HB 0141

CS

CHAMBER ACTION

1	The Committee on Health Care recommends the following:
2
3	Committee Substitute
4	Remove the entire bill and insert:
5	A bill to be entitled
6	An act relating to pharmacy; amending s. 465.003, F.S.;
7	defining the term "Internet pharmacy"; amending s.
8	465.0156, F.S.; exempting Internet pharmacies from
9	registration requirements applicable to nonresident
10	pharmacies; requiring a registered nonresident pharmacy
11	and the pharmacist designated by that pharmacy to serve as
12	the prescription department manager or the equivalent to
13	be licensed in the state of location to dispense medicinal
14	drugs into this state; amending s. 465.016, F.S.;
15	providing for disciplinary action for dispensing a
16	medicinal drug when the pharmacist knows or has reason to
17	believe a prescription is not based on a valid
18	practitioner-patient relationship; creating s. 465.0161,
19	F.S.; prohibiting the distribution of medicinal drugs by
20	an Internet pharmacy without a permit; providing
21	penalties; amending s. 465.0196, F.S., relating to special
22	pharmacy permits, to conform; creating s. 465.0197, F.S.;
23	requiring Internet pharmacies to be permitted and
24	providing requirements therefor; requiring the Internet
25	pharmacy and the pharmacist designated by that pharmacy to
26	serve as the prescription department manager or its
27	equivalent to be licensed in the state of location to
28	dispense medicinal drugs into this state; amending s.
29	465.023, F.S.; providing an additional ground for which
30	the Department of Health or the Board of Pharmacy may take
31	action against a permitted pharmacy; amending s. 465.0255,
32	F.S.; revising requirements for certain pharmacists and
33	practitioners to deliver specified disclosures to
34	purchasers when dispensing a medicinal drug; amending s.
35	465.026, F.S.; creating an exception to the requirements
36	for filling or refilling a transferred prescription for a
37	medicinal drug listed in Schedule II under ch. 893, F.S.;
38	amending s. 499.0121, F.S.; providing recordkeeping
39	requirements relating to the storage and handling of
40	prescription drugs which affiliated groups must fulfill;
41	providing for future repeal; amending s. 895.02, F.S.;
42	including violation of s. 465.0161, F.S., in the
43	definition of the term "racketeering activity" for
44	prosecution under ch. 895, F.S.; providing an
45	appropriation and authorizing positions; providing an
46	effective date.
47
48	Be It Enacted by the Legislature of the State of Florida:
49
50	Section 1.  Paragraph (a) of subsection (11) of section
51	465.003, Florida Statutes, is amended to read:
52	465.003  Definitions.--As used in this chapter, the term:
53	(11)(a)  "Pharmacy" includes a community pharmacy, an
54	institutional pharmacy, a nuclear pharmacy, and a special
55	pharmacy, and an Internet pharmacy.
56	1.  The term "community pharmacy" includes every location
57	where medicinal drugs are compounded, dispensed, stored, or sold
58	or where prescriptions are filled or dispensed on an outpatient
59	basis.
60	2.  The term "institutional pharmacy" includes every
61	location in a hospital, clinic, nursing home, dispensary,
62	sanitarium, extended care facility, or other facility,
63	hereinafter referred to as "health care institutions," where
64	medicinal drugs are compounded, dispensed, stored, or sold.
65	3.  The term "nuclear pharmacy" includes every location
66	where radioactive drugs and chemicals within the classification
67	of medicinal drugs are compounded, dispensed, stored, or sold.
68	The term "nuclear pharmacy" does not include hospitals licensed
69	under chapter 395 or the nuclear medicine facilities of such
70	hospitals.
71	4.  The term "special pharmacy" includes every location
72	where medicinal drugs are compounded, dispensed, stored, or sold
73	if such locations are not otherwise defined in this subsection.
74	5.  The term "Internet pharmacy" includes locations not
75	otherwise licensed or issued a permit under this chapter, within
76	or outside this state, which use the Internet to communicate
77	with or obtain information from consumers in this state and use
78	such communication or information to fill or refill
79	prescriptions or to dispense, distribute, or otherwise engage in
80	the practice of pharmacy in this state. Any act described in
81	this subparagraph constitutes the practice of the profession of
82	pharmacy as defined in subsection (13).
83	Section 2.  Subsections (7) and (8) are added to section
84	465.0156, Florida Statutes, to read:
85	465.0156  Registration of nonresident pharmacies.--
86	(7)  This section does not apply to Internet pharmacies
87	required to be permitted under s. 465.0197.
88	(8)  Notwithstanding s. 465.003(10), for purposes of this
89	section, the registered pharmacy and the pharmacist designated
90	by the registered pharmacy as the prescription department
91	manager or the equivalent must be licensed in the state of
92	location in order to dispense medicinal drugs into this state.
93	Section 3.  Paragraph (s) is added to subsection (1) of
94	section 465.016, Florida Statutes, to read:
95	465.016  Disciplinary actions.--
96	(1)  The following acts constitute grounds for denial of a
97	license or disciplinary action, as specified in s. 456.072(2):
98	(s)  Dispensing any medicinal drug based upon a
99	communication that purports to be a prescription as defined in
100	s. 465.003(14) or s. 893.02(20) when the pharmacist knows or has
101	reason to believe that the purported prescription is not based
102	upon a valid practitioner-patient relationship.
103	Section 4.  Section 465.0161, Florida Statutes, is created
104	to read:
105	465.0161  Distribution of medicinal drugs without a
106	permit.--An Internet pharmacy that distributes a medicinal drug
107	to any person in this state without being permitted as a
108	pharmacy under this chapter commits a felony of the second
109	degree, punishable as provided in s. 775.082, s. 775.083, or s.
110	775.084.
111	Section 5.  Section 465.0196, Florida Statutes, is amended
112	to read:
113	465.0196  Special pharmacy permits.--Any person desiring a
114	permit to operate a special pharmacy which does not fall within
115	the definitions set forth in s. 465.003(11)(a)1., 2., and 3.
116	shall apply to the department for a special pharmacy permit. If
117	the board certifies that the application complies with the
118	applicable laws and rules of the board governing the practice of
119	the profession of pharmacy, the department shall issue the
120	permit. No permit shall be issued unless a licensed pharmacist
121	is designated to undertake the professional supervision of the
122	compounding and dispensing of all drugs dispensed by the
123	pharmacy. The licensed pharmacist shall be responsible for
124	maintaining all drug records and for providing for the security
125	of the area in the facility in which the compounding, storing,
126	and dispensing of medicinal drugs occurs. The permittee shall
127	notify the department within 10 days of any change of the
128	licensed pharmacist responsible for such duties. Every permittee
129	that employs or otherwise utilizes pharmacy technicians shall
130	have a written policy and procedures manual specifying those
131	duties, tasks, and functions which a pharmacy technician is
132	allowed to perform.
133	Section 6.  Section 465.0197, Florida Statutes, is created
134	to read:
135	465.0197  Internet pharmacy permits.--
136	(1)  Any person desiring a permit to operate an Internet
137	pharmacy shall apply to the department for an Internet pharmacy
138	permit. If the board certifies that the application complies
139	with the applicable laws and rules of the board governing the
140	practice of the profession of pharmacy, the department shall
141	issue the permit. No permit shall be issued unless a licensed
142	pharmacist is designated as the prescription department manager
143	for dispensing medicinal drugs to persons in this state. The
144	licensed pharmacist shall be responsible for maintaining all
145	drug records and for providing for the security of the area in
146	the facility in which the compounding, storing, and dispensing
147	of medicinal drugs to persons in this state occurs. The
148	permittee shall notify the department within 30 days of any
149	change of the licensed pharmacist responsible for such duties.
150	Every permittee that employs or otherwise utilizes pharmacy
151	technicians shall have a written policy and procedures manual
152	specifying those duties, tasks, and functions which a pharmacy
153	technician is allowed to perform.
154	(2)  An Internet pharmacy must obtain a permit under this
155	section to sell medicinal drugs to persons in this state.
156	(3)  An Internet pharmacy shall provide pharmacy services
157	at a high level of protection and competence and shall disclose
158	to the board the following specific information:
159	(a)  That it maintains at all times a valid, unexpired
160	license, permit, or registration to operate the pharmacy in
161	compliance with the laws of the state in which the dispensing
162	facility is located and from which the medicinal drugs shall be
163	dispensed.
164	(b)  The location, names, and titles of all principal
165	corporate officers and the pharmacist who serves as the
166	prescription department manager for dispensing medicinal drugs
167	to persons in this state. This disclosure shall be made within
168	30 days after any change of location, principal corporate
169	officer, or pharmacist serving as the prescription department
170	manager for dispensing medicinal drugs to persons in this state.
171	(c)  That it complies with all lawful directions and
172	requests for information from the regulatory or licensing agency
173	of all states in which it is licensed as well as with all
174	requests for information made by the board pursuant to this
175	section. It shall respond directly to all communications from
176	the board concerning emergency circumstances arising from errors
177	in the dispensing of medicinal drugs to persons in this state.
178	(d)  That it maintains its records of medicinal drugs
179	dispensed to patients in this state so that the records are
180	readily retrievable from the other business records of the
181	pharmacy and from the records of other medicinal drugs
182	dispensed.
183	(e)  That during its regular hours of operation but not
184	less than 6 days per week, for a minimum of 40 hours per week, a
185	toll-free telephone service shall be provided to facilitate
186	communication between patients in this state and a pharmacist at
187	the pharmacy who has access to the patient's records. This toll-
188	free number must be disclosed on the label affixed to each
189	container of dispensed medicinal drugs.
190	(4)  Notwithstanding s. 465.003(10), for purposes of this
191	section, the Internet pharmacy and the pharmacist designated by
192	the Internet pharmacy as the prescription department manager or
193	the equivalent must be licensed in the state of location in
194	order to dispense medicinal drugs into this state.
195	Section 7.  Subsection (1) of section 465.023, Florida
196	Statutes, is amended to read:
197	465.023  Pharmacy permittee; disciplinary action.--
198	(1)  The department or the board may revoke or suspend the
199	permit of any pharmacy permittee, and may fine, place on
200	probation, or otherwise discipline any pharmacy permittee who
201	has:
202	(a)  Obtained a permit by misrepresentation or fraud or
203	through an error of the department or the board;
204	(b)  Attempted to procure, or has procured, a permit for
205	any other person by making, or causing to be made, any false
206	representation;
207	(c)  Violated any of the requirements of this chapter or
208	any of the rules of the Board of Pharmacy; of chapter 499, known
209	as the "Florida Drug and Cosmetic Act"; of 21 U.S.C. ss. 301-
210	392, known as the "Federal Food, Drug, and Cosmetic Act"; of 21
211	U.S.C. ss. 821 et seq., known as the Comprehensive Drug Abuse
212	Prevention and Control Act; or of chapter 893; or
213	(d)  Been convicted or found guilty, regardless of
214	adjudication, of a felony or any other crime involving moral
215	turpitude in any of the courts of this state, of any other
216	state, or of the United States; or
217	(e)  Dispensed any medicinal drug based upon a
218	communication that purports to be a prescription as defined in
219	s. 465.003(14) or s. 893.02(20) when the pharmacist knows or has
220	reason to believe that the purported prescription is not based
221	upon a valid practitioner-patient relationship that includes a
222	documented patient evaluation, including history and a physical
223	examination adequate to establish the diagnosis for which any
224	drug is prescribed and any other requirement established by
225	board rule under chapter 458, chapter 459, chapter 461, chapter
226	463, chapter 464, or chapter 466.
227	Section 8.  Section 465.0255, Florida Statutes, is amended
228	to read:
229	465.0255  Expiration date of medicinal drugs; display;
230	related use and storage instructions.--
231	(1)  The manufacturer, repackager, or other distributor of
232	any medicinal drug shall display the expiration date of each
233	drug in a readable fashion on the container and on its
234	packaging. The term "readable" means conspicuous and bold.
235	(2)  Each pharmacist for a community pharmacy dispensing
236	medicinal drugs and each practitioner dispensing medicinal drugs
237	on an outpatient basis shall display on the outside of the
238	container of each medicinal drug dispensed, or in other written
239	form delivered to the purchaser:,
240	(a)  The expiration date when provided by the manufacturer,
241	repackager, or other distributor of the drug; or and
242	(b)  An earlier beyond-use date for expiration, which may
243	be up to 1 year after the date of dispensing.
244
245	The dispensing pharmacist or practitioner must provide
246	information concerning the expiration date to the purchaser upon
247	request and must provide appropriate instructions regarding the
248	proper use and storage of the drug.
249	(3)  Nothing in This section does not shall impose
250	liability on the dispensing pharmacist or practitioner for
251	damages related to, or caused by, a medicinal drug that loses
252	its effectiveness prior to the expiration date displayed by the
253	dispensing pharmacist or practitioner.
254	(4)(3)  The provisions of this section are intended to
255	notify the patient receiving a medicinal drug of the information
256	required by this section, and the dispensing pharmacist or
257	practitioner shall not be liable for the patient's failure to
258	heed such notice or to follow the instructions for storage.
259	Section 9.  Subsection (7) is added to section 465.026,
260	Florida Statutes, to read:
261	465.026  Filling of certain prescriptions.--Nothing
262	contained in this chapter shall be construed to prohibit a
263	pharmacist licensed in this state from filling or refilling a
264	valid prescription which is on file in a pharmacy located in
265	this state or in another state and has been transferred from one
266	pharmacy to another by any means, including any electronic
267	means, under the following conditions:
268	(7)  A community pharmacy licensed under this chapter which
269	only receives and transfers prescriptions for dispensing by
270	another pharmacy may transfer a prescription for a medicinal
271	drug listed in Schedule II under chapter 893. The pharmacy
272	receiving the prescription may ship, mail, or deliver into this
273	state, in any manner, the dispensed Schedule II medicinal drug
274	under the following conditions:
275	(a)  The pharmacy receiving and dispensing the transferred
276	prescription maintains at all times a valid, unexpired license,
277	permit, or registration to operate the pharmacy in compliance
278	with the laws of the state in which the pharmacy is located and
279	from which the medicinal drugs are dispensed.
280	(b)  The community pharmacy and the receiving pharmacy are
281	owned and operated by the same person and share a centralized
282	database.
283	(c)  The community pharmacy assures its compliance with
284	federal laws and subsections (1)-(5).
285	Section 10.  Paragraph (h) is added to subsection (6) of
286	section 499.0121, Florida Statutes, to read:
287	499.0121  Storage and handling of prescription drugs;
288	recordkeeping.--The department shall adopt rules to implement
289	this section as necessary to protect the public health, safety,
290	and welfare. Such rules shall include, but not be limited to,
291	requirements for the storage and handling of prescription drugs
292	and for the establishment and maintenance of prescription drug
293	distribution records.
294	(6)  RECORDKEEPING.--The department shall adopt rules that
295	require keeping such records of prescription drugs as are
296	necessary for the protection of the public health.
297	(h)1.  This paragraph applies only to an affiliated group,
298	as defined in s. 1504 of the Internal Revenue Code of 1986, as
299	amended, which is composed of chain drug entities, including at
300	least 50 retail pharmacies, warehouses, or repackagers, which
301	are members of the same affiliated group if:
302	a.  The group discloses to the department the names of all
303	the members of the affiliated group; and
304	b.  The affiliated group agrees in writing to provide
305	records on prescription drug purchases by the members of the
306	affiliated group not later than 48 hours after the department
307	requests access to such records, regardless of the location of
308	where the records are stored.
309	2.  Each warehouse within the affiliated group must comply
310	with all applicable federal and state drug wholesale permit
311	requirements and must purchase, receive, hold, and distribute
312	prescription drugs only to a retail pharmacy or warehouse within
313	the affiliated group. Such a warehouse is exempt from providing
314	a pedigree paper in accordance with paragraph (d) or paragraph
315	(e) to its affiliated group member warehouse, provided that:
316	a.  Any affiliated group member that purchases or receives
317	a prescription drug from outside the affiliated group must
318	receive a pedigree paper if the prescription drug is distributed
319	in or into this state and a pedigree paper is required under
320	this section and must authenticate the documentation as required
321	in subsection (4), regardless of whether the affiliated group
322	member is directly subject to regulation under this chapter; and
323	b.  The affiliated group makes available to the department
324	on request all records related to the purchase or acquisition of
325	prescription drugs by members of the affiliated group,
326	regardless of the location where the records are stored, if the
327	prescription drugs were distributed in or into this state.
328	3.  If a repackager repackages prescription drugs solely
329	for distribution to its affiliated group members for the
330	exclusive distribution to and among retail pharmacies that are
331	members of the affiliated group to which the repackager is a
332	member:
333	a.  The repackager must:
334	(I)  In lieu of the written statement required by paragraph
335	(d) or paragraph (e), for all repackaged prescription drugs
336	distributed in or into this state, state in writing under oath
337	with each distribution of a repackaged prescription drug to an
338	affiliated group member warehouse or repackager: "All repackaged
339	prescription drugs are purchased by the affiliated group
340	directly from the manufacturer or from a prescription drug
341	wholesaler that purchased the prescription drugs directly from
342	the manufacturer.";
343	(II)  Purchase all prescription drugs it repackages:
344	(A)  Directly from the manufacturer; or
345	(B)  From a prescription drug wholesaler that purchased the
346	prescription drugs directly from the manufacturer; and
347	(III)  Maintain records in accordance with this section to
348	document that it purchased the prescription drugs directly from
349	the manufacturer or that its prescription drug wholesale
350	supplier purchased the prescription drugs directly from the
351	manufacturer.
352	b.  In addition, all members of the affiliated group must
353	provide to agents of the department on request records of
354	purchases by all members of the affiliated group of prescription
355	drugs that have been repackaged, regardless of the location
356	where the records are stored or where the repackager is located.
357	4.  This paragraph expires July 1, 2006.
358	Section 11.  Paragraph (a) of subsection (1) of section
359	895.02, Florida Statutes, is amended to read:
360	895.02  Definitions.--As used in ss. 895.01-895.08, the
361	term:
362	(1)  "Racketeering activity" means to commit, to attempt to
363	commit, to conspire to commit, or to solicit, coerce, or
364	intimidate another person to commit:
365	(a)  Any crime which is chargeable by indictment or
366	information under the following provisions of the Florida
367	Statutes:
368	1.  Section 210.18, relating to evasion of payment of
369	cigarette taxes.
370	2.  Section 403.727(3)(b), relating to environmental
371	control.
372	3.4.  Section 409.920, relating to Medicaid provider fraud.
373	4.3.  Section 414.39, relating to public assistance fraud.
374	5.  Section 440.105 or s. 440.106, relating to workers'
375	compensation.
376	6.  Section 465.0161, relating to distribution of medicinal
377	drugs without a permit as an Internet pharmacy.
378	7.6.  Sections 499.0051, 499.0052, 499.0053, 499.0054, and
379	499.0691, relating to crimes involving contraband and
380	adulterated drugs.
381	8.7.  Part IV of chapter 501, relating to telemarketing.
382	9.8.  Chapter 517, relating to sale of securities and
383	investor protection.
384	10.9.  Section 550.235, s. 550.3551, or s. 550.3605,
385	relating to dogracing and horseracing.
386	11.10.  Chapter 550, relating to jai alai frontons.
387	12.11.  Chapter 552, relating to the manufacture,
388	distribution, and use of explosives.
389	13.12.  Chapter 560, relating to money transmitters, if the
390	violation is punishable as a felony.
391	14.13.  Chapter 562, relating to beverage law enforcement.
392	15.14.  Section 624.401, relating to transacting insurance
393	without a certificate of authority, s. 624.437(4)(c)1., relating
394	to operating an unauthorized multiple-employer welfare
395	arrangement, or s. 626.902(1)(b), relating to representing or
396	aiding an unauthorized insurer.
397	16.15.  Section 655.50, relating to reports of currency
398	transactions, when such violation is punishable as a felony.
399	17.16.  Chapter 687, relating to interest and usurious
400	practices.
401	18.17.  Section 721.08, s. 721.09, or s. 721.13, relating
402	to real estate timeshare plans.
403	19.18.  Chapter 782, relating to homicide.
404	20.19.  Chapter 784, relating to assault and battery.
405	21.20.  Chapter 787, relating to kidnapping.
406	22.21.  Chapter 790, relating to weapons and firearms.
407	23.22.  Section 796.03, s. 796.04, s. 796.05, or s. 796.07,
408	relating to prostitution.
409	24.23.  Chapter 806, relating to arson.
410	25.24.  Section 810.02(2)(c), relating to specified
411	burglary of a dwelling or structure.
412	26.25.  Chapter 812, relating to theft, robbery, and
413	related crimes.
414	27.26.  Chapter 815, relating to computer-related crimes.
415	28.27.  Chapter 817, relating to fraudulent practices,
416	false pretenses, fraud generally, and credit card crimes.
417	29.28.  Chapter 825, relating to abuse, neglect, or
418	exploitation of an elderly person or disabled adult.
419	30.29.  Section 827.071, relating to commercial sexual
420	exploitation of children.
421	31.30.  Chapter 831, relating to forgery and
422	counterfeiting.
423	32.31.  Chapter 832, relating to issuance of worthless
424	checks and drafts.
425	33.32.  Section 836.05, relating to extortion.
426	34.33.  Chapter 837, relating to perjury.
427	35.34.  Chapter 838, relating to bribery and misuse of
428	public office.
429	36.35.  Chapter 843, relating to obstruction of justice.
430	37.36.  Section 847.011, s. 847.012, s. 847.013, s. 847.06,
431	or s. 847.07, relating to obscene literature and profanity.
432	38.37.  Section 849.09, s. 849.14, s. 849.15, s. 849.23, or
433	s. 849.25, relating to gambling.
434	39.38.  Chapter 874, relating to criminal street gangs.
435	40.39.  Chapter 893, relating to drug abuse prevention and
436	control.
437	41.40.  Chapter 896, relating to offenses related to
438	financial transactions.
439	42.41.  Sections 914.22 and 914.23, relating to tampering
440	with a witness, victim, or informant, and retaliation against a
441	witness, victim, or informant.
442	43.42.  Sections 918.12 and 918.13, relating to tampering
443	with jurors and evidence.
444	Section 12.  The sum of $590,051 is appropriated from the
445	Medical Quality Assurance Trust Fund to the Department of
446	Health, and nine full-time equivalent positions are authorized,
447	for the 2004-2005 fiscal year for the purpose of implementing
448	this act.
449	Section 13.  This act shall take effect July 1, 2004.

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