Senate Bill sb0178c2
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Florida Senate - 2006 CS for CS for SB 178
By the Committees on Health and Human Services Appropriations;
Criminal Justice; and Senator Saunders
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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.; providing a definition; requiring the
14 Department of Health to establish an electronic
15 system to monitor the prescribing of controlled
16 substances listed in Schedules II, III, and 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; requiring
21 that the department and regulatory boards adopt
22 rules; requiring the department to cover all
23 costs for the system; providing for annual
24 appropriations, subject to availability of
25 funds; prohibiting using funds from the Medical
26 Quality Assurance Trust Fund to administer the
27 program; creating s. 893.065, F.S.; requiring
28 the department to develop and adopt by rule the
29 form and content for a counterfeit-proof
30 prescription blank for voluntary use by
31 physicians to prescribe a controlled substance
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1 listed in Schedule II, Schedule III, or
2 Schedule IV; providing an appropriation and
3 authorizing additional positions; providing for
4 the contingent applicability of penalties;
5 providing contingent effective dates.
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7 Be It Enacted by the Legislature of the State of Florida:
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9 Section 1. Section 831.311, Florida Statutes, is
10 created to read:
11 831.311 Unlawful sale, manufacture, alteration,
12 delivery, uttering, or possession of counterfeit-resistant
13 prescription blanks for controlled substances listed in
14 Schedules II, III, and IV.--
15 (1) It is unlawful for any person having the intent to
16 injure or defraud any person or to facilitate any violation of
17 s. 893.13 to sell, manufacture, alter, deliver, utter, or
18 possess any counterfeit-resistant prescription blanks for
19 controlled substances, the form and content of which are
20 adopted by rule of the Department of Health pursuant to s.
21 893.065.
22 (2) Any person who violates this section commits a
23 felony of the third degree, punishable as provided in s.
24 775.082, s. 775.083, or s. 775.084.
25 Section 2. Section 893.04, Florida Statutes, is
26 amended to read:
27 893.04 Pharmacist and practitioner.--
28 (1) A pharmacist, in good faith and in the course of
29 professional practice only, may dispense controlled substances
30 upon a written or oral prescription of a practitioner, under
31 the following conditions:
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1 (a) Oral prescriptions must be promptly reduced to
2 writing by the pharmacist or recorded electronically if
3 permitted by federal law.
4 (b) The written prescription must be dated and signed
5 by the prescribing practitioner on the day when issued.
6 (c) There shall appear on the face of the prescription
7 or written record thereof for the controlled substance the
8 following information:
9 1. The full name and address of the person for whom,
10 or the owner of the animal for which, the controlled substance
11 is dispensed.
12 2. The full name and address of the prescribing
13 practitioner and the practitioner's federal controlled
14 substance registry number shall be printed thereon.
15 3. If the prescription is for an animal, the species
16 of animal for which the controlled substance is prescribed.
17 4. The name of the controlled substance prescribed and
18 the strength, quantity, and directions for use thereof.
19 5. The number of the prescription, as recorded in the
20 prescription files of the pharmacy in which it is filled.
21 6. The initials of the pharmacist filling the
22 prescription and the date filled.
23 (d) The prescription shall be retained on file by the
24 proprietor of the pharmacy in which it is filled for a period
25 of 2 years.
26 (e) Affixed to the original container in which a
27 controlled substance is delivered upon a prescription or
28 authorized refill thereof, as hereinafter provided, there
29 shall be a label bearing the following information:
30 1. The name and address of the pharmacy from which
31 such controlled substance was dispensed.
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1 2. The date on which the prescription for such
2 controlled substance was filled.
3 3. The number of such prescription, as recorded in the
4 prescription files of the pharmacy in which it is filled.
5 4. The name of the prescribing practitioner.
6 5. The name of the patient for whom, or of the owner
7 and species of the animal for which, the controlled substance
8 is prescribed.
9 6. The directions for the use of the controlled
10 substance prescribed in the prescription.
11 7. A clear, concise warning that it is a crime to
12 transfer the controlled substance to any person other than the
13 patient for whom prescribed.
14 (f) A prescription for a controlled substance listed
15 in Schedule II may be dispensed only upon a written
16 prescription of a practitioner, except that in an emergency
17 situation, as defined by regulation of the Department of
18 Health, such controlled substance may be dispensed upon oral
19 prescription but is limited to a 72-hour supply. A No
20 prescription for a controlled substance listed in Schedule II
21 may not be refilled.
22 (g) A No prescription for a controlled substance
23 listed in Schedule Schedules III, Schedule IV, or Schedule V
24 may not be filled or refilled more than five times within a
25 period of 6 months after the date on which the prescription
26 was written unless the prescription is renewed by a
27 practitioner.
28 (2)(a) A pharmacist may not dispense a controlled
29 substance listed in Schedule II, Schedule III, or Schedule IV
30 to any patient or patient's agent without first determining,
31 in the exercise of her or his professional judgment, that the
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1 order is valid. The pharmacist or pharmacist's agent shall
2 obtain a government-issued or other form of documentary
3 identification substantiating the identity of a patient or
4 patient's agent prior to dispensing any Schedule II, Schedule
5 III, or Schedule IV controlled substance to such patient or
6 patient's agent. The pharmacist or pharmacist's agent shall
7 make a record of the type of documentary identification
8 provided by the patient or patient's agent. If the patient or
9 patient's agent does not have appropriate identification, the
10 pharmacist may dispense the controlled substance only when the
11 pharmacist determines, in the exercise of her or his
12 professional judgment, that the order is valid and includes
13 such information in the patient's record. The Board of
14 Pharmacy may adopt, by rule, required patient-identification
15 information for controlled substances and procedures for a
16 pharmacist to verify the validity of a prescription for
17 controlled substances for circumstances in which the
18 pharmacist was not provided required identification
19 information.
20 (b) Any pharmacist who dispenses by mail a controlled
21 substance listed in Schedule II, Schedule III, or Schedule IV
22 is exempt from the requirement to obtain suitable
23 identification for the prescription dispensed by mail if the
24 pharmacist has obtained the patient's identification through
25 the patient's prescription benefit plan.
26 (c) Any controlled substance listed in Schedule III or
27 Schedule IV may be dispensed by a pharmacist upon an oral
28 prescription if, before filling the prescription, the
29 pharmacist reduces it to writing or records the prescription
30 electronically if permitted by federal law. Such prescriptions
31 must contain the date of the oral authorization.
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1 (d) Each written prescription prescribed by a
2 practitioner in this state for a controlled substance listed
3 in Schedule II, Schedule III, or Schedule IV must include both
4 a written and a numerical notation of the quantity on the face
5 of the prescription and a notation of the date, with the
6 abbreviated month written out on the face of the prescription.
7 A pharmacist may, upon verification by the prescriber,
8 document any information required by this paragraph.
9 (e) A pharmacist may not dispense more than a 30-day
10 supply of a controlled substance listed in Schedule III upon
11 an oral prescription issued in this state.
12 (f) A pharmacist may not knowingly fill a prescription
13 that has been forged for a controlled substance listed in
14 Schedule II, Schedule III, or Schedule IV.
15 (3)(2) Notwithstanding the provisions of subsection
16 (1), a pharmacist may dispense a one-time emergency refill of
17 up to a 72-hour supply of the prescribed medication for any
18 medicinal drug other than a medicinal drug listed in Schedule
19 II, in compliance with the provisions of s. 465.0275.
20 (4)(3) The legal owner of any stock of controlled
21 substances in a pharmacy, upon discontinuance of dealing in
22 controlled substances, may sell said stock to a manufacturer,
23 wholesaler, or pharmacy. Such controlled substances may be
24 sold only upon an order form, when such an order form is
25 required for sale by the drug abuse laws of the United States
26 or this state, or regulations pursuant thereto.
27 Section 3. Section 893.055, Florida Statutes, is
28 created to read:
29 893.055 Electronic-monitoring system for prescription
30 of controlled substances listed in Schedules II, III, and
31 IV.--
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1 (1) As used in this section, the term "pharmacy" means
2 any pharmacy subject to licensure or regulation by the
3 Department of Health pursuant to chapter 465 which dispenses
4 or delivers a controlled substance included on Schedule II,
5 Schedule III, or Schedule IV to a patient in this state.
6 (2) By June 30, 2007, the Department of Health shall
7 design and establish an electronic system consistent with
8 standards of the American Society for Automation in Pharmacy
9 to monitor the prescribing and dispensing of controlled
10 substances listed in Schedules II, III, and IV by health care
11 practitioners within the state and the dispensing of such
12 controlled substances to an individual at a specific address
13 within the state by a pharmacy permitted or registered by the
14 Board of Pharmacy.
15 (3) Any controlled substance listed in Schedule II,
16 Schedule III, or Schedule IV which is dispensed to an
17 individual in this state must be reported to the Department of
18 Health through the system as soon thereafter as possible, but
19 not more than 35 days after the date the controlled substance
20 is dispensed, each time the controlled substance is dispensed.
21 A pharmacy or dispensing practitioner may meet the reporting
22 requirements of this section by providing to the Department of
23 Health in written or any electronic or magnetic format,
24 including, but not limited to, electronic submission via the
25 Internet or magnetic disc or tape, each controlled substance
26 listed in Schedule II, Schedule III, or Schedule IV which it
27 dispenses.
28 (4) This section does not apply to controlled
29 substances:
30 (a) Administered by a health care practitioner
31 directly to a patient.
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1 (b) Dispensed by a health care practitioner authorized
2 to prescribe controlled substances directly to a patient and
3 limited to an amount adequate to treat the patient for a
4 period of no more than 72 hours.
5 (c) Dispensed by a health care practitioner or a
6 pharmacist to an inpatient of a facility that holds an
7 institutional pharmacy permit.
8 (d) Ordered from an institutional pharmacy permitted
9 under s. 465.019 in accordance with the institutional policy
10 for such controlled substances or drugs.
11 (e) Dispensed by a pharmacist or administered by a
12 health care practitioner to a patient or resident receiving
13 care from a hospital, nursing home, assisted living facility,
14 home health agency, hospice, or intermediate care facility for
15 the developmentally disabled which is licensed in this state.
16 (f) Prescribed by a health care practitioner for a
17 patient younger than 16 years of age.
18 (5) The data required to be reported under this
19 section shall be determined by the Department of Health by
20 rule but may include any data required under s. 893.04.
21 (6) A practitioner or pharmacist who dispenses a
22 controlled substance under this section must submit the
23 information required by this section in an electronic or other
24 format approved by rule of the Department of Health. The cost
25 to the dispenser in submitting the information required by
26 this section may not be material or extraordinary. Costs not
27 considered to be material or extraordinary include, but are
28 not limited to, regular postage, compact discs, zip-drive
29 storage, regular electronic mail, magnetic tapes, diskettes,
30 and facsimile charges. The information submitted to the
31 Department of Health under this section may be transmitted to
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1 any person or agency authorized to receive it pursuant to
2 section 1 of Senate Bill 176, or similar legislation, and that
3 person or agency may maintain the information received for up
4 to 24 months before purging the information from its records.
5 All transmissions required by this subsection must comply with
6 relevant federal and state privacy and security laws. However,
7 any authorized agency receiving such information may maintain
8 it for longer than 24 months if the information is pertinent
9 to an ongoing investigation or prosecution.
10 (7) Any person who knowingly fails to report the
11 dispensing of a controlled substance listed in Schedule II,
12 Schedule III, or Schedule IV as required by this section
13 commits a misdemeanor of the first degree, punishable as
14 provided in s. 775.082 or s. 775.083.
15 (8) The Department of Health and the regulatory boards
16 for the health care practitioners subject to this section
17 shall adopt rules pursuant to ss. 120.536(1) and 120.54 to
18 administer this section.
19 (9) All costs incurred by the Department of Health in
20 administering the prescription-monitoring system shall be
21 borne by the department, and an amount necessary to cover such
22 costs shall be appropriated annually, subject to the
23 availability of funds, from the Grants and Donations Trust
24 Fund. The Medical Quality Assurance Trust Fund may not be used
25 to administer or otherwise fund this program.
26 Section 4. Section 893.065, Florida Statutes, is
27 created to read:
28 893.065 Counterfeit-resistant prescription blanks for
29 controlled substances listed in Schedules II, III, and
30 IV.--The Department of Health shall develop and adopt by rule
31 the form and content for a counterfeit-resistant prescription
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1 blank which may be used by practitioners to prescribe a
2 controlled substance listed in Schedule II, Schedule III, or
3 Schedule IV. The Department of Health may require the
4 prescription blanks to be printed on distinctive, watermarked
5 paper and to bear the preprinted name, address, and category
6 of professional licensure of the practitioner and that
7 practitioner's federal registry number for controlled
8 substances. The prescription blanks may not be transferred.
9 Section 5. The sum of $2,564,670 in recurring general
10 revenue funds and $1,837,677 in nonrecurring general revenue
11 funds are appropriated to the Department of Health to
12 implement the provisions of this bill. Three additional
13 full-time equivalent positions are authorized for the
14 2006-2007 fiscal year to implement the provisions of ss.
15 893.055 and 893.065, Florida Statutes, as created by this act.
16 Section 6. The penalties created in ss. 831.311(2) and
17 893.055(7), Florida Statutes, by this act shall take effect
18 only upon the adoption by the Department of Health and each
19 applicable professional regulatory board of the rules required
20 pursuant to ss. 893.055(8) and 893.065, Florida Statutes, as
21 created by this act.
22 Section 7. Except as otherwise expressly provided in
23 this act, this act shall take effect July 1, 2006, if Senate
24 Bill 176, or similar legislation, is adopted in the same
25 legislative session or an extension thereof and becomes law.
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1 STATEMENT OF SUBSTANTIAL CHANGES CONTAINED IN
COMMITTEE SUBSTITUTE FOR
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4 Provides that any pharmacist who dispenses by mail a
controlled substance listed in Schedule II, Schedule III, or
5 Schedule IV is exempt from the requirement to obtain suitable
identification for the prescription dispensed by mail provided
6 the pharmacist has patient identification through a
prescription benefit plan.
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Changes the amount of the appropriation and the source of
8 funds from the Grants and Donations Trust Fund to the General
Revenue Fund.
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