January 23, 2019
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Senate Bill 0580

Senate Bill sb0580c1

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    Florida Senate - 2004                            CS for SB 580

    By the Committee on Health, Aging, and Long-Term Care; and
    Senator Fasano




    317-1130-04

  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         Schedules II, III, and IV; requiring the

17         dispensing of such controlled substances to be

18         reported through the system; providing

19         exceptions; providing reporting requirements;

20         providing penalties; requiring the department

21         and regulatory boards to adopt rules; requiring

22         the department to cover all costs for the

23         system; providing for an appropriation, subject

24         to availability of funds; providing that a

25         certain trust fund may not be used to fund the

26         program; creating s. 893.065, F.S.; requiring

27         the 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

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    Florida Senate - 2004                            CS for SB 580
    317-1130-04




 1         Schedule IV; providing an appropriation and

 2         authorizing positions; providing contingent

 3         applicability of penalties; providing

 4         contingent effective 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 the form and content of which are

19  adopted by rule of the Department of Health pursuant to s.

20  893.065.

21         (2)  Any person who violates this section commits a

22  felony of the third degree, punishable as provided in s.

23  775.082, s. 775.083, or s. 775.084.

24         Section 2.  Section 893.04, Florida Statutes, is

25  amended to read:

26         893.04  Pharmacist and practitioner.--

27         (1)  A pharmacist, in good faith and in the course of

28  professional practice only, may dispense controlled substances

29  upon a written or oral prescription of a practitioner, under

30  the following conditions:

31  

                                  2

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    Florida Senate - 2004                            CS for SB 580
    317-1130-04




 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.

                                  3

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    Florida Senate - 2004                            CS for SB 580
    317-1130-04




 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. No

20  prescription for a controlled substance listed in Schedule II

21  may be refilled.

22         (g)  No prescription for a controlled substance listed

23  in Schedule Schedules III, Schedule IV, or Schedule V may be

24  filled or refilled more than five times within a period of 6

25  months after the date on which the prescription was written

26  unless the prescription is renewed by a practitioner.

27         (2)(a)  A pharmacist may not dispense a controlled

28  substance listed in Schedule II, Schedule III, or Schedule IV

29  to any patient or patient's agent without first determining,

30  in the exercise of her or his professional judgment, that the

31  order is valid.  The pharmacist or pharmacist's agent must

                                  4

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    Florida Senate - 2004                            CS for SB 580
    317-1130-04




 1  also obtain the patient or patient's agent identification

 2  information, in writing, electronic format, or other approved

 3  manner prior to dispensing any controlled substance. If the

 4  patient or patient's agent does not have appropriate

 5  identification, the pharmacist may dispense the controlled

 6  substance only when the pharmacist determines, in the exercise

 7  of her or his professional judgment, that the order is valid

 8  and includes such information in the patient's record. The

 9  Board of Pharmacy may adopt, by rule, required patient

10  identification information for controlled substances and

11  procedures for a pharmacist to verify the validity of a

12  prescription for controlled substances for circumstances in

13  which the pharmacist was not provided required identification

14  information.

15         (b)  Any pharmacist that dispenses by mail a controlled

16  substance listed in Schedule II, Schedule III, or Schedule IV

17  shall be exempt from the requirement to obtain suitable

18  identification for the prescription dispensed by mail.

19         (c)  Any controlled substance listed in Schedule III or

20  Schedule IV may be dispensed by a pharmacist upon an oral

21  prescription if, before filling the prescription, the

22  pharmacist reduces it to writing or records the prescription

23  electronically if permitted by federal law. Such prescriptions

24  must contain the date of the oral authorization.

25         (d)  Each written prescription prescribed by a

26  practitioner in this state for a controlled substance listed

27  in Schedule II, Schedule III, or Schedule IV must include both

28  a written and a numerical notation of the quantity on the face

29  of the prescription and a notation of the date with the

30  abbreviated month written out on the face of the prescription.

31  A pharmacist shall be permitted, upon verification by the

                                  5

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    Florida Senate - 2004                            CS for SB 580
    317-1130-04




 1  prescriber, to document any information required by this

 2  paragraph.

 3         (e)  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         (f)  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)  By June 30, 2005, the Department of Health shall

27  design and establish an electronic system consistent with the

28  American Society for Automation in Pharmacy (ASAP) standards

29  to monitor the prescribing and dispensing of controlled

30  substances listed in Schedules II, III, and IV by health care

31  practitioners within the state and the dispensing of such

                                  6

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    Florida Senate - 2004                            CS for SB 580
    317-1130-04




 1  controlled substances to an individual at a specific address

 2  within the state by a pharmacy permitted or registered by the

 3  Board of Pharmacy.

 4         (2)  Any controlled substance listed in Schedule II,

 5  Schedule III, or Schedule IV which is dispensed to an

 6  individual in this state must be reported to the Department of

 7  Health through the system, as soon thereafter as possible but

 8  not more than 35 days after the date the controlled substance

 9  is dispensed, each time the controlled substance is dispensed.

10  A pharmacy may meet the reporting requirements of this section

11  by providing the Department of Health an exchangeable

12  electronic disc or tape of each controlled substance listed in

13  Schedules II, III, and IV which it dispenses.

14         (3)  This section does not apply to controlled

15  substances:

16         (a)  Administered by a health care practitioner

17  directly to a patient.

18         (b)  Dispensed by a health care practitioner authorized

19  to prescribe controlled substances directly to a patient and

20  limited to an amount adequate to treat the patient for a

21  period of no more than 72 hours.

22         (c)  Dispensed by a health care practitioner or a

23  pharmacist to an inpatient of a facility with an institutional

24  pharmacy permit.

25         (d)  Ordered from an institutional pharmacy permitted

26  under s. 465.019 in accordance with the institutional policy

27  for such controlled substances or drugs.

28         (e)  Either dispensed by a pharmacist or administered

29  by a health care practitioner to a patient or resident

30  receiving care from a hospital, nursing home, assisted living

31  facility, home health agency, hospice, or intermediate care

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    Florida Senate - 2004                            CS for SB 580
    317-1130-04




 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 younger 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 may not be material or extraordinary. Costs

14  not considered to be material or extraordinary include, but

15  are not limited to, regular postage, compact discs, 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 1 of Senate Bill 578, 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 must comply with

24  relevant federal and state privacy and security laws. However,

25  any authorized agency receiving such information may maintain

26  it longer than 24 months if the information is pertinent to an

27  ongoing investigation or prosecution.

28         (6)  Any person who knowingly fails to report the

29  dispensing of a controlled substance listed in Schedule II,

30  Schedule III, or Schedule IV as required by this section

31  

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    Florida Senate - 2004                            CS for SB 580
    317-1130-04




 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, subject

10  to the availability of funds, from the Grants and Donations

11  Trust Fund an amount necessary to cover such costs. The

12  Medical Quality Assurance Trust Fund may not be used to

13  implement or otherwise fund this program.

14         Section 4.  Section 893.065, Florida Statutes, is

15  created to read:

16         893.065  Counterfeit-resistant prescription blanks for

17  controlled substances listed in Schedules II, III, and

18  IV.--The Department of Health shall develop and adopt by rule

19  the form and content for a counterfeit-resistant prescription

20  blank which may be used by practitioners to prescribe a

21  controlled substance listed in Schedule II, Schedule III, or

22  Schedule IV. The Department of Health may require the

23  prescription blanks to be printed on distinctive, watermarked

24  paper and to bear the preprinted name, address, and category

25  of professional licensure of the practitioner and that

26  practitioner's federal registry number for controlled

27  substances. The prescription blanks may not be transferred.

28         Section 5.  There is appropriated $2,196,352 from the

29  Grants and Donations Trust Fund to the Department of Health,

30  and three full-time equivalent positions are authorized for

31  

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    Florida Senate - 2004                            CS for SB 580
    317-1130-04




 1  fiscal year 2004-2005 to implement the provisions of sections

 2  893.055 and 893.065, Florida Statutes, as created by this act.

 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, 2005, if Senate

11  Bill 578, 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 580

16                                 

17  The committee substitute conforms criminal provisions relating
    to the sale, manufacturing, altering, delivery, uttering, or
18  possession of any counterfeit-resistant prescription blanks to
    the rulemaking authority already granted to the Department of
19  Health to specify the form and content of such blanks. A
    reference to the public records bill which is a companion to
20  the committee substitute is corrected.

21  

22  

23  

24  

25  

26  

27  

28  

29  

30  

31  

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