HB 0989 2003
1	A bill to be entitled
2	An act relating to controlled substances; amending s.
3	893.04, F.S.; providing additional requirements for the
4	dispensing of a controlled substance listed in Schedule
5	II, Schedule III, or Schedule IV; providing rulemaking
6	authority to the Board of Pharmacy; creating s. 893.055,
7	F.S.; requiring the Department of Health to establish an
8	electronic system to monitor the prescribing of controlled
9	substances listed in Schedules II, III, and IV; requiring
10	the dispensing of such controlled substances to be
11	reported through the system; providing exceptions;
12	providing reporting requirements; providing penalties;
13	providing rulemaking authority to the department;
14	requiring the department to cover all costs for the
15	system; providing a continuing appropriation; creating s.
16	893.065, F.S.; requiring the department to develop and
17	adopt by rule the form and content for a counterfeit-proof
18	prescription blank for voluntary use by physicians to
19	prescribe a controlled substance listed in Schedule II,
20	Schedule III, or Schedule IV; providing an appropriation;
21	providing effective dates.
22
23	Be It Enacted by the Legislature of the State of Florida:
24
25	Section 1. Section 893.04, Florida Statutes, is amended to
26	read:
27	893.04 Pharmacist and practitioner.--
28	(1) A pharmacist, in good faith and in the course of
29	professional practice only, may dispense controlled substances
30	upon a written or oral prescription of a practitioner, under the
31	following conditions:
32	(a) Oral prescriptions must be promptly reduced to writing
33	by the pharmacist.
34	(b) The written prescription must be dated and signed by
35	the prescribing practitioner on the day when issued.
36	(c) There shall appear on the face of the prescription or
37	written record thereof for the controlled substance the
38	following information:
39	1. The full name and address of the person for whom, or
40	the owner of the animal for which, the controlled substance is
41	dispensed.
42	2. The full name and address of the prescribing
43	practitioner and the practitioner's federal controlled substance
44	registry number shall be printed thereon.
45	3. If the prescription is for an animal, the species of
46	animal for which the controlled substance is prescribed.
47	4. The name of the controlled substance prescribed and the
48	strength, quantity, and directions for use thereof.
49	5. The number of the prescription, as recorded in the
50	prescription files of the pharmacy in which it is filled.
51	6. The initials of the pharmacist filling the prescription
52	and the date filled.
53	(d) The prescription shall be retained on file by the
54	proprietor of the pharmacy in which it is filled for a period of
55	2 years.
56	(e) Affixed to the original container in which a
57	controlled substance is delivered upon a prescription or
58	authorized refill thereof, as hereinafter provided, there shall
59	be a label bearing the following information:
60	1. The name and address of the pharmacy from which such
61	controlled substance was dispensed.
62	2. The date on which the prescription for such controlled
63	substance was filled.
64	3. The number of such prescription, as recorded in the
65	prescription files of the pharmacy in which it is filled.
66	4. The name of the prescribing practitioner.
67	5. The name of the patient for whom, or of the owner and
68	species of the animal for which, the controlled substance is
69	prescribed.
70	6. The directions for the use of the controlled substance
71	prescribed in the prescription.
72	7. A clear, concise warning that it is a crime to transfer
73	the controlled substance to any person other than the patient
74	for whom prescribed.
75	(f) A prescription for a controlled substance listed in
76	Schedule II may be dispensed only upon a written prescription of
77	a practitioner, except that in an emergency situation, as
78	defined by regulation of the Department of Health, such
79	controlled substance may be dispensed upon oral prescription but
80	shall be limited to a 48-hour supply. No prescription for a
81	controlled substance listed in Schedule II may be refilled.
82	(g) No prescription for a controlled substance listed in
83	ScheduleSchedules III, Schedule IV, or ScheduleV may be filled
84	or refilled more than five times within a period of 6 months
85	after the date on which the prescription was written unless the
86	prescription is renewed by a practitioner.
87	(2)(a) A pharmacist may not dispense a controlled
88	substance listed in Schedule II, Schedule III, or Schedule IV to
89	any individual without first obtaining suitable identification
90	and documenting, in a log book kept by the pharmacist, the
91	identity of the individual obtaining the controlled substance.
92	The log book entry shall contain the printed name, address,
93	phone number (if available), driver's license number or other
94	suitable identification number, and signature of the person
95	obtaining the controlled substance. If the individual does not
96	have suitable identification or it is impracticable to obtain
97	such identification, the pharmacist may dispense the controlled
98	substance only when the pharmacist determines, in the exercise
99	of her or his professional judgment, that the order is valid. In
100	such case, the pharmacist or his or her designee must obtain the
101	other information required by this paragraph and must sign the
102	log book to indicate that suitable identification was not
103	available and that the pharmacist's professional judgment was
104	exercised prior to dispensing the controlled substance. The
105	Board of Pharmacy may adopt, by rule, procedures for a
106	pharmacist to verify the validity of a prescription for a
107	controlled substance listed in Schedule II, Schedule III, or
108	Schedule IV for circumstances when it is otherwise impracticable
109	for the pharmacist to obtain suitable identification from the
110	patient or the patient's agent. For purposes of this paragraph,
111	identification is suitable only if it contains the photograph,
112	printed name, and signature of the individual obtaining the
113	controlled substance.
114	(b) Any pharmacist that dispenses by mail a controlled
115	substance listed in Schedule II, Schedule III, or Schedule IV
116	shall be exempt from the requirement to obtain suitable
117	identification.
118	(c) Any controlled substance listed in Schedule III or
119	Schedule IV may be dispensed by a pharmacist upon an oral
120	prescription if, before filling the prescription, the pharmacist
121	reduces it to writing. Such prescriptions must contain the date
122	of the oral authorization.
123	(d) All prescriptions issued for a controlled substance
124	listed in Schedule II, Schedule III, or Schedule IV must include
125	both a written and numerical notation of the date and quantity
126	on the face of the prescription.
127	(e) A pharmacist may not dispense more than a 30-day
128	supply of a controlled substance listed in Schedule III upon an
129	oral prescription.
130	(f) A pharmacist may not knowingly fill a prescription
131	that has been mutilated or forged for a controlled substance
132	listed in Schedule II, Schedule III, or Schedule IV.
133	(3)(2)Notwithstanding the provisions of subsection (1), a
134	pharmacist may dispense a one-time emergency refill of up to a
135	72-hour supply of the prescribed medication for any medicinal
136	drug other than a medicinal drug listed in Schedule II, in
137	compliance with the provisions of s. 465.0275.
138	(4)(3)The legal owner of any stock of controlled
139	substances in a pharmacy, upon discontinuance of dealing in
140	controlled substances, may sell said stock to a manufacturer,
141	wholesaler, or pharmacy. Such controlled substances may be sold
142	only upon an order form, when such an order form is required for
143	sale by the drug abuse laws of the United States or this state,
144	or regulations pursuant thereto.
145	Section 2. Section 893.055, Florida Statutes, is created
146	to read:
147	893.055 Electronic monitoring system for prescription of
148	controlled substances listed in Schedules II, III, and IV.--
149	(1) By January 1, 2004, the Department of Health shall
150	design and establish an electronic system to monitor the
151	prescribing of controlled substances listed in Schedules II,
152	III, and IV by health care practitioners within the state or the
153	dispensing of such controlled substances to an address within
154	the state by a pharmacy permitted or registered by the Board of
155	Pharmacy.
156	(2) Any controlled substance listed in Schedule II,
157	Schedule III, or Schedule IV that is dispensed in this state
158	must be reported to the Department of Health through the system,
159	as soon thereafter as possible but not more than 30 days after
160	the date the controlled substance is dispensed, each time the
161	controlled substance is dispensed.
162	(3) This section does not apply to controlled substances:
163	(a) Administered by a health care practitioner directly to
164	a patient.
165	(b) Dispensed by a health care practitioner to a patient
166	and limited to an amount adequate to treat the patient for a
167	period of no more than 48 hours.
168	(c) Dispensed by a health care practitioner to an in-
169	patient of a facility with an institutional pharmacy permit.
170	(d) Prescribed by a health care practitioner for a patient
171	less than 16 years of age.
172	(4) The data required to be reported under this section
173	shall be determined by the Department of Health by rule but may
174	include any data required under s. 893.04 and must include the
175	category of professional licensure of the prescribing
176	practitioner.
177	(5) A dispenser must transmit the information required by
178	this section in an electronic format approved by rule of the
179	Board of Pharmacy after consultation with the Department of
180	Health, unless a specific waiver is granted to that dispenser by
181	the Department of Health. The information transmitted to the
182	Department of Health under this section may be transmitted to
183	any agency authorized to receive it, and that agency may
184	maintain the information received for up to 12 months before
185	purging it from its records. Notwithstanding the foregoing, any
186	authorized agency receiving such information may maintain it
187	longer than 12 months if the information is pertinent to an
188	ongoing investigation arising under this section.
189	(6) Any person who willfully fails to report the
190	dispensing of a controlled substance listed in Schedule II,
191	Schedule III, or Schedule IV as required by this section commits
192	a misdemeanor of the first degree, punishable as provided in s.
193	775.082 or s. 775.083.
194	(7) The Department of Health shall adopt rules pursuant to
195	ss. 120.536(1) and 120.54 necessary to implement and administer
196	this section.
197	(8) The Department of Health must cover all costs for the
198	prescription monitoring system, and there is appropriated
199	annually out of the General Revenue Fund, to be paid to the
200	Administrative Trust Fund of the department, an amount necessary
201	to cover such costs.
202	Section 3. Section 893.065, Florida Statutes, is created
203	to read:
204	893.065 Counterfeit-resistant prescription blanks for
205	controlled substances listed in Schedules II, III, and IV.--The
206	Department of Health shall develop and adopt by rule the form
207	and content for a counterfeit-proof prescription blank which may
208	be used by practitioners to prescribe a controlled substance
209	listed in Schedule II, Schedule III, or Schedule IV. The
210	Department of Health may require the prescription blanks to be
211	printed on distinctive, watermarked paper and to bear the
212	preprinted name, address, and category of professional licensure
213	of the practitioner and that practitioner's federal registry
214	number for controlled substances. The prescription blanks may
215	not be transferred.
216	Section 4. There is appropriated from the General Revenue
217	Fund to the Administrative Trust Fund of the Department of
218	Health an amount sufficient to cover the costs for fiscal year
219	2003-2004 of implementing the provisions of s. 893.055, Florida
220	Statutes, as created by this act. This section shall take effect
221	July 1, 2003.
222	Section 5. Except as otherwise provided herein, this act
223	shall take effect January 1, 2004.