HB 0397 2004
1	A bill to be entitled
2	An act relating to controlled substances; creating s.
3	831.311, F.S.; prohibiting the sale, manufacture,
4	alteration, delivery, uttering, or possession of
5	counterfeit-resistant prescription blanks for controlled
6	substances; providing penalties; amending s. 893.04, F.S.;
7	providing additional requirements for the dispensing of a
8	controlled substance listed in Schedule II, Schedule III,
9	or Schedule IV; providing rulemaking authority to the
10	Board of Pharmacy; creating s. 893.055, F.S.; requiring
11	the Department of Health to establish an electronic system
12	to monitor the prescribing of controlled substances listed
13	in Schedules II, III, and IV; requiring the dispensing of
14	such controlled substances to be reported through the
15	system; providing exceptions; providing reporting
16	requirements; providing penalties; requiring the
17	department and regulatory boards to adopt rules; requiring
18	the department to cover all costs for the system, subject
19	to availability of funds; providing a continuing
20	appropriation; providing that a certain trust fund may not
21	be used to fund the program; providing for future
22	legislative review and repeal; creating s. 893.065, F.S.;
23	requiring the department to develop and adopt by rule the
24	form and content for a counterfeit-proof prescription
25	blank for voluntary use by physicians to prescribe a
26	controlled substance listed in Schedule II, Schedule III,
27	or Schedule IV; providing an appropriation and authorizing
28	positions; providing contingent applicability of
29	penalties; providing contingent effective dates.
30
31	Be It Enacted by the Legislature of the State of Florida:
32
33	Section 1. Section 831.311, Florida Statutes, is created
34	to read:
35	831.311 Unlawful sale, manufacture, alteration, delivery,
36	uttering, or possession of counterfeit-resistant prescription
37	blanks for controlled substances listed in Schedules II, III,
38	and IV.--
39	(1) It is unlawful for any person with the intent to
40	injure or defraud any person or to facilitate any violation of
41	s. 893.13 to sell, manufacture, alter, deliver, utter, or
42	possess any counterfeit-resistant prescription blanks for
43	controlled substances adopted by rule of the Department of
44	Health pursuant to s. 893.065.
45	(2) Any person who violates this section commits a felony
46	of the third degree, punishable as provided in s. 775.082, s.
47	775.083, or s. 775.084.
48	Section 2. Section 893.04, Florida Statutes, is amended to
49	read:
50	893.04 Pharmacist and practitioner.--
51	(1) A pharmacist, in good faith and in the course of
52	professional practice only, may dispense controlled substances
53	upon a written or oral prescription of a practitioner, under the
54	following conditions:
55	(a) Oral prescriptions must be promptly reduced to writing
56	by the pharmacist or recorded electronically.
57	(b) The written prescription must be dated and signed by
58	the prescribing practitioner on the day when issued.
59	(c) There shall appear on the face of the prescription or
60	written record thereof for the controlled substance the
61	following information:
62	1. The full name and address of the person for whom, or
63	the owner of the animal for which, the controlled substance is
64	dispensed.
65	2. The full name and address of the prescribing
66	practitioner and the practitioner's federal controlled substance
67	registry number shall be printed thereon.
68	3. If the prescription is for an animal, the species of
69	animal for which the controlled substance is prescribed.
70	4. The name of the controlled substance prescribed and the
71	strength, quantity, and directions for use thereof.
72	5. The number of the prescription, as recorded in the
73	prescription files of the pharmacy in which it is filled.
74	6. The initials of the pharmacist filling the prescription
75	and the date filled.
76	(d) The prescription shall be retained on file by the
77	proprietor of the pharmacy in which it is filled for a period of
78	2 years.
79	(e) Affixed to the original container in which a
80	controlled substance is delivered upon a prescription or
81	authorized refill thereof, as hereinafter provided, there shall
82	be a label bearing the following information:
83	1. The name and address of the pharmacy from which such
84	controlled substance was dispensed.
85	2. The date on which the prescription for such controlled
86	substance was filled.
87	3. The number of such prescription, as recorded in the
88	prescription files of the pharmacy in which it is filled.
89	4. The name of the prescribing practitioner.
90	5. The name of the patient for whom, or of the owner and
91	species of the animal for which, the controlled substance is
92	prescribed.
93	6. The directions for the use of the controlled substance
94	prescribed in the prescription.
95	7. A clear, concise warning that it is a crime to transfer
96	the controlled substance to any person other than the patient
97	for whom prescribed.
98	(f) A prescription for a controlled substance listed in
99	Schedule II may be dispensed only upon a written prescription of
100	a practitioner, except that in an emergency situation, as
101	defined by regulation of the Department of Health, such
102	controlled substance may be dispensed upon oral prescription but
103	is limited to a 72-hour supply. No prescription for a controlled
104	substance listed in Schedule II may be refilled.
105	(g) No prescription for a controlled substance listed in
106	Schedule Schedules III, Schedule IV, or ScheduleV may be filled
107	or refilled more than five times within a period of 6 months
108	after the date on which the prescription was written unless the
109	prescription is renewed by a practitioner.
110	(2)(a) A pharmacist may not dispense a controlled
111	substance listed in Schedule II, Schedule III, or Schedule IV to
112	any patient or patient's agent without first determining, in the
113	exercise of her or his professional judgment, that the order is
114	valid. The pharmacist or pharmacist's agent must also obtain
115	the patient or patient's agent identification information, in
116	writing, electronic format, or other approved manner prior to
117	dispensing any controlled substance. If the patient or patient's
118	agent does not have appropriate identification, the pharmacist
119	may dispense the controlled substance only when the pharmacist
120	determines, in the exercise of her or his professional judgment,
121	that the order is valid and includes such information in the
122	patient's record. The Board of Pharmacy may adopt, by rule,
123	required patient identification information for controlled
124	substances and procedures for a pharmacist to verify the
125	validity of a prescription for controlled substances for
126	circumstances in which the pharmacist was not provided required
127	identification information.
128	(b) Any pharmacist that dispenses by mail a controlled
129	substance listed in Schedule II, Schedule III, or Schedule IV
130	shall be exempt from the requirement to obtain suitable
131	identification for the prescription dispensed by mail.
132	(c) Any controlled substance listed in Schedule III or
133	Schedule IV may be dispensed by a pharmacist upon an oral
134	prescription if, before filling the prescription, the pharmacist
135	reduces it to writing or records the prescription
136	electronically. Such prescriptions must contain the date of the
137	oral authorization.
138	(d) Each written prescription prescribed by a practitioner
139	in this state for a controlled substance listed in Schedule II,
140	Schedule III, or Schedule IV must include both a written and a
141	numerical notation of the quantity on the face of the
142	prescription and a notation of the date with the abbreviated
143	month written out on the face of the prescription. A pharmacist
144	shall be permitted, upon verification by the prescriber, to
145	document any information required by this paragraph.
146	(e) A pharmacist may not dispense more than a 30-day
147	supply of a controlled substance listed in Schedule III upon an
148	oral prescription issued in this state.
149	(f) A pharmacist may not knowingly fill a prescription
150	that has been forged for a controlled substance listed in
151	Schedule II, Schedule III, or Schedule IV.
152	(3)(2)Notwithstanding the provisions of subsection (1), a
153	pharmacist may dispense a one-time emergency refill of up to a
154	72-hour supply of the prescribed medication for any medicinal
155	drug other than a medicinal drug listed in Schedule II, in
156	compliance with the provisions of s. 465.0275.
157	(4)(3)The legal owner of any stock of controlled
158	substances in a pharmacy, upon discontinuance of dealing in
159	controlled substances, may sell said stock to a manufacturer,
160	wholesaler, or pharmacy. Such controlled substances may be sold
161	only upon an order form, when such an order form is required for
162	sale by the drug abuse laws of the United States or this state,
163	or regulations pursuant thereto.
164	Section 3. Effective July 1, 2004, subsection (1) of
165	section 893.055, Florida Statutes, is created, and effective
166	July 1, 2005, subsections (2) through (9) of said section are
167	created, to read:
168	893.055 Electronic monitoring system for prescription of
169	controlled substances listed in Schedules II, III, and IV.--
170	(1) By June 30, 2005, the Department of Health shall
171	design and establish an electronic system consistent with the
172	American Society for Automation in Pharmacy (ASAP) standards to
173	monitor the prescribing and dispensing of controlled substances
174	listed in Schedules II, III, and IV by health care practitioners
175	within the state and the dispensing of such controlled
176	substances to an individual at a specific address within the
177	state by a pharmacy permitted or registered by the Board of
178	Pharmacy. The system shall be put into operation on July 1,
179	2005.
180	(2) Any controlled substance listed in Schedule II,
181	Schedule III, or Schedule IV which is dispensed to an individual
182	in this state must be reported to the Department of Health
183	through the system, as soon thereafter as possible but not more
184	than 35 days after the date the controlled substance is
185	dispensed, each time the controlled substance is dispensed. A
186	pharmacy may meet the reporting requirements of this section by
187	providing the Department of Health an exchangeable electronic
188	disc or tape of each controlled substance listed in Schedules
189	II, III, and IV which it dispenses.
190	(3) This section does not apply to controlled substances:
191	(a) Administered by a health care practitioner directly to
192	a patient.
193	(b) Dispensed by a health care practitioner authorized to
194	prescribe controlled substances directly to a patient and
195	limited to an amount adequate to treat the patient for a period
196	of no more than 72 hours.
197	(c) Dispensed by a health care practitioner or a
198	pharmacist to an inpatient of a facility with an institutional
199	pharmacy permit.
200	(d) Ordered from an institutional pharmacy permitted under
201	s. 465.019 in accordance with the institutional policy for such
202	controlled substances or drugs.
203	(e) Either dispensed by a pharmacist or administered by a
204	health care practitioner to a patient or resident receiving care
205	from a hospital, nursing home, assisted living facility, home
206	health agency, hospice, or intermediate care facility for the
207	developmentally disabled which is licensed in this state.
208	(f) Prescribed by a health care practitioner for a patient
209	younger than 16 years of age.
210	(4) The data required to be reported under this section
211	shall be determined by the Department of Health by rule but may
212	include any data required under s. 893.04.
213	(5) A practitioner or pharmacist who dispenses a
214	controlled substance under this section must submit the
215	information required by this section in an electronic or other
216	format approved by rule of the Department of Health. The cost to
217	the dispenser in submitting the information required by this
218	subsection may not be material or extraordinary. Costs not
219	considered to be material or extraordinary include, but are not
220	limited to, regular postage, compact discs, zip drive storage,
221	regular electronic mail, magnetic tapes, diskettes, and
222	facsimile charges. The information submitted to the Department
223	of Health under this section may be transmitted to any person or
224	agency authorized to receive it pursuant to House Bill 399, or
225	similar legislation, and that person or agency may maintain the
226	information received for up to 24 months before purging it from
227	its records. All transmissions required by this paragraph must
228	comply with relevant federal and state privacy and security
229	laws. However, any authorized agency receiving such information
230	may maintain it longer than 24 months if the information is
231	pertinent to an ongoing investigation or prosecution.
232	(6) Any person who knowingly fails to report the
233	dispensing of a controlled substance listed in Schedule II,
234	Schedule III, or Schedule IV as required by this section commits
235	a misdemeanor of the first degree, punishable as provided in s.
236	775.082 or s. 775.083.
237	(7) The Department of Health and the regulatory boards for
238	the health care practitioners subject to this section shall
239	adopt rules pursuant to ss. 120.536(1) and 120.54 necessary to
240	implement and administer this section.
241	(8) All costs incurred by the Department of Health in
242	implementing the prescription monitoring system shall be borne
243	by the department, subject to the availability of funds, and
244	there is appropriated annually from the Grants and Donations
245	Trust Fund an amount necessary to cover such costs. The Medical
246	Quality Assurance Trust Fund may not be used to implement or
247	otherwise fund this program.
248	(9) This section is repealed June 30, 2008, unless
249	reviewed and saved from repeal through reenactment by the
250	Legislature.
251	Section 4. Section 893.065, Florida Statutes, is created
252	to read:
253	893.065 Counterfeit-resistant prescription blanks for
254	controlled substances listed in Schedules II, III, and IV.--The
255	Department of Health shall develop and adopt by rule the form
256	and content for a counterfeit-resistant prescription blank which
257	may be used by practitioners to prescribe a controlled substance
258	listed in Schedule II, Schedule III, or Schedule IV. The
259	Department of Health may require the prescription blanks to be
260	printed on distinctive, watermarked paper and to bear the
261	preprinted name, address, and category of professional licensure
262	of the practitioner and that practitioner's federal registry
263	number for controlled substances. The prescription blanks may
264	not be transferred.
265	Section 5. Effective July 1, 2004, there is appropriated
266	$2,196,352 from the Grants and Donations Trust Fund to the
267	Department of Health, and three full-time equivalent positions
268	are authorized for fiscal year 2004-2005, to implement the
269	provisions of ss. 893.055 and 893.065, Florida Statutes, as
270	created by this act.
271	Section 6. The penalties created in ss. 831.311(2) and
272	893.055(6), Florida Statutes, by this act shall be effective
273	only upon the adoption by the Department of Health and each
274	applicable professional regulatory board of the rules required
275	pursuant to ss. 893.055(7) and 893.065, Florida Statutes, as
276	created by this act.
277	Section 7. Except as otherwise expressly provided in this
278	act, this act shall take effect July 1, 2005, if House Bill 399
279	or similar legislation is adopted in the same legislative
280	session or an extension thereof and becomes law.