PRINTER'S NO. 1418
No. 1260 Session of 1997
INTRODUCED BY ALLEN, THOMAS, ITKIN, OLASZ, ARGALL, LUCYK, BOYES, PERZEL, JOSEPHS, KAISER, GANNON, TANGRETTI, KENNEY, STERN, CAWLEY, M. COHEN, HARHART, BOSCOLA, WALKO, COWELL, FLEAGLE, ROBERTS, TRICH, TRELLO, CURRY, LAUGHLIN, DEMPSEY, STEIL, PHILLIPS, BROWN, VAN HORNE, JAROLIN, TRUE, TIGUE, DeLUCA, SEMMEL, CORRIGAN, GIGLIOTTI, SHANER, COLAIZZO, YOUNGBLOOD, BENNINGHOFF, BATTISTO, HESS, HERSHEY, PETRARCA, SURRA, HASAY, HALUSKA, LaGROTTA, WOGAN AND LESCOVITZ, APRIL 9, 1997
REFERRED TO COMMITTEE ON PROFESSIONAL LICENSURE, APRIL 9, 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.
1 Section 306. Removal. 2 Section 307. Organization. 3 Section 308. Compensation of board members. 4 Section 309. Meetings. 5 Section 310. Executive director. 6 Section 311. Employees. 7 Section 312. Rules and regulations. 8 Section 313. Powers and responsibilities. 9 Section 314. Communication to licensees. 10 Section 315. Annual report. 11 Chapter 5. Pharmacists and Pharmacies 12 Subchapter A. Pharmacists 13 Section 501. Declaration. 14 Section 502. Licensing of pharmacists. 15 Section 503. Prerequisites for pharmacist license. 16 Section 504. Examinations. 17 Section 505. Internship. 18 Section 506. Qualifications for reciprocal license transfer. 19 Section 507. Renewal of licenses. 20 Section 508. Continuing pharmacy education. 21 Section 509. Reporting multiple licensures. 22 Subchapter C. Pharmacies 23 Section 521. Licensing of pharmacies. 24 Section 522. Renewal of pharmacy permit. 25 Section 523. Permit required for operation. 26 Section 524. Display of ownership information. 27 Section 525. Extraterritorial pharmacy permits. 28 Section 526. Regulatory power over pharmacies. 29 Chapter 7. Enforcement 30 Section 701. Refusal to grant, revocation and suspension 19970H1260B1418 - 2 -
1 of licenses and permits. 2 Section 702. Temporary suspension. 3 Section 703. Automatic suspension. 4 Section 704. Impaired licensee. 5 Section 705. Reinstatement. 6 Section 706. No bar to criminal action. 7 Section 707. Administrative Agency Law. 8 Section 708. Board action. 9 Section 709. Pharmacy permits. 10 Section 710. Return of license or permit. 11 Section 711. Hearings. 12 Section 712. Docket and other records. 13 Chapter 9. Pharmacist Practice 14 Section 901. Practice of pharmacy. 15 Section 902. Pharmacy is health care service. 16 Section 903. Drug regimen review. 17 Section 904. Disease state management. 18 Section 905. Collaborative care agreements. 19 Section 906. Compensation. 20 Section 907. Pharmacy technicians. 21 Section 908. Prescriptions. 22 Section 909. Emergency refills. 23 Section 910. Impaired pharmacist or pharmacist intern. 24 Chapter 11. Unlawful Activities 25 Section 1101. Unlawful acts. 26 Section 1102. Criminal penalties. 27 Section 1103. Additional civil penalty. 28 Chapter 13. Fiscal Affairs 29 Section 1301. Setting of fees. 30 Section 1302. Account and fees disposition. 19970H1260B1418 - 3 -
1 Section 1303. Annual submissions. 2 Section 1304. Hiring of pharmacy inspectors. 3 Chapter 15. Miscellaneous Provisions 4 Section 1501. Board members. 5 Section 1502. Rules and regulations. 6 Section 1503. Current licensees. 7 Section 1504. Severability. 8 Section 1505. Repeals. 9 Section 1506. Effective date. 10 The General Assembly of the Commonwealth of Pennsylvania 11 hereby enacts as follows: 12 CHAPTER 1 13 PRELIMINARY PROVISIONS 14 Section 101. Short title. 15 This act shall be known and may be cited as the Pharmacy 16 Practice Act. 17 Section 102. Legislative declaration. 18 It is declared to be a matter of public interest and concern 19 that the practice of pharmacy, as defined in this act, merit and 20 receive the confidence of the public. It is further declared 21 that only qualified persons be permitted to engage in the 22 practice of pharmacy in the Commonwealth of Pennsylvania. 23 Section 103. Statement of purpose. 24 It is the purpose of this act to promote, preserve and 25 protect the public health, safety and welfare by the effective 26 control and regulation of the practice of pharmacy through: 27 (1) The licensure of pharmacists. 28 (2) The licensure of pharmacist interns. 29 (3) The registration of technicians. 30 (4) The licensure, control and regulation of all sites 19970H1260B1418 - 4 -
1 or persons who are required to obtain a license or permit 2 from the board, whether located in or out of the 3 Commonwealth, that deliver, dispense, administer, distribute, 4 manufacture, promote or sell drugs within this Commonwealth. 5 Section 104. Definitions. 6 The following words and phrases when used in this act shall 7 have the meanings given to them in this section unless the 8 context clearly indicates otherwise: 9 "Administer." The direct introduction of or the application 10 of a drug into or on the body of a patient or research subject 11 by injection, inhalation, ingestion or any other means. 12 "Beyond-use date." A date determined by a pharmacist and 13 placed on a prescription label at the time dispensing that is 14 intended to indicate to the patient or caregiver a time beyond 15 which the contents of that prescription are not recommended for 16 use. 17 "Board." The Pennsylvania State Board of Pharmacy. 18 "Collaborative care agreement." A written agreement or 19 protocol between a licensed prescriber and a pharmacist 20 authorizing that pharmacist to: 21 (1) Initiate, modify, monitor, continue or discontinue 22 drug therapy. 23 (2) Administer medications. 24 (3) Order and perform laboratory or other diagnostic 25 tests in accordance with regulations adopted by the 26 Pennsylvania State Board of Pharmacy. 27 "Collaborative pharmacy practice." The practice of pharmacy 28 whereby a pharmacist has jointly agreed to work in conjunction 29 with one or more licensed prescribers under a protocol whereby 30 the pharmacist may perform certain patient care functions 19970H1260B1418 - 5 -
1 authorized by the practitioner or practitioners under certain 2 specified conditions or limitations, including, but not limited 3 to, the initiating, continuing or discontinuing of drug therapy; 4 the administration of drugs; and the ordering and/or the 5 performing of laboratory tests which may be necessarily incident 6 to the treatment. 7 "Compounding." The preparation, mixing, assembling, 8 packaging or labeling of a drug pursuant to or in anticipation 9 of a valid prescription drug order, including, but not limited 10 to, packaging, intravenous admixture or manual combination of 11 drug ingredients. 12 "Confidential information." Information relevant to a 13 patient's health care which is acquired by the pharmacist 14 incident to a professional relationship. Confidential 15 information is privileged and may be released only to the 16 patient, or to a third party upon the authorization of the 17 patient, or where such release is necessary to protect the 18 patient's health and well-being, or to such other persons or 19 government agencies authorized by law to receive that 20 information. 21 "Controlled substance." Any drug designated as such under 22 the provisions of the act of April 14, 1972 (P.L.233, No.64), 23 known as The Controlled Substance, Drug, Device and Cosmetic 24 Act. 25 "Deliver" or "delivery." The actual, constructive or 26 attempted transfer of a drug or device from one person to 27 another, whether or not for consideration. 28 "Device." An instrument, apparatus, implement, machine, 29 contrivance, implant, in vitro reagent or other similar or 30 related article, including any component part or accessory, 19970H1260B1418 - 6 -
1 which is required under Federal or State law to be prescribed by 2 a health practitioner and dispensed by a pharmacist. 3 "Disease state management." A comprehensive, integrated 4 approach to patient care based upon the natural course of 5 disease which emphasizes treatments designed to address an 6 illness with maximum efficiency. 7 "Dispense" or "dispensing." The procedure entailing the 8 interpretation of a health practitioner's medical order or a 9 prescription drug order for a drug or device and pursuant to 10 that order, the proper selection, measuring, labeling and 11 packaging of a drug or device in a proper container for 12 subsequent administration to or use by a patient. 13 "Distribute." The delivery of a drug or device other than by 14 administering or dispensing. 15 "Drug." 16 (1) Articles, including radioactive substances, 17 recognized as drugs in any official compendium, or supplement 18 thereto, or designated from time to time by the Pennsylvania 19 State Board of Pharmacy for use in the diagnosis, cure, 20 mitigation, treatment, or prevention of disease in humans or 21 other animals. 22 (2) Articles, other than food, intended to affect the 23 structure or any function of the body of humans or other 24 animals. 25 (3) Articles intended for use as a component of any 26 articles specified in paragraphs (1) and (2), but not 27 including devices or their component parts or accessories. 28 "Drug regimen review." Any retrospective, concurrent and 29 prospective review by a pharmacist of a patient's drug-related 30 therapy, including, but not limited to, evaluation of any or all 19970H1260B1418 - 7 -
1 of the following areas: 2 (1) Known allergies. 3 (2) Rational therapy-contraindications. 4 (3) Appropriate dose and route of administration. 5 (4) Appropriate directions for use. 6 (5) Duplicative therapies. 7 (6) Potential misuse or abuse. 8 (7) Drug-drug, drug-food, drug-disease and drug-clinical 9 laboratory interactions. 10 (8) Adverse drug reactions. 11 (9) Drug utilization review and optimal therapeutic 12 outcomes. 13 "Electronic data transmission." The transmission of 14 information in electronic form or the transmission of the exact 15 visual image of a document by way of electronic equipment. 16 "Emergency refill prescription." A refill of a prescription 17 which is essential to the continuation of therapy for which that 18 refill has not been authorized and for which the pharmacist 19 notifies the prescriber within 72 hours, of dispensing that 20 prescription that an emergency refill prescription has been 21 dispensed. 22 "Federal act." The Federal Food, Drug and Cosmetic Act (52 23 Stat. 1040, 21 U.S.C. § 301 et seq.) 24 "Health care provider" or "health practitioner." An 25 individual licensed by the Commonwealth to provide patient care 26 under the authority of a professional practice act, and includes 27 licensed prescribers and health care providers or health 28 practitioners. 29 "Home infusion pharmacy." A pharmacy which compounds 30 solutions for direct administration to a patient in a private 19970H1260B1418 - 8 -
1 residence, long-term care facility, hospice or similar setting 2 by means of parenteral, intravenous, intramuscular, 3 subcutaneous, or intraspinal infusion. 4 "Immediate supervision." A level of control which assures 5 that the pharmacist has the ultimate responsibility for the 6 accuracy, safety and patient outcomes with respect to the 7 actions of pharmacy technicians and pharmacist interns and the 8 use of automation in all practice settings. 9 "Impaired professional support group." A peer assistance 10 group whose goals are to direct an impaired colleague into 11 treatment. 12 "Labeling." The process of preparing and affixing a label to 13 any drug container, which label shall include all information 14 required by Federal and State law, rule or regulation. 15 "Licensed prescriber." A physician, dentist, veterinarian, 16 podiatrist, or other individual duly authorized and licensed by 17 law to independently prescribe drugs, including prescription 18 drugs. 19 "Long-term care facility." A nursing home, retirement care 20 facility, mental care facility or other facility or institution 21 which provides extended health care to resident patients. 22 "Managing drug therapy." Adjusting a drug regimen; changing 23 the duration of therapy; adjusting drug strength, frequency of 24 administration and/or route; and the initiation or 25 discontinuation of therapy, including the administration of 26 drugs. 27 "Manufacturer." Any person, except a pharmacist compounding 28 in the normal course of professional practice within this 29 Commonwealth, engaged in the commercial production, preparation, 30 propagation, compounding, conversion, or processing of a drug, 19970H1260B1418 - 9 -
1 either directly or indirectly, by extraction from substances of 2 natural origin or independently by means of chemical synthesis, 3 or both, and includes any packaging or repackaging of a drug or 4 the labeling or relabeling of the drug container. 5 "Medical order." A lawful order by a specifically identified 6 health practitioner for a specifically identified patient. 7 "Nonprescription drug." A drug which may be sold without 8 prescription and which is labeled for use by the consumer in 9 accordance with the requirements of the laws and rules of the 10 Federal Government and this Commonwealth. 11 "Nonresident pharmacy." A pharmacy located outside this 12 Commonwealth. 13 "Patient counseling." The process of the communication of 14 information between the pharmacist and the patient, including, 15 but not limited to, both verbal and written information as 16 defined in the rules of the Pennsylvania State Board of Pharmacy 17 in order to promote the proper use of any drug and to enhance 18 drug therapy. 19 "Person." An individual, corporation, partnership, 20 association, or any other legal entity including government. 21 "Pharmacist." A health care provider or practitioner 22 currently licensed by the Pennsylvania State Board of Pharmacy 23 to engage in the practice of pharmacy. 24 "Pharmacist care" or "pharmaceutical care" or "pharmacy 25 care." The provision, by a pharmacist, of drug therapy and other 26 patient care services to achieve patient outcomes which improve 27 the patient's quality of life as it is related to the cure or 28 prevention of a disease, elimination or reduction of a patient's 29 symptoms, or arresting or slowing of a disease process. 30 "Pharmacist intern." An individual licensed by the 19970H1260B1418 - 10 -
1 Pennsylvania State Board of Pharmacy to engage in the practice 2 of pharmacy under the immediate supervision of a licensed 3 pharmacist and who makes satisfactory progress toward meeting 4 the requirements for licensure as a pharmacist. 5 "Pharmacy." Any place within this Commonwealth which is 6 properly issued a permit by the Pennsylvania State Board of 7 Pharmacy where drugs, devices, radiopharmaceuticals and 8 diagnostic agents for human or animal consumption are stored, 9 dispensed or compounded, or any place outside this Commonwealth 10 where drugs, devices, radiopharmaceuticals and diagnostic agents 11 for human and animal consumption are dispensed to residents of 12 this Commonwealth. The term "pharmacy" shall not include the 13 operation of a manufacturer or distributor as defined in the Act 14 of April 14, 1972 (P.L.233, No.64), known as The Controlled 15 Substance, Drug, Device and Cosmetic Act. Within an institution 16 the term "pharmacy" refers to all organized pharmacy service 17 within that institution. 18 "Pharmacy practice site." Any place within or outside this 19 Commonwealth where the practice of pharmacy is provided to 20 residents of this Commonwealth. 21 "Pharmacy technician." An individual who is registered with 22 the board and who may assist in the practice of pharmacy under 23 the immediate supervision of a licensed pharmacist. 24 "Practice of pharmacy," The provision of health care 25 services by a pharmacist, including, but not limited to: 26 (1) The interpretation, evaluation and implementation of 27 medical orders. 28 (2) The delivering, dispensing or distributing of 29 prescription drugs. 30 (3) Participation in drug and device selection. 19970H1260B1418 - 11 -
1 (4) Drug administration. 2 (5) Drug regimen review. 3 (6) Drug or drug-related research. 4 (7) The provision of pharmacist care in all areas 5 including primary care. 6 (8) Compounding. 7 (9) Proper and safe storage of drugs and devices. 8 (10) Managing drug therapy. 9 (11) Participation in collaborative care agreements. 10 (12) Maintaining proper records. 11 (13) Patient counseling. 12 (14) Performing physical assessment. 13 (15) Ordering and performing laboratory or other 14 diagnostic tests. 15 (16) Disease state management. 16 (17) Any other acts, services, operations or 17 transactions necessary or incident to providing pharmacist 18 care. 19 "Preceptor." An individual who is currently licensed as a 20 pharmacist by the Pennsylvania State Board of Pharmacy, meets 21 the qualifications as a preceptor under the rules of the board, 22 has filed with the board any application or documentation and 23 the board may require and participates in the instructional 24 training of pharmacy interns. 25 "Prescription drug" or "legend drug" or "nonproprietary 26 drug." Any drug which is required by any applicable Federal or 27 State law or regulation to be dispensed only pursuant to a 28 prescription drug order or which is restricted to use by health 29 practitioners. 30 "Prescription drug order." A lawful order issued by a duly 19970H1260B1418 - 12 -
1 licensed health practitioner for drugs, drug-related devices or 2 treatment for a human or animal, including orders issued through 3 collaborative care agreements. 4 "Primary care." A pharmacist's activities in patient 5 education, health promotion, assistance in the selection of and 6 use of over-the-counter drugs and appliances for the treatment 7 of common diseases and injuries; drug selection under protocol; 8 nutrition; and any other activities falling within the 9 pharmacist's statutory or regulatory scope of practice. 10 "Protocol." A written document that describes the nature and 11 scope of the drug therapy management to be carried out by the 12 pharmacist or other health practitioner. 13 "Wholesaler." Any person within this Commonwealth who 14 legally buys drugs for resale or distribution to persons other 15 than patients or consumers. 16 Section 105. Construction of act. 17 This act shall be liberally construed to carry out these 18 objectives and purposes. 19 CHAPTER 3 20 PENNSYLVANIA STATE BOARD OF PHARMACY 21 Section 301. Pennsylvania State Board of Pharmacy. 22 The responsibility for enforcement of the provisions of this 23 act is hereby vested in the Pennsylvania State Board of 24 Pharmacy. The board shall have all the powers, duties and 25 authority specifically granted by or necessary for the 26 enforcement of this act, as well as any other powers, duties and 27 authorities that may be granted by law. 28 Section 302. Membership. 29 Beginning with any vacancies existing on the effective date 30 of this act, and as terms expire or vacancies occur thereafter, 19970H1260B1418 - 13 -
1 the board shall consist of: 2 (1) The Commissioner of Professional and Occupational 3 Affairs. 4 (2) The Director of the Bureau of Consumer Protection in 5 the Office of Attorney General or a designee of the director. 6 (3) Two persons representing the public at large. 7 (4) Seven persons who are licensed to practice pharmacy 8 in this Commonwealth. Of the seven appointees under this 9 paragraph: 10 (i) Two pharmacists shall be appointed from 11 independent retail pharmacies. 12 (ii) Two pharmacists shall be appointed who are 13 employees of retail chain pharmacies which operate five 14 or more pharmacies licensed within this Commonwealth. 15 (iii) One pharmacist shall be appointed from an 16 acute care institutional pharmacy. 17 (iv) Two pharmacists shall be appointed who are each 18 involved in one of the following areas: 19 (A) Long-term care pharmacy or consulting 20 pharmacy. 21 (B) Pharmacy education at an accredited school 22 or college of pharmacy, as recognized by the board, 23 within this Commonwealth. 24 (C) Nuclear pharmacy, home health care practice 25 or any other specialty recognized by the board and 26 not yet represented. 27 Section 303. Qualification. 28 Each pharmacist member of the board shall at the time of 29 appointment: 30 (1) Be a resident of this Commonwealth for not less than 19970H1260B1418 - 14 -
1 one year. 2 (2) Must have been registered as a pharmacist in this 3 Commonwealth for at least five years immediately preceding 4 appointment. 5 (3) The public members of the board shall have been 6 residents of this Commonwealth for not less than two years at 7 the time of their appointment, shall have attained the age of 8 majority, and shall not be, nor shall ever have been, a 9 pharmacist, or the spouse of a pharmacist, or a person who 10 has ever had any material financial interest in the provision 11 of pharmacy services or who has engaged in any activity 12 directly related to the practice of pharmacy. 13 Section 304. Appointment. 14 Nominations for appointment to the board may be made to the 15 Governor by any individual, any professional pharmacy 16 association within this Commonwealth or any other entity. All 17 professional and public members of the board shall be appointed 18 by the Governor with the advice and consent of a majority of the 19 members elected to the Senate. 20 Section 305. Terms of office. 21 (a) Regular term.--Except as provided in subsection (b), the 22 terms of each professional member and each public member of the 23 Board shall be four years, or until a successor has been 24 appointed and qualified, but not longer than six months beyond 25 the four-year period. In the event that any member shall die or 26 resign or otherwise become disqualified during that member's 27 term, a successor shall be appointed in the same way and with 28 the same qualifications as the original member and shall hold 29 office for the unexpired portion of the term. 30 (b) Terms to be staggered.--The terms of the professional 19970H1260B1418 - 15 -
1 and public members of the board shall be staggered, so that the 2 terms of no more than three members shall expire in any year. 3 Each member shall serve until a successor is appointed and 4 qualified as provided in subsection (a). 5 (c) Existing board members.--The present members of the 6 board on the effective date of this act shall serve the balance 7 of their terms. 8 (d) Reappointment.--No professional or public member of the 9 board shall be eligible for appointment to serve more than three 10 consecutive full terms. The completion of the unexpired portion 11 of a full term shall not constitute a full term for purposes of 12 this subsection. Any present board member appointed initially 13 for a term of less than four years shall be eligible to serve 14 for three additional full terms. 15 (e) Vacancies.--Any vacancy which occurs in the membership 16 of the board for any reason, shall be filled by the Governor in 17 the manner provided for appointment of board members in section 18 304. 19 Section 306. Removal. 20 (a) Grounds for removal.--A board member may be removed 21 pursuant to the procedure set forth in subsection (b), upon one 22 or more of the following grounds: 23 (1) The refusal or inability for any reason of a board 24 member to perform the duties as a member of the board in an 25 efficient, responsible, and professional manner. 26 (2) The misuse of office by a member of the board to 27 obtain personal, pecuniary, or material gain or advantage for 28 that member or another person through such office. 29 (3) The violation by any member of the board of laws 30 governing the practice of pharmacy or the distribution of 19970H1260B1418 - 16 -
1 drugs and/or devices. 2 (4) The failure of the board member to attend three 3 consecutive board meetings unless the Commissioner of 4 Professional and Occupational Affairs, upon written request 5 from that member, finds that member should be excused from a 6 meeting because of illness or the death of a family member, 7 or other valid reason. 8 (5) The failure of a public member to attend two 9 consecutive statutorily mandated training seminars under 10 section 813(e) of the Act of April 9, 1929 (P.L.177, No.175), 11 known as The Administrative Code of 1929, unless the 12 Commissioner of Professional and Occupational Affairs, upon 13 written request from the public member, finds that the public 14 member should be excused from a meeting because of illness or 15 the death of a family member, or other valid reason. 16 (b) Procedure.--Removal of a member of the board shall be in 17 accordance with 2 Pa.C.S. Ch. 5 Subch. A (relating to practice 18 and procedure of Commonwealth agencies). 19 Section 307. Organization. 20 (a) Officers.--The board shall elect from its members a 21 chairperson and any other officers deemed appropriate and 22 necessary to conduct the business of the board. The chair of the 23 board shall preside at all meetings of the board and shall be 24 responsible for the performance of all of the duties and 25 functions of the board required or permitted by this act. Each 26 additional officer elected by the board shall perform those 27 duties normally associated with that position and any other 28 duties assigned by the board. 29 (b) Terms of office for officers.--Officers elected by the 30 board shall serve terms of one year commencing with the day of 19970H1260B1418 - 17 -
1 their election and ending upon election of their successors, and 2 shall serve no more than two consecutive full terms in each 3 office to which they are elected. 4 Section 308. Compensation of board members. 5 Each member of the board, except the Commissioner of 6 Professional and Occupational Affairs and the Director of the 7 Bureau of Consumer Protection, shall receive $250 per day when 8 actually attending to the work of the board. Members shall also 9 receive timely reimbursement for reasonable traveling, lodging 10 and other necessary expenses incurred in the performance of 11 their duties in accordance with Commonwealth regulations. 12 Section 309. Meetings. 13 (a) Regular meetings.--The board shall meet at least once 14 every two months and at any additional times that may be 15 necessary to conduct the business of the board. Any additional 16 meetings may be called by the chairperson of the board or by 17 two-thirds of the members of the board. 18 (b) Place of meeting.--The board shall meet at such place as 19 it may, from time to time, determine. The place for each meeting 20 shall be determined prior to giving notice of that meeting to 21 each member. The place of a meeting may not be changed after 22 notice is given without adequate prior to all members of the 23 board. 24 (c) Quorum.--A majority of the members of the board serving 25 in accordance with law shall constitute a quorum for the 26 purposes of conducting the business of the board. Except for 27 temporary and automatic suspensions under this act, a member may 28 not be counted as part of a quorum or vote on any issue unless 29 that member is physically in attendance at the meeting. 30 (d) Open meetings.--All board meetings and hearings shall be 19970H1260B1418 - 18 -
1 open to the public. The board may, in its discretion and 2 according to law, conduct any portion of its meeting in 3 executive session, closed to the public. Executive sessions may 4 not be utilized during hearings or discussion of current 5 regulations or development of regulations. 6 Section 310. Executive director. 7 (a) Selection.--The board shall select and employ, with the 8 approval of the Commissioner of Professional and Occupational 9 Affairs, an executive director who shall be a full-time employee 10 and who shall be a pharmacist licensed in this Commonwealth. The 11 executive director shall be paid such compensation as determined 12 by the board to be commensurate with the level of compensation 13 paid other executive directors to professional licensing boards 14 in this Commonwealth. 15 (b) Duties.--The executive director shall have the following 16 duties: 17 (1) Establish guidelines and information, with the 18 concurrence of the board, for training of inspectors within 19 the Department of State who are responsible for inspecting 20 pharmacies. 21 (2) Assist the board in revising and promulgating 22 regulations. 23 (3) Review recorded minutes and proceedings of all board 24 meetings and be the custodian of such documents. 25 (4) Maintain a record of policies set by the board and 26 disseminate that information to all board licensees. 27 (5) Perform any other duties the board may request. 28 The executive director shall be provided adequate facilities, 29 staff and pharmacy inspectors to perform the aforesaid 30 functions. 19970H1260B1418 - 19 -
1 Section 311. Employees. 2 The board may, in its discretion, employ persons in addition 3 to the executive director in such other positions or capacities 4 as it deems necessary for the proper conduct of board business 5 and to fulfill the board's responsibilities as defined by this 6 act. 7 Section 312. Rules and regulations. 8 The board shall, within 180 days of the effective date of 9 this act and at times necessary thereafter promulgate, adopt, 10 amend and repeal rules and/or regulations as deemed necessary by 11 the board for the proper administration and enforcement of this 12 act. Rules and regulations shall be promulgated in accordance 13 with the procedures specified in the act of July 31, 1968 14 (P.L.769, No.240), referred to as the Commonwealth Documents 15 Law, and the act of June 25, 1982 (P.L.633, No.181), known as 16 the Regulatory Review Act. 17 Section 313. Powers and responsibilities. 18 The board shall have sole responsibility for the control and 19 regulation of the practice of pharmacy in this Commonwealth, 20 including, but not limited to, the following: 21 (1) To determine the nature of examinations for any 22 applicant for a pharmacist license. 23 (2) To examine, inspect and investigate all applications 24 and all applicants for licensure as pharmacists, pharmacies 25 or pharmacy interns, or registration as pharmacy technicians, 26 and to grant certificates of licensure or registration to all 27 applicants whom it shall judge to be properly qualified. 28 (3) To renew licenses to engage in the practice of 29 pharmacy and to operate a pharmacy. 30 (4) To establish and enforce compliance with 19970H1260B1418 - 20 -
1 professional standards of conduct of pharmacists engaged in 2 the practice of pharmacy. 3 (5) To determine and issue standards for recognition and 4 approval of degree programs of schools and colleges of 5 pharmacy whose graduates shall be eligible for licensure in 6 this Commonwealth, and to specific and enforce requirements 7 for practical training, including internship. 8 (6) To enforce those provisions of this act relating to 9 the conduct or competence of pharmacists practicing in this 10 Commonwealth and to suspend, revoke or restrict licenses to 11 engage in the practice of pharmacy. 12 (7) To prepare position descriptions, to employ a 13 minimum of eight pharmacy inspectors, or more of such 14 inspectors if the board deems necessary, who shall be 15 pharmacists licensed in this Commonwealth. 16 (8) To retain appropriate consultants to assist it for 17 any purpose which it may deem necessary, subject to the 18 limitation that the board may not delegate any of its final 19 decision making responsibilities to any consultant. 20 (9) To investigate or cause to be investigated all 21 violations of the provisions of this act and its regulations 22 and to cause prosecutions to be instituted in the courts upon 23 advice from the Office of Attorney General. 24 (10) To inspect any pharmacy licensed by this 25 Commonwealth at reasonable hours for the purpose of 26 determining if any provisions of the laws governing the legal 27 distribution of drugs or devices for the practice of pharmacy 28 are being violated. The board, its officers, inspectors and 29 representatives shall cooperate with all agencies charged 30 with the enforcement of the laws of the United States, of 19970H1260B1418 - 21 -
1 this Commonwealth and of all other states relating to drugs, 2 devices and the practice of pharmacy. 3 (11) To make or order inspections of other places in 4 which drugs or devices are stored, held, compounded, 5 dispensed or sold to a consumer, and to take and analyze any 6 drugs or devices and to seize and condemn any drugs or 7 devices which are adulterated, misbranded, or stored, held, 8 dispensed, distributed, or compounded in violation of the 9 provisions of this act or the provisions of the act of April 10 14, 1972 (P.L.233, No.64), known as The Controlled Substance, 11 Drug, Device and Cosmetic Act. 12 (12) To establish minimum specifications for the 13 physical facilities, technical equipment, environment, 14 supplies, personnel and procedures, for the storage, 15 compounding and/or dispensing of drugs or devices and for the 16 monitoring of drug therapy. 17 (13) To establish minimum standards for maintaining the 18 integrity and confidentiality of prescription information and 19 other patient care information. 20 (14) To conduct hearings for the revocation or 21 suspension of licenses, permits or registrations, for which 22 hearings the board shall have the power to subpoena 23 witnesses. 24 (15) To assist the regularly constituted enforcement 25 agencies of this Commonwealth in enforcing all laws 26 pertaining to drugs, controlled substances and the practice 27 of pharmacy. 28 (16) To have authority to issue subpoenas, upon 29 application of an attorney responsible for representing the 30 Commonwealth in disciplinary matters before the board, for 19970H1260B1418 - 22 -
1 the purpose of investigating alleged violations of the 2 disciplinary provisions administered by the board. 3 (i) The board shall have the power to subpoena 4 witnesses, to administer oaths, to examine witnesses and 5 to take such testimony or compel the production of such 6 books, records, papers and documents as it may deem 7 necessary or proper in, and pertinent to, any proceeding, 8 investigation or hearing held or had by it. 9 (ii) Patient records may not be subpoenaed without 10 the consent of the patient or without order of a court of 11 competent jurisdiction on a showing that the records are 12 reasonably necessary for the conduct of the 13 investigation. 14 (iii) The court may impose such limitations on the 15 scope of the subpoena as are necessary to prevent 16 unnecessary intrusion into a patient confidential 17 situation. 18 (iv) The board is authorized to apply to 19 Commonwealth Court to enforce its subpoenas. 20 (17) In addition to its appropriation from the 21 Commonwealth, to receive and expend funds from parties other 22 than the Commonwealth, subject to the following restrictions: 23 (i) The funds are awarded for the pursuit of a 24 specific objective which the board is authorized to 25 accomplish by this act, or which the board is qualified 26 to accomplish by reason of its jurisdiction or 27 professional expertise. 28 (ii) Activities connected with or occasioned by 29 the expenditure of these funds do not interfere with the 30 performance of the board's duties and responsibilities 19970H1260B1418 - 23 -
1 and do not conflict with the exercise of the board's 2 powers as specified by this act. 3 (iii) The funds are kept in a separate special 4 account and periodic reports are made to the Commissioner 5 of Professional and Occupational Affairs concerning the 6 board's receipt and expenditure of such funds. 7 The powers and duties of the board, as enumerated in this 8 section, shall not be applicable to manufacturers or 9 distributors as defined in the act of April 14, 1972 (P.L.233, 10 No.64), known as The Controlled Substance, Drug, Device and 11 Cosmetic Act. 12 Section 314. Communication to licensees. 13 The board shall at least every six months, and more 14 frequently if necessary, convey relevant information concerning 15 this act, rules or regulations promulgated thereunder, and the 16 practice of pharmacy to all pharmacists and pharmacies 17 registered in this Commonwealth and any nonresident pharmacies 18 licensed by the board. 19 Section 315. Annual report. 20 The board shall submit annually a report to the Consumer 21 Protection and Professional Licensure Committee of the Senate 22 and the Professional Licensure Committee of the House of 23 Representatives containing a description of the types of 24 complaints received, the status of cases, any board action which 25 has been taken and the length of time from the initial complaint 26 to final board resolution. 27 CHAPTER 5 28 PHARMACISTS AND PHARMACIES 29 SUBCHAPTER A 30 PHARMACISTS 19970H1260B1418 - 24 -
1 Section 501. Declaration. 2 The practice of pharmacy in this Commonwealth is hereby 3 declared to be a health care professional practice in which the 4 pharmacist is considered a health care provider affecting the 5 public health, safety and welfare, and is subject to regulation 6 and control in the public interest. 7 Section 502. Licensing of pharmacists. 8 Except as otherwise provided in this act, it shall be 9 unlawful for any individual to engage in the practice of 10 pharmacy within this Commonwealth unless that individual is 11 currently licensed to practice pharmacy pursuant to the 12 provisions of this act. 13 Section 503. Prerequisites for pharmacist license. 14 The board may license as a pharmacist any person who has 15 filed an application therefore, subscribed by the person under 16 oath or affirmation, containing such information as the board 17 may by regulation require, and who: 18 (1) Has satisfied the board that the applicant is of 19 good moral and professional character, and not unfit or 20 unable to practice pharmacy by reason of the extent or manner 21 of the applicant's use of alcoholic beverages or controlled 22 substances or by reason of a physical or mental disability. 23 (2) Holds an entry level practice degree in pharmacy 24 granted by a school or college of pharmacy which is 25 accredited by an accrediting body recognized by the board. 26 (3) Has completed an internship or other equivalent 27 program which has been approved by the board or has 28 demonstrated experience in the practice of pharmacy which 29 meets or exceeds the minimum internship requirements of the 30 board. 19970H1260B1418 - 25 -
1 (4) Has satisfactorily passed such examinations as 2 required by the board. 3 (5) Has paid the fee specified by the board for the 4 examination and any related materials and has paid for the 5 issuance of the license. 6 (6) Has not been convicted of any felonious act 7 prohibited by the act of April 14, 1972 (P.L.233, No.64), 8 known as The Controlled Substance, Drug, Device and Cosmetic 9 Act, or convicted of a felony relating to a controlled 10 substance in a court of law of the United States or any other 11 state, territory or country unless all of the following 12 criteria are satisfied: 13 (i) At least ten years have elapsed from the date of 14 conviction. 15 (ii) The applicant satisfactorily demonstrates to 16 the board that the applicant has made significant 17 progress in personal rehabilitation since the conviction 18 such that licensure of that applicant should not be 19 expected to create a substantial risk of harm to the 20 health and safety of patients or the public or a 21 substantial risk of further criminal violations. 22 (iii) The applicant otherwise satisfies the 23 qualifications contained in or authorized by this act. 24 An applicant's statement on the application declaring the 25 absence of a conviction shall be deemed satisfactory evidence 26 of the absence of a conviction, unless the board has evidence 27 to the contrary. 28 Section 504. Examinations. 29 (a) Schedule of examinations.--The board shall, at least 30 once each year, examine in the practice of pharmacy all 19970H1260B1418 - 26 -
1 applicants who: 2 (1) Have completed their education requirements. 3 (2) Make application for examination pursuant to 4 regulations promulgated by the board. 5 (3) Shall be otherwise eligible for licensure. 6 (b) Content of examination.--The examination shall be 7 prepared to measure the competence of the applicant to engage in 8 the practice of pharmacy. The board may employ, cooperate with 9 or contract with any organization or consultant or professional 10 testing organization for the preparation, administration and 11 grading of the examination, but the board shall retain the sole 12 discretional responsibility for determining which applicants 13 have successfully passed an examination. 14 (c) Reexamination.--In case of failure at a first 15 examination, the applicant shall have within two years the 16 privilege of a second and third examination. In case of failure 17 with the third examination, the applicant shall have the 18 privilege of examination only after satisfactorily completing 19 additional preparation as directed and approved by the board. 20 Section 505. Internship. 21 (a) Requirement.--To ensure proficiency in the practical 22 aspects of pharmacy, the board shall, by regulation, prescribe 23 internship requirements which must be satisfactorily completed 24 prior to the issuance of a pharmacist license. 25 (b) Supervision of intern.--To assure adequate practical 26 instruction, pharmacist internship experience as required under 27 this act shall be obtained under the immediate supervision of a 28 pharmacist meeting the requirements established by the board. 29 (c) Examination to obtain pharmacist license.--Each 30 pharmacist intern applying for examination shall pay to the 19970H1260B1418 - 27 -
1 board an examination fee established by the board through 2 regulation. Upon passing the required examination and complying 3 with all the rules and regulations of the board and the 4 provisions of this act, the board shall grant the applicant 5 licensure as a pharmacist and issue a license qualifying the 6 applicant to enter into the practice of pharmacy. This license 7 shall not be issued until a fee established by the board through 8 regulation shall be paid to the board. 9 Section 506. Qualifications for reciprocal license transfer. 10 (a) Procedure.--The board may, without examination, license 11 as a pharmacist any individual who, at the time of filing an 12 application for licensure, is licensed as a pharmacist in any 13 other state, territory or possession of the United States; 14 provided that that individual shall meet those standards 15 established by the board by regulation and meet all of the 16 following criteria: 17 (1) Produce evidence satisfactory to the board of having 18 had the required secondary and professional education and 19 training, including internship. 20 (2) Be of good character and morals as required of 21 applicants for licensure under the provisions of this act. 22 (3) At the time of initial licensure as a pharmacist 23 have all the qualifications necessary to have been eligible 24 for licensure as a pharmacist in this Commonwealth at the 25 time of licensure in the other state. 26 (4) Have presented to the board proof of initial 27 licensure by examination and proof that such license is in 28 good standing. 29 (5) Not be eligible for reciprocal license transfer 30 unless the state in which that individual is licensed shall 19970H1260B1418 - 28 -
1 under similar conditions grant reciprocal licensure as a 2 pharmacist without examination to pharmacists duly licensed 3 by examination in this Commonwealth. 4 (b) Fee.--Every application under this subsection shall be 5 accompanied by a fee established by the board through regulation 6 for the application and expense of investigation by the board. A 7 fee established by the board through regulation shall be paid 8 for the license and certificate prior to its approval and 9 issuance by the board. 10 Section 507. Renewal of licenses. 11 The board shall provide for, regulate and require all 12 individuals licensed as pharmacists to renew their licenses 13 biennially. The board shall prescribe the form of the renewal 14 application and the information required to be submitted by all 15 applicants, including proof of continuing education. The 16 applicant shall file with the board the renewal application 17 accompanied by a biennial license fee established by the board 18 through regulation. An additional fee established by the board 19 through regulation shall be paid for late licensure renewal of a 20 pharmacist. 21 Section 508. Continuing pharmacy education. 22 (a) General rule.--Continuing pharmacy education as the board 23 may require shall be a prerequisite for licensure renewal. 24 (b) Requirements.--The board shall have authority to: 25 (1) Define, by regulation, the requirements for 26 continuing education. 27 (2) Approve programs of continuing education. 28 (3) Adopt rules and regulations necessary to carry out 29 and enforce this section, which shall include the methods of 30 determining approved programs and any required fees. 19970H1260B1418 - 29 -
1 Section 509. Reporting multiple licensure. 2 Any licensed pharmacist of this Commonwealth who is also 3 licensed to practice pharmacy in any other state, territory or 4 country shall report this information to the board on the 5 biennial registration application. Any disciplinary action in 6 any other state, territory and country shall be reported to the 7 board on the biennial renewal application or within 90 days of 8 final disposition, whichever is sooner. Multiple licensure shall 9 be noted by the board on the pharmacist's record, and such 10 state, territory or country shall be notified by the board of 11 any disciplinary actions taken against said pharmacist in this 12 Commonwealth. 13 SUBCHAPTER C 14 PHARMACIES 15 Section 521. Licensing of pharmacies. 16 (a) General rule.--The board shall issue a permit to any 17 person to conduct a pharmacy: 18 (1) Who has filed an application to operate a pharmacy. 19 (2) Who has subscribed the application under oath or 20 affirmation. 21 (3) Who provides all information the board may require. 22 (4) Who pays any fee established by the board by 23 regulation. 24 (5) Whose proposed pharmacy complies with all 25 regulations of the board and with all requirements of this 26 act. 27 (b) Additional information.--Each applicant for a permit 28 shall provide sufficient evidence to the board that the proposed 29 pharmacy: 30 (1) Has the necessary reference materials, current 19970H1260B1418 - 30 -
1 supplements to these reference materials and the professional 2 equipment, technical equipment and other pharmaceutical 3 equipment which such reference materials, supplements and 4 equipment have been determined by the board as necessary to 5 meet the needs of the practice of pharmacy for the area and 6 type of practice to protect the health and welfare of the 7 citizens of this Commonwealth. 8 (2) Has sufficient physical facilities, including 9 equipment, size, space and sanitation for adequately 10 providing pharmacist care and distributing and dispensing 11 drugs and devices consistent with the protection of the 12 public health, safety and welfare as the board may by 13 regulation establish. 14 (3) Contains a suitable book or file in which shall be 15 preserved, for a period of not less than two years, every 16 prescription compounded or dispensed therein. 17 (4) Will be under the immediate supervision of a 18 pharmacist licensed in this Commonwealth at all times that 19 the pharmacy is open for business. 20 (5) (i) If the applicant is an individual or 21 partnership, that the individual or co-partner, if not a 22 pharmacist, has not previously been found or pleaded 23 guilty or nolo contendere to any crime concerning the 24 practice of pharmacy or involving moral turpitude. 25 (ii) If the applicant is an individual or 26 partnership and a pharmacist, that that pharmacist is 27 presently licensed by the board. 28 (iii) If the applicant is an association, that no 29 director or officer has been found or pleaded guilty or 30 nolo contendere to said crimes or had a pharmacy or 19970H1260B1418 - 31 -
1 pharmacist's license revoked or renewal refused for 2 cause. 3 (6) If the applicant is a corporation, that no director, 4 officer or person having a beneficial interest of more than 5 ten percent of the stock has been found or pleaded guilty or 6 nolo contendere to said crimes or had a pharmacy or 7 pharmacist's license revoked or renewal refused for cause. 8 (7) All applicants shall be of good moral and 9 professional character. In determining this qualification, 10 the board may take into consideration, among other things, 11 the conduct and operation of other pharmacies conducted by 12 the applicant. 13 (c) Supervision.--Every pharmacy shall be under the 14 supervision and management of a pharmacist duly licensed in this 15 Commonwealth. 16 (d) Display of license.--All licenses and permits issued 17 under the provisions of this act shall be displayed in a 18 conspicuous place in the pharmacy for which they were issued. 19 (e) Separate applications for each pharmacy.--Separate 20 applications and permits shall be required for each pharmacy. 21 Each permit shall be issued bearing the name of the pharmacist 22 who will be in charge of that pharmacy as defined by regulation 23 and who will be responsible for all operations involving the 24 practice of pharmacy in that pharmacy. 25 (f) Fees.--All applications for a permit to conduct a 26 pharmacy shall be accompanied by an initial registration fee 27 established by the board by regulation. 28 (g) Expiration.--All permits granted under this section, 29 unless sooner revoked or suspended, shall expire on the date set 30 forth in the permit. The board may promulgate regulations 19970H1260B1418 - 32 -
1 authorizing the application by a personal representative of a 2 deceased grantee for an extension of the deceased grantee's 3 permit for a period not to exceed one year from the date of 4 death. 5 Section 522. Renewal of pharmacy permit. 6 The board shall renew each permit for the succeeding 7 biennium, unless the board shall have given ten days' previous 8 notice to the applicant for the permit of objections to the 9 renewal based upon a finding or plea of guilty or nolo 10 contendere by the applicant, its partners or officers, to a 11 violation of any of the laws of the United States or of this 12 Commonwealth relating to the practice of pharmacy or to the 13 enforcement of controlled substances or involving moral 14 turpitude, upon payment of a fee established by the board by 15 regulation for each pharmacy. The application for renewal shall 16 be made on or before September 1 of each odd-numbered year. 17 Section 523. Permit required for operation. 18 No person shall operate a pharmacy until that person has been 19 granted a pharmacy permit by the board. 20 Section 524. Display of ownership information. 21 The full name or names of the proprietor, or if a 22 partnership, the partners, or if an association or corporation, 23 the name of the pharmacist manager, must be conspicuously 24 displayed in the pharmacy along with any corporate association 25 or duly registered fictitious name. 26 Section 525. Extraterritorial pharmacy permits. 27 (a) Requirement.--Any person, entity, pharmacy or pharmacist 28 located outside of this Commonwealth who ships, mails, 29 distributes, dispenses or delivers prescription drugs or devices 30 to individuals within this Commonwealth shall be required to 19970H1260B1418 - 33 -
1 obtain a pharmacy permit from the board. 2 (b) Waiver.--If the person, entity, pharmacy or pharmacist 3 holds a valid pharmacy permit issued by the state in which that 4 pharmacy is operated, the board may waive any requirements 5 imposed upon pharmacies within this Commonwealth if the waiver 6 of these requirements will not endanger the public health, 7 safety or welfare of the citizens of this Commonwealth. 8 (c) Nonlicensure, no waiver.--If the person or entity does 9 not hold a valid pharmacy permit from the jurisdiction in which 10 the person or entity is operating, then the board shall mandate 11 that all requirements imposed upon pharmacies in this 12 Commonwealth be met by the person or entity desiring to ship, 13 mail, dispense, distribute or deliver prescription drugs or 14 devices within this Commonwealth. 15 (d) Registered agent.--Each person, entity, pharmacy or 16 pharmacist located outside of this Commonwealth who ships, 17 mails, dispenses, distributes or delivers prescription drugs or 18 devices in this Commonwealth shall designate a registered agent 19 in this Commonwealth for service of process. Any such person, 20 entity, pharmacy or pharmacist who does not so designate a 21 registered agent shall be deemed to have designated the 22 Secretary of State of this Commonwealth to be its true and 23 lawful attorney, upon whom may be served all legal process in 24 any action or proceeding against such person, entity, pharmacy 25 or pharmacist growing out of or arising from such shipping, 26 mailing, dispensing, distributing or delivery. A copy of any 27 such service of process shall be mailed to such person, entity, 28 pharmacy or pharmacist by the board by certified mail, return 29 receipt requested, postage prepaid, at the address designated on 30 the application for licensure in this Commonwealth. If any such 19970H1260B1418 - 34 -
1 person, entity, pharmacy or pharmacist is not licensed by the 2 board, service on the Secretary of State only shall be 3 sufficient service for legal purposes. 4 Section 526. Regulatory power over pharmacies. 5 The board may promulgate regulations designed to insure 6 methods of operation and conduct which protect the public health 7 and welfare. 8 CHAPTER 7 9 ENFORCEMENT 10 Section 701. Refusal to grant, revocation and suspension of 11 licenses and permits. 12 The board shall have the power to refuse to grant, refuse to 13 renew, suspend, revoke or restrict the license of any pharmacist 14 or pharmacist intern upon one or more of the following grounds: 15 (1) Unprofessional conduct as that term is defined by 16 the rules of the board. 17 (2) Unfit to practice pharmacy because of intemperance 18 in the use of alcoholic beverages, controlled substances or 19 any other substance which impairs the intellect and judgment 20 to such an extent as to impair the performance of 21 professional duties. 22 (3) Unfit or unable to practice pharmacy by reason of a 23 physical or mental disease or disability. In enforcing this 24 paragraph, the board shall, upon probable cause, have 25 authority to compel a pharmacist or a pharmacist intern to 26 submit to a mental or physical examination by physicians or 27 psychologists approved by the board. Failure to submit to 28 such examination when directed by the board, unless such 29 failure is due to circumstances beyond the individual's 30 control, shall constitute an admission of the allegations 19970H1260B1418 - 35 -
1 against him or her, consequent upon which a default and final 2 order may be entered without the taking of testimony or 3 presentation of evidence. A pharmacist or a pharmacist intern 4 affected under this paragraph shall at reasonable intervals 5 be afforded an opportunity to demonstrate that the pharmacist 6 or pharmacist intern can resume a competent practice of 7 pharmacy with reasonable skill and safety to patients. 8 (4) Procured a license through fraud, misrepresentation 9 or deceit. 10 (5) Been found guilty, pleaded guilty, entered a plea of 11 nolo contendere, or received probation without verdict, 12 disposition in lieu of trial or an Accelerated Rehabilitative 13 Disposition in the disposition of one or more of the 14 following: 15 (i) A felony. 16 (ii) Any offense involving moral turpitude or gross 17 immorality. 18 (iii) Violation of the pharmacy or drug laws of this 19 Commonwealth or rules and regulations pertaining thereto; 20 or of pharmacy laws, rules and regulations of the Federal 21 government or of any other state. 22 (6) Violated or knowingly permitted the violation of any 23 provision of this act or regulation of the board. 24 (7) Knowingly: 25 (i) Allowed, aided or abetted an individual to 26 engage in the practice of pharmacy without a license. 27 (ii) Aided or abetted an individual to assist in the 28 practice of pharmacy without having registered with the 29 board; or falsely used the title of pharmacist or 30 pharmacist intern. Nothing contained in this paragraph 19970H1260B1418 - 36 -
1 shall prohibit pharmacist interns or registered pharmacy 2 technicians from assisting in the practice of pharmacy 3 under the immediate supervision of a licensed pharmacist 4 provided such assistance is consistent with proper 5 pharmacy practices and with board regulations. 6 (8) Willfully deceiving or attempting to deceive the 7 board or its agents with respect to any significant matter 8 under investigation by the board. 9 (9) Advertising of prices for drugs and pharmaceutical 10 services to the public which does not conform with Federal 11 laws or regulations or with the laws or regulations of this 12 Commonwealth, or which is untrue, false, misleading or 13 deceptive. 14 (10) Public assertion or implication of professional 15 superiority in the practice of pharmacy. 16 (11) Paying rebates to physicians or other persons, or 17 the entering into of any agreement with a medical 18 practitioner or any other person for the payment or 19 acceptance of compensation in any form for the recommending 20 of the professional services of either party. 21 (12) Entering into any agreement with a licensed medical 22 practitioner for the compounding or dispensing of secret 23 formula (coded) prescriptions. 24 (13) Misbranding or adulteration of any drug or device, 25 or the sale, distribution, or dispensing of any misbranded or 26 adulterated drug or device as defined in the Act of April 14, 27 1972 (P.L. 233, No. 64), known as The Controlled Substance, 28 Drug, Device and Cosmetic Act. 29 (14) Displaying or permitting the display of his or her 30 certificate of licensure and/or current registration document 19970H1260B1418 - 37 -
1 in a pharmacy of which he or she is not the proprietor or is 2 not employed. 3 (15) For any holder of a current pocket registration 4 card to fail, when practicing, to have the card available for 5 inspection by an authorized agent of the board. 6 (16) The acceptance back and redistribution of any 7 unused drug or part thereof as defined by regulations. 8 (17) Accept employment as a pharmacist, or share or 9 receive compensation in any form arising out of, or 10 incidental to, his or her professional activities from any 11 person who orders said pharmacist, directly or indirectly, to 12 engage in any aspect of the practice of pharmacy in 13 contravention of any provision of this act or regulation of 14 the board. 15 (18) Had a license to practice pharmacy suspended, 16 revoked or refused, or received other disciplinary action by 17 the proper pharmacist licensing authority of another state, 18 territory or country. 19 (19) Acted in such a manner as to present an immediate 20 and clear danger to the public health or safety. 21 (20) Is guilty of incompetence, gross negligence or 22 other malpractice, or the departure from, or failure to 23 conform to, the standards of acceptable pharmacy practice, in 24 which case actual injury need not be established. 25 (21) Knowing that a pharmacist or pharmacist intern is 26 incapable of engaging in the practice of pharmacy or that a 27 pharmacy technician is incapable of assisting in the practice 28 of pharmacy, with reasonable skill, competence, and safety to 29 the public, and failing to report any relevant information to 30 the board. 19970H1260B1418 - 38 -
1 (22) Engaging in any conduct which subverts or attempts 2 to subvert any licensing examination or the administration of 3 any licensing exam. 4 (23) Failing to pay the costs assessed in a disciplinary 5 hearing. 6 Section 702. Temporary suspension. 7 (a) Authorization.--A license duly issued under this act may 8 be temporarily suspended under circumstances as determined by 9 the board to be an immediate and clear danger to the public 10 health and safety. The board shall issue an order to that effect 11 without a hearing, but upon due notice to the licensee concerned 12 at his or her last known address, which shall include a written 13 statement of all allegations against the licensee. The case of a 14 temporary suspension pursuant to this section, hearings, appeals 15 from, and rulings resulting therefrom, need not comply with the 16 provisions of 2 Pa.C.S. § 103 (relating to Administrative Agency 17 Law). 18 (b) Commencement of formal proceedings.--The board shall 19 thereupon commence formal action to suspend, revoke or restrict 20 the license of the person concerned, as otherwise provided for 21 in this act. All actions shall be taken promptly and without 22 delay. 23 (c) Preliminary hearing.--Within 30 days following the 24 issuance of an order temporarily suspending a license, the board 25 shall conduct or cause to be conducted a preliminary hearing to 26 determine that there is a prima facie case supporting the 27 suspension. The licensee whose license has been temporarily 28 suspended may be present at the preliminary hearing and may be 29 represented by counsel, cross-examine witnesses, inspect 30 physical evidence, call witnesses, offer evidence and testimony 19970H1260B1418 - 39 -
1 and make record of the proceedings. If it is determined that 2 there is not a prima facie case, the suspended license shall be 3 immediately restored. 4 (d) Duration of temporary suspension.--The temporary 5 suspension shall remain in effect until vacated by the board, 6 but in no event longer than 180 days. 7 Section 703. Automatic suspension. 8 A pharmacist license or a pharmacist intern license issued 9 under this act shall be automatically suspended upon the legal 10 commitment to an institution of a licensee or registrant because 11 of mental incompetency from any cause upon filing with the board 12 a certified copy of such commitment, or upon the conviction of a 13 felony under the Act of April 14, 1972 (P.L.233, No.64), known 14 as The Controlled Substance, Drug, Device and Cosmetic Act, or 15 conviction of an offense under the laws of another jurisdiction, 16 which if committed in this Commonwealth would be a felony under 17 The Controlled Substance, Drug, Device and Cosmetic Act. 18 Automatic suspension under this section shall not be stayed 19 pending any appeal of conviction. Restoration of such license or 20 registration shall be made as hereinafter provided in the case 21 of revocation or suspension of such license or registration. 22 Section 704. Impaired licensee. 23 (a) Board action.--When an impaired pharmacist or pharmacist 24 intern is subject to disciplinary action, the board may defer 25 and ultimately dismiss any of the types of corrective action set 26 forth in this act for an impaired professional so long as the 27 pharmacist or pharmacist intern is progressing satisfactorily in 28 an approved treatment program and in an impaired professional 29 support group recognized by the board. 30 (b) Information disclosure to board.--If an impaired 19970H1260B1418 - 40 -
1 pharmacist or pharmacist intern enters an approved treatment 2 program and an impaired professional support group, the approved 3 program provider shall, upon request, disclose to a professional 4 consultant appointed and employed by the board as hereinafter 5 described, such information in his or her possession regarding 6 the impaired pharmacist or pharmacist intern in treatment, when 7 the program provider is not prohibited from disclosing such 8 information by an act of the United States, this Commonwealth or 9 another state. 10 (c) Agreement by licensee.--An impaired pharmacist or 11 pharmacist intern who enrolls in an approved treatment program 12 shall enter into either: 13 (1) An agreement with the peer assistance group which 14 will monitor the licensee's progress, monitor compliance with 15 the terms of the agreement and monitor adherence to any 16 limitations on the practice of pharmacy as required by the 17 terms of the agreement so as to protect the public. 18 (2) An agreement with the board under which the 19 pharmacist's or pharmacist intern's license shall be 20 suspended or revoked, but enforcement of that suspension or 21 revocation shall be stayed for the length of time the 22 impaired pharmacist or pharmacist intern remains in the 23 treatment program and makes satisfactory progress, complies 24 with the terms of the agreement and adheres to any 25 limitations on his or her practice imposed by the board to 26 protect the public. 27 Failure to enter into one of the agreements shall disqualify the 28 impaired professional from the impaired pharmacist or pharmacist 29 intern program and shall activate an immediate investigation and 30 disciplinary proceeding by the board. 19970H1260B1418 - 41 -
1 (d) Lack of satisfactory progress.--If, in the opinion of 2 the professional consultant after consultation with the program 3 provider and/or the peer assistance group, an impaired 4 pharmacist or pharmacist intern who is enrolled in an approved 5 treatment program or the peer assistance program and has entered 6 into an agreement under subsection (a) has not progressed 7 satisfactorily, the professional consultant shall disclose to 8 the board all information in the consultant's possession 9 regarding said pharmacist or pharmacist intern, and the board 10 shall institute proceedings to determine if the stay of the 11 enforcement of the suspension or revocation of the impaired 12 pharmacist's or pharmacist intern's license shall be vacated if 13 the licensee has executed a board agreement. If the licensee has 14 not executed a board agreement but has executed an agreement 15 with the peer assistance program, the board shall immediately 16 institute proceedings to determine if the impaired pharmacist's 17 or pharmacist intern's license should be revoked or suspended. 18 Section 705. Reinstatement. 19 (a) Petition.--Any person whose license to practice pharmacy 20 in this Commonwealth has been suspended, revoked or restricted 21 pursuant to this act, whether voluntarily or by action of the 22 board, shall have the right, after any statutorily mandated 23 period of time, or, if no statutory limitation exists, at 24 reasonable intervals, to petition the board for reinstatement of 25 such license. 26 (b) Forms.--Such petition shall be made in writing and in 27 the form prescribed by the board. 28 (c) Board procedures.--Upon investigation and hearing, the 29 board may, in its discretion, grant or deny such petition, or it 30 may modify its original findings to reflect any circumstances 19970H1260B1418 - 42 -
1 which have changed sufficiently to warrant such modifications. 2 The board, also at its discretion, may require such person to 3 pass an examination for reentry into the practice of pharmacy. 4 (d) Nonreinstatment for revocation.--Unless ordered to do so 5 by Commonwealth Court or an appeal therefrom, the board shall 6 not reinstate the license of a person to the practice of 7 pharmacy pursuant to this act which license has been revoked. 8 Any person whose license has been revoked may apply for 9 reinstatement after a period of five years from the date of 10 revocation, but must meet all of the licensing qualifications of 11 this act for the license applied for, to include the examination 12 requirement. 13 Section 706. No bar to criminal action. 14 Nothing herein shall be construed as barring criminal 15 prosecutions for violations of this act. 16 Section 707. Administrative Agency Law. 17 All final decisions of the board shall be subject to judicial 18 review pursuant to 2 Pa.C.S. § 103 (relating to Administrative 19 Agency Law). 20 Section 708. Board action. 21 When the board finds that the license of any pharmacist or 22 pharmacist intern may be refused, revoked or suspended under the 23 terms of this section, the board may: 24 (1) Deny the application for a license. 25 (2) Administer a public reprimand. 26 (3) Revoke, suspend, limit or otherwise restrict the 27 license as determined by the board. 28 (4) Require the licensee to submit to the care, 29 counseling or treatment of a physician or a psychologist 30 designated by the board, or enter into an appropriate 19970H1260B1418 - 43 -
1 treatment program as determined by the board. 2 (5) Suspend enforcement of its findings thereof and 3 place the licensee on probation with the right to vacate the 4 probationary order for noncompliance, unless such suspension 5 is otherwise prohibited by this act. 6 Section 709. Pharmacy permits. 7 The board shall have the power to refuse, revoke or suspend 8 the permit of any pharmacy upon proof satisfactory to it that 9 any of the following occurred: 10 (1) The permit was procured through fraud, 11 misrepresentation or deceit. 12 (2) The holder or partner or officer thereof has 13 violated any of the provisions of this act, regulations of 14 the board or any provisions of the act of April 14, 1972 15 (P.L.433, No.64), known as The Controlled Substance, Drug, 16 Device or Cosmetic Act, or the Federal act, or has ordered a 17 pharmacist, pharmacist intern or pharmacy technician in the 18 employ of that pharmacy to engage in any aspect of the 19 practice of pharmacy in contravention of any provisions of 20 the aforesaid acts or regulations. 21 (3) The holder of the pharmacy permit sold, dispensed or 22 caused or allowed to be sold or dispensed any controlled 23 substance or nonproprietary drug, except by a licensed 24 pharmacist. 25 (4) Upon the suspension or revocation of a license of a 26 pharmacist or pharmacist intern employed by said pharmacy, it 27 is shown that the illegal acts of the pharmacist or 28 pharmacist intern were within the knowledge or should have 29 been within the knowledge of the permit holder, partner or 30 officer. 19970H1260B1418 - 44 -
1 (5) The holder of the pharmacy permit, after issuance of 2 a permit, fails to continue to comply with all requirements 3 of Subchapter C of Chapter 5. 4 Section 710. Return of license or permit. 5 Any individual or entity whose license to practice pharmacy 6 or registration to assist in the practice of pharmacy is 7 revoked, suspended or not renewed shall return the license or 8 registration certificate to the offices of the board within ten 9 days after receipt of notice of such action. 10 Section 711. Hearings. 11 (a) Notice of determination.--Upon refusal of the board to 12 issue any license or permit, written notices of the grounds 13 supporting such decision shall be given to the applicant, either 14 personally or by registered or certified mail, return receipt 15 requested, and the board shall accord the applicant opportunity 16 of a hearing, upon written request received within 15 days from 17 the date of giving the written notice. 18 (b) Investigation.--The board may, upon its own motion, and 19 shall, promptly, upon the verified complaint in writing of any 20 person setting forth specifically the wrongful act or acts 21 complained of, investigate any alleged violations of this act by 22 any persons, and shall have the power temporarily to suspend or 23 permanently revoke licenses or permit issued by the board under 24 the provisions of this act at any time when, after due 25 proceedings as provided, it shall find the holder thereof to 26 have been guilty of any violation of the provisions of this act 27 or the rules or regulations of the board. 28 (c) Conduct of hearings.--Hearings, appeals and rulings 29 resulting therefrom, unless otherwise provided in this act, 30 shall be in accordance with the provisions of the 2 Pa.C.S. § 19970H1260B1418 - 45 -
1 103 (relating to Administrative Agency Law). 2 (d) Presence of board member.--A majority of the board shall 3 designate the member or members to be present at each hearing. 4 Subsequent to each hearing, the notes of testimony shall be 5 transcribed and a copy of the transcription shall be given to 6 each member of the board who shall review the same prior to 7 voting thereon. All decisions shall be reached by a majority 8 vote of the entire board. The board shall, by regulation, 9 establish and publish procedural rules concerning the conduct of 10 hearings. 11 Section 712. Docket and other records. 12 The board shall maintain in its office a docket or other 13 record of the rulings and decisions upon all complaints filed 14 with it and all investigations instituted by it. The board shall 15 also give immediate written notice of such rulings or decisions 16 to the licensee affected thereby and where the investigation 17 shall have been instituted by complaint filed, to the party or 18 parties by whom the complaint was made. If such ruling shall be 19 to the prejudice or shall injuriously affect the licensee, the 20 board shall also state in the notice the date upon which the 21 ruling shall become effective. If the licensee, at such time, 22 cannot be found, his or her whereabouts being unknown, such 23 notice may be given by the board by advertisement inserted in 24 one issue of a newspaper of general circulation published within 25 the county which was designated by the licensee as his or her 26 mailing address. When any revocation or suspension shall become 27 final, the board shall publish notice thereof in one issue of 28 one or more newspapers of general circulation published within 29 the county in which the licensee was engaged in the practice of 30 pharmacy at the time of such revocation or suspension. 19970H1260B1418 - 46 -
1 CHAPTER 9 2 PHARMACIST PRACTICE 3 Section 901. Practice of pharmacy. 4 The practice of pharmacy in this Commonwealth is hereby 5 declared a health care professional practice in which the 6 pharmacist is considered a health care provider affecting the 7 public health, safety and welfare and is subject to regulation 8 and control in the public interest. It is declared to be a 9 matter of public interest and concern that the practice of 10 pharmacy, as defined in this act, merit and receive the 11 confidence of the public and that only qualified persons be 12 permitted to engage in the practice of pharmacy in this 13 Commonwealth. 14 Section 902. Pharmacy is health care service. 15 The practice of pharmacy is the provision of health care 16 services by a pharmacist including, but not limited to, the 17 interpretation, evaluation and implementation of medical orders; 18 the delivering, dispensing or distributing of prescription 19 drugs; participation in drug and device selection; drug 20 administration; drug regimen review; drug or drug-related 21 research; provision of pharmacist care in all areas including 22 primary care; compounding; proper and safe storage of drugs and 23 devices; managing drug therapy; participation in collaborative 24 care agreements; maintaining proper records; patient counseling, 25 physical assessment; order and perform laboratory or other 26 diagnostic tests; disease state management; and such acts, 27 services, operations or transactions necessary or incident to 28 providing pharmacist care. 29 Section 903. Drug regimen review. 30 In all practice care settings a pharmacist shall: 19970H1260B1418 - 47 -
1 (1) Perform a drug regimen review prior to dispensing a 2 prescription. 3 (2) Maintain a patient history in compliance with 4 regulations of the board for each patient for whom 5 prescriptions are dispensed. 6 (3) Offer to provide drug information to the patient, 7 caregiver or patient's agent in compliance with regulations 8 of the board. 9 Section 904. Disease state management. 10 In all practice care settings a pharmacist who has completed 11 a certified program may perform disease state management 12 through a comprehensive, integrated systems approach to both 13 care and reimbursement based upon natural course of disease 14 which emphasizes treatments designed to address an illness with 15 maximum efficiency. 16 Section 905. Collaborative care agreements. 17 (a) Authority to enter.--A pharmacist shall be permitted to 18 enter into a collaborative care agreement with a licensed 19 prescriber. A pharmacist may be permitted to initiate, modify or 20 discontinue prescription drug therapy, administer medications 21 and order or perform laboratory tests as appropriate pursuant to 22 written protocols contained in a collaborative care agreement 23 with a licensed prescriber in this Commonwealth. The 24 collaborative care agreement shall contain a written protocol 25 specifically authorizing the pharmacist to initiate, modify or 26 discontinue drug therapy, to administer medications and to order 27 or perform laboratory tests, all in accordance with regulations 28 adopted by the board. 29 (b) Licensed prescriber.--The licensed prescriber who is a 30 party to the collaborative care agreement shall be in active 19970H1260B1418 - 48 -
1 practice, and the scope of the agreement shall be within the 2 scope of the licensed prescriber's current practice. 3 (c) Content of written protocol.--The protocol required in 4 the collaborative care agreement shall include: 5 (1) A statement identifying the licensed prescriber and 6 the pharmacist who is a party to the agreement. 7 (2) A statement of the types of therapeutic decisions 8 that the pharmacist is authorized to make which may include, 9 but are not limited to, a statement of the types of diseases, 10 drugs or drug categories involved and general statement of 11 the procedures, decision criteria or plan the pharmacist is 12 to follow when exercising the licensed prescriber's authority 13 pursuant to the collaborative care agreement. 14 (3) A statement of the activities the pharmacist is to 15 follow in the course of exercising the authority granted 16 under the collaborative care agreement, including 17 documentation of decisions made and a plan for communication 18 or feedback to the licensed prescriber concerning specific 19 decisions made. 20 (4) A statement that describes appropriate mechanisms 21 for reporting to the licensed prescriber the monitoring 22 activities of the pharmacist and the results of treatment. 23 (d) Review.--The collaborative care agreement and protocols 24 contained therein shall be reviewed at least every two years and 25 shall be modified or revised whenever necessary. 26 (e) Regulatory authority.--The board shall adopt regulations 27 to assure for the protection of the health and welfare of 28 patients treated pursuant to a collaborative care agreement. 29 Section 906. Compensation. 30 Pharmacists performing services under sections 903, 904 and 19970H1260B1418 - 49 -
1 905 shall be compensated for such services. 2 Section 907. Pharmacy technicians. 3 (a) Use.--Pharmacy technicians may be utilized to assist 4 pharmacists in the preparation of prescriptions and drug orders 5 in compliance with regulations adopted by the board. 6 (b) Training.--Technicians may be trained at any licensed 7 pharmacy or trained through educational programs provided by 8 colleges, universities, professional associations, private 9 schools or other entities. 10 (c) Registration.--Pharmacy technicians must register with 11 the board on a form prescribed by the board and pay a 12 registration fee as determined by the board. 13 (d) Pharmacist supervision.--Pharmacy technicians shall work 14 only under the immediate supervision of a licensed pharmacist 15 who may supervise no more than three pharmacy technicians in any 16 setting or a higher number of pharmacy technicians if in the 17 best interest of assuring the health and safety of patients and 18 if permitted by the regulations of the board. 19 (e) Prohibited activities.--Pharmacy technicians shall be 20 prohibited from performing those functions requiring the skill 21 and competence of a licensed pharmacist such as, but not limited 22 to, performing drug regimen reviews, providing drug information 23 and/or patient counseling to patients or caregivers or the 24 monitoring of drug therapy. 25 Section 908. Prescriptions. 26 (a) Transmission.--Prescriptions and drug orders may be 27 written by the health practitioner, transmitted by telephone to 28 the pharmacy by the health practitioner or his or her agent, 29 transmitted to the pharmacy by facsimile provided there is no 30 prohibition in Federal or State law prohibiting facsimile 19970H1260B1418 - 50 -
1 transmission of prescription or drug orders for the specific 2 drug involved or transmitted by electronic data transmission 3 from the health practitioner directly to the pharmacy. The board 4 shall establish regulations governing the use of facsimile or 5 electronic data transmission to assure for the protection of the 6 public health and safety and to provide adequate security to 7 assure confidentiality of such information and data. 8 (b) Transfer between pharmacies.--A prescription may be 9 transferred between pharmacies in this Commonwealth pursuant to 10 the following requirements and any regulations of the board: 11 (1) The prescription is for a drug which is lawfully 12 refillable. 13 (2) The drug is not a Schedule II controlled substance. 14 (3) An original or new prescription is not required from 15 the prescriber by law. 16 (4) The pharmacist transferring the prescription cancels 17 the original prescription in his or her records and indicates 18 on the prescription records to whom the prescription was 19 transferred, including the name of the pharmacy, the date of 20 the transfer and the name or initials of the transferring 21 pharmacist. 22 (5) The pharmacist receiving the transferred 23 prescription: 24 (i) Notes on the prescription that it is a 25 transferred prescription. 26 (ii) Records all of the following on the 27 prescription records in addition to other information 28 required by law: 29 (A) Date of issuance of original prescription. 30 (B) Date of original filling of prescription and 19970H1260B1418 - 51 -
1 date of last refill. 2 (C) Original number of refills authorized on 3 prescription. 4 (D) Number of valid refills remaining. 5 (iii) Notes the location and file number of the 6 original prescription. 7 (iv) Notes the name of the pharmacy and pharmacist 8 from whom the prescription was transferred. 9 (6) A pharmacist may transfer a prescription to another 10 pharmacist employed by the same corporation without regard to 11 the requirements of paragraphs (4) and (5) provided that both 12 pharmacists have access to the same computerized prescription 13 transfer system which contains the prescription refill 14 records and incorporates procedures to prevent unauthorized 15 refills. 16 Section 909. Emergency refills. 17 A pharmacist shall be permitted to provide an emergency 18 refill of a prescription that would otherwise not be legally 19 refillable only pursuant to all of the following terms and 20 conditions: 21 (1) The pharmacist first attempts to obtain an 22 authorization from the authorized prescriber but cannot 23 contact the prescriber. 24 (2) The drug which is the subject of the refill is 25 essential to the continuation of therapy and, in the 26 pharmacist's professional judgment, the interruption of the 27 therapy might reasonably produce an undesirable health 28 consequence, be detrimental to the patient's welfare or cause 29 physical or mental discomfort. 30 (3) The drug which is the subject of the refill is not a 19970H1260B1418 - 52 -
1 controlled substance. 2 (4) The pharmacist enters on the back of the 3 prescription or on another appropriate, uniformly maintained 4 and readily retrievable record, the date and quantity of the 5 refill and the pharmacist must verify the prescription. 6 (5) The pharmacist provides no more than a 72-hour 7 emergency supply of the medication in conformity with the 8 prescribed directions for use. 9 (6) Within 72 hours of dispensing the refill, the 10 pharmacist notified the prescriber that an emergency 11 prescription had been dispensed and the quantity of drug 12 provided to the patient. 13 Section 910. Impaired pharmacist or pharmacist intern. 14 (a) Board power.--In addition to the provision of section 15 704, the board, with the approval of the Commissioner of 16 Professional and Occupational Affairs, shall appoint and fix 17 compensation of a professional consultant who is a licensee of 18 the board with education and experience in the identification, 19 treatment and rehabilitation of persons with chemical, physical 20 and mental impairments. Such consultants shall be accountable to 21 the board and shall act as a liaison between the board and 22 treatment programs, such as alcohol and drug treatment programs 23 licensed by the Department of Health, psychological counseling 24 and impaired professional support groups approved by the board 25 and which provide services to licensees under this act. 26 (b) Required report.--Any hospital or health care facility, 27 peer or colleague who has substantial evidence that a pharmacist 28 or pharmacist intern has an active, addictive disease for which 29 the pharmacist or pharmacist intern is not receiving treatment, 30 is diverting a controlled substance for personal use or is 19970H1260B1418 - 53 -
1 mentally or physically incompetent to carry out the duties of 2 his or her license or certificate shall make or cause to be made 3 a report to the board except that any person or facility who 4 acts in a treatment capacity to an impaired pharmacist in an 5 approved treatment program is exempt from the mandatory 6 reporting requirements of this subsection. Any person or 7 facility who reports in good faith and without malice shall be 8 immune from any civil or criminal liability resulting from such 9 report. Failure to provide such report within a reasonable time 10 from receipt of such knowledge of impairment shall subject the 11 person or facility to a fine not to exceed $1,000. The board 12 shall levy such penalty only after affording the accused party 13 the opportunity for a hearing, as provided in 2 Pa.C.S. 14 (relating to administrative law and procedure). 15 (c) Report by provider.--An approved program provider who 16 makes disclosure to the board pursuant to the requirements of 17 this act shall not be subject to civil liability for such 18 disclosure or its consequences. 19 CHAPTER 11 20 UNLAWFUL ACTIVITIES 21 Section 1101. Unlawful acts. 22 It shall be unlawful for: 23 (1) Any person to procure or attempt to procure a 24 license, permit or certificate for himself or herself or for 25 any other person by making or causing to be made any false 26 representations. 27 (2) Any person not duly licensed as a pharmacist 28 pursuant to this act to engage in the practice of pharmacy, 29 except a pharmacy intern or such other authorized personnel 30 under the immediate personal supervision of a pharmacist, 19970H1260B1418 - 54 -
1 provided that nothing herein shall be construed to prevent a 2 duly licensed medical practitioner from administering any 3 drug to his or her own patients after diagnosis or treatment 4 of the patient, nor shall anything herein prevent any person 5 from selling or distributing at retail household remedies or 6 proprietary medicines when the same are offered for sale or 7 sold in the original manufacturer's package which was 8 prepared for sale to consumers. 9 (3) Any unlicensed person to operate or conduct, or to 10 have charge or to supervise any pharmacy. For violation of 11 this section, the owner of the pharmacy shall be equally 12 liable as principle. 13 (4) Any person to represent that person to be licensed 14 under this act when in fact that person is not licensed. 15 (5) Any person to knowingly prevent or refuse to permit 16 any member of the board or its duly authorized agents to 17 enter a pharmacy or any other place where drugs or devices 18 are kept, stored, dispensed or distributed to a patient or 19 consumer for the purpose of lawful inspection or other 20 purposes in accordance with the provisions of this act and 21 regulations pursuant thereto. 22 (6) Any person whose license, permit or certification 23 has been revoked, suspended or refused renewal to fail to 24 deliver the license, permit or certificate to the board 25 within ten days after receipt of notice of such action. 26 (7) Any person to sell at auction drugs or devices in 27 bulk or in open or unopened packages, unless such sale has 28 been approved in advance by the board and unless such sale 29 shall be under the personal supervision of a licensed 30 pharmacist appointed by the board and whose fee shall be paid 19970H1260B1418 - 55 -
1 by the seller. 2 (8) Any person, firm or corporation to use the title 3 "pharmacist," "pharmacist care," "pharmacy care," 4 "pharmaceutical care," "assistant pharmacist," "druggist," 5 "apothecary" or similar terms except a person duly licensed 6 as a pharmacist in this Commonwealth or any person to conduct 7 or transact business under a name which contains as part 8 thereof the words "drug store," "pharmacy," "drugs," 9 "medicine store," "medicines," "drug shop," "apothecary," 10 "pharmaceutical" or any term having a similar meaning, or in 11 any manner by advertisement, display or show globes or 12 otherwise describe or refer to the place of the conducted 13 business or person unless the place is a pharmacy duly issued 14 a permit by the board. 15 (9) Any person who buys, sells or causes to be sold or 16 offers for sale any drug or device which bears or which 17 package bears, or originally did bear, the inscription 18 "sample" or "not for resale" or "for investigational or 19 experimental use only" or other similar words, except where a 20 cost is incurred in the bona fide acquisition of an 21 investigational or experimental drug. 22 (10) Any person using to that person's own advantage or 23 revealing to anyone other than the board, its duly authorized 24 representatives or to the courts when relevant to any 25 judicial proceeding under this act, any information acquired 26 under authority of this act or concerning any method or 27 process which is a trade secret. 28 (11) Any pharmacist or owner of a pharmacy advertising 29 or promoting prices for drugs and pharmaceutical services to 30 the public which do not conform to Federal and State laws and 19970H1260B1418 - 56 -
1 regulations. 2 (12) Any person who knowingly and willfully forges or 3 counterfeits upon any goods, wares or merchandise the private 4 stamps or labels of any mechanic or manufacturer with intent 5 to defraud the purchasers or manufacturers of any goods, 6 wares or merchandise, or keeps in possession or conceals any 7 goods, wares or merchandise or keeps in control, custody or 8 possession any punch plate, stone or other thing in the 9 likeness of any punch plate or stone designated for the 10 printing or imprinting of the private stamps or labels of any 11 mechanic or manufacturer, or who vends any goods, wares or 12 merchandise having thereon any forged or counterfeited stamps 13 or labels purporting to be the stamps or labels of any 14 mechanic or manufacturer, knowing the same to be forged or 15 counterfeited. 16 (13) Any person by himself or herself or through another 17 to procure or attempt to procure for himself or herself or 18 another any drug: 19 (i) By fraud, deceit, misrepresentation or 20 subterfuge. 21 (ii) By the forgery or alteration of a prescription 22 or any written order. 23 (iii) By the concealment of material facts. 24 (iv) By the use of a false statement and a 25 prescription order or report. 26 (14) Any person to deliver a prescription medication by 27 mail or otherwise to a patient within this Commonwealth 28 unless the prescription is filled or refilled in a pharmacy 29 licensed by the board. 30 (15) One or more licensed prescribers to have a 19970H1260B1418 - 57 -
1 proprietary or beneficial interest in a pharmacy sufficient 2 to permit them to exercise supervision or control over a 3 pharmacist working in the pharmacy in his or her professional 4 responsibilities and duties. 5 Section 1102. Criminal penalties. 6 Any person who violates any of the provisions of section 1101 7 shall be guilty of a misdemeanor and shall, upon conviction, be 8 sentenced to pay a fine of not more than $5,000, or to 9 imprisonment for not more than one year, or both and for each 10 subsequent offense, shall be sentenced to pay a fine of not more 11 than $15,000, or to imprisonment for not more than three years, 12 or both. 13 Section 1103. Additional civil penalty. 14 In addition to any other civil remedy or criminal penalty 15 provided for in this act, the board may levy a civil penalty of 16 up $1,000 on any current licensee who violates any provision of 17 this act or on any person who practices pharmacy without being 18 properly licensed to do so under this act. The board shall levy 19 such penalty only after affording the accused party the 20 opportunity for a hearing, as provided in 2 Pa.C.S. (relating to 21 administrative law and procedure). 22 CHAPTER 13 23 FISCAL AFFAIRS 24 Section 1301. Setting of fees 25 (a) General rule.--All fees required under this act shall be 26 fixed by the board by regulation and shall be subject to the act 27 of June 25, 1982 (P.L.633, No.181), known as the Regulatory 28 Review Act. If the revenues raised by fees, fines and civil 29 penalties imposed under this act are not sufficient to meet 30 expenditures over a two-year period, the board shall increase 19970H1260B1418 - 58 -
1 those fees by regulation, so that the projected revenues will 2 meet or exceed projected expenditures. 3 (b) Increases in fees.--If the Bureau of Professional and 4 Occupational Affairs determines that the fees, fines and civil 5 penalties established by the board under subsection (a) are 6 inadequate to meet the minimum enforcement efforts required by 7 this act, then the bureau, after consultation with the board and 8 subject to the Regulatory Review Act, shall increase the fees by 9 regulation in an amount such that adequate revenues are raised 10 to meet the required enforcement effort. 11 Section 1302. Account and fees disposition. 12 The Commissioner of Professional and Occupational Affairs 13 shall establish a Pharmacy Professional Development Account and 14 all fees, fines and civil penalties imposed in accordance with 15 this act shall be paid into the Pharmacy Professional 16 Development Account. The funds shall be used by the board for 17 professional development and for enforcement efforts mandated by 18 this act. 19 Section 1303. Annual submissions. 20 (a) Estimate to department.--The board shall submit annually 21 to the Department of State an estimate of the financial 22 requirements of the board for its administrative, investigative, 23 legal and miscellaneous expenses. 24 (b) Report to General Assembly.--The board shall submit 25 annually to the and Appropriations Committee of the Senate and 26 the Appropriations Committee of the House of Representatives, 15 27 days after the Governor has submitted the budget to the General 28 Assembly, a copy of the budget request for the upcoming fiscal 29 year which the board previously submitted to the Department of 30 State. 19970H1260B1418 - 59 -
1 Section 1304. Hiring of pharmacy inspectors. 2 The board shall employ a minimum of eight pharmacy inspectors 3 who shall be licensed pharmacists in this Commonwealth. If the 4 board determines that additional pharmacy inspectors are 5 necessary to protect the health and safety of the citizens of 6 this Commonwealth, the board shall hire such additional 7 inspectors. Inspectors shall inspect all licensed locations. All 8 pharmacy inspectors shall be under the authority of the board 9 and shall report to the executive director. 10 CHAPTER 15 11 MISCELLANEOUS PROVISIONS 12 Section 1501. Board members. 13 Members of the board appropriately confirmed as of the 14 effective date of this act shall continue to serve as members of 15 the board until their present terms expire or until a successor 16 has been appointed and qualified, but no longer than six months 17 after present terms have expired. 18 Section 1502. Rules and regulations. 19 Each rule and regulation of the board in effect on the 20 effective date of this act, not inconsistent with this act, 21 shall remain in effect until repealed or amended by the board. 22 Each fee of the board in effect on the effective date of this 23 act, and not inconsistent with this act, shall remain in effect 24 until repealed or amended in accordance with the provisions of 25 this act. 26 Section 1503. Current licensees. 27 Any person who holds a valid license issued by the board on 28 the effective date of this act shall, on and after the effective 29 date of this act, be deemed to be licensed by the board as 30 provided for in this act. 19970H1260B1418 - 60 -
1 Section 1504. Severability. 2 The provisions of this act are severable. If any provision of 3 this act or its application to any person or circumstance is 4 held invalid, the invalidity shall not affect other provisions 5 or applications of this act which can be given effect without 6 the invalid provision or application. 7 Section 1505. Repeals. 8 (a) Absolute.--The act of September 27, 1961 (P.L.1700, 9 No.699), known as the Pharmacy Act, is repealed. 10 (b) Inconsistent.--The act of April 9, 1929 (P.L.177, 11 No.175), known as The Administrative Code of 1929, is repealed 12 insofar as it is inconsistent with this act. 13 (c) General.--All other acts and parts of acts are repealed 14 insofar as they are inconsistent with this act. 15 Section 1506. Effective date. 16 This act shall take effect January 1, 1998. C25L63RZ/19970H1260B1418 - 61 -