HB 893

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.;
7authorizing electronic recording of oral prescriptions for
8a controlled substance; providing additional requirements
9for the dispensing of a controlled substance listed in
10Schedule II, Schedule III, or Schedule IV; creating s.
11893.055, F.S.; providing a definition; requiring the
12Department of Health to establish an electronic system to
13monitor the prescribing and dispensing of controlled
14substances listed in Schedules II, III, and IV; requiring
15the dispensing of such controlled substances to be
16reported through the system; providing exceptions;
17providing liability for the improper release of any
18confidential information; precluding the use of a
19specified defense by specified defendants in certain
20actions; providing reporting requirements; providing
21penalties; requiring that the department and regulatory
22boards adopt rules; requiring the department to cover all
23costs for the system; providing for annual appropriations,
24subject to availability of funds; prohibiting the use of
25funds from the Medical Quality Assurance Trust Fund to
26administer the program; providing immunity from liability
27for certain practitioners and pharmacists; providing for
28future repeal and review; creating s. 893.065, F.S.;
29requiring the department to develop and adopt by rule the
30form and content for a counterfeit-resistant prescription
31blank for voluntary use by practitioners to prescribe a
32controlled substance listed in Schedule II, Schedule III,
33or Schedule IV; providing contingent applicability of
34penalties; requiring reports of law enforcement agencies
35and medical examiners to include specified information if
36a person dies of an apparent overdose of a controlled
37substance listed in Schedule II, Schedule III, or Schedule
38IV; providing an effective date.
39
40Be It Enacted by the Legislature of the State of Florida:
41
42     Section 1.  Section 831.311, Florida Statutes, is created
43to read:
44     831.311  Violations involving certain prescription blanks
45for controlled substances in Schedules II-IV.--
46     (1)  It is unlawful for any person with the intent to
47injure or defraud any person or to facilitate any violation of
48s. 893.13 to sell, manufacture, alter, deliver, utter, or
49possess any counterfeit-resistant prescription blank for
50controlled substances as provided in 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
62or recorded electronically by the pharmacist.
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 may dispense the controlled substance, in
121the exercise of her or his professional judgment, when the
122pharmacist or pharmacist's agent has obtained satisfactory
123patient information from the patient or the patient's agent.
124     (b)  Any pharmacist who dispenses by mail a controlled
125substance listed in Schedule II, Schedule III, or Schedule IV
126shall be exempt from the requirement to obtain suitable
127identification for the prescription dispensed by mail.
128     (c)  Any controlled substance listed in Schedule III or
129Schedule IV may be dispensed by a pharmacist upon an oral
130prescription if, before filling the prescription, the pharmacist
131reduces the prescription to writing or records it
132electronically. Such prescriptions must contain the date of the
133oral authorization.
134     (d)  Each written prescription from a practitioner in this
135state for a controlled substance listed in Schedule II, Schedule
136III, or Schedule IV must include both a written and a numerical
137notation of the quantity on the face of the prescription and a
138notation of the date with the abbreviated month written out on
139the face of the prescription. A pharmacist may, upon
140verification by the prescriber, document any information
141required by this paragraph.
142     (e)  A pharmacist may not dispense more than a 30-day
143supply of a controlled substance listed in Schedule III upon an
144oral prescription issued in this state.
145     (f)  A pharmacist may not knowingly fill a prescription
146that has been forged for a controlled substance listed in
147Schedule II, Schedule III, or Schedule IV.
148     (3)(2)  Notwithstanding the provisions of subsection (1), a
149pharmacist may dispense a one-time emergency refill of up to a
15072-hour supply of the prescribed medication for any medicinal
151drug other than a medicinal drug listed in Schedule II, in
152compliance with the provisions of s. 465.0275.
153     (4)(3)  The legal owner of any stock of controlled
154substances in a pharmacy, upon discontinuance of dealing in
155controlled substances, may sell said stock to a manufacturer,
156wholesaler, or pharmacy. Such controlled substances may be sold
157only upon an order form, when such an order form is required for
158sale by the drug abuse laws of the United States or this state,
159or regulations pursuant thereto.
160     Section 3.  Section 893.055, Florida Statutes, is created
161to read:
162     893.055  Electronic monitoring system for prescription of
163controlled substances listed in Schedules II-IV.--
164     (1)  As used in this section, the term "pharmacy" means any
165pharmacy subject to licensure or regulation by the department
166under chapter 465 that dispenses or delivers a controlled
167substance listed in Schedule II, Schedule III, or Schedule IV to
168a patient in this state.
169     (2)  By June 30, 2008, the department shall contract for
170the design, establishment, and maintenance of an electronic
171system consistent with standards of the American Society for
172Automation in Pharmacy to monitor the prescribing and dispensing
173of controlled substances listed in Schedules II, III, and IV by
174health care practitioners within the state and the dispensing of
175such controlled substances to an individual at a specific
176address within the state by a pharmacy permitted or registered
177by the Board of Pharmacy. The contracted vendor shall maintain
178the database within the United States.
179     (3)  Any controlled substance listed in Schedule II,
180Schedule III, or Schedule IV that is dispensed to an individual
181in this state must be reported to the department's contract
182vendor through the system established under this section as soon
183thereafter as possible, but not more than 35 days after the date
184the controlled substance is dispensed, each time the controlled
185substance is dispensed. A pharmacy may meet the reporting
186requirements of this section by providing to the department's
187contract vendor an exchangeable electronic disc, file, or tape
188containing the required data concerning each controlled
189substance listed in Schedule II, Schedule III, or Schedule IV
190that the pharmacy dispenses.
191     (4)  This section does not apply to controlled substances:
192     (a)  Administered by a health care practitioner directly to
193a patient.
194     (b)  Dispensed by a health care practitioner authorized to
195prescribe controlled substances directly to a patient and
196limited to an amount adequate to treat the patient for a period
197of no more than 72 hours.
198     (c)  Dispensed by a health care practitioner or a
199pharmacist to an inpatient of a facility that holds an
200institutional pharmacy permit.
201     (d)  Ordered from an institutional pharmacy holding a
202permit under s. 465.019 in accordance with the institutional
203policy for such controlled substances or drugs.
204     (e)  Dispensed by a pharmacist or administered by a health
205care practitioner to a patient or resident receiving care from a
206hospital, nursing home, assisted living facility, home health
207agency, hospice, or intermediate care facility for the
208developmentally disabled that is licensed in this state.
209     (f)  Prescribed by a health care practitioner for a patient
210younger than 16 years of age.
211     (5)  The data required to be reported under this section
212shall be determined by the department by rule and may include
213any data required under s. 893.04.
214     (6)  A practitioner or pharmacist who dispenses a
215controlled substance under this section must submit the
216information required by this section in an electronic or other
217format approved by rule of the department. The cost to the
218dispenser in submitting the information required by this section
219may not be material or extraordinary. Costs not considered to be
220material or extraordinary include, but are not limited to,
221regular postage, compact discs, zip drive storage, regular
222electronic mail, magnetic tapes, diskettes, and facsimile
223charges. The information submitted to the department's contract
224vendor under this section may be transmitted to any person or
225agency authorized to receive such information under s. 893.056
226and that person or agency may maintain the information received
227for up to 24 months before purging the information from its
228records. All transmissions required by this subsection must
229comply with relevant federal and state privacy and security
230laws. However, any authorized agency receiving such information
231may maintain the information for longer than 24 months if the
232information is pertinent to an ongoing investigation or
233prosecution.
234     (7)  Any contractor entering into a contract under this
235section is liable in tort for the improper release of any
236confidential information received in addition to any breach of
237contract liability. Sovereign immunity may not be raised by the
238contractor, or the insurer of that contractor on the
239contractor's behalf, as a defense in any action arising out of
240the performance of any contract entered into under this section
241or as a defense in tort, or any other application, for the
242maintenance of confidentiality of information and for any breach
243of contract.
244     (8)  Any person who knowingly fails to report the
245dispensing of a controlled substance listed in Schedule II,
246Schedule III, or Schedule IV as required by this section commits
247a misdemeanor of the first degree, punishable as provided in s.
248775.082 or s. 775.083.
249     (9)  The department and the regulatory boards for the
250health care practitioners subject to this section shall adopt
251rules under ss. 120.536(1) and 120.54 to administer this
252section.
253     (10)  All costs incurred by the department in administering
254the prescription monitoring system shall be borne by the
255department, and an amount necessary to cover such costs shall be
256appropriated annually, subject to the availability of funds,
257from the Grants and Donations Trust Fund. The Medical Quality
258Assurance Trust Fund shall not be used to administer or
259otherwise fund this program.
260     (11)  A practitioner or pharmacist authorized to obtain
261information under this section is not liable for accessing or
262failing to access such information.
263     (12)  This section is repealed effective October 2, 2010,
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, 2007.


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