Senate Bill sb0178c1
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Florida Senate - 2006 CS for SB 178
By the Committee on 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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Florida Senate - 2006 CS for SB 178
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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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Florida Senate - 2006 CS for SB 178
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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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Florida Senate - 2006 CS for SB 178
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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 controlled substance listed in Schedule III or
21 Schedule IV may be dispensed by a pharmacist upon an oral
22 prescription if, before filling the prescription, the
23 pharmacist reduces it to writing or records the prescription
24 electronically if permitted by federal law. Such prescriptions
25 must contain the date of the oral authorization.
26 (c) Each written prescription prescribed by a
27 practitioner in this state for a controlled substance listed
28 in Schedule II, Schedule III, or Schedule IV must include both
29 a written and a numerical notation of the quantity on the face
30 of the prescription and a notation of the date, with the
31 abbreviated month written out on the face of the prescription.
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1 A pharmacist may, upon verification by the prescriber,
2 document any information required by this paragraph.
3 (d) A pharmacist may not dispense more than a 30-day
4 supply of a controlled substance listed in Schedule III upon
5 an oral prescription issued in this state.
6 (e) A pharmacist may not knowingly fill a prescription
7 that has been forged for a controlled substance listed in
8 Schedule II, Schedule III, or Schedule IV.
9 (3)(2) Notwithstanding the provisions of subsection
10 (1), a pharmacist may dispense a one-time emergency refill of
11 up to a 72-hour supply of the prescribed medication for any
12 medicinal drug other than a medicinal drug listed in Schedule
13 II, in compliance with the provisions of s. 465.0275.
14 (4)(3) The legal owner of any stock of controlled
15 substances in a pharmacy, upon discontinuance of dealing in
16 controlled substances, may sell said stock to a manufacturer,
17 wholesaler, or pharmacy. Such controlled substances may be
18 sold only upon an order form, when such an order form is
19 required for sale by the drug abuse laws of the United States
20 or this state, or regulations pursuant thereto.
21 Section 3. Section 893.055, Florida Statutes, is
22 created to read:
23 893.055 Electronic-monitoring system for prescription
24 of controlled substances listed in Schedules II, III, and
25 IV.--
26 (1) As used in this section, the term "pharmacy" means
27 any pharmacy subject to licensure or regulation by the
28 Department of Health pursuant to chapter 465 which dispenses
29 or delivers a controlled substance included on Schedule II,
30 Schedule III, or Schedule IV to a patient in this state.
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1 (2) By June 30, 2007, the Department of Health shall
2 design and establish an electronic system consistent with
3 standards of the American Society for Automation in Pharmacy
4 to monitor the prescribing and dispensing of controlled
5 substances listed in Schedules II, III, and IV by health care
6 practitioners within the state and the dispensing of such
7 controlled substances to an individual at a specific address
8 within the state by a pharmacy permitted or registered by the
9 Board of Pharmacy.
10 (3) Any controlled substance listed in Schedule II,
11 Schedule III, or Schedule IV which is dispensed to an
12 individual in this state must be reported to the Department of
13 Health through the system as soon thereafter as possible, but
14 not more than 35 days after the date the controlled substance
15 is dispensed, each time the controlled substance is dispensed.
16 A pharmacy or dispensing practitioner may meet the reporting
17 requirements of this section by providing to the Department of
18 Health in written or any electronic or magnetic format,
19 including, but not limited to, electronic submission via the
20 Internet or magnetic disc or tape, each controlled substance
21 listed in Schedule II, Schedule III, or Schedule IV which it
22 dispenses.
23 (4) This section does not apply to controlled
24 substances:
25 (a) Administered by a health care practitioner
26 directly to a patient.
27 (b) Dispensed by a health care practitioner authorized
28 to prescribe controlled substances directly to a patient and
29 limited to an amount adequate to treat the patient for a
30 period of no more than 72 hours.
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1 (c) Dispensed by a health care practitioner or a
2 pharmacist to an inpatient of a facility that holds an
3 institutional pharmacy permit.
4 (d) Ordered from an institutional pharmacy permitted
5 under s. 465.019 in accordance with the institutional policy
6 for such controlled substances or drugs.
7 (e) Dispensed by a pharmacist or administered by a
8 health care practitioner to a patient or resident receiving
9 care from a hospital, nursing home, assisted living facility,
10 home health agency, hospice, or intermediate care facility for
11 the developmentally disabled which is licensed in this state.
12 (f) Prescribed by a health care practitioner for a
13 patient younger than 16 years of age.
14 (5) The data required to be reported under this
15 section shall be determined by the Department of Health by
16 rule but may include any data required under s. 893.04.
17 (6) A practitioner or pharmacist who dispenses a
18 controlled substance under this section must submit the
19 information required by this section in an electronic or other
20 format approved by rule of the Department of Health. The cost
21 to the dispenser in submitting the information required by
22 this section may not be material or extraordinary. Costs not
23 considered to be material or extraordinary include, but are
24 not limited to, regular postage, compact discs, zip-drive
25 storage, regular electronic mail, magnetic tapes, diskettes,
26 and facsimile charges. The information submitted to the
27 Department of Health under this section may be transmitted to
28 any person or agency authorized to receive it pursuant to
29 section 1 of Senate Bill 176, or similar legislation, and that
30 person or agency may maintain the information received for up
31 to 24 months before purging the information from its records.
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1 All transmissions required by this subsection must comply with
2 relevant federal and state privacy and security laws. However,
3 any authorized agency receiving such information may maintain
4 it for longer than 24 months if the information is pertinent
5 to an ongoing investigation or prosecution.
6 (7) Any person who knowingly fails to report the
7 dispensing of a controlled substance listed in Schedule II,
8 Schedule III, or Schedule IV as required by this section
9 commits a misdemeanor of the first degree, punishable as
10 provided in s. 775.082 or s. 775.083.
11 (8) The Department of Health and the regulatory boards
12 for the health care practitioners subject to this section
13 shall adopt rules pursuant to ss. 120.536(1) and 120.54 to
14 administer this section.
15 (9) All costs incurred by the Department of Health in
16 administering the prescription-monitoring system shall be
17 borne by the department, and an amount necessary to cover such
18 costs shall be appropriated annually, subject to the
19 availability of funds, from the Grants and Donations Trust
20 Fund. The Medical Quality Assurance Trust Fund may not be used
21 to administer or otherwise fund this program.
22 Section 4. Section 893.065, Florida Statutes, is
23 created to read:
24 893.065 Counterfeit-resistant prescription blanks for
25 controlled substances listed in Schedules II, III, and
26 IV.--The Department of Health shall develop and adopt by rule
27 the form and content for a counterfeit-resistant prescription
28 blank which may be used by practitioners to prescribe a
29 controlled substance listed in Schedule II, Schedule III, or
30 Schedule IV. The Department of Health may require the
31 prescription blanks to be printed on distinctive, watermarked
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1 paper and to bear the preprinted name, address, and category
2 of professional licensure of the practitioner and that
3 practitioner's federal registry number for controlled
4 substances. The prescription blanks may not be transferred.
5 Section 5. The sum of $2,196,352 is appropriated from
6 the Grants and Donations Trust Fund to the Department of
7 Health, and three additional full-time equivalent positions
8 are authorized for the 2006-2007 fiscal year to implement the
9 provisions of ss. 893.055 and 893.065, Florida Statutes, as
10 created by this act.
11 Section 6. The penalties created in ss. 831.311(2) and
12 893.055(6), Florida Statutes, by this act shall take effect
13 only upon the adoption by the Department of Health and each
14 applicable professional regulatory board of the rules required
15 pursuant to ss. 893.055(7) and 893.065, Florida Statutes, as
16 created by this act.
17 Section 7. Except as otherwise expressly provided in
18 this act, this act shall take effect July 1, 2006, if Senate
19 Bill 176, or similar legislation, is adopted in the same
20 legislative session or an extension thereof and becomes law.
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1 STATEMENT OF SUBSTANTIAL CHANGES CONTAINED IN
COMMITTEE SUBSTITUTE FOR
2 Senate Bill 178
3
4 - Provides that the pharmacist or pharmacist's agent shall
obtain a government-issued or other form of documentary
5 identification substantiating the identity of a patient
or patient's agent prior to dispensing any Schedule II,
6 Schedule III, or Schedule IV controlled substance to such
patient or patient's agent. The pharmacist or
7 pharmacist's agent shall make a record of the type of
documentary identification provided by the patient or
8 patient's agent.
9 - Provides a definition of "pharmacy" in s. 893.055, F.S.,
which is created by the bill and which creates an
10 electronic monitoring system for prescription of
controlled substances in Schedules II, III, and IV.
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- Provides that a pharmacy or dispensing practitioner may
12 meet the reporting requirements of the bill by providing
to the Department of Health in written or any electronic
13 or magnetic format, including but not limited to,
electronic submission via the Internet or magnetic disc
14 or tape of each controlled substance listed in Schedule
II, Schedule III, or Schedule IV which it dispenses.
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- Inserts reference to SB 176, which is tied to SB 178 and
16 which makes confidential and exempt from public
disclosure identifying information of a patient,
17 patient's agent, health care practitioner, pharmacist's
agent, or pharmacy, which is contained in records held by
18 the Department of Health or other specified agencies in
an electronic-monitoring system for prescription of
19 controlled substances.
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