Senate Bill sb2390
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Florida Senate - 2003 SB 2390
By Senator Fasano
11-393-03 See HB 989
1 A bill to be entitled
2 An act relating to controlled substances;
3 amending s. 893.04, F.S.; providing additional
4 requirements for the dispensing of a controlled
5 substance listed in Schedule II, Schedule III,
6 or Schedule IV; providing rulemaking authority
7 to the Board of Pharmacy; creating s. 893.055,
8 F.S.; requiring the Department of Health to
9 establish an electronic system to monitor the
10 prescribing of controlled substances listed in
11 Schedules II, III, and IV; requiring the
12 dispensing of such controlled substances to be
13 reported through the system; providing
14 exceptions; providing reporting requirements;
15 providing penalties; providing rulemaking
16 authority to the department; requiring the
17 department to cover all costs for the system;
18 providing a continuing appropriation; creating
19 s. 893.065, F.S.; requiring the department to
20 develop and adopt by rule the form and content
21 for a counterfeit-proof prescription blank for
22 voluntary use by physicians in prescribing a
23 controlled substance listed in Schedule II,
24 Schedule III, or Schedule IV; providing an
25 appropriation; providing effective dates.
26
27 Be It Enacted by the Legislature of the State of Florida:
28
29 Section 1. Section 893.04, Florida Statutes, is
30 amended to read:
31 893.04 Pharmacist and practitioner.--
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Florida Senate - 2003 SB 2390
11-393-03 See HB 989
1 (1) A pharmacist, in good faith and in the course of
2 professional practice only, may dispense controlled substances
3 upon a written or oral prescription of a practitioner, under
4 the following conditions:
5 (a) Oral prescriptions must be promptly reduced to
6 writing by the pharmacist.
7 (b) The written prescription must be dated and signed
8 by the prescribing practitioner on the day when issued.
9 (c) There shall appear on the face of the prescription
10 or written record thereof for the controlled substance the
11 following information:
12 1. The full name and address of the person for whom,
13 or the owner of the animal for which, the controlled substance
14 is dispensed.
15 2. The full name and address of the prescribing
16 practitioner and the practitioner's federal controlled
17 substance registry number shall be printed thereon.
18 3. If the prescription is for an animal, the species
19 of animal for which the controlled substance is prescribed.
20 4. The name of the controlled substance prescribed and
21 the strength, quantity, and directions for use thereof.
22 5. The number of the prescription, as recorded in the
23 prescription files of the pharmacy in which it is filled.
24 6. The initials of the pharmacist filling the
25 prescription and the date filled.
26 (d) The prescription shall be retained on file by the
27 proprietor of the pharmacy in which it is filled for a period
28 of 2 years.
29 (e) Affixed to the original container in which a
30 controlled substance is delivered upon a prescription or
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Florida Senate - 2003 SB 2390
11-393-03 See HB 989
1 authorized refill thereof, as hereinafter provided, there
2 shall be a label bearing the following information:
3 1. The name and address of the pharmacy from which
4 such controlled substance was dispensed.
5 2. The date on which the prescription for such
6 controlled substance was filled.
7 3. The number of such prescription, as recorded in the
8 prescription files of the pharmacy in which it is filled.
9 4. The name of the prescribing practitioner.
10 5. The name of the patient for whom, or of the owner
11 and species of the animal for which, the controlled substance
12 is prescribed.
13 6. The directions for the use of the controlled
14 substance prescribed in the prescription.
15 7. A clear, concise warning that it is a crime to
16 transfer the controlled substance to any person other than the
17 patient for whom prescribed.
18 (f) A prescription for a controlled substance listed
19 in Schedule II may be dispensed only upon a written
20 prescription of a practitioner, except that in an emergency
21 situation, as defined by regulation of the Department of
22 Health, such controlled substance may be dispensed upon oral
23 prescription but shall be limited to a 48-hour supply. No
24 prescription for a controlled substance listed in Schedule II
25 may be refilled.
26 (g) No prescription for a controlled substance listed
27 in Schedule Schedules III, Schedule IV, or Schedule V may be
28 filled or refilled more than five times within a period of 6
29 months after the date on which the prescription was written
30 unless the prescription is renewed by a practitioner.
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Florida Senate - 2003 SB 2390
11-393-03 See HB 989
1 (2)(a) A pharmacist may not dispense a controlled
2 substance listed in Schedule II, Schedule III, or Schedule IV
3 to any individual without first obtaining suitable
4 identification and documenting, in a log book kept by the
5 pharmacist, the identity of the individual obtaining the
6 controlled substance. The log book entry shall contain the
7 printed name, address, phone number (if available), driver's
8 license number or other suitable identification number, and
9 signature of the person obtaining the controlled substance. If
10 the individual does not have suitable identification or it is
11 impracticable to obtain such identification, the pharmacist
12 may dispense the controlled substance only when the pharmacist
13 determines, in the exercise of her or his professional
14 judgment, that the order is valid. In such case, the
15 pharmacist or his or her designee must obtain the other
16 information required by this paragraph and must sign the log
17 book to indicate that suitable identification was not
18 available and that the pharmacist's professional judgment was
19 exercised prior to dispensing the controlled substance. The
20 Board of Pharmacy may adopt, by rule, procedures by which a
21 pharmacist may verify the validity of a prescription for a
22 controlled substance listed in Schedule II, Schedule III, or
23 Schedule IV for circumstances when it is otherwise
24 impracticable for the pharmacist to obtain suitable
25 identification from the patient or the patient's agent. For
26 purposes of this paragraph, identification is suitable only if
27 it contains the photograph, printed name, and signature of the
28 individual obtaining the controlled substance.
29 (b) Any pharmacist that dispenses by mail a controlled
30 substance listed in Schedule II, Schedule III, or Schedule IV
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Florida Senate - 2003 SB 2390
11-393-03 See HB 989
1 shall be exempt from the requirement to obtain suitable
2 identification.
3 (c) Any controlled substance listed in Schedule III or
4 Schedule IV may be dispensed by a pharmacist upon an oral
5 prescription if, before filling the prescription, the
6 pharmacist reduces it to writing. Such prescriptions must
7 contain the date of the oral authorization.
8 (d) All prescriptions issued for a controlled
9 substance listed in Schedule II, Schedule III, or Schedule IV
10 must include both a written and numerical notation of the date
11 and quantity on the face of the prescription.
12 (e) A pharmacist may not dispense more than a 30-day
13 supply of a controlled substance listed in Schedule III upon
14 an oral prescription.
15 (f) A pharmacist may not knowingly fill a prescription
16 that has been mutilated or forged for a controlled substance
17 listed in Schedule II, Schedule III, or Schedule IV.
18 (3)(2) Notwithstanding the provisions of subsection
19 (1), a pharmacist may dispense a one-time emergency refill of
20 up to a 72-hour supply of the prescribed medication for any
21 medicinal drug other than a medicinal drug listed in Schedule
22 II, in compliance with the provisions of s. 465.0275.
23 (4)(3) The legal owner of any stock of controlled
24 substances in a pharmacy, upon discontinuance of dealing in
25 controlled substances, may sell said stock to a manufacturer,
26 wholesaler, or pharmacy. Such controlled substances may be
27 sold only upon an order form, when such an order form is
28 required for sale by the drug abuse laws of the United States
29 or this state, or regulations pursuant thereto.
30 Section 2. Section 893.055, Florida Statutes, is
31 created to read:
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Florida Senate - 2003 SB 2390
11-393-03 See HB 989
1 893.055 Electronic monitoring system for prescription
2 of controlled substances listed in Schedules II, III, and
3 IV.--
4 (1) By January 1, 2004, the Department of Health shall
5 design and establish an electronic system to monitor the
6 prescribing of controlled substances listed in Schedules II,
7 III, and IV by health care practitioners within the state or
8 the dispensing of such controlled substances to an address
9 within the state by a pharmacy permitted or registered by the
10 Board of Pharmacy.
11 (2) Any controlled substance listed in Schedule II,
12 Schedule III, or Schedule IV that is dispensed in this state
13 must be reported to the Department of Health through the
14 system, as soon thereafter as possible but not more than 30
15 days after the date the controlled substance is dispensed,
16 each time the controlled substance is dispensed.
17 (3) This section does not apply to controlled
18 substances that are:
19 (a) Administered by a health care practitioner
20 directly to a patient.
21 (b) Dispensed by a health care practitioner to a
22 patient and limited to an amount adequate to treat the patient
23 for a period of no more than 48 hours.
24 (c) Dispensed by a health care practitioner to an
25 in-patient of a facility with an institutional pharmacy
26 permit.
27 (d) Prescribed by a health care practitioner for a
28 patient less than 16 years of age.
29 (e) Ordered from an institutional pharmacy licensed
30 under s. 465.019(2), Florida Statutes, in accordance with the
31 institutional policy for such controlled substances or drugs.
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Florida Senate - 2003 SB 2390
11-393-03 See HB 989
1 (f) Administered by a health care practitioner to a
2 patient or resident receiving care from a hospital, nursing
3 home, assisted living facility, home health agency, hospice,
4 or intermediate care facility for the developmentally disabled
5 which is licensed in this state.
6 (4) The data required to be reported under this
7 section shall be determined by the Department of Health by
8 rule but may include any data required under s. 893.04 and
9 must include the category of professional licensure of the
10 prescribing practitioner.
11 (5) A dispenser must transmit the information required
12 by this section in an electronic format approved by rule of
13 the Board of Pharmacy after consultation with the Department
14 of Health, unless a specific waiver is granted to that
15 dispenser by the Department of Health. The information
16 transmitted to the Department of Health under this section may
17 be transmitted to any agency authorized to receive it, and
18 that agency may maintain the information received for up to 12
19 months before purging it from its records. Notwithstanding the
20 foregoing, any authorized agency receiving such information
21 may maintain it longer than 12 months if the information is
22 pertinent to an ongoing investigation arising under this
23 section.
24 (6) Any person who willfully fails to report the
25 dispensing of a controlled substance listed in Schedule II,
26 Schedule III, or Schedule IV as required by this section
27 commits a misdemeanor of the first degree, punishable as
28 provided in s. 775.082 or s. 775.083.
29 (7) The Department of Health shall adopt rules
30 pursuant to ss. 120.536(1) and 120.54 necessary to implement
31 and administer this section.
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Florida Senate - 2003 SB 2390
11-393-03 See HB 989
1 (8) The Department of Health must cover all costs for
2 the prescription monitoring system, and there is appropriated
3 annually out of the General Revenue Fund, to be paid to the
4 Administrative Trust Fund of the department, an amount
5 necessary to cover such costs.
6 Section 3. Section 893.065, Florida Statutes, is
7 created to read:
8 893.065 Counterfeit-resistant prescription blanks for
9 controlled substances listed in Schedules II, III, and
10 IV.--The Department of Health shall develop and adopt by rule
11 the form and content for a counterfeit-proof prescription
12 blank which may be used by practitioners to prescribe a
13 controlled substance listed in Schedule II, Schedule III, or
14 Schedule IV. The Department of Health may require the
15 prescription blanks to be printed on distinctive, watermarked
16 paper and to bear the preprinted name, address, and category
17 of professional licensure of the practitioner and that
18 practitioner's federal registry number for controlled
19 substances. The prescription blanks may not be transferred.
20 Section 4. There is appropriated from the General
21 Revenue Fund to the Administrative Trust Fund of the
22 Department of Health an amount sufficient to cover the costs
23 for fiscal year 2003-2004 of implementing the provisions of
24 section 893.055, Florida Statutes, as created by this act.
25 This section shall take effect July 1, 2003.
26 Section 5. This act shall take effect January 1, 2004,
27 except that section 2 of this act shall take effect on the
28 same date that SB ___ or similar legislation takes effect, if
29 such legislation is enacted in the same legislative session or
30 an extension thereof.
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