Senate Bill sb2100c2

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    Florida Senate - 2007                    CS for CS for SB 2100

    By the Committees on Health and Human Services Appropriations;
    Health Regulation; and Senator Peaden




    603-2445-07

  1                      A bill to be entitled

  2         An act relating to pharmacy technicians;

  3         amending s. 465.014, F.S.; providing for the

  4         registration of pharmacy technicians; requiring

  5         the Board of Pharmacy to set fees and rules to

  6         register pharmacy technicians; providing

  7         qualification requirements; providing a

  8         limitation; exempting pharmacy technician

  9         students and licensed pharmacy interns from

10         certain registration requirements; providing

11         continuing education requirements for

12         registration renewal; requiring the board to

13         adopt rules; providing grounds for denial,

14         suspension, or revocation of registration or

15         other disciplinary action; authorizing the

16         board to impose certain penalties; requiring

17         the board to adopt rules requiring a pharmacy

18         to notify the board when employing technicians;

19         requiring the board to maintain a directory of

20         technicians and publish the directory on the

21         Internet; amending s. 465.015, F.S.;

22         prohibiting a person who is not registered as a

23         pharmacy technician from performing certain

24         functions or holding himself or herself out to

25         others as a pharmacy technician; amending ss.

26         465.019, 465.0196, and 465.0197, F.S.;

27         conforming references; amending s. 465.0235,

28         F.S.; authorizing pharmacies to use an

29         automated pharmacy system located on its

30         premises; prohibiting automated pharmacy

31         systems from dispensing substances controlled

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    Florida Senate - 2007                    CS for CS for SB 2100
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 1         in Schedule I of ch. 893, F.S.; requiring the

 2         Board of Pharmacy to adopt rules for the

 3         security of an automated pharmacy system which

 4         require a photographic record of the recipient

 5         if the drug is dispensed directly to the

 6         recipient in a public location; providing an

 7         appropriation and authorizing additional

 8         positions; providing effective dates.

 9  

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

11  

12         Section 1.  Effective January 1, 2009, section 465.014,

13  Florida Statutes, is amended to read:

14         465.014  Pharmacy technician.--

15         (1)  A No person other than a licensed pharmacist or

16  pharmacy intern may not engage in the practice of the

17  profession of pharmacy, except that a licensed pharmacist may

18  delegate to nonlicensed pharmacy technicians registered

19  pursuant to this section those duties, tasks, and functions

20  which do not fall within the purview of s. 465.003(13). All

21  such delegated acts shall be performed under the direct

22  supervision of a licensed pharmacist who shall be responsible

23  for all such acts performed by persons under his or her

24  supervision. A registered pharmacy technician, under the

25  supervision of a pharmacist, may initiate or receive

26  communications with a practitioner or his or her agent, on

27  behalf of a patient, regarding refill authorization requests.

28  A No licensed pharmacist may not shall supervise more than one

29  registered pharmacy technician unless otherwise permitted by

30  the guidelines adopted by the board. The board shall establish

31  guidelines to be followed by licensees or permittees in

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    Florida Senate - 2007                    CS for CS for SB 2100
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 1  determining the circumstances under which a licensed

 2  pharmacist may supervise up to four registered more than one

 3  but not more than three pharmacy technicians.

 4         (2)  Any person who wishes to work as a pharmacy

 5  technician in this state must register by filing an

 6  application with the board on a form adopted by rule of the

 7  board. The board shall register each applicant who has

 8  remitted a registration fee set by the board, not to exceed

 9  $50 biennially; has completed the application form and

10  remitted a nonrefundable application fee set by the board, not

11  to exceed $50; and is at least 16 years of age.

12         (3)  A person whose license to practice pharmacy has

13  been denied, suspended, or restricted for disciplinary

14  purposes is not eligible to be registered as a pharmacy

15  technician.

16         (4)  Notwithstanding the requirements of this section

17  or any other provision of law, a pharmacy technician student

18  may be placed in a pharmacy for the purpose of obtaining

19  practical training required by the body accrediting the

20  pharmacy technician training program. A pharmacy technician

21  student shall wear identification that indicates his or her

22  student status when performing the functions of a pharmacy

23  technician, and registration under this section is not

24  required.

25         (5)  Notwithstanding the requirements of this section

26  or any other provision of law, a person licensed by the state

27  as a pharmacy intern may be employed as a registered pharmacy

28  technician without paying a registration fee or filing an

29  application with the board to register as a pharmacy

30  technician.

31  

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    Florida Senate - 2007                    CS for CS for SB 2100
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 1         (6)  As a condition of registration renewal, a pharmacy

 2  technician shall complete 20 hours biennially of continuing

 3  education courses approved by the board or the Accreditation

 4  Council for Pharmaceutical Education, of which 4 hours must be

 5  via live presentation and 2 hours must be related to the

 6  prevention of medication errors and pharmacy law.

 7         (7)  The board shall adopt rules that require each

 8  registration issued by the board under this section to be

 9  displayed in such a manner as to make it available to the

10  public and to facilitate inspection by the department and such

11  other rules as necessary to administer the provisions of this

12  section.

13         (8)  If the board finds that an applicant for

14  registration as a pharmacy technician or that a registered

15  pharmacy technician has committed an act that constitutes

16  grounds for discipline as set forth in s. 456.072(1) or has

17  committed an act that constitutes grounds for denial of a

18  license or disciplinary action as set forth in this chapter,

19  including an act that constitutes a substantial violation of

20  s. 456.072(1) or a violation of this chapter which occurred

21  before the applicant or registrant was registered as a

22  pharmacy technician, the board may enter an order imposing any

23  of the penalties specified in s. 456.072(2) against the

24  applicant or registrant.

25         (9)  The board shall adopt rules requiring and

26  specifying the manner in which a pharmacy shall notify the

27  board when a registered technician is employed or ceases

28  employment with the pharmacy.

29         (10)  The board shall maintain a current directory of

30  registered pharmacy technicians indicating their place of

31  employment and which must be published on the Internet.

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    Florida Senate - 2007                    CS for CS for SB 2100
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 1         Section 2.  Effective January 1, 2009, paragraph (d) is

 2  added to subsection (3) of section 465.015, Florida Statutes,

 3  to read:

 4         465.015  Violations and penalties.--

 5         (3)

 6         (d)  It is unlawful for a person who is not registered

 7  as a pharmacy technician under this chapter, or who is not

 8  otherwise exempt from the requirement to register as a

 9  pharmacy technician, to perform the functions of a registered

10  pharmacy technician or hold himself or herself out to others

11  as a person who is registered to perform the functions of a

12  registered pharmacy technician in this state.

13         Section 3.  Effective January 1, 2009, subsection (5)

14  of section 465.019, Florida Statutes, is amended to read:

15         465.019  Institutional pharmacies; permits.--

16         (5)  All institutional pharmacies shall be under the

17  professional supervision of a consultant pharmacist, and the

18  compounding and dispensing of medicinal drugs shall be done

19  only by a licensed pharmacist. Every institutional pharmacy

20  that employs or otherwise utilizes registered pharmacy

21  technicians shall have a written policy and procedures manual

22  specifying those duties, tasks, and functions which a pharmacy

23  technician is allowed to perform.

24         Section 4.  Effective January 1, 2009, section

25  465.0196, Florida Statutes, is amended to read:

26         465.0196  Special pharmacy permits.--Any person

27  desiring a permit to operate a special pharmacy shall apply to

28  the department for a special pharmacy permit. If the board

29  certifies that the application complies with the applicable

30  laws and rules of the board governing the practice of the

31  profession of pharmacy, the department shall issue the permit.

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    Florida Senate - 2007                    CS for CS for SB 2100
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 1  No permit shall be issued unless a licensed pharmacist is

 2  designated to undertake the professional supervision of the

 3  compounding and dispensing of all drugs dispensed by the

 4  pharmacy. The licensed pharmacist shall be responsible for

 5  maintaining all drug records and for providing for the

 6  security of the area in the facility in which the compounding,

 7  storing, and dispensing of medicinal drugs occurs. The

 8  permittee shall notify the department within 10 days of any

 9  change of the licensed pharmacist responsible for such duties.

10  Every permittee that employs or otherwise utilizes pharmacy

11  technicians shall have a written policy and procedures manual

12  specifying those duties, tasks, and functions which a

13  registered pharmacy technician is allowed to perform.

14         Section 5.  Effective January 1, 2009, subsection (1)

15  of section 465.0197, Florida Statutes, is amended to read:

16         465.0197  Internet pharmacy permits.--

17         (1)  Any person desiring a permit to operate an

18  Internet pharmacy shall apply to the department for an

19  Internet pharmacy permit. If the board certifies that the

20  application complies with the applicable laws and rules of the

21  board governing the practice of the profession of pharmacy,

22  the department shall issue the permit. No permit shall be

23  issued unless a licensed pharmacist is designated as the

24  prescription department manager for dispensing medicinal drugs

25  to persons in this state. The licensed pharmacist shall be

26  responsible for maintaining all drug records and for providing

27  for the security of the area in the facility in which the

28  compounding, storing, and dispensing of medicinal drugs to

29  persons in this state occurs. The permittee shall notify the

30  department within 30 days of any change of the licensed

31  pharmacist responsible for such duties. Every permittee that

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    Florida Senate - 2007                    CS for CS for SB 2100
    603-2445-07




 1  employs or otherwise utilizes registered pharmacy technicians

 2  shall have a written policy and procedures manual specifying

 3  those duties, tasks, and functions which a registered pharmacy

 4  technician is allowed to perform.

 5         Section 6.  Section 465.0235, Florida Statutes, is

 6  amended to read:

 7         465.0235  Automated pharmacy systems used by long-term

 8  care facilities, hospices, or state correctional institutions,

 9  or pharmacies.--

10         (1)  A pharmacy may provide pharmacy services through

11  the use of an automated pharmacy system located on its

12  premises and may provide pharmacy services to a long-term care

13  facility or hospice licensed under chapter 400 or chapter 429

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, or pharmacy

20  are part of the inventory of the pharmacy providing pharmacy

21  services to that facility, hospice, or institution, or

22  pharmacy and drugs delivered by the automated pharmacy system

23  are considered to have been dispensed by that pharmacy and

24  certified by a pharmacist. Automated pharmacy systems shall

25  not dispense substances controlled in Schedule I of s. 893.03.

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

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

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

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

30  automated pharmacy system and may supervise the system

31  electronically. The Florida-licensed pharmacist shall be

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    Florida Senate - 2007                    CS for CS for SB 2100
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 1  required to develop and implement policies and procedures

 2  designed to verify that the medicinal drugs delivered by the

 3  automated dispensing system are accurate and valid and that

 4  the machine is properly restocked.

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

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

 7  section is intended to allow automated pharmacy systems to

 8  enhance the ability of a pharmacist to provide pharmacy

 9  services in locations that may do not employ a full-time

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

11  a consultant pharmacist.

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

13  an automated pharmacy system by January 1, 2008 2005, which

14  must specify:

15         (a)  Recordkeeping requirements;

16         (b)  Security requirements, including a photographic

17  record of the recipient if the drug is dispensed directly to

18  the recipient in a public location; and

19         (c)  Labeling requirements that permit the use of

20  unit-dose medications if the facility, hospice, or

21  institution, or pharmacy maintains medication-administration

22  records that include directions for use of the medication and

23  the automated pharmacy system identifies:

24         1.  The dispensing pharmacy;

25         2.  The prescription number;

26         3.  The name of the patient; and

27         4.  The name of the prescribing practitioner.

28         Section 7.  The sum of $812,334 is appropriated from

29  the Medical Quality Assurance Trust Fund to the Department of

30  Health, and 13.5 positions and associated salary rate of

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    Florida Senate - 2007                    CS for CS for SB 2100
    603-2445-07




 1  514,673 is authorized to implement this act during the

 2  2007-2008 fiscal year.

 3         Section 8.  Except as otherwise expressly provided in

 4  this act, this act shall take effect upon becoming a law.

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 6          STATEMENT OF SUBSTANTIAL CHANGES CONTAINED IN
                       COMMITTEE SUBSTITUTE FOR
 7                          CS for SB 2100

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 9  Authorizes pharmacies to provide automated pharmacy services
    to long-term care facilities, hospices, and correctional
10  institutions.  Requires a photographic record of the recipient
    if the drug is dispensed directly to the recipient in a public
11  location.

12  Appropriates $812,334 from the Medical Quality Assurance Trust
    Fund, 13.5 positions, and salary rate of 514,673 to implement
13  the bill during the 2007-2008 fiscal year.

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