
3352	office address of the manufacturer, wholesaler, seller, or
3353	advertising agency that asked him or her to disseminate such
3354	advertisement.
3355	Section 34. Section 499.0691, Florida Statutes, is created
3356	to read:
3357	499.0691 Criminal punishment for violations related to
3358	drugs; dissemination of false advertisement.--
3359	(1) Any person who violates any of the following
3360	provisions commits a misdemeanor of the second degree,
3361	punishable as provided in s. 775.082 or s. 775.083; but, if the
3362	violation is committed after a conviction of such person under
3363	this section has become final, such person commits a misdemeanor
3364	of the first degree, punishable as provided in s. 775.082 or s.
3365	775.083, or as otherwise provided in ss. 499.001-499.081:
3366	(a) The manufacture, repackaging, sale, delivery, or
3367	holding or offering for sale of any drug that is adulterated or
3368	misbranded or has otherwise been rendered unfit for human or
3369	animal use.
3370	(b) The adulteration or misbranding of any drug intended
3371	for further distribution.
3372	(c) The receipt of any drug that is adulterated or
3373	misbranded, and the delivery or proffered delivery of such drug,
3374	for pay or otherwise.
3375	(d) The dissemination of any false or misleading
3376	advertisement of a drug.
3377	(e) The use, on the labeling of any drug or in any
3378	advertisement relating to such drug, of any representation or
3379	suggestion that an application of the drug is effective when it
3380	is not or that the drug complies with ss. 499.001-499.081 when
3381	it does not.
3382	(f) The purchase or receipt of a compressed medical gas
3383	from a person that is not authorized under this chapter to
3384	distribute compressed medical gases.
3385	(g) Charging a dispensing fee for dispensing,
3386	administering, or distributing a prescription drug sample.
3387	(h) The failure to maintain records related to a drug as
3388	required by ss. 499.001-499.081 and rules adopted under those
3389	sections, except for pedigree papers, invoices, or shipping
3390	documents related to legend drugs.
3391	(i) The possession of any drug in violation of ss.
3392	499.001-499.081, except if the violation relates to a deficiency
3393	in pedigree papers.
3394	(2) Any person who violates any of the following
3395	provisions commits a felony of the third degree, punishable as
3396	provided in s. 775.082, s. 775.083, or s. 775.084, or as
3397	otherwise provided in ss. 499.001-499.081:
3398	(a) The refusal or constructive refusal to allow:
3399	1. The department to enter or inspect an establishment in
3400	which drugs are manufactured, processed, repackaged, sold,
3401	brokered, or held;
3402	2. Inspection of any record of that establishment;
3403	3. The department to enter and inspect any vehicle that is
3404	being used to transport drugs; or
3405	4. The department to take samples of any drug.
3406	(b) The sale, purchase, or trade, or the offer to sell,
3407	purchase, or trade, a drug sample as defined in s. 499.028; the
3408	distribution of a drug sample in violation of s. 499.028; or the
3409	failure to otherwise comply with s. 499.028.
3410	(c) Providing the department with false or fraudulent
3411	records, or making false or fraudulent statements, regarding any
3412	matter within the provisions of this chapter related to a drug.
3413	(d) The failure to receive, maintain, or provide invoices
3414	and shipping documents, other than pedigree papers, if
3415	applicable, related to the distribution of a legend drug.
3416	(e) The importation of a legend drug for wholesale
3417	distribution, except as provided by s. 801(d) of the Federal
3418	Food, Drug, and Cosmetic Act.
3419	(f) The wholesale distribution of any prescription drug
3420	that was:
3421	1. Purchased by a public or private hospital or other
3422	health care entity; or
3423	2. Donated or supplied at a reduced price to a charitable
3424	organization.
3425	(g) The failure to obtain a permit as a prescription drug
3426	wholesaler when a permit is required by ss. 499.001-499.081 for
3427	that activity.
3428	(h) Knowingly possessing any adulterated or misbranded
3429	legend drug outside of a designated quarantine area.
3430	(i) The purchase or sale of prescription drugs for
3431	wholesale distribution in exchange for currency, as defined in
3432	s. 560.103(6).
3433	(3) Any person who violates any of the following
3434	provisions commits a felony of the second degree, punishable as
3435	provided in s. 775.082, s. 775.083, or s. 775.084, or as
3436	otherwise provided in ss. 499.001-499.081:
3437	(a) Knowingly manufacturing, repackaging, selling,
3438	delivering, or holding or offering for sale any drug that is
3439	adulterated or misbranded or has otherwise been rendered unfit
3440	for human or animal use.
3441	(b) Knowingly adulterating a drug that is intended for
3442	further distribution.
3443	(c) Knowingly receiving a drug that is adulterated and
3444	delivering or proffering delivery of such drug for pay or
3445	otherwise.
3446	(d) Committing any act that causes a drug to be a
3447	counterfeit drug, or selling, dispensing, or knowingly holding
3448	for sale a counterfeit drug.
3449	(e) Forging, counterfeiting, simulating, or falsely
3450	representing any drug, or, without the authority of the
3451	manufacturer, using any mark, stamp, tag, label, or other
3452	identification device authorized or required by rules adopted
3453	under ss. 499.001-499.081.
3454	(f) Knowingly obtaining or attempting to obtain a
3455	prescription drug for wholesale distribution by fraud, deceit,
3456	misrepresentation, or subterfuge, or engaging in
3457	misrepresentation or fraud in the distribution of a drug.
3458	(g) Removing a pharmacy's dispensing label from a
3459	dispensed prescription drug with the intent to further
3460	distribute the prescription drug.
3461	(h) Knowingly distributing a prescription drug that was
3462	previously dispensed by a licensed pharmacy, unless such
3463	distribution was authorized in chapter 465 or the rules adopted
3464	under chapter 465.
3465	(4) A publisher, radio broadcast licensee, or agency or
3466	medium for the dissemination of an advertisement, except the
3467	manufacturer, repackager, wholesaler, or seller of the article
3468	to which a false advertisement relates, is not liable under this
3469	section by reason of the dissemination by him or her of such
3470	false advertisement, unless he or she has refused, on the
3471	request of the department, to furnish to the department the name
3472	and post office address of the manufacturer, repackager,
3473	wholesaler, seller, or advertising agency that asked him or her
3474	to disseminate such advertisement.
3475	Section 35. Paragraphs (d), (f), (h), (i), and (j) of
3476	subsection (3) of section 921.0022, Florida Statutes, are
3477	amended to read:
3478	921.0022 Criminal Punishment Code; offense severity
3479	ranking chart.--
3480	(3) OFFENSE SEVERITY RANKING CHART
3481	Florida Felony
3482	Statute Degree Description
3483	(d) LEVEL 4
3484	316.1935(3) 2nd Driving at high speed or with wanton disregard for safety while fleeing or attempting to elude law enforcement officer who is in a marked patrol vehicle with siren and lights activated.
3485	499.0051(1) 3rd Failure to maintain or deliver pedigree papers.
3486	499.0051(2) 3rd Failure to authenticate pedigree papers.
3487	499.0051(6) 2nd Sale or delivery, or possession with intent to sell, contraband legend drugs.
3488	784.07(2)(b) 3rd Battery of law enforcement officer, firefighter, intake officer, etc.
3489	784.074(1)(c) 3rd Battery of sexually violent predators facility staff.
3490	784.075 3rd Battery on detention or commitment facility staff.
3491	784.078 3rd Battery of facility employee by throwing, tossing, or expelling certain fluids or materials.
3492	784.08(2)(c) 3rd Battery on a person 65 years of age or older.
3493	784.081(3) 3rd Battery on specified official or employee.
3494	784.082(3) 3rd Battery by detained person on visitor or other detainee.
3495	784.083(3) 3rd Battery on code inspector.
3496	784.085 3rd Battery of child by throwing, tossing, projecting, or expelling certain fluids or materials.
3497	787.03(1) 3rd Interference with custody; wrongly takes child from appointed guardian.
3498	787.04(2) 3rd Take, entice, or remove child beyond state limits with criminal intent pending custody proceedings.
3499	787.04(3) 3rd Carrying child beyond state lines with criminal intent to avoid producing child at custody hearing or delivering to designated person.
3500	790.115(1) 3rd Exhibiting firearm or weapon within 1,000 feet of a school.
3501	790.115(2)(b) 3rd Possessing electric weapon or device, destructive device, or other weapon on school property.
3502	790.115(2)(c) 3rd Possessing firearm on school property.
3503	800.04(7)(d) 3rd Lewd or lascivious exhibition; offender less than 18 years.
3504	810.02(4)(a) 3rd Burglary, or attempted burglary, of an unoccupied structure; unarmed; no assault or battery.
3505	810.02(4)(b) 3rd Burglary, or attempted burglary, of an unoccupied conveyance; unarmed; no assault or battery.
3506	810.06 3rd Burglary; possession of tools.
3507	810.08(2)(c) 3rd Trespass on property, armed with firearm or dangerous weapon.
3508	812.014(2)(c)3. 3rd Grand theft, 3rd degree $10,000 or more but less than $20,000.
3509	812.014 (2)(c)4.-10. 3rd Grand theft, 3rd degree, a will, firearm, motor vehicle, livestock, etc.
3510	812.0195(2) 3rd Dealing in stolen property by use of the Internet; property stolen $300 or more.
3511	817.563(1) 3rd Sell or deliver substance other than controlled substance agreed upon, excluding s. 893.03(5) drugs.
3512	817.568(2)(a) 3rd Fraudulent use of personal identification information.
3513	817.625(2)(a) 3rd Fraudulent use of scanning device or reencoder.
3514	828.125(1) 2nd Kill, maim, or cause great bodily harm or permanent breeding disability to any registered horse or cattle.
3515	837.02(1) 3rd Perjury in official proceedings.
3516	837.021(1) 3rd Make contradictory statements in official proceedings.
3517	839.13(2)(a) 3rd Falsifying records of an individual in the care and custody of a state agency.
3518	839.13(2)(c) 3rd Falsifying records of the Department of Children and Family Services.
3519	843.021 3rd Possession of a concealed handcuff key by a person in custody.
3520	843.025 3rd Deprive law enforcement, correctional, or correctional probation officer of means of protection or communication.
3521	843.15(1)(a) 3rd Failure to appear while on bail for felony (bond estreature or bond jumping).
3522	874.05(1) 3rd Encouraging or recruiting another to join a criminal street gang.
3523	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).
3524	914.14(2) 3rd Witnesses accepting bribes.
3525	914.22(1) 3rd Force, threaten, etc., witness, victim, or informant.
3526	914.23(2) 3rd Retaliation against a witness, victim, or informant, no bodily injury.
3527	918.12 3rd Tampering with jurors.
3528	934.215 3rd Use of two-way communications device to facilitate commission of a crime.
3529	(f) LEVEL 6
3530	316.027(1)(b) 2nd Accident involving death, failure to stop; leaving scene.
3531	316.193(2)(b) 3rd Felony DUI, 4th or subsequent conviction.
3532	499.0051(3) 2nd Forgery of pedigree papers.
3533	499.0051(4) 2nd Purchase or receipt of legend drug from unauthorized person.
3534	499.0051(5) 2nd Sale of legend drug to unauthorized person.
3535	775.0875(1) 3rd Taking firearm from law enforcement officer.
3536	775.21(10) 3rd Sexual predators; failure to register; failure to renew driver's license or identification card.
3537	784.021(1)(a) 3rd Aggravated assault; deadly weapon without intent to kill.
3538	784.021(1)(b) 3rd Aggravated assault; intent to commit felony.
3539	784.041 3rd Felony battery.
3540	784.048(3) 3rd Aggravated stalking; credible threat.
3541	784.048(5) 3rd Aggravated stalking of person under 16.
3542	784.07(2)(c) 2nd Aggravated assault on law enforcement officer.
3543	784.074(1)(b) 2nd Aggravated assault on sexually violent predators facility staff.
3544	784.08(2)(b) 2nd Aggravated assault on a person 65 years of age or older.
3545	784.081(2) 2nd Aggravated assault on specified official or employee.
3546	784.082(2) 2nd Aggravated assault by detained person on visitor or other detainee.
3547	784.083(2) 2nd Aggravated assault on code inspector.
3548	787.02(2) 3rd False imprisonment; restraining with purpose other than those in s. 787.01.
3549	790.115(2)(d) 2nd Discharging firearm or weapon on school property.
3550	790.161(2) 2nd Make, possess, or throw destructive device with intent to do bodily harm or damage property.
3551	790.164(1) 2nd False report of deadly explosive, weapon of mass destruction, or act of arson or violence to state property.
3552	790.19 2nd Shooting or throwing deadly missiles into dwellings, vessels, or vehicles.
3553	794.011(8)(a) 3rd Solicitation of minor to participate in sexual activity by custodial adult.
3554	794.05(1) 2nd Unlawful sexual activity with specified minor.
3555	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.
3556	800.04(6)(b) 2nd Lewd or lascivious conduct; offender 18 years of age or older.
3557	806.031(2) 2nd Arson resulting in great bodily harm to firefighter or any other person.
3558	810.02(3)(c) 2nd Burglary of occupied structure; unarmed; no assault or battery.
3559	812.014(2)(b)1. 2nd Property stolen $20,000 or more, but less than $100,000, grand theft in 2nd degree.
3560	812.014(2)(b)2. 2nd Property stolen; cargo valued at less than $50,000, grand theft in 2nd degree.
3561	812.015(9) 2nd Retail theft; property stolen $300 or more; second or subsequent conviction.
3562	812.13(2)(c) 2nd Robbery, no firearm or other weapon (strong-arm robbery).
3563	817.034(4)(a)1. 1st Communications fraud, value greater than $50,000.
3564	817.4821(5) 2nd Possess cloning paraphernalia with intent to create cloned cellular telephones.
3565	825.102(1) 3rd Abuse of an elderly person or disabled adult.
3566	825.102(3)(c) 3rd Neglect of an elderly person or disabled adult.
3567	825.1025(3) 3rd Lewd or lascivious molestation of an elderly person or disabled adult.
3568	825.103(2)(c) 3rd Exploiting an elderly person or disabled adult and property is valued at less than $20,000.
3569	827.03(1) 3rd Abuse of a child.
3570	827.03(3)(c) 3rd Neglect of a child.
3571	827.071(2)&(3) 2nd Use or induce a child in a sexual performance, or promote or direct such performance.
3572	836.05 2nd Threats; extortion.
3573	836.10 2nd Written threats to kill or do bodily injury.
3574	843.12 3rd Aids or assists person to escape.
3575	847.0135(3) 3rd Solicitation of a child, via a computer service, to commit an unlawful sex act.
3576	914.23 2nd Retaliation against a witness, victim, or informant, with bodily injury.
3577	943.0435(9) 3rd Sex offenders; failure to comply with reporting requirements.
3578	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.
3579	944.40 2nd Escapes.
3580	944.46 3rd Harboring, concealing, aiding escaped prisoners.
3581	944.47(1)(a)5. 2nd Introduction of contraband (firearm, weapon, or explosive) into correctional facility.
3582	951.22(1) 3rd Intoxicating drug, firearm, or weapon introduced into county facility.
3583	(h) LEVEL 8
3584	316.193 (3)(c)3.a. 2nd DUI manslaughter.
3585	327.35(3)(c)3. 2nd Vessel BUI manslaughter.
3586	499.0051(7) 1st Forgery of prescription or legend drug labels.
3587	499.0052 1st Trafficking in contraband legend drugs.
3588	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.
3589	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.
3590	655.50(10)(b)2. 2nd Failure to report financial transactions totaling or exceeding $20,000, but less than $100,000 by financial institutions.
3591	777.03(2)(a) 1st Accessory after the fact, capital felony.
3592	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.
3593	782.051(2) 1st Attempted felony murder while perpetrating or attempting to perpetrate a felony not enumerated in s. 782.04(3).
3594	782.071(1)(b) 1st Committing vehicular homicide and failing to render aid or give information.
3595	782.072(2) 1st Committing vessel homicide and failing to render aid or give information.
3596	790.161(3) 1st Discharging a destructive device which results in bodily harm or property damage.
3597	794.011(5) 2nd Sexual battery, victim 12 years or over, offender does not use physical force likely to cause serious injury.
3598	800.04(4) 2nd Lewd or lascivious battery.
3599	806.01(1) 1st Maliciously damage dwelling or structure by fire or explosive, believing person in structure.
3600	810.02(2)(a) 1st,PBL Burglary with assault or battery.
3601	810.02(2)(b) 1st,PBL Burglary; armed with explosives or dangerous weapon.
3602	810.02(2)(c) 1st Burglary of a dwelling or structure causing structural damage or $1,000 or more property damage.
3603	812.13(2)(b) 1st Robbery with a weapon.
3604	812.135(2) 1st Home-invasion robbery.
3605	825.102(2) 2nd Aggravated abuse of an elderly person or disabled adult.
3606	825.1025(2) 2nd Lewd or lascivious battery upon an elderly person or disabled adult.
3607	825.103(2)(a) 1st Exploiting an elderly person or disabled adult and property is valued at $100,000 or more.
3608	837.02(2) 2nd Perjury in official proceedings relating to prosecution of a capital felony.
3609	837.021(2) 2nd Making contradictory statements in official proceedings relating to prosecution of a capital felony.
3610	860.121(2)(c) 1st Shooting at or throwing any object in path of railroad vehicle resulting in great bodily harm.
3611	860.16 1st Aircraft piracy.
3612	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).
3613	893.13(2)(b) 1st Purchase in excess of 10 grams of any substance specified in s. 893.03(1)(a) or (b).
3614	893.13(6)(c) 1st Possess in excess of 10 grams of any substance specified in s. 893.03(1)(a) or (b).
3615	893.135(1)(a)2. 1st Trafficking in cannabis, more than 2,000 lbs., less than 10,000 lbs.
3616	893.135(1)(b)1.b. 1st Trafficking in cocaine, more than 200 grams, less than 400 grams.
3617	893.135(1)(c)1.b. 1st Trafficking in illegal drugs, more than 14 grams, less than 28 grams.
3618	893.135(1)(d)1.b. 1st Trafficking in phencyclidine, more than 200 grams, less than 400 grams.
3619	893.135(1)(e)1.b. 1st Trafficking in methaqualone, more than 5 kilograms, less than 25 kilograms.
3620	893.135(1)(f)1.b. 1st Trafficking in amphetamine, more than 28 grams, less than 200 grams.
3621	893.135(1)(g)1.b. 1st Trafficking in flunitrazepam, 14 grams or more, less than 28 grams.
3622	893.135(1)(h)1.b. 1st Trafficking in gamma-hydroxybutyric acid (GHB), 5 kilograms or more, less than 10 kilograms.
3623	893.135(1)(j)1.b. 1st Trafficking in 1,4-Butanediol, 5 kilograms or more, less than 10 kilograms.
3624	893.135(1)(k)2.b. 1st Trafficking in Phenethylamines, 200 grams or more, less than 400 grams.
3625	895.03(1) 1st Use or invest proceeds derived from pattern of racketeering activity.
3626	895.03(2) 1st Acquire or maintain through racketeering activity any interest in or control of any enterprise or real property.
3627	895.03(3) 1st Conduct or participate in any enterprise through pattern of racketeering activity.
3628	896.101(5)(b) 2nd Money laundering, financial transactions totaling or exceeding $20,000, but less than $100,000.
3629	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.
3630	(i) LEVEL 9
3631	316.193(3)(c)3.b. 1st DUI manslaughter; failing to render aid or give information.
3632	327.35(3)(c)3.b. 1st BUI manslaughter; failing to render aid or give information.
3633	499.00523 1st Sale or purchase of contraband legend drugs resulting in great bodily harm.
3634	560.123(8)(b)3. 1st Failure to report currency or payment instruments totaling or exceeding $100,000 by money transmitter.
3635	560.125(5)(c) 1st Money transmitter business by unauthorized person, currency, or payment instruments totaling or exceeding $100,000.
3636	655.50(10)(b)3. 1st Failure to report financial transactions totaling or exceeding $100,000 by financial institution.
3637	775.0844 1st Aggravated white collar crime.
3638	782.04(1) 1st Attempt, conspire, or solicit to commit premeditated murder.
3639	782.04(3) 1st,PBL Accomplice to murder in connection with arson, sexual battery, robbery, burglary, and other specified felonies.
3640	782.051(1) 1st Attempted felony murder while perpetrating or attempting to perpetrate a felony enumerated in s. 782.04(3).
3641	782.07(2) 1st Aggravated manslaughter of an elderly person or disabled adult.
3642	787.01(1)(a)1. 1st,PBL Kidnapping; hold for ransom or reward or as a shield or hostage.
3643	787.01(1)(a)2. 1st,PBL Kidnapping with intent to commit or facilitate commission of any felony.
3644	787.01(1)(a)4. 1st,PBL Kidnapping with intent to interfere with performance of any governmental or political function.
3645	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.
3646	790.161 1st Attempted capital destructive device offense.
3647	790.166(2) 1st,PBL Possessing, selling, using, or attempting to use a weapon of mass destruction.
3648	794.011(2) 1st Attempted sexual battery; victim less than 12 years of age.
3649	794.011(2) Life Sexual battery; offender younger than 18 years and commits sexual battery on a person less than 12 years.
3650	794.011(4) 1st Sexual battery; victim 12 years or older, certain circumstances.
3651	794.011(8)(b) 1st Sexual battery; engage in sexual conduct with minor 12 to 18 years by person in familial or custodial authority.
3652	800.04(5)(b) 1st Lewd or lascivious molestation; victim less than 12 years; offender 18 years or older.
3653	812.13(2)(a) 1st,PBL Robbery with firearm or other deadly weapon.
3654	812.133(2)(a) 1st,PBL Carjacking; firearm or other deadly weapon.
3655	827.03(2) 1st Aggravated child abuse.
3656	847.0145(1) 1st Selling, or otherwise transferring custody or control, of a minor.
3657	847.0145(2) 1st Purchasing, or otherwise obtaining custody or control, of a minor.
3658	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.
3659	893.135 1st Attempted capital trafficking offense.
3660	893.135(1)(a)3. 1st Trafficking in cannabis, more than 10,000 lbs.
3661	893.135 (1)(b)1.c. 1st Trafficking in cocaine, more than 400 grams, less than 150 kilograms.
3662	893.135(1)(c)1.c. 1st Trafficking in illegal drugs, more than 28 grams, less than 30 kilograms.
3663	893.135(1)(d)1.c. 1st Trafficking in phencyclidine, more than 400 grams.
3664	893.135(1)(e)1.c. 1st Trafficking in methaqualone, more than 25 kilograms.
3665	893.135(1)(f)1.c. 1st Trafficking in amphetamine, more than 200 grams.
3666	893.135(1)(h)1.c. 1st Trafficking in gamma-hydroxybutyric acid (GHB), 10 kilograms or more.
3667	893.135(1)(j)1.c. 1st Trafficking in 1,4-Butanediol, 10 kilograms or more.
3668	893.135(1)(k)2.c. 1st Trafficking in Phenethylamines, 400 grams or more.
3669	896.101(5)(c) 1st Money laundering, financial instruments totaling or exceeding $100,000.
3670	896.104(4)(a)3. 1st Structuring transactions to evade reporting or registration requirements, financial transactions totaling or exceeding $100,000.
3671	(j) LEVEL 10
3672	499.00525 1st Sale or purchase of contraband legend drugs resulting in death.
3673	782.04(2) 1st,PBL Unlawful killing of human; act is homicide, unpremeditated.
3674	787.01(1)(a)3. 1st,PBL Kidnapping; inflict bodily harm upon or terrorize victim.
3675	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.
3676	782.07(3) 1st Aggravated manslaughter of a child.
3677	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.
3678	876.32 1st Treason against the state.
3679	Section 36. Paragraph (a) of subsection (1) of section
3680	16.56, Florida Statutes, is amended to read:
3681	16.56 Office of Statewide Prosecution.--
3682	(1) There is created in the Department of Legal Affairs an
3683	Office of Statewide Prosecution. The office shall be a separate
3684	"budget entity" as that term is defined in chapter 216. The
3685	office may:
3686	(a) Investigate and prosecute the offenses of:
3687	1. Bribery, burglary, criminal usury, extortion, gambling,
3688	kidnapping, larceny, murder, prostitution, perjury, robbery,
3689	carjacking, and home-invasion robbery;
3690	2. Any crime involving narcotic or other dangerous drugs;
3691	3. Any violation of the provisions of the Florida RICO
3692	(Racketeer Influenced and Corrupt Organization) Act, including
3693	any offense listed in the definition of racketeering activity in
3694	s. 895.02(1)(a), providing such listed offense is investigated
3695	in connection with a violation of s. 895.03 and is charged in a
3696	separate count of an information or indictment containing a
3697	count charging a violation of s. 895.03, the prosecution of
3698	which listed offense may continue independently if the
3699	prosecution of the violation of s. 895.03 is terminated for any
3700	reason;
3701	4. Any violation of the provisions of the Florida Anti-
3702	Fencing Act;
3703	5. Any violation of the provisions of the Florida
3704	Antitrust Act of 1980, as amended;
3705	6. Any crime involving, or resulting in, fraud or deceit
3706	upon any person;
3707	7. Any violation of s. 847.0135, relating to computer
3708	pornography and child exploitation prevention, or any offense
3709	related to a violation of s. 847.0135; or
3710	8. Any violation of the provisions of chapter 815; or
3711	9. Any criminal violation of part I of chapter 499.
3712
3713	or any attempt, solicitation, or conspiracy to commit any of the
3714	crimes specifically enumerated above. The office shall have
3715	such power only when any such offense is occurring, or has
3716	occurred, in two or more judicial circuits as part of a related
3717	transaction, or when any such offense is connected with an
3718	organized criminal conspiracy affecting two or more judicial
3719	circuits.
3720	Section 37. Paragraph (a) of subsection (1) of section
3721	895.02, Florida Statutes, is amended to read:
3722	895.02 Definitions.--As used in ss. 895.01-895.08, the
3723	term:
3724	(1) "Racketeering activity" means to commit, to attempt to
3725	commit, to conspire to commit, or to solicit, coerce, or
3726	intimidate another person to commit:
3727	(a) Any crime which is chargeable by indictment or
3728	information under the following provisions of the Florida
3729	Statutes:
3730	1. Section 210.18, relating to evasion of payment of
3731	cigarette taxes.
3732	2. Section 403.727(3)(b), relating to environmental
3733	control.
3734	3. Section 414.39, relating to public assistance fraud.
3735	4. Section 409.920, relating to Medicaid provider fraud.
3736	5. Section 440.105 or s. 440.106, relating to workers'
3737	compensation.
3738	6. Sections 499.0051, 499.0052, 499.00523, 499.00525, and
3739	499.0691, relating to crimes involving contraband and
3740	adulterated drugs.
3741	7.6.Part IV of chapter 501, relating to telemarketing.
3742	8.7.Chapter 517, relating to sale of securities and
3743	investor protection.
3744	9.8.Section 550.235, s. 550.3551, or s. 550.3605,
3745	relating to dogracing and horseracing.
3746	10.9.Chapter 550, relating to jai alai frontons.
3747	11.10.Chapter 552, relating to the manufacture,
3748	distribution, and use of explosives.
3749	12.11.Chapter 560, relating to money transmitters, if the
3750	violation is punishable as a felony.
3751	13.12.Chapter 562, relating to beverage law enforcement.
3752	14.13.Section 624.401, relating to transacting insurance
3753	without a certificate of authority, s. 624.437(4)(c)1., relating
3754	to operating an unauthorized multiple-employer welfare
3755	arrangement, or s. 626.902(1)(b), relating to representing or
3756	aiding an unauthorized insurer.
3757	15.14.Section 655.50, relating to reports of currency
3758	transactions, when such violation is punishable as a felony.
3759	16.15.Chapter 687, relating to interest and usurious
3760	practices.
3761	17.16.Section 721.08, s. 721.09, or s. 721.13, relating
3762	to real estate timeshare plans.
3763	18.17.Chapter 782, relating to homicide.
3764	19.18.Chapter 784, relating to assault and battery.
3765	20.19.Chapter 787, relating to kidnapping.
3766	21.20.Chapter 790, relating to weapons and firearms.
3767	22.21.Section 796.03, s. 796.04, s. 796.05, or s.
3768	796.07, relating to prostitution.
3769	23.22.Chapter 806, relating to arson.
3770	24.23.Section 810.02(2)(c), relating to specified
3771	burglary of a dwelling or structure.
3772	25.24.Chapter 812, relating to theft, robbery, and
3773	related crimes.
3774	26.25.Chapter 815, relating to computer-related crimes.
3775	27.26.Chapter 817, relating to fraudulent practices,
3776	false pretenses, fraud generally, and credit card crimes.
3777	28.27.Chapter 825, relating to abuse, neglect, or
3778	exploitation of an elderly person or disabled adult.
3779	29.28.Section 827.071, relating to commercial sexual
3780	exploitation of children.
3781	30.29.Chapter 831, relating to forgery and
3782	counterfeiting.
3783	31.30.Chapter 832, relating to issuance of worthless
3784	checks and drafts.
3785	32.31.Section 836.05, relating to extortion.
3786	33.32.Chapter 837, relating to perjury.
3787	34.33.Chapter 838, relating to bribery and misuse of
3788	public office.
3789	35.34.Chapter 843, relating to obstruction of justice.
3790	36.35.Section 847.011, s. 847.012, s. 847.013, s. 847.06,
3791	or s. 847.07, relating to obscene literature and profanity.
3792	37.36.Section 849.09, s. 849.14, s. 849.15, s. 849.23, or
3793	s. 849.25, relating to gambling.
3794	38.37.Chapter 874, relating to criminal street gangs.
3795	39.38.Chapter 893, relating to drug abuse prevention and
3796	control.
3797	40.39.Chapter 896, relating to offenses related to
3798	financial transactions.
3799	41.40.Sections 914.22 and 914.23, relating to tampering
3800	with a witness, victim, or informant, and retaliation against a
3801	witness, victim, or informant.
3802	42.41.Sections 918.12 and 918.13, relating to tampering
3803	with jurors and evidence.
3804	Section 38. Section 905.34, Florida Statutes, is amended
3805	to read:
3806	905.34 Powers and duties; law applicable.--The
3807	jurisdiction of a statewide grand jury impaneled under this
3808	chapter shall extend throughout the state. The subject matter
3809	jurisdiction of the statewide grand jury shall be limited to the
3810	offenses of:
3811	(1) Bribery, burglary, carjacking, home-invasion robbery,
3812	criminal usury, extortion, gambling, kidnapping, larceny,
3813	murder, prostitution, perjury, and robbery;
3814	(2) Crimes involving narcotic or other dangerous drugs;
3815	(3) Any violation of the provisions of the Florida RICO
3816	(Racketeer Influenced and Corrupt Organization) Act, including
3817	any offense listed in the definition of racketeering activity in
3818	s. 895.02(1)(a), providing such listed offense is investigated
3819	in connection with a violation of s. 895.03 and is charged in a
3820	separate count of an information or indictment containing a
3821	count charging a violation of s. 895.03, the prosecution of
3822	which listed offense may continue independently if the
3823	prosecution of the violation of s. 895.03 is terminated for any
3824	reason;
3825	(4) Any violation of the provisions of the Florida Anti-
3826	Fencing Act;
3827	(5) Any violation of the provisions of the Florida
3828	Antitrust Act of 1980, as amended;
3829	(6) Any violation of the provisions of chapter 815;
3830	(7) Any crime involving, or resulting in, fraud or deceit
3831	upon any person;
3832	(8) Any violation of s. 847.0135, s. 847.0137, or s.
3833	847.0138 relating to computer pornography and child exploitation
3834	prevention, or any offense related to a violation of s.
3835	847.0135, s. 847.0137, or s. 847.0138;
3836	(9) Any criminal violation of part I of chapter 499;
3837
3838	or any attempt, solicitation, or conspiracy to commit any
3839	violation of the crimes specifically enumerated above, when any
3840	such offense is occurring, or has occurred, in two or more
3841	judicial circuits as part of a related transaction or when any
3842	such offense is connected with an organized criminal conspiracy
3843	affecting two or more judicial circuits. The statewide grand
3844	jury may return indictments and presentments irrespective of the
3845	county or judicial circuit where the offense is committed or
3846	triable. If an indictment is returned, it shall be certified
3847	and transferred for trial to the county where the offense was
3848	committed. The powers and duties of, and law applicable to,
3849	county grand juries shall apply to a statewide grand jury except
3850	when such powers, duties, and law are inconsistent with the
3851	provisions of ss. 905.31-905.40.
3852	Section 39. If any provision of this act or its
3853	application to any person or circumstance is held invalid, the
3854	invalidity does not affect other provisions or applications of
3855	the act which can be given effect without the invalid provision
3856	or application, and to this end the provisions of this act are
3857	severable.
3858	Section 40. Except as otherwise expressly provided in this
3859	act, this act shall take effect July 1, 2003.