Senate Bill sb0518
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Florida Senate - 2007 SB 518
By Senator Saunders
37-60-07
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; specifying
13 circumstances under which a pharmacist who
14 dispenses controlled substances by mail is
15 exempt from certain requirements governing
16 patient identification; providing requirements
17 and limitations for dispensing controlled
18 substances upon an oral prescription; creating
19 s. 893.055, F.S.; providing a definition;
20 requiring the Department of Health to establish
21 an electronic system to monitor the prescribing
22 of controlled substances listed in Schedule II,
23 Schedule III, or Schedule IV; requiring the
24 dispensing of such controlled substances to be
25 reported through the system; providing
26 exceptions; providing reporting requirements;
27 providing penalties; requiring that the
28 department and regulatory boards adopt rules;
29 requiring the department to cover all costs for
30 the system; providing for annual
31 appropriations, subject to availability of
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1 funds; prohibiting using funds from the Medical
2 Quality Assurance Trust Fund to administer the
3 program; creating s. 893.065, F.S.; requiring
4 the department to develop and adopt by rule the
5 form and content for a counterfeit-proof
6 prescription blank for voluntary use by
7 physicians in prescribing a controlled
8 substance listed in Schedule II, Schedule III,
9 or Schedule IV; providing an appropriation and
10 authorizing additional positions; providing for
11 the contingent applicability of penalties;
12 providing contingent effective dates.
13
14 Be It Enacted by the Legislature of the State of Florida:
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16 Section 1. Section 831.311, Florida Statutes, is
17 created to read:
18 831.311 Unlawful sale, manufacture, alteration,
19 delivery, uttering, or possession of counterfeit-resistant
20 prescription blanks for controlled substances listed in
21 Schedules II, III, and IV.--
22 (1) It is unlawful for any person having the intent to
23 injure or defraud any person or to facilitate any violation of
24 s. 893.13 to sell, manufacture, alter, deliver, utter, or
25 possess any counterfeit-resistant prescription blanks for
26 controlled substances, the form and content of which are
27 adopted by rule of the Department of Health pursuant to s.
28 893.065.
29 (2) Any person who violates this section commits a
30 felony of the third degree, punishable as provided in s.
31 775.082, s. 775.083, or s. 775.084.
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Florida Senate - 2007 SB 518
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1 Section 2. Section 893.04, Florida Statutes, is
2 amended to read:
3 893.04 Pharmacist and practitioner.--
4 (1) A pharmacist, in good faith and in the course of
5 professional practice only, may dispense controlled substances
6 upon a written or oral prescription of a practitioner, under
7 the following conditions:
8 (a) Oral prescriptions must be promptly reduced to
9 writing by the pharmacist or recorded electronically if
10 permitted by federal law.
11 (b) The written prescription must be dated and signed
12 by the prescribing practitioner on the day when issued.
13 (c) There shall appear on the face of the prescription
14 or written record thereof for the controlled substance the
15 following information:
16 1. The full name and address of the person for whom,
17 or the owner of the animal for which, the controlled substance
18 is dispensed.
19 2. The full name and address of the prescribing
20 practitioner and the practitioner's federal controlled
21 substance registry number shall be printed thereon.
22 3. If the prescription is for an animal, the species
23 of animal for which the controlled substance is prescribed.
24 4. The name of the controlled substance prescribed and
25 the strength, quantity, and directions for use thereof.
26 5. The number of the prescription, as recorded in the
27 prescription files of the pharmacy in which it is filled.
28 6. The initials of the pharmacist filling the
29 prescription and the date filled.
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Florida Senate - 2007 SB 518
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1 (d) The prescription shall be retained on file by the
2 proprietor of the pharmacy in which it is filled for a period
3 of 2 years.
4 (e) Affixed to the original container in which a
5 controlled substance is delivered upon a prescription or
6 authorized refill thereof, as hereinafter provided, there
7 shall be a label bearing the following information:
8 1. The name and address of the pharmacy from which
9 such controlled substance was dispensed.
10 2. The date on which the prescription for such
11 controlled substance was filled.
12 3. The number of such prescription, as recorded in the
13 prescription files of the pharmacy in which it is filled.
14 4. The name of the prescribing practitioner.
15 5. The name of the patient for whom, or of the owner
16 and species of the animal for which, the controlled substance
17 is prescribed.
18 6. The directions for the use of the controlled
19 substance prescribed in the prescription.
20 7. A clear, concise warning that it is a crime to
21 transfer the controlled substance to any person other than the
22 patient for whom prescribed.
23 (f) A prescription for a controlled substance listed
24 in Schedule II may be dispensed only upon a written
25 prescription of a practitioner, except that in an emergency
26 situation, as defined by regulation of the Department of
27 Health, such controlled substance may be dispensed upon oral
28 prescription but is limited to a 72-hour supply. A No
29 prescription for a controlled substance listed in Schedule II
30 may not be refilled.
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1 (g) A No prescription for a controlled substance
2 listed in Schedule Schedules III, Schedule IV, or Schedule V
3 may not be filled or refilled more than five times within a
4 period of 6 months after the date on which the prescription
5 was written unless the prescription is renewed by a
6 practitioner.
7 (2)(a) A pharmacist may not dispense a controlled
8 substance listed in Schedule II, Schedule III, or Schedule IV
9 to any patient or patient's agent without first determining,
10 in the exercise of her or his professional judgment, that the
11 order is valid. The pharmacist or pharmacist's agent shall
12 obtain a government-issued identification card or other form
13 of documentary identification substantiating the identity of a
14 patient or patient's agent before dispensing to such patient
15 or patient's agent any controlled substance listed in Schedule
16 II, Schedule III, or Schedule IV. The pharmacist or
17 pharmacist's agent shall make a record of the type of
18 documentary identification provided by the patient or
19 patient's agent. If the patient or patient's agent does not
20 have appropriate identification, the pharmacist may dispense
21 the controlled substance only when the pharmacist determines,
22 in the exercise of her or his professional judgment, that the
23 order is valid and includes such information in the patient's
24 record. The Board of Pharmacy may adopt, by rule, the
25 patient-identification information required for dispensing
26 controlled substances and procedures by which a pharmacist may
27 verify the validity of a prescription for controlled
28 substances in circumstances in which the required
29 identification information is not provided to the pharmacist.
30 (b) Any pharmacist who dispenses by mail a controlled
31 substance listed in Schedule II, Schedule III, or Schedule IV
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1 is exempt from the requirement to obtain suitable
2 identification for the prescription dispensed by mail if the
3 pharmacist has obtained the patient's identification through
4 the patient's prescription benefit plan.
5 (c) Any controlled substance listed in Schedule III or
6 Schedule IV may be dispensed by a pharmacist upon an oral
7 prescription if, before filling the prescription, the
8 pharmacist reduces it to writing or records the prescription
9 electronically if permitted by federal law. Such prescriptions
10 must contain the date of the oral authorization.
11 (d) Each written prescription prescribed by a
12 practitioner in this state for a controlled substance listed
13 in Schedule II, Schedule III, or Schedule IV must include both
14 a written and a numerical notation of the quantity on the face
15 of the prescription and a notation of the date, with the
16 abbreviated month written out on the face of the prescription.
17 A pharmacist may, upon verification by the prescriber,
18 document any information required by this paragraph.
19 (e) A pharmacist may not dispense more than a 30-day
20 supply of a controlled substance listed in Schedule III upon
21 an oral prescription issued in this state.
22 (f) A pharmacist may not knowingly fill a prescription
23 that has been forged for a controlled substance listed in
24 Schedule II, Schedule III, or Schedule IV.
25 (3)(2) Notwithstanding the provisions of subsection
26 (1), a pharmacist may dispense a one-time emergency refill of
27 up to a 72-hour supply of the prescribed medication for any
28 medicinal drug other than a medicinal drug listed in Schedule
29 II, in compliance with the provisions of s. 465.0275.
30 (4)(3) The legal owner of any stock of controlled
31 substances in a pharmacy, upon discontinuance of dealing in
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1 controlled substances, may sell said stock to a manufacturer,
2 wholesaler, or pharmacy. Such controlled substances may be
3 sold only upon an order form, when such an order form is
4 required for sale by the drug abuse laws of the United States
5 or this state, or regulations pursuant thereto.
6 Section 3. Section 893.055, Florida Statutes, is
7 created to read:
8 893.055 Electronic-monitoring system for prescription
9 of controlled substances listed in Schedule II, Schedule III,
10 or Schedule IV.--
11 (1) As used in this section, the term "pharmacy" means
12 any pharmacy subject to licensure or regulation by the
13 Department of Health pursuant to chapter 465 which dispenses
14 or delivers a controlled substance included on Schedule II,
15 Schedule III, or Schedule IV to a patient in this state.
16 (2) By June 30, 2008, the Department of Health shall
17 design and establish an electronic system consistent with
18 standards of the American Society for Automation in Pharmacy
19 to monitor the prescribing and dispensing of controlled
20 substances listed in Schedule II, Schedule III, or Schedule IV
21 by health care practitioners within the state and the
22 dispensing of such controlled substances to an individual at a
23 specific address within the state by a pharmacy permitted or
24 registered by the Board of Pharmacy.
25 (3) Each time a controlled substance listed in
26 Schedule II, Schedule III, or Schedule IV is dispensed to an
27 individual in this state, the controlled substance must be
28 reported to the Department of Health through the system as
29 soon thereafter as possible, but not more than 35 days after
30 the date the controlled substance is dispensed. A pharmacy or
31 dispensing practitioner may meet the reporting requirements of
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1 this section by providing to the Department of Health in
2 written or any electronic or magnetic format, including, but
3 not limited to, electronic submission via the Internet or
4 magnetic disc or tape, each controlled substance listed in
5 Schedule II, Schedule III, or Schedule IV which it dispenses.
6 (4) This section does not apply to controlled
7 substances:
8 (a) Administered by a health care practitioner
9 directly to a patient.
10 (b) Dispensed by a health care practitioner authorized
11 to prescribe controlled substances directly to a patient and
12 limited to an amount adequate to treat the patient for a
13 period of not more than 72 hours.
14 (c) Dispensed by a health care practitioner or a
15 pharmacist to an inpatient of a facility that holds an
16 institutional pharmacy permit.
17 (d) Ordered from an institutional pharmacy permitted
18 under s. 465.019 in accordance with the institutional policy
19 for such controlled substances or drugs.
20 (e) Dispensed by a pharmacist or administered by a
21 health care practitioner to a patient or resident receiving
22 care from a hospital, nursing home, assisted living facility,
23 home health agency, hospice, or intermediate care facility for
24 the developmentally disabled which is licensed in this state.
25 (f) Prescribed by a health care practitioner for a
26 patient younger than 16 years of age.
27 (5) The data required to be reported under this
28 section shall be determined by the Department of Health by
29 rule but may include any data required under s. 893.04.
30 (6) A practitioner or pharmacist who dispenses a
31 controlled substance under this section must submit the
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1 information required by this section in an electronic or other
2 format approved by rule of the Department of Health. The cost
3 to the dispenser in submitting the information required by
4 this section may not be material or extraordinary. Costs not
5 considered to be material or extraordinary include, but are
6 not limited to, regular postage, compact discs, zip-drive
7 storage, regular electronic mail, magnetic tapes, diskettes,
8 and facsimile charges. The information submitted to the
9 Department of Health under this section may be transmitted to
10 any person or agency authorized to receive it pursuant to
11 section 1 of Senate Bill ____, or similar legislation, and
12 that person or agency may maintain the information received
13 for up to 24 months before purging the information from its
14 records. All transmissions required by this subsection must
15 comply with relevant privacy and security laws of the state
16 and Federal Government. However, any authorized agency
17 receiving such information may maintain it for longer than 24
18 months if the information is pertinent to an ongoing
19 investigation or prosecution.
20 (7) Any person who knowingly fails to report the
21 dispensing of a controlled substance listed in Schedule II,
22 Schedule III, or Schedule IV as required by this section
23 commits a misdemeanor of the first degree, punishable as
24 provided in s. 775.082 or s. 775.083.
25 (8) The Department of Health and the regulatory boards
26 for the health care practitioners subject to this section
27 shall adopt rules pursuant to ss. 120.536(1) and 120.54 to
28 administer this section.
29 (9) All costs incurred by the Department of Health in
30 administering the prescription-monitoring system shall be
31 borne by the department, and an amount necessary to cover such
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1 costs shall be appropriated annually, subject to the
2 availability of funds, from the Grants and Donations Trust
3 Fund. The Medical Quality Assurance Trust Fund may not be used
4 to administer or otherwise fund this program.
5 Section 4. Section 893.065, Florida Statutes, is
6 created to read:
7 893.065 Counterfeit-resistant prescription blanks for
8 controlled substances listed in Schedule II, Schedule III, or
9 Schedule IV.--The Department of Health shall develop and adopt
10 by rule the form and content for a counterfeit-resistant
11 prescription blank which may be used by practitioners for the
12 purpose of prescribing a controlled substance listed in
13 Schedule II, Schedule III, or Schedule IV. The Department of
14 Health may require the prescription blanks to be printed on
15 distinctive, watermarked paper and to bear the preprinted
16 name, address, and category of professional licensure of the
17 practitioner and that practitioner's federal registry number
18 for controlled substances. The prescription blanks may not be
19 transferred.
20 Section 5. The sum of $2,564,670 in recurring general
21 revenue funds and $1,837,677 in nonrecurring general revenue
22 funds are appropriated to the Department of Health to
23 implement the provisions of this bill. Three additional
24 full-time equivalent positions are authorized for the
25 2007-2008 fiscal year to implement the provisions of ss.
26 893.055 and 893.065, Florida Statutes, as created by this act.
27 Section 6. The penalties created in ss. 831.311(2) and
28 893.055(7), Florida Statutes, by this act shall take effect
29 only upon the adoption by the Department of Health and each
30 applicable professional regulatory board of the rules required
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1 pursuant to ss. 893.055(8) and 893.065, Florida Statutes, as
2 created by this act.
3 Section 7. Except as otherwise expressly provided in
4 this act, this act shall take effect July 1, 2007, if Senate
5 Bill ____, or similar legislation, is adopted in the same
6 legislative session or an extension thereof and becomes law.
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9 SENATE SUMMARY
10 Prohibits the sale, manufacture, alteration, delivery,
uttering, or possession of counterfeit-resistant
11 prescription blanks for controlled substances. Provides
additional requirements for the dispensing of a
12 controlled substance listed in Schedule II, Schedule III,
or Schedule IV. Requires the Department of Health to
13 establish an electronic system to monitor the prescribing
of controlled substances listed in Schedule II, Schedule
14 III, or Schedule IV. Requires the dispensing of such
controlled substances to be reported through the system.
15 Requires that the department and regulatory boards adopt
rules. Requires the department to cover all costs for the
16 system. Prohibits using funds from the Medical Quality
Assurance Trust Fund to administer the program. Requires
17 the department to develop and adopt by rule the form and
content for a counterfeit-proof prescription blank for
18 voluntary use by physicians in prescribing a controlled
substance listed in Schedule II, Schedule III, or
19 Schedule IV.
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