Senate Bill sb2390c1
CODING: Words stricken are deletions; words underlined are additions.
Florida Senate - 2003 CS for SB 2390
By the Committee on Health, Aging, and Long-Term Care; and
Senator Fasano
317-2251-03
1 A bill to be entitled
2 An act relating to controlled substances;
3 creating s. 831.311, F.S.; prohibiting the
4 sale, manufacture, alteration, delivery,
5 uttering, or possession of
6 counterfeit-resistant prescription blanks for
7 controlled substances; providing penalties;
8 amending s. 893.04, F.S.; providing additional
9 requirements for the dispensing of a controlled
10 substance listed in Schedule II, Schedule III,
11 or Schedule IV; providing rulemaking authority
12 to the Board of Pharmacy; creating s. 893.055,
13 F.S.; requiring the Department of Health to
14 establish an electronic system to monitor the
15 prescribing of controlled substances listed in
16 Schedule II, Schedule III, and Schedule IV;
17 requiring the dispensing of such controlled
18 substances to be reported through the system;
19 providing exceptions; providing reporting
20 requirements; providing penalties; providing
21 rulemaking authority to the department;
22 requiring the department to cover all costs for
23 the system; providing a continuing
24 appropriation; providing that a certain trust
25 fund may not be used to fund the program;
26 creating s. 893.065, F.S.; requiring the
27 department to develop and adopt by rule the
28 form and content for a counterfeit-proof
29 prescription blank for voluntary use by
30 physicians to prescribe a controlled substance
31 listed in Schedule II, Schedule III, or
1
CODING: Words stricken are deletions; words underlined are additions.
Florida Senate - 2003 CS for SB 2390
317-2251-03
1 Schedule IV; providing an appropriation;
2 providing contingent applicability of
3 penalties; providing contingent effective
4 dates.
5
6 Be It Enacted by the Legislature of the State of Florida:
7
8 Section 1. Section 831.311, Florida Statutes, is
9 created to read:
10 831.311 Unlawful sale, manufacture, alteration,
11 delivery, uttering, or possession of counterfeit-resistant
12 prescription blanks for controlled substances listed in
13 Schedules II, III, and IV.--
14 (1) It is unlawful for any person with the intent to
15 injure or defraud any person or to facilitate any violation of
16 s. 893.13 to sell, manufacture, alter, deliver, utter, or
17 possess any counterfeit-resistant prescription blanks for
18 controlled substances adopted by rule of the Department of
19 Health pursuant to s. 893.065.
20 (2) Any person who violates this section commits a
21 felony of the third degree, punishable as provided in s.
22 775.082, s. 775.083, or s. 775.084.
23 Section 2. Section 893.04, Florida Statutes, is
24 amended to read:
25 893.04 Pharmacist and practitioner.--
26 (1) A pharmacist, in good faith and in the course of
27 professional practice only, may dispense controlled substances
28 upon a written or oral prescription of a practitioner, under
29 the following conditions:
30 (a) Oral prescriptions must be promptly reduced to
31 writing by the pharmacist.
2
CODING: Words stricken are deletions; words underlined are additions.
Florida Senate - 2003 CS for SB 2390
317-2251-03
1 (b) The written prescription must be dated and signed
2 by the prescribing practitioner on the day when issued.
3 (c) There shall appear on the face of the prescription
4 or written record thereof for the controlled substance the
5 following information:
6 1. The full name and address of the person for whom,
7 or the owner of the animal for which, the controlled substance
8 is dispensed.
9 2. The full name and address of the prescribing
10 practitioner and the practitioner's federal controlled
11 substance registry number shall be printed thereon.
12 3. If the prescription is for an animal, the species
13 of animal for which the controlled substance is prescribed.
14 4. The name of the controlled substance prescribed and
15 the strength, quantity, and directions for use thereof.
16 5. The number of the prescription, as recorded in the
17 prescription files of the pharmacy in which it is filled.
18 6. The initials of the pharmacist filling the
19 prescription and the date filled.
20 (d) The prescription shall be retained on file by the
21 proprietor of the pharmacy in which it is filled for a period
22 of 2 years.
23 (e) Affixed to the original container in which a
24 controlled substance is delivered upon a prescription or
25 authorized refill thereof, as hereinafter provided, there
26 shall be a label bearing the following information:
27 1. The name and address of the pharmacy from which
28 such controlled substance was dispensed.
29 2. The date on which the prescription for such
30 controlled substance was filled.
31
3
CODING: Words stricken are deletions; words underlined are additions.
Florida Senate - 2003 CS for SB 2390
317-2251-03
1 3. The number of such prescription, as recorded in the
2 prescription files of the pharmacy in which it is filled.
3 4. The name of the prescribing practitioner.
4 5. The name of the patient for whom, or of the owner
5 and species of the animal for which, the controlled substance
6 is prescribed.
7 6. The directions for the use of the controlled
8 substance prescribed in the prescription.
9 7. A clear, concise warning that it is a crime to
10 transfer the controlled substance to any person other than the
11 patient for whom prescribed.
12 (f) A prescription for a controlled substance listed
13 in Schedule II may be dispensed only upon a written
14 prescription of a practitioner, except that in an emergency
15 situation, as defined by regulation of the Department of
16 Health, such controlled substance may be dispensed upon oral
17 prescription but is limited to a 72-hour supply. No
18 prescription for a controlled substance listed in Schedule II
19 may be refilled.
20 (g) No prescription for a controlled substance listed
21 in Schedule Schedules III, Schedule IV, or Schedule V may be
22 filled or refilled more than five times within a period of 6
23 months after the date on which the prescription was written
24 unless the prescription is renewed by a practitioner.
25 (2)(a) A pharmacist may not dispense a controlled
26 substance listed in Schedule II, Schedule III, or Schedule IV
27 to any patient or patient's agent without first determining,
28 in the exercise of her or his professional judgment, that the
29 order is valid. The pharmacist or pharmacist's agent shall
30 also obtain the patient or patient's agent identification
31 information, in writing, electronic format or other approved
4
CODING: Words stricken are deletions; words underlined are additions.
Florida Senate - 2003 CS for SB 2390
317-2251-03
1 manner prior to dispensing any controlled substance. If the
2 patient or patient's agent does not have appropriate
3 identification, the pharmacist may dispense the controlled
4 substance only when the pharmacist determines, in the exercise
5 of her or his professional judgment, that the order is valid
6 and includes such information in the patient's record. The
7 Board of Pharmacy may adopt, by rule, required patient
8 identification information for controlled substances and
9 procedures for a pharmacist to verify the validity of a
10 prescription for controlled substances for circumstances in
11 which the pharmacist was not provided required identification
12 information.
13 (b) Any pharmacist that dispenses by mail a controlled
14 substance listed in Schedule II, Schedule III, or Schedule IV
15 shall be exempt from the requirement to obtain suitable
16 identification for the prescription dispensed by mail.
17 (c) Any controlled substance listed in Schedule III or
18 Schedule IV may be dispensed by a pharmacist upon an oral
19 prescription if, before filling the prescription, the
20 pharmacist reduces it to writing. Such prescriptions must
21 contain the date of the oral authorization.
22 (d) All written prescriptions prescribed by a
23 practitioner in this state for a controlled substance listed
24 in Schedule II, Schedule III, or Schedule IV must include both
25 a written and a numerical notation of the quantity on the face
26 of the prescription and a notation of the date with the month
27 written out on the face of the prescription. A pharmacist
28 shall be permitted, upon verification by the prescriber, to
29 document any information required by this paragraph.
30
31
5
CODING: Words stricken are deletions; words underlined are additions.
Florida Senate - 2003 CS for SB 2390
317-2251-03
1 (e) A pharmacist may not dispense more than a 30-day
2 supply of a controlled substance listed in Schedule III upon
3 an oral prescription issued in this state.
4 (f) A pharmacist may not knowingly fill a prescription
5 that has been forged for a controlled substance listed in
6 Schedule II, Schedule III, or Schedule IV.
7 (3)(2) Notwithstanding the provisions of subsection
8 (1), a pharmacist may dispense a one-time emergency refill of
9 up to a 72-hour supply of the prescribed medication for any
10 medicinal drug other than a medicinal drug listed in Schedule
11 II, in compliance with the provisions of s. 465.0275.
12 (4)(3) The legal owner of any stock of controlled
13 substances in a pharmacy, upon discontinuance of dealing in
14 controlled substances, may sell said stock to a manufacturer,
15 wholesaler, or pharmacy. Such controlled substances may be
16 sold only upon an order form, when such an order form is
17 required for sale by the drug abuse laws of the United States
18 or this state, or regulations pursuant thereto.
19 Section 3. Section 893.055, Florida Statutes, is
20 created to read:
21 893.055 Electronic monitoring system for prescription
22 of controlled substances listed in Schedules II, III, and
23 IV.--
24 (1) By January 1, 2004, the Department of Health shall
25 design and establish an electronic system consistent with the
26 American Society for Automation in Pharmacy (ASAP) standards
27 to monitor the prescribing and dispensing of controlled
28 substances listed in Schedules II, III, and IV by health care
29 practitioners within the state and the dispensing of such
30 controlled substances to an individual at a specific address
31
6
CODING: Words stricken are deletions; words underlined are additions.
Florida Senate - 2003 CS for SB 2390
317-2251-03
1 within the state by a pharmacy permitted or registered by the
2 Board of Pharmacy.
3 (2) Any controlled substance listed in Schedule II,
4 Schedule III, or Schedule IV which is dispensed to an
5 individual in this state must be reported to the Department of
6 Health through the system, as soon thereafter as possible but
7 not more than 35 days after the date the controlled substance
8 is dispensed, each time the controlled substance is dispensed.
9 A pharmacy may meet the reporting requirements of this section
10 by providing the Department of Health an exchangeable
11 electronic disc or tape of each controlled substance listed in
12 Schedules II, III, and IV which it dispenses.
13 (3) This section does not apply to controlled
14 substances:
15 (a) Administered by a health care practitioner
16 directly to a patient.
17 (b) Dispensed by a health care practitioner authorized
18 to prescribe controlled substances directly to a patient and
19 limited to an amount adequate to treat the patient for a
20 period of no more than 72 hours.
21 (c) Dispensed by a health care practitioner or a
22 pharmacist to an in-patient of a facility with an
23 institutional pharmacy permit.
24 (d) Ordered from an institutional pharmacy permitted
25 under s. 465.019 in accordance with the institutional policy
26 for such controlled substances or drugs.
27 (e) Either dispensed by a pharmacist or administered
28 by a health care practitioner to a patient or resident
29 receiving care from a hospital, nursing home, assisted living
30 facility, home health agency, hospice, or intermediate care
31
7
CODING: Words stricken are deletions; words underlined are additions.
Florida Senate - 2003 CS for SB 2390
317-2251-03
1 facility for the developmentally disabled which is licensed in
2 this state.
3 (f) Prescribed by a health care practitioner for a
4 patient less than 16 years of age.
5 (4) The data required to be reported under this
6 section shall be determined by the Department of Health by
7 rule but may include any data required under s. 893.04.
8 (5) A practitioner or pharmacist who dispenses a
9 controlled substance under this section must submit the
10 information required by this section in an electronic or other
11 format approved by rule of the Department of Health. The cost
12 to the dispenser in submitting the information required by
13 this subsection shall not be material or extraordinary. Costs
14 not considered to be material or extraordinary include, but
15 are not limited to, regular postage, compact disks, zip drive
16 storage, regular electronic mail, magnetic tapes, diskettes,
17 and facsimile charges. The information submitted to the
18 Department of Health under this section may be transmitted to
19 any person or agency authorized to receive it pursuant to
20 section 2 of Senate Bill 1784 or similar legislation, and that
21 person or agency may maintain the information received for up
22 to 24 months before purging it from its records. All
23 transmissions required by this paragraph shall comply with
24 relevant federal and state privacy and security laws.
25 Notwithstanding the foregoing, any authorized agency receiving
26 such information may maintain it longer than 24 months if the
27 information is pertinent to an ongoing investigation or
28 prosecution.
29 (6) Any person who knowingly fails to report the
30 dispensing of a controlled substance listed in Schedule II,
31 Schedule III, or Schedule IV as required by this section
8
CODING: Words stricken are deletions; words underlined are additions.
Florida Senate - 2003 CS for SB 2390
317-2251-03
1 commits a misdemeanor of the first degree, punishable as
2 provided in s. 775.082 or s. 775.083.
3 (7) The Department of Health and the regulatory boards
4 for the health care practitioners subject to this section
5 shall adopt rules pursuant to ss. 120.536(1) and 120.54
6 necessary to implement and administer this section.
7 (8) All costs incurred by the Department of Health in
8 implementing the prescription monitoring system shall be borne
9 by the department, and there is appropriated annually from the
10 General Revenue Fund an amount necessary to cover such costs.
11 The Medical Quality Assurance Trust Fund may not be used to
12 implement or otherwise fund this program.
13 Section 4. Section 893.065, Florida Statutes, is
14 created to read:
15 893.065 Counterfeit-resistant prescription blanks for
16 controlled substances listed in Schedules II, III, and
17 IV.--The Department of Health shall develop and adopt by rule
18 the form and content for a counterfeit-resistant prescription
19 blank which may be used by practitioners to prescribe a
20 controlled substance listed in Schedule II, Schedule III, or
21 Schedule IV. The Department of Health may require the
22 prescription blanks to be printed on distinctive, watermarked
23 paper and to bear the preprinted name, address, and category
24 of professional licensure of the practitioner and that
25 practitioner's federal registry number for controlled
26 substances. The prescription blanks may not be transferred.
27 Section 5. There is appropriated from the General
28 Revenue Fund to the Department of Health for fiscal year
29 2003-2004 an amount sufficient to cover the costs incurred by
30 the department in implementing the provisions of sections
31
9
CODING: Words stricken are deletions; words underlined are additions.
Florida Senate - 2003 CS for SB 2390
317-2251-03
1 893.055 and 893.065, Florida Statutes, as created by this act.
2 This section shall take effect July 1, 2003.
3 Section 6. The penalties created in sections
4 831.311(2) and 893.055(6), Florida Statutes, by this act shall
5 be effective only upon the adoption by the Department of
6 Health and each applicable professional regulatory board of
7 the rules required pursuant to sections 893.055(7) and
8 893.065, Florida Statutes, as created by this act.
9 Section 7. Except as otherwise expressly provided in
10 this act, this act shall take effect July 1, 2004, if Senate
11 Bill 1784 or similar legislation is adopted in the same
12 legislative session or an extension thereof and becomes law.
13
14 STATEMENT OF SUBSTANTIAL CHANGES CONTAINED IN
COMMITTEE SUBSTITUTE FOR
15 Senate Bill 2390
16
17 The Committee Substitute creates a third degree felony offense
for any person, with the intent to injure or defraud any
18 person or to facilitate any violation of the Florida
Comprehensive Drug Abuse Prevention and Control Act, to sell,
19 manufacture, alter, deliver, utter, or possess any
counterfeit-resistant prescription blanks for controlled
20 substances adopted by rule of the Department of Health. The
Committee Substitute revises the reporting requirements for
21 data to be reported under the electronic prescription
monitoring system and exemptions to such requirements. It
22 revises guidelines for purging records by persons or agencies
receiving disclosures under the electronic prescription
23 monitoring system. The Committee Substitute revises
requirements for pharmacists to obtain identification of a
24 patient when dispensing controlled substances. The effective
date of the bill is revised to take effect on July 1, 2004, if
25 SB 1784 or similar legislation is adopted in the same
legislative session or an extension thereof and becomes law.
26
27
28
29
30
31
10
CODING: Words stricken are deletions; words underlined are additions.