HB 0913CS

CHAMBER ACTION



1The Health Care Regulation Committee recommends the following:
2
3     Council/Committee Substitute
4     Remove the entire bill and insert:
5
A bill to be entitled
6An act relating to controlled substances; creating s.
7831.311, F.S.; prohibiting the sale, manufacture,
8alteration, delivery, uttering, or possession of
9counterfeit-resistant prescription blanks for controlled
10substances; providing penalties; amending s. 893.04, F.S.;
11authorizing electronic recording of oral prescriptions for
12a controlled substance; providing additional requirements
13for the dispensing of a controlled substance listed in
14Schedule II, Schedule III, or Schedule IV; creating s.
15893.055, F.S.; providing a definition; requiring the
16Department of Health to establish an electronic system to
17monitor the prescribing and dispensing of controlled
18substances listed in Schedules II, III, and IV; requiring
19the dispensing of such controlled substances to be
20reported through the system; providing exceptions;
21providing liability for the improper release of any
22confidential information; precluding the use of a
23specified defense by specified defendants in certain
24actions; providing reporting requirements; providing
25penalties; requiring that the department and regulatory
26boards adopt rules; requiring the department to cover all
27costs for the system; providing for annual appropriations,
28subject to availability of funds; prohibiting the use of
29funds from the Medical Quality Assurance Trust Fund to
30administer the program; providing for future repeal and
31review; creating s. 893.065, F.S.; requiring the
32department to develop and adopt by rule the form and
33content for a counterfeit-resistant prescription blank for
34voluntary use by practitioners to prescribe a controlled
35substance listed in Schedule II, Schedule III, or Schedule
36IV; providing contingent applicability of penalties;
37requiring reports of law enforcement agencies and medical
38examiners to include specified information if a person
39dies of an apparent overdose of a controlled substance
40listed in Schedule II, Schedule III, or Schedule IV;
41providing an effective date.
42
43Be It Enacted by the Legislature of the State of Florida:
44
45     Section 1.  Section 831.311, Florida Statutes, is created
46to read:
47     831.311  Violations involving certain prescription blanks
48for controlled substances in Schedules II-IV.--
49     (1)  It is unlawful for any person with the intent to
50injure or defraud any person or to facilitate any violation of
51s. 893.13 to sell, manufacture, alter, deliver, utter, or
52possess any counterfeit-resistant prescription blank for
53controlled substances as provided in s. 893.065.
54     (2)  Any person who violates this section commits a felony
55of the third degree, punishable as provided in s. 775.082, s.
56775.083, or s. 775.084.
57     Section 2.  Section 893.04, Florida Statutes, is amended to
58read:
59     893.04  Pharmacist and practitioner.--
60     (1)  A pharmacist, in good faith and in the course of
61professional practice only, may dispense controlled substances
62upon a written or oral prescription of a practitioner, under the
63following conditions:
64     (a)  Oral prescriptions must be promptly reduced to writing
65or recorded electronically by the pharmacist.
66     (b)  The written prescription must be dated and signed by
67the prescribing practitioner on the day when issued.
68     (c)  There shall appear on the face of the prescription or
69written record thereof for the controlled substance the
70following information:
71     1.  The full name and address of the person for whom, or
72the owner of the animal for which, the controlled substance is
73dispensed.
74     2.  The full name and address of the prescribing
75practitioner and the practitioner's federal controlled substance
76registry number shall be printed thereon.
77     3.  If the prescription is for an animal, the species of
78animal for which the controlled substance is prescribed.
79     4.  The name of the controlled substance prescribed and the
80strength, quantity, and directions for use thereof.
81     5.  The number of the prescription, as recorded in the
82prescription files of the pharmacy in which it is filled.
83     6.  The initials of the pharmacist filling the prescription
84and the date filled.
85     (d)  The prescription shall be retained on file by the
86proprietor of the pharmacy in which it is filled for a period of
872 years.
88     (e)  Affixed to the original container in which a
89controlled substance is delivered upon a prescription or
90authorized refill thereof, as hereinafter provided, there shall
91be a label bearing the following information:
92     1.  The name and address of the pharmacy from which such
93controlled substance was dispensed.
94     2.  The date on which the prescription for such controlled
95substance was filled.
96     3.  The number of such prescription, as recorded in the
97prescription files of the pharmacy in which it is filled.
98     4.  The name of the prescribing practitioner.
99     5.  The name of the patient for whom, or of the owner and
100species of the animal for which, the controlled substance is
101prescribed.
102     6.  The directions for the use of the controlled substance
103prescribed in the prescription.
104     7.  A clear, concise warning that it is a crime to transfer
105the controlled substance to any person other than the patient
106for whom prescribed.
107     (f)  A prescription for a controlled substance listed in
108Schedule II may be dispensed only upon a written prescription of
109a practitioner, except that in an emergency situation, as
110defined by regulation of the Department of Health, such
111controlled substance may be dispensed upon oral prescription but
112is limited to a 72-hour supply. No prescription for a controlled
113substance listed in Schedule II may be refilled.
114     (g)  No prescription for a controlled substance listed in
115Schedule Schedules III, Schedule IV, or Schedule V may be filled
116or refilled more than five times within a period of 6 months
117after the date on which the prescription was written unless the
118prescription is renewed by a practitioner.
119     (2)(a)  A pharmacist may not dispense a controlled
120substance listed in Schedule II, Schedule III, or Schedule IV to
121any patient or patient's agent without first determining, in the
122exercise of her or his professional judgment, that the order is
123valid. The pharmacist may dispense the controlled substance, in
124the exercise of her or his professional judgment, when the
125pharmacist or pharmacist's agent has obtained satisfactory
126patient information from the patient or the patient's agent.
127     (b)  Any pharmacist who dispenses by mail a controlled
128substance listed in Schedule II, Schedule III, or Schedule IV
129shall be exempt from the requirement to obtain suitable
130identification for the prescription dispensed by mail.
131     (c)  Any controlled substance listed in Schedule III or
132Schedule IV may be dispensed by a pharmacist upon an oral
133prescription if, before filling the prescription, the pharmacist
134reduces the prescription to writing or records it
135electronically. Such prescriptions must contain the date of the
136oral authorization.
137     (d)  Each written prescription from a practitioner in this
138state for a controlled substance listed in Schedule II, Schedule
139III, or Schedule IV must include both a written and a numerical
140notation of the quantity on the face of the prescription and a
141notation of the date with the abbreviated month written out on
142the face of the prescription. A pharmacist may, upon
143verification by the prescriber, document any information
144required by this paragraph.
145     (e)  A pharmacist may not dispense more than a 30-day
146supply of a controlled substance listed in Schedule III upon an
147oral prescription issued in this state.
148     (f)  A pharmacist may not knowingly fill a prescription
149that has been forged for a controlled substance listed in
150Schedule II, Schedule III, or Schedule IV.
151     (3)(2)  Notwithstanding the provisions of subsection (1), a
152pharmacist may dispense a one-time emergency refill of up to a
15372-hour supply of the prescribed medication for any medicinal
154drug other than a medicinal drug listed in Schedule II, in
155compliance with the provisions of s. 465.0275.
156     (4)(3)  The legal owner of any stock of controlled
157substances in a pharmacy, upon discontinuance of dealing in
158controlled substances, may sell said stock to a manufacturer,
159wholesaler, or pharmacy. Such controlled substances may be sold
160only upon an order form, when such an order form is required for
161sale by the drug abuse laws of the United States or this state,
162or regulations pursuant thereto.
163     Section 3.  Section 893.055, Florida Statutes, is created
164to read:
165     893.055  Electronic monitoring system for prescription of
166controlled substances listed in Schedules II-IV.--
167     (1)  As used in this section, the term "pharmacy" means any
168pharmacy subject to licensure or regulation by the department
169under chapter 465 that dispenses or delivers a controlled
170substance listed in Schedule II, Schedule III, or Schedule IV to
171a patient in this state.
172     (2)  By June 30, 2007, the department shall contract for
173the design, establishment, and maintenance of an electronic
174system consistent with standards of the American Society for
175Automation in Pharmacy to monitor the prescribing and dispensing
176of controlled substances listed in Schedules II, III, and IV by
177health care practitioners within the state and the dispensing of
178such controlled substances to an individual at a specific
179address within the state by a pharmacy permitted or registered
180by the Board of Pharmacy. The contracted vendor shall maintain
181the database within the United States.
182     (3)  Any controlled substance listed in Schedule II,
183Schedule III, or Schedule IV that is dispensed to an individual
184in this state must be reported to the department's contract
185vendor through the system established under this section as soon
186thereafter as possible, but not more than 35 days after the date
187the controlled substance is dispensed, each time the controlled
188substance is dispensed. A pharmacy may meet the reporting
189requirements of this section by providing to the department's
190contract vendor an exchangeable electronic disc, file, or tape
191containing the required data concerning each controlled
192substance listed in Schedule II, Schedule III, or Schedule IV
193that the pharmacy dispenses.
194     (4)  This section does not apply to controlled substances:
195     (a)  Administered by a health care practitioner directly to
196a patient.
197     (b)  Dispensed by a health care practitioner authorized to
198prescribe controlled substances directly to a patient and
199limited to an amount adequate to treat the patient for a period
200of no more than 72 hours.
201     (c)  Dispensed by a health care practitioner or a
202pharmacist to an inpatient of a facility that holds an
203institutional pharmacy permit.
204     (d)  Ordered from an institutional pharmacy holding a
205permit under s. 465.019 in accordance with the institutional
206policy for such controlled substances or drugs.
207     (e)  Dispensed by a pharmacist or administered by a health
208care practitioner to a patient or resident receiving care from a
209hospital, nursing home, assisted living facility, home health
210agency, hospice, or intermediate care facility for the
211developmentally disabled that is licensed in this state.
212     (f)  Prescribed by a health care practitioner for a patient
213younger than 16 years of age.
214     (5)  The data required to be reported under this section
215shall be determined by the department by rule and may include
216any data required under s. 893.04.
217     (6)  A practitioner or pharmacist who dispenses a
218controlled substance under this section must submit the
219information required by this section in an electronic or other
220format approved by rule of the department. The cost to the
221dispenser in submitting the information required by this section
222may not be material or extraordinary. Costs not considered to be
223material or extraordinary include, but are not limited to,
224regular postage, compact discs, zip drive storage, regular
225electronic mail, magnetic tapes, diskettes, and facsimile
226charges. The information submitted to the department's contract
227vendor under this section may be transmitted to any person or
228agency authorized to receive such information under s. 893.056
229and that person or agency may maintain the information received
230for up to 24 months before purging the information from its
231records. All transmissions required by this subsection must
232comply with relevant federal and state privacy and security
233laws. However, any authorized agency receiving such information
234may maintain the information for longer than 24 months if the
235information is pertinent to an ongoing investigation or
236prosecution.
237     (7)  Any contractor entering into a contract under this
238section is liable in tort for the improper release of any
239confidential information received in addition to any breach of
240contract liability. Sovereign immunity may not be raised by the
241contractor, or the insurer of that contractor on the
242contractor's behalf, as a defense in any action arising out of
243the performance of any contract entered into under this section
244or as a defense in tort, or any other application, for the
245maintenance of confidentiality of information and for any breach
246of contract.
247     (8)  Any person who knowingly fails to report the
248dispensing of a controlled substance listed in Schedule II,
249Schedule III, or Schedule IV as required by this section commits
250a misdemeanor of the first degree, punishable as provided in s.
251775.082 or s. 775.083.
252     (9)  The department and the regulatory boards for the
253health care practitioners subject to this section shall adopt
254rules under ss. 120.536(1) and 120.54 to administer this
255section.
256     (10)  All costs incurred by the department in administering
257the prescription monitoring system shall be borne by the
258department, and an amount necessary to cover such costs shall be
259appropriated annually, subject to the availability of funds,
260from the Grants and Donations Trust Fund. The Medical Quality
261Assurance Trust Fund shall not be used to administer or
262otherwise fund this program.
263     (11)  This section is repealed effective October 2, 2009,
264unless reviewed and saved from repeal through reenactment by the
265Legislature.
266     Section 4.  Section 893.065, Florida Statutes, is created
267to read:
268     893.065  Counterfeit-resistant prescription blanks for
269controlled substances listed in Schedules II-IV.--The department
270shall develop and adopt by rule the form and content for a
271counterfeit-resistant prescription blank that may be used by
272practitioners to prescribe a controlled substance listed in
273Schedule II, Schedule III, or Schedule IV. The department may
274require the prescription blanks to be printed on distinctive,
275watermarked paper and to bear the preprinted name, address, and
276category of professional licensure of the practitioner and that
277practitioner's federal registry number for controlled
278substances. The prescription blanks may not be transferred.
279     Section 5.  The penalties created in s. 831.311(2), Florida
280Statutes, by this act shall be effective only upon the adoption
281of the rules required pursuant to s. 893.065, Florida Statutes,
282as created by this act.
283     Section 6.  If a person dies of an apparent drug overdose:
284     (1)  A law enforcement agency shall prepare a report
285identifying each prescribed controlled substance listed in
286Schedule II, Schedule III, or Schedule IV of s. 893.03, Florida
287Statutes, that is found on or near the deceased or among the
288deceased's possessions. The report must identify the person who
289prescribed the controlled substance, if known or ascertainable.
290Thereafter, the law enforcement agency shall submit a copy of
291the report to the medical examiner.
292     (2)  A medical examiner who is preparing a report pursuant
293to s. 406.11, Florida Statutes, shall include in the report
294information identifying each prescribed controlled substance
295listed in Schedule II, Schedule III, or Schedule IV of s.
296893.03, Florida Statutes, that was found in, on, or near the
297deceased or among the deceased's possessions.
298     Section 7.  This act shall take effect July 1, 2006.


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