PRINTER'S NO. 933
No. 874 Session of 1997
INTRODUCED BY RHOADES, AFFLERBACH, GREENLEAF, TOMLINSON,
LAVALLE, KUKOVICH, COSTA, ROBBINS, MADIGAN, MUSTO, STOUT,
HELFRICK, WOZNIAK, PUNT, CORMAN, BRIGHTBILL, KASUNIC,
WILLIAMS AND WHITE, APRIL 2, 1997
REFERRED TO CONSUMER PROTECTION AND PROFESSIONAL LICENSURE,
APRIL 2, 1997
AN ACT
1 Relating to the regulation of the practice of pharmacy; and
2 making repeals.
3 TABLE OF CONTENTS
4 Chapter 1. Preliminary Provisions
5 Section 101. Short title.
6 Section 102. Legislative declaration.
7 Section 103. Statement of purpose.
8 Section 104. Definitions.
9 Section 105. Construction of act.
10 Chapter 3. State Board of Pharmacy
11 Section 301. Pennsylvania State Board of Pharmacy.
12 Section 302. Membership.
13 Section 303. Qualification.
14 Section 304. Appointment.
15 Section 305. Terms of office.
16 Section 306. Removal.
1 Section 307. Organization.
2 Section 308. Compensation of board members.
3 Section 309. Meetings.
4 Section 310. Executive director.
5 Section 311. Employees.
6 Section 312. Rules and regulations.
7 Section 313. Powers and responsibilities.
8 Section 314. Communication to licensees.
9 Section 315. Annual report.
10 Chapter 5. Pharmacists and Pharmacies
11 Subchapter A. Pharmacists
12 Section 501. Declaration.
13 Section 502. Licensing of pharmacists.
14 Section 503. Prerequisites for pharmacist license.
15 Section 504. Examinations.
16 Section 505. Internship.
17 Section 506. Qualifications for reciprocal license transfer.
18 Section 507. Renewal of licenses.
19 Section 508. Continuing pharmacy education.
20 Section 509. Reporting multiple licensures.
21 Subchapter C. Pharmacies
22 Section 521. Licensing of pharmacies.
23 Section 522. Renewal of pharmacy permit.
24 Section 523. Permit required for operation.
25 Section 524. Display of ownership information.
26 Section 525. Extraterritorial pharmacy permits.
27 Section 526. Regulatory power over pharmacies.
28 Chapter 7. Enforcement
29 Section 701. Refusal to grant, revocation and suspension
30 of licenses and permits.
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1 Section 702. Temporary suspension.
2 Section 703. Automatic suspension.
3 Section 704. Impaired licensee.
4 Section 705. Reinstatement.
5 Section 706. No bar to criminal action.
6 Section 707. Administrative Agency Law.
7 Section 708. Board action.
8 Section 709. Pharmacy permits.
9 Section 710. Return of license or permit.
10 Section 711. Hearings.
11 Section 712. Docket and other records.
12 Chapter 9. Pharmacist Practice
13 Section 901. Practice of pharmacy.
14 Section 902. Pharmacy is health care service.
15 Section 903. Drug regimen review.
16 Section 904. Disease state management.
17 Section 905. Collaborative care agreements.
18 Section 906. Compensation.
19 Section 907. Pharmacy technicians.
20 Section 908. Prescriptions.
21 Section 909. Emergency refills.
22 Section 910. Impaired pharmacist or pharmacist intern.
23 Chapter 11. Unlawful Activities
24 Section 1101. Unlawful acts.
25 Section 1102. Criminal penalties.
26 Section 1103. Additional civil penalty.
27 Chapter 13. Fiscal Affairs
28 Section 1301. Setting of fees.
29 Section 1302. Account and fees disposition.
30 Section 1303. Annual submissions.
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1 Section 1304. Hiring of pharmacy inspectors.
2 Chapter 15. Miscellaneous Provisions
3 Section 1501. Board members.
4 Section 1502. Rules and regulations.
5 Section 1503. Current licensees.
6 Section 1504. Severability.
7 Section 1505. Repeals.
8 Section 1506. Effective date.
9 The General Assembly of the Commonwealth of Pennsylvania
10 hereby enacts as follows:
11 CHAPTER 1
12 PRELIMINARY PROVISIONS
13 Section 101. Short title.
14 This act shall be known and may be cited as the Pharmacy
15 Practice Act.
16 Section 102. Legislative declaration.
17 It is declared to be a matter of public interest and concern
18 that the practice of pharmacy, as defined in this act, merit and
19 receive the confidence of the public. It is further declared
20 that only qualified persons be permitted to engage in the
21 practice of pharmacy in the Commonwealth of Pennsylvania.
22 Section 103. Statement of purpose.
23 It is the purpose of this act to promote, preserve and
24 protect the public health, safety and welfare by the effective
25 control and regulation of the practice of pharmacy through:
26 (1) The licensure of pharmacists.
27 (2) The licensure of pharmacist interns.
28 (3) The registration of technicians.
29 (4) The licensure, control and regulation of all sites
30 or persons who are required to obtain a license or permit
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1 from the board, whether located in or out of the
2 Commonwealth, that deliver, dispense, administer, distribute,
3 manufacture, promote or sell drugs within this Commonwealth.
4 Section 104. Definitions.
5 The following words and phrases when used in this act shall
6 have the meanings given to them in this section unless the
7 context clearly indicates otherwise:
8 "Administer." The direct introduction of or the application
9 of a drug into or on the body of a patient or research subject
10 by injection, inhalation, ingestion or any other means.
11 "Beyond-use date." A date determined by a pharmacist and
12 placed on a prescription label at the time dispensing that is
13 intended to indicate to the patient or caregiver a time beyond
14 which the contents of that prescription are not recommended for
15 use.
16 "Board." The Pennsylvania State Board of Pharmacy.
17 "Collaborative care agreement." A written agreement or
18 protocol between a licensed prescriber and a pharmacist
19 authorizing that pharmacist to:
20 (1) Initiate, modify, monitor, continue or discontinue
21 drug therapy.
22 (2) Administer medications.
23 (3) Order and perform laboratory or other diagnostic
24 tests in accordance with regulations adopted by the
25 Pennsylvania State Board of Pharmacy.
26 "Collaborative pharmacy practice." The practice of pharmacy
27 whereby a pharmacist has jointly agreed to work in conjunction
28 with one or more licensed prescribers under a protocol whereby
29 the pharmacist may perform certain patient care functions
30 authorized by the practitioner or practitioners under certain
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1 specified conditions or limitations, including, but not limited
2 to, the initiating, continuing or discontinuing of drug therapy;
3 the administration of drugs; and the ordering and/or the
4 performing of laboratory tests which may be necessarily incident
5 to the treatment.
6 "Compounding." The preparation, mixing, assembling,
7 packaging or labeling of a drug pursuant to or in anticipation
8 of a valid prescription drug order, including, but not limited
9 to, packaging, intravenous admixture or manual combination of
10 drug ingredients.
11 "Confidential information." Information relevant to a
12 patient's health care which is acquired by the pharmacist
13 incident to a professional relationship. Confidential
14 information is privileged and may be released only to the
15 patient, or to a third party upon the authorization of the
16 patient, or where such release is necessary to protect the
17 patient's health and well-being, or to such other persons or
18 government agencies authorized by law to receive that
19 information.
20 "Controlled substance." Any drug designated as such under
21 the provisions of the act of April 14, 1972 (P.L.233, No.64),
22 known as The Controlled Substance, Drug, Device and Cosmetic
23 Act.
24 "Deliver" or "delivery." The actual, constructive or
25 attempted transfer of a drug or device from one person to
26 another, whether or not for consideration.
27 "Device." An instrument, apparatus, implement, machine,
28 contrivance, implant, in vitro reagent or other similar or
29 related article, including any component part or accessory,
30 which is required under Federal or State law to be prescribed by
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1 a health practitioner and dispensed by a pharmacist.
2 "Disease state management." A comprehensive, integrated
3 approach to patient care based upon the natural course of
4 disease which emphasizes treatments designed to address an
5 illness with maximum efficiency.
6 "Dispense" or "dispensing." The procedure entailing the
7 interpretation of a health practitioner's medical order or a
8 prescription drug order for a drug or device and pursuant to
9 that order, the proper selection, measuring, labeling and
10 packaging of a drug or device in a proper container for
11 subsequent administration to or use by a patient.
12 "Distribute." The delivery of a drug or device other than by
13 administering or dispensing.
14 "Drug."
15 (1) Articles, including radioactive substances,
16 recognized as drugs in any official compendium, or supplement
17 thereto, or designated from time to time by the Pennsylvania
18 State Board of Pharmacy for use in the diagnosis, cure,
19 mitigation, treatment, or prevention of disease in humans or
20 other animals.
21 (2) Articles, other than food, intended to affect the
22 structure or any function of the body of humans or other
23 animals.
24 (3) Articles intended for use as a component of any
25 articles specified in paragraphs (1) and (2), but not
26 including devices or their component parts or accessories.
27 "Drug regimen review." Any retrospective, concurrent and
28 prospective review by a pharmacist of a patient's drug-related
29 therapy, including, but not limited to, evaluation of any or all
30 of the following areas:
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1 (1) Known allergies.
2 (2) Rational therapy-contraindications.
3 (3) Appropriate dose and route of administration.
4 (4) Appropriate directions for use.
5 (5) Duplicative therapies.
6 (6) Potential misuse or abuse.
7 (7) Drug-drug, drug-food, drug-disease and drug-clinical
8 laboratory interactions.
9 (8) Adverse drug reactions.
10 (9) Drug utilization review and optimal therapeutic
11 outcomes.
12 "Electronic data transmission." The transmission of
13 information in electronic form or the transmission of the exact
14 visual image of a document by way of electronic equipment.
15 "Emergency refill prescription." A refill of a prescription
16 which is essential to the continuation of therapy for which that
17 refill has not been authorized and for which the pharmacist
18 notifies the prescriber within 72 hours, of dispensing that
19 prescription that an emergency refill prescription has been
20 dispensed.
21 "Federal act." The Federal Food, Drug and Cosmetic Act (52
22 Stat. 1040, 21 U.S.C. § 301 et seq.)
23 "Health care provider" or "health practitioner." An
24 individual licensed by the Commonwealth to provide patient care
25 under the authority of a professional practice act, and includes
26 licensed prescribers and health care providers or health
27 practitioners.
28 "Home infusion pharmacy." A pharmacy which compounds
29 solutions for direct administration to a patient in a private
30 residence, long-term care facility, hospice or similar setting
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1 by means of parenteral, intravenous, intramuscular,
2 subcutaneous, or intraspinal infusion.
3 "Immediate supervision." A level of control which assures
4 that the pharmacist has the ultimate responsibility for the
5 accuracy, safety and patient outcomes with respect to the
6 actions of pharmacy technicians and pharmacist interns and the
7 use of automation in all practice settings.
8 "Impaired professional support group." A peer assistance
9 group whose goals are to direct an impaired colleague into
10 treatment.
11 "Labeling." The process of preparing and affixing a label to
12 any drug container, which label shall include all information
13 required by Federal and State law, rule or regulation.
14 "Licensed prescriber." A physician, dentist, veterinarian,
15 podiatrist, or other individual duly authorized and licensed by
16 law to independently prescribe drugs, including prescription
17 drugs.
18 "Long-term care facility." A nursing home, retirement care
19 facility, mental care facility or other facility or institution
20 which provides extended health care to resident patients.
21 "Managing drug therapy." Adjusting a drug regimen; changing
22 the duration of therapy; adjusting drug strength, frequency of
23 administration and/or route; and the initiation or
24 discontinuation of therapy, including the administration of
25 drugs.
26 "Manufacturer." Any person, except a pharmacist compounding
27 in the normal course of professional practice within this
28 Commonwealth, engaged in the commercial production, preparation,
29 propagation, compounding, conversion, or processing of a drug,
30 either directly or indirectly, by extraction from substances of
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1 natural origin or independently by means of chemical synthesis,
2 or both, and includes any packaging or repackaging of a drug or
3 the labeling or relabeling of the drug container.
4 "Medical order." A lawful order by a specifically identified
5 health practitioner for a specifically identified patient.
6 "Nonprescription drug." A drug which may be sold without
7 prescription and which is labeled for use by the consumer in
8 accordance with the requirements of the laws and rules of the
9 Federal Government and this Commonwealth.
10 "Nonresident pharmacy." A pharmacy located outside this
11 Commonwealth.
12 "Patient counseling." The process of the communication of
13 information between the pharmacist and the patient, including,
14 but not limited to, both verbal and written information as
15 defined in the rules of the Pennsylvania State Board of Pharmacy
16 in order to promote the proper use of any drug and to enhance
17 drug therapy.
18 "Person." An individual, corporation, partnership,
19 association, or any other legal entity including government.
20 "Pharmacist." A health care provider or practitioner
21 currently licensed by the Pennsylvania State Board of Pharmacy
22 to engage in the practice of pharmacy.
23 "Pharmacist care" or "pharmaceutical care" or "pharmacy
24 care." The provision, by a pharmacist, of drug therapy and other
25 patient care services to achieve patient outcomes which improve
26 the patient's quality of life as it is related to the cure or
27 prevention of a disease, elimination or reduction of a patient's
28 symptoms, or arresting or slowing of a disease process.
29 "Pharmacist intern." An individual licensed by the
30 Pennsylvania State Board of Pharmacy to engage in the practice
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1 of pharmacy under the immediate supervision of a licensed
2 pharmacist and who makes satisfactory progress toward meeting
3 the requirements for licensure as a pharmacist.
4 "Pharmacy." Any place within this Commonwealth which is
5 properly issued a permit by the Pennsylvania State Board of
6 Pharmacy where drugs, devices, radiopharmaceuticals and
7 diagnostic agents for human or animal consumption are stored,
8 dispensed or compounded, or any place outside this Commonwealth
9 where drugs, devices, radiopharmaceuticals and diagnostic agents
10 for human and animal consumption are dispensed to residents of
11 this Commonwealth. The term "pharmacy" shall not include the
12 operation of a manufacturer or distributor as defined in the Act
13 of April 14, 1972 (P.L.233, No.64), known as The Controlled
14 Substance, Drug, Device and Cosmetic Act. Within an institution
15 the term "pharmacy" refers to all organized pharmacy service
16 within that institution.
17 "Pharmacy practice site." Any place within or outside this
18 Commonwealth where the practice of pharmacy is provided to
19 residents of this Commonwealth.
20 "Pharmacy technician." An individual who is registered with
21 the board and who may assist in the practice of pharmacy under
22 the immediate supervision of a licensed pharmacist.
23 "Practice of pharmacy," The provision of health care
24 services by a pharmacist, including, but not limited to:
25 (1) The interpretation, evaluation and implementation of
26 medical orders.
27 (2) The delivering, dispensing or distributing of
28 prescription drugs.
29 (3) Participation in drug and device selection.
30 (4) Drug administration.
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1 (5) Drug regimen review.
2 (6) Drug or drug-related research.
3 (7) The provision of pharmacist care in all areas
4 including primary care.
5 (8) Compounding.
6 (9) Proper and safe storage of drugs and devices.
7 (10) Managing drug therapy.
8 (11) Participation in collaborative care agreements.
9 (12) Maintaining proper records.
10 (13) Patient counseling.
11 (14) Performing physical assessment.
12 (15) Ordering and performing laboratory or other
13 diagnostic tests.
14 (16) Disease state management.
15 (17) Any other acts, services, operations or
16 transactions necessary or incident to providing pharmacist
17 care.
18 "Preceptor." An individual who is currently licensed as a
19 pharmacist by the Pennsylvania State Board of Pharmacy, meets
20 the qualifications as a preceptor under the rules of the board,
21 has filed with the board any application or documentation and
22 the board may require and participates in the instructional
23 training of pharmacy interns.
24 "Prescription drug" or "legend drug" or "nonproprietary
25 drug." Any drug which is required by any applicable Federal or
26 State law or regulation to be dispensed only pursuant to a
27 prescription drug order or which is restricted to use by health
28 practitioners.
29 "Prescription drug order." A lawful order issued by a duly
30 licensed health practitioner for drugs, drug-related devices or
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1 treatment for a human or animal, including orders issued through
2 collaborative care agreements.
3 Primary care." A pharmacist's activities in patient
4 education, health promotion, assistance in the selection of and
5 use of over-the-counter drugs and appliances for the treatment
6 of common diseases and injuries; drug selection under protocol;
7 nutrition; and any other activities falling within the
8 pharmacist's statutory or regulatory scope of practice.
9 "Protocol." A written document that describes the nature and
10 scope of the drug therapy management to be carried out by the
11 pharmacist or other health practitioner.
12 "Wholesaler." Any person within this Commonwealth who
13 legally buys drugs for resale or distribution to persons other
14 than patients or consumers.
15 Section 105. Construction of act.
16 This act shall be liberally construed to carry out these
17 objectives and purposes.
18 CHAPTER 3
19 PENNSYLVANIA STATE BOARD OF PHARMACY
20 Section 301. Pennsylvania State Board of Pharmacy.
21 The responsibility for enforcement of the provisions of this
22 act is hereby vested in the Pennsylvania State Board of
23 Pharmacy. The board shall have all the powers, duties and
24 authority specifically granted by or necessary for the
25 enforcement of this act, as well as any other powers, duties and
26 authorities that may be granted by law.
27 Section 302. Membership.
28 Beginning with any vacancies existing on the effective date
29 of this act, and as terms expire or vacancies occur thereafter,
30 the board shall consist of:
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1 (1) The Commissioner of Professional and Occupational
2 Affairs.
3 (2) The Director of the Bureau of Consumer Protection in
4 the Office of Attorney General or a designee of the director.
5 (3) Two persons representing the public at large.
6 (4) Seven persons who are licensed to practice pharmacy
7 in this Commonwealth. Of the seven appointees under this
8 paragraph:
9 (i) Two pharmacists shall be appointed from
10 independent retail pharmacies.
11 (ii) Two pharmacists shall be appointed who are
12 employees of retail chain pharmacies which operate five
13 or more pharmacies licensed within this Commonwealth.
14 (iii) One pharmacist shall be appointed from an
15 acute care institutional pharmacy.
16 (iv) Two pharmacists shall be appointed who are each
17 involved in one of the following areas:
18 (A) Long-term care pharmacy or consulting
19 pharmacy.
20 (B) Pharmacy education at an accredited school
21 or college of pharmacy, as recognized by the board,
22 within this Commonwealth.
23 (C) Nuclear pharmacy, home health care practice
24 or any other specialty recognized by the board and
25 not yet represented.
26 Section 303. Qualification.
27 Each pharmacist member of the board shall at the time of
28 appointment:
29 (1) Be a resident of this Commonwealth for not less than
30 one year.
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1 (2) Must have been registered as a pharmacist in this
2 Commonwealth for at least five years immediately preceding
3 appointment.
4 (3) The public members of the board shall have been
5 residents of this Commonwealth for not less than two years at
6 the time of their appointment, shall have attained the age of
7 majority, and shall not be, nor shall ever have been, a
8 pharmacist, or the spouse of a pharmacist, or a person who
9 has ever had any material financial interest in the provision
10 of pharmacy services or who has engaged in any activity
11 directly related to the practice of pharmacy.
12 Section 304. Appointment.
13 Nominations for appointment to the board may be made to the
14 Governor by any individual, any professional pharmacy
15 association within this Commonwealth or any other entity. All
16 professional and public members of the board shall be appointed
17 by the Governor with the advice and consent of a majority of the
18 members elected to the Senate.
19 Section 305. Terms of office.
20 (a) Regular term.--Except as provided in subsection (b), the
21 terms of each professional member and each public member of the
22 Board shall be four years, or until a successor has been
23 appointed and qualified, but not longer than six months beyond
24 the four-year period. In the event that any member shall die or
25 resign or otherwise become disqualified during that member's
26 term, a successor shall be appointed in the same way and with
27 the same qualifications as the original member and shall hold
28 office for the unexpired portion of the term.
29 (b) Terms to be staggered.--The terms of the professional
30 and public members of the board shall be staggered, so that the
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1 terms of no more than three members shall expire in any year.
2 Each member shall serve until a successor is appointed and
3 qualified as provided in subsection (a).
4 (c) Existing board members.--The present members of the
5 board on the effective date of this act shall serve the balance
6 of their terms.
7 (d) Reappointment.--No professional or public member of the
8 board shall be eligible for appointment to serve more than three
9 consecutive full terms. The completion of the unexpired portion
10 of a full term shall not constitute a full term for purposes of
11 this subsection. Any present board member appointed initially
12 for a term of less than four years shall be eligible to serve
13 for three additional full terms.
14 (e) Vacancies.--Any vacancy which occurs in the membership
15 of the board for any reason, shall be filled by the Governor in
16 the manner provided for appointment of board members in section
17 304.
18 Section 306. Removal.
19 (a) Grounds for removal.--A board member may be removed
20 pursuant to the procedure set forth in subsection (b), upon one
21 or more of the following grounds:
22 (1) The refusal or inability for any reason of a board
23 member to perform the duties as a member of the board in an
24 efficient, responsible, and professional manner.
25 (2) The misuse of office by a member of the board to
26 obtain personal, pecuniary, or material gain or advantage for
27 that member or another person through such office.
28 (3) The violation by any member of the board of laws
29 governing the practice of pharmacy or the distribution of
30 drugs and/or devices.
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1 (4) The failure of the board member to attend three
2 consecutive board meetings unless the Commissioner of
3 Professional and Occupational Affairs, upon written request
4 from that member, finds that member should be excused from a
5 meeting because of illness or the death of a family member,
6 or other valid reason.
7 (5) The failure of a public member to attend two
8 consecutive statutorily mandated training seminars under
9 section 813(e) of the Act of April 9, 1929 (P.L.177, No.175),
10 known as The Administrative Code of 1929, unless the
11 Commissioner of Professional and Occupational Affairs, upon
12 written request from the public member, finds that the public
13 member should be excused from a meeting because of illness or
14 the death of a family member, or other valid reason.
15 (b) Procedure.--Removal of a member of the board shall be in
16 accordance with 2 Pa.C.S. Ch. 5 Subch. A (relating to practice
17 and procedure of Commonwealth agencies).
18 Section 307. Organization.
19 (a) Officers.--The board shall elect from its members a
20 chairperson and any other officers deemed appropriate and
21 necessary to conduct the business of the board. The chair of the
22 board shall preside at all meetings of the board and shall be
23 responsible for the performance of all of the duties and
24 functions of the board required or permitted by this act. Each
25 additional officer elected by the board shall perform those
26 duties normally associated with that position and any other
27 duties assigned by the board.
28 (b) Terms of office for officers.--Officers elected by the
29 board shall serve terms of one year commencing with the day of
30 their election and ending upon election of their successors, and
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1 shall serve no more than two consecutive full terms in each
2 office to which they are elected.
3 Section 308. Compensation of board members.
4 Each member of the board, except the Commissioner of
5 Professional and Occupational Affairs and the Director of the
6 Bureau of Consumer Protection, shall receive $250 per day when
7 actually attending to the work of the board. Members shall also
8 receive timely reimbursement for reasonable traveling, lodging
9 and other necessary expenses incurred in the performance of
10 their duties in accordance with Commonwealth regulations.
11 Section 309. Meetings.
12 (a) Regular meetings.--The board shall meet at least once
13 every two months and at any additional times that may be
14 necessary to conduct the business of the board. Any additional
15 meetings may be called by the chairperson of the board or by
16 two-thirds of the members of the board.
17 (b) Place of meeting.--The board shall meet at such place as
18 it may, from time to time, determine. The place for each meeting
19 shall be determined prior to giving notice of that meeting to
20 each member. The place of a meeting may not be changed after
21 notice is given without adequate prior to all members of the
22 board.
23 (c) Quorum.--A majority of the members of the board serving
24 in accordance with law shall constitute a quorum for the
25 purposes of conducting the business of the board. Except for
26 temporary and automatic suspensions under this act, a member may
27 not be counted as part of a quorum or vote on any issue unless
28 that member is physically in attendance at the meeting.
29 (d) Open meetings.--All board meetings and hearings shall be
30 open to the public. The board may, in its discretion and
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1 according to law, conduct any portion of its meeting in
2 executive session, closed to the public. Executive sessions may
3 not be utilized during hearings or discussion of current
4 regulations or development of regulations.
5 Section 310. Executive director.
6 (a) Selection.--The board shall select and employ, with the
7 approval of the Commissioner of Professional and Occupational
8 Affairs, an executive director who shall be a full-time employee
9 and who shall be a pharmacist licensed in this Commonwealth. The
10 executive director shall be paid such compensation as determined
11 by the board to be commensurate with the level of compensation
12 paid other executive directors to professional licensing boards
13 in this Commonwealth.
14 (b) Duties.--The executive director shall have the following
15 duties:
16 (1) Establish guidelines and information, with the
17 concurrence of the board, for training of inspectors within
18 the Department of State who are responsible for inspecting
19 pharmacies.
20 (2) Assist the board in revising and promulgating
21 regulations.
22 (3) Review recorded minutes and proceedings of all board
23 meetings and be the custodian of such documents.
24 (4) Maintain a record of policies set by the board and
25 disseminate that information to all board licensees.
26 (5) Perform any other duties the board may request.
27 The executive director shall be provided adequate facilities,
28 staff and pharmacy inspectors to perform the aforesaid
29 functions.
30 Section 311. Employees.
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1 The board may, in its discretion, employ persons in addition
2 to the executive director in such other positions or capacities
3 as it deems necessary for the proper conduct of board business
4 and to fulfill the board's responsibilities as defined by this
5 act.
6 Section 312. Rules and regulations.
7 The board shall, within 180 days of the effective date of
8 this act and at times necessary thereafter promulgate, adopt,
9 amend and repeal rules and/or regulations as deemed necessary by
10 the board for the proper administration and enforcement of this
11 act. Rules and regulations shall be promulgated in accordance
12 with the procedures specified in the act of July 31, 1968
13 (P.L.769, No.240), referred to as the Commonwealth Documents
14 Law, and the act of June 25, 1982 (P.L.633, No.181), known as
15 the Regulatory Review Act.
16 Section 313. Powers and responsibilities.
17 The board shall have sole responsibility for the control and
18 regulation of the practice of pharmacy in this Commonwealth,
19 including, but not limited to, the following:
20 (1) To determine the nature of examinations for any
21 applicant for a pharmacist license.
22 (2) To examine, inspect and investigate all applications
23 and all applicants for licensure as pharmacists, pharmacies
24 or pharmacy interns, or registration as pharmacy technicians,
25 and to grant certificates of licensure or registration to all
26 applicants whom it shall judge to be properly qualified.
27 (3) To renew licenses to engage in the practice of
28 pharmacy and to operate a pharmacy.
29 (4) To establish and enforce compliance with
30 professional standards of conduct of pharmacists engaged in
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1 the practice of pharmacy.
2 (5) To determine and issue standards for recognition and
3 approval of degree programs of schools and colleges of
4 pharmacy whose graduates shall be eligible for licensure in
5 this Commonwealth, and to specific and enforce requirements
6 for practical training, including internship.
7 (6) To enforce those provisions of this act relating to
8 the conduct or competence of pharmacists practicing in this
9 Commonwealth and to suspend, revoke or restrict licenses to
10 engage in the practice of pharmacy.
11 (7) To prepare position descriptions, to employ a
12 minimum of eight pharmacy inspectors, or more of such
13 inspectors if the board deems necessary, who shall be
14 pharmacists licensed in this Commonwealth.
15 (8) To retain appropriate consultants to assist it for
16 any purpose which it may deem necessary, subject to the
17 limitation that the board may not delegate any of its final
18 decision making responsibilities to any consultant.
19 (9) To investigate or cause to be investigated all
20 violations of the provisions of this act and its regulations
21 and to cause prosecutions to be instituted in the courts upon
22 advice from the Office of Attorney General.
23 (10) To inspect any pharmacy licensed by this
24 Commonwealth at reasonable hours for the purpose of
25 determining if any provisions of the laws governing the legal
26 distribution of drugs or devices for the practice of pharmacy
27 are being violated. The board, its officers, inspectors and
28 representatives shall cooperate with all agencies charged
29 with the enforcement of the laws of the United States, of
30 this Commonwealth and of all other states relating to drugs,
19970S0874B0933 - 21 -
1 devices and the practice of pharmacy.
2 (11) To make or order inspections of other places in
3 which drugs or devices are stored, held, compounded,
4 dispensed or sold to a consumer, and to take and analyze any
5 drugs or devices and to seize and condemn any drugs or
6 devices which are adulterated, misbranded, or stored, held,
7 dispensed, distributed, or compounded in violation of the
8 provisions of this act or the provisions of the act of April
9 14, 1972 (P.L.233, No.64), known as The Controlled Substance,
10 Drug, Device and Cosmetic Act.
11 (12) To establish minimum specifications for the
12 physical facilities, technical equipment, environment,
13 supplies, personnel and procedures, for the storage,
14 compounding and/or dispensing of drugs or devices and for the
15 monitoring of drug therapy.
16 (13) To establish minimum standards for maintaining the
17 integrity and confidentiality of prescription information and
18 other patient care information.
19 (14) To conduct hearings for the revocation or
20 suspension of licenses, permits or registrations, for which
21 hearings the board shall have the power to subpoena
22 witnesses.
23 (15) To assist the regularly constituted enforcement
24 agencies of this Commonwealth in enforcing all laws
25 pertaining to drugs, controlled substances and the practice
26 of pharmacy.
27 (16) To have authority to issue subpoenas, upon
28 application of an attorney responsible for representing the
29 Commonwealth in disciplinary matters before the board, for
30 the purpose of investigating alleged violations of the
19970S0874B0933 - 22 -
1 disciplinary provisions administered by the board.
2 (i) The board shall have the power to subpoena
3 witnesses, to administer oaths, to examine witnesses and
4 to take such testimony or compel the production of such
5 books, records, papers and documents as it may deem
6 necessary or proper in, and pertinent to, any proceeding,
7 investigation or hearing held or had by it.
8 (ii) Patient records may not be subpoenaed without
9 the consent of the patient or without order of a court of
10 competent jurisdiction on a showing that the records are
11 reasonably necessary for the conduct of the
12 investigation.
13 (iii) The court may impose such limitations on the
14 scope of the subpoena as are necessary to prevent
15 unnecessary intrusion into a patient confidential
16 situation.
17 (iv) The board is authorized to apply to
18 Commonwealth Court to enforce its subpoenas.
19 (17) In addition to its appropriation from the
20 Commonwealth, to receive and expend funds from parties other
21 than the Commonwealth, subject to the following restrictions:
22 (i) The funds are awarded for the pursuit of a
23 specific objective which the board is authorized to
24 accomplish by this act, or which the board is qualified
25 to accomplish by reason of its jurisdiction or
26 professional expertise.
27 (ii) Activities connected with or occasioned by
28 the expenditure of these funds do not interfere with the
29 performance of the board's duties and responsibilities
30 and do not conflict with the exercise of the board's
19970S0874B0933 - 23 -
1 powers as specified by this act.
2 (iii) The funds are kept in a separate special
3 account and periodic reports are made to the Commissioner
4 of Professional and Occupational Affairs concerning the
5 board's receipt and expenditure of such funds.
6 The powers and duties of the board, as enumerated in this
7 section, shall not be applicable to manufacturers or
8 distributors as defined in the act of April 14, 1972 (P.L.233,
9 No.64), known as The Controlled Substance, Drug, Device and
10 Cosmetic Act.
11 Section 314. Communication to licensees.
12 The board shall at least every six months, and more
13 frequently if necessary, convey relevant information concerning
14 this act, rules or regulations promulgated thereunder, and the
15 practice of pharmacy to all pharmacists and pharmacies
16 registered in this Commonwealth and any nonresident pharmacies
17 licensed by the board.
18 Section 315. Annual report.
19 The board shall submit annually a report to the Consumer
20 Protection and Professional Licensure Committee of the Senate
21 and the Professional Licensure Committee of the House of
22 Representatives containing a description of the types of
23 complaints received, the status of cases, any board action which
24 has been taken and the length of time from the initial complaint
25 to final board resolution.
26 CHAPTER 5
27 PHARMACISTS AND PHARMACIES
28 SUBCHAPTER A
29 PHARMACISTS
30 Section 501. Declaration.
19970S0874B0933 - 24 -
1 The practice of pharmacy in this Commonwealth is hereby
2 declared to be a health care professional practice in which the
3 pharmacist is considered a health care provider affecting the
4 public health, safety and welfare, and is subject to regulation
5 and control in the public interest.
6 Section 502. Licensing of pharmacists.
7 Except as otherwise provided in this act, it shall be
8 unlawful for any individual to engage in the practice of
9 pharmacy within this Commonwealth unless that individual is
10 currently licensed to practice pharmacy pursuant to the
11 provisions of this act.
12 Section 503. Prerequisites for pharmacist license.
13 The board may license as a pharmacist any person who has
14 filed an application therefore, subscribed by the person under
15 oath or affirmation, containing such information as the board
16 may by regulation require, and who:
17 (1) Has satisfied the board that the applicant is of
18 good moral and professional character, and not unfit or
19 unable to practice pharmacy by reason of the extent or manner
20 of the applicant's use of alcoholic beverages or controlled
21 substances or by reason of a physical or mental disability.
22 (2) Holds an entry level practice degree in pharmacy
23 granted by a school or college of pharmacy which is
24 accredited by an accrediting body recognized by the board.
25 (3) Has completed an internship or other equivalent
26 program which has been approved by the board or has
27 demonstrated experience in the practice of pharmacy which
28 meets or exceeds the minimum internship requirements of the
29 board.
30 (4) Has satisfactorily passed such examinations as
19970S0874B0933 - 25 -
1 required by the board.
2 (5) Has paid the fee specified by the board for the
3 examination and any related materials and has paid for the
4 issuance of the license.
5 (6) Has not been convicted of any felonious act
6 prohibited by the act of April 14, 1972 (P.L.233, No.64),
7 known as The Controlled Substance, Drug, Device and Cosmetic
8 Act, or convicted of a felony relating to a controlled
9 substance in a court of law of the United States or any other
10 state, territory or country unless all of the following
11 criteria are satisfied:
12 (i) At least ten years have elapsed from the date of
13 conviction.
14 (ii) The applicant satisfactorily demonstrates to
15 the board that the applicant has made significant
16 progress in personal rehabilitation since the conviction
17 such that licensure of that applicant should not be
18 expected to create a substantial risk of harm to the
19 health and safety of patients or the public or a
20 substantial risk of further criminal violations.
21 (iii) The applicant otherwise satisfies the
22 qualifications contained in or authorized by this act.
23 An applicant's statement on the application declaring the
24 absence of a conviction shall be deemed satisfactory evidence
25 of the absence of a conviction, unless the board has evidence
26 to the contrary.
27 Section 504. Examinations.
28 (a) Schedule of examinations.--The board shall, at least
29 once each year, examine in the practice of pharmacy all
30 applicants who:
19970S0874B0933 - 26 -
1 (1) Have completed their education requirements.
2 (2) Make application for examination pursuant to
3 regulations promulgated by the board.
4 (3) Shall be otherwise eligible for licensure.
5 (b) Content of examination.--The examination shall be
6 prepared to measure the competence of the applicant to engage in
7 the practice of pharmacy. The board may employ, cooperate with
8 or contract with any organization or consultant or professional
9 testing organization for the preparation, administration and
10 grading of the examination, but the board shall retain the sole
11 discretional responsibility for determining which applicants
12 have successfully passed an examination.
13 (c) Reexamination.--In case of failure at a first
14 examination, the applicant shall have within two years the
15 privilege of a second and third examination. In case of failure
16 with the third examination, the applicant shall have the
17 privilege of examination only after satisfactorily completing
18 additional preparation as directed and approved by the board.
19 Section 505. Internship.
20 (a) Requirement.--To ensure proficiency in the practical
21 aspects of pharmacy, the board shall, by regulation, prescribe
22 internship requirements which must be satisfactorily completed
23 prior to the issuance of a pharmacist license.
24 (b) Supervision of intern.--To assure adequate practical
25 instruction, pharmacist internship experience as required under
26 this act shall be obtained under the immediate supervision of a
27 pharmacist meeting the requirements established by the board.
28 (c) Examination to obtain pharmacist license.--Each
29 pharmacist intern applying for examination shall pay to the
30 board an examination fee established by the board through
19970S0874B0933 - 27 -
1 regulation. Upon passing the required examination and complying
2 with all the rules and regulations of the board and the
3 provisions of this act, the board shall grant the applicant
4 licensure as a pharmacist and issue a license qualifying the
5 applicant to enter into the practice of pharmacy. This license
6 shall not be issued until a fee established by the board through
7 regulation shall be paid to the board.
8 Section 506. Qualifications for reciprocal license transfer.
9 (a) Procedure.--The board may, without examination, license
10 as a pharmacist any individual who, at the time of filing an
11 application for licensure, is licensed as a pharmacist in any
12 other state, territory or possession of the United States;
13 provided that that individual shall meet those standards
14 established by the board by regulation and meet all of the
15 following criteria:
16 (1) Produce evidence satisfactory to the board of having
17 had the required secondary and professional education and
18 training, including internship.
19 (2) Be of good character and morals as required of
20 applicants for licensure under the provisions of this act.
21 (3) At the time of initial licensure as a pharmacist
22 have all the qualifications necessary to have been eligible
23 for licensure as a pharmacist in this Commonwealth at the
24 time of licensure in the other state.
25 (4) Have presented to the board proof of initial
26 licensure by examination and proof that such license is in
27 good standing.
28 (5) Not be eligible for reciprocal license transfer
29 unless the state in which that individual is licensed shall
30 under similar conditions grant reciprocal licensure as a
19970S0874B0933 - 28 -
1 pharmacist without examination to pharmacists duly licensed
2 by examination in this Commonwealth.
3 (b) Fee.--Every application under this subsection shall be
4 accompanied by a fee established by the board through regulation
5 for the application and expense of investigation by the board. A
6 fee established by the board through regulation shall be paid
7 for the license and certificate prior to its approval and
8 issuance by the board.
9 Section 507. Renewal of licenses.
10 The board shall provide for, regulate and require all
11 individuals licensed as pharmacists to renew their licenses
12 biennially. The board shall prescribe the form of the renewal
13 application and the information required to be submitted by all
14 applicants, including proof of continuing education. The
15 applicant shall file with the board the renewal application
16 accompanied by a biennial license fee established by the board
17 through regulation. An additional fee established by the board
18 through regulation shall be paid for late licensure renewal of a
19 pharmacist.
20 Section 508. Continuing pharmacy education.
21 (a) General rule.--Continuing pharmacy education as the board
22 may require shall be a prerequisite for licensure renewal.
23 (b) Requirements.--The board shall have authority to:
24 (1) Define, by regulation, the requirements for
25 continuing education.
26 (2) Approve programs of continuing education.
27 (3) Adopt rules and regulations necessary to carry out
28 and enforce this section, which shall include the methods of
29 determining approved programs and any required fees.
30 Section 509. Reporting multiple licensure.
19970S0874B0933 - 29 -
1 Any licensed pharmacist of this Commonwealth who is also
2 licensed to practice pharmacy in any other state, territory or
3 country shall report this information to the board on the
4 biennial registration application. Any disciplinary action in
5 any other state, territory and country shall be reported to the
6 board on the biennial renewal application or within 90 days of
7 final disposition, whichever is sooner. Multiple licensure shall
8 be noted by the board on the pharmacist's record, and such
9 state, territory or country shall be notified by the board of
10 any disciplinary actions taken against said pharmacist in this
11 Commonwealth.
12 SUBCHAPTER C
13 PHARMACIES
14 Section 521. Licensing of pharmacies.
15 (a) General rule.--The board shall issue a permit to any
16 person to conduct a pharmacy:
17 (1) Who has filed an application to operate a pharmacy.
18 (2) Who has subscribed the application under oath or
19 affirmation.
20 (3) Who provides all information the board may require.
21 (4) Who pays any fee established by the board by
22 regulation.
23 (5) Whose proposed pharmacy complies with all
24 regulations of the board and with all requirements of this
25 act.
26 (b) Additional information.--Each applicant for a permit
27 shall provide sufficient evidence to the board that the proposed
28 pharmacy:
29 (1) Has the necessary reference materials, current
30 supplements to these reference materials and the professional
19970S0874B0933 - 30 -
1 equipment, technical equipment and other pharmaceutical
2 equipment which such reference materials, supplements and
3 equipment have been determined by the board as necessary to
4 meet the needs of the practice of pharmacy for the area and
5 type of practice to protect the health and welfare of the
6 citizens of this Commonwealth.
7 (2) Has sufficient physical facilities, including
8 equipment, size, space and sanitation for adequately
9 providing pharmacist care and distributing and dispensing
10 drugs and devices consistent with the protection of the
11 public health, safety and welfare as the board may by
12 regulation establish.
13 (3) Contains a suitable book or file in which shall be
14 preserved, for a period of not less than two years, every
15 prescription compounded or dispensed therein.
16 (4) Will be under the immediate supervision of a
17 pharmacist licensed in this Commonwealth at all times that
18 the pharmacy is open for business.
19 (5) (i) If the applicant is an individual or
20 partnership, that the individual or co-partner, if not a
21 pharmacist, has not previously been found or pleaded
22 guilty or nolo contendere to any crime concerning the
23 practice of pharmacy or involving moral turpitude.
24 (ii) If the applicant is an individual or
25 partnership and a pharmacist, that that pharmacist is
26 presently licensed by the board.
27 (iii) If the applicant is an association, that no
28 director or officer has been found or pleaded guilty or
29 nolo contendere to said crimes or had a pharmacy or
30 pharmacist's license revoked or renewal refused for
19970S0874B0933 - 31 -
1 cause.
2 (6) If the applicant is a corporation, that no director,
3 officer or person having a beneficial interest of more than
4 ten percent of the stock has been found or pleaded guilty or
5 nolo contendere to said crimes or had a pharmacy or
6 pharmacist's license revoked or renewal refused for cause.
7 (7) All applicants shall be of good moral and
8 professional character. In determining this qualification,
9 the board may take into consideration, among other things,
10 the conduct and operation of other pharmacies conducted by
11 the applicant.
12 (c) Supervision.--Every pharmacy shall be under the
13 supervision and management of a pharmacist duly licensed in this
14 Commonwealth.
15 (d) Display of license.--All licenses and permits issued
16 under the provisions of this act shall be displayed in a
17 conspicuous place in the pharmacy for which they were issued.
18 (e) Separate applications for each pharmacy.--Separate
19 applications and permits shall be required for each pharmacy.
20 Each permit shall be issued bearing the name of the pharmacist
21 who will be in charge of that pharmacy as defined by regulation
22 and who will be responsible for all operations involving the
23 practice of pharmacy in that pharmacy.
24 (f) Fees.--All applications for a permit to conduct a
25 pharmacy shall be accompanied by an initial registration fee
26 established by the board by regulation.
27 (g) Expiration.--All permits granted under this section,
28 unless sooner revoked or suspended, shall expire on the date set
29 forth in the permit. The board may promulgate regulations
30 authorizing the application by a personal representative of a
19970S0874B0933 - 32 -
1 deceased grantee for an extension of the deceased grantee's
2 permit for a period not to exceed one year from the date of
3 death.
4 Section 522. Renewal of pharmacy permit.
5 The board shall renew each permit for the succeeding
6 biennium, unless the board shall have given ten days' previous
7 notice to the applicant for the permit of objections to the
8 renewal based upon a finding or plea of guilty or nolo
9 contendere by the applicant, its partners or officers, to a
10 violation of any of the laws of the United States or of this
11 Commonwealth relating to the practice of pharmacy or to the
12 enforcement of controlled substances or involving moral
13 turpitude, upon payment of a fee established by the board by
14 regulation for each pharmacy. The application for renewal shall
15 be made on or before September 1 of each odd-numbered year.
16 Section 523. Permit required for operation.
17 No person shall operate a pharmacy until that person has been
18 granted a pharmacy permit by the board.
19 Section 524. Display of ownership information.
20 The full name or names of the proprietor, or if a
21 partnership, the partners, or if an association or corporation,
22 the name of the pharmacist manager, must be conspicuously
23 displayed in the pharmacy along with any corporate association
24 or duly registered fictitious name.
25 Section 525. Extraterritorial pharmacy permits.
26 (a) Requirement.--Any person, entity, pharmacy or pharmacist
27 located outside of this Commonwealth who ships, mails,
28 distributes, dispenses or delivers prescription drugs or devices
29 to individuals within this Commonwealth shall be required to
30 obtain a pharmacy permit from the board.
19970S0874B0933 - 33 -
1 (b) Waiver.--If the person, entity, pharmacy or pharmacist
2 holds a valid pharmacy permit issued by the state in which that
3 pharmacy is operated, the board may waive any requirements
4 imposed upon pharmacies within this Commonwealth if the waiver
5 of these requirements will not endanger the public health,
6 safety or welfare of the citizens of this Commonwealth.
7 (c) Nonlicensure, no waiver.--If the person or entity does
8 not hold a valid pharmacy permit from the jurisdiction in which
9 the person or entity is operating, then the board shall mandate
10 that all requirements imposed upon pharmacies in this
11 Commonwealth be met by the person or entity desiring to ship,
12 mail, dispense, distribute or deliver prescription drugs or
13 devices within this Commonwealth.
14 (d) Registered agent.--Each person, entity, pharmacy or
15 pharmacist located outside of this Commonwealth who ships,
16 mails, dispenses, distributes or delivers prescription drugs or
17 devices in this Commonwealth shall designate a registered agent
18 in this Commonwealth for service of process. Any such person,
19 entity, pharmacy or pharmacist who does not so designate a
20 registered agent shall be deemed to have designated the
21 Secretary of State of this Commonwealth to be its true and
22 lawful attorney, upon whom may be served all legal process in
23 any action or proceeding against such person, entity, pharmacy
24 or pharmacist growing out of or arising from such shipping,
25 mailing, dispensing, distributing or delivery. A copy of any
26 such service of process shall be mailed to such person, entity,
27 pharmacy or pharmacist by the board by certified mail, return
28 receipt requested, postage prepaid, at the address designated on
29 the application for licensure in this Commonwealth. If any such
30 person, entity, pharmacy or pharmacist is not licensed by the
19970S0874B0933 - 34 -
1 board, service on the Secretary of State only shall be
2 sufficient service for legal purposes.
3 Section 526. Regulatory power over pharmacies.
4 The board may promulgate regulations designed to insure
5 methods of operation and conduct which protect the public health
6 and welfare.
7 CHAPTER 7
8 ENFORCEMENT
9 Section 701. Refusal to grant, revocation and suspension of
10 licenses and permits.
11 The board shall have the power to refuse to grant, refuse to
12 renew, suspend, revoke or restrict the license of any pharmacist
13 or pharmacist intern upon one or more of the following grounds:
14 (1) Unprofessional conduct as that term is defined by
15 the rules of the board.
16 (2) Unfit to practice pharmacy because of intemperance
17 in the use of alcoholic beverages, controlled substances or
18 any other substance which impairs the intellect and judgment
19 to such an extent as to impair the performance of
20 professional duties.
21 (3) Unfit or unable to practice pharmacy by reason of a
22 physical or mental disease or disability. In enforcing this
23 paragraph, the board shall, upon probable cause, have
24 authority to compel a pharmacist or a pharmacist intern to
25 submit to a mental or physical examination by physicians or
26 psychologists approved by the board. Failure to submit to
27 such examination when directed by the board, unless such
28 failure is due to circumstances beyond the individual's
29 control, shall constitute an admission of the allegations
30 against him or her, consequent upon which a default and final
19970S0874B0933 - 35 -
1 order may be entered without the taking of testimony or
2 presentation of evidence. A pharmacist or a pharmacist intern
3 affected under this paragraph shall at reasonable intervals
4 be afforded an opportunity to demonstrate that the pharmacist
5 or pharmacist intern can resume a competent practice of
6 pharmacy with reasonable skill and safety to patients.
7 (4) Procured a license through fraud, misrepresentation
8 or deceit.
9 (5) Been found guilty, pleaded guilty, entered a plea of
10 nolo contendere, or received probation without verdict,
11 disposition in lieu of trial or an Accelerated Rehabilitative
12 Disposition in the disposition of one or more of the
13 following:
14 (i) A felony.
15 (ii) Any offense involving moral turpitude or gross
16 immorality.
17 (iii) Violation of the pharmacy or drug laws of this
18 Commonwealth or rules and regulations pertaining thereto;
19 or of pharmacy laws, rules and regulations of the Federal
20 government or of any other state.
21 (6) Violated or knowingly permitted the violation of any
22 provision of this act or regulation of the board.
23 (7) Knowingly:
24 (i) Allowed, aided or abetted an individual to
25 engage in the practice of pharmacy without a license.
26 (ii) Aided or abetted an individual to assist in the
27 practice of pharmacy without having registered with the
28 board; or falsely used the title of pharmacist or
29 pharmacist intern. Nothing contained in this paragraph
30 shall prohibit pharmacist interns or registered pharmacy
19970S0874B0933 - 36 -
1 technicians from assisting in the practice of pharmacy
2 under the immediate supervision of a licensed pharmacist
3 provided such assistance is consistent with proper
4 pharmacy practices and with board regulations.
5 (8) Willfully deceiving or attempting to deceive the
6 board or its agents with respect to any significant matter
7 under investigation by the board.
8 (9) Advertising of prices for drugs and pharmaceutical
9 services to the public which does not conform with Federal
10 laws or regulations or with the laws or regulations of this
11 Commonwealth, or which is untrue, false, misleading or
12 deceptive.
13 (10) Public assertion or implication of professional
14 superiority in the practice of pharmacy.
15 (11) Paying rebates to physicians or other persons, or
16 the entering into of any agreement with a medical
17 practitioner or any other person for the payment or
18 acceptance of compensation in any form for the recommending
19 of the professional services of either party.
20 (12) Entering into any agreement with a licensed medical
21 practitioner for the compounding or dispensing of secret
22 formula (coded) prescriptions.
23 (13) Misbranding or adulteration of any drug or device,
24 or the sale, distribution, or dispensing of any misbranded or
25 adulterated drug or device as defined in the Act of April 14,
26 1972 (P.L. 233, No. 64), known as The Controlled Substance,
27 Drug, Device and Cosmetic Act.
28 (14) Displaying or permitting the display of his or her
29 certificate of licensure and/or current registration document
30 in a pharmacy of which he or she is not the proprietor or is
19970S0874B0933 - 37 -
1 not employed.
2 (15) For any holder of a current pocket registration
3 card to fail, when practicing, to have the card available for
4 inspection by an authorized agent of the board.
5 (16) The acceptance back and redistribution of any
6 unused drug or part thereof as defined by regulations.
7 (17) Accept employment as a pharmacist, or share or
8 receive compensation in any form arising out of, or
9 incidental to, his or her professional activities from any
10 person who orders said pharmacist, directly or indirectly, to
11 engage in any aspect of the practice of pharmacy in
12 contravention of any provision of this act or regulation of
13 the board.
14 (18) Had a license to practice pharmacy suspended,
15 revoked or refused, or received other disciplinary action by
16 the proper pharmacist licensing authority of another state,
17 territory or country.
18 (19) Acted in such a manner as to present an immediate
19 and clear danger to the public health or safety.
20 (20) Is guilty of incompetence, gross negligence or
21 other malpractice, or the departure from, or failure to
22 conform to, the standards of acceptable pharmacy practice, in
23 which case actual injury need not be established.
24 (21) Knowing that a pharmacist or pharmacist intern is
25 incapable of engaging in the practice of pharmacy or that a
26 pharmacy technician is incapable of assisting in the practice
27 of pharmacy, with reasonable skill, competence, and safety to
28 the public, and failing to report any relevant information to
29 the board.
30 (22) Engaging in any conduct which subverts or attempts
19970S0874B0933 - 38 -
1 to subvert any licensing examination or the administration of
2 any licensing exam.
3 (23) Failing to pay the costs assessed in a disciplinary
4 hearing.
5 Section 702. Temporary suspension.
6 (a) Authorization.--A license duly issued under this act may
7 be temporarily suspended under circumstances as determined by
8 the board to be an immediate and clear danger to the public
9 health and safety. The board shall issue an order to that effect
10 without a hearing, but upon due notice to the licensee concerned
11 at his or her last known address, which shall include a written
12 statement of all allegations against the licensee. The case of a
13 temporary suspension pursuant to this section, hearings, appeals
14 from, and rulings resulting therefrom, need not comply with the
15 provisions of 2 Pa.C.S. § 103 (relating to Administrative Agency
16 Law).
17 (b) Commencement of formal proceedings.--The board shall
18 thereupon commence formal action to suspend, revoke or restrict
19 the license of the person concerned, as otherwise provided for
20 in this act. All actions shall be taken promptly and without
21 delay.
22 (c) Preliminary hearing.--Within 30 days following the
23 issuance of an order temporarily suspending a license, the board
24 shall conduct or cause to be conducted a preliminary hearing to
25 determine that there is a prima facie case supporting the
26 suspension. The licensee whose license has been temporarily
27 suspended may be present at the preliminary hearing and may be
28 represented by counsel, cross-examine witnesses, inspect
29 physical evidence, call witnesses, offer evidence and testimony
30 and make record of the proceedings. If it is determined that
19970S0874B0933 - 39 -
1 there is not a prima facie case, the suspended license shall be
2 immediately restored.
3 (d) Duration of temporary suspension.--The temporary
4 suspension shall remain in effect until vacated by the board,
5 but in no event longer than 180 days.
6 Section 703. Automatic suspension.
7 A pharmacist license or a pharmacist intern license issued
8 under this act shall be automatically suspended upon the legal
9 commitment to an institution of a licensee or registrant because
10 of mental incompetency from any cause upon filing with the board
11 a certified copy of such commitment, or upon the conviction of a
12 felony under the Act of April 14, 1972 (P.L.233, No.64), known
13 as The Controlled Substance, Drug, Device and Cosmetic Act, or
14 conviction of an offense under the laws of another jurisdiction,
15 which if committed in this Commonwealth would be a felony under
16 The Controlled Substance, Drug, Device and Cosmetic Act.
17 Automatic suspension under this section shall not be stayed
18 pending any appeal of conviction. Restoration of such license or
19 registration shall be made as hereinafter provided in the case
20 of revocation or suspension of such license or registration.
21 Section 704. Impaired licensee.
22 (a) Board action.--When an impaired pharmacist or pharmacist
23 intern is subject to disciplinary action, the board may defer
24 and ultimately dismiss any of the types of corrective action set
25 forth in this act for an impaired professional so long as the
26 pharmacist or pharmacist intern is progressing satisfactorily in
27 an approved treatment program and in an impaired professional
28 support group recognized by the board.
29 (b) Information disclosure to board.--If an impaired
30 pharmacist or pharmacist intern enters an approved treatment
19970S0874B0933 - 40 -
1 program and an impaired professional support group, the approved
2 program provider shall, upon request, disclose to a professional
3 consultant appointed and employed by the board as hereinafter
4 described, such information in his or her possession regarding
5 the impaired pharmacist or pharmacist intern in treatment, when
6 the program provider is not prohibited from disclosing such
7 information by an act of the United States, this Commonwealth or
8 another state.
9 (c) Agreement by licensee.--An impaired pharmacist or
10 pharmacist intern who enrolls in an approved treatment program
11 shall enter into either:
12 (1) An agreement with the peer assistance group which
13 will monitor the licensee's progress, monitor compliance with
14 the terms of the agreement and monitor adherence to any
15 limitations on the practice of pharmacy as required by the
16 terms of the agreement so as to protect the public.
17 (2) An agreement with the board under which the
18 pharmacist's or pharmacist intern's license shall be
19 suspended or revoked, but enforcement of that suspension or
20 revocation shall be stayed for the length of time the
21 impaired pharmacist or pharmacist intern remains in the
22 treatment program and makes satisfactory progress, complies
23 with the terms of the agreement and adheres to any
24 limitations on his or her practice imposed by the board to
25 protect the public.
26 Failure to enter into one of the agreements shall disqualify the
27 impaired professional from the impaired pharmacist or pharmacist
28 intern program and shall activate an immediate investigation and
29 disciplinary proceeding by the board.
30 (d) Lack of satisfactory progress.--If, in the opinion of
19970S0874B0933 - 41 -
1 the professional consultant after consultation with the program
2 provider and/or the peer assistance group, an impaired
3 pharmacist or pharmacist intern who is enrolled in an approved
4 treatment program or the peer assistance program and has entered
5 into an agreement under subsection (a) has not progressed
6 satisfactorily, the professional consultant shall disclose to
7 the board all information in the consultant's possession
8 regarding said pharmacist or pharmacist intern, and the board
9 shall institute proceedings to determine if the stay of the
10 enforcement of the suspension or revocation of the impaired
11 pharmacist's or pharmacist intern's license shall be vacated if
12 the licensee has executed a board agreement. If the licensee has
13 not executed a board agreement but has executed an agreement
14 with the peer assistance program, the board shall immediately
15 institute proceedings to determine if the impaired pharmacist's
16 or pharmacist intern's license should be revoked or suspended.
17 Section 705. Reinstatement.
18 (a) Petition.--Any person whose license to practice pharmacy
19 in this Commonwealth has been suspended, revoked or restricted
20 pursuant to this act, whether voluntarily or by action of the
21 board, shall have the right, after any statutorily mandated
22 period of time, or, if no statutory limitation exists, at
23 reasonable intervals, to petition the board for reinstatement of
24 such license.
25 (b) Forms.--Such petition shall be made in writing and in
26 the form prescribed by the board.
27 (c) Board procedures.--Upon investigation and hearing, the
28 board may, in its discretion, grant or deny such petition, or it
29 may modify its original findings to reflect any circumstances
30 which have changed sufficiently to warrant such modifications.
19970S0874B0933 - 42 -
1 The board, also at its discretion, may require such person to
2 pass an examination for reentry into the practice of pharmacy.
3 (d) Nonreinstatment for revocation.--Unless ordered to do so
4 by Commonwealth Court or an appeal therefrom, the board shall
5 not reinstate the license of a person to the practice of
6 pharmacy pursuant to this act which license has been revoked.
7 Any person whose license has been revoked may apply for
8 reinstatement after a period of five years from the date of
9 revocation, but must meet all of the licensing qualifications of
10 this act for the license applied for, to include the examination
11 requirement.
12 Section 706. No bar to criminal action.
13 Nothing herein shall be construed as barring criminal
14 prosecutions for violations of this act.
15 Section 707. Administrative Agency Law.
16 All final decisions of the board shall be subject to judicial
17 review pursuant to 2 Pa.C.S. § 103 (relating to Administrative
18 Agency Law).
19 Section 708. Board action.
20 When the board finds that the license of any pharmacist or
21 pharmacist intern may be refused, revoked or suspended under the
22 terms of this section, the board may:
23 (1) Deny the application for a license.
24 (2) Administer a public reprimand.
25 (3) Revoke, suspend, limit or otherwise restrict the
26 license as determined by the board.
27 (4) Require the licensee to submit to the care,
28 counseling or treatment of a physician or a psychologist
29 designated by the board, or enter into an appropriate
30 treatment program as determined by the board.
19970S0874B0933 - 43 -
1 (5) Suspend enforcement of its findings thereof and
2 place the licensee on probation with the right to vacate the
3 probationary order for noncompliance, unless such suspension
4 is otherwise prohibited by this act.
5 Section 709. Pharmacy permits.
6 The board shall have the power to refuse, revoke or suspend
7 the permit of any pharmacy upon proof satisfactory to it that
8 any of the following occurred:
9 (1) The permit was procured through fraud,
10 misrepresentation or deceit.
11 (2) The holder or partner or officer thereof has
12 violated any of the provisions of this act, regulations of
13 the board or any provisions of the act of April 14, 1972
14 (P.L.433, No.64), known as The Controlled Substance, Drug,
15 Device or Cosmetic Act, or the Federal act, or has ordered a
16 pharmacist, pharmacist intern or pharmacy technician in the
17 employ of that pharmacy to engage in any aspect of the
18 practice of pharmacy in contravention of any provisions of
19 the aforesaid acts or regulations.
20 (3) The holder of the pharmacy permit sold, dispensed or
21 caused or allowed to be sold or dispensed any controlled
22 substance or nonproprietary drug, except by a licensed
23 pharmacist.
24 (4) Upon the suspension or revocation of a license of a
25 pharmacist or pharmacist intern employed by said pharmacy, it
26 is shown that the illegal acts of the pharmacist or
27 pharmacist intern were within the knowledge or should have
28 been within the knowledge of the permit holder, partner or
29 officer.
30 (5) The holder of the pharmacy permit, after issuance of
19970S0874B0933 - 44 -
1 a permit, fails to continue to comply with all requirements
2 of Subchapter C of Chapter 5.
3 Section 710. Return of license or permit.
4 Any individual or entity whose license to practice pharmacy
5 or registration to assist in the practice of pharmacy is
6 revoked, suspended or not renewed shall return the license or
7 registration certificate to the offices of the board within ten
8 days after receipt of notice of such action.
9 Section 711. Hearings.
10 (a) Notice of determination.--Upon refusal of the board to
11 issue any license or permit, written notices of the grounds
12 supporting such decision shall be given to the applicant, either
13 personally or by registered or certified mail, return receipt
14 requested, and the board shall accord the applicant opportunity
15 of a hearing, upon written request received within 15 days from
16 the date of giving the written notice.
17 (b) Investigation.--The board may, upon its own motion, and
18 shall, promptly, upon the verified complaint in writing of any
19 person setting forth specifically the wrongful act or acts
20 complained of, investigate any alleged violations of this act by
21 any persons, and shall have the power temporarily to suspend or
22 permanently revoke licenses or permit issued by the board under
23 the provisions of this act at any time when, after due
24 proceedings as provided, it shall find the holder thereof to
25 have been guilty of any violation of the provisions of this act
26 or the rules or regulations of the board.
27 (c) Conduct of hearings.--Hearings, appeals and rulings
28 resulting therefrom, unless otherwise provided in this act,
29 shall be in accordance with the provisions of the 2 Pa.C.S. §
30 103 (relating to Administrative Agency Law).
19970S0874B0933 - 45 -
1 (d) Presence of board member.--A majority of the board shall
2 designate the member or members to be present at each hearing.
3 Subsequent to each hearing, the notes of testimony shall be
4 transcribed and a copy of the transcription shall be given to
5 each member of the board who shall review the same prior to
6 voting thereon. All decisions shall be reached by a majority
7 vote of the entire board. The board shall, by regulation,
8 establish and publish procedural rules concerning the conduct of
9 hearings.
10 Section 712. Docket and other records.
11 The board shall maintain in its office a docket or other
12 record of the rulings and decisions upon all complaints filed
13 with it and all investigations instituted by it. The board shall
14 also give immediate written notice of such rulings or decisions
15 to the licensee affected thereby and where the investigation
16 shall have been instituted by complaint filed, to the party or
17 parties by whom the complaint was made. If such ruling shall be
18 to the prejudice or shall injuriously affect the licensee, the
19 board shall also state in the notice the date upon which the
20 ruling shall become effective. If the licensee, at such time,
21 cannot be found, his or her whereabouts being unknown, such
22 notice may be given by the board by advertisement inserted in
23 one issue of a newspaper of general circulation published within
24 the county which was designated by the licensee as his or her
25 mailing address. When any revocation or suspension shall become
26 final, the board shall publish notice thereof in one issue of
27 one or more newspapers of general circulation published within
28 the county in which the licensee was engaged in the practice of
29 pharmacy at the time of such revocation or suspension.
30 CHAPTER 9
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1 PHARMACIST PRACTICE
2 Section 901. Practice of pharmacy.
3 The practice of pharmacy in this Commonwealth is hereby
4 declared a health care professional practice in which the
5 pharmacist is considered a health care provider affecting the
6 public health, safety and welfare and is subject to regulation
7 and control in the public interest. It is declared to be a
8 matter of public interest and concern that the practice of
9 pharmacy, as defined in this act, merit and receive the
10 confidence of the public and that only qualified persons be
11 permitted to engage in the practice of pharmacy in this
12 Commonwealth.
13 Section 902. Pharmacy is health care service.
14 The practice of pharmacy is the provision of health care
15 services by a pharmacist including, but not limited to, the
16 interpretation, evaluation and implementation of medical orders;
17 the delivering, dispensing or distributing of prescription
18 drugs; participation in drug and device selection; drug
19 administration; drug regimen review; drug or drug-related
20 research; provision of pharmacist care in all areas including
21 primary care; compounding; proper and safe storage of drugs and
22 devices; managing drug therapy; participation in collaborative
23 care agreements; maintaining proper records; patient counseling,
24 physical assessment; order and perform laboratory or other
25 diagnostic tests; disease state management; and such acts,
26 services, operations or transactions necessary or incident to
27 providing pharmacist care.
28 Section 903. Drug regimen review.
29 In all practice care settings a pharmacist shall:
30 (1) Perform a drug regimen review prior to dispensing a
19970S0874B0933 - 47 -
1 prescription.
2 (2) Maintain a patient history in compliance with
3 regulations of the board for each patient for whom
4 prescriptions are dispensed.
5 (3) Offer to provide drug information to the patient,
6 caregiver or patient's agent in compliance with regulations
7 of the board.
8 Section 904. Disease state management.
9 In all practice care settings a pharmacist who has completed
10 a certified program may perform disease state management
11 through a comprehensive, integrated systems approach to both
12 care and reimbursement based upon natural course of disease
13 which emphasizes treatments designed to address an illness with
14 maximum efficiency.
15 Section 905. Collaborative care agreements.
16 (a) Authority to enter.--A pharmacist shall be permitted to
17 enter into a collaborative care agreement with a licensed
18 prescriber. A pharmacist may be permitted to initiate, modify or
19 discontinue prescription drug therapy, administer medications
20 and order or perform laboratory tests as appropriate pursuant to
21 written protocols contained in a collaborative care agreement
22 with a licensed prescriber in this Commonwealth. The
23 collaborative care agreement shall contain a written protocol
24 specifically authorizing the pharmacist to initiate, modify or
25 discontinue drug therapy, to administer medications and to order
26 or perform laboratory tests, all in accordance with regulations
27 adopted by the board.
28 (b) Licensed prescriber.--The licensed prescriber who is a
29 party to the collaborative care agreement shall be in active
30 practice, and the scope of the agreement shall be within the
19970S0874B0933 - 48 -
1 scope of the licensed prescriber's current practice.
2 (c) Content of written protocol.--The protocol required in
3 the collaborative care agreement shall include:
4 (1) A statement identifying the licensed prescriber and
5 the pharmacist who is a party to the agreement.
6 (2) A statement of the types of therapeutic decisions
7 that the pharmacist is authorized to make which may include,
8 but are not limited to, a statement of the types of diseases,
9 drugs or drug categories involved and general statement of
10 the procedures, decision criteria or plan the pharmacist is
11 to follow when exercising the licensed prescriber's authority
12 pursuant to the collaborative care agreement.
13 (3) A statement of the activities the pharmacist is to
14 follow in the course of exercising the authority granted
15 under the collaborative care agreement, including
16 documentation of decisions made and a plan for communication
17 or feedback to the licensed prescriber concerning specific
18 decisions made.
19 (4) A statement that describes appropriate mechanisms
20 for reporting to the licensed prescriber the monitoring
21 activities of the pharmacist and the results of treatment.
22 (d) Review.--The collaborative care agreement and protocols
23 contained therein shall be reviewed at least every two years and
24 shall be modified or revised whenever necessary.
25 (e) Regulatory authority.--The board shall adopt regulations
26 to assure for the protection of the health and welfare of
27 patients treated pursuant to a collaborative care agreement.
28 Section 906. Compensation.
29 Pharmacists performing services under sections 903, 904 and
30 905 shall be compensated for such services.
19970S0874B0933 - 49 -
1 Section 907. Pharmacy technicians.
2 (a) Use.--Pharmacy technicians may be utilized to assist
3 pharmacists in the preparation of prescriptions and drug orders
4 in compliance with regulations adopted by the board.
5 (b) Training.--Technicians may be trained at any licensed
6 pharmacy or trained through educational programs provided by
7 colleges, universities, professional associations, private
8 schools or other entities.
9 (c) Registration.--Pharmacy technicians must register with
10 the board on a form prescribed by the board and pay a
11 registration fee as determined by the board.
12 (d) Pharmacist supervision.--Pharmacy technicians shall work
13 only under the immediate supervision of a licensed pharmacist
14 who may supervise no more than three pharmacy technicians in any
15 setting or a higher number of pharmacy technicians if in the
16 best interest of assuring the health and safety of patients and
17 if permitted by the regulations of the board.
18 (e) Prohibited activities.--Pharmacy technicians shall be
19 prohibited from performing those functions requiring the skill
20 and competence of a licensed pharmacist such as, but not limited
21 to, performing drug regimen reviews, providing drug information
22 and/or patient counseling to patients or caregivers or the
23 monitoring of drug therapy.
24 Section 908. Prescriptions.
25 (a) Transmission.--Prescriptions and drug orders may be
26 written by the health practitioner, transmitted by telephone to
27 the pharmacy by the health practitioner or his or her agent,
28 transmitted to the pharmacy by facsimile provided there is no
29 prohibition in Federal or State law prohibiting facsimile
30 transmission of prescription or drug orders for the specific
19970S0874B0933 - 50 -
1 drug involved or transmitted by electronic data transmission
2 from the health practitioner directly to the pharmacy. The board
3 shall establish regulations governing the use of facsimile or
4 electronic data transmission to assure for the protection of the
5 public health and safety and to provide adequate security to
6 assure confidentiality of such information and data.
7 (b) Transfer between pharmacies.--A prescription may be
8 transferred between pharmacies in this Commonwealth pursuant to
9 the following requirements and any regulations of the board:
10 (1) The prescription is for a drug which is lawfully
11 refillable.
12 (2) The drug is not a Schedule II controlled substance.
13 (3) An original or new prescription is not required from
14 the prescriber by law.
15 (4) The pharmacist transferring the prescription cancels
16 the original prescription in his or her records and indicates
17 on the prescription records to whom the prescription was
18 transferred, including the name of the pharmacy, the date of
19 the transfer and the name or initials of the transferring
20 pharmacist.
21 (5) The pharmacist receiving the transferred
22 prescription:
23 (i) Notes on the prescription that it is a
24 transferred prescription.
25 (ii) Records all of the following on the
26 prescription records in addition to other information
27 required by law:
28 (A) Date of issuance of original prescription.
29 (B) Date of original filling of prescription and
30 date of last refill.
19970S0874B0933 - 51 -
1 (C) Original number of refills authorized on
2 prescription.
3 (D) Number of valid refills remaining.
4 (iii) Notes the location and file number of the
5 original prescription.
6 (iv) Notes the name of the pharmacy and pharmacist
7 from whom the prescription was transferred.
8 (6) A pharmacist may transfer a prescription to another
9 pharmacist employed by the same corporation without regard to
10 the requirements of paragraphs (4) and (5) provided that both
11 pharmacists have access to the same computerized prescription
12 transfer system which contains the prescription refill
13 records and incorporates procedures to prevent unauthorized
14 refills.
15 Section 909. Emergency refills.
16 A pharmacist shall be permitted to provide an emergency
17 refill of a prescription that would otherwise not be legally
18 refillable only pursuant to all of the following terms and
19 conditions:
20 (1) The pharmacist first attempts to obtain an
21 authorization from the authorized prescriber but cannot
22 contact the prescriber.
23 (2) The drug which is the subject of the refill is
24 essential to the continuation of therapy and, in the
25 pharmacist's professional judgment, the interruption of the
26 therapy might reasonably produce an undesirable health
27 consequence, be detrimental to the patient's welfare or cause
28 physical or mental discomfort.
29 (3) The drug which is the subject of the refill is not a
30 controlled substance.
19970S0874B0933 - 52 -
1 (4) The pharmacist enters on the back of the
2 prescription or on another appropriate, uniformly maintained
3 and readily retrievable record, the date and quantity of the
4 refill and the pharmacist must verify the prescription.
5 (5) The pharmacist provides no more than a 72-hour
6 emergency supply of the medication in conformity with the
7 prescribed directions for use.
8 (6) Within 72 hours of dispensing the refill, the
9 pharmacist notified the prescriber that an emergency
10 prescription had been dispensed and the quantity of drug
11 provided to the patient.
12 Section 910. Impaired pharmacist or pharmacist intern.
13 (a) Board power.--In addition to the provision of section
14 704, the board, with the approval of the Commissioner of
15 Professional and Occupational Affairs, shall appoint and fix
16 compensation of a professional consultant who is a licensee of
17 the board with education and experience in the identification,
18 treatment and rehabilitation of persons with chemical, physical
19 and mental impairments. Such consultants shall be accountable to
20 the board and shall act as a liaison between the board and
21 treatment programs, such as alcohol and drug treatment programs
22 licensed by the Department of Health, psychological counseling
23 and impaired professional support groups approved by the board
24 and which provide services to licensees under this act.
25 (b) Required report.--Any hospital or health care facility,
26 peer or colleague who has substantial evidence that a pharmacist
27 or pharmacist intern has an active, addictive disease for which
28 the pharmacist or pharmacist intern is not receiving treatment,
29 is diverting a controlled substance for personal use or is
30 mentally or physically incompetent to carry out the duties of
19970S0874B0933 - 53 -
1 his or her license or certificate shall make or cause to be made
2 a report to the board except that any person or facility who
3 acts in a treatment capacity to an impaired pharmacist in an
4 approved treatment program is exempt from the mandatory
5 reporting requirements of this subsection. Any person or
6 facility who reports in good faith and without malice shall be
7 immune from any civil or criminal liability resulting from such
8 report. Failure to provide such report within a reasonable time
9 from receipt of such knowledge of impairment shall subject the
10 person or facility to a fine not to exceed $1,000. The board
11 shall levy such penalty only after affording the accused party
12 the opportunity for a hearing, as provided in 2 Pa.C.S.
13 (relating to administrative law and procedure).
14 (c) Report by provider.--An approved program provider who
15 makes disclosure to the board pursuant to the requirements of
16 this act shall not be subject to civil liability for such
17 disclosure or its consequences.
18 CHAPTER 11
19 UNLAWFUL ACTIVITIES
20 Section 1101. Unlawful acts.
21 It shall be unlawful for:
22 (1) Any person to procure or attempt to procure a
23 license, permit or certificate for himself or herself or for
24 any other person by making or causing to be made any false
25 representations.
26 (2) Any person not duly licensed as a pharmacist
27 pursuant to this act to engage in the practice of pharmacy,
28 except a pharmacy intern or such other authorized personnel
29 under the immediate personal supervision of a pharmacist,
30 provided that nothing herein shall be construed to prevent a
19970S0874B0933 - 54 -
1 duly licensed medical practitioner from administering any
2 drug to his or her own patients after diagnosis or treatment
3 of the patient, nor shall anything herein prevent any person
4 from selling or distributing at retail household remedies or
5 proprietary medicines when the same are offered for sale or
6 sold in the original manufacturer's package which was
7 prepared for sale to consumers.
8 (3) Any unlicensed person to operate or conduct, or to
9 have charge or to supervise any pharmacy. For violation of
10 this section, the owner of the pharmacy shall be equally
11 liable as principle.
12 (4) Any person to represent that person to be licensed
13 under this act when in fact that person is not licensed.
14 (5) Any person to knowingly prevent or refuse to permit
15 any member of the board or its duly authorized agents to
16 enter a pharmacy or any other place where drugs or devices
17 are kept, stored, dispensed or distributed to a patient or
18 consumer for the purpose of lawful inspection or other
19 purposes in accordance with the provisions of this act and
20 regulations pursuant thereto.
21 (6) Any person whose license, permit or certification
22 has been revoked, suspended or refused renewal to fail to
23 deliver the license, permit or certificate to the board
24 within ten days after receipt of notice of such action.
25 (7) Any person to sell at auction drugs or devices in
26 bulk or in open or unopened packages, unless such sale has
27 been approved in advance by the board and unless such sale
28 shall be under the personal supervision of a licensed
29 pharmacist appointed by the board and whose fee shall be paid
30 by the seller.
19970S0874B0933 - 55 -
1 (8) Any person, firm or corporation to use the title
2 "pharmacist," "pharmacist care," "pharmacy care,"
3 "pharmaceutical care," "assistant pharmacist," "druggist,"
4 "apothecary" or similar terms except a person duly licensed
5 as a pharmacist in this Commonwealth or any person to conduct
6 or transact business under a name which contains as part
7 thereof the words "drug store," "pharmacy," "drugs,"
8 "medicine store," "medicines," "drug shop," "apothecary,"
9 "pharmaceutical" or any term having a similar meaning, or in
10 any manner by advertisement, display or show globes or
11 otherwise describe or refer to the place of the conducted
12 business or person unless the place is a pharmacy duly issued
13 a permit by the board.
14 (9) Any person who buys, sells or causes to be sold or
15 offers for sale any drug or device which bears or which
16 package bears, or originally did bear, the inscription
17 "sample" or "not for resale" or "for investigational or
18 experimental use only" or other similar words, except where a
19 cost is incurred in the bona fide acquisition of an
20 investigational or experimental drug.
21 (10) Any person using to that person's own advantage or
22 revealing to anyone other than the board, its duly authorized
23 representatives or to the courts when relevant to any
24 judicial proceeding under this act, any information acquired
25 under authority of this act or concerning any method or
26 process which is a trade secret.
27 (11) Any pharmacist or owner of a pharmacy advertising
28 or promoting prices for drugs and pharmaceutical services to
29 the public which do not conform to Federal and State laws and
30 regulations.
19970S0874B0933 - 56 -
1 (12) Any person who knowingly and willfully forges or
2 counterfeits upon any goods, wares or merchandise the private
3 stamps or labels of any mechanic or manufacturer with intent
4 to defraud the purchasers or manufacturers of any goods,
5 wares or merchandise, or keeps in possession or conceals any
6 goods, wares or merchandise or keeps in control, custody or
7 possession any punch plate, stone or other thing in the
8 likeness of any punch plate or stone designated for the
9 printing or imprinting of the private stamps or labels of any
10 mechanic or manufacturer, or who vends any goods, wares or
11 merchandise having thereon any forged or counterfeited stamps
12 or labels purporting to be the stamps or labels of any
13 mechanic or manufacturer, knowing the same to be forged or
14 counterfeited.
15 (13) Any person by himself or herself or through another
16 to procure or attempt to procure for himself or herself or
17 another any drug:
18 (i) By fraud, deceit, misrepresentation or
19 subterfuge.
20 (ii) By the forgery or alteration of a prescription
21 or any written order.
22 (iii) By the concealment of material facts.
23 (iv) By the use of a false statement and a
24 prescription order or report.
25 (14) Any person to deliver a prescription medication by
26 mail or otherwise to a patient within this Commonwealth
27 unless the prescription is filled or refilled in a pharmacy
28 licensed by the board.
29 (15) One or more licensed prescribers to have a
30 proprietary or beneficial interest in a pharmacy sufficient
19970S0874B0933 - 57 -
1 to permit them to exercise supervision or control over a
2 pharmacist working in the pharmacy in his or her professional
3 responsibilities and duties.
4 Section 1102. Criminal penalties.
5 Any person who violates any of the provisions of section 1101
6 shall be guilty of a misdemeanor and shall, upon conviction, be
7 sentenced to pay a fine of not more than $5,000, or to
8 imprisonment for not more than one year, or both and for each
9 subsequent offense, shall be sentenced to pay a fine of not more
10 than $15,000, or to imprisonment for not more than three years,
11 or both.
12 Section 1103. Additional civil penalty.
13 In addition to any other civil remedy or criminal penalty
14 provided for in this act, the board may levy a civil penalty of
15 up $1,000 on any current licensee who violates any provision of
16 this act or on any person who practices pharmacy without being
17 properly licensed to do so under this act. The board shall levy
18 such penalty only after affording the accused party the
19 opportunity for a hearing, as provided in 2 Pa.C.S. (relating to
20 administrative law and procedure).
21 CHAPTER 13
22 FISCAL AFFAIRS
23 Section 1301. Setting of Fees
24 (a) General rule.--All fees required under this act shall be
25 fixed by the board by regulation and shall be subject to the act
26 of June 25, 1982 (P.L.633, No.181), known as the Regulatory
27 Review Act. If the revenues raised by fees, fines and civil
28 penalties imposed under this act are not sufficient to meet
29 expenditures over a two-year period, the board shall increase
30 those fees by regulation, so that the projected revenues will
19970S0874B0933 - 58 -
1 meet or exceed projected expenditures.
2 (b) Increases in fees.--If the Bureau of Professional and
3 Occupational Affairs determines that the fees, fines and civil
4 penalties established by the board under subsection (a) are
5 inadequate to meet the minimum enforcement efforts required by
6 this act, then the bureau, after consultation with the board and
7 subject to the Regulatory Review Act, shall increase the fees by
8 regulation in an amount such that adequate revenues are raised
9 to meet the required enforcement effort.
10 Section 1302. Account and fees disposition.
11 The Commissioner of Professional and Occupational Affairs
12 shall establish a Pharmacy Professional Development Account and
13 all fees, fines and civil penalties imposed in accordance with
14 this act shall be paid into the Pharmacy Professional
15 Development Account. The funds shall be used by the board for
16 professional development and for enforcement efforts mandated by
17 this act.
18 Section 1303. Annual submissions.
19 (a) Estimate to department.--The board shall submit annually
20 to the Department of State an estimate of the financial
21 requirements of the board for its administrative, investigative,
22 legal and miscellaneous expenses.
23 (b) Report to General Assembly.--The board shall submit
24 annually to the and Appropriations Committee of the Senate and
25 the Appropriations Committee of the House of Representatives, 15
26 days after the Governor has submitted the budget to the General
27 Assembly, a copy of the budget request for the upcoming fiscal
28 year which the board previously submitted to the Department of
29 State.
30 Section 1304. Hiring of pharmacy inspectors.
19970S0874B0933 - 59 -
1 The board shall employ a minimum of eight pharmacy inspectors
2 who shall be licensed pharmacists in this Commonwealth. If the
3 board determines that additional pharmacy inspectors are
4 necessary to protect the health and safety of the citizens of
5 this Commonwealth, the board shall hire such additional
6 inspectors. Inspectors shall inspect all licensed locations. All
7 pharmacy inspectors shall be under the authority of the board
8 and shall report to the executive director.
9 CHAPTER 15
10 MISCELLANEOUS PROVISIONS
11 Section 1501. Board members.
12 Members of the board appropriately confirmed as of the
13 effective date of this act shall continue to serve as members of
14 the board until their present terms expire or until a successor
15 has been appointed and qualified, but no longer than six months
16 after present terms have expired.
17 Section 1502. Rules and regulations.
18 Each rule and regulation of the board in effect on the
19 effective date of this act, not inconsistent with this act,
20 shall remain in effect until repealed or amended by the board.
21 Each fee of the board in effect on the effective date of this
22 act, and not inconsistent with this act, shall remain in effect
23 until repealed or amended in accordance with the provisions of
24 this act.
25 Section 1503. Current licensees.
26 Any person who holds a valid license issued by the board on
27 the effective date of this act shall, on and after the effective
28 date of this act, be deemed to be licensed by the board as
29 provided for in this act.
30 Section 1504. Severability.
19970S0874B0933 - 60 -
1 The provisions of this act are severable. If any provision of
2 this act or its application to any person or circumstance is
3 held invalid, the invalidity shall not affect other provisions
4 or applications of this act which can be given effect without
5 the invalid provision or application.
6 Section 1505. Repeals.
7 (a) Absolute.--The act of September 27, 1961 (P.L.1700,
8 No.699), known as the Pharmacy Act, is repealed.
9 (b) Inconsistent.--The act of April 9, 1929 (P.L.177,
10 No.175), known as The Administrative Code of 1929, is repealed
11 insofar as it is inconsistent with this act.
12 (c) General.--All other acts and parts of acts are repealed
13 insofar as they are inconsistent with this act.
14 Section 1506. Effective date.
15 This act shall take effect January 1, 1998.
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