HB 1367

1	A bill to be entitled
2	An act relating to drugs, cosmetics, and certain devices;
3	amending s. 499.01, F.S.; requiring the Department of
4	Health to notify an applicant for a prescription drug
5	wholesale distributor permit or an out-of-state
6	prescription drug wholesale distributor permit of the
7	status of its permit application within a specified period
8	after receipt of all required documentation; deleting
9	provisions relating to the submission of a bond or certain
10	other security; amending s. 499.012, F.S.; revising permit
11	application requirements to apply those requirements to
12	all applicants and delete provisions specific to certain
13	applicants; amending ss. 499.003, 499.0121, and 499.067,
14	F.S.; conforming provisions; providing an effective date.
15
16	Be It Enacted by the Legislature of the State of Florida:
17
18	Section 1.  Paragraphs (d) and (e) of subsection (2) of
19	section 499.01, Florida Statutes, are amended to read:
20	499.01  Permits.-
21	(2)  The following permits are established:
22	(d)  Prescription drug wholesale distributor permit.-A
23	prescription drug wholesale distributor is a wholesale
24	distributor that may engage in the wholesale distribution of
25	prescription drugs. A prescription drug wholesale distributor
26	that applies to the department for a new permit or the renewal
27	of a permit must submit a bond of $100,000, or other equivalent
28	means of security acceptable to the department, such as an
29	irrevocable letter of credit or a deposit in a trust account or
30	financial institution, payable to the Florida Drug, Device, and
31	Cosmetic Trust Fund. The purpose of the bond is to secure
32	payment of any administrative penalties imposed by the
33	department and any fees and costs incurred by the department
34	regarding that permit which are authorized under state law and
35	which the permittee fails to pay 30 days after the fine or costs
36	become final. The department may make a claim against such bond
37	or security until 1 year after the permittee's license ceases to
38	be valid or until 60 days after any administrative or legal
39	proceeding authorized in this part which involves the permittee
40	is concluded, including any appeal, whichever occurs later. The
41	department may adopt rules for issuing a prescription drug
42	wholesale distributor distributor-broker permit to a person who
43	engages in the wholesale distribution of prescription drugs and
44	does not take physical possession of any prescription drugs. The
45	department shall notify a prescription drug wholesale
46	distributor that applies for a permit the status of its permit
47	within 60 days after receipt of all documentation required by
48	the application.
49	(e)  Out-of-state prescription drug wholesale distributor
50	permit.-An out-of-state prescription drug wholesale distributor
51	is a wholesale distributor located outside this state which
52	engages in the wholesale distribution of prescription drugs into
53	this state and which must be permitted by the department and
54	comply with all the provisions required of a wholesale
55	distributor under this part. An out-of-state prescription drug
56	wholesale distributor that applies to the department for a new
57	permit or the renewal of a permit must submit a bond of
58	$100,000, or other equivalent means of security acceptable to
59	the department, such as an irrevocable letter of credit or a
60	deposit in a trust account or financial institution, payable to
61	the Florida Drug, Device, and Cosmetic Trust Fund. The purpose
62	of the bond is to secure payment of any administrative penalties
63	imposed by the department and any fees and costs incurred by the
64	department regarding that permit which are authorized under
65	state law and which the permittee fails to pay 30 days after the
66	fine or costs become final. The department may make a claim
67	against such bond or security until 1 year after the permittee's
68	license ceases to be valid or until 60 days after any
69	administrative or legal proceeding authorized in this part which
70	involves the permittee is concluded, including any appeal,
71	whichever occurs later.
72	1.  The out-of-state prescription drug wholesale
73	distributor must maintain at all times a license or permit to
74	engage in the wholesale distribution of prescription drugs in
75	compliance with laws of the state in which it is a resident.
76	2.  The department shall notify an out-of-state
77	prescription drug wholesale distributor that applies for a
78	permit the status of its permit within 60 days after receipt of
79	all documentation required by the application.
80	3.2.  An out-of-state prescription drug wholesale
81	distributor permit is not required for an intracompany sale or
82	transfer of a prescription drug from an out-of-state
83	establishment that is duly licensed as a prescription drug
84	wholesale distributor, in its state of residence, to a licensed
85	prescription drug wholesale distributor in this state, if both
86	wholesale distributors conduct wholesale distributions of
87	prescription drugs under the same business name. The
88	recordkeeping requirements of ss. 499.0121(6) and 499.01212 must
89	be followed for this transaction.
90	Section 2.  Section 499.012, Florida Statutes, is amended
91	to read:
92	499.012  Permit application requirements.-
93	(1)(a)  A permit issued pursuant to this part may be issued
94	only to a natural person who is at least 18 years of age or to
95	an applicant that is not a natural person if each person who,
96	directly or indirectly, manages, controls, or oversees the
97	operation of that applicant is at least 18 years of age.
98	(b)  An establishment that is a place of residence may not
99	receive a permit and may not operate under this part.
100	(c)  A person that applies for or renews a permit to
101	manufacture or distribute prescription drugs may not use a name
102	identical to the name used by any other establishment or
103	licensed person authorized to purchase prescription drugs in
104	this state, except that a restricted drug distributor permit
105	issued to a health care entity will be issued in the name in
106	which the institutional pharmacy permit is issued and a retail
107	pharmacy drug wholesale distributor will be issued a permit in
108	the name of its retail pharmacy permit.
109	(d)  A permit for a prescription drug manufacturer,
110	prescription drug repackager, prescription drug wholesale
111	distributor, limited prescription drug veterinary wholesale
112	distributor, or retail pharmacy drug wholesale distributor may
113	not be issued to the address of a health care entity or to a
114	pharmacy licensed under chapter 465, except as provided in this
115	paragraph. The department may issue a prescription drug
116	manufacturer permit to an applicant at the same address as a
117	licensed nuclear pharmacy, which is a health care entity, for
118	the purpose of manufacturing prescription drugs used in positron
119	emission tomography or other radiopharmaceuticals, as listed in
120	a rule adopted by the department pursuant to this paragraph. The
121	purpose of this exemption is to assure availability of state-of-
122	the-art pharmaceuticals that would pose a significant danger to
123	the public health if manufactured at a separate establishment
124	address from the nuclear pharmacy from which the prescription
125	drugs are dispensed. The department may also issue a retail
126	pharmacy drug wholesale distributor permit to the address of a
127	community pharmacy licensed under chapter 465 which does not
128	meet the definition of a closed pharmacy in s. 499.003.
129	(e)  A county or municipality may not issue an occupational
130	license for any licensing period beginning on or after October
131	1, 2003, for any establishment that requires a permit pursuant
132	to this part, unless the establishment exhibits a current permit
133	issued by the department for the establishment. Upon
134	presentation of the requisite permit issued by the department,
135	an occupational license may be issued by the municipality or
136	county in which application is made. The department shall
137	furnish to local agencies responsible for issuing occupational
138	licenses a current list of all establishments licensed pursuant
139	to this part.
140	(2)  Notwithstanding subsection (6), a permitted person in
141	good standing may change the type of permit issued to that
142	person by completing a new application for the requested permit,
143	paying the amount of the difference in the permit fees if the
144	fee for the new permit is more than the fee for the original
145	permit, and meeting the applicable permitting conditions for the
146	new permit type. The new permit expires on the expiration date
147	of the original permit being changed; however, a new permit for
148	a prescription drug wholesale distributor, an out-of-state
149	prescription drug wholesale distributor, or a retail pharmacy
150	drug wholesale distributor shall expire on the expiration date
151	of the original permit or 1 year after the date of issuance of
152	the new permit, whichever is earlier. A refund may not be issued
153	if the fee for the new permit is less than the fee that was paid
154	for the original permit.
155	(3)  A written application for a permit or to renew a
156	permit must be filed with the department on forms furnished by
157	the department. The department shall establish, by rule, the
158	form and content of the application to obtain or renew a permit.
159	The applicant must submit to the department with the application
160	a statement that swears or affirms that the information is true
161	and correct.
162	(4)(a)  Except for a permit for a prescription drug
163	wholesale distributor or an out-of-state prescription drug
164	wholesale distributor, An application for a permit must include:
165	1.  The name, full business address, and telephone number
166	of the applicant;
167	2.  All trade or business names used by the applicant;
168	3.  The address, telephone numbers, and the names of
169	contact persons for each facility used by the applicant for the
170	storage, handling, and distribution of prescription drugs;
171	4.  The type of ownership or operation, such as a
172	partnership, corporation, or sole proprietorship; and
173	5.  The names of the owner and the operator of the
174	establishment, including:
175	a.  If an individual, the name of the individual;
176	b.  If a partnership, the name of each partner and the name
177	of the partnership;
178	c.  If a corporation, the name and title of each corporate
179	officer and director, the corporate names, and the name of the
180	state of incorporation;
181	d.  If a sole proprietorship, the full name of the sole
182	proprietor and the name of the business entity;
183	e.  If a limited liability company, the name of each
184	member, the name of each manager, the name of the limited
185	liability company, and the name of the state in which the
186	limited liability company was organized; and
187	f.  Any other relevant information that the department
188	requires.
189	(b)  Upon approval of the application by the department and
190	payment of the required fee, the department shall issue a permit
191	to the applicant, if the applicant meets the requirements of
192	this part and rules adopted under this part.
193	(c)  Any change in information required under paragraph (a)
194	must be submitted to the department before the change occurs.
195	(d)  The department shall consider, at a minimum, the
196	following factors in reviewing the qualifications of persons to
197	be permitted under this part:
198	1.  The applicant's having been found guilty, regardless of
199	adjudication, in a court of this state or other jurisdiction, of
200	a violation of a law that directly relates to a drug, device, or
201	cosmetic. A plea of nolo contendere constitutes a finding of
202	guilt for purposes of this subparagraph.
203	2.  The applicant's having been disciplined by a regulatory
204	agency in any state for any offense that would constitute a
205	violation of this part.
206	3.  Any felony conviction of the applicant under a federal,
207	state, or local law;
208	4.  The applicant's past experience in manufacturing or
209	distributing drugs, devices, or cosmetics;
210	5.  The furnishing by the applicant of false or fraudulent
211	material in any application made in connection with
212	manufacturing or distributing drugs, devices, or cosmetics;
213	6.  Suspension or revocation by a federal, state, or local
214	government of any permit currently or previously held by the
215	applicant for the manufacture or distribution of any drugs,
216	devices, or cosmetics;
217	7.  Compliance with permitting requirements under any
218	previously granted permits;
219	8.  Compliance with requirements to maintain or make
220	available to the state permitting authority or to federal,
221	state, or local law enforcement officials those records required
222	under this section; and
223	9.  Any other factors or qualifications the department
224	considers relevant to and consistent with the public health and
225	safety.
226	(5)  Except for a permit for a prescription drug wholesale
227	distributor or an out-of-state prescription drug wholesale
228	distributor:
229	(a)  The department shall adopt rules for the biennial
230	renewal of permits.
231	(b)  The department shall renew a permit upon receipt of
232	the renewal application and renewal fee if the applicant meets
233	the requirements established under this part and the rules
234	adopted under this part.
235	(c)  A permit, unless sooner suspended or revoked,
236	automatically expires 2 years after the last day of the
237	anniversary month in which the permit was originally issued. A
238	permit issued under this part may be renewed by making
239	application for renewal on forms furnished by the department and
240	paying the appropriate fees. If a renewal application and fee
241	are submitted and postmarked after the expiration date of the
242	permit, the permit may be renewed only upon payment of a late
243	renewal delinquent fee of $100, plus the required renewal fee,
244	not later than 60 days after the expiration date.
245	(d)  Failure to renew a permit in accordance with this
246	section precludes any future renewal of that permit. If a permit
247	issued pursuant to this part has expired and cannot be renewed,
248	before an establishment may engage in activities that require a
249	permit under this part, the establishment must submit an
250	application for a new permit, pay the applicable application
251	fee, the initial permit fee, and all applicable penalties, and
252	be issued a new permit by the department.
253	(6)  A permit issued by the department is nontransferable.
254	Each permit is valid only for the person or governmental unit to
255	which it is issued and is not subject to sale, assignment, or
256	other transfer, voluntarily or involuntarily; nor is a permit
257	valid for any establishment other than the establishment for
258	which it was originally issued.
259	(a)  A person permitted under this part must notify the
260	department before making a change of address. The department
261	shall set a change of location fee not to exceed $100.
262	(b)1.  An application for a new permit is required when a
263	majority of the ownership or controlling interest of a permitted
264	establishment is transferred or assigned or when a lessee agrees
265	to undertake or provide services to the extent that legal
266	liability for operation of the establishment will rest with the
267	lessee. The application for the new permit must be made before
268	the date of the sale, transfer, assignment, or lease.
269	2.  A permittee that is authorized to distribute
270	prescription drugs may transfer such drugs to the new owner or
271	lessee under subparagraph 1. only after the new owner or lessee
272	has been approved for a permit to distribute prescription drugs.
273	(c)  If an establishment permitted under this part closes,
274	the owner must notify the department in writing before the
275	effective date of closure and must:
276	1.  Return the permit to the department;
277	2.  If the permittee is authorized to distribute
278	prescription drugs, indicate the disposition of such drugs,
279	including the name, address, and inventory, and provide the name
280	and address of a person to contact regarding access to records
281	that are required to be maintained under this part. Transfer of
282	ownership of prescription drugs may be made only to persons
283	authorized to possess prescription drugs under this part.
284
285	The department may revoke the permit of any person that fails to
286	comply with the requirements of this subsection.
287	(7)  A permit must be posted in a conspicuous place on the
288	licensed premises.
289	(8)  An application for a permit or to renew a permit for a
290	prescription drug wholesale distributor or an out-of-state
291	prescription drug wholesale distributor submitted to the
292	department must include:
293	(a)  The name, full business address, and telephone number
294	of the applicant.
295	(b)  All trade or business names used by the applicant.
296	(c)  The address, telephone numbers, and the names of
297	contact persons for each facility used by the applicant for the
298	storage, handling, and distribution of prescription drugs.
299	(d)  The type of ownership or operation, such as a
300	partnership, corporation, or sole proprietorship.
301	(e)  The names of the owner and the operator of the
302	establishment, including:
303	1.  If an individual, the name of the individual.
304	2.  If a partnership, the name of each partner and the name
305	of the partnership.
306	3.  If a corporation:
307	a.  The name, address, and title of each corporate officer
308	and director.
309	b.  The name and address of the corporation, resident agent
310	of the corporation, the resident agent's address, and the
311	corporation's state of incorporation.
312	c.  The name and address of each shareholder of the
313	corporation that owns 5 percent or more of the outstanding stock
314	of the corporation.
315	4.  If a sole proprietorship, the full name of the sole
316	proprietor and the name of the business entity.
317	5.  If a limited liability company:
318	a.  The name and address of each member.
319	b.  The name and address of each manager.
320	c.  The name and address of the limited liability company,
321	the resident agent of the limited liability company, and the
322	name of the state in which the limited liability company was
323	organized.
324	(f)  If applicable, the name and address of each member of
325	the affiliated group of which the applicant is a member.
326	(g)1.  For an application for a new permit, the estimated
327	annual dollar volume of prescription drug sales of the
328	applicant, the estimated annual percentage of the applicant's
329	total company sales that are prescription drugs, the applicant's
330	estimated annual total dollar volume of purchases of
331	prescription drugs, and the applicant's estimated annual total
332	dollar volume of prescription drug purchases directly from
333	manufacturers.
334	2.  For an application to renew a permit, the total dollar
335	volume of prescription drug sales in the previous year, the
336	total dollar volume of prescription drug sales made in the
337	previous 6 months, the percentage of total company sales that
338	were prescription drugs in the previous year, the total dollar
339	volume of purchases of prescription drugs in the previous year,
340	and the total dollar volume of prescription drug purchases
341	directly from manufacturers in the previous year.
342
343	Such portions of the information required pursuant to this
344	paragraph which are a trade secret, as defined in s. 812.081,
345	shall be maintained by the department as trade secret
346	information is required to be maintained under s. 499.051.
347	(h)  The tax year of the applicant.
348	(i)  A copy of the deed for the property on which
349	applicant's establishment is located, if the establishment is
350	owned by the applicant, or a copy of the applicant's lease for
351	the property on which applicant's establishment is located that
352	has an original term of not less than 1 calendar year, if the
353	establishment is not owned by the applicant.
354	(j)  A list of all licenses and permits issued to the
355	applicant by any other state which authorize the applicant to
356	purchase or possess prescription drugs.
357	(k)  The name of the manager of the establishment that is
358	applying for the permit or to renew the permit, the next four
359	highest ranking employees responsible for prescription drug
360	wholesale operations for the establishment, and the name of all
361	affiliated parties for the establishment, together with the
362	personal information statement and fingerprints required
363	pursuant to subsection (9) for each of such persons.
364	(l)  The name of each of the applicant's designated
365	representatives as required by subsection (16), together with
366	the personal information statement and fingerprints required
367	pursuant to subsection (9) for each such person.
368	(m)  For an applicant that is a secondary wholesale
369	distributor, each of the following:
370	1.  A personal background information statement containing
371	the background information and fingerprints required pursuant to
372	subsection (9) for each person named in the applicant's response
373	to paragraphs (k) and (l) and for each affiliated party of the
374	applicant.
375	2.  If any of the five largest shareholders of the
376	corporation seeking the permit is a corporation, the name,
377	address, and title of each corporate officer and director of
378	each such corporation; the name and address of such corporation;
379	the name of such corporation's resident agent, such
380	corporation's resident agent's address, and such corporation's
381	state of its incorporation; and the name and address of each
382	shareholder of such corporation that owns 5 percent or more of
383	the stock of such corporation.
384	3.  The name and address of all financial institutions in
385	which the applicant has an account which is used to pay for the
386	operation of the establishment or to pay for drugs purchased for
387	the establishment, together with the names of all persons that
388	are authorized signatories on such accounts. The portions of the
389	information required pursuant to this subparagraph which are a
390	trade secret, as defined in s. 812.081, shall be maintained by
391	the department as trade secret information is required to be
392	maintained under s. 499.051.
393	4.  The sources of all funds and the amounts of such funds
394	used to purchase or finance purchases of prescription drugs or
395	to finance the premises on which the establishment is to be
396	located.
397	5.  If any of the funds identified in subparagraph 4. were
398	borrowed, copies of all promissory notes or loans used to obtain
399	such funds.
400	(n)  Any other relevant information that the department
401	requires, including, but not limited to, any information related
402	to whether the applicant satisfies the definition of a primary
403	wholesale distributor or a secondary wholesale distributor.
404	(9)(a)  Each person required by subsection (8) to provide a
405	personal information statement and fingerprints shall provide
406	the following information to the department on forms prescribed
407	by the department:
408	1.  The person's places of residence for the past 7 years.
409	2.  The person's date and place of birth.
410	3.  The person's occupations, positions of employment, and
411	offices held during the past 7 years.
412	4.  The principal business and address of any business,
413	corporation, or other organization in which each such office of
414	the person was held or in which each such occupation or position
415	of employment was carried on.
416	5.  Whether the person has been, during the past 7 years,
417	the subject of any proceeding for the revocation of any license
418	and, if so, the nature of the proceeding and the disposition of
419	the proceeding.
420	6.  Whether, during the past 7 years, the person has been
421	enjoined, temporarily or permanently, by a court of competent
422	jurisdiction from violating any federal or state law regulating
423	the possession, control, or distribution of prescription drugs,
424	together with details concerning any such event.
425	7.  A description of any involvement by the person with any
426	business, including any investments, other than the ownership of
427	stock in a publicly traded company or mutual fund, during the
428	past 7 years, which manufactured, administered, prescribed,
429	distributed, or stored pharmaceutical products and any lawsuits
430	in which such businesses were named as a party.
431	8.  A description of any felony criminal offense of which
432	the person, as an adult, was found guilty, regardless of whether
433	adjudication of guilt was withheld or whether the person pled
434	guilty or nolo contendere. A criminal offense committed in
435	another jurisdiction which would have been a felony in this
436	state must be reported. If the person indicates that a criminal
437	conviction is under appeal and submits a copy of the notice of
438	appeal of that criminal offense, the applicant must, within 15
439	days after the disposition of the appeal, submit to the
440	department a copy of the final written order of disposition.
441	9.  A photograph of the person taken in the previous 30
442	days.
443	10.  A set of fingerprints for the person on a form and
444	under procedures specified by the department, together with
445	payment of an amount equal to the costs incurred by the
446	department for the criminal record check of the person.
447	11.  The name, address, occupation, and date and place of
448	birth for each member of the person's immediate family who is 18
449	years of age or older. As used in this subparagraph, the term
450	"member of the person's immediate family" includes the person's
451	spouse, children, parents, siblings, the spouses of the person's
452	children, and the spouses of the person's siblings.
453	12.  Any other relevant information that the department
454	requires.
455	(b)  The information required pursuant to paragraph (a)
456	shall be provided under oath.
457	(c)  The department shall submit the fingerprints provided
458	by a person for initial licensure to the Department of Law
459	Enforcement for a statewide criminal record check and for
460	forwarding to the Federal Bureau of Investigation for a national
461	criminal record check of the person. The department shall submit
462	the fingerprints provided by a person as a part of a renewal
463	application to the Department of Law Enforcement for a statewide
464	criminal record check, and for forwarding to the Federal Bureau
465	of Investigation for a national criminal record check, for the
466	initial renewal of a permit after January 1, 2004; for any
467	subsequent renewal of a permit, the department shall submit the
468	required information for a statewide and national criminal
469	record check of the person. Any person who as a part of an
470	initial permit application or initial permit renewal after
471	January 1, 2004, submits to the department a set of fingerprints
472	required for the criminal record check required in this
473	paragraph shall not be required to provide a subsequent set of
474	fingerprints for a criminal record check to the department, if
475	the person has undergone a criminal record check as a condition
476	of the issuance of an initial permit or the initial renewal of a
477	permit of an applicant after January 1, 2004.
478	(10)  The department may deny an application for a permit
479	or refuse to renew a permit for a prescription drug wholesale
480	distributor or an out-of-state prescription drug wholesale
481	distributor if:
482	(a)  The applicant has not met the requirements for the
483	permit.
484	(b)  The management, officers, or directors of the
485	applicant or any affiliated party are found by the department to
486	be incompetent or untrustworthy.
487	(c)  The applicant is so lacking in experience in managing
488	a wholesale distributor as to make the issuance of the proposed
489	permit hazardous to the public health.
490	(d)  The applicant is so lacking in experience in managing
491	a wholesale distributor as to jeopardize the reasonable promise
492	of successful operation of the wholesale distributor.
493	(e)  The applicant is lacking in experience in the
494	distribution of prescription drugs.
495	(f)  The applicant's past experience in manufacturing or
496	distributing prescription drugs indicates that the applicant
497	poses a public health risk.
498	(g)  The applicant is affiliated directly or indirectly
499	through ownership, control, or other business relations, with
500	any person or persons whose business operations are or have been
501	detrimental to the public health.
502	(h)  The applicant, or any affiliated party, has been found
503	guilty of or has pleaded guilty or nolo contendere to any felony
504	or crime punishable by imprisonment for 1 year or more under the
505	laws of the United States, any state, or any other country,
506	regardless of whether adjudication of guilt was withheld.
507	(i)  The applicant or any affiliated party has been charged
508	with a felony in a state or federal court and the disposition of
509	that charge is pending during the application review or renewal
510	review period.
511	(j)  The applicant has furnished false or fraudulent
512	information or material in any application made in this state or
513	any other state in connection with obtaining a permit or license
514	to manufacture or distribute drugs, devices, or cosmetics.
515	(k)  That a federal, state, or local government permit
516	currently or previously held by the applicant, or any affiliated
517	party, for the manufacture or distribution of any drugs,
518	devices, or cosmetics has been disciplined, suspended, or
519	revoked and has not been reinstated.
520	(l)  The applicant does not possess the financial or
521	physical resources to operate in compliance with the permit
522	being sought, this chapter, and the rules adopted under this
523	chapter.
524	(m)  The applicant or any affiliated party receives,
525	directly or indirectly, financial support and assistance from a
526	person who was an affiliated party of a permittee whose permit
527	was subject to discipline or was suspended or revoked, other
528	than through the ownership of stock in a publicly traded company
529	or a mutual fund.
530	(n)  The applicant or any affiliated party receives,
531	directly or indirectly, financial support and assistance from a
532	person who has been found guilty of any violation of this part
533	or chapter 465, chapter 501, or chapter 893, any rules adopted
534	under this part or those chapters, any federal or state drug
535	law, or any felony where the underlying facts related to drugs,
536	regardless of whether the person has been pardoned, had her or
537	his civil rights restored, or had adjudication withheld, other
538	than through the ownership of stock in a publicly traded company
539	or a mutual fund.
540	(o)  The applicant for renewal of a permit under s.
541	499.01(2)(d) or (e) has not actively engaged in the wholesale
542	distribution of prescription drugs, as demonstrated by the
543	regular and systematic distribution of prescription drugs
544	throughout the year as evidenced by not fewer than 12 wholesale
545	distributions in the previous year and not fewer than three
546	wholesale distributions in the previous 6 months.
547	(p)  Information obtained in response to s. 499.01(2)(d) or
548	(e) demonstrates it would not be in the best interest of the
549	public health, safety, and welfare to issue a permit.
550	(q)  The applicant does not possess the financial standing
551	and business experience for the successful operation of the
552	applicant.
553	(r)  The applicant or any affiliated party has failed to
554	comply with the requirements for manufacturing or distributing
555	prescription drugs under this part, similar federal laws,
556	similar laws in other states, or the rules adopted under such
557	laws.
558	(11)  Upon approval of the application by the department
559	and payment of the required fee, the department shall issue or
560	renew a prescription drug wholesale distributor or an out-of-
561	state prescription drug wholesale distributor permit to the
562	applicant.
563	(12)  For a permit for a prescription drug wholesale
564	distributor or an out-of-state prescription drug wholesale
565	distributor:
566	(a)  The department shall adopt rules for the annual
567	renewal of permits. At least 90 days before the expiration of a
568	permit, the department shall forward a permit renewal
569	notification and renewal application to the prescription drug
570	wholesale distributor or out-of-state prescription drug
571	wholesale distributor at the mailing address of the permitted
572	establishment on file with the department. The permit renewal
573	notification must state conspicuously the date on which the
574	permit for the establishment will expire and that the
575	establishment may not operate unless the permit for the
576	establishment is renewed timely.
577	(b)  A permit, unless sooner suspended or revoked,
578	automatically expires 1 year after the last day of the
579	anniversary month in which the permit was originally issued. A
580	permit may be renewed by making application for renewal on forms
581	furnished by the department and paying the appropriate fees. If
582	a renewal application and fee are submitted and postmarked after
583	45 days prior to the expiration date of the permit, the permit
584	may be renewed only upon payment of a late renewal fee of $100,
585	plus the required renewal fee. A permittee that has submitted a
586	renewal application in accordance with this paragraph may
587	continue to operate under its permit, unless the permit is
588	suspended or revoked, until final disposition of the renewal
589	application.
590	(c)  Failure to renew a permit in accordance with this
591	section precludes any future renewal of that permit. If a permit
592	issued pursuant to this section has expired and cannot be
593	renewed, before an establishment may engage in activities that
594	require a permit under this part, the establishment must submit
595	an application for a new permit; pay the applicable application
596	fee, initial permit fee, and all applicable penalties; and be
597	issued a new permit by the department.
598	(13)  A person that engages in wholesale distribution of
599	prescription drugs in this state must have a wholesale
600	distributor's permit issued by the department, except as noted
601	in this section. Each establishment must be separately permitted
602	except as noted in this subsection.
603	(a)  A separate establishment permit is not required when a
604	permitted prescription drug wholesale distributor consigns a
605	prescription drug to a pharmacy that is permitted under chapter
606	465 and located in this state, provided that:
607	1.  The consignor wholesale distributor notifies the
608	department in writing of the contract to consign prescription
609	drugs to a pharmacy along with the identity and location of each
610	consignee pharmacy;
611	2.  The pharmacy maintains its permit under chapter 465;
612	3.  The consignor wholesale distributor, which has no legal
613	authority to dispense prescription drugs, complies with all
614	wholesale distribution requirements of ss. 499.0121 and
615	499.01212 with respect to the consigned drugs and maintains
616	records documenting the transfer of title or other completion of
617	the wholesale distribution of the consigned prescription drugs;
618	4.  The distribution of the prescription drug is otherwise
619	lawful under this chapter and other applicable law;
620	5.  Open packages containing prescription drugs within a
621	pharmacy are the responsibility of the pharmacy, regardless of
622	how the drugs are titled; and
623	6.  The pharmacy dispenses the consigned prescription drug
624	in accordance with the limitations of its permit under chapter
625	465 or returns the consigned prescription drug to the consignor
626	wholesale distributor. In addition, a person who holds title to
627	prescription drugs may transfer the drugs to a person permitted
628	or licensed to handle the reverse distribution or destruction of
629	drugs. Any other distribution by and means of the consigned
630	prescription drug by any person, not limited to the consignor
631	wholesale distributor or consignee pharmacy, to any other person
632	is prohibited.
633	(b)  A wholesale distributor's permit is not required for
634	the one-time transfer of title of a pharmacy's lawfully acquired
635	prescription drug inventory by a pharmacy with a valid permit
636	issued under chapter 465 to a consignor prescription drug
637	wholesale distributor, permitted under this chapter, in
638	accordance with a written consignment agreement between the
639	pharmacy and that wholesale distributor if the permitted
640	pharmacy and the permitted prescription drug wholesale
641	distributor comply with all of the provisions of paragraph (a)
642	and the prescription drugs continue to be within the permitted
643	pharmacy's inventory for dispensing in accordance with the
644	limitations of the pharmacy permit under chapter 465. A
645	consignor drug wholesale distributor may not use the pharmacy as
646	a wholesale distributor through which it distributes the
647	prescription drugs to other pharmacies. Nothing in this section
648	is intended to prevent a wholesale distributor from obtaining
649	this inventory in the event of nonpayment by the pharmacy.
650	(c)  A separate establishment permit is not required when a
651	permitted prescription drug wholesale distributor operates
652	temporary transit storage facilities for the sole purpose of
653	storage, for up to 16 hours, of a delivery of prescription drugs
654	when the wholesale distributor was temporarily unable to
655	complete the delivery to the recipient.
656	(d)  The department shall require information from each
657	wholesale distributor as part of the permit and renewal of such
658	permit, as required under this section.
659	(14)  Personnel employed in wholesale distribution must
660	have appropriate education and experience to enable them to
661	perform their duties in compliance with state permitting
662	requirements.
663	(15)  The name of a permittee or establishment on a
664	prescription drug wholesale distributor permit or an out-of-
665	state prescription drug wholesale distributor permit may not
666	include any indicia of attainment of any educational degree, any
667	indicia that the permittee or establishment possesses a
668	professional license, or any name or abbreviation that the
669	department determines is likely to cause confusion or mistake or
670	that the department determines is deceptive, including that of
671	any other entity authorized to purchase prescription drugs.
672	(16)(a)  Each establishment that is issued an initial or
673	renewal permit as a prescription drug wholesale distributor or
674	an out-of-state prescription drug wholesale distributor must
675	designate in writing to the department at least one natural
676	person to serve as the designated representative of the
677	wholesale distributor. Such person must have an active
678	certification as a designated representative from the
679	department.
680	(b)  To be certified as a designated representative, a
681	natural person must:
682	1.  Submit an application on a form furnished by the
683	department and pay the appropriate fees;
684	2.  Be at least 18 years of age;
685	3.  Have not less than 2 years of verifiable full-time work
686	experience in a pharmacy licensed in this state or another
687	state, where the person's responsibilities included, but were
688	not limited to, recordkeeping for prescription drugs, or have
689	not less than 2 years of verifiable full-time managerial
690	experience with a prescription drug wholesale distributor
691	licensed in this state or in another state;
692	4.  Receive a passing score of at least 75 percent on an
693	examination given by the department regarding federal laws
694	governing distribution of prescription drugs and this part and
695	the rules adopted by the department governing the wholesale
696	distribution of prescription drugs. This requirement shall be
697	effective 1 year after the results of the initial examination
698	are mailed to the persons that took the examination. The
699	department shall offer such examinations at least four times
700	each calendar year; and
701	5.  Provide the department with a personal information
702	statement and fingerprints pursuant to subsection (9).
703	(c)  The department may deny an application for
704	certification as a designated representative or may suspend or
705	revoke a certification of a designated representative pursuant
706	to s. 499.067.
707	(d)  A designated representative:
708	1.  Must be actively involved in and aware of the actual
709	daily operation of the wholesale distributor.
710	2.  Must be employed full time in a managerial position by
711	the wholesale distributor.
712	3.  Must be physically present at the establishment during
713	normal business hours, except for time periods when absent due
714	to illness, family illness or death, scheduled vacation, or
715	other authorized absence.
716	4.  May serve as a designated representative for only one
717	wholesale distributor at any one time.
718	(e)  A wholesale distributor must notify the department
719	when a designated representative leaves the employ of the
720	wholesale distributor. Such notice must be provided to the
721	department within 10 business days after the last day of
722	designated representative's employment with the wholesale
723	distributor.
724	(f)  A wholesale distributor may not operate under a
725	prescription drug wholesale distributor permit or an out-of-
726	state prescription drug wholesale distributor permit for more
727	than 10 business days after the designated representative leaves
728	the employ of the wholesale distributor, unless the wholesale
729	distributor employs another designated representative and
730	notifies the department within 10 business days of the identity
731	of the new designated representative.
732	Section 3.  Subsection (3) of section 499.003, Florida
733	Statutes, is amended to read:
734	499.003  Definitions of terms used in this part.-As used in
735	this part, the term:
736	(3)  "Affiliated party" means:
737	(a)  A director, officer, trustee, partner, or committee
738	member of a permittee or applicant or a subsidiary or service
739	corporation of the permittee or applicant;
740	(b)  A person who, directly or indirectly, manages,
741	controls, or oversees the operation of a permittee or applicant,
742	regardless of whether such person is a partner, shareholder,
743	manager, member, officer, director, independent contractor, or
744	employee of the permittee or applicant;
745	(c)  A person who has filed or is required to file a
746	personal information statement pursuant to s. 499.012(9) or is
747	required to be identified in an application for a permit or to
748	renew a permit pursuant to s. 499.012(8); or
749	(c)(d)  The five largest natural shareholders that own at
750	least 5 percent of the permittee or applicant.
751	Section 4.  Paragraph (b) of subsection (13) of section
752	499.0121, Florida Statutes, is amended to read:
753	499.0121  Storage and handling of prescription drugs;
754	recordkeeping.-The department shall adopt rules to implement
755	this section as necessary to protect the public health, safety,
756	and welfare. Such rules shall include, but not be limited to,
757	requirements for the storage and handling of prescription drugs
758	and for the establishment and maintenance of prescription drug
759	distribution records.
760	(13)  DUE DILIGENCE OF SUPPLIERS.-Prior to purchasing any
761	prescription drugs from another wholesale distributor, a
762	prescription drug wholesale distributor, an out-of-state
763	prescription drug wholesale distributor, or a prescription drug
764	repackager must:
765	(b)  Determine that the selling wholesale distributor has
766	insurance coverage of not less than the greater of 1 percent of
767	the amount of the total dollar volume of the prescription drug
768	sales in the previous year reported to the department under s.
769	499.012(8)(g) or $500,000; however, the coverage need not exceed
770	$2 million.
771	Section 5.  Paragraph (b) of subsection (1) of section
772	499.067, Florida Statutes, is amended to read:
773	499.067  Denial, suspension, or revocation of permit,
774	certification, or registration.-
775	(1)
776	(b)  The department may deny an application for a permit or
777	certification, or suspend or revoke a permit or certification,
778	if the department finds that:
779	1.  The applicant is not of good moral character or that it
780	would be a danger or not in the best interest of the public
781	health, safety, and welfare if the applicant were issued a
782	permit or certification.
783	2.  The applicant has not met the requirements for the
784	permit or certification.
785	3.  The applicant is not eligible for a permit or
786	certification for any of the reasons enumerated in s. 499.012.
787	4.  The applicant, permittee, or person certified under s.
788	499.012(16) demonstrates any of the conditions enumerated in s.
789	499.012.
790	5.  The applicant, permittee, or person certified under s.
791	499.012(16) has committed any violation of ss. 499.005-499.0054.
792	Section 6.  This act shall take effect July 1, 2011.

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