PRIOR PRINTER'S NO. 579

PRINTER'S NO.  2888

  

THE GENERAL ASSEMBLY OF PENNSYLVANIA

  

HOUSE BILL

 

No.

528

Session of

2009

  

  

INTRODUCED BY DeLUCA, CIVERA, DALEY, FABRIZIO, W. KELLER, KORTZ, KULA, MANN, MELIO, M. O'BRIEN, REICHLEY, SIPTROTH, STABACK, STURLA AND WALKO, FEBRUARY 19, 2009

  

  

AS REPORTED FROM COMMITTEE ON PROFESSIONAL LICENSURE, HOUSE OF REPRESENTATIVES, AS AMENDED, NOVEMBER 16, 2009   

  

  

  

AN ACT

  

1

Amending the act of September 27, 1961 (P.L.1700, No.699),

2

entitled "An act relating to the regulation of the practice

3

of pharmacy, including the sales, use and distribution of

4

drugs and devices at retail; and amending, revising,

5

consolidating and repealing certain laws relating thereto,"

6

further providing for definitions; providing for registration

7

and permits for pharmacy technicians; and further providing

8

for multiple licensure, for refusal to grant, revocation and

9

suspension, for State Board of Pharmacy, for hearings and

10

suspensions, for unlawful acts and for injunction.

11

The General Assembly of the Commonwealth of Pennsylvania

12

hereby enacts as follows:

13

Section 1.  Section 2 of the act of September 27, 1961 (P.L.

14

1700, No.699), known as the Pharmacy Act, is amended by adding

15

clauses to read:

16

Section 2.  Definitions.--As used in this act:

17

* * *

18

(10.1)  "Pharmacy technician" means an individual who is

19

registered by the Sate State Board of Pharmacy under section 2.1

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20

to assist in the practice of pharmacy.

21

(10.2)  "Pharmacy technician trainee" means an individual who

 


1

holds a temporary permit issued by the State Board of Pharmacy

2

under section 2.1.

3

(10.3)  "Direct and personal supervision of a pharmacist"

4

means:

5

(i)  review by the pharmacist of the prescription or drug

6

order prior to dispensing;

7

(ii)  verification by the pharmacist of the final product;

8

and

9

(iii)  availability of the pharmacist on the premises to

10

direct the work of the supervised individual and to respond to

11

questions or problems.

12

* * *

13

Section 2.  The act is amended by adding a section to read:

14

Section 2.1.  Registration and Permits for Pharmacy

15

Technicians.--(a)  The board may register as a pharmacy

16

technician a person who:

17

(1)  Pays an application fee prescribed by the department a

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18

fee as prescribed by the board by regulation.

19

(2)  Files an application for registration, subscribed by the

20

individual under oath or affirmation, containing information the

21

board requires.

22

(3)  Except as set forth in subsection (b), complies with all

23

of the following:

24

(i)  Is not less than eighteen seventeen years of age. and is

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25

a legal resident of the United States.

26

(ii)  Has a high school diploma or its equivalent.

27

(iii)  Has satisfied the board that the applicant is of good

28

moral character and is not unfit or unable to practice as a

29

pharmacy technician by reason of the extent or manner of the

30

applicant's use of alcoholic beverages or controlled substances

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1

or by reason of a physical or mental disability.

2

(iv)  has completed a pharmacy technician training program

3

approved by the board.

4

(v)  Has received certification from a nationally recognized

5

certifying agency approved by the board.

6

(vi)  Has successfully completed an examination approved by

7

the board

8

(ii)  Has satisfied the board that the applicant is of good

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9

moral character.

10

(iii)  Meets one of the following requirements:

11

(A)  has received certification from a nationally recognized

12

certifying agency approved by the board; or

13

(B)  has successfully completed an examination approved by

14

the board that would require the applicant to demonstrate a

15

basic competency level of the skills required of a pharmacy

16

technician and administered in accordance with the requirements

17

set forth in section 812.1(a) of the act of April 9, 1929 (P.L.

18

177, No.175), known as "The Administrative Code of 1929."

19

(vii) (iv)  Has not been convicted of a felonious act

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20

prohibited by the act of April 14, 1972 (P.L.233, No.64), known

21

as "The Controlled Substance, Drug, Device and Cosmetic Act," or

22

convicted of a felony relating to a controlled substance in a

23

court of law of the United States or any other state, territory

24

or country unless:

25

(A)  at least ten years have elapsed from the date of

26

conviction; and

27

(B)  the applicant satisfactorily demonstrates to the board

28

that the applicant has made significant progress in personal

29

rehabilitation since the conviction such that licensure of the

30

applicant should not be expected to create a substantial risk of

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1

harm to the health and safety of patients or the public or a

2

substantial risk of further criminal violations.

3

As used in this clause, the term "convicted" shall include a

4

judgment, an admission of guilt or a plea of nolo contendere. An

5

applicant's statement on the application declaring the absence

6

of a conviction shall be deemed satisfactory evidence of the

7

absence of a conviction, unless the board has some evidence to

8

the contrary.

9

(v)  Had not had the applicant's license to practice as a

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10

pharmacist revoked or suspended or had other disciplinary action

11

taken by a proper licensing authority.

12

(b)  The following exceptions shall apply:

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13

(1)  Notwithstanding subsection (a)(3)(iv) and (v) 

14

Notwithstanding subsection (a)(3)(iii), the board shall register

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15

all an individual who applies for registration within two years

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16

after final regulations under this section are promulgated and

17

complies with one of the following:

18

(i)  An individual who, at the time of filing an application,

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19

has (1)  Demonstrates to the satisfaction of the board proof of

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20

registration, certification or licensure or its equivalent as a

21

pharmacy technician in another state, territory or possession of

22

the United States that has registration, certification,

23

licensure or equivalent requirements comparable to those set

24

forth in this section and regulations of the board.

25

(ii)  An individual who:

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26

(A)  applies for registration within two years after the

27

effective date of this section; and

28

(B)  on the effective date of this section maintains a

29

(2)  Maintains a current certification by a nationally

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30

recognized pharmacy technician association.

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(2)  Notwithstanding subsection (a)(3)(ii), (iv) and (v), the

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2

board shall issue registration to an individual who:

3

(i)  Has been employed (3)  Demonstrates to the satisfaction

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4

of the board proof of employment as a pharmacy technician for a

5

minimum of two thousand hours during the three years immediately

6

preceding the enactment of this act section.

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7

(ii)  Demonstrates to the satisfaction of the board proof of

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8

practice as a pharmacy technician for at least two thousand

9

hours immediately prior to the date of application.

10

(c)  A registration shall authorize the registrant to assist

11

in the practice of pharmacy under the direct and personal

12

supervision of a pharmacist.

13

(d)  A registration is subject to biennial renewal. The board

14

shall establish by regulation a fee for renewal.

15

(e)  The following apply to pharmacy technician trainees:

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16

(1)  The board may issue a temporary permit to practice as a

17

pharmacy technician trainee to an applicant who is seventeen

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18

years of age or older and meets the requirements of subsection

19

(a)(3)(ii) and (iii) (a)(3)(i), (ii), (iv) and (v) and complies

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20

with the following:

21

(i)  The applicant is a student enrolled in a board-approved 

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22

pharmacy technician training program and as part of the program

23

may be required to serve an externship or internship; or

24

(ii)  The individual is employed by a pharmacy and

25

participates in a board-approved pharmacy technician training

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26

program that may include an externship or internship program.

27

(2)  A temporary practice permit shall be issued for one year

28

and may be extended for a single six-month period upon

29

verification to the satisfaction of the board that the trainee

30

has completed the board-approved training program.

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1

(3)  A temporary permit shall not be reissued.

2

(4)  A temporary permit shall authorize the permittee to

3

perform the duties of a pharmacy technician under the direct and

4

personal supervision of a pharmacist.

5

(f)  Identification requirements are as follows:

6

(1)  A pharmacy technician shall wear a name tag that clearly

7

identifies the temporary permit holder with the title "pharmacy

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8

technician trainee." pharmacy technician with the title

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9

"registered pharmacy technician."

10

(2)  A holder of a temporary permit shall wear a name tag

11

that clearly identifies the temporary permit holder with the

12

title "pharmacy technician trainee."

13

(g)  This section shall not apply to a student who is

14

enrolled in an accredited school of pharmacy and who is in good

15

standing.

16

Section 3.  Section 3.2 of the act, added December 20, 1985

17

(P.L.433, No.111), is amended to read:

18

Section 3.2.  Reporting of Multiple Licensure, Registration

19

or its Equivalent.--Any [licensed] pharmacist or pharmacy

20

technician of this Commonwealth who is also registered,

21

certified or licensed [to practice pharmacy] in any other state,

22

territory or country shall report this information to the board

23

on the biennial registration application. Any disciplinary

24

action taken in other states, territories and countries shall be

25

reported to the board on the biennial registration application

26

or within ninety days of final disposition, whichever is sooner.

27

Multiple registration, certification or licensure shall be noted

28

by the board on the [pharmacist's] licensee's or registrant's 

29

record, and such state, territory or country shall be notified

30

by the board of any disciplinary actions taken against [said

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1

pharmacist] that licensee or registrant in this Commonwealth.

2

Section 4.  Section 5(c) of the act, amended December 20,

3

1985 (P.L.433, No.111), is amended and the section is amended by

4

adding a subsection to read:

5

Section 5.  Refusal to Grant, Revocation and Suspension.--* *

6

*

7

(a.1)  The board shall have the power to refuse, revoke or

8

suspend the registration of any pharmacy technician upon proof

9

satisfactory to it that the pharmacy technician has done any of

10

the following:

11

(1)  Procured a personal registration through fraud,

12

misrepresentation or deceit.

13

(2)  Has been found guilty, pleaded guilty, entered a plea of

14

nolo contendere, or has received probation without verdict,

15

disposition in lieu of trial or an Accelerated Rehabilitation

16

Disposition in the disposition of felony charges, to any offense

17

in connection with the practice of pharmacy or any offense

18

involving moral turpitude before any court of record of any

19

jurisdiction.

20

(3)  Is unfit to practice as a pharmacy technician because of

21

intemperance in the use of alcoholic beverages, controlled

22

substances or any other substance which impairs the intellect

23

and judgment to such an extent as to impair the performance of

24

professional duties.

25

(4)  Is unfit or unable to practice as a pharmacy technician

26

by reason of a physical or mental disease or disability. In

27

enforcing this clause, the board shall, upon probable cause,

28

have authority to compel a pharmacy technician to submit to a

29

mental or physical examination by physicians or psychologists

30

approved by the board. Failure of a pharmacy technician to

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1

submit to an examination when directed by the board, unless due

2

to circumstances beyond the pharmacy technician's control, shall

3

constitute an admission of the allegations against the pharmacy

4

technician, consequent upon which a default and final order may

5

be entered without the taking of testimony or presentation of

6

evidence. A pharmacy technician affected under this clause shall

7

at reasonable intervals be afforded an opportunity to

8

demonstrate the ability to resume a competent practice as a

9

pharmacy technician with reasonable skill and safety to

10

patients.

11

(5)  Has had a registration, certification or license to

12

practice as a pharmacy technician denied, revoked or suspended

13

by an appropriate pharmacy technician registration,

14

certification or licensing authority or has received

15

disciplinary action from an appropriate pharmacy technician

16

registration, certification or licensing authority.

17

(6)  Has acted in such a manner as to present an immediate

18

and clear danger to the public health or safety.

19

(7)  Is guilty of incompetence, gross negligence or other

20

malpractice, or the departure from, or failure to conform to,

21

the standards of acceptable and prevailing pharmacy technician

22

practice, in which case actual injury need not be established.

23

* * *

24

(c)  When the board finds that the registration,

25

certification or license [of any pharmacist] may be refused,

26

revoked or suspended under the terms of subsection (a) or (a.1),

27

the board may:

28

(1)  Deny the application for a registration, certification

29

or license.

30

(2)  Administer a public reprimand.

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1

(3)  Revoke, suspend, limit or otherwise restrict a

2

registration, certification or license as determined by the

3

board.

4

(4)  Require a licensee to submit to the care, counseling or

5

treatment of a physician or a psychologist designated by the

6

board. This clause does not apply to a pharmacy technician.

7

(5)  Suspend enforcement of its finding thereof and place a

8

licensee on probation with the right to vacate the probationary

9

order for noncompliance.

10

(6)  Restore or reissue, in its discretion, a suspended

11

license [to practice pharmacy] or registration and impose any

12

disciplinary or corrective measure which it might originally

13

have imposed.

14

* * *

15

Section 5.  Section 6(k) of the act, amended December 20,

16

1985 (P.L.433, No.111), is amended to read:

17

Section 6.  State Board of Pharmacy.--* * *

18

(k)  The board shall have the power, and it shall be its

19

duty:

20

(1)  To regulate the practice of pharmacy and of pharmacy

21

technicians;

22

(2)  To determine the nature of examinations for all

23

applicants for [pharmacists'] licenses;

24

(3)  To examine, inspect and investigate all applications and

25

all applicants for licensure as pharmacists, pharmacies or

26

registration as pharmacy interns and pharmacy technicians, and 

27

to grant certificates of licensure or registration to all

28

applicants whom it shall judge to be properly qualified;

29

(4)  With the approval of the Commissioner of Professional

30

and Occupational Affairs, to prepare position descriptions,

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1

employ inspectors who shall be licensed pharmacists and employ

2

appropriate consultants to assist it for any purposes which it

3

may deem necessary, provided that the board may not delegate any

4

of its final decisionmaking responsibilities to any consultant;

5

(5)  To investigate or cause to be investigated all

6

violations of the provisions of this act and its regulations and

7

to cause prosecutions to be instituted in the courts upon advice

8

from the Attorney General;

9

(6)  To make or order inspections of all pharmacies, except

10

health care facilities, as defined in the act of July 19, 1979

11

(P.L.130, No.48), known as the "Health Care Facilities Act," and

12

which are periodically inspected by the Department of Health in

13

accordance with the standards in this act and the board's

14

regulations promulgated thereto: Provided, That the Department

15

of Health shall forward a copy of their inspection report to the

16

board noting any violations of the act: And, provided further,

17

That, if a violation is reported, the board shall have the power

18

to inspect such pharmacies and take appropriate action as

19

specified in this act; and to make or order inspections of other

20

places in which drugs or devices are stored, held, compounded,

21

dispensed or sold to a consumer, to take and analyze any drugs

22

or devices and to seize and condemn any drugs or devices which

23

are adulterated, misbranded or stored, held, dispensed,

24

distributed or compounded in violation of the provisions of this

25

act or the provisions of the act of April 14, 1972 (P.L.233, No.

26

64), known as "The Controlled Substance, Drug, Device and

27

Cosmetic Act";

28

(7)  To conduct hearings for the revocation or suspension of

29

licenses, permits or registrations, for which hearings the board

30

shall have the power to subpoena witnesses;

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1

(8)  To assist the regularly constituted enforcement agencies

2

of this Commonwealth in enforcing all laws pertaining to drugs,

3

controlled substances, and practice of pharmacy;

4

(8.1)  To approve programs for the training of pharmacy

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5

technicians;

6

(9)  To promulgate rules and regulations to effectuate the

7

purposes of this act and to regulate the distribution of drugs

8

and devices and the practice of pharmacy for the protection and

9

promotion of the public health, safety and welfare.

10

* * *

11

Section 6.  Section 7 of the act is amended by adding a

12

subsection to read:

13

Section 7.  Hearings and Suspensions.--* * *

14

(e)  Notwithstanding any other provision, subsections (d.3),

15

(d.4), (d.5), (d.6), (d.7) and (d.8) and (d.7) shall not apply

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16

to pharmacy technicians, except as those subsections relate to

17

the professional health monitoring program.

18

Section 7.  Sections 8(2) and (8) and 8.1 of the act, amended

19

or added December 20, 1986 (P.L.433, No.111), are amended to

20

read:

21

Section 8.  Unlawful Acts.--It shall be unlawful for:

22

* * *

23

(2)  Any person not duly licensed as a pharmacist, pursuant

24

to section 3 hereof, to engage in the practice of pharmacy,

25

including the preparing, compounding, dispensing, selling or

26

distributing at retail to any person any drug, except by a

27

pharmacy intern, pharmacy technician or such other authorized

28

personnel under the direct and [immediate] personal supervision

29

of a pharmacist: Provided, however, That nothing herein shall be

30

construed to prevent a duly licensed medical practitioner from

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1

dispensing, compounding or otherwise giving any drug to his own

2

patients after diagnosis or treatment of said patient, if such

3

compounding, preparing and dispensing is done by said licensee

4

himself, nor shall anything herein prevent any person from

5

selling or distributing at retail household remedies or

6

proprietary medicines when the same are offered for sale or sold

7

in the original packages which have been put up ready for sale

8

to consumers, provided household remedies or proprietary

9

medicines shall not include any controlled substances or non-

10

proprietary drug under the act of April 14, 1972 (P.L.233, No.

11

64), known as "The Controlled Substance, Drug, Device and

12

Cosmetic Act."

13

* * *

14

(8)  Any person, firm or corporation to use the title

15

"pharmacist", "assistant pharmacist", "pharmacy technician",

16

"pharmacy technician trainee", "druggist"[,] or "apothecary",

17

except a person duly licensed as a pharmacist or registered as a

18

pharmacy technician in Pennsylvania, or any person to conduct or

19

transact business under a name which contains as part thereof

20

the words "drug store", "pharmacy", "drugs", "medicine store",

21

"medicines", "drug shop," "apothecary," "pharmaceutical,"

22

"homeopathic," "homeopathy" or any term having a similar

23

meaning, or in any manner by advertisement, display of show

24

globes or otherwise describe or refer to the place of the

25

conducted business or person, unless the place is a pharmacy

26

duly issued a permit by the State Board of Pharmacy.

27

* * *

28

Section 8.1.  Injunction.--It shall be unlawful for any

29

person to practice or attempt to offer to practice pharmacy or

30

as a pharmacy technician, as defined in this act, without having

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1

at the time of so doing a valid, unexpired, unrevoked and

2

unsuspended license or registration issued under this act. The

3

unlawful practice of pharmacy as defined in this act may be

4

enjoined by the courts on petition of the board or the

5

Commissioner of Professional and Occupational Affairs. In any

6

such proceeding it shall not be necessary to show that any

7

person is individually injured by the actions complained of. If

8

it is found that the respondent has engaged in the unlawful

9

practice of pharmacy, the court shall enjoin him or her from so

10

practicing unless and until he or she has been duly licensed.

11

Procedure in such cases shall be the same as in any other

12

injunction suit. The remedy by injunction hereby given is in

13

addition to any other civil or criminal prosecution and

14

punishment.

15

Section 8.  No person is required to be registered as a

16

pharmacy technician under section 2.1 of the act until two years

17

after the State Board of Pharmacy has promulgated regulations

18

under section 8 9 of this act. 

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19

Section 9.  The State Board of Pharmacy shall promulgate

20

regulations to implement the addition of section 2.1 of the act

21

within 18 months of the effective date of this section. The

22

addition of section 2.1 of the act shall not be enforceable by

23

the State Board of Pharmacy until the publication of final

24

regulations. 

25

Section 20.  This act shall take effect in 60 days.

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