PRINTER'S NO.  579

  

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

  

  

REFERRED TO COMMITTEE ON PROFESSIONAL LICENSURE, FEBRUARY 19, 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.

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The General Assembly of the Commonwealth of Pennsylvania

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hereby enacts as follows:

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

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

15

clauses to read:

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

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* * *

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

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registered by the Sate Board of Pharmacy under section 2.1 to

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assist in the practice of pharmacy.

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

 


1

holds a temporary permit issued by the State Board of Pharmacy

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under section 2.1.

3

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

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means:

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(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

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questions or problems.

12

* * *

13

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

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Section 2.1.  Registration and Permits for Pharmacy

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

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technician a person who:

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

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

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individual under oath or affirmation, containing information the

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board requires.

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

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of the following:

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(i)  Is not less than eighteen years of age and is a legal

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resident of the United States.

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

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

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

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pharmacy technician by reason of the extent or manner of the

29

applicant's use of alcoholic beverages or controlled substances

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or by reason of a physical or mental disability.

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(iv)  has completed a pharmacy technician training program

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approved by the board.

3

(v)  Has received certification from a nationally recognized

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certifying agency approved by the board.

5

(vi)  Has successfully completed an examination approved by

6

the board and administered in accordance with the requirements

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

8

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

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

10

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

11

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

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convicted of a felony relating to a controlled substance in a

13

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

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or country unless:

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

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conviction; and

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(B)  the applicant satisfactorily demonstrates to the board

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that the applicant has made significant progress in personal

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rehabilitation since the conviction such that licensure of the

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applicant should not be expected to create a substantial risk of

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

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substantial risk of further criminal violations.

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

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

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applicant's statement on the application declaring the absence

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of a conviction shall be deemed satisfactory evidence of the

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

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the contrary.

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(b)  The following exceptions shall apply:

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(1)  Notwithstanding subsection (a)(3)(iv) and (v), the board

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shall register all of the following:

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

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has proof of registration, certification or licensure or its

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equivalent as a pharmacy technician in another state, territory

5

or possession of the United States that has registration,

6

certification, licensure or equivalent requirements comparable

7

to those set forth in this section and regulations of the board.

8

(ii)  An individual who:

9

(A)  applies for registration within two years after the

10

effective date of this section; and

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

12

current certification by a nationally recognized pharmacy

13

technician association.

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

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board shall issue registration to an individual who:

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(i)  Has been employed as a pharmacy technician for a minimum

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of two thousand hours during the three years immediately

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preceding the enactment of this act.

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

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practice as a pharmacy technician for at least two thousand

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hours immediately prior to the date of application.

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(c)  A registration shall authorize the registrant to assist

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in the practice of pharmacy under the direct and personal

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supervision of a pharmacist.

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

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shall establish by regulation a fee for renewal.

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(e)  The following apply to pharmacy technician trainees:

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

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pharmacy technician trainee to an applicant who is seventeen

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years of age or older and meets the requirements of subsection

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(a)(3)(ii) and (iii) and complies with the following:

2

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

3

pharmacy technician training program and as part of the program

4

may be required to serve an externship or internship; or

5

(ii)  The individual is employed by a pharmacy and

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participates in a board-approved pharmacy technician training

7

program that may include an externship or internship program.

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

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

10

verification to the satisfaction of the board that the trainee

11

has completed the board-approved training program.

12

(3)  A temporary permit shall not be reissued.

13

(4)  A temporary permit shall authorize the permittee to

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perform the duties of a pharmacy technician under the direct and

15

personal supervision of a pharmacist.

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(f)  Identification requirements are as follows:

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

18

identifies the temporary permit holder with the title "pharmacy

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technician trainee."

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

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

22

standing.

23

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

24

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

25

Section 3.2.  Reporting of Multiple Licensure, Registration

26

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

27

technician of this Commonwealth who is also registered,

28

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

29

territory or country shall report this information to the board

30

on the biennial registration application. Any disciplinary

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action taken in other states, territories and countries shall be

2

reported to the board on the biennial registration application

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

4

Multiple registration, certification or licensure shall be noted

5

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

6

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

7

by the board of any disciplinary actions taken against [said

8

pharmacist] that licensee or registrant in this Commonwealth.

9

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

10

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

11

adding a subsection to read:

12

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

13

  

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

15

suspend the registration of any pharmacy technician upon proof

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satisfactory to it that the pharmacy technician has done any of

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the following:

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(1)  Procured a personal registration through fraud,

19

misrepresentation or deceit.

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

21

nolo contendere, or has received probation without verdict,

22

disposition in lieu of trial or an Accelerated Rehabilitation

23

Disposition in the disposition of felony charges, to any offense

24

in connection with the practice of pharmacy or any offense

25

involving moral turpitude before any court of record of any

26

jurisdiction.

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

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intemperance in the use of alcoholic beverages, controlled

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substances or any other substance which impairs the intellect

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

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professional duties.

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

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

4

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

5

have authority to compel a pharmacy technician to submit to a

6

mental or physical examination by physicians or psychologists

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approved by the board. Failure of a pharmacy technician to

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

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to circumstances beyond the pharmacy technician's control, shall

10

constitute an admission of the allegations against the pharmacy

11

technician, consequent upon which a default and final order may

12

be entered without the taking of testimony or presentation of

13

evidence. A pharmacy technician affected under this clause shall

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at reasonable intervals be afforded an opportunity to

15

demonstrate the ability to resume a competent practice as a

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pharmacy technician with reasonable skill and safety to

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patients.

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

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practice as a pharmacy technician denied, revoked or suspended

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by an appropriate pharmacy technician registration,

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certification or licensing authority or has received

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disciplinary action from an appropriate pharmacy technician

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registration, certification or licensing authority.

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

25

and clear danger to the public health or safety.

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

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

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the standards of acceptable and prevailing pharmacy technician

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

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* * *

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(c)  When the board finds that the registration,

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

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

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the board may:

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(1)  Deny the application for a registration, certification

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or license.

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(2)  Administer a public reprimand.

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

9

registration, certification or license as determined by the

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board.

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

12

treatment of a physician or a psychologist designated by the

13

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

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

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licensee on probation with the right to vacate the probationary

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order for noncompliance.

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

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license [to practice pharmacy] or registration and impose any

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disciplinary or corrective measure which it might originally

20

have imposed.

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* * *

22

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

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

24

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

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

26

duty:

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

28

technicians;

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(2)  To determine the nature of examinations for all

30

applicants for [pharmacists'] licenses;

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

2

all applicants for licensure as pharmacists, pharmacies or

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registration as pharmacy interns and pharmacy technicians, and 

4

to grant certificates of licensure or registration to all

5

applicants whom it shall judge to be properly qualified;

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(4)  With the approval of the Commissioner of Professional

7

and Occupational Affairs, to prepare position descriptions,

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employ inspectors who shall be licensed pharmacists and employ

9

appropriate consultants to assist it for any purposes which it

10

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

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of its final decisionmaking responsibilities to any consultant;

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(5)  To investigate or cause to be investigated all

13

violations of the provisions of this act and its regulations and

14

to cause prosecutions to be instituted in the courts upon advice

15

from the Attorney General;

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

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

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

19

which are periodically inspected by the Department of Health in

20

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

21

regulations promulgated thereto: Provided, That the Department

22

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

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

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

25

to inspect such pharmacies and take appropriate action as

26

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

27

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

28

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

29

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

30

are adulterated, misbranded or stored, held, dispensed,

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distributed or compounded in violation of the provisions of this

2

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

3

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

4

Cosmetic Act";

5

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

6

licenses, permits or registrations, for which hearings the board

7

shall have the power to subpoena witnesses;

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(8)  To assist the regularly constituted enforcement agencies

9

of this Commonwealth in enforcing all laws pertaining to drugs,

10

controlled substances, and practice of pharmacy;

11

(8.1)  To approve programs for the training of pharmacy

12

technicians;

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(9)  To promulgate rules and regulations to effectuate the

14

purposes of this act and to regulate the distribution of drugs

15

and devices and the practice of pharmacy for the protection and

16

promotion of the public health, safety and welfare.

17

* * *

18

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

19

subsection to read:

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

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

22

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

23

technicians, except as those subsections relate to the

24

professional health monitoring program.

25

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

26

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

27

read:

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

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* * *

30

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

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

2

including the preparing, compounding, dispensing, selling or

3

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

4

pharmacy intern, pharmacy technician or such other authorized

5

personnel under the direct and [immediate] personal supervision

6

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

7

construed to prevent a duly licensed medical practitioner from

8

dispensing, compounding or otherwise giving any drug to his own

9

patients after diagnosis or treatment of said patient, if such

10

compounding, preparing and dispensing is done by said licensee

11

himself, nor shall anything herein prevent any person from

12

selling or distributing at retail household remedies or

13

proprietary medicines when the same are offered for sale or sold

14

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

15

to consumers, provided household remedies or proprietary

16

medicines shall not include any controlled substances or non-

17

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

18

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

19

Cosmetic Act."

20

* * *

21

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

22

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

23

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

24

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

25

pharmacy technician in Pennsylvania, or any person to conduct or

26

transact business under a name which contains as part thereof

27

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

28

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

29

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

30

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

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1

globes or otherwise describe or refer to the place of the

2

conducted business or person, unless the place is a pharmacy

3

duly issued a permit by the State Board of Pharmacy.

4

* * *

5

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

6

person to practice or attempt to offer to practice pharmacy or

7

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

8

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

9

unsuspended license or registration issued under this act. The

10

unlawful practice of pharmacy as defined in this act may be

11

enjoined by the courts on petition of the board or the

12

Commissioner of Professional and Occupational Affairs. In any

13

such proceeding it shall not be necessary to show that any

14

person is individually injured by the actions complained of. If

15

it is found that the respondent has engaged in the unlawful

16

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

17

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

18

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

19

injunction suit. The remedy by injunction hereby given is in

20

addition to any other civil or criminal prosecution and

21

punishment.

22

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

23

pharmacy technician under section 2.1 of the act until two years

24

after the State Board of Pharmacy has promulgated regulations

25

under section 8 of this act. 

26

Section 9.  The State Board of Pharmacy shall promulgate

27

regulations to implement the addition of section 2.1 of the act

28

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

29

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

30

the State Board of Pharmacy until the publication of final

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regulations. 

2

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

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