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| PRIOR PRINTER'S NO. 579 | PRINTER'S NO. 2888 |
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| THE GENERAL ASSEMBLY OF PENNSYLVANIA |
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| HOUSE BILL |
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| INTRODUCED BY DeLUCA, CIVERA, DALEY, FABRIZIO, W. KELLER, KORTZ, KULA, MANN, MELIO, M. O'BRIEN, REICHLEY, SIPTROTH, STABACK, STURLA AND WALKO, FEBRUARY 19, 2009 |
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| AS REPORTED FROM COMMITTEE ON PROFESSIONAL LICENSURE, HOUSE OF REPRESENTATIVES, AS AMENDED, NOVEMBER 16, 2009 |
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| AN ACT |
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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 | <-- |
20 | to assist in the practice of pharmacy. |
21 | (10.2) "Pharmacy technician trainee" means an individual who |
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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 | <-- |
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 | <-- |
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 | <-- |
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 | <-- |
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 | <-- |
10 | pharmacist revoked or suspended or had other disciplinary action |
11 | taken by a proper licensing authority. |
12 | (b) The following exceptions shall apply: | <-- |
13 | (1) Notwithstanding subsection (a)(3)(iv) and (v) |
14 | Notwithstanding subsection (a)(3)(iii), the board shall register | <-- |
15 | all an individual who applies for registration within two years | <-- |
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, | <-- |
19 | has (1) Demonstrates to the satisfaction of the board proof of | <-- |
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: | <-- |
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 | <-- |
30 | recognized pharmacy technician association. |
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1 | (2) Notwithstanding subsection (a)(3)(ii), (iv) and (v), the | <-- |
2 | board shall issue registration to an individual who: |
3 | (i) Has been employed (3) Demonstrates to the satisfaction | <-- |
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. | <-- |
7 | (ii) Demonstrates to the satisfaction of the board proof of | <-- |
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: | <-- |
16 | (1) The board may issue a temporary permit to practice as a |
17 | pharmacy technician trainee to an applicant who is seventeen | <-- |
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 | <-- |
20 | with the following: |
21 | (i) The applicant is a student enrolled in a board-approved | <-- |
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 | <-- |
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 | <-- |
8 | technician trainee." pharmacy technician with the title | <-- |
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 | <-- |
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 | <-- |
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. | <-- |
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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