HB 1481 2003
1	A bill to be entitled
2	An act relating to pharmaceutical wholesalers; amending s.
3	499.003, F.S.; defining "affiliated party"; amending s.
4	499.005, F.S.; prohibiting acts relating to previously
5	dispensed drugs; amending s. 499.01, F.S.; revising permit
6	requirements; amending s. 499.012, F.S.; providing
7	definitions; providing additional permit requirements for
8	prescription drug wholesalers, out-of-state prescription
9	drug wholesalers, and retail pharmacy drug wholesalers;
10	providing for renewal on an annual basis; requiring
11	designation of a natural person as a wholesaler's
12	representative; amending s. 499.0121, F.S.; providing for
13	wholesale distributor due diligence; requiring reporting
14	with respect to previous sales of prescription drugs,
15	including high-risk prescription drugs; requiring
16	wholesale distributors to submit annually a list of the
17	wholesalers from whom they purchase drugs; prohibiting a
18	wholesale drug distributor from paying for any drug with
19	currency; creating s. 499.0125, F.S.; creating the Drug
20	Wholesaler Advisory Council; providing for the council's
21	organization, powers, and duties; amending ss. 499.015,
22	499.024, and 499.03, F.S.; conforming cross references;
23	amending s. 499.041, F.S.; increasing permit fees for
24	prescription drug wholesalers, out-of-state prescription
25	drug wholesalers, and retail pharmacy drug wholesalers;
26	amending s. 499.05, F.S.; conforming a cross reference;
27	amending s. 499.051, F.S.; expanding authority of the
28	Department of Health and the Department of Law Enforcement
29	to inspect financial records and investigate complaints
30	and violations; creating s. 499.0671, F.S.; providing
31	enforcement provisions, including cease and desist orders
32	and removal of affiliated parties; amending s. 499.069,
33	F.S.; providing penalties; providing an effective date.
34
35	Be It Enacted by the Legislature of the State of Florida:
36
37	Section 1. Subsections (2) through (28) of section
38	499.003, Florida Statutes, are renumbered as subsections (3)
39	through (29), respectively, and a new subsection (2) is added to
40	said section, to read:
41	499.003 Definitions of terms used in ss. 499.001-
42	499.081.--As used in ss. 499.001-499.081, the term:
43	(2) "Affiliated party" means any person who directs or
44	participates in the conduct of the affairs of a permittee or
45	applicant pursuant to s. 499.012 and who is:
46	(a) A director, officer, employee, trustee, committee
47	member, or controlling stockholder of a permittee or applicant
48	or a subsidiary or service corporation of the permittee or
49	applicant;
50	(b) A person who has filed or is required to file a
51	personal information statement pursuant to s. 499.012(4) or is
52	required to be identified in an application for a permit or to
53	renew a permit pursuant to s. 499.012(3); or
54	(c) A stockholder who participates in the conduct of the
55	affairs of the permittee or applicant.
56	Section 2. Subsections (26) and (27) are added to section
57	499.005, Florida Statutes, to read:
58	499.005 Prohibited acts.--It is unlawful to perform or
59	cause the performance of any of the following acts in this
60	state:
61	(26) Removing the label of a pharmacy licensed pursuant to
62	chapter 465 from a dispensed prescription drug with the intent
63	to further distribute the prescription drug.
64	(27) Knowing distribution of a prescription drug that was
65	previously dispensed by a pharmacy licensed pursuant to chapter
66	465, unless such distribution was authorized in chapter 465 or
67	the rules adopted thereunder.
68	Section 3. Section 499.01, Florida Statutes, is amended to
69	read:
70	499.01 Permits; applications; renewal; general
71	requirements.--
72	(1) A permit is required for each establishment that
73	operates as a:
74	(a) Prescription drug manufacturer;
75	(b) Over-the-counter drug manufacturer;
76	(c) Compressed medical gas manufacturer;
77	(d) Device manufacturer;
78	(e) Cosmetic manufacturer;
79	(f) Prescription drug wholesaler;
80	(g) Compressed medical gas wholesaler;
81	(h) Out-of-state prescription drug wholesaler;
82	(i) Retail pharmacy drug wholesaler;
83	(j) Veterinary legend drug retail establishment;
84	(k) Medical oxygen retail establishment;
85	(l) Complimentary drug distributor; or
86	(m) Restricted prescription drug distributor.
87	(1) Any person that is required under ss. 499.001-499.081
88	to have a permit must apply to the department on forms furnished
89	by the department.
90	(2)(a) A permit issued pursuant to ss. 499.001-499.081 may
91	be issued only to an individual who is at least 18 years of age
92	or to a corporation that is registered pursuant to chapter 607
93	or chapter 617 and each officer of which is at least 18 years of
94	age.
95	(b) An establishment that is a place of residence may not
96	receive a permit and may not operate under ss. 499.001-499.081.
97	(c) A person that applies for or renews a permit to
98	manufacture or distribute legend drugs may not use a name
99	identical to the name used by any other establishment or
100	licensed person authorized to purchase prescription drugs in
101	this state, except that a restricted drug distributor permit
102	issued to a health care entity will be issued in the name in
103	which the institutional pharmacy permit is issued and a retail
104	pharmacy drug wholesaler will be issued a permit in the name of
105	its retail pharmacy permit.
106	(d) A permit is required for each establishment that
107	operates as a:
108	1. Prescription drug manufacturer;
109	2. Over-the-counter drug manufacturer;
110	3. Compressed medical gas manufacturer;
111	4. Device manufacturer;
112	5. Cosmetic manufacturer;
113	6. Prescription drug wholesaler;
114	7. Compressed medical gas wholesaler;
115	8. Out-of-state prescription drug wholesaler;
116	9. Retail pharmacy drug wholesaler;
117	10. Veterinary legend drug retail establishment;
118	11. Medical oxygen retail establishment;
119	12. Complimentary drug distributor; or
120	13. Restricted prescription drug distributor.
121	(d)(e)A permit for a prescription drug manufacturer,
122	prescription drug wholesaler, or retail pharmacy drugwholesaler
123	may not be issued to the address of a health care entity.
124	(3)(f) Notwithstanding subsection (7)(4), a permitted
125	person in good standing may change the type of permit issued to
126	that person by completing a new application for the requested
127	permit, paying the amount of the difference in the permit fees
128	if the fee for the new permit is more than the fee for the
129	original permit, and meeting the applicable permitting
130	conditions for the new permit type. The new permit expires on
131	the expiration date of the original permit being changed,
132	provided, however, that a new permit for a prescription drug
133	wholesaler, an out-of-state prescription drug wholesaler, or a
134	retail pharmacy drug wholesaler shall expire on the expiration
135	date of the original permit or 1 year after the date of issuance
136	of the new permit, whichever is earlier. A refund may not be
137	issued if the biennial fee for the new permit is less than the
138	fee that was paid for the original permit for which a fee was
139	paid.
140	(4)(2)A written application for a permit shall be filed
141	with the department on forms furnished by the department.The
142	department shall establish, by rule, the form and content of the
143	application to obtain or renew a permit. The applicant must
144	submit to the department with the application a statement that
145	swears or affirms that the information contained in the
146	applicationis true and correct.
147	(5)(a) Except for a permit for a prescription drug
148	wholesaler, an out-of-state prescription drug wholesaler, or a
149	retail pharmacy drug wholesaler, an application for a permit
150	must includeInformation that an applicant must provide
151	includes, but need not be limited to:
152	1. The name, full business address, and telephone number
153	of the applicant;
154	2. All trade or business names used by the applicant;
155	3. The address, telephone numbers, and the names of
156	contact persons for each facility used by the applicant for the
157	storage, handling, and distribution of prescription drugs;
158	4. The type of ownership or operation, such as a
159	partnership, corporation, or sole proprietorship; and
160	5. The names of the owner and the operator of the
161	establishment, including:
162	a. If an individual, the name of the individual;
163	b. If a partnership, the name of each partner and the name
164	of the partnership;
165	c. If a corporation, the name and title of each corporate
166	officer and director, the corporate names, and the name of the
167	state of incorporation;
168	d. If a sole proprietorship, the full name of the sole
169	proprietor and the name of the business entity; and
170	e. Any other relevant information that the department
171	requires.
172	(b) Upon approval of the application by the department and
173	payment of the required fee, the department shall issue a permit
174	to the applicant, if the applicant meets the requirements of ss.
175	499.001-499.081 and rules adopted under those sections.
176	(c) Any change in information required under paragraph (a)
177	must be submitted to the department before the change occurs.
178	(d) The department shall consider, at a minimum, the
179	following factors in reviewing the qualifications of persons to
180	be permitted under ss. 499.001-499.081:
181	1. The applicant's having been found guilty, regardless of
182	adjudication, in a court of this state or other jurisdiction, of
183	a violation of a law that directly relates to a drug, device, or
184	cosmetic. A plea of nolo contendere constitutes a finding of
185	guilt for purposes of this subparagraph.
186	2. The applicant's having been disciplined by a regulatory
187	agency in any state for any offense that would constitute a
188	violation of ss. 499.001-499.081.
189	3. Any felony conviction of the applicant under a federal,
190	state, or local law;
191	4. The applicant's past experience in manufacturing or
192	distributing drugs, devices, or cosmetics;
193	5. The furnishing by the applicant of false or fraudulent
194	material in any application made in connection with
195	manufacturing or distributing drugs, devices, or cosmetics;
196	6. Suspension or revocation by a federal, state, or local
197	government of any permit currently or previously held by the
198	applicant for the manufacture or distribution of any drugs,
199	devices, or cosmetics;
200	7. Compliance with permitting requirements under any
201	previously granted permits;
202	8. Compliance with requirements to maintain or make
203	available to the state permitting authority or to federal,
204	state, or local law enforcement officials those records required
205	under this section; and
206	9. Any other factors or qualifications the department
207	considers relevant to and consistent with the public health and
208	safety.
209	(6)(3)Except for permits for prescription drug
210	wholesalers, out-of-state prescription drug wholesalers, and
211	retail pharmacy drug wholesalers:
212	(a)The department shall adopt rules for the biennial
213	renewal of permits.
214	(b)(a)The department shall renew a permit upon receipt of
215	the renewal application and renewal fee if the applicant meets
216	the requirements established under ss. 499.001-499.081 and the
217	rules adopted under those sections.
218	(c)(b)A permit, unless sooner suspended or revoked,
219	automatically expires 2 years after the last day of the
220	anniversary month in which the permit was originally issued. A
221	permit issued under ss. 499.001-499.081 must be renewed by
222	making application for renewal on forms furnished by the
223	department and paying the appropriate fees. If a renewal
224	application and fee are not submitted and postmarked by the
225	expiration date of the permit, the permit may be reinstated only
226	upon payment of a delinquent fee of $100, plus the required
227	renewal fee, within 60 days after the expiration date.
228	(d)(c)Failure to renew a permit in accordance with this
229	section precludes any future renewal of that permit. Continuing
230	to engage in activities that require a permit under ss. 499.001-
231	499.081 requires a new permit application and payment of an
232	application fee, initial permit fee, and applicable penalties.
233	(7)(4)A permit issued by the department is
234	nontransferable. Each permit is valid only for the person or
235	governmental unit to which it is issued and is not subject to
236	sale, assignment, or other transfer, voluntarily or
237	involuntarily; nor is a permit valid for any establishment other
238	than the establishment for which it was originally issued.
239	(a) A person permitted under ss. 499.001-499.081 must
240	notify the department before making a change of address. The
241	department shall set a change of location fee not to exceed
242	$100.
243	(b)1. An application for a new permit is required when a
244	majority of the ownership or controlling interest of a permitted
245	establishment is transferred or assigned or when a lessee agrees
246	to undertake or provide services to the extent that legal
247	liability for operation of the establishment will rest with the
248	lessee. The application for the new permit must be made before
249	the date of the sale, transfer, assignment, or lease.
250	2. A permittee that is authorized to distribute legend
251	drugs may transfer such drugs to the new owner or lessee under
252	subparagraph 1. only after the new owner or lessee has been
253	approved for a permit to distribute legend drugs.
254	(c) The department shall deny, suspend, or revoke the
255	permit of any person or establishment if the assignment, sale,
256	transfer, or lease of an establishment permitted under ss.
257	499.001-499.081 will avoid an administrative penalty, civil
258	action, or criminal prosecution.
259	(d) If an establishment permitted under ss. 499.001-
260	499.081 closes, the owner must notify the department in writing
261	before the effective date of closure and must:
262	1. Return the permit to the department;
263	2. If the permittee is authorized to distribute legend
264	drugs, indicate the disposition of such drugs, including the
265	name, address, and inventory, and provide the name and address
266	of a person to contact regarding access to records that are
267	required to be maintained under ss. 499.001-499.081. Transfer of
268	ownership of legend drugs may be made only to persons authorized
269	to possess legend drugs under ss. 499.001-499.081.
270	(8)(5)A permit must be posted in a conspicuous place on
271	the licensed premise.
272	Section 4. Section 499.012, Florida Statutes, is amended
273	to read:
274	499.012 Wholesale distribution; definitions; permits;
275	applications;general requirements.--
276	(1) As used in this section, the term:
277	(a) "Wholesale distribution" means distribution of
278	prescription drugs to persons other than a consumer or patient,
279	but does not include:
280	1. Any of the following activities, which is not a
281	violation of s. 499.005(21) if such activity is conducted in
282	accordance with s. 499.014:
283	a. The purchase or other acquisition by a hospital or
284	other health care entity that is a member of a group purchasing
285	organization of a prescription drug for its own use from the
286	group purchasing organization or from other hospitals or health
287	care entities that are members of that organization.
288	b. The sale, purchase, or trade of a prescription drug or
289	an offer to sell, purchase, or trade a prescription drug by a
290	charitable organization described in s. 501(c)(3) of the
291	Internal Revenue Code of 1986, as amended and revised, to a
292	nonprofit affiliate of the organization to the extent otherwise
293	permitted by law.
294	c. The sale, purchase, or trade of a prescription drug or
295	an offer to sell, purchase, or trade a prescription drug among
296	hospitals or other health care entities that are under common
297	control. For purposes of this section, "common control" means
298	the power to direct or cause the direction of the management and
299	policies of a person or an organization, whether by ownership of
300	stock, by voting rights, by contract, or otherwise.
301	d. The sale, purchase, trade, or other transfer of a
302	prescription drug from or for any federal, state, or local
303	government agency or any entity eligible to purchase
304	prescription drugs at public health services prices pursuant to
305	Pub. L. No. 102-585, s. 602 to a contract provider or its
306	subcontractor for eligible patients of the agency or entity
307	under the following conditions:
308	(I) The agency or entity must obtain written authorization
309	for the sale, purchase, trade, or other transfer of a
310	prescription drug under this sub-subparagraph from the Secretary
311	of Health or his or her designee.
312	(II) The contract provider or subcontractor must be
313	authorized by law to administer or dispense prescription drugs.
314	(III) In the case of a subcontractor, the agency or entity
315	must be a party to and execute the subcontract.
316	(IV) A contract provider or subcontractor must maintain
317	separate and apart from other prescription drug inventory any
318	prescription drugs of the agency or entity in its possession.
319	(V) The contract provider and subcontractor must maintain
320	and produce immediately for inspection all records of movement
321	or transfer of all the prescription drugs belonging to the
322	agency or entity, including, but not limited to, the records of
323	receipt and disposition of prescription drugs. Each contractor
324	and subcontractor dispensing or administering these drugs must
325	maintain and produce records documenting the dispensing or
326	administration. Records that are required to be maintained
327	include, but are not limited to, a perpetual inventory itemizing
328	drugs received and drugs dispensed by prescription number or
329	administered by patient identifier, which must be submitted to
330	the agency or entity quarterly.
331	(VI) The contract provider or subcontractor may administer
332	or dispense the prescription drugs only to the eligible patients
333	of the agency or entity or must return the prescription drugs
334	for or to the agency or entity. The contract provider or
335	subcontractor must require proof from each person seeking to
336	fill a prescription or obtain treatment that the person is an
337	eligible patient of the agency or entity and must, at a minimum,
338	maintain a copy of this proof as part of the records of the
339	contractor or subcontractor required under sub-sub-subparagraph
340	(V).
341	(VII) In addition to the departmental inspection authority
342	set forth in s. 499.051, the establishment of the contract
343	provider and subcontractor and all records pertaining to
344	prescription drugs subject to this sub-subparagraph shall be
345	subject to inspection by the agency or entity. All records
346	relating to prescription drugs of a manufacturer under this sub-
347	subparagraph shall be subject to audit by the manufacturer of
348	those drugs, without identifying individual patient information.
349	2. Any of the following activities, which is not a
350	violation of s. 499.005(21) if such activity is conducted in
351	accordance with rules established by the department:
352	a. The sale, purchase, or trade of a prescription drug
353	among federal, state, or local government health care entities
354	that are under common control and are authorized to purchase
355	such prescription drug.
356	b. The sale, purchase, or trade of a prescription drug or
357	an offer to sell, purchase, or trade a prescription drug for
358	emergency medical reasons. For purposes of this sub-
359	subparagraph, the term "emergency medical reasons" includes
360	transfers of prescription drugs by a retail pharmacy to another
361	retail pharmacy to alleviate a temporary shortage.
362	c. The transfer of a prescription drug acquired by a
363	medical director on behalf of a licensed emergency medical
364	services provider to that emergency medical services provider
365	and its transport vehicles for use in accordance with the
366	provider's license under chapter 401.
367	d. The revocation of a sale or the return of a
368	prescription drug to the person's prescription drug wholesale
369	supplier.
370	e. The donation of a prescription drug by a health care
371	entity to a charitable organization that has been granted an
372	exemption under s. 501(c)(3) of the Internal Revenue Code of
373	1986, as amended, and that is authorized to possess prescription
374	drugs.
375	f. The transfer of a prescription drug by a person
376	authorized to purchase or receive prescription drugs to a person
377	licensed or permitted to handle reverse distributions or
378	destruction under the laws of the jurisdiction in which the
379	person handling the reverse distribution or destruction receives
380	the drug.
381	3. The distribution of prescription drug samples by
382	manufacturers' representatives or distributors' representatives
383	conducted in accordance with s. 499.028.
384	4. The sale, purchase, or trade of blood and blood
385	components intended for transfusion. As used in this
386	subparagraph, the term "blood" means whole blood collected from
387	a single donor and processed either for transfusion or further
388	manufacturing, and the term "blood components" means that part
389	of the blood separated by physical or mechanical means.
390	5. The lawful dispensing of a prescription drug in
391	accordance with chapter 465.
392	(b) "Wholesale distributor" means any person engaged in
393	wholesale distribution of prescription drugs in or into this
394	state, including, but not limited to, manufacturers; repackers;
395	own-label distributors; jobbers; private-label distributors;
396	brokers; warehouses, including manufacturers' and distributors'
397	warehouses, chain drug warehouses, and wholesale drug
398	warehouses; independent wholesale drug traders; exporters;
399	retail pharmacies; and the agents thereof that conduct wholesale
400	distributions.
401	(c) "Retail pharmacy" means a community pharmacy licensed
402	under chapter 465 that purchases prescription drugs at fair
403	market prices and provides prescription services to the public.
404	(d) "Primary wholesaler" means any wholesale distributor
405	that purchased 90 percent or more of its prescription drugs
406	directly from a manufacturer, in the immediately preceding 12
407	calendar months.
408	(e) "Directly from a manufacturer" means:
409	1. Purchases made by the wholesale distributor directly
410	from the manufacturer of prescription drugs.
411	2. Transfers from a member of an affiliated group, as
412	defined in s. 1504 of the Internal Revenue Code, of which the
413	wholesale distributor is a member, if:
414	a. The affiliated group purchases 90 percent or more of
415	all of its prescription drugs from a manufacturer.
416	b. The wholesale distributor discloses to the department
417	the names of all members of the affiliated group of which the
418	wholesale distributor is a member and the affiliated group
419	agrees in writing to provide records on such transfers not later
420	than 48 hours after the department requests access to such
421	records, regardless of the location where the records are
422	stored.
423	(f) "Secondary wholesaler" means a wholesale distributor
424	that is not a primary wholesaler.
425	(2) The following types of wholesaler permits are
426	established:
427	(a) A prescription drug wholesaler's permit. A
428	prescription drug wholesaler is a wholesale distributor that may
429	engage in the wholesale distribution of prescription drugs. A
430	prescription drug wholesaler that applies to the department
431	after July 1, 2003January 1, 1993, must submit a bond or letter
432	of credit of $100,000$200, payable to the Florida Drug, Device,
433	and Cosmetic Trust Fund. This bond will be refunded to the
434	permittee when the permit is returned to the department and the
435	permittee ceases to function as a business. If a permittee that
436	fails to notify the department before changing the address of
437	the business, fails to notify the department before closing the
438	business, fails to pay any administrative fine levied by the
439	department within 30 days after any such fine becomes final,or
440	fails to notify the department before a change of ownership, the
441	department shall collect the applicable administrative fines
442	from the bond's suretyforfeits its bond. The department may
443	adopt rules for issuing a prescription drug wholesaler-broker
444	permit to a person who engages in the wholesale distribution of
445	prescription drugs and does not take physical possession of any
446	prescription drugs.
447	(b) A compressed medical gas wholesaler's permit. A
448	compressed medical gas wholesaler is a wholesale distributor
449	that is limited to the wholesale distribution of compressed
450	medical gases to other than the consumer or patient. The
451	compressed medical gas must be in the original sealed container
452	that was purchased by that wholesaler. A compressed medical gas
453	wholesaler may not possess or engage in the wholesale
454	distribution of any prescription drug other than compressed
455	medical gases. The department shall adopt rules that govern the
456	wholesale distribution of prescription medical oxygen for
457	emergency use. With respect to the emergency use of prescription
458	medical oxygen, those rules may not be inconsistent with rules
459	and regulations of federal agencies unless the Legislature
460	specifically directs otherwise.
461	(c) An out-of-state prescription drug wholesaler's permit.
462	An out-of-state prescription drug wholesaler is a wholesale
463	distributor located outside this state which engages in the
464	wholesale distribution of prescription drugs into this state and
465	which must be permitted by the department and comply with all
466	the provisions required of a wholesale distributor under ss.
467	499.001-499.081. An out-of-state prescription drug wholesaler
468	that applies to the department after July 1, 2003, must submit a
469	bond or letter of credit of $100,000, payable to the Florida
470	Drug, Device, and Cosmetic Trust Fund. This bond shall be
471	refunded to the permittee when the permit is returned to the
472	department and the permittee ceases to function as a business.
473	If a permittee fails to notify the department before changing
474	the address of the business, fails to notify the department
475	before closing the business, fails to pay any administrative
476	fine levied by the department within 30 days after any such fine
477	becomes final, or fails to notify the department before a change
478	of ownership, the department shall collect the applicable
479	administrative fines from the bond's surety.
480	1. The out-of-state drug wholesaler must maintain at all
481	times a license or permit to engage in the wholesale
482	distribution of prescription drugs in compliance with laws of
483	the state in which it is a resident.
484	2. An out-of-state prescription drug wholesaler's permit
485	is not required for an intracompany sale or transfer of a
486	prescription drug from an out-of-state establishment that is
487	duly licensed as a prescription drug wholesaler, in its state of
488	residence, to a licensed prescription drug wholesaler in this
489	state, if both wholesalers are under common control. The
490	recordkeeping requirements of s. 499.0121(7)(6)must be followed
491	for this transaction.
492	3. The department may adopt rules that allow out-of-state
493	drug wholesalers to obtain a drug wholesale permit on the basis
494	of reciprocity to the extent that an out-of-state drug
495	wholesaler:
496	a. Possesses a valid permit granted by another state that
497	has requirements comparable to those that a drug wholesaler in
498	this state must meet as prerequisites to obtaining a permit
499	under the laws of this state.
500	b. Can show that the other state from which the wholesaler
501	holds a permit would extend reciprocal treatment under its own
502	laws to a drug wholesaler of this state.
503	(d) A retail pharmacy drugwholesaler's permit. A retail
504	pharmacy drugwholesaler is a retail pharmacy engaged in
505	wholesale distribution of prescription drugs within this state
506	under the following conditions:
507	1. The pharmacy must obtain a retail pharmacy drug
508	wholesaler's permit pursuant to ss. 499.001-499.081 and the
509	rules adopted under those sections.
510	2. The wholesale distribution activity does not exceed 30
511	percent of the total annual purchases of prescription drugs. If
512	the wholesale distribution activity exceeds the 30-percent
513	maximum, the pharmacy must obtain a prescription drug
514	wholesaler's permit.
515	3. The transfer of prescription drugs that appear in any
516	schedule contained in chapter 893 is subject to chapter 893 and
517	the federal Comprehensive Drug Abuse Prevention and Control Act
518	of 1970.
519	4. The transfer is between a retail pharmacy and another
520	retail pharmacy, or a Modified Class II institutional pharmacy,
521	or a health care practitioner licensed in this state and
522	authorized by law to dispense or prescribe prescription drugs.
523	5. All records of sales of prescription drugs subject to
524	this section must be maintained separate and distinct from other
525	records and comply with the recordkeeping requirements of ss.
526	499.001-499.081.
527	(3) An application for a permit or to renew a permit for a
528	prescription drug wholesaler, an out-of-state prescription drug
529	wholesaler, or a retail pharmacy drug wholesaler submitted to
530	the department on or after July 1, 2003, must include:
531	(a) The name, full business address, and telephone number
532	of the applicant.
533	(b) All trade or business names used by the applicant.
534	(c) The address, telephone numbers, and names of contact
535	persons for each facility used by the applicant for the storage,
536	handling, and distribution of prescription drugs.
537	(d) The type of ownership or operation, such as a
538	partnership, corporation, or sole proprietorship.
539	(e) The names of the owner and the operator of the
540	establishment, including:
541	1. If an individual, the name of the individual.
542	2. If a partnership, the name of each partner and the name
543	of the partnership.
544	3. If a corporation:
545	a. The name, address, and title of each corporate officer
546	and director.
547	b. The name and address of the corporation, resident agent
548	of the corporation, the resident agent's address, and the
549	corporation's state of incorporation.
550	c. The name and address of each shareholder of the
551	corporation that owns 5 percent or more of the outstanding stock
552	of the corporation.
553	d. If a sole proprietorship, the full name of the sole
554	proprietor and the name of the business entity.
555	(f)1. For an application for a new permit, the estimated
556	annual dollar volume of prescription drug sales of the applicant
557	and the estimated percentage of applicant's total company sales
558	that are prescription drugs.
559	2. For an application to renew a permit, the total dollar
560	volume of prescription drug sales in the previous year, the
561	total dollar volume of prescription drug sales made in the
562	previous 6 months, the percentage of total company sales that
563	were prescription drugs, the total dollar volume of purchases of
564	prescription drugs, and the total volume of prescription drug
565	purchases made directly from the manufacturers of prescription
566	drugs. However, if the prescription drug wholesaler, out-of-
567	state prescription drug wholesaler, or retail pharmacy drug
568	wholesaler made no sales of prescription drugs in the previous 6
569	months, the permit may not be renewed.
570	(g) The tax year of the applicant.
571	(h) A copy of the deed for the property on which the
572	applicant's establishment is located, if the establishment is
573	owned by the applicant, or a copy of the applicant's lease for
574	the property on which the applicant's establishment is located
575	that has an original term of not less than 1 calendar year, if
576	the establishment is not owned by the applicant.
577	(i) A list of all licenses and permits issued to the
578	applicant by any other state which authorize the applicant to
579	purchase or possess prescription drugs, except when the
580	applicant is applying for a retail pharmacy drug wholesaler
581	permit.
582	(j) The name of the manager of the establishment that is
583	applying for the permit or to renew the permit and the next four
584	highest ranking employees responsible for prescription drug
585	wholesale operations, together with the personal information
586	statement and fingerprints required pursuant to subsection (4)
587	for each of such persons.
588	(k) The name of the applicant's initial wholesaler's
589	representative as required by subsection (6), together with the
590	personal information statement and fingerprints required
591	pursuant to subsection ( 4) for that person.
592	(l) For each applicant that is a secondary wholesaler,
593	each of the following:
594	1. A personal background information statement containing
595	the background information and fingerprints required pursuant to
596	subsection (4) for each person named in applicant's response to
597	paragraphs (a)-(i) and for each affiliated party of the
598	applicant.
599	2. If any of the five largest shareholders of the
600	corporation seeking the permit is a corporation, the name,
601	address, and title of each corporate officer and director of
602	each such corporation, the name and address of such corporation,
603	the name of such corporation's resident agent, such
604	corporation's resident agent's address and such corporation's
605	state of its incorporation, and the name and address of each
606	shareholder of such corporation that owns 5 percent or more of
607	the stock of such corporation.
608	3. The name and address of all financial institutions in
609	which the applicant has an account which is used to pay for the
610	operation of the establishment or to pay for drugs purchased for
611	the establishment, together with the names of all persons that
612	are authorized signatories on such accounts.
613	4. The sources of all funds and the amounts of such funds
614	used to purchase or finance purchases of prescription drugs or
615	to finance the premises on which the establishment is to be
616	located.
617	5. If any of the funds identified in subparagraph 3. were
618	borrowed, copies of all promissory notes or loans used to obtain
619	such funds.
620	(m) Any other relevant information that the department
621	requires.
622	(4)(a) Each person required by subsection (3) to provide a
623	personal information statement and fingerprints shall provide
624	the following information to the department on forms prescribed
625	by the department:
626	1. The person's places of residence for the past 7 years.
627	2. The person's date and place of birth.
628	3. The person's occupations, positions of employment, and
629	offices held during the past 7 years.
630	4. The principal business and address of any business,
631	corporation, or other organization in which each such office of
632	the person was held or in which each such occupation or position
633	of employment was carried on.
634	5. Whether the person was, at any time during such 7-year
635	period, convicted of or pleaded nolo contendere to any criminal
636	offense other than a traffic violation, regardless of whether
637	adjudication of guilt was withheld, and a description of the
638	circumstances involved with the criminal offense. A criminal
639	offense committed in another state which would have been a
640	felony in this state must be reported.
641	6. Whether the person has been, during such 7-year period,
642	the subject of any proceeding for the revocation of any license
643	and, if so, the nature of the proceeding and the disposition of
644	the proceeding.
645	7. Whether, during the 7-year period, the person has been
646	the subject of any proceeding under the federal Bankruptcy Act
647	or whether, during the 7-year period, any corporation,
648	partnership, firm, trust, or association in which the person was
649	a director, officer, trustee, partner, or other official has
650	been subject to any such proceeding, either during the time in
651	which the person was a director, officer, trustee, partner, or
652	other official or within 12 months thereafter.
653	8. Whether, during the 7-year period, the person has been
654	enjoined, either temporarily or permanently, by a court of
655	competent jurisdiction from violating any federal or state law
656	regulating the possession, control, or distribution of
657	prescription drugs, together with details as to any such event.
658	9. A description of any involvement by the person with any
659	business, including any investments (other than the ownership of
660	stock in a publicly traded company or mutual fund), during the
661	7-year period, that manufactured, administered, prescribed,
662	distributed, or stored pharmaceutical products.
663	10. The names of, dates of attendance at, and degrees
664	awarded by all postsecondary education institutions attended by
665	the person.
666	11. A description of all lawsuits in which the person was
667	a party during the 7-year period.
668	12. A description of any criminal offense of which the
669	person was found guilty, regardless of whether adjudication of
670	guilt was withheld, or to which the person pleaded guilty or
671	nolo contendere. A criminal offense committed in another
672	jurisdiction which would have been a felony in this state must
673	be reported. If the person indicates that a criminal conviction
674	is under appeal and submits a copy of the notice of appeal of
675	that criminal offense, the applicant must, within 15 days after
676	the disposition of the appeal, submit to the department a copy
677	of the final written order of disposition.
678	13. A photograph of the person taken in the previous 30
679	days.
680	14. A set of fingerprints for the person on a form and
681	under procedures specified by the department together with
682	payment of an amount equal to the costs incurred by the
683	department for a national criminal background check of the
684	person.
685	15. The names, addresses, occupations, and date and place
686	of birth for the members of the person's immediate family and a
687	description of any criminal offense, other than a traffic
688	infraction, which any of such persons was convicted during the
689	7-year period, regardless of whether adjudication of guilt was
690	withheld, or to which the person pleaded guilty or nolo
691	contendere. A criminal offense committed in another jurisdiction
692	which would have been a felony in this state must be reported.
693	For the purposes of this subsection, the "members of the
694	person's immediate family" includes the person's spouse,
695	children, parents, siblings, the spouses of the person's
696	children, and the spouses of the person's siblings.
697	16. Any other relevant information that the department
698	requires.
699	(b) The information required pursuant to paragraph (a)
700	shall be provided under oath.
701	(c) The department shall submit the fingerprints provided
702	by a person for initial licensure to the Department of Law
703	Enforcement for a statewide criminal history check, and the
704	Department of Law Enforcement shall forward the fingerprints to
705	the Federal Bureau of Investigation for a national criminal
706	history check of the person. The department shall submit the
707	fingerprints provided by a person as a part of a renewal
708	application to the Department of Law Enforcement for a statewide
709	criminal background history check, and the Department of Law
710	Enforcement shall forward the fingerprints to the Federal Bureau
711	of Investigation for a national criminal background history
712	check, for the initial renewal of a permit after July 1, 2003.
713	For any subsequent renewal of a permit, the department shall
714	submit the required information for a statewide criminal history
715	check of the person. Any person who, as a part of an initial
716	permit application or initial permit renewal after July 1, 2003,
717	submits to the department a set of fingerprints required for the
718	criminal history check required in this subsection shall not be
719	required to provide a subsequent set of fingerprints for a
720	criminal history check to the department, if the person has
721	undergone a criminal history check as a condition of the
722	issuance of an initial permit or the initial renewal of a permit
723	after July 1, 2003.
724	(5)(a) The department shall consider, at a minimum, the
725	following factors in reviewing the qualifications of persons to
726	be permitted pursuant to this section:
727	1. The applicant's having been found guilty, regardless of
728	adjudication, in a court of this state or other jurisdiction, of
729	a violation of a law that directly relates to a drug, device, or
730	cosmetic. A plea of nolo contendere constitutes a finding of
731	guilt for purposes of this subparagraph.
732	2. The applicant's past experience in distributing drugs.
733	3. The applicant's compliance with permitting requirements
734	under any previously granted permits.
735	4. The applicant's compliance with requirements to
736	maintain or make available to the state permitting authority or
737	to federal, state, or local law enforcement officials those
738	records required under this section.
739	5. The applicant or any affiliated party of the applicant
740	has been disciplined by a regulatory agency in any state for any
741	offense that would constitute a violation of ss. 499.001-
742	499.081.
743	6. Any other factors or qualifications the department
744	considers relevant to and consistent with the public health and
745	safety.
746	(b) The department shall not approve a permit or renew a
747	permit for a prescription drug wholesaler, an out-of-state
748	prescription drug wholesaler, or a retail pharmacy drug
749	wholesaler, if the department finds:
750	1. The management, officers, or directors of the applicant
751	or any affiliated party are found by the department to be
752	incompetent or untrustworthy;
753	2. The applicant is so lacking in experience in managing a
754	wholesale distributor as to make the issuance of the proposed
755	permit hazardous to the public health;
756	3. The applicant is so lacking in experience in managing a
757	wholesale distributor as to jeopardize the reasonable promise of
758	successful operation of the wholesale distributor;
759	4. It has good reason to believe the applicant is
760	affiliated directly or indirectly, through ownership, control,
761	or other business relations, with any person or persons whose
762	business operations are or have been marked to the detriment of
763	the public health or by bad faith;
764	5. The applicant, or any affiliated party, has been found
765	guilty of or has pleaded guilty or nolo contendere to any felony
766	or crime punishable by imprisonment for 1 year or more under the
767	laws of the United States, any state, or any other country,
768	regardless of whether adjudication of guilt was withheld;
769	6. The applicant has furnished false or fraudulent
770	material in any application made in connection with
771	manufacturing or distributing drugs, devices, or cosmetics; or
772	7. That a federal, state, or local government permit
773	currently or previously held by the applicant, or any affiliated
774	party, for the manufacture or distribution of any drugs,
775	devices, or cosmetics has been suspended or revoked and has not
776	been reinstated.
777	(c) The department shall not approve or renew any permit
778	for any prescription drug wholesaler, out-of-state prescription
779	drug wholesaler, or retail pharmacy drug wholesaler if any
780	affiliated party who exercises or has the ability to exercise
781	effective control of the applicant, or who influences or has the
782	ability to influence the transaction of the business of the
783	applicant, does not possess the financial standing and business
784	experience for the successful operation of the applicant.
785	(d) The department shall suspend or revoke the permit and
786	shall deny the renewal of the permit of any prescription drug
787	wholesaler, out-of-state prescription drug wholesaler, or retail
788	pharmacy drug wholesaler if any affiliated party who exercises
789	or has the ability to exercise effective control of the
790	applicant, or who influences or has the ability to influence the
791	transaction of the business of the applicant, has been found
792	guilty or pleaded guilty or nolo contendere to any felony or
793	crime punishable by imprisonment for 1 year or more under the
794	laws of the United States, any state, or any other country,
795	regardless of whether adjudication of guilt was withheld.
796	(e) The department shall suspend or revoke the permit and
797	shall deny the renewal of the permit of any prescription drug
798	wholesaler, out-of-state prescription drug wholesaler, or retail
799	pharmacy drug wholesaler in this state if any affiliated party
800	who exercises or has the ability to exercise effective control
801	of the permittee or applicant, or who influences or has the
802	ability to influence the transaction of the business of the
803	permittee or applicant, the department has good reason to
804	believe is now or was in the past affiliated directly or
805	indirectly, through ownership interest of 5 percent or more
806	control, with any business, corporation, or other entity that
807	has been found guilty of or has pleaded guilty or nolo
808	contendere to any felony or crime punishable by imprisonment for
809	1 year or more under the laws of the United States, any state,
810	or any other country, regardless of whether adjudication of
811	guilt was withheld.
812	(f) Upon approval of the application by the department and
813	payment of the required fee, the department shall issue or renew
814	a prescription drug wholesaler, out-of-state prescription drug
815	wholesaler, or retail pharmacy drug wholesaler permit to the
816	applicant, if the applicant meets the requirements of ss.
817	499.001-499.081 and rules adopted under those sections.
818	(6) For permits for prescription drug wholesalers, out-of-
819	state prescription drug wholesalers, and retail pharmacy drug
820	wholesalers:
821	(a) The department shall adopt rules for the annual
822	renewal of permits. At least 90 days before the expiration of a
823	permit, the department shall forward a permit renewal
824	notification and renewal application to the prescription drug
825	wholesaler, out-of-state prescription drug wholesaler, and
826	retail pharmacy drug wholesaler at the address of the permitted
827	establishment. The permit renewal notification must state
828	conspicuously the date on which the permit for the establishment
829	will expire and that the establishment may not operate unless
830	the permit for the establishment is renewed timely.
831	(b) The department shall renew a permit upon receipt of
832	the renewal application and renewal fee if the applicant meets
833	the requirements established under ss. 499.001-499.081 and the
834	rules adopted under those sections.
835	(c) A permit, unless sooner suspended or revoked,
836	automatically expires 1 year after the last day of the
837	anniversary month in which the permit was originally issued.
838	Such permit must be renewed by making application for renewal on
839	forms furnished by the department and paying the appropriate
840	fees. If a renewal application and fee are not submitted and
841	postmarked by the expiration date of the permit, the permit may
842	be reinstated only upon payment of a delinquent fee of $100,
843	plus the required renewal fee, within 60 days after the
844	expiration date.
845	(d) Failure to renew a permit in accordance with this
846	section precludes any future renewal of that permit. If a permit
847	issued pursuant to this section has expired and cannot be
848	renewed, before an establishment may continue to engage in
849	activities that require a permit under ss. 499.001-499.081, the
850	establishment must submit an application for a new permit, pay
851	the applicable application fee, initial permit fee, and all
852	applicable penalties.
853	(7)A person that engages in wholesale distribution of
854	prescription drugs in this state must have a wholesale
855	distributor's permit issued by the department, except as noted
856	in this section. Each establishment must be separately permitted
857	except as noted in this subsection.
858	(a) A separate establishment permit is not required when a
859	permitted prescription drug wholesaler consigns a prescription
860	drug to a pharmacy that is permitted under chapter 465 and
861	located in this state, provided that:
862	1. The consignor wholesaler notifies the department in
863	writing of the contract to consign prescription drugs to a
864	pharmacy along with the identity and location of each consignee
865	pharmacy;
866	2. The pharmacy maintains its permit under chapter 465;
867	3. The consignor wholesaler, which has no legal authority
868	to dispense prescription drugs, complies with all wholesale
869	distribution requirements of s. 499.0121 with respect to the
870	consigned drugs and maintains records documenting the transfer
871	of title or other completion of the wholesale distribution of
872	the consigned prescription drugs;
873	4. The distribution of the prescription drug is otherwise
874	lawful under this chapter and other applicable law;
875	5. Open packages containing prescription drugs within a
876	pharmacy are the responsibility of the pharmacy, regardless of
877	how the drugs are titled; and
878	6. The pharmacy dispenses the consigned prescription drug
879	in accordance with the limitations of its permit under chapter
880	465 or returns the consigned prescription drug to the consignor
881	wholesaler. In addition, a person who holds title to
882	prescription drugs may transfer the drugs to a person permitted
883	or licensed to handle the reverse distribution or destruction of
884	drugs. Any other distribution by and means of the consigned
885	prescription drug by any person, not limited to the consignor
886	wholesaler or consignee pharmacy, to any other person is
887	prohibited.
888	(b) A wholesale distributor's permit is not required for
889	the one-time transfer of title of a pharmacy's lawfully acquired
890	prescription drug inventory by a pharmacy with a valid permit
891	issued under chapter 465 to a consignor prescription drug
892	wholesaler, permitted under this chapter, in accordance with a
893	written consignment agreement between the pharmacy and that
894	wholesaler if: the permitted pharmacy and the permitted
895	prescription drug wholesaler comply with all of the provisions
896	of paragraph (a) and the prescription drugs continue to be
897	within the permitted pharmacy's inventory for dispensing in
898	accordance with the limitations of the pharmacy permit under
899	chapter 465. A consignor drug wholesaler may not use the
900	pharmacy as a wholesale distributor through which it distributes
901	the legend drugs to other pharmacies. Nothing in this section is
902	intended to prevent a wholesale drug distributor from obtaining
903	this inventory in the event of nonpayment by the pharmacy.
904	(c) The department shall require information from each
905	wholesale distributor as part of the permit and renewal of such
906	permit, as required under s. 499.01.
907	(8)(4)Personnel employed in wholesale distribution must
908	have appropriate education and experience to enable them to
909	perform their duties in compliance with state permitting
910	requirements.
911	(9)(a) Each establishment that is issued a prescription
912	drug wholesaler's permit, an out-of-state prescription drug
913	permit, or a retail pharmacy drug wholesaler's permit must
914	designate in writing to the department at least one natural
915	person to serve as the wholesaler's representative.
916	(b) Each such natural person must meet the following
917	qualifications:
918	1. Is at least 18 years of age.
919	2. Has at least 2 years' experience working full-time in a
920	pharmacy or with a wholesale distributor that holds a
921	prescription drug wholesaler permit or that holds an out-of-
922	state wholesaler permit.
923	3. Has received a passing score of at least 75 percent on
924	an examination given by the department regarding federal laws
925	governing distribution of prescription drugs and ss. 499.001-
926	499.081 and the rules adopted by the department governing the
927	wholesale distribution of prescription drugs. Such requirement
928	shall be effective 1 year after the results of the initial
929	examination are mailed to the persons that took the examination.
930	The department shall offer such examinations at least four times
931	each calendar year. A pharmacist licensed under chapter 465
932	shall be exempt from the requirements of this subparagraph.
933	4. Has provided the department with a personal information
934	statement and fingerprints pursuant to subsection (4).
935	(c) The wholesaler's representative:
936	1. Must be actively involved in and aware of the actual
937	daily operation of the wholesale distributor.
938	2. Must be employed full-time in a managerial position
939	with the wholesale distributor.
940	3. Must be physically present at the establishment during
941	normal business hours, except for time periods when absent due
942	to illness, family illness or death, scheduled vacation, or
943	other authorized absence.
944	4. May serve as a wholesaler's representative for only one
945	wholesale distributor at one time.
946	(d) A wholesale distributor must notify the department
947	when a wholesale representative leaves the employ of the
948	wholesale distributor. Such notice must be provided within 10
949	business days after the last day of the wholesale
950	representative's employment with the wholesale distributor.
951	(e) A wholesale distributor may not operate under a
952	prescription drug permit or an out-of-state prescription drug
953	permit for more than 10 business days after the wholesale
954	representative leaves the employ of the wholesale distributor,
955	unless the wholesale distributor employs another wholesaler's
956	representative.
957	(10)(5)The department may adopt rules governing the
958	recordkeeping, storage, and handling with respect to each of the
959	distributions of prescription drugs specified in subparagraphs
960	(1)(a)1.-4.
961	Section 5. Section 499.0121, Florida Statutes, is amended
962	to read:
963	499.0121 Storage and handling of prescription drugs;
964	wholesale distributor due diligence;recordkeeping.--The
965	department shall adopt rules to implement this section as
966	necessary to protect the public health, safety, and welfare.
967	Such rules shall include, but not be limited to, requirements
968	for the storage and handling of prescription drugs, for the due
969	diligence that wholesale distributors must perform on their
970	suppliers,and for the establishment and maintenance of
971	prescription drug distribution records.
972	(1) ESTABLISHMENTS.--An establishment at which
973	prescription drugs are stored, warehoused, handled, held,
974	offered, marketed, or displayed must:
975	(a) Be of suitable size and construction to facilitate
976	cleaning, maintenance, and proper operations;
977	(b) Have storage areas designed to provide adequate
978	lighting, ventilation, temperature, sanitation, humidity, space,
979	equipment, and security conditions;
980	(c) Have a quarantine area for storage of prescription
981	drugs that are outdated, damaged, deteriorated, misbranded, or
982	adulterated, or that are in immediate or sealed, secondary
983	containers that have been opened;
984	(d) Be maintained in a clean and orderly condition; and
985	(e) Be free from infestation by insects, rodents, birds,
986	or vermin of any kind.
987	(2) SECURITY.--
988	(a) An establishment that is used for wholesale drug
989	distribution must be secure from unauthorized entry.
990	1. Access from outside the premises must be kept to a
991	minimum and be well-controlled.
992	2. The outside perimeter of the premises must be well-
993	lighted.
994	3. Entry into areas where prescription drugs are held must
995	be limited to authorized personnel.
996	(b) An establishment that is used for wholesale drug
997	distribution must be equipped with:
998	1. An alarm system to detect entry after hours; however,
999	the department may exempt by rule establishments that only hold
1000	a permit as prescription drug wholesaler-brokers and
1001	establishments that only handle medical oxygen; and
1002	2. A security system that will provide suitable protection
1003	against theft and diversion. When appropriate, the security
1004	system must provide protection against theft or diversion that
1005	is facilitated or hidden by tampering with computers or
1006	electronic records.
1007	(c) Any vehicle that contains prescription drugs must be
1008	secure from unauthorized access to the prescription drugs in the
1009	vehicle.
1010	(3) STORAGE.--All prescription drugs shall be stored at
1011	appropriate temperatures and under appropriate conditions in
1012	accordance with requirements, if any, in the labeling of such
1013	drugs, or with requirements in the official compendium.
1014	(a) If no storage requirements are established for a
1015	prescription drug, the drug may be held at "controlled" room
1016	temperature, as defined in the official compendium, to help
1017	ensure that its identity, strength, quality, and purity are not
1018	adversely affected.
1019	(b) Appropriate manual, electromechanical, or electronic
1020	temperature and humidity recording equipment, devices, or logs
1021	must be used to document proper storage of prescription drugs.
1022	(c) The recordkeeping requirements in subsection (6) must
1023	be followed for all stored prescription drugs.
1024	(4) EXAMINATION OF MATERIALS.--
1025	(a) Upon receipt, each outside shipping container must be
1026	visually examined for identity and to prevent the acceptance of
1027	contaminated prescription drugs that are otherwise unfit for
1028	distribution. This examination must be adequate to reveal
1029	container damage that would suggest possible contamination or
1030	other damage to the contents.
1031	(b) Each outgoing shipment must be carefully inspected for
1032	identity of the prescription drug products and to ensure that
1033	there is no delivery of prescription drugs that have expired or
1034	been damaged in storage or held under improper conditions.
1035	(c) The recordkeeping requirements in subsection (6) must
1036	be followed for all incoming and outgoing prescription drugs.
1037	(5) DUE DILIGENCE.--
1038	(a) Prior to purchasing any prescription drugs from
1039	another wholesale drug distributor, a wholesale drug distributor
1040	must:
1041	1. Enter an agreement with the selling wholesale drug
1042	distributor by which the selling wholesale drug distributor will
1043	indemnify the purchasing wholesale drug distributor for any loss
1044	caused to the purchasing wholesale drug distributor related to
1045	the purchase of drugs from the selling wholesale drug
1046	distributor that are determined to be counterfeit or to have
1047	been distributed in violation of any federal or state law
1048	governing the distribution of drugs.
1049	2. Determine that the selling wholesale drug distributor
1050	has insurance coverage of not less than the greater of 1 percent
1051	of the amount of total dollar volume of the prescription drug
1052	sales reported to the department pursuant to paragraph (7)(f) or
1053	$500,000, provided such coverage does not have to exceed $2
1054	million.
1055	3. Obtain information about the selling wholesale drug
1056	distributor, including the length of time the selling wholesale
1057	drug distributor has been licensed in Florida, a copy of the
1058	selling wholesale drug distributor's licenses or permits, and
1059	appropriate background information concerning the selling
1060	wholesale drug distributor.
1061	4. Verify that the selling wholesale drug distributor's
1062	Florida permit is valid.
1063	5. Inspect the selling wholesale drug distributor's
1064	licensed establishment to document that it has a policies and
1065	procedures manual relating to the distribution of drugs, the
1066	appropriate temperature controlled environment for drugs
1067	requiring temperature control, an alarm system, appropriate
1068	access restrictions, and procedures to ensure that records
1069	related to the wholesale distribution of prescription drugs are
1070	maintained as required by law before:
1071	a. Purchasing any drug from the wholesale drug
1072	distributor, and at least once each subsequent year; or
1073	b. Purchasing any drug from the wholesale drug
1074	distributor, and each subsequent year obtaining a complete copy
1075	of the most recent annual inspection report for the
1076	establishment that was prepared by the department or the
1077	regulatory authority responsible for wholesale drug distributors
1078	in the state in which the establishment is located and that
1079	indicates that no regulatory violations were found at the
1080	establishment.
1081	(b) The department shall publish on the department's
1082	website:
1083	1. A list of the prescription drug wholesalers, out-of-
1084	state prescription drug wholesalers, and retail pharmacy drug
1085	wholesalers against whom the department has initiated
1086	enforcement action pursuant to ss. 499.001–499.081 and their
1087	permit numbers.
1088	2. A list of all prescription drug wholesalers, out-of-
1089	state prescription drug wholesalers, and retail pharmacy drug
1090	wholesalers to which the department has issued a permit together
1091	with the date on which each permit will expire.
1092	3. A list of all prescription drug wholesaler, out-of-
1093	state prescription drug wholesaler, and retail pharmacy drug
1094	wholesaler permits that became inactive, were suspended, were
1095	revoked or were not renewed in the previous year.
1096	(6)(5)RETURNED, DAMAGED, OR OUTDATED PRESCRIPTION
1097	DRUGS.--
1098	(a)1. Prescription drugs that are outdated, damaged,
1099	deteriorated, misbranded, or adulterated must be quarantined and
1100	physically separated from other prescription drugs until they
1101	are destroyed or returned to their supplier. A quarantine
1102	section must be separate and apart from other sections where
1103	prescription drugs are stored so that prescription drugs in this
1104	section are not confused with usable prescription drugs.
1105	2. Prescription drugs must be examined at least every 12
1106	months, and drugs for which the expiration date has passed must
1107	be removed and quarantined.
1108	(b) Any prescription drugs of which the immediate or
1109	sealed outer containers or sealed secondary containers have been
1110	opened or used must be identified as such and must be
1111	quarantined and physically separated from other prescription
1112	drugs until they are either destroyed or returned to the
1113	supplier.
1114	(c) If the conditions under which a prescription drug has
1115	been returned cast doubt on the drug's safety, identity,
1116	strength, quality, or purity, the drug must be destroyed or
1117	returned to the supplier, unless examination, testing, or other
1118	investigation proves that the drug meets appropriate standards
1119	of safety, identity, strength, quality, and purity. In
1120	determining whether the conditions under which a drug has been
1121	returned cast doubt on the drug's safety, identity, strength,
1122	quality, or purity, the wholesale drug distributor must
1123	consider, among other things, the conditions under which the
1124	drug has been held, stored, or shipped before or during its
1125	return and the conditions of the drug and its container, carton,
1126	or labeling, as a result of storage or shipping.
1127	(d) The recordkeeping requirements in subsection (6) must
1128	be followed for all outdated, damaged, deteriorated, misbranded,
1129	or adulterated prescription drugs.
1130	(7)(6)RECORDKEEPING.--The department shall adopt rules
1131	that require keeping such records of prescription drugs as are
1132	necessary for the protection of the public health.
1133	(a) Wholesale drug distributors must establish and
1134	maintain inventories and records of all transactions regarding
1135	the receipt and distribution or other disposition of
1136	prescription drugs. These records must provide a complete audit
1137	trail from receipt to sale or other disposition, be readily
1138	retrievable for inspection, and include, at a minimum, the
1139	following information:
1140	1. The source of the drugs, including the name and
1141	principal address of the seller or transferor, and the address
1142	of the location from which the drugs were shipped;
1143	2. The name, principal address, and state license permit
1144	or registration number of the person authorized to purchase
1145	prescription drugs;
1146	3. The name, strength, dosage form, and quantity of the
1147	drugs received and distributed or disposed of; and
1148	4. The dates of receipt and distribution or other
1149	disposition of the drugs.
1150	(b) Inventories and records must be made available for
1151	inspection and photocopying by authorized federal, state, or
1152	local officials for a period of 2 years following disposition of
1153	the drugs.
1154	(c) Records described in this section that are kept at the
1155	inspection site or that can be immediately retrieved by computer
1156	or other electronic means must be readily available for
1157	authorized inspection during the retention period. Records that
1158	are kept at a central location outside of this state and that
1159	are not electronically retrievable must be made available for
1160	inspection within 2 working days after a request by an
1161	authorized official of a federal, state, or local law
1162	enforcement agency. Records that are maintained at a central
1163	location within this state must be maintained at an
1164	establishment that is permitted pursuant to ss. 499.001-499.081
1165	and must be readily available.
1166	(d)1. Each person who is engaged in the wholesale
1167	distribution of a prescription drug, and who is not an
1168	authorized distributor of record for the drug manufacturer's
1169	productsof such drug, must provide to each wholesale
1170	distributor of such drug, before the sale is made to such
1171	wholesale distributor, a written statement under oath
1172	identifying each previous sale of the drug back to the last
1173	authorized distributor of record, the lot number of the drug,
1174	and the sales invoice number of the invoice evidencing the sale
1175	of the drug. The written statement identifying all sales of such
1176	drug must accompany the drug for each subsequent wholesale
1177	distribution of the drug to the nextawholesale distributor.
1178	The department shall adopt rules relating to the requirements of
1179	this written statement.
1180	2. Each wholesale distributor of prescription drugs must
1181	maintain separate and distinct from other required records all
1182	statements that are required under subparagraph 1. and paragraph
1183	(e).
1184	3. Each manufacturer of a prescription drug sold in this
1185	state must maintain at its corporate offices a current list of
1186	authorized distributors and must make such list available to the
1187	department upon request.
1188	(e)1. Notwithstanding paragraph (d), each person who is
1189	engaged in the wholesale distribution of a high-risk
1190	prescription drug must provide to each wholesale distributor of
1191	such high-risk prescription drug, before any sale of such high-
1192	risk prescription drug is made to such wholesale distributor, a
1193	written statement under oath identifying each previous sale of
1194	the high-risk prescription drug back to the manufacturer of the
1195	high-risk prescription drug, the lot number of the high-risk
1196	prescription drug, and the sales invoice number of the invoice
1197	evidencing each previous sale of the high-risk prescription
1198	drug. The written statement identifying all sales of such high-
1199	risk prescription drug must accompany the high-risk prescription
1200	drug for each subsequent wholesale distribution of the high-risk
1201	prescription drug to a wholesale distributor. The department
1202	shall adopt rules relating to the requirements of this written
1203	statement.
1204	2. For the purposes of this paragraph, a "high-risk
1205	prescription drug" is a specific drug on the list of drugs
1206	adopted by the department by rule each of which is a specific
1207	drug seized by the department on at least five separate
1208	occasions because such drug was adulterated, counterfeited, or
1209	diverted from legal prescription drug distribution channels and
1210	the department has begun an administrative action to revoke the
1211	permits of two or more wholesale distributors that engaged in
1212	the illegal distribution of that specific drug.
1213	(f) Each wholesale distributor, except for a manufacturer,
1214	shall annually provide the department with a written list of all
1215	prescription drug wholesalers and out-of-state prescription drug
1216	wholesalers from whom the wholesale distributor purchases drugs.
1217	A wholesale distributor, except a manufacturer, shall notify the
1218	department not later than 10 days after any change to said list.
1219
1220	For the purposes of this subsection, the term "authorized
1221	distributors of record" means those distributors with whom a
1222	manufacturer has established an ongoing relationship to
1223	distribute the manufacturer's products, without regard to
1224	whether the wholesale distributor acquired the products directly
1225	from the manufacturer. An ongoing relationship is deemed to
1226	exist when a wholesale distributor is listed on the
1227	manufacturer's current list of authorized distributors or when a
1228	wholesale distributor has made at least three purchases of a
1229	manufacturer's products directly from that manufacturer within a
1230	6-month period from the date for which the authorized
1231	distributor-of-record relationship is claimed.
1232	(8)(7)WRITTEN POLICIES AND PROCEDURES.--Wholesale drug
1233	distributors must establish, maintain, and adhere to written
1234	policies and procedures, which must be followed for the receipt,
1235	security, storage, inventory, and distribution of prescription
1236	drugs, including policies and procedures for identifying,
1237	recording, and reporting losses or thefts, and for correcting
1238	all errors and inaccuracies in inventories. Wholesale drug
1239	distributors must include in their written policies and
1240	procedures:
1241	(a) A procedure whereby the oldest approved stock of a
1242	prescription drug product is distributed first. The procedure
1243	may permit deviation from this requirement, if the deviation is
1244	temporary and appropriate.
1245	(b) A procedure to be followed for handling recalls and
1246	withdrawals of prescription drugs. Such procedure must be
1247	adequate to deal with recalls and withdrawals due to:
1248	1. Any action initiated at the request of the Food and
1249	Drug Administration or any other federal, state, or local law
1250	enforcement or other government agency, including the
1251	department.
1252	2. Any voluntary action by the manufacturer to remove
1253	defective or potentially defective drugs from the market; or
1254	3. Any action undertaken to promote public health and
1255	safety by replacing existing merchandise with an improved
1256	product or new package design.
1257	(c) A procedure to ensure that wholesale drug distributors
1258	prepare for, protect against, and handle any crisis that affects
1259	security or operation of any facility if a strike, fire, flood,
1260	or other natural disaster, or a local, state, or national
1261	emergency, occurs.
1262	(d) A procedure to ensure that any outdated prescription
1263	drugs are segregated from other drugs and either returned to the
1264	manufacturer or destroyed. This procedure must provide for
1265	written documentation of the disposition of outdated
1266	prescription drugs. This documentation must be maintained for 2
1267	years after disposition of the outdated drugs.
1268	(9)(8)RESPONSIBLE PERSONS.--Wholesale drug distributors
1269	must establish and maintain lists of officers, directors,
1270	managers, wholesaler's representatives,and other persons in
1271	charge of wholesale drug distribution, storage, and handling,
1272	including a description of their duties and a summary of their
1273	qualifications.
1274	(10)(9)COMPLIANCE WITH FEDERAL, STATE, AND LOCAL LAW.--A
1275	wholesale drug distributor must operate in compliance with
1276	applicable federal, state, and local laws and regulations.
1277	(a) A wholesale drug distributor must allow the department
1278	and authorized federal, state, and local officials to enter and
1279	inspect its premises and delivery vehicles, and to audit its
1280	records and written operating procedures, at reasonable times
1281	and in a reasonable manner, to the extent authorized by law.
1282	(b) A wholesale drug distributor that deals in controlled
1283	substances must register with the Drug Enforcement
1284	Administration and must comply with all applicable state, local,
1285	and federal laws. A wholesale drug distributor that distributes
1286	any substance controlled under chapter 893 must notify the
1287	department when registering with the Drug Enforcement
1288	Administration pursuant to that chapter and must provide the
1289	department with its DEA number.
1290	(c) A wholesale drug distributor shall not pay for any
1291	drug with currency, as defined in s. 560.103(6).
1292	(11)(10)SALVAGING AND REPROCESSING.--A wholesale drug
1293	distributor is subject to any applicable federal, state, or
1294	local laws or regulations that relate to prescription drug
1295	product salvaging or reprocessing.
1296	Section 6. Paragraphs (b) and (c) of subsection (2) of
1297	section 499.0122, Florida Statutes, are amended to read:
1298	499.0122 Medical oxygen and veterinary legend drug retail
1299	establishments; definitions, permits, general requirements.--
1300	(2)
1301	(b) The department shall adopt rules relating to
1302	information required from each retail establishment pursuant to
1303	s. 499.01(4) and (5)(2), including requirements for
1304	prescriptions or orders.
1305	(c) A retail establishment must comply with all of the
1306	wholesale distribution requirements of s. 499.0121 except those
1307	set forth in s. 499.0121(7)(6)(d) and (e).
1308	Section 7. Section 499.0125, Florida Statutes, is created
1309	to read:
1310	499.0125 Drug Wholesaler Advisory Council.--
1311	(1) There is created the Drug Wholesaler Advisory Council
1312	in the department. The council shall meet at least three times
1313	each year. Staff for the council shall be provided by the
1314	department. The council shall consist of nine members who shall
1315	serve without compensation.
1316	(2) The secretary of the department shall appoint three
1317	members, one of whom must be a pharmacist licensed pursuant to
1318	chapter 465 who is employed in a retail pharmacy drug wholesaler
1319	licensed pursuant to this chapter, one of whom must be a person
1320	employed by a prescription drug wholesaler licensed pursuant to
1321	this chapter, and one of whom must be the department employee
1322	responsible for supervising the administration of ss. 499.001–
1323	499.081. The Speaker of the House of Representatives shall
1324	appoint three members, one of whom must be a person
1325	knowledgeable about the pharmaceutical distribution industry who
1326	is employed by a primary wholesaler, as defined in s.
1327	499.012(1)(d), that is licensed pursuant to this chapter, one of
1328	whom must be an employee of a retail pharmacy chain located in
1329	Florida, and one of whom must be a member of the Florida House
1330	of Representatives. The President of the Senate shall appoint
1331	three members, one of whom must be a person knowledgeable about
1332	the pharmaceutical distribution industry who is employed by a
1333	secondary wholesaler, as defined in s. 499.012(1)(f), that is
1334	licensed pursuant to this chapter, one of whom must be an
1335	employee of a retail grocery chain that operates a retail
1336	pharmacy in Florida, and one of whom must be a member of the
1337	Senate. The members of the council shall elect a chair and a
1338	vice chair who will serve a term of 1 year each.
1339	(3) The council shall review ss. 499.001-499.081 and the
1340	rules adopted to implement ss. 499.001–499.081 annually, provide
1341	input to the department regarding all proposed rules to
1342	implement ss. 499.001–499.081, make recommendations to the
1343	department to improve the protection of prescription drugs and
1344	the public health, improve the technology and means used in the
1345	wholesale distribution of drugs, make recommendations to improve
1346	coordination with other states' regulatory agencies and the
1347	Federal Government concerning wholesale distribution of drugs,
1348	and make recommendations to minimize the impact of regulation of
1349	the wholesale distribution industry while ensuring protection of
1350	the public health.
1351	Section 8. Paragraph (a) of subsection (1) and subsection
1352	(3) of section 499.015, Florida Statutes, are amended to read:
1353	499.015 Registration of drugs, devices, and cosmetics;
1354	issuance of certificates of free sale.--
1355	(1)(a) Except for those persons exempted from the
1356	definition in s. 499.003(22)(21), any person who manufactures,
1357	packages, repackages, labels, or relabels a drug, device, or
1358	cosmetic in this state must register such drug, device, or
1359	cosmetic biennially with the department; pay a fee in accordance
1360	with the fee schedule provided by s. 499.041; and comply with
1361	this section. The registrant must list each separate and
1362	distinct drug, device, or cosmetic at the time of registration.
1363	(3) Except for those persons exempted from the definition
1364	in s. 499.003(22)(21), a person may not sell any product that he
1365	or she has failed to register in conformity with this section.
1366	Such failure to register subjects such drug, device, or cosmetic
1367	product to seizure and condemnation as provided in ss. 499.062-
1368	499.064, and subjects such person to the penalties and remedies
1369	provided in ss. 499.001-499.081.
1370	Section 9. Subsection (3) of section 499.024, Florida
1371	Statutes, is amended to read:
1372	499.024 Drug product classification.--The secretary shall
1373	adopt rules to classify drug products intended for use by humans
1374	which the United States Food and Drug Administration has not
1375	classified in the federal act or the Code of Federal
1376	Regulations.
1377	(3) Any product that falls under the drug definition, s.
1378	499.003(13)(12), may be classified under the authority of this
1379	section. This section does not subject portable emergency oxygen
1380	inhalators to classification; however, this section does not
1381	exempt any person from ss. 499.01 and 499.015.
1382	Section 10. Subsection (1) of section 499.03, Florida
1383	Statutes, is amended to read:
1384	499.03 Possession of new drugs or legend drugs without
1385	prescriptions unlawful; exemptions and exceptions.--
1386	(1) A person may not possess, or possess with intent to
1387	sell, dispense, or deliver, any habit-forming, toxic, harmful,
1388	or new drug subject to s. 499.003(23)(22), or legend drug as
1389	defined in s. 499.003(20)(19), unless the possession of the drug
1390	has been obtained by a valid prescription of a practitioner
1391	licensed by law to prescribe the drug. However, this section
1392	does not apply to the delivery of such drugs to persons included
1393	in any of the classes named in this subsection, or to the agents
1394	or employees of such persons, for use in the usual course of
1395	their businesses or practices or in the performance of their
1396	official duties, as the case may be; nor does this section apply
1397	to the possession of such drugs by those persons or their agents
1398	or employees for such use:
1399	(a) A licensed pharmacist or any person under the licensed
1400	pharmacist's supervision while acting within the scope of the
1401	licensed pharmacist's practice;
1402	(b) A licensed practitioner authorized by law to prescribe
1403	legend drugs or any person under the licensed practitioner's
1404	supervision while acting within the scope of the licensed
1405	practitioner's practice;
1406	(c) A qualified person who uses legend drugs for lawful
1407	research, teaching, or testing, and not for resale;
1408	(d) A licensed hospital or other institution that procures
1409	such drugs for lawful administration or dispensing by
1410	practitioners;
1411	(e) An officer or employee of a federal, state, or local
1412	government; or
1413	(f) A person that holds a valid permit issued by the
1414	department pursuant to ss. 499.001-499.081 which authorizes that
1415	person to possess prescription drugs.
1416	Section 11. Subsection (2) and subsection (4) of section
1417	499.041, Florida Statutes, are amended to read:
1418	499.041 Schedule of fees for drug, device, and cosmetic
1419	applications and permits, product registrations, and free-sale
1420	certificates.--
1421	(2) The department shall assess an applicant that is
1422	required to have a wholesaling permit an annual fee within the
1423	ranges established in this section for the specific type of
1424	wholesaling.
1425	(a) The fee for a prescription drug wholesaler's permit
1426	may not be less than $300 or more than $800$400annually;
1427	(b) The fee for a compressed medical gas wholesaler's
1428	permit may not be less than $200 or more than $300 annually;
1429	(c) The fee for an out-of-state prescription drug
1430	wholesaler's permit may not be less than $300$200 or more than
1431	$600$300annually;
1432	(d) The fee for a retail pharmacy drugwholesaler's permit
1433	may not be less than $35 or more than $100$50annually.
1434	(4) The department shall assess an applicant that is
1435	required to have a restricted prescription drug distributor's
1436	permit an annual fee of not less than $200 or more than $600
1437	$300.
1438	Section 12. Paragraph (g) of subsection (1) of section
1439	499.05, Florida Statutes, is amended to read:
1440	499.05 Rules.--
1441	(1) The department shall adopt rules to implement and
1442	enforce ss. 499.001-499.081 with respect to:
1443	(g) Inspections and investigations conducted under s.
1444	499.051, and the identification of information claimed to be a
1445	trade secret and exempt from the public records law as provided
1446	in s. 499.051(6)(5).
1447	Section 13. Section 499.051, Florida Statutes, is amended
1448	to read:
1449	499.051 Inspections and investigations.--
1450	(1) The agents of the Department of Health and of the
1451	Department of Law Enforcement, after they present proper
1452	identification, may inspect, monitor, and investigate any
1453	establishment permitted pursuant to ss. 499.001-499.081 during
1454	business hours for the purpose of enforcing ss. 499.001-499.081,
1455	chapters 465, 501, and 893, and the rules of the department that
1456	protect the public health, safety, and welfare.
1457	(2) In addition to the authority set forth in subsection
1458	(1), the department and any duly designated officer or employee
1459	of the department may enter and inspect any other establishment
1460	for the purpose of determining compliance with ss. 499.001-
1461	499.081 and rules adopted under those sections regarding any
1462	drug, device, or cosmetic product. The authority to enter and
1463	inspect does not extend to the practice of the profession of
1464	pharmacy, as defined in chapter 465 and the rules adopted under
1465	that chapter, in a pharmacy permitted under chapter 465. The
1466	Department of Business and Professional Regulation shall conduct
1467	routine inspections of retail pharmacy drugwholesalers at the
1468	time of the regular pharmacy permit inspection and shall send
1469	the inspection report regarding drug wholesale activity to the
1470	Department of Health.
1471	(3) Any application for a permit or product registration
1472	or for renewal of such permit or registration made pursuant to
1473	ss. 499.001-499.081 and rules adopted under those sections
1474	constitutes permission for any entry or inspection of the
1475	premises in order to verify compliance with those sections and
1476	rules; to discover, investigate, and determine the existence of
1477	compliance; or to elicit, receive, respond to, and resolve
1478	complaints and violations.
1479	(4) Any application for a permit made pursuant to s.
1480	499.012 and rules adopted under those sections constitutes
1481	permission for agents of the Department of Health and the
1482	Department of Law Enforcement, after they present proper
1483	identification, to inspect and copy any financial document or
1484	record related to the distribution of a drug as is necessary to
1485	verify compliance with ss. 499.001–499.081 and the rules adopted
1486	by the department to implement those sections, to discover,
1487	investigate, and determine the existence of compliance, or to
1488	elicit, receive, respond to, and resolve complaints and
1489	violations.
1490	(5)(4)The authority to inspect under this section
1491	includes the authority to secure:
1492	(a) Samples or specimens of any drug, device, or cosmetic;
1493	or
1494	(b) Such other evidence as is needed for any action to
1495	enforce ss. 499.001-499.081 and the rules adopted under those
1496	sections.
1497	(6)(5)The complaint and all information obtained pursuant
1498	to the investigation by the department are confidential and
1499	exempt from the provisions of s. 119.07(1) and s. 24(a), Art. I
1500	of the State Constitution until the investigation and the
1501	enforcement action are completed. However, trade secret
1502	information contained therein as defined by s. 812.081(1)(c)
1503	shall remain confidential and exempt from the provisions of s.
1504	119.07(1) and s. 24(a), Art. I of the State Constitution, as
1505	long as the information is retained by the department. This
1506	subsection does not prohibit the department from using such
1507	information for regulatory or enforcement proceedings under this
1508	chapter or from providing such information to any law
1509	enforcement agency or any other regulatory agency. However, the
1510	receiving agency shall keep such records confidential and exempt
1511	as provided in this subsection. In addition, this subsection is
1512	not intended to prevent compliance with the provisions of s.
1513	499.0121(7)(6)(d) or (e), and the pedigree papers required in
1514	that subsection shall not be deemed a trade secret.
1515	Section 14. Section 499.0671, Florida Statutes, is created
1516	to read:
1517	499.0671 Enforcement; cease and desist orders; removal of
1518	certain persons.--
1519	(1) DEFINITION.--For the purposes of this section, the
1520	term "permittee" means any person holding a permit issued
1521	pursuant to s. 499.021.
1522	(2) ENFORCEMENT GENERALLY.--The department may institute
1523	such suits or other legal proceedings as may be required to
1524	enforce any provision of ss. 499.001 – 499-081. If it appears
1525	that any person has violated any provision of ss. 499.001-
1526	499.081 for which criminal prosecution is provided, the
1527	department shall provide the appropriate state attorney or other
1528	prosecuting agency having jurisdiction with respect to such
1529	prosecution with the relevant information in its possession.
1530	(3) CEASE AND DESIST ORDERS.--
1531	(a) The department may issue and serve a complaint stating
1532	charges upon any permittee or upon any affiliated party,
1533	whenever the department has reasonable cause to believe that the
1534	person or individual named therein is engaging in or has engaged
1535	in conduct that is:
1536	1. An act that demonstrates a lack of fitness or
1537	trustworthiness to engage in the business authorized under the
1538	permit issued pursuant to ss. 499.001-499.081, is hazardous to
1539	the public health, or constitutes business operations that are a
1540	detriment to the public health, stockholders, investors,
1541	creditors, or the public;
1542	2. A violation of any provision of ss. 499.001-499.081;
1543	3. A violation of any rule of the department;
1544	4. A violation of any order of the department; or
1545	5. A breach of any written agreement with the department.
1546	(b) The complaint shall contain a statement of facts and
1547	notice of opportunity for a hearing pursuant to ss. 120.569 and
1548	120.57.
1549	(c) If no hearing is requested within the time allowed by
1550	ss. 120.569 and 120.57, or if a hearing is held and the
1551	department finds that any of the charges are proven, the
1552	department may enter an order directing the permittee or the
1553	affiliated party named in the complaint to cease and desist from
1554	engaging in the conduct complained of and take corrective action
1555	to remedy the effects of past improper conduct and ensure future
1556	compliance.
1557	(d) If the permittee or affiliated party named in the
1558	order fails to respond to the complaint within the time allotted
1559	by ss. 120.569 and 120.57, the failure constitutes a default and
1560	justifies the entry of a cease and desist order.
1561	(e) A contested or default cease and desist order is
1562	effective when reduced to writing and served upon the permittee
1563	or affiliated party named therein. An uncontested cease and
1564	desist order is effective as agreed.
1565	(f) Whenever the department finds that conduct described
1566	in paragraph (a) is likely to cause an immediate threat to the
1567	public health, it may issue an emergency cease and desist order
1568	requiring the licensee or any affiliated party to immediately
1569	cease and desist from engaging in the conduct complained of and
1570	to take corrective and remedial action. The emergency order is
1571	effective immediately upon service of a copy of the order upon
1572	the permittee or affiliated party named therein and remains
1573	effective for 90 days. If the department begins nonemergency
1574	cease and desist proceedings under this subsection, the
1575	emergency order remains effective until the conclusion of the
1576	proceedings under ss. 120.569 and 120.57.
1577	(4) REMOVAL OF AFFILIATED PARTIES BY THE DEPARTMENT.--
1578	(a) The department may issue and serve a complaint stating
1579	charges upon any affiliated party and upon the licensee
1580	involved, whenever the department has reason to believe that an
1581	affiliated party is engaging in or has engaged in conduct that
1582	constitutes:
1583	1. An act that demonstrates a lack of fitness or
1584	trustworthiness to engage in the business authorized under the
1585	permit issued pursuant to ss. 499.001-499.081, is hazardous to
1586	the public health, or constitutes business operations that are a
1587	detriment to the public health, stockholders, investors,
1588	creditors, or the public;
1589	2. A willful violation of ss. 499-001–499.081; however, if
1590	the violation constitutes a misdemeanor, no complaint shall be
1591	served as provided in this section until the affiliated party is
1592	notified in writing of the matter of the violation and has been
1593	afforded a reasonable period of time, as set forth in the
1594	notice, to correct the violation and has failed to do so;
1595	3. A violation of any other law involving fraud or moral
1596	turpitude that constitutes a felony;
1597	4. A willful violation of any rule of the department;
1598	5. A willful violation of any order of the department;
1599	6. A material misrepresentation of fact, made knowingly
1600	and willfully or made with reckless disregard for the truth of
1601	the matter; or
1602	7. An act of commission or omission or a practice which is
1603	a breach of trust or a breach of fiduciary duty.
1604	(b) The complaint shall contain a statement of facts and
1605	notice of opportunity for a hearing pursuant to ss. 120.569 and
1606	120.57.
1607	(c) If no hearing is requested within the time allotted by
1608	ss. 120.569 and 120.57, or if a hearing is held and the
1609	department finds that any of the charges in the complaint are
1610	proven true and that:
1611	1. The permittee has suffered or will likely suffer loss
1612	or other damage;
1613	2. The interests of the permittee' stockholders or
1614	creditors, or the public are, or could be, seriously prejudiced
1615	by reason of the violation or act or breach of fiduciary duty;
1616	3. The affiliated party has received financial gain by
1617	reason of the violation, act, or breach of fiduciary duty; or
1618	4. The violation, act, or breach of fiduciary duty is one
1619	involving personal dishonesty on the part of the affiliated
1620	party or the conduct jeopardizes or could reasonably be
1621	anticipated to jeopardize the public health or financial
1622	soundness of the permittee,
1623
1624	the department may enter an order removing the affiliated party
1625	or restricting or prohibiting participation by the person in the
1626	affairs of that particular permittee or of any other permittee.
1627	(d) If the affiliated party fails to respond to the
1628	complaint within the time allotted by ss. 120.569 and 120.57,
1629	the failure constitutes a default and justifies the entry of an
1630	order of removal, suspension, or restriction.
1631	(e) A contested or default order of removal, restriction,
1632	or prohibition is effective when reduced to writing and served
1633	on the licensee and the affiliated party. An uncontested order
1634	of removal, restriction, or prohibition is effective as agreed.
1635	(f)1. The chief executive officer, designated
1636	representative, or the person holding the equivalent office, of
1637	a permittee shall promptly notify the department if she or he
1638	has actual knowledge that any affiliated party is charged with a
1639	felony in a state or federal court.
1640	2. Whenever any affiliated party is charged with a felony
1641	in a state or federal court or with the equivalent of a felony
1642	in the courts of any foreign country with which the United
1643	States maintains diplomatic relations, and the charge alleges
1644	violation of any law involving prescription drugs,
1645	pharmaceuticals, fraud, theft, or moral turpitude, the
1646	department may enter an emergency order suspending the
1647	affiliated party or restricting or prohibiting participation by
1648	the affiliated party in the affairs of the particular permittee
1649	or of any other permittee upon service of the order upon the
1650	permittee and the affiliated party charged. The order shall
1651	contain notice of opportunity for a hearing pursuant to ss.
1652	120.569 and 120.57, where the affiliated party may request a
1653	postsuspension hearing to show that continued service to or
1654	participation in the affairs of the licensee does not pose a
1655	threat to the public health or the interests of the permittee
1656	and does not threaten to impair public confidence in the
1657	permittee. In accordance with applicable departmental rules, the
1658	department shall notify the affiliated party whether the order
1659	suspending or prohibiting the person from participation in the
1660	affairs of a permittee will be rescinded or otherwise modified.
1661	The emergency order remains in effect, unless otherwise modified
1662	by the department, until the criminal charge is disposed of. The
1663	acquittal of the person charged, or the final, unappealed
1664	dismissal of all charges against the person, dissolves the
1665	emergency order, but does not prohibit the department from
1666	instituting proceedings under paragraph (a). If the person
1667	charged is convicted or pleads guilty or nolo contendere,
1668	whether or not an adjudication of guilt is entered by the court,
1669	the emergency order shall become final.
1670	(g) Any affiliated party removed from office pursuant to
1671	this section is not eligible for reemployment by the permittee
1672	or reelection or appointment to the position, to any other
1673	official position in any licensee in this state except upon the
1674	written consent of the department. Any affiliated party who is
1675	removed, restricted, or prohibited from participation in the
1676	affairs of a permittee pursuant to this section may petition the
1677	department for modification or termination of the removal,
1678	restriction, or prohibition.
1679	(h) Resignation or termination of an affiliated party does
1680	not affect the department's jurisdiction to proceed under this
1681	subsection.
1682	Section 15. Section 499.069, Florida Statutes, is amended
1683	to read:
1684	499.069 Punishment for violations of s. 499.005;
1685	dissemination of false advertisement.--
1686	(1) Any person who violates any of the provisions of s.
1687	499.005 is guilty of a misdemeanor of the second degree,
1688	punishable as provided in s. 775.082 or s. 775.083; but, if the
1689	violation is committed after a conviction of such person under
1690	this section has become final, such person is guilty of a
1691	misdemeanor of the first degree, punishable as provided in s.
1692	775.082 or s. 775.083 or as otherwise provided in ss. 499.001-
1693	499.081, except that any person who violates subsection (8),
1694	subsection (9),subsection (10), subsection (14), subsection
1695	(15), or subsection (17), subsection (18), subsection (19),
1696	subsection (20), subsection (21), subsection (22), subsection
1697	(26), or subsection (27)of s. 499.005 is guilty of a felony of
1698	the secondthirddegree, punishable as provided in s. 775.082,
1699	s. 775.083, or s. 775.084, or as otherwise provided in ss.
1700	499.001-499.081.
1701	(2) A person is not subject to the penalties of subsection
1702	(1) for having violated any of the provisions of s. 499.005 if
1703	he or she establishes a guaranty or undertaking, which guaranty
1704	or undertaking is signed by and contains the name and address of
1705	the person residing in the state, or the manufacturer, from whom
1706	he or she received the article in good faith, to the effect that
1707	such article is not adulterated or misbranded within the meaning
1708	of ss. 499.001-499.081, citing such sections.
1709	(3) A publisher, radio broadcast licensee, or agency or
1710	medium for the dissemination of an advertisement, except the
1711	manufacturer, wholesaler, or seller of the article to which a
1712	false advertisement relates, is not liable under this section by
1713	reason of the dissemination by him or her of such false
1714	advertisement, unless he or she has refused, on the request of
1715	the department, to furnish to the department the name and post
1716	office address of the manufacturer, wholesaler, seller, or
1717	advertising agency that asked him or her to disseminate such
1718	advertisement.
1719	Section 16. This act shall take effect July 1, 2003.