Senate Bill sb2100e1
CODING: Words stricken are deletions; words underlined are additions.
CS for CS for SB 2100 First Engrossed
1 A bill to be entitled
2 An act relating to pharmacy; amending s.
3 465.0075, F.S.; revising provisions governing
4 licensure by endorsement to require
5 certification that an applicant holds a doctor
6 of pharmacy degree; amending s. 465.014, F.S.;
7 providing for the registration of pharmacy
8 technicians; requiring the Board of Pharmacy to
9 set fees and rules to register pharmacy
10 technicians; providing qualification
11 requirements; providing a limitation; exempting
12 pharmacy technician students and licensed
13 pharmacy interns from certain registration
14 requirements; providing continuing education
15 requirements for registration renewal;
16 requiring the board to adopt rules; providing
17 grounds for denial, suspension, or revocation
18 of registration or other disciplinary action;
19 authorizing the board to impose certain
20 penalties; requiring the board to adopt rules
21 requiring a pharmacy to notify the board when
22 employing technicians; requiring the board to
23 maintain a directory of technicians and publish
24 the directory on the Internet; amending s.
25 465.015, F.S.; prohibiting a person who is not
26 registered as a pharmacy technician from
27 performing certain functions or holding himself
28 or herself out to others as a pharmacy
29 technician; amending ss. 465.019, 465.0196, and
30 465.0197, F.S.; conforming references; amending
31 s. 465.0235, F.S.; authorizing pharmacies to
1
CODING: Words stricken are deletions; words underlined are additions.
CS for CS for SB 2100 First Engrossed
1 use an automated pharmacy system located on its
2 premises; prohibiting automated pharmacy
3 systems from dispensing substances controlled
4 in Schedule I of ch. 893, F.S.; requiring the
5 Board of Pharmacy to adopt rules for the
6 security of an automated pharmacy system which
7 require a photographic record of the recipient
8 if the drug is dispensed directly to the
9 recipient in a pharmacy; providing an
10 appropriation and authorizing additional
11 positions; providing effective dates.
12
13 Be It Enacted by the Legislature of the State of Florida:
14
15 Section 1. Subsection (1) of section 465.0075, Florida
16 Statutes, is amended to read:
17 465.0075 Licensure by endorsement; requirements;
18 fee.--
19 (1) The department shall issue a license by
20 endorsement to any applicant who applies to the department and
21 remits a nonrefundable fee of not more than $100, as set by
22 the board, and whom the board certifies:
23 (a) Has met the qualifications for licensure in s.
24 465.007(1)(b) and (c);
25 (b) Has obtained a passing score, as established by
26 rule of the board, on the licensure examination of the
27 National Association of Boards of Pharmacy or a similar
28 nationally recognized examination, if the board certifies that
29 the applicant has taken the required examination and holds a
30 doctor of pharmacy degree not more than 12 years prior to
31 application;
2
CODING: Words stricken are deletions; words underlined are additions.
CS for CS for SB 2100 First Engrossed
1 (c)1. Has submitted evidence of the active licensed
2 practice of pharmacy, including practice in community or
3 public health by persons employed by a governmental entity, in
4 another jurisdiction for at least 2 of the immediately
5 preceding 5 years or evidence of successful completion of
6 board-approved postgraduate training or a board-approved
7 clinical competency examination within the year immediately
8 preceding application for licensure; or
9 2. Has completed an internship meeting the
10 requirements of s. 465.007(1)(c) within the 2 years
11 immediately preceding application; and
12 (d) Has obtained a passing score on the pharmacy
13 jurisprudence portions of the licensure examination, as
14 required by board rule.
15 Section 2. Effective January 1, 2009, section 465.014,
16 Florida Statutes, is amended to read:
17 465.014 Pharmacy technician.--
18 (1) A No person other than a licensed pharmacist or
19 pharmacy intern may not engage in the practice of the
20 profession of pharmacy, except that a licensed pharmacist may
21 delegate to nonlicensed pharmacy technicians registered
22 pursuant to this section those duties, tasks, and functions
23 which do not fall within the purview of s. 465.003(13). All
24 such delegated acts shall be performed under the direct
25 supervision of a licensed pharmacist who shall be responsible
26 for all such acts performed by persons under his or her
27 supervision. A registered pharmacy technician, under the
28 supervision of a pharmacist, may initiate or receive
29 communications with a practitioner or his or her agent, on
30 behalf of a patient, regarding refill authorization requests.
31 A No licensed pharmacist may not shall supervise more than one
3
CODING: Words stricken are deletions; words underlined are additions.
CS for CS for SB 2100 First Engrossed
1 registered pharmacy technician unless otherwise permitted by
2 the guidelines adopted by the board. The board shall establish
3 guidelines to be followed by licensees or permittees in
4 determining the circumstances under which a licensed
5 pharmacist may supervise up to four registered more than one
6 but not more than three pharmacy technicians. When a
7 pharmacist supervises four registered technicians under the
8 guidelines of the board, at least one of the four must be
9 certified by the Pharmacy Technician Certification Board or
10 any other nationally accredited certifying body approved by
11 the board.
12 (2) Any person who wishes to work as a pharmacy
13 technician in this state must register by filing an
14 application with the board on a form adopted by rule of the
15 board. The board shall register each applicant who has
16 remitted a registration fee set by the board, not to exceed
17 $50 biennially; has completed the application form and
18 remitted a nonrefundable application fee set by the board, not
19 to exceed $50; and is at least 16 years of age.
20 (3) A person whose license to practice pharmacy has
21 been denied, suspended, or restricted for disciplinary
22 purposes is not eligible to be registered as a pharmacy
23 technician.
24 (4) Notwithstanding the requirements of this section
25 or any other provision of law, a pharmacy technician student
26 may be placed in a pharmacy for the purpose of obtaining
27 practical training required by the body accrediting the
28 pharmacy technician training program. A pharmacy technician
29 student shall wear identification that indicates his or her
30 student status when performing the functions of a pharmacy
31
4
CODING: Words stricken are deletions; words underlined are additions.
CS for CS for SB 2100 First Engrossed
1 technician, and registration under this section is not
2 required.
3 (5) Notwithstanding the requirements of this section
4 or any other provision of law, a person licensed by the state
5 as a pharmacy intern may be employed as a registered pharmacy
6 technician without paying a registration fee or filing an
7 application with the board to register as a pharmacy
8 technician.
9 (6) As a condition of registration renewal, a pharmacy
10 technician shall complete 20 hours biennially of continuing
11 education courses approved by the board or the Accreditation
12 Council for Pharmaceutical Education, of which 4 hours must be
13 via live presentation and 2 hours must be related to the
14 prevention of medication errors and pharmacy law.
15 (7) The board shall adopt rules that require each
16 registration issued by the board under this section to be
17 displayed in such a manner as to make it available to the
18 public and to facilitate inspection by the department and such
19 other rules as necessary to administer the provisions of this
20 section.
21 (8) If the board finds that an applicant for
22 registration as a pharmacy technician or that a registered
23 pharmacy technician has committed an act that constitutes
24 grounds for discipline as set forth in s. 456.072(1) or has
25 committed an act that constitutes grounds for denial of a
26 license or disciplinary action as set forth in this chapter,
27 including an act that constitutes a substantial violation of
28 s. 456.072(1) or a violation of this chapter which occurred
29 before the applicant or registrant was registered as a
30 pharmacy technician, the board may enter an order imposing any
31
5
CODING: Words stricken are deletions; words underlined are additions.
CS for CS for SB 2100 First Engrossed
1 of the penalties specified in s. 456.072(2) against the
2 applicant or registrant.
3 (9) The board shall adopt rules requiring and
4 specifying the manner in which a pharmacy shall notify the
5 board when a registered technician is employed or ceases
6 employment with the pharmacy.
7 (10) The board shall maintain a current directory of
8 registered pharmacy technicians indicating their place of
9 employment and which must be published on the Internet.
10 Section 3. Effective January 1, 2009, paragraph (d) is
11 added to subsection (3) of section 465.015, Florida Statutes,
12 to read:
13 465.015 Violations and penalties.--
14 (3)
15 (d) It is unlawful for a person who is not registered
16 as a pharmacy technician under this chapter, or who is not
17 otherwise exempt from the requirement to register as a
18 pharmacy technician, to perform the functions of a registered
19 pharmacy technician or hold himself or herself out to others
20 as a person who is registered to perform the functions of a
21 registered pharmacy technician in this state.
22 Section 4. Effective January 1, 2009, subsection (5)
23 of section 465.019, Florida Statutes, is amended to read:
24 465.019 Institutional pharmacies; permits.--
25 (5) All institutional pharmacies shall be under the
26 professional supervision of a consultant pharmacist, and the
27 compounding and dispensing of medicinal drugs shall be done
28 only by a licensed pharmacist. Every institutional pharmacy
29 that employs or otherwise utilizes registered pharmacy
30 technicians shall have a written policy and procedures manual
31
6
CODING: Words stricken are deletions; words underlined are additions.
CS for CS for SB 2100 First Engrossed
1 specifying those duties, tasks, and functions which a pharmacy
2 technician is allowed to perform.
3 Section 5. Effective January 1, 2009, section
4 465.0196, Florida Statutes, is amended to read:
5 465.0196 Special pharmacy permits.--Any person
6 desiring a permit to operate a special pharmacy shall apply to
7 the department for a special pharmacy permit. If the board
8 certifies that the application complies with the applicable
9 laws and rules of the board governing the practice of the
10 profession of pharmacy, the department shall issue the permit.
11 No permit shall be issued unless a licensed pharmacist is
12 designated to undertake the professional supervision of the
13 compounding and dispensing of all drugs dispensed by the
14 pharmacy. The licensed pharmacist shall be responsible for
15 maintaining all drug records and for providing for the
16 security of the area in the facility in which the compounding,
17 storing, and dispensing of medicinal drugs occurs. The
18 permittee shall notify the department within 10 days of any
19 change of the licensed pharmacist responsible for such duties.
20 Every permittee that employs or otherwise utilizes pharmacy
21 technicians shall have a written policy and procedures manual
22 specifying those duties, tasks, and functions which a
23 registered pharmacy technician is allowed to perform.
24 Section 6. Effective January 1, 2009, subsection (1)
25 of section 465.0197, Florida Statutes, is amended to read:
26 465.0197 Internet pharmacy permits.--
27 (1) Any person desiring a permit to operate an
28 Internet pharmacy shall apply to the department for an
29 Internet pharmacy permit. If the board certifies that the
30 application complies with the applicable laws and rules of the
31 board governing the practice of the profession of pharmacy,
7
CODING: Words stricken are deletions; words underlined are additions.
CS for CS for SB 2100 First Engrossed
1 the department shall issue the permit. No permit shall be
2 issued unless a licensed pharmacist is designated as the
3 prescription department manager for dispensing medicinal drugs
4 to persons in this state. The licensed pharmacist shall be
5 responsible for maintaining all drug records and for providing
6 for the security of the area in the facility in which the
7 compounding, storing, and dispensing of medicinal drugs to
8 persons in this state occurs. The permittee shall notify the
9 department within 30 days of any change of the licensed
10 pharmacist responsible for such duties. Every permittee that
11 employs or otherwise utilizes registered pharmacy technicians
12 shall have a written policy and procedures manual specifying
13 those duties, tasks, and functions which a registered pharmacy
14 technician is allowed to perform.
15 Section 7. Section 465.0235, Florida Statutes, is
16 amended to read:
17 465.0235 Automated pharmacy systems used by long-term
18 care facilities, hospices, or state correctional institutions,
19 or pharmacies.--
20 (1) A pharmacy may provide pharmacy services through
21 the use of an automated pharmacy system located on its
22 premises and may provide pharmacy services to a long-term care
23 facility or hospice licensed under chapter 400 or chapter 429
24 or a state correctional institution operated under chapter 944
25 through the use of an automated pharmacy system that need not
26 be located at the same location as the pharmacy.
27 (2) Medicinal drugs stored in bulk or unit of use in
28 an automated pharmacy system servicing a long-term care
29 facility, hospice, or correctional institution, or pharmacy
30 are part of the inventory of the pharmacy providing pharmacy
31 services to that facility, hospice, or institution, or
8
CODING: Words stricken are deletions; words underlined are additions.
CS for CS for SB 2100 First Engrossed
1 pharmacy and drugs delivered by the automated pharmacy system
2 are considered to have been dispensed by that pharmacy and
3 certified by a pharmacist. Automated pharmacy systems shall
4 not dispense substances controlled in Schedule I of s. 893.03.
5 (3) The operation of an automated pharmacy system must
6 be under the supervision of a Florida-licensed pharmacist. To
7 qualify as a supervisor for an automated pharmacy system, the
8 pharmacist need not be physically present at the site of the
9 automated pharmacy system and may supervise the system
10 electronically. The Florida-licensed pharmacist shall be
11 required to develop and implement policies and procedures
12 designed to verify that the medicinal drugs delivered by the
13 automated dispensing system are accurate and valid and that
14 the machine is properly restocked.
15 (4) The Legislature does not intend this section to
16 limit the current practice of pharmacy in this state. This
17 section is intended to allow automated pharmacy systems to
18 enhance the ability of a pharmacist to provide pharmacy
19 services in locations that may do not employ a full-time
20 pharmacist. This section does not limit or replace the use of
21 a consultant pharmacist.
22 (5) The board shall adopt rules governing the use of
23 an automated pharmacy system by January 1, 2008 2005, which
24 must specify:
25 (a) Recordkeeping requirements;
26 (b) Security requirements, including a photographic
27 record of the recipient if the drug is dispensed directly to
28 the recipient in a pharmacy; and
29 (c) Labeling requirements that permit the use of
30 unit-dose medications if the facility, hospice, or
31 institution, or pharmacy maintains medication-administration
9
CODING: Words stricken are deletions; words underlined are additions.
CS for CS for SB 2100 First Engrossed
1 records that include directions for use of the medication and
2 the automated pharmacy system identifies:
3 1. The dispensing pharmacy;
4 2. The prescription number;
5 3. The name of the patient; and
6 4. The name of the prescribing practitioner.
7 Section 8. The sum of $812,334 is appropriated from
8 the Medical Quality Assurance Trust Fund to the Department of
9 Health, and 13.5 positions and associated salary rate of
10 514,673 is authorized to implement this act during the
11 2007-2008 fiscal year.
12 Section 9. Except as otherwise expressly provided in
13 this act, this act shall take effect upon becoming a law.
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
31
10
CODING: Words stricken are deletions; words underlined are additions.