HB 0397

1
A bill to be entitled
2An act relating to controlled substances; creating s.
3831.311, F.S.; prohibiting the sale, manufacture,
4alteration, delivery, uttering, or possession of
5counterfeit-resistant prescription blanks for controlled
6substances; providing penalties; amending s. 893.04, F.S.;
7providing additional requirements for the dispensing of a
8controlled substance listed in Schedule II, Schedule III,
9or Schedule IV; providing rulemaking authority to the
10Board of Pharmacy; creating s. 893.055, F.S.; requiring
11the Department of Health to establish an electronic system
12to monitor the prescribing of controlled substances listed
13in Schedules II, III, and IV; requiring the dispensing of
14such controlled substances to be reported through the
15system; providing exceptions; providing restrictions on
16access; providing reporting requirements; providing
17penalties; limiting liability; requiring confidentiality
18of information to be maintained; requiring the department
19and regulatory boards to adopt rules; requiring the
20department to cover all costs for the system, subject to
21availability of funds; providing a continuing
22appropriation; providing that a certain trust fund may not
23be used to fund the program; providing for future
24legislative review and repeal; creating s. 893.065, F.S.;
25requiring the department to develop and adopt by rule the
26form and content for a counterfeit-proof prescription
27blank for voluntary use by physicians to prescribe a
28controlled substance listed in Schedule II, Schedule III,
29or Schedule IV; providing an appropriation and authorizing
30positions; providing contingent applicability of
31penalties; requiring reports of law enforcement agencies
32and medical examiners to include specified information if
33a person dies of an apparent overdose of a controlled
34substance listed in Schedule II, Schedule III, or Schedule
35IV; providing contingent effective dates.
36
37Be It Enacted by the Legislature of the State of Florida:
38
39     Section 1.  Section 831.311, Florida Statutes, is created
40to read:
41     831.311  Unlawful sale, manufacture, alteration, delivery,
42uttering, or possession of counterfeit-resistant prescription
43blanks for controlled substances listed in Schedules II, III,
44and IV.--
45     (1)  It is unlawful for any person with the intent to
46injure or defraud any person or to facilitate any violation of
47s. 893.13 to sell, manufacture, alter, deliver, utter, or
48possess any counterfeit-resistant prescription blanks for
49controlled substances adopted by rule of the Department of
50Health pursuant to s. 893.065.
51     (2)  Any person who violates this section commits a felony
52of the third degree, punishable as provided in s. 775.082, s.
53775.083, or s. 775.084.
54     Section 2.  Section 893.04, Florida Statutes, is amended to
55read:
56     893.04  Pharmacist and practitioner.--
57     (1)  A pharmacist, in good faith and in the course of
58professional practice only, may dispense controlled substances
59upon a written or oral prescription of a practitioner, under the
60following conditions:
61     (a)  Oral prescriptions must be promptly reduced to writing
62by the pharmacist or recorded electronically.
63     (b)  The written prescription must be dated and signed by
64the prescribing practitioner on the day when issued.
65     (c)  There shall appear on the face of the prescription or
66written record thereof for the controlled substance the
67following information:
68     1.  The full name and address of the person for whom, or
69the owner of the animal for which, the controlled substance is
70dispensed.
71     2.  The full name and address of the prescribing
72practitioner and the practitioner's federal controlled substance
73registry number shall be printed thereon.
74     3.  If the prescription is for an animal, the species of
75animal for which the controlled substance is prescribed.
76     4.  The name of the controlled substance prescribed and the
77strength, quantity, and directions for use thereof.
78     5.  The number of the prescription, as recorded in the
79prescription files of the pharmacy in which it is filled.
80     6.  The initials of the pharmacist filling the prescription
81and the date filled.
82     (d)  The prescription shall be retained on file by the
83proprietor of the pharmacy in which it is filled for a period of
842 years.
85     (e)  Affixed to the original container in which a
86controlled substance is delivered upon a prescription or
87authorized refill thereof, as hereinafter provided, there shall
88be a label bearing the following information:
89     1.  The name and address of the pharmacy from which such
90controlled substance was dispensed.
91     2.  The date on which the prescription for such controlled
92substance was filled.
93     3.  The number of such prescription, as recorded in the
94prescription files of the pharmacy in which it is filled.
95     4.  The name of the prescribing practitioner.
96     5.  The name of the patient for whom, or of the owner and
97species of the animal for which, the controlled substance is
98prescribed.
99     6.  The directions for the use of the controlled substance
100prescribed in the prescription.
101     7.  A clear, concise warning that it is a crime to transfer
102the controlled substance to any person other than the patient
103for whom prescribed.
104     (f)  A prescription for a controlled substance listed in
105Schedule II may be dispensed only upon a written prescription of
106a practitioner, except that in an emergency situation, as
107defined by regulation of the Department of Health, such
108controlled substance may be dispensed upon oral prescription but
109is limited to a 72-hour supply. No prescription for a controlled
110substance listed in Schedule II may be refilled.
111     (g)  No prescription for a controlled substance listed in
112Schedule Schedules III, Schedule IV, or Schedule V may be filled
113or refilled more than five times within a period of 6 months
114after the date on which the prescription was written unless the
115prescription is renewed by a practitioner.
116     (2)(a)  A pharmacist may not dispense a controlled
117substance listed in Schedule II, Schedule III, or Schedule IV to
118any patient or patient's agent without first determining, in the
119exercise of her or his professional judgment, that the order is
120valid. The pharmacist or pharmacist's agent must also obtain the
121patient or patient's agent identification information, in
122writing, electronic format, or other approved manner prior to
123dispensing any controlled substance. If the patient or patient's
124agent does not have appropriate identification, the pharmacist
125may dispense the controlled substance only when the pharmacist
126determines, in the exercise of her or his professional judgment,
127that the order is valid and includes such information in the
128patient's record. The Board of Pharmacy may adopt, by rule,
129required patient identification information for controlled
130substances and procedures for a pharmacist to verify the
131validity of a prescription for controlled substances for
132circumstances in which the pharmacist was not provided required
133identification information.
134     (b)  Any pharmacist that dispenses by mail a controlled
135substance listed in Schedule II, Schedule III, or Schedule IV
136shall be exempt from the requirement to obtain suitable
137identification for the prescription dispensed by mail.
138     (c)  Any controlled substance listed in Schedule III or
139Schedule IV may be dispensed by a pharmacist upon an oral
140prescription if, before filling the prescription, the pharmacist
141reduces it to writing or records the prescription
142electronically. Such prescriptions must contain the date of the
143oral authorization.
144     (d)  Each written prescription prescribed by a practitioner
145in this state for a controlled substance listed in Schedule II,
146Schedule III, or Schedule IV must include both a written and a
147numerical notation of the quantity on the face of the
148prescription and a notation of the date with the abbreviated
149month written out on the face of the prescription. A pharmacist
150shall be permitted, upon verification by the prescriber, to
151document any information required by this paragraph.
152     (e)  A pharmacist may not dispense more than a 30-day
153supply of a controlled substance listed in Schedule III upon an
154oral prescription issued in this state.
155     (f)  A pharmacist may not knowingly fill a prescription
156that has been forged for a controlled substance listed in
157Schedule II, Schedule III, or Schedule IV.
158     (3)(2)  Notwithstanding the provisions of subsection (1), a
159pharmacist may dispense a one-time emergency refill of up to a
16072-hour supply of the prescribed medication for any medicinal
161drug other than a medicinal drug listed in Schedule II, in
162compliance with the provisions of s. 465.0275.
163     (4)(3)  The legal owner of any stock of controlled
164substances in a pharmacy, upon discontinuance of dealing in
165controlled substances, may sell said stock to a manufacturer,
166wholesaler, or pharmacy.  Such controlled substances may be sold
167only upon an order form, when such an order form is required for
168sale by the drug abuse laws of the United States or this state,
169or regulations pursuant thereto.
170     Section 3.  Effective July 1, 2004, subsection (1) of
171section 893.055, Florida Statutes, is created, and effective
172July 1, 2005, subsections (2) through (12) of said section are
173created, to read:
174     893.055  Electronic monitoring system for prescription of
175controlled substances listed in Schedules II, III, and IV.--
176     (1)  By June 30, 2005, the Department of Health shall
177design and establish an electronic system consistent with the
178American Society for Automation in Pharmacy (ASAP) standards to
179monitor the prescribing and dispensing of controlled substances
180listed in Schedules II, III, and IV by health care practitioners
181within the state and the dispensing of such controlled
182substances to an individual at a specific address within the
183state by a pharmacy permitted or registered by the Board of
184Pharmacy. The system shall be put into operation on July 1,
1852005. The secretary of the department shall ensure that only
186those department employees who are authorized to investigate a
187specific violation of this section in response to a complaint
188initiated by a patient, practitioner, or pharmacist pursuant to
189procedure adopted by rule by the department have access to the
190electronic monitoring system created by this section; however,
191nothing in this section shall preclude access to the system by
192employees or agents for purposes of creating, maintaining, or
193repairing the system.
194     (2)  Any controlled substance listed in Schedule II,
195Schedule III, or Schedule IV which is dispensed to an individual
196in this state must be reported to the Department of Health
197through the system, as soon thereafter as possible but not more
198than 35 days after the date the controlled substance is
199dispensed, each time the controlled substance is dispensed. A
200pharmacy may meet the reporting requirements of this section by
201providing the Department of Health an exchangeable electronic
202disc or tape of each controlled substance listed in Schedules
203II, III, and IV which it dispenses.
204     (3)  This section does not apply to controlled substances:
205     (a)  Administered by a health care practitioner directly to
206a patient.
207     (b)  Dispensed by a health care practitioner authorized to
208prescribe controlled substances directly to a patient and
209limited to an amount adequate to treat the patient for a period
210of no more than 72 hours.
211     (c)  Dispensed by a health care practitioner or a
212pharmacist to an inpatient of a facility with an institutional
213pharmacy permit.
214     (d)  Ordered from an institutional pharmacy permitted under
215s. 465.019 in accordance with the institutional policy for such
216controlled substances or drugs.
217     (e)  Either dispensed by a pharmacist or administered by a
218health care practitioner to a patient or resident receiving care
219from a hospital, nursing home, assisted living facility, home
220health agency, hospice, or intermediate care facility for the
221developmentally disabled which is licensed in this state.
222     (f)  Prescribed by a health care practitioner for a patient
223younger than 16 years of age.
224     (4)  The data required to be reported under this section
225shall be determined by the Department of Health by rule but may
226include any data required under s. 893.04.
227     (5)  A practitioner or pharmacist who dispenses a
228controlled substance under this section must submit the
229information required by this section in an electronic or other
230format approved by rule of the Department of Health. The cost to
231the dispenser in submitting the information required by this
232subsection may not be material or extraordinary. Costs not
233considered to be material or extraordinary include, but are not
234limited to, regular postage, compact discs, zip drive storage,
235regular electronic mail, magnetic tapes, diskettes, and
236facsimile charges. The information submitted to the Department
237of Health under this section may be transmitted to any person or
238agency authorized to receive it pursuant to House Bill 399, or
239similar legislation, and that person or agency may maintain the
240information received for up to 24 months before purging it from
241its records. All transmissions required by this paragraph must
242comply with relevant federal and state privacy and security
243laws. However, any authorized agency receiving such information
244may maintain it longer than 24 months if the information is
245pertinent to an ongoing investigation or prosecution.
246     (6)  Any person who knowingly fails to report the
247dispensing of a controlled substance listed in Schedule II,
248Schedule III, or Schedule IV as required by this section commits
249a misdemeanor of the first degree, punishable as provided in s.
250775.082 or s. 775.083.
251     (7)  The Department of Health and the regulatory boards for
252the health care practitioners subject to this section shall
253adopt rules pursuant to ss. 120.536(1) and 120.54 necessary to
254implement and administer this section.
255     (8)  All costs incurred by the Department of Health in
256implementing the prescription monitoring system shall be borne
257by the department, subject to the availability of funds, and
258there is appropriated annually from the Grants and Donations
259Trust Fund an amount necessary to cover such costs. The Medical
260Quality Assurance Trust Fund may not be used to implement or
261otherwise fund this program.
262     (9)  Any person who willfully or knowingly violates this
263section commits a felony of the third degree, punishable as
264provided in s. 775.082 or s. 775.083.
265     (10)  A practitioner or pharmacist authorized to obtain
266information under this section is not liable for accessing or
267failing to access such information.
268     (11)  A practitioner, pharmacist, or other person who
269obtains information from the electronic information system
270authorized by this section shall maintain the confidentiality of
271such information pursuant to ss. 456.057 and 465.017, or as
272otherwise required by law.
273     (12)  This section is repealed June 30, 2008, unless
274reviewed and saved from repeal through reenactment by the
275Legislature.
276     Section 4.  Section 893.065, Florida Statutes, is created
277to read:
278     893.065  Counterfeit-resistant prescription blanks for
279controlled substances listed in Schedules II, III, and IV.--The
280Department of Health shall develop and adopt by rule the form
281and content for a counterfeit-resistant prescription blank which
282may be used by practitioners to prescribe a controlled substance
283listed in Schedule II, Schedule III, or Schedule IV. The
284Department of Health may require the prescription blanks to be
285printed on distinctive, watermarked paper and to bear the
286preprinted name, address, and category of professional licensure
287of the practitioner and that practitioner's federal registry
288number for controlled substances. The prescription blanks may
289not be transferred.
290     Section 5.  Effective July 1, 2004, there is appropriated
291$2,196,352 from the Grants and Donations Trust Fund to the
292Department of Health, and three full-time equivalent positions
293are authorized for fiscal year 2004-2005, to implement the
294provisions of ss. 893.055 and 893.065, Florida Statutes, as
295created by this act.
296     Section 6.  The penalties created in ss. 831.311(2) and
297893.055(6), Florida Statutes, by this act shall be effective
298only upon the adoption by the Department of Health and each
299applicable professional regulatory board of the rules required
300pursuant to ss. 893.055(7) and 893.065, Florida Statutes, as
301created by this act.
302     Section 7.  If a person dies of an apparent drug overdose:
303     (1)  A law enforcement agency shall prepare a report
304identifying each prescribed controlled substance listed in
305Schedule II, Schedule III, or Schedule IV which is found on or
306near the deceased or among the deceased's possessions. The
307report must identify the person who prescribed the controlled
308substance, if known or ascertainable. Thereafter, the law
309enforcement agency shall submit a copy of the report to the
310medical examiner.
311     (2)  A medical examiner who is preparing his or her report
312pursuant to s. 406.11, Florida Statutes, shall include in the
313report information identifying each prescribed controlled
314substance listed in Schedule II, Schedule III, or Schedule IV
315which is found in, on, or near the deceased or among the
316deceased's possessions.
317     Section 8.  Except as otherwise expressly provided in this
318act, this act shall take effect July 1, 2005, if House Bill 399
319or similar legislation is adopted in the same legislative
320session or an extension thereof and becomes law.


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