Senate Bill sb1294c2

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    Florida Senate - 2004                    CS for CS for SB 1294

    By the Committees on Criminal Justice; Health, Aging, and
    Long-Term Care; and Senators Fasano, Peaden and Aronberg




    307-2129-04

  1                      A bill to be entitled

  2         An act relating to the Florida Pharmacy Act;

  3         amending s. 465.003, F.S.; defining the term

  4         "automated pharmacy system" for purposes of the

  5         Florida Pharmacy Act; amending s. 465.015,

  6         F.S.; providing that it is unlawful for a

  7         person, firm, or corporation that is not

  8         licensed or registered under the act to use

  9         certain terms implying that the person, firm,

10         or corporation is so licensed or registered, or

11         to hold himself or herself out as licensed or

12         registered to practice pharmacy in this state;

13         providing penalties; creating s. 465.0235,

14         F.S.; authorizing a pharmacy to provide

15         services to a long-term care facility or

16         hospice licensed under ch. 400, F.S., or a

17         state correctional institution operated under

18         ch. 944, F.S., through an automated pharmacy

19         system; providing that drugs dispensed from an

20         automated pharmacy system are considered to

21         have been dispensed by the pharmacy that

22         services a long-term care facility, hospice, or

23         correctional institution; requiring that the

24         operation of an automated pharmacy system be

25         under the supervision of a pharmacist;

26         providing legislative intent relating to

27         automated pharmacy systems; requiring the Board

28         of Pharmacy to adopt rules; amending s.

29         465.026, F.S.; permitting a mail order pharmacy

30         that uses a common database to perform

31         automated prescription functions to process a

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    Florida Senate - 2004                    CS for CS for SB 1294
    307-2129-04




 1         prescription for a controlled substance using

 2         that common database to perform those

 3         functions; providing an effective date.

 4  

 5  Be It Enacted by the Legislature of the State of Florida:

 6  

 7         Section 1.  Subsection (17) is added to section

 8  465.003, Florida Statutes, to read:

 9         465.003  Definitions.--As used in this chapter, the

10  term:

11         (17)  "Automated pharmacy system" means a mechanical

12  system that dispenses prescription drugs received from a

13  Florida licensed pharmacy and maintains related transaction

14  information.

15         Section 2.  Paragraph (c) is added to subsection (3) of

16  section 465.015, Florida Statutes, and subsection (4) of that

17  section is amended, to read:

18         465.015  Violations and penalties.--

19         (3)

20         (c)  It is unlawful for a person, firm, or corporation

21  that is not licensed or registered under this chapter to:

22         1.  Use in a trade name, sign, letter, or advertisement

23  any term, including "drug," "pharmacy," "prescription drugs,"

24  "Rx," or "apothecary," which implies that the person, firm, or

25  corporation is licensed or registered to practice pharmacy in

26  this state.

27         2.  Hold himself or herself out to others as a person,

28  firm, or corporation licensed or registered to practice

29  pharmacy in this state.

30         (4)  Any person who violates any provision of

31  subsection (1) or subsection (3) commits is guilty of a

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    Florida Senate - 2004                    CS for CS for SB 1294
    307-2129-04




 1  misdemeanor of the first degree, punishable as provided in s.

 2  775.082 or s. 775.083. Any person who violates any provision

 3  of subsection (2) commits is guilty of a felony of the third

 4  degree, punishable as provided in s. 775.082, s. 775.083, or

 5  s. 775.084. In any warrant, information, or indictment, it

 6  shall not be necessary to negative any exceptions, and the

 7  burden of any exception shall be upon the defendant.

 8         Section 3.  Section 465.0235, Florida Statutes, is

 9  created to read:

10         465.0235  Automated pharmacy systems used by long-term

11  care facilities or state correctional institutions.--

12         (1)  A pharmacy may provide pharmacy services to a

13  long-term care facility or hospice licensed under chapter 400

14  or a state correctional institution operated under chapter 944

15  through the use of an automated pharmacy system that need not

16  be located at the same location as the pharmacy.

17         (2)  Medicinal drugs stored in bulk or unit of use in

18  an automated pharmacy system servicing a long-term care

19  facility, hospice, or correctional institution are part of the

20  inventory of the pharmacy providing pharmacy services to that

21  facility or institution, and drugs dispensed from the

22  automated pharmacy system are considered to have been

23  dispensed by that pharmacy.

24         (3)  The operation of an automated pharmacy system must

25  be under the supervision of a Florida-licensed pharmacist. To

26  qualify as a supervisor for an automated pharmacy system, the

27  pharmacist need not be physically present at the site of the

28  automated pharmacy system and may supervise the system

29  electronically. The Florida-licensed pharmacist shall be

30  required to develop and implement policies and procedures

31  designed to verify that the prescriptions filled by the

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    Florida Senate - 2004                    CS for CS for SB 1294
    307-2129-04




 1  automated dispensing system are accurate and valid and that

 2  the machine is properly restocked.

 3         (4)  The Legislature does not intend this section to

 4  limit the current practice of pharmacy in this state. This

 5  section is intended to allow automated pharmacy systems to

 6  enhance the ability of a pharmacist to provide pharmacy

 7  services in locations that do not employ a full-time

 8  pharmacist. This section does not limit or replace the use of

 9  a consultant pharmacist.

10         (5)  The board shall adopt rules governing the use of

11  an automated pharmacy system by January 1, 2005, which must

12  specify:

13         (a)  Recordkeeping requirements;

14         (b)  Security requirements; and

15         (c)  Labeling requirements that permit the use of

16  unit-dose medications if the facility or institution maintains

17  medication-administration records that include directions for

18  use of the medication and the automated pharmacy system

19  identifies:

20         1.  The dispensing pharmacy;

21         2.  The prescription number;

22         3.  The name of the patient; and

23         4.  The name of the prescribing practitioner.

24         Section 4.  Subsection (7) is added to section 465.026,

25  Florida Statutes, to read:

26         465.026  Filling of certain prescriptions.--Nothing

27  contained in this chapter shall be construed to prohibit a

28  pharmacist licensed in this state from filling or refilling a

29  valid prescription which is on file in a pharmacy located in

30  this state or in another state and has been transferred from

31  

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    Florida Senate - 2004                    CS for CS for SB 1294
    307-2129-04




 1  one pharmacy to another by any means, including any electronic

 2  means, under the following conditions:

 3         (7)  For purposes of this section, a mail order

 4  pharmacy that uses a common database to perform automated

 5  prescription filling and dispensing functions may process a

 6  prescription for a controlled substance using that common

 7  database to perform those functions in compliance with federal

 8  law and regulation.

 9         Section 5.  This act shall take effect upon becoming a

10  law.

11  

12          STATEMENT OF SUBSTANTIAL CHANGES CONTAINED IN
                       COMMITTEE SUBSTITUTE FOR
13                            CS/SB 1294

14                                 

15  -    Requires the Florida-licensed pharmacist to develop and
         implement quality control policies and procedures for the
16       automated dispensing system he or she supervises.

17  -    Clarifies that a mail order pharmacy that uses a common
         database to perform automated prescription filling and
18       dispensing functions may use that database to process
         prescriptions for controlled substances, in compliance
19       with federal law.

20  -    Creates a first degree misdemeanor offense when a person,
         firm, or corporation not licensed under chapter 465, uses
21       deceptive advertising or other means to imply that the
         person, firm, or corporation is licensed or registered to
22       practice pharmacy in this state.

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