HB 7005

1	A reviser's bill to be entitled
2	An act relating to the Florida Statutes; repealing ss.
3	29.0086, 29.014, 120.551, 215.18(2), 216.181(17),
4	218.503(6), 253.034(6)(f)2., 287.057(14)(b) and (25),
5	339.135(8), 375.041(6), 394.76(3)(b)2., 402.305(2)(g),
6	420.0005(2), 420.36(4)(d), 497.161(1)(g), 499.0051(2)(a),
7	499.0121(6)(d) and (e), and 1004.065, F.S., all of which
8	provisions have become inoperative by noncurrent repeal or
9	expiration and, pursuant to s. 11.242(5)(b) and (i), may
10	be omitted from the 2007 Florida Statutes only through a
11	reviser's bill duly enacted by the Legislature; amending
12	s. 29.008, F.S., to conform to the repeal of s. 29.0086,
13	F.S.; and amending ss. 499.003, 499.005, 499.012,
14	499.0121, 499.01211, 499.0122, 499.014, and 499.051, F.S.,
15	to conform to the repeal of s. 499.0121(6)(d) and (e),
16	F.S.; providing an effective date.
17
18	Be It Enacted by the Legislature of the State of Florida:
19
20	Section 1.  Section 29.0086, Florida Statutes, is repealed.
21
22	Reviser's note.--The cited section, which relates to
23	the Article V Technology Board, was repealed pursuant
24	to its own terms, effective July 1, 2006.
25
26	Section 2.  Section 29.014, Florida Statutes, is repealed.
27
28	Reviser's note.--The cited section, which relates to
29	the Article V Indigent Services Advisory Board was
30	repealed by s. 70, ch. 2005-236, Laws of Florida,
31	effective July 1, 2006. Since the section was not
32	repealed by a "current session" of the Legislature, it
33	may be omitted from the 2007 Florida Statutes only
34	through a reviser's bill duly enacted by the
35	Legislature. See s. 11.242(5)(b) and (i).
36
37	Section 3.  Section 120.551, Florida Statutes, is repealed.
38
39	Reviser's note.--The cited section, which relates to
40	Internet publication of agency notices in the Florida
41	Administrative Weekly, was repealed pursuant to its
42	own terms, effective July 1, 2006.
43
44	Section 4.  Subsection (2) of section 215.18, Florida
45	Statutes, is repealed.
46
47	Reviser's note.--The cited subsection, which relates
48	to extension of a repayment period, for the 2005-2006
49	fiscal year only, for certain funds to meet
50	deficiencies resulting from 2004 hurricanes, expired
51	pursuant to its own terms, effective July 1, 2006.
52
53	Section 5.  Subsection (17) of section 216.181, Florida
54	Statutes, is repealed.
55
56	Reviser's note.--The cited subsection, which relates
57	to amendments to approved operating budgets
58	authorizing the expenditure of moneys from the Working
59	Capital Fund as specifically authorized in the General
60	Appropriations Act, expired pursuant to its own terms,
61	effective July 1, 2006.
62
63	Section 6.  Subsection (6) of section 218.503, Florida
64	Statutes, is repealed.
65
66	Reviser's note.--The cited subsection, which relates
67	to a discretionary per-vehicle surcharge by a
68	governing authority of a municipality with a resident
69	population of 300,000 or more on or after April 1,
70	1999, which has been declared in a state of financial
71	emergency pursuant to s. 218.503, expired pursuant to
72	its own terms, effective June 30, 2006.
73
74	Section 7.  Subparagraph 2. of paragraph (f) of subsection
75	(6) of section 253.034, Florida Statutes, is repealed.
76
77	Reviser's note.--The cited subparagraph, which relates
78	to a requirement that certain surplus state lands that
79	were acquired from a municipality for no consideration
80	prior to 1958 must be first offered for reconveyance
81	to the municipality at no cost, expired pursuant to
82	its own terms, effective July 1, 2006.
83
84	Section 8.  Paragraph (b) of subsection (14) and subsection
85	(25) of section 287.057, Florida Statutes, are repealed.
86
87	Reviser's note.--Paragraph (14)(b), which authorizes
88	the Department of Children and Family Services to
89	enter into certain agreements with a private provider
90	to finance, design, and construct a forensic treatment
91	facility, expired pursuant to its own terms, effective
92	July 1, 2006. Subsection (25), which authorizes the
93	Department of Management Services to issue an
94	invitation to negotiate to contract for specified
95	additional beds for certain correctional facilities,
96	for the 2005-2006 fiscal year only, expired pursuant
97	to its own terms, effective July 1, 2006.
98
99	Section 9.  Subsection (8) of section 339.135, Florida
100	Statutes, is repealed.
101
102	Reviser's note.--The cited subsection, which relates
103	to certain increased appropriations for projects
104	funded within the Department of Transportation,
105	expired pursuant to its own terms, effective July 1,
106	2006.
107
108	Section 10.  Subsection (6) of section 375.041, Florida
109	Statutes, is repealed.
110
111	Reviser's note.--The cited subsection, which
112	authorizes appropriations of funds allocated to the
113	Land Acquisition Trust Fund for water quality issues
114	in the General Appropriations Act for the 2005-2006
115	fiscal year only, expired pursuant to its own terms,
116	effective July 1, 2006.
117
118	Section 11.  Subparagraph 2. of paragraph (b) of subsection
119	(3) of section 394.76, Florida Statutes, is repealed.
120
121	Reviser's note.--The cited subparagraph, which
122	requires a 75-to-25 state-to-local ratio for specified
123	contracted community alcohol and mental health
124	services and programs for the 2005-2006 fiscal year
125	only, expired pursuant to its own terms, effective
126	July 1, 2006.
127
128	Section 12.  Paragraph (g) of subsection (2) of section
129	402.305, Florida Statutes, is repealed.
130
131	Reviser's note.--The cited paragraph, which requires
132	the Department of Children and Family Services to
133	provide at least one Child Care Competency Exam in
134	Spanish during the 2005-2006 fiscal year, expired
135	pursuant to its own terms, effective July 1, 2006.
136
137	Section 13.  Subsection (2) of section 420.0005, Florida
138	Statutes, is repealed.
139
140	Reviser's note.--The cited subsection, which permits,
141	for the 2005-2006 fiscal year only, any unappropriated
142	balance in the State Housing Trust Fund in the
143	Department of Community Affairs to be transferred by
144	the General Appropriations Act to the Emergency
145	Management Preparedness and Assistance Trust Fund,
146	expired pursuant to its own terms, effective July 1,
147	2006.
148
149	Section 14.  Paragraph (d) of subsection (4) of section
150	420.36, Florida Statutes, is repealed.
151
152	Reviser's note.--The cited paragraph, which authorizes
153	transfer, by the General Appropriations Act and for
154	the 2005-2006 fiscal year only, of any unappropriated
155	balance in the Energy Consumption Trust Fund to the
156	Emergency Management Preparedness and Assistance Trust
157	Fund, expired pursuant to its own terms, effective
158	July 1, 2006.
159
160	Section 15.  Paragraph (g) of subsection (1) of section
161	497.161, Florida Statutes, is repealed.
162
163	Reviser's note.--The cited paragraph, which provides
164	for extraordinary rulemaking authority relating to the
165	merging of chapters 470 and 497, specifies that the
166	rulemaking authority and rules adopted under that
167	authority expired July 1, 2006.
168
169	Section 16.  Paragraph (a) of subsection (2) of section
170	499.0051, Florida Statutes, is repealed.
171
172	Reviser's note.--The cited paragraph, which relates to
173	failure to authenticate pedigree papers relating to
174	legend drug distribution and which is replaced by
175	similar provisions in paragraph (2)(b) effective July
176	1, 2006, expired pursuant to its own terms, effective
177	July 1, 2006.
178
179	Section 17.  Paragraphs (d) and (e) of subsection (6) of
180	section 499.0121, Florida Statutes, are repealed, and paragraphs
181	(f), (g), and (h) of that subsection are amended to read:
182	499.0121  Storage and handling of prescription drugs;
183	recordkeeping.--The department shall adopt rules to implement
184	this section as necessary to protect the public health, safety,
185	and welfare.  Such rules shall include, but not be limited to,
186	requirements for the storage and handling of prescription drugs
187	and for the establishment and maintenance of prescription drug
188	distribution records.
189	(6)  RECORDKEEPING.--The department shall adopt rules that
190	require keeping such records of prescription drugs as are
191	necessary for the protection of the public health.
192	(d)(f)1.  Effective July 1, 2006, each person who is
193	engaged in the wholesale distribution of a prescription drug and
194	who is not the manufacturer of that drug must, before each
195	wholesale distribution of such drug, provide to the person who
196	receives the drug a pedigree paper as defined in s. 499.003(31).
197	2.  A repackager must comply with this paragraph.
198	3.  The pedigree paper requirements in this paragraph do
199	not apply to compressed medical gases or veterinary legend
200	drugs.
201	4.  Each wholesale distributor of prescription drugs must
202	maintain separate and distinct from other required records all
203	statements that are required under subparagraph 1.
204	5.  In order to verify compliance with subparagraph (d)1.,
205	each manufacturer of a prescription drug sold in this state must
206	make available upon request distribution documentation related
207	to its sales of prescription drugs, regardless of whether the
208	prescription drug was sold directly by the manufacturer to a
209	person in Florida.
210	5.6.  Subparagraph 1. is satisfied when a wholesale
211	distributor takes title to, but not possession of, a
212	prescription drug and the prescription drug's manufacturer ships
213	the prescription drug directly to a person authorized by law to
214	purchase prescription drugs for the purpose of administering or
215	dispensing the drug, as defined in s. 465.003, or a member of an
216	affiliated group, as described in paragraph (f)(h), with the
217	exception of a repackager.
218	a.  The wholesale distributor must deliver to the recipient
219	of the prescription drug, within 14 days after the shipment
220	notification from the manufacturer, an invoice and the following
221	sworn statement: "This wholesale distributor purchased the
222	specific unit of the prescription drug listed on the invoice
223	directly from the manufacturer, and the specific unit of
224	prescription drug was shipped by the manufacturer directly to a
225	person authorized by law to administer or dispense the legend
226	drug, as defined in s. 465.003, Florida Statutes, or a member of
227	an affiliated group, as described in s. 499.0121(6)(f)
228	499.0121(6)(h), Florida Statutes, with the exception of a
229	repackager." The invoice must contain a unique cross-reference
230	to the shipping document sent by the manufacturer to the
231	recipient of the prescription drug.
232	b.  The manufacturer of the prescription drug shipped
233	directly to the recipient under this section must provide and
234	the recipient of the prescription drug must acquire, within 14
235	days after receipt of the prescription drug, a shipping document
236	from the manufacturer that contains, at a minimum:
237	(I)  The name and address of the manufacturer, including
238	the point of origin of the shipment, and the names and addresses
239	of the wholesaler and the purchaser.
240	(II)  The name of the prescription drug as it appears on
241	the label.
242	(III)  The quantity, dosage form, and strength of the
243	prescription drug.
244	(IV)  The date of the shipment from the manufacturer.
245	c.  The wholesale distributor must also maintain and make
246	available to the department, upon request, the lot number of
247	such drug if not contained in the shipping document acquired by
248	the recipient.
249	6.7.  Failure of the manufacturer to provide, the recipient
250	to acquire, or the wholesale distributor to deliver, the
251	documentation required under subparagraph 5.6. shall constitute
252	failure to acquire or deliver a pedigree paper under s.
253	499.0051. Forgery by the manufacturer, the recipient, or the
254	wholesale distributor of the documentation required to be
255	acquired or delivered under subparagraph 5.6. shall constitute
256	forgery of a pedigree paper under s. 499.0051.
257	7.8.  The department may, by rule, specify alternatives to
258	compliance with subparagraph 1. for a prescription drug in the
259	inventory of a permitted prescription drug wholesaler as of June
260	30, 2006, and the return of a prescription drug purchased prior
261	to July 1, 2006. The department may specify time limits for such
262	alternatives.
263	(e)(g)  Each wholesale distributor, except for a
264	manufacturer, shall annually provide the department with a
265	written list of all wholesale distributors and manufacturers
266	from whom the wholesale distributor purchases prescription
267	drugs. A wholesale distributor, except a manufacturer, shall
268	notify the department not later than 10 days after any change to
269	either list. Such portions of the information required pursuant
270	to this paragraph which are a trade secret, as defined in s.
271	812.081, shall be maintained by the department as trade secret
272	information is required to be maintained under s. 499.051.
273	(f)(h)1.  This paragraph applies only to an affiliated
274	group, as defined by s. 1504 of the Internal Revenue Code of
275	1986, as amended, which is composed of chain drug entities,
276	including at least 50 retail pharmacies, warehouses, or
277	repackagers, which are members of the same affiliated group, if
278	the affiliated group:
279	a.  Discloses to the department the names of all its
280	members; and
281	b.  Agrees in writing to provide records on prescription
282	drug purchases by members of the affiliated group not later than
283	48 hours after the department requests such records, regardless
284	of the location where the records are stored.
285	2.  Each warehouse within the affiliated group must comply
286	with all applicable federal and state drug wholesale permit
287	requirements and must purchase, receive, hold, and distribute
288	prescription drugs only to a retail pharmacy or warehouse within
289	the affiliated group. Such a warehouse is exempt from providing
290	a pedigree paper in accordance with paragraph (d) paragraphs
291	(d), (e), and (f) to its affiliated group member warehouse or
292	retail pharmacy, provided that:
293	a.  Any affiliated group member that purchases or receives
294	a prescription drug from outside the affiliated group must
295	receive a pedigree paper if the prescription drug is distributed
296	in or into this state and a pedigree paper is required under
297	this section and must authenticate the documentation as required
298	in subsection (4), regardless of whether the affiliated group
299	member is directly subject to regulation under this chapter; and
300	b.  The affiliated group makes available to the department
301	on request all records related to the purchase or acquisition of
302	prescription drugs by members of the affiliated group,
303	regardless of the location where the records are stored, if the
304	prescription drugs were distributed in or into this state.
305	3.  If a repackager repackages prescription drugs solely
306	for distribution to its affiliated group members for the
307	exclusive distribution to and among retail pharmacies that are
308	members of the affiliated group to which the repackager is a
309	member:
310	a.  The repackager must:
311	(I)  In lieu of the written statement required by paragraph
312	(d), paragraph (e), or paragraph (f), for all repackaged
313	prescription drugs distributed in or into this state, state in
314	writing under oath with each distribution of a repackaged
315	prescription drug to an affiliated group member warehouse or
316	repackager: "All repackaged prescription drugs are purchased by
317	the affiliated group directly from the manufacturer or from a
318	prescription drug wholesaler that purchased the prescription
319	drugs directly from the manufacturer.";
320	(II)  Purchase all prescription drugs it repackages:
321	(A)  Directly from the manufacturer; or
322	(B)  From a prescription drug wholesaler that purchased the
323	prescription drugs directly from the manufacturer; and
324	(III)  Maintain records in accordance with this section to
325	document that it purchased the prescription drugs directly from
326	the manufacturer or that its prescription drug wholesale
327	supplier purchased the prescription drugs directly from the
328	manufacturer.
329	b.  All members of the affiliated group must provide to
330	agents of the department on request records of purchases by all
331	members of the affiliated group of prescription drugs that have
332	been repackaged, regardless of the location where the records
333	are stored or where the repackager is located.
334
335	Reviser's note.--Paragraphs (6)(d) and (e), which
336	relate to certain recordkeeping requirements for
337	persons engaged in the manufacture or wholesale
338	distribution of a prescription drug and placement of
339	prescription drugs on a list of specified drugs,
340	expired pursuant to their own terms, effective July 1,
341	2006. Paragraphs (6)(f), (g), and (h) are redesignated
342	and amended to conform to the expiration of paragraphs
343	(d) and (e).
344
345	Section 18.  Section 1004.065, Florida Statutes, is
346	repealed.
347
348	Reviser's note.--The cited section, which relates to a
349	limitation on university and direct-support
350	organization financings, expired pursuant to its own
351	terms, effective July 1, 2006.
352
353	Section 19.  Paragraph (f) of subsection (1) of section
354	29.008, Florida Statutes, is amended to read:
355	29.008  County funding of court-related functions.--
356	(1)  Counties are required by s. 14, Art. V of the State
357	Constitution to fund the cost of communications services,
358	existing radio systems, existing multiagency criminal justice
359	information systems, and the cost of construction or lease,
360	maintenance, utilities, and security of facilities for the
361	circuit and county courts, public defenders' offices, state
362	attorneys' offices, guardian ad litem offices, and the offices
363	of the clerks of the circuit and county courts performing court-
364	related functions. For purposes of this section, the term
365	"circuit and county courts" shall include the offices and
366	staffing of the guardian ad litem programs. The county
367	designated under s. 35.05(1) as the headquarters for each
368	appellate district shall fund these costs for the appellate
369	division of the public defender's office in that county. For
370	purposes of implementing these requirements, the term:
371	(f)  "Communications services" are defined as any
372	reasonable and necessary transmission, emission, and reception
373	of signs, signals, writings, images, and sounds of intelligence
374	of any nature by wire, radio, optical, audio equipment, or other
375	electromagnetic systems and includes all facilities and
376	equipment owned, leased, or used by judges, clerks, public
377	defenders, state attorneys, and all staff of the state courts
378	system, state attorneys' offices, public defenders' offices, and
379	clerks of the circuit and county courts performing court-related
380	functions. Such system or services shall include, but not be
381	limited to:
382	1.  Telephone system infrastructure, including computer
383	lines, telephone switching equipment, and maintenance, and
384	facsimile equipment, wireless communications, cellular
385	telephones, pagers, and video teleconferencing equipment and
386	line charges. Each county shall continue to provide access to a
387	local carrier for local and long distance service and shall pay
388	toll charges for local and long distance service.
389	2.  All computer networks, systems and equipment, including
390	computer hardware and software, modems, printers, wiring,
391	network connections, maintenance, support staff or services
392	including any county-funded support staff located in the offices
393	of the circuit court, county courts, state attorneys, and public
394	defenders, training, supplies, and line charges necessary for an
395	integrated computer system to support the operations and
396	management of the state courts system, the offices of the public
397	defenders, the offices of the state attorneys, and the offices
398	of the clerks of the circuit and county courts and the
399	capability to connect those entities and reporting data to the
400	state as required for the transmission of revenue, performance
401	accountability, case management, data collection, budgeting, and
402	auditing purposes. The integrated computer system shall be
403	operational by July 1, 2006, and, at a minimum, permit the
404	exchange of financial, performance accountability, case
405	management, case disposition, and other data across multiple
406	state and county information systems involving multiple users at
407	both the state level and within each judicial circuit and be
408	able to electronically exchange judicial case background data,
409	sentencing scoresheets, and video evidence information stored in
410	integrated case management systems over secure networks. Once
411	the integrated system becomes operational, counties may reject
412	requests to purchase communication services included in this
413	subparagraph not in compliance with standards, protocols, or
414	processes adopted by the board established pursuant to s.
415	29.0086.
416	3.  Courier messenger and subpoena services.
417	4.  Auxiliary aids and services for qualified individuals
418	with a disability which are necessary to ensure access to the
419	courts. Such auxiliary aids and services include, but are not
420	limited to, sign language interpretation services required under
421	the federal Americans with Disabilities Act other than services
422	required to satisfy due-process requirements and identified as a
423	state funding responsibility pursuant to ss. 29.004, 29.005,
424	29.006, and 29.007, real-time transcription services for
425	individuals who are hearing impaired, and assistive listening
426	devices and the equipment necessary to implement such
427	accommodations.
428
429	Reviser's note.--Amended to delete language relating
430	to compliance with standards, protocols, or processes
431	adopted by the Article V Technology Board. Section
432	29.0086, which created the board, expired July 1,
433	2006; that expiration is confirmed by this act.
434
435	Section 20.  Subsection (31) of section 499.003, Florida
436	Statutes, is amended to read:
437	499.003  Definitions of terms used in ss. 499.001-
438	499.081.--As used in ss. 499.001-499.081, the term:
439	(31)  "Pedigree paper" means:
440	(a)  A document required pursuant to s. 499.0121(6)(d) or
441	(e); or
442	(a)(b)1.  Effective July 1, 2006, a document or electronic
443	form approved by the Department of Health and containing
444	information that records each distribution of any given legend
445	drug, from sale by a pharmaceutical manufacturer, through
446	acquisition and sale by any wholesaler or repackager, until
447	final sale to a pharmacy or other person administering or
448	dispensing the drug. The information required to be included on
449	the form approved by the department pursuant to this paragraph
450	subparagraph must at least detail the amount of the legend drug;
451	its dosage form and strength; its lot numbers; the name and
452	address of each owner of the legend drug and his or her
453	signature; its shipping information, including the name and
454	address of each person certifying delivery or receipt of the
455	legend drug; an invoice number, a shipping document number, or
456	another number uniquely identifying the transaction; and a
457	certification that the recipient wholesaler has authenticated
458	the pedigree papers. If the manufacturer or repackager has
459	uniquely serialized the individual legend drug unit, that
460	identifier must also be included on the form approved pursuant
461	to this paragraph subparagraph. It must also include the name,
462	address, telephone number and, if available, e-mail contact
463	information of each wholesaler involved in the chain of the
464	legend drug's custody; or
465	(b)2.  A statement, under oath, in written or electronic
466	form, confirming that a wholesale distributor purchases and
467	receives the specific unit of the prescription drug directly
468	from the manufacturer of the prescription drug and distributes
469	the prescription drug directly, or through an intracompany
470	transfer, to a chain pharmacy warehouse or a person authorized
471	by law to purchase prescription drugs for the purpose of
472	administering or dispensing the drug, as defined in s. 465.003.
473	For purposes of this subsection paragraph, the term "chain
474	pharmacy warehouse" means a wholesale distributor permitted
475	pursuant to s. 499.01 that maintains a physical location for
476	prescription drugs that functions solely as a central warehouse
477	to perform intracompany transfers of such drugs to a member of
478	its affiliated group as described in s. 499.0121(6)(f)1.
479	499.0121(6)(h)1.
480	1.a.  The information required to be included pursuant to
481	this paragraph subparagraph must include:
482	a.(I)  The following statement: "This wholesale distributor
483	purchased the specific unit of the prescription drug directly
484	from the manufacturer."
485	b.(II)  The manufacturer's national drug code identifier
486	and the name and address of the wholesaler and the purchaser of
487	the prescription drug.
488	c.(III)  The name of the prescription drug as it appears on
489	the label.
490	d.(IV)  The quantity, dosage form, and strength of the
491	prescription drug.
492	2.b.  The wholesale distributor must also maintain and make
493	available to the department, upon request, the point of origin
494	of the prescription drugs, including intracompany transfers; the
495	date of the shipment from the manufacturer to the wholesale
496	distributor; the lot numbers of such drugs; and the invoice
497	numbers from the manufacturer.
498
499	The department may adopt rules and forms relating to the
500	requirements of this subsection.
501
502	Reviser's note.--Amended to conform to the expiration
503	of s. 499.0121(6)(d) and (e) by their own terms,
504	effective July 1, 2006; those expirations are
505	confirmed by this act.
506
507	Section 21.  Subsection (29) of section 499.005, Florida
508	Statutes, is amended to read:
509	499.005  Prohibited acts.--It is unlawful for a person to
510	perform or cause the performance of any of the following acts in
511	this state:
512	(29)  The receipt of a prescription drug pursuant to a
513	wholesale distribution without either first receiving a pedigree
514	paper that was attested to as accurate and complete by the
515	wholesale distributor or complying with the provisions of s.
516	499.0121(6)(d)6. 499.0121(6)(f)6.
517
518	Reviser's note.--Amended to conform to the expiration
519	of s. 499.0121(6)(d) and (e) by their own terms,
520	effective July 1, 2006; those expirations are
521	confirmed by this act.
522
523	Section 22.  Paragraphs (e), (f), (g), and (h) of
524	subsection (2) of section 499.012, Florida Statutes, are amended
525	to read:
526	499.012  Wholesale distribution; definitions; permits;
527	applications; general requirements.--
528	(2)  The following types of wholesaler permits are
529	established:
530	(e)  Nonresident prescription drug manufacturer permit.--A
531	nonresident prescription drug manufacturer permit is required
532	for any person that is a manufacturer of prescription drugs, or
533	the distribution point for a manufacturer of prescription drugs,
534	and located outside of this state, or that is an entity to whom
535	an approved new drug application has been issued by the United
536	States Food and Drug Administration, or the contracted
537	manufacturer of the approved new drug application holder, and
538	located outside the United States, which engages in the
539	wholesale distribution in this state of the prescription drugs
540	it manufactures or is responsible for manufacturing. Each such
541	manufacturer or entity must be permitted by the department and
542	comply with all the provisions required of a wholesale
543	distributor under ss. 499.001-499.081, except s. 499.0121(6)(d),
544	(e), or (f).
545	1.  A person that distributes prescription drugs that it
546	did not manufacture must also obtain an out-of-state
547	prescription drug wholesaler permit pursuant to this section to
548	engage in the wholesale distribution of the prescription drugs
549	manufactured by another person and comply with the requirements
550	of an out-of-state prescription drug wholesaler.
551	2.  Any such person must comply with the licensing or
552	permitting requirements of the jurisdiction in which the
553	establishment is located and the federal act, and any product
554	wholesaled into this state must comply with ss. 499.001-499.081.
555	If a person intends to import prescription drugs from a foreign
556	country into this state, the nonresident prescription drug
557	manufacturer must provide to the department a list identifying
558	each prescription drug it intends to import and document
559	approval by the United States Food and Drug Administration for
560	such importation.
561	(f)  Freight forwarder permit.--A freight forwarder permit
562	is required for any person that engages in the distribution of a
563	legend drug as a freight forwarder unless the person is a common
564	carrier. The storage, handling, and recordkeeping of such
565	distributions must comply with the requirements for wholesale
566	distributors under s. 499.0121, except those set forth in s.
567	499.0121(6)(d), (e), or (f). A freight forwarder must provide
568	the source of the legend drugs with a validated airway bill,
569	bill of lading, or other appropriate documentation to evidence
570	the exportation of the product.
571	(g)  A veterinary prescription drug wholesaler permit.--A
572	veterinary prescription drug wholesaler permit is required for
573	any person that engages in the distribution of veterinary
574	prescription drugs in or into this state. A veterinary
575	prescription drug wholesaler that also distributes prescription
576	drugs subject to, defined by, or described by s. 503(b) of the
577	Federal Food, Drug, and Cosmetic Act which it did not
578	manufacture must obtain a permit as a prescription drug
579	wholesaler, an out-of-state prescription drug wholesaler, or a
580	limited prescription drug veterinary wholesaler in lieu of the
581	veterinary prescription drug wholesaler permit. A veterinary
582	prescription drug wholesaler must comply with the requirements
583	for wholesale distributors under s. 499.0121, except those set
584	forth in s. 499.0121(6)(d), (e), or (f).
585	(h)  Limited prescription drug veterinary wholesaler
586	permit.--Unless engaging in the activities of and permitted as a
587	prescription drug manufacturer, nonresident prescription drug
588	manufacturer, prescription drug wholesaler, or out-of-state
589	prescription drug wholesaler, a limited prescription drug
590	veterinary wholesaler permit is required for any person that
591	engages in the distribution in or into this state of veterinary
592	prescription drugs and prescription drugs subject to, defined
593	by, or described by s. 503(b) of the Federal Food, Drug, and
594	Cosmetic Act under the following conditions:
595	1.  The person is engaged in the business of wholesaling
596	prescription and veterinary legend drugs to persons:
597	a.  Licensed as veterinarians practicing on a full-time
598	basis;
599	b.  Regularly and lawfully engaged in instruction in
600	veterinary medicine;
601	c.  Regularly and lawfully engaged in law enforcement
602	activities;
603	d.  For use in research not involving clinical use; or
604	e.  For use in chemical analysis or physical testing or for
605	purposes of instruction in law enforcement activities, research,
606	or testing.
607	2.  No more than 30 percent of total annual prescription
608	drug sales may be prescription drugs approved for human use
609	which are subject to, defined by, or described by s. 503(b) of
610	the Federal Food, Drug, and Cosmetic Act.
611	3.  The person is not permitted, licensed, or otherwise
612	authorized in any state to wholesale prescription drugs subject
613	to, defined by, or described by s. 503(b) of the Federal Food,
614	Drug, and Cosmetic Act to any person who is authorized to sell,
615	distribute, purchase, trade, or use these drugs on or for
616	humans.
617	4.  A limited prescription drug veterinary wholesaler that
618	applies to the department for a new permit or the renewal of a
619	permit must submit a bond of $20,000, or other equivalent means
620	of security acceptable to the department, such as an irrevocable
621	letter of credit or a deposit in a trust account or financial
622	institution, payable to the Florida Drug, Device, and Cosmetic
623	Trust Fund. The purpose of the bond is to secure payment of any
624	administrative penalties imposed by the department and any fees
625	and costs incurred by the department regarding that permit which
626	are authorized under state law and which the permittee fails to
627	pay 30 days after the fine or costs become final. The department
628	may make a claim against such bond or security until 1 year
629	after the permittee's license ceases to be valid or until 60
630	days after any administrative or legal proceeding authorized in
631	ss. 499.001-499.081 which involves the permittee is concluded,
632	including any appeal, whichever occurs later.
633	5.  A limited prescription drug veterinary wholesaler must
634	maintain at all times a license or permit to engage in the
635	wholesale distribution of prescription drugs in compliance with
636	laws of the state in which it is a resident.
637	6.  A limited prescription drug veterinary wholesaler must
638	comply with the requirements for wholesale distributors under s.
639	499.0121, except that a limited prescription drug veterinary
640	wholesaler is not required to provide a pedigree paper as
641	required by s. 499.0121(6)(d) 499.0121(6)(f) upon the wholesale
642	distribution of a prescription drug to a veterinarian.
643	7.  A limited prescription drug veterinary wholesaler may
644	not return to inventory for subsequent wholesale distribution
645	any prescription drug subject to, defined by, or described by s.
646	503(b) of the Federal Food, Drug, and Cosmetic Act which has
647	been returned by a veterinarian.
648	8.  An out-of-state prescription drug wholesaler's permit
649	or a limited prescription drug veterinary wholesaler permit is
650	not required for an intracompany sale or transfer of a
651	prescription drug from an out-of-state establishment that is
652	duly licensed to engage in the wholesale distribution of
653	prescription drugs in its state of residence to a licensed
654	limited prescription drug veterinary wholesaler in this state if
655	both wholesalers conduct wholesale distributions of prescription
656	drugs under the same business name. The recordkeeping
657	requirements of s. 499.0121(6) must be followed for this
658	transaction.
659
660	Reviser's note.--Amended to conform to the expiration
661	of s. 499.0121(6)(d) and (e) by their own terms,
662	effective July 1, 2006; those expirations are
663	confirmed by this act.
664
665	Section 23.  Subsection (3) of section 499.01211, Florida
666	Statutes, is amended to read:
667	499.01211  Drug Wholesaler Advisory Council.--
668	(3)  The council shall review ss. 499.001-499.081 and the
669	rules adopted to administer ss. 499.001-499.081 annually,
670	provide input to the department regarding all proposed rules to
671	administer ss. 499.001-499.081, make written recommendation to
672	the secretary of the department regarding the listing of all
673	specified drugs pursuant to s. 499.0121(6)(e), make
674	recommendations to the department to improve the protection of
675	the prescription drugs and public health, make recommendations
676	to improve coordination with other states' regulatory agencies
677	and the federal government concerning the wholesale distribution
678	of drugs, and make recommendations to minimize the impact of
679	regulation of the wholesale distribution industry while ensuring
680	protection of the public health.
681
682	Reviser's note.--Amended to conform to the expiration
683	of s. 499.0121(6)(e) by its own terms, effective July
684	1, 2006; that expiration is confirmed by this act.
685
686	Section 24.  Paragraph (c) of subsection (2) of section
687	499.0122, Florida Statutes, is amended to read:
688	499.0122  Medical oxygen and veterinary legend drug retail
689	establishments; definitions, permits, general requirements.--
690	(2)
691	(c)  A retail establishment must comply with all of the
692	wholesale distribution requirements of s. 499.0121 except those
693	set forth in s. 499.0121(6)(d).
694
695	Reviser's note.--Amended to conform to the expiration
696	of s. 499.0121(6)(d) by its own terms, effective July
697	1, 2006; that expiration is confirmed by this act.
698
699	Section 25.  Subsection (3) of section 499.014, Florida
700	Statutes, is amended to read:
701	499.014  Distribution of legend drugs by hospitals, health
702	care entities, charitable organizations, and return or
703	destruction companies; permits, general requirements.--
704	(3)  Storage, handling, and recordkeeping of these
705	distributions must comply with the requirements for wholesale
706	distributors under s. 499.0121, except those set forth in s.
707	499.0121(6)(d), (e), or (f).
708
709	Reviser's note.--Amended to conform to the expiration
710	of s. 499.0121(6)(d) and (e) by their own terms,
711	effective July 1, 2006; those expirations are
712	confirmed by this act.
713
714	Section 26.  Subsection (7) of section 499.051, Florida
715	Statutes, is amended to read:
716	499.051  Inspections and investigations.--
717	(7)  The complaint and all information obtained pursuant to
718	the investigation by the department are confidential and exempt
719	from the provisions of s. 119.07(1) and s. 24(a), Art. I of the
720	State Constitution until the investigation and the enforcement
721	action are completed. However, trade secret information
722	contained therein as defined by s. 812.081(1)(c) shall remain
723	confidential and exempt from the provisions of s. 119.07(1) and
724	s. 24(a), Art. I of the State Constitution, as long as the
725	information is retained by the department.  This subsection does
726	not prohibit the department from using such information for
727	regulatory or enforcement proceedings under this chapter or from
728	providing such information to any law enforcement agency or any
729	other regulatory agency.  However, the receiving agency shall
730	keep such records confidential and exempt as provided in this
731	subsection.  In addition, this subsection is not intended to
732	prevent compliance with the provisions of s. 499.0121(6)(d),
733	(e), or (f), and the pedigree papers required in that subsection
734	shall not be deemed a trade secret.
735
736	Reviser's note.--Amended to conform to the expiration
737	of s. 499.0121(6)(d) and (e) by their own terms,
738	effective July 1, 2006; those expirations are
739	confirmed by this act.
740
741	Section 27.  This act shall take effect on the 60th day
742	after adjournment sine die of the session of the Legislature in
743	which enacted.

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