HB 0397CS

CHAMBER ACTION



1The Committee on Health Care recommends the following:
2
3     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.;
11providing additional requirements for the dispensing of a
12controlled substance listed in Schedule II, Schedule III,
13or Schedule IV; providing rulemaking authority to the
14Board of Pharmacy; creating s. 893.055, F.S.; requiring
15the Department of Health to establish an electronic system
16to monitor the prescribing of controlled substances listed
17in Schedules II, III, and IV; requiring the dispensing of
18such controlled substances to be reported through the
19system; providing exceptions; providing restrictions on
20access; providing reporting requirements; providing
21penalties; limiting liability; requiring confidentiality
22of information to be maintained; requiring the department
23and regulatory boards to adopt rules; requiring the
24department to cover all costs for the system, subject to
25availability of funds; providing a continuing
26appropriation; providing that a certain trust fund may not
27be used to fund the program; providing for future
28legislative review and repeal; creating s. 893.065, F.S.;
29requiring the department to develop and adopt by rule the
30form and content for a counterfeit-proof prescription
31blank for voluntary use by physicians to prescribe a
32controlled substance listed in Schedule II, Schedule III,
33or Schedule IV; providing an appropriation and authorizing
34positions; providing contingent applicability of
35penalties; requiring reports of law enforcement agencies
36and medical examiners to include specified information if
37a person dies of an apparent overdose of a controlled
38substance listed in Schedule II, Schedule III, or Schedule
39IV; providing contingent effective dates.
40
41Be It Enacted by the Legislature of the State of Florida:
42
43     Section 1.  Section 831.311, Florida Statutes, is created
44to read:
45     831.311  Unlawful sale, manufacture, alteration, delivery,
46uttering, or possession of counterfeit-resistant prescription
47blanks for controlled substances listed in Schedules II, III,
48and 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 blanks for
53controlled substances adopted by rule of the Department of
54Health pursuant to s. 893.065.
55     (2)  Any person who violates this section commits a felony
56of the third degree, punishable as provided in s. 775.082, s.
57775.083, or s. 775.084.
58     Section 2.  Section 893.04, Florida Statutes, is amended to
59read:
60     893.04  Pharmacist and practitioner.--
61     (1)  A pharmacist, in good faith and in the course of
62professional practice only, may dispense controlled substances
63upon a written or oral prescription of a practitioner, under the
64following conditions:
65     (a)  Oral prescriptions must be promptly reduced to writing
66by the pharmacist or recorded electronically.
67     (b)  The written prescription must be dated and signed by
68the prescribing practitioner on the day when issued.
69     (c)  There shall appear on the face of the prescription or
70written record thereof for the controlled substance the
71following information:
72     1.  The full name and address of the person for whom, or
73the owner of the animal for which, the controlled substance is
74dispensed.
75     2.  The full name and address of the prescribing
76practitioner and the practitioner's federal controlled substance
77registry number shall be printed thereon.
78     3.  If the prescription is for an animal, the species of
79animal for which the controlled substance is prescribed.
80     4.  The name of the controlled substance prescribed and the
81strength, quantity, and directions for use thereof.
82     5.  The number of the prescription, as recorded in the
83prescription files of the pharmacy in which it is filled.
84     6.  The initials of the pharmacist filling the prescription
85and the date filled.
86     (d)  The prescription shall be retained on file by the
87proprietor of the pharmacy in which it is filled for a period of
882 years.
89     (e)  Affixed to the original container in which a
90controlled substance is delivered upon a prescription or
91authorized refill thereof, as hereinafter provided, there shall
92be a label bearing the following information:
93     1.  The name and address of the pharmacy from which such
94controlled substance was dispensed.
95     2.  The date on which the prescription for such controlled
96substance was filled.
97     3.  The number of such prescription, as recorded in the
98prescription files of the pharmacy in which it is filled.
99     4.  The name of the prescribing practitioner.
100     5.  The name of the patient for whom, or of the owner and
101species of the animal for which, the controlled substance is
102prescribed.
103     6.  The directions for the use of the controlled substance
104prescribed in the prescription.
105     7.  A clear, concise warning that it is a crime to transfer
106the controlled substance to any person other than the patient
107for whom prescribed.
108     (f)  A prescription for a controlled substance listed in
109Schedule II may be dispensed only upon a written prescription of
110a practitioner, except that in an emergency situation, as
111defined by regulation of the Department of Health, such
112controlled substance may be dispensed upon oral prescription but
113is limited to a 72-hour supply. No prescription for a controlled
114substance listed in Schedule II may be refilled.
115     (g)  No prescription for a controlled substance listed in
116Schedule Schedules III, Schedule IV, or Schedule V may be filled
117or refilled more than five times within a period of 6 months
118after the date on which the prescription was written unless the
119prescription is renewed by a practitioner.
120     (2)(a)  A pharmacist may not dispense a controlled
121substance listed in Schedule II, Schedule III, or Schedule IV to
122any patient or patient's agent without first determining, in the
123exercise of her or his professional judgment, that the order is
124valid. The pharmacist or pharmacist's agent must also obtain the
125patient or patient's agent identification information, in
126writing, electronic format, or other approved manner prior to
127dispensing any controlled substance. If the patient or patient's
128agent does not have appropriate identification, the pharmacist
129may dispense the controlled substance only when the pharmacist
130determines, in the exercise of her or his professional judgment,
131that the order is valid and includes such information in the
132patient's record. The Board of Pharmacy may adopt, by rule,
133required patient identification information for controlled
134substances and procedures for a pharmacist to verify the
135validity of a prescription for controlled substances for
136circumstances in which the pharmacist was not provided required
137identification information.
138     (b)  Any pharmacist that dispenses by mail a controlled
139substance listed in Schedule II, Schedule III, or Schedule IV
140shall be exempt from the requirement to obtain suitable
141identification for the prescription dispensed by mail.
142     (c)  Any controlled substance listed in Schedule III or
143Schedule IV may be dispensed by a pharmacist upon an oral
144prescription if, before filling the prescription, the pharmacist
145reduces it to writing or records the prescription
146electronically. Such prescriptions must contain the date of the
147oral authorization.
148     (d)  Each written prescription prescribed by a practitioner
149in this state for a controlled substance listed in Schedule II,
150Schedule III, or Schedule IV must include both a written and a
151numerical notation of the quantity on the face of the
152prescription and a notation of the date with the abbreviated
153month written out on the face of the prescription. A pharmacist
154shall be permitted, upon verification by the prescriber, to
155document any information required by this paragraph.
156     (e)  A pharmacist may not dispense more than a 30-day
157supply of a controlled substance listed in Schedule III upon an
158oral prescription issued in this state.
159     (f)  A pharmacist may not knowingly fill a prescription
160that has been forged for a controlled substance listed in
161Schedule II, Schedule III, or Schedule IV.
162     (3)(2)  Notwithstanding the provisions of subsection (1), a
163pharmacist may dispense a one-time emergency refill of up to a
16472-hour supply of the prescribed medication for any medicinal
165drug other than a medicinal drug listed in Schedule II, in
166compliance with the provisions of s. 465.0275.
167     (4)(3)  The legal owner of any stock of controlled
168substances in a pharmacy, upon discontinuance of dealing in
169controlled substances, may sell said stock to a manufacturer,
170wholesaler, or pharmacy.  Such controlled substances may be sold
171only upon an order form, when such an order form is required for
172sale by the drug abuse laws of the United States or this state,
173or regulations pursuant thereto.
174     Section 3.  Effective July 1, 2004, subsection (1) of
175section 893.055, Florida Statutes, is created, and effective
176July 1, 2005, subsections (2) through (12) of said section are
177created, to read:
178     893.055  Electronic monitoring system for prescription of
179controlled substances listed in Schedules II, III, and IV.--
180     (1)  By June 30, 2005, the Department of Health shall
181design and establish an electronic system consistent with the
182American Society for Automation in Pharmacy (ASAP) standards to
183monitor the prescribing and dispensing of controlled substances
184listed in Schedules II, III, and IV by health care practitioners
185within the state and the dispensing of such controlled
186substances to an individual at a specific address within the
187state by a pharmacy permitted or registered by the Board of
188Pharmacy. The system shall be put into operation on July 1,
1892005. The secretary of the department shall ensure that only
190those department employees who are authorized to investigate a
191specific violation of this section in response to a complaint
192initiated by a patient, practitioner, or pharmacist pursuant to
193procedure adopted by rule by the department have access to the
194electronic monitoring system created by this section; however,
195nothing in this section shall preclude access to the system by
196employees or agents for purposes of creating, maintaining, or
197repairing the system.
198     (2)  Any controlled substance listed in Schedule II,
199Schedule III, or Schedule IV which is dispensed to an individual
200in this state must be reported to the Department of Health
201through the system, as soon thereafter as possible but not more
202than 35 days after the date the controlled substance is
203dispensed, each time the controlled substance is dispensed. A
204pharmacy may meet the reporting requirements of this section by
205providing the Department of Health an exchangeable electronic
206disc or tape of each controlled substance listed in Schedules
207II, III, and IV which it dispenses.
208     (3)  This section does not apply to controlled substances:
209     (a)  Administered by a health care practitioner directly to
210a patient.
211     (b)  Dispensed by a health care practitioner authorized to
212prescribe controlled substances directly to a patient and
213limited to an amount adequate to treat the patient for a period
214of no more than 72 hours.
215     (c)  Dispensed by a health care practitioner or a
216pharmacist to an inpatient of a facility with an institutional
217pharmacy permit.
218     (d)  Ordered from an institutional pharmacy permitted under
219s. 465.019 in accordance with the institutional policy for such
220controlled substances or drugs.
221     (e)  Either dispensed by a pharmacist or administered by a
222health care practitioner to a patient or resident receiving care
223from a hospital, nursing home, assisted living facility, home
224health agency, hospice, or intermediate care facility for the
225developmentally disabled which is licensed in this state.
226     (f)  Prescribed by a health care practitioner for a patient
227younger than 16 years of age.
228     (4)  The data required to be reported under this section
229shall be determined by the Department of Health by rule but may
230include any data required under s. 893.04.
231     (5)  A practitioner or pharmacist who dispenses a
232controlled substance under this section must submit the
233information required by this section in an electronic or other
234format approved by rule of the Department of Health. The cost to
235the dispenser in submitting the information required by this
236subsection may not be material or extraordinary. Costs not
237considered to be material or extraordinary include, but are not
238limited to, regular postage, compact discs, zip drive storage,
239regular electronic mail, magnetic tapes, diskettes, and
240facsimile charges. The information submitted to the Department
241of Health under this section may be transmitted to any person or
242agency authorized to receive it pursuant to House Bill 399, or
243similar legislation, and that person or agency may maintain the
244information received for up to 24 months before purging it from
245its records. All transmissions required by this paragraph must
246comply with relevant federal and state privacy and security
247laws. However, any authorized agency receiving such information
248may maintain it longer than 24 months if the information is
249pertinent to an ongoing investigation or prosecution.
250     (6)  Any person who knowingly fails to report the
251dispensing of a controlled substance listed in Schedule II,
252Schedule III, or Schedule IV as required by this section commits
253a misdemeanor of the first degree, punishable as provided in s.
254775.082 or s. 775.083.
255     (7)  The Department of Health and the regulatory boards for
256the health care practitioners subject to this section shall
257adopt rules pursuant to ss. 120.536(1) and 120.54 necessary to
258implement and administer this section.
259     (8)  All costs incurred by the Department of Health in
260implementing the prescription monitoring system shall be borne
261by the department, subject to the availability of funds, and
262there is appropriated annually from the Grants and Donations
263Trust Fund an amount necessary to cover such costs. The Medical
264Quality Assurance Trust Fund may not be used to implement or
265otherwise fund this program.
266     (9)  Any person who willfully or knowingly violates this
267section commits a felony of the third degree, punishable as
268provided in s. 775.082 or s. 775.083.
269     (10)  A practitioner or pharmacist authorized to obtain
270information under this section is not liable for accessing or
271failing to access such information.
272     (11)  A practitioner, pharmacist, or other person who
273obtains information from the electronic information system
274authorized by this section shall maintain the confidentiality of
275such information pursuant to ss. 456.057 and 465.017, or as
276otherwise required by law.
277     (12)  This section is repealed June 30, 2008, unless
278reviewed and saved from repeal through reenactment by the
279Legislature.
280     Section 4.  Section 893.065, Florida Statutes, is created
281to read:
282     893.065  Counterfeit-resistant prescription blanks for
283controlled substances listed in Schedules II, III, and IV.--The
284Department of Health shall develop and adopt by rule the form
285and content for a counterfeit-resistant prescription blank which
286may be used by practitioners to prescribe a controlled substance
287listed in Schedule II, Schedule III, or Schedule IV. The
288Department of Health may require the prescription blanks to be
289printed on distinctive, watermarked paper and to bear the
290preprinted name, address, and category of professional licensure
291of the practitioner and that practitioner's federal registry
292number for controlled substances. The prescription blanks may
293not be transferred.
294     Section 5.  Effective July 1, 2004, there is appropriated
295$2,196,352 from the Grants and Donations Trust Fund to the
296Department of Health, and three full-time equivalent positions
297are authorized for fiscal year 2004-2005, to implement the
298provisions of ss. 893.055 and 893.065, Florida Statutes, as
299created by this act.
300     Section 6.  The penalties created in ss. 831.311(2) and
301893.055(6), Florida Statutes, by this act shall be effective
302only upon the adoption by the Department of Health and each
303applicable professional regulatory board of the rules required
304pursuant to ss. 893.055(7) and 893.065, Florida Statutes, as
305created by this act.
306     Section 7.  If a person dies of an apparent drug overdose:
307     (1)  A law enforcement agency shall prepare a report
308identifying each prescribed controlled substance listed in
309Schedule II, Schedule III, or Schedule IV which is found on or
310near the deceased or among the deceased's possessions. The
311report must identify the person who prescribed the controlled
312substance, if known or ascertainable. Thereafter, the law
313enforcement agency shall submit a copy of the report to the
314medical examiner.
315     (2)  A medical examiner who is preparing his or her report
316pursuant to s. 406.11, Florida Statutes, shall include in the
317report information identifying each prescribed controlled
318substance listed in Schedule II, Schedule III, or Schedule IV
319which is found in, on, or near the deceased or among the
320deceased's possessions.
321     Section 8.  Except as otherwise expressly provided in this
322act, this act shall take effect July 1, 2005, if House Bill 399
323or similar legislation is adopted in the same legislative
324session or an extension thereof and becomes law.


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