HB 0989 2003
1	CHAMBER ACTION
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6	The Committee on Health Care recommends the following:
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8	Committee Substitute
9	Remove the entire bill and insert:
10	A bill to be entitled
11	An act relating to controlled substances; creating s.
12	831.311, F.S.; prohibiting the sale, manufacture,
13	alteration, delivery, uttering, or possession of
14	counterfeit-resistant prescription blanks for controlled
15	substances; providing penalties; amending s. 893.04, F.S.;
16	providing additional requirements for the dispensing of a
17	controlled substance listed in Schedule II, Schedule III,
18	or Schedule IV; providing rulemaking authority to the
19	Board of Pharmacy; creating s. 893.055, F.S.; requiring
20	the Department of Health to establish an electronic system
21	to monitor the prescribing of controlled substances listed
22	in Schedules II, III, and IV; requiring the dispensing of
23	such controlled substances to be reported through the
24	system; providing exceptions; providing reporting
25	requirements; providing penalties; providing rulemaking
26	authority to the department; requiring the department to
27	cover all costs for the system; providing a continuing
28	appropriation; creating s. 893.065, F.S.; requiring the
29	department to develop and adopt by rule the form and
30	content for a counterfeit-resistant prescription blank for
31	voluntary use by physicians to prescribe a controlled
32	substance listed in Schedule II, Schedule III, or Schedule
33	IV; providing an appropriation; providing contingent
34	applicability of penalties; providing contingent effective
35	dates.
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37	Be It Enacted by the Legislature of the State of Florida:
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39	Section 1. Section 831.311, Florida Statutes, is created
40	to read:
41	831.311 Unlawful sale, manufacture, alteration, delivery,
42	uttering, or possession of counterfeit-resistant prescription
43	blanks for controlled substances listed in Schedules II, III,
44	and IV.--
45	(1) It is unlawful for any person with the intent to
46	injure or defraud any person or to facilitate any violation of
47	s. 893.13 to sell, manufacture, alter, deliver, utter, or
48	possess any counterfeit-resistant prescription blanks for
49	controlled substances adopted by rule of the Department of
50	Health pursuant to s. 893.065.
51	(2) Any person who violates this section commits a felony
52	of the third degree, punishable as provided in s. 775.082, s.
53	775.083, or s. 775.084.
54	Section 2. Section 893.04, Florida Statutes, is amended to
55	read:
56	893.04 Pharmacist and practitioner.--
57	(1) A pharmacist, in good faith and in the course of
58	professional practice only, may dispense controlled substances
59	upon a written or oral prescription of a practitioner, under the
60	following conditions:
61	(a) Oral prescriptions must be promptly reduced to writing
62	by the pharmacist or recorded electronically if permitted by
63	federal law.
64	(b) The written prescription must be dated and signed by
65	the prescribing practitioner on the day when issued.
66	(c) There shall appear on the face of the prescription or
67	written record thereof for the controlled substance the
68	following information:
69	1. The full name and address of the person for whom, or
70	the owner of the animal for which, the controlled substance is
71	dispensed.
72	2. The full name and address of the prescribing
73	practitioner and the practitioner's federal controlled substance
74	registry number shall be printed thereon.
75	3. If the prescription is for an animal, the species of
76	animal for which the controlled substance is prescribed.
77	4. The name of the controlled substance prescribed and the
78	strength, quantity, and directions for use thereof.
79	5. The number of the prescription, as recorded in the
80	prescription files of the pharmacy in which it is filled.
81	6. The initials of the pharmacist filling the prescription
82	and the date filled.
83	(d) The prescription shall be retained on file by the
84	proprietor of the pharmacy in which it is filled for a period of
85	2 years.
86	(e) Affixed to the original container in which a
87	controlled substance is delivered upon a prescription or
88	authorized refill thereof, as hereinafter provided, there shall
89	be a label bearing the following information:
90	1. The name and address of the pharmacy from which such
91	controlled substance was dispensed.
92	2. The date on which the prescription for such controlled
93	substance was filled.
94	3. The number of such prescription, as recorded in the
95	prescription files of the pharmacy in which it is filled.
96	4. The name of the prescribing practitioner.
97	5. The name of the patient for whom, or of the owner and
98	species of the animal for which, the controlled substance is
99	prescribed.
100	6. The directions for the use of the controlled substance
101	prescribed in the prescription.
102	7. A clear, concise warning that it is a crime to transfer
103	the controlled substance to any person other than the patient
104	for whom prescribed.
105	(f) A prescription for a controlled substance listed in
106	Schedule II may be dispensed only upon a written prescription of
107	a practitioner, except that in an emergency situation, as
108	defined by regulation of the Department of Health, such
109	controlled substance may be dispensed upon oral prescription but
110	shall be limited to a 72-hour supply. No prescription for a
111	controlled substance listed in Schedule II may be refilled.
112	(g) No prescription for a controlled substance listed in
113	ScheduleSchedules III, Schedule IV, or ScheduleV may be filled
114	or refilled more than five times within a period of 6 months
115	after the date on which the prescription was written unless the
116	prescription is renewed by a practitioner.
117	(2)(a) A pharmacist may not dispense a controlled
118	substance listed in Schedule II, Schedule III, or Schedule IV to
119	any patient or patient's agent without first determining, in the
120	exercise of her or his professional judgment, that the order is
121	valid. The pharmacist or pharmacist's agent shall also obtain
122	the patient's or patient's agent identification, in writing,
123	electronic format, or other approved manner prior to dispensing
124	any controlled substance. If the patient or the patient's agent
125	does not have appropriate identification, the pharmacist may
126	dispense the controlled substance only when the pharmacist
127	determines, in the exercise or her or his professional judgment,
128	that the order is valid and includes such information in the
129	patient's record. The Board of Pharmacy may adopt, by rule,
130	required patient identification information for controlled
131	substances and procedures for a pharmacist to verify the
132	validity of a prescription for controlled substance for
133	circumstances in which the pharmacist was not provided required
134	identification information.
135	(b) Any pharmacist that dispenses by mail a controlled
136	substance listed in Schedule II, Schedule III, or Schedule IV
137	shall be exempt from the requirement to obtain suitable
138	identification for the prescription dispensed by mail.
139	(c) Any controlled substance listed in Schedule III or
140	Schedule IV may be dispensed by a pharmacist upon an oral
141	prescription if, before filling the prescription, the pharmacist
142	reduces it to writing or records the prescription electronically
143	if permitted by federal law. Such prescriptions must contain the
144	date of the oral authorization.
145	(d) All written prescriptions prescribed by a practitioner
146	in this state for a controlled substance listed in Schedule II,
147	Schedule III, or Schedule IV must include both a written and a
148	numerical notation of the quantity on the face of the
149	prescription and a notation of the date with the abbreviated
150	month written out on the face of the prescription. A pharmacist
151	shall be permitted, upon verification by the prescriber, to
152	document any information required by this paragraph.
153	(e) A pharmacist may not dispense more than a 30-day
154	supply of a controlled substance listed in Schedule III upon an
155	oral prescription prescribed by a practitioner in this state.
156	(f) A pharmacist may not knowingly fill a prescription
157	that has been forged for a controlled substance listed in
158	Schedule II, Schedule III, or Schedule IV.
159	(3)(2)Notwithstanding the provisions of subsection (1), a
160	pharmacist may dispense a one-time emergency refill of up to a
161	72-hour supply of the prescribed medication for any medicinal
162	drug other than a medicinal drug listed in Schedule II, in
163	compliance with the provisions of s. 465.0275.
164	(4)(3)The legal owner of any stock of controlled
165	substances in a pharmacy, upon discontinuance of dealing in
166	controlled substances, may sell said stock to a manufacturer,
167	wholesaler, or pharmacy. Such controlled substances may be sold
168	only upon an order form, when such an order form is required for
169	sale by the drug abuse laws of the United States or this state,
170	or regulations pursuant thereto.
171	Section 3. Section 893.055, Florida Statutes, is created
172	to read:
173	893.055 Electronic monitoring system for prescription of
174	controlled substances listed in Schedules II, III, and IV.--
175	(1) By January 1, 2004, the Department of Health shall
176	design and establish an electronic system consistent with the
177	American Society for Automation in Pharmacy (ASAP) standards to
178	monitor the prescribing and dispensing of controlled substances
179	listed in Schedules II, III, and IV by health care practitioners
180	within the state and the dispensing of such controlled
181	substances to an individual at a specific address within the
182	state by a pharmacy permitted or registered by the Board of
183	Pharmacy.
184	(2) Any controlled substance listed in Schedule II,
185	Schedule III, or Schedule IV which is dispensed to an individual
186	in this state must be reported to the Department of Health
187	through the system, as soon thereafter as possible but not more
188	than 30 days after the date the controlled substance is
189	dispensed, each time the controlled substance is dispensed. A
190	pharmacy may meet the reporting requirements of this section by
191	providing the Department of Health an exchangeable electronic
192	disc or tape of each controlled substance listed in Schedules
193	II, III, and IV dispensed.
194	(3) This section does not apply to controlled substances:
195	(a) Administered by a health care practitioner directly to
196	a patient.
197	(b) Dispensed by a health care practitioner authorized to
198	prescribe controlled substances directly to a patient and
199	limited to an amount adequate to treat the patient for a period
200	of no more than 72 hours.
201	(c) Dispensed by a health care practitioner or a
202	pharmacist to an inpatient of a facility with an institutional
203	pharmacy permit.
204	(d) Ordered from an institutional pharmacy permitted under
205	s. 465.019 in accordance with the institutional policy for such
206	controlled substances or drugs.
207	(e) Either dispensed by a pharmacist or administered by a
208	health care practitioner to a patient or resident receiving care
209	from a hospital, nursing home, assisted living facility, home
210	health agency, hospice, or intermediate care facility for the
211	developmentally disabled which is licensed in this state.
212	(f) Prescribed or dispensed by a health care practitioner
213	for a patient less than 16 years of age.
214	(4) The data required to be reported under this section
215	shall be determined by the Department of Health by rule but may
216	include any data required under s. 893.04.
217	(5) A practitioner or pharmacist who dispenses a
218	controlled substance under this section must submit the
219	information required by this section in an electronic or other
220	format approved by rule of the Department of Health. The cost to
221	the dispenser in submitting the information required by this
222	subsection shall not be material or extraordinary. Costs not
223	considered to be material or extraordinary include, but are not
224	limited to, regular postage, compact discs, zip drive storage,
225	regular electronic mail, magnetic tapes, diskettes, and
226	facsimile charges. The information submitted to the Department
227	of Health under this section may be transmitted to any person or
228	agency authorized to receive it pursuant to section 2 of House
229	Bill 997 or similar legislation, and that person or agency may
230	maintain the information received for up to 24 months before
231	purging it from its records. All transmissions required by this
232	paragraph shall comply with relevant federal and state privacy
233	and security laws. Notwithstanding the foregoing, any authorized
234	agency receiving such information may maintain it longer than 24
235	months if the information is pertinent to an ongoing
236	investigation or prosecution.
237	(6) Any person who knowingly fails to report the
238	dispensing of a controlled substance listed in Schedule II,
239	Schedule III, or Schedule IV as required by this section commits
240	a misdemeanor of the first degree, punishable as provided in s.
241	775.082 or s. 775.083.
242	(7) The Department of Health and the regulatory boards for
243	the health care practitioners subject to this section shall
244	adopt rules pursuant to ss. 120.536(1) and 120.54 necessary to
245	implement and administer this section.
246	(8) All costs incurred by the Department of Health in
247	implementing the prescription monitoring system shall be borne
248	by the department, and there is appropriated annually from the
249	General Revenue Fund an amount necessary to cover such costs.
250	The Medical Quality Assurance Trust Fund may not be used to
251	implement or otherwise fund the program.
252	Section 4. Section 893.065, Florida Statutes, is created
253	to read:
254	893.065 Counterfeit-resistant prescription blanks for
255	controlled substances listed in Schedules II, III, and IV.--The
256	Department of Health shall develop and adopt by rule the form
257	and content for a counterfeit-resistant prescription blank which
258	may be used by practitioners to prescribe a controlled substance
259	listed in Schedule II, Schedule III, or Schedule IV. The
260	Department of Health may require the prescription blanks to be
261	printed on distinctive, watermarked paper and to bear the
262	preprinted name, address, and category of professional licensure
263	of the practitioner and that practitioner's federal registry
264	number for controlled substances. The prescription blanks may
265	not be transferred.
266	Section 5. There is appropriated from the General Revenue
267	Fund to the Department of Health for fiscal year 2003-2004 an
268	amount sufficient to cover the costs incurred by the department
269	in implementing the provisions of ss. 893.055 and 893.065,
270	Florida Statutes, as created by this act. This section shall
271	take effect July 1, 2003.
272	Section 6. The penalties created in ss. 831.311(2) and
273	893.055(6), Florida Statutes, by this act shall be effective
274	only upon the adoption by the Department of Health and each
275	applicable professional regulatory board of the rules required
276	pursuant to ss. 893.055(7) and 893.065, Florida Statutes, as
277	created by this act.
278	Section 7. Except as otherwise provided herein, this act
279	shall take effect July 1, 2004, if House Bill 997 or similar
280	legislation is adopted in the same legislative session or an
281	extension thereof and becomes law.