HB 0397 2004
   
1 A bill to be entitled
2          An act relating to controlled substances; creating s.
3    831.311, F.S.; prohibiting the sale, manufacture,
4    alteration, delivery, uttering, or possession of
5    counterfeit-resistant prescription blanks for controlled
6    substances; providing penalties; amending s. 893.04, F.S.;
7    providing additional requirements for the dispensing of a
8    controlled substance listed in Schedule II, Schedule III,
9    or Schedule IV; providing rulemaking authority to the
10    Board of Pharmacy; creating s. 893.055, F.S.; requiring
11    the Department of Health to establish an electronic system
12    to monitor the prescribing of controlled substances listed
13    in Schedules II, III, and IV; requiring the dispensing of
14    such controlled substances to be reported through the
15    system; providing exceptions; providing reporting
16    requirements; providing penalties; requiring the
17    department and regulatory boards to adopt rules; requiring
18    the department to cover all costs for the system, subject
19    to availability of funds; providing a continuing
20    appropriation; providing that a certain trust fund may not
21    be used to fund the program; providing for future
22    legislative review and repeal; creating s. 893.065, F.S.;
23    requiring the department to develop and adopt by rule the
24    form and content for a counterfeit-proof prescription
25    blank for voluntary use by physicians to prescribe a
26    controlled substance listed in Schedule II, Schedule III,
27    or Schedule IV; providing an appropriation and authorizing
28    positions; providing contingent applicability of
29    penalties; providing contingent effective dates.
30         
31          Be It Enacted by the Legislature of the State of Florida:
32         
33          Section 1. Section 831.311, Florida Statutes, is created
34    to read:
35          831.311 Unlawful sale, manufacture, alteration, delivery,
36    uttering, or possession of counterfeit-resistant prescription
37    blanks for controlled substances listed in Schedules II, III,
38    and IV.--
39          (1) It is unlawful for any person with the intent to
40    injure or defraud any person or to facilitate any violation of
41    s. 893.13 to sell, manufacture, alter, deliver, utter, or
42    possess any counterfeit-resistant prescription blanks for
43    controlled substances adopted by rule of the Department of
44    Health pursuant to s. 893.065.
45          (2) Any person who violates this section commits a felony
46    of the third degree, punishable as provided in s. 775.082, s.
47    775.083, or s. 775.084.
48          Section 2. Section 893.04, Florida Statutes, is amended to
49    read:
50          893.04 Pharmacist and practitioner.--
51          (1) A pharmacist, in good faith and in the course of
52    professional practice only, may dispense controlled substances
53    upon a written or oral prescription of a practitioner, under the
54    following conditions:
55          (a) Oral prescriptions must be promptly reduced to writing
56    by the pharmacist or recorded electronically.
57          (b) The written prescription must be dated and signed by
58    the prescribing practitioner on the day when issued.
59          (c) There shall appear on the face of the prescription or
60    written record thereof for the controlled substance the
61    following information:
62          1. The full name and address of the person for whom, or
63    the owner of the animal for which, the controlled substance is
64    dispensed.
65          2. The full name and address of the prescribing
66    practitioner and the practitioner's federal controlled substance
67    registry number shall be printed thereon.
68          3. If the prescription is for an animal, the species of
69    animal for which the controlled substance is prescribed.
70          4. The name of the controlled substance prescribed and the
71    strength, quantity, and directions for use thereof.
72          5. The number of the prescription, as recorded in the
73    prescription files of the pharmacy in which it is filled.
74          6. The initials of the pharmacist filling the prescription
75    and the date filled.
76          (d) The prescription shall be retained on file by the
77    proprietor of the pharmacy in which it is filled for a period of
78    2 years.
79          (e) Affixed to the original container in which a
80    controlled substance is delivered upon a prescription or
81    authorized refill thereof, as hereinafter provided, there shall
82    be a label bearing the following information:
83          1. The name and address of the pharmacy from which such
84    controlled substance was dispensed.
85          2. The date on which the prescription for such controlled
86    substance was filled.
87          3. The number of such prescription, as recorded in the
88    prescription files of the pharmacy in which it is filled.
89          4. The name of the prescribing practitioner.
90          5. The name of the patient for whom, or of the owner and
91    species of the animal for which, the controlled substance is
92    prescribed.
93          6. The directions for the use of the controlled substance
94    prescribed in the prescription.
95          7. A clear, concise warning that it is a crime to transfer
96    the controlled substance to any person other than the patient
97    for whom prescribed.
98          (f) A prescription for a controlled substance listed in
99    Schedule II may be dispensed only upon a written prescription of
100    a practitioner, except that in an emergency situation, as
101    defined by regulation of the Department of Health, such
102    controlled substance may be dispensed upon oral prescription but
103    is limited to a 72-hour supply. No prescription for a controlled
104    substance listed in Schedule II may be refilled.
105          (g) No prescription for a controlled substance listed in
106    Schedule Schedules III, Schedule IV, or ScheduleV may be filled
107    or refilled more than five times within a period of 6 months
108    after the date on which the prescription was written unless the
109    prescription is renewed by a practitioner.
110          (2)(a) A pharmacist may not dispense a controlled
111    substance listed in Schedule II, Schedule III, or Schedule IV to
112    any patient or patient's agent without first determining, in the
113    exercise of her or his professional judgment, that the order is
114    valid. The pharmacist or pharmacist's agent must also obtain
115    the patient or patient's agent identification information, in
116    writing, electronic format, or other approved manner prior to
117    dispensing any controlled substance. If the patient or patient's
118    agent does not have appropriate identification, the pharmacist
119    may dispense the controlled substance only when the pharmacist
120    determines, in the exercise of her or his professional judgment,
121    that the order is valid and includes such information in the
122    patient's record. The Board of Pharmacy may adopt, by rule,
123    required patient identification information for controlled
124    substances and procedures for a pharmacist to verify the
125    validity of a prescription for controlled substances for
126    circumstances in which the pharmacist was not provided required
127    identification information.
128          (b) Any pharmacist that dispenses by mail a controlled
129    substance listed in Schedule II, Schedule III, or Schedule IV
130    shall be exempt from the requirement to obtain suitable
131    identification for the prescription dispensed by mail.
132          (c) Any controlled substance listed in Schedule III or
133    Schedule IV may be dispensed by a pharmacist upon an oral
134    prescription if, before filling the prescription, the pharmacist
135    reduces it to writing or records the prescription
136    electronically. Such prescriptions must contain the date of the
137    oral authorization.
138          (d) Each written prescription prescribed by a practitioner
139    in this state for a controlled substance listed in Schedule II,
140    Schedule III, or Schedule IV must include both a written and a
141    numerical notation of the quantity on the face of the
142    prescription and a notation of the date with the abbreviated
143    month written out on the face of the prescription. A pharmacist
144    shall be permitted, upon verification by the prescriber, to
145    document any information required by this paragraph.
146          (e) A pharmacist may not dispense more than a 30-day
147    supply of a controlled substance listed in Schedule III upon an
148    oral prescription issued in this state.
149          (f) A pharmacist may not knowingly fill a prescription
150    that has been forged for a controlled substance listed in
151    Schedule II, Schedule III, or Schedule IV.
152          (3)(2)Notwithstanding the provisions of subsection (1), a
153    pharmacist may dispense a one-time emergency refill of up to a
154    72-hour supply of the prescribed medication for any medicinal
155    drug other than a medicinal drug listed in Schedule II, in
156    compliance with the provisions of s. 465.0275.
157          (4)(3)The legal owner of any stock of controlled
158    substances in a pharmacy, upon discontinuance of dealing in
159    controlled substances, may sell said stock to a manufacturer,
160    wholesaler, or pharmacy. Such controlled substances may be sold
161    only upon an order form, when such an order form is required for
162    sale by the drug abuse laws of the United States or this state,
163    or regulations pursuant thereto.
164          Section 3. Effective July 1, 2004, subsection (1) of
165    section 893.055, Florida Statutes, is created, and effective
166    July 1, 2005, subsections (2) through (9) of said section are
167    created, to read:
168          893.055 Electronic monitoring system for prescription of
169    controlled substances listed in Schedules II, III, and IV.--
170          (1) By June 30, 2005, the Department of Health shall
171    design and establish an electronic system consistent with the
172    American Society for Automation in Pharmacy (ASAP) standards to
173    monitor the prescribing and dispensing of controlled substances
174    listed in Schedules II, III, and IV by health care practitioners
175    within the state and the dispensing of such controlled
176    substances to an individual at a specific address within the
177    state by a pharmacy permitted or registered by the Board of
178    Pharmacy. The system shall be put into operation on July 1,
179    2005.
180          (2) Any controlled substance listed in Schedule II,
181    Schedule III, or Schedule IV which is dispensed to an individual
182    in this state must be reported to the Department of Health
183    through the system, as soon thereafter as possible but not more
184    than 35 days after the date the controlled substance is
185    dispensed, each time the controlled substance is dispensed. A
186    pharmacy may meet the reporting requirements of this section by
187    providing the Department of Health an exchangeable electronic
188    disc or tape of each controlled substance listed in Schedules
189    II, III, and IV which it dispenses.
190          (3) This section does not apply to controlled substances:
191          (a) Administered by a health care practitioner directly to
192    a patient.
193          (b) Dispensed by a health care practitioner authorized to
194    prescribe controlled substances directly to a patient and
195    limited to an amount adequate to treat the patient for a period
196    of no more than 72 hours.
197          (c) Dispensed by a health care practitioner or a
198    pharmacist to an inpatient of a facility with an institutional
199    pharmacy permit.
200          (d) Ordered from an institutional pharmacy permitted under
201    s. 465.019 in accordance with the institutional policy for such
202    controlled substances or drugs.
203          (e) Either dispensed by a pharmacist or administered by a
204    health care practitioner to a patient or resident receiving care
205    from a hospital, nursing home, assisted living facility, home
206    health agency, hospice, or intermediate care facility for the
207    developmentally disabled which is licensed in this state.
208          (f) Prescribed by a health care practitioner for a patient
209    younger than 16 years of age.
210          (4) The data required to be reported under this section
211    shall be determined by the Department of Health by rule but may
212    include any data required under s. 893.04.
213          (5) A practitioner or pharmacist who dispenses a
214    controlled substance under this section must submit the
215    information required by this section in an electronic or other
216    format approved by rule of the Department of Health. The cost to
217    the dispenser in submitting the information required by this
218    subsection may not be material or extraordinary. Costs not
219    considered to be material or extraordinary include, but are not
220    limited to, regular postage, compact discs, zip drive storage,
221    regular electronic mail, magnetic tapes, diskettes, and
222    facsimile charges. The information submitted to the Department
223    of Health under this section may be transmitted to any person or
224    agency authorized to receive it pursuant to House Bill 399, or
225    similar legislation, and that person or agency may maintain the
226    information received for up to 24 months before purging it from
227    its records. All transmissions required by this paragraph must
228    comply with relevant federal and state privacy and security
229    laws. However, any authorized agency receiving such information
230    may maintain it longer than 24 months if the information is
231    pertinent to an ongoing investigation or prosecution.
232          (6) Any person who knowingly fails to report the
233    dispensing of a controlled substance listed in Schedule II,
234    Schedule III, or Schedule IV as required by this section commits
235    a misdemeanor of the first degree, punishable as provided in s.
236    775.082 or s. 775.083.
237          (7) The Department of Health and the regulatory boards for
238    the health care practitioners subject to this section shall
239    adopt rules pursuant to ss. 120.536(1) and 120.54 necessary to
240    implement and administer this section.
241          (8) All costs incurred by the Department of Health in
242    implementing the prescription monitoring system shall be borne
243    by the department, subject to the availability of funds, and
244    there is appropriated annually from the Grants and Donations
245    Trust Fund an amount necessary to cover such costs. The Medical
246    Quality Assurance Trust Fund may not be used to implement or
247    otherwise fund this program.
248          (9) This section is repealed June 30, 2008, unless
249    reviewed and saved from repeal through reenactment by the
250    Legislature.
251          Section 4. Section 893.065, Florida Statutes, is created
252    to read:
253          893.065 Counterfeit-resistant prescription blanks for
254    controlled substances listed in Schedules II, III, and IV.--The
255    Department of Health shall develop and adopt by rule the form
256    and content for a counterfeit-resistant prescription blank which
257    may be used by practitioners to prescribe a controlled substance
258    listed in Schedule II, Schedule III, or Schedule IV. The
259    Department of Health may require the prescription blanks to be
260    printed on distinctive, watermarked paper and to bear the
261    preprinted name, address, and category of professional licensure
262    of the practitioner and that practitioner's federal registry
263    number for controlled substances. The prescription blanks may
264    not be transferred.
265          Section 5. Effective July 1, 2004, there is appropriated
266    $2,196,352 from the Grants and Donations Trust Fund to the
267    Department of Health, and three full-time equivalent positions
268    are authorized for fiscal year 2004-2005, to implement the
269    provisions of ss. 893.055 and 893.065, Florida Statutes, as
270    created by this act.
271          Section 6. The penalties created in ss. 831.311(2) and
272    893.055(6), Florida Statutes, by this act shall be effective
273    only upon the adoption by the Department of Health and each
274    applicable professional regulatory board of the rules required
275    pursuant to ss. 893.055(7) and 893.065, Florida Statutes, as
276    created by this act.
277          Section 7. Except as otherwise expressly provided in this
278    act, this act shall take effect July 1, 2005, if House Bill 399
279    or similar legislation is adopted in the same legislative
280    session or an extension thereof and becomes law.