PRIOR PRINTER'S NO. 2434 PRINTER'S NO. 4165
No. 1946 Session of 1999
INTRODUCED BY ALLEN, LUCYK, HARHART, PERZEL, DeWEESE, PHILLIPS,
FAIRCHILD, ARGALL, BAKER, BARRAR, BENNINGHOFF, CALTAGIRONE,
CLYMER, M. COHEN, CORRIGAN, DALLY, DeLUCA, DEMPSEY, FLEAGLE,
FRANKEL, GANNON, GEORGE, GIGLIOTTI, HALUSKA, HENNESSEY, HESS,
KAISER, LAUGHLIN, LEH, McILHATTAN, MICHLOVIC, PETRARCA,
ROBERTS, ROHRER, ROONEY, SATHER, SAYLOR, SCRIMENTI, SEMMEL,
SEYFERT, STERN, STEVENSON, TANGRETTI, THOMAS, TIGUE,
VAN HORNE, WILT, WOJNAROSKI, YOUNGBLOOD AND FEESE,
OCTOBER 12, 1999
AS REPORTED FROM COMMITTEE ON PROFESSIONAL LICENSURE, HOUSE OF
REPRESENTATIVES, AS AMENDED, NOVEMBER 13, 2000
AN ACT
1 Regulating the practice of pharmacy; providing for the powers <--
2 and duties of the State Board of Pharmacy, for reporting of
3 impaired pharmacists or pharmacist interns and for immunity
4 and for unlawful acts; imposing penalties; establishing the
5 Pharmacy Professional Development Fund; and making repeals.
6 TABLE OF CONTENTS
7 Chapter 1. Preliminary Provisions
8 Section 101. Short title.
9 Section 102. Legislative declaration.
10 Section 103. Statement of purpose.
11 Section 104. Definitions.
12 Section 105. Construction of act.
13 Chapter 3. State Board of Pharmacy
14 Section 301. State Board of Pharmacy.
15 Section 302. Membership.
1 Section 303. Qualification.
2 Section 304. Appointment.
3 Section 305. Terms of office.
4 Section 306. Removal.
5 Section 307. Organization.
6 Section 308. Compensation of board members.
7 Section 309. Meetings.
8 Section 310. Executive director.
9 Section 311. Employees.
10 Section 312. Rules and regulations.
11 Section 313. Powers and responsibilities.
12 Section 314. Communication to licensees.
13 Section 315. Annual report.
14 Chapter 5. Pharmacists and Pharmacies
15 Section 501. Declaration.
16 Section 502. Licensing of pharmacists.
17 Section 503. Prerequisites for pharmacist license.
18 Section 504. Examinations.
19 Section 505. Internship.
20 Section 506. Qualifications for reciprocal license transfer.
21 Section 507. Renewal of licenses.
22 Section 508. Continuing pharmacy education.
23 Section 509. Reporting multiple licensure.
24 Section 521. Licensing of pharmacies.
25 Section 522. Renewal of pharmacy permit.
26 Section 523. Permit required for operation.
27 Section 524. Display of ownership information.
28 Section 525. Extraterritorial pharmacy permits.
29 Section 526. Regulatory power over pharmacies.
30 Chapter 7. Enforcement
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1 Section 701. Refusal to grant, revocation and suspension of
2 licenses and permits.
3 Section 702. Temporary suspension.
4 Section 703. Automatic suspension.
5 Section 704. Impaired licensee.
6 Section 705. Reinstatement.
7 Section 706. No bar to criminal action.
8 Section 707. Administrative Agency Law.
9 Section 708. Board action.
10 Section 709. Pharmacy permits.
11 Section 710. Return of license or permit.
12 Section 711. Hearings.
13 Section 712. Docket and other records.
14 Chapter 9. Pharmacist Practice
15 Section 901. Practice of pharmacy.
16 Section 902. Pharmacy health care service.
17 Section 903. Drug regimen review.
18 Section 904. Managing drug therapy.
19 Section 905. Pharmacy technicians.
20 Section 906. Prescriptions.
21 Section 907. Emergency refills.
22 Section 908. Impaired pharmacist or pharmacist intern.
23 Chapter 11. Unlawful Activities
24 Section 1101. Unlawful acts.
25 Section 1102. Criminal penalties.
26 Section 1103. Additional civil penalty.
27 Chapter 13. Fiscal Affairs
28 Section 1301. Setting of fees.
29 Section 1302. Pharmacy Professional Development Fund.
30 Section 1303. Annual submissions.
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1 Section 1304. Hiring of pharmacy inspectors.
2 Chapter 15. Miscellaneous Provisions
3 Section 1501. Existing board members.
4 Section 1502. Existing rules, regulations and fees.
5 Section 1503. Current licensees.
6 Section 1504. Severability.
7 Section 1505. Repeals.
8 Section 1506. Effective date.
9 AMENDING THE ACT OF SEPTEMBER 27, 1961 (P.L.1700, NO.699), <--
10 ENTITLED "AN ACT RELATING TO THE REGULATION OF THE PRACTICE
11 OF PHARMACY, INCLUDING THE SALES, USE AND DISTRIBUTION OF
12 DRUGS AND DEVICES AT RETAIL; AND AMENDING, REVISING,
13 CONSOLIDATING AND REPEALING CERTAIN LAWS RELATING THERETO,"
14 FURTHER PROVIDING FOR DEFINITIONS; AND PROVIDING FOR DRUG
15 THERAPY PROTOCOL.
16 The General Assembly of the Commonwealth of Pennsylvania
17 hereby enacts as follows:
18 CHAPTER 1 <--
19 PRELIMINARY PROVISIONS
20 Section 101. Short title.
21 This act shall be known and may be cited as the Pharmacy
22 Practice Act.
23 Section 102. Legislative declaration.
24 It is decided to be a matter of public interest and concern
25 that the practice of pharmacy merit and receive the confidence
26 of the public. It is further declared that only qualified
27 persons be permitted to engage in the practice of pharmacy in
28 this Commonwealth.
29 Section 103. Statement of purpose.
30 It is the purpose of this act to promote, preserve and
31 protect the public health, safety and welfare by the effective
32 control and regulation of the practice of pharmacy through:
33 (1) The licensure of pharmacists.
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1 (2) The licensure of pharmacist interns.
2 (3) The registration of technicians.
3 (4) The licensure, control and regulation of all sites
4 or persons who are required to obtain a license or permit
5 from the board, whether located in or out of this
6 Commonwealth, that deliver, dispense, administer, distribute,
7 manufacture, promote or sell drugs within this Commonwealth.
8 Section 104. Definitions.
9 The following words and phrases when used in this act shall
10 have the meanings given to them in this section unless the
11 context clearly indicates otherwise:
12 "Administer." The direct introduction of or the application
13 of a drug into or on the body of a patient or research subject
14 by injection, inhalation, ingestion or any other means.
15 "Beyond-use date." A date determined by a pharmacist and
16 placed on a prescription label at the time of dispensing that is
17 intended to indicate to the patient or caregiver a time beyond
18 which the contents of that prescription are not recommended for
19 use.
20 "Board." The State Board of Pharmacy of the Commonwealth.
21 "Compounding." The preparation, mixing, assembling,
22 packaging or labeling of a drug pursuant to or in anticipation
23 of a valid prescription drug order, including, but not limited
24 to, packaging, intravenous admixture or manual combination of
25 drug ingredients.
26 "Confidential information." Information relevant to a
27 patient's health care which is acquired by the pharmacist
28 incidental to a professional relationship. Confidential
29 information shall be privileged and may be released only to the
30 patient, or to a third party upon the authorization of the
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1 patient, or where such release is necessary to protect the
2 patient's health and well-being, or to such other persons or
3 government agencies authorized by law to receive that
4 information.
5 "Controlled substance." A drug designated as such under the
6 provisions of the act of April 14, 1972 (P.L.233, No.64), known
7 as The Controlled Substance, Drug, Device and Cosmetic Act.
8 "Deliver" or "delivery." The actual, constructive or
9 attempted transfer of a drug or device from one person to
10 another, whether or not for consideration.
11 "Device." An instrument, apparatus, implement, machine,
12 contrivance, implant, in vitro reagent or other similar or
13 related article, including any component part or accessory,
14 which is required under Federal or State law to be prescribed by
15 a health practitioner and dispensed by a pharmacist.
16 "Dispense" or "dispensing." The procedure entailing the
17 interpretation of a health practitioner's medical order or a
18 prescription drug order for a drug or device and, pursuant to
19 that order, the proper selection, measuring, labeling and
20 packaging of the drug or device in a proper container for
21 subsequent administration to or use by a patient.
22 "Distribute." The act of delivering a drug or device other
23 than by administering or dispensing.
24 "Drug."
25 (1) An article, including a radioactive substance,
26 recognized as a drug in any official compendium, or
27 supplement thereto, or designated from time to time by the
28 State Board of Pharmacy for use in the diagnosis, cure,
29 mitigation, treatment or prevention of disease in humans or
30 animals.
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1 (2) An article, other than food, intended to affect the
2 structure or any function of the body of humans or animals.
3 (3) An article intended for use as a component of any
4 article specified in paragraphs (1) and (2), but not
5 including a device or its component parts or accessories.
6 "Drug regimen review." A retrospective, concurrent and
7 prospective review by a pharmacist of a patient's drug-related
8 therapy, including, but not limited to, evaluation of any or all
9 of the following areas:
10 (1) Known allergies.
11 (2) Rational therapy-contraindications.
12 (3) Appropriate dose and route of administration.
13 (4) Appropriate directions for use.
14 (5) Duplicative therapies.
15 (6) Potential misuse or abuse.
16 (7) Drug-drug, drug-food, drug-disease and drug-clinical
17 laboratory test interactions.
18 (8) Adverse drug reactions.
19 (9) Drug utilization review and optimal therapeutic
20 outcomes.
21 "Electronic data transmission." The transmission of
22 information in electronic form or the transmission of the exact
23 visual image of a document by way of electronic equipment.
24 "Emergency refill prescription." A refill of a prescription
25 which is essential to the continuation of therapy for which that
26 refill has not been authorized and for which the pharmacist
27 notifies the prescriber within 72 hours of dispensing that
28 prescription that an emergency refill prescription has been
29 dispensed.
30 "Federal act." The Federal Food, Drug, and Cosmetic Act (52
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1 Stat. 1040, 21 U.S.C. § 301 et seq.).
2 "Health care provider" or "health practitioner." An
3 individual licensed by the Commonwealth to provide patient care
4 under the authority of a professional practice act, and includes
5 licensed prescribers and health care providers or health
6 practitioners.
7 "Home infusion pharmacy." A pharmacy which compounds
8 solutions for direct administration to a patient in a private
9 residence, long-term care facility, hospice or similar setting
10 by means of parenteral, intravenous, intramuscular, subcutaneous
11 or intraspinal infusion.
12 "Immediate supervision." A level of control which assures
13 that a pharmacist has the ultimate responsibility for the
14 accuracy, safety and patient outcome with respect to the actions
15 of pharmacy technicians and pharmacist interns and the use of
16 automation in all practice settings.
17 "Impaired professional support group." A peer assistance
18 group whose goals are to direct an impaired colleague into
19 treatment.
20 "Labeling." The process of preparing and affixing a label to
21 a drug container, which label shall include all information
22 required by Federal and State law, rule or regulation.
23 "Licensed prescriber." A physician, dentist, veterinarian,
24 podiatrist or other individual duly authorized and licensed by
25 law to independently prescribe drugs, including prescription
26 drugs.
27 "Long-term care facility." A nursing home, retirement care
28 facility, mental care facility or other facility or institution
29 which provides extended health care to resident patients.
30 "Managing drug therapy." Any of the following processes:
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1 (1) Adjusting a drug regimen.
2 (2) Changing the duration of therapy.
3 (3) Adjusting drug strength, frequency of administration
4 or route.
5 (4) Initiation or discontinuation of therapy.
6 (5) Administration of drugs and ordering and performing
7 of laboratory or other diagnostic tests necessary in the
8 management of drug therapy.
9 All pursuant to a written agreement or protocol authorizing the
10 delegation of the management of drug therapy from a licensed
11 prescriber to a pharmacist and pursuant to the licensed
12 prescriber's authority under section 17 of the act of December
13 20, 1985 (P.L.457, No.112), known as the Medical Practice Act of
14 1985, which authorize a medical doctor to delegate duties to
15 health care practitioners.
16 "Manufacturer." A person, except a pharmacist compounding in
17 the normal course of professional practice within this
18 Commonwealth, engaged in the commercial production, preparation,
19 propagation, compounding, conversion or processing of a drug,
20 either directly or indirectly, by extraction from substances of
21 natural origin or independently by means of chemical synthesis,
22 or both, and includes any packaging or repackaging of a drug or
23 the labeling or relabeling of the drug container.
24 "Medical order." A lawful order by a specifically identified
25 health practitioner for a specifically identified patient.
26 "Nonprescription drug." A drug which may be sold without
27 prescription and which is labeled for use by the consumer in
28 accordance with the requirements of the laws and rules of the
29 Federal Government and this Commonwealth.
30 "Nonresident pharmacy." A pharmacy located outside this
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1 Commonwealth.
2 "Patient counseling." The process of the communication of
3 information between a pharmacist and a patient, including, but
4 not limited to, both verbal and written information as defined
5 in the rules of the State Board of Pharmacy in order to promote
6 the proper use of any drug and to enhance drug therapy.
7 "Person." An individual, corporation, partnership,
8 association or any other legal entity, including a government.
9 "Pharmacist." A health care provider or practitioner
10 currently licensed by the State Board of Pharmacy to engage in
11 the practice of pharmacy.
12 "Pharmacist intern." An individual licensed by the State
13 Board of Pharmacy to engage in the practice of pharmacy under
14 the immediate supervision of a licensed pharmacist and who makes
15 satisfactory progress toward meeting the requirements for
16 licensure as a pharmacist.
17 "Pharmacy." A place within this Commonwealth which is
18 properly issued a permit by the State Board of Pharmacy where
19 drugs, devices, radiopharmaceuticals and diagnostic agents for
20 human or animal consumption are stored, dispensed or compounded,
21 or a place outside this Commonwealth where drugs, devices,
22 radiopharmaceuticals and diagnostic agents for human and animal
23 consumption are dispensed to residents of this Commonwealth. The
24 term shall not include the operation of a manufacturer or
25 distributor as defined in the act of April 14, 1972 (P.L.233,
26 No.64), known as The Controlled Substance, Drug, Device and
27 Cosmetic Act. Within an institution, the term shall refer to all
28 organized pharmacy service within that institution.
29 "Pharmacy practice site." A place within or outside this
30 Commonwealth where the practice of pharmacy is provided to
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1 residents of this Commonwealth.
2 "Pharmacy technician." An individual who is registered with
3 the State Board of Pharmacy and who may assist in the practice
4 of pharmacy under the immediate supervision of a licensed
5 pharmacist.
6 "Practice of pharmacy." The provision of health care
7 services by a pharmacist, including, but not limited to, any of
8 the following:
9 (1) The interpretation, evaluation and implementation of
10 medical orders.
11 (2) The delivery, dispensing or distributing of
12 prescription drugs.
13 (3) Participation in drug and device selection.
14 (4) Drug administration.
15 (5) Drug regimen review.
16 (6) Drug or drug-related research.
17 (7) Compounding.
18 (8) Proper and safe storage of drugs and devices.
19 (9) Managing drug therapy.
20 (10) Maintaining proper records.
21 (11) Patient counseling.
22 "Preceptor." An individual who is currently licensed as a
23 pharmacist by the State Board of Pharmacy, meets the
24 qualifications as a preceptor under the rules of the board, has
25 filed with the board any application or documentation that the
26 board may require and participates in the instructional training
27 of pharmacy interns.
28 "Prescription drug" or "legend drug" or "nonproprietary
29 drug." A drug which is required by any applicable Federal or
30 State law or regulation to be dispensed only pursuant to a
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1 prescription drug order or which is restricted to use by health
2 practitioners.
3 "Prescription drug order." A lawful order by a duly licensed
4 health practitioner for drugs, drug-related devices or treatment
5 for a human or animal, including orders issued through an
6 agreement for managing drug therapy.
7 "Protocol." A written document that describes the nature and
8 scope of the drug therapy management to be carried out by the
9 pharmacist or other health practitioner.
10 "Wholesaler." A person within this Commonwealth who legally
11 buys drugs for resale or distribution to persons other than
12 patients or consumers.
13 Section 105. Construction of act.
14 This act shall be liberally construed to carry out these
15 objectives and purposes.
16 CHAPTER 3
17 STATE BOARD OF PHARMACY
18 Section 301. State Board of Pharmacy.
19 the responsibility for enforcement of this act is hereby
20 vested in the State Board of Pharmacy. The board shall have all
21 the powers, duties and authority specifically granted by or
22 necessary for the enforcement of this act, as well as any other
23 powers, duties and authorities that may be granted by law.
24 Section 302. Membership.
25 Beginning with any vacancies existing on the effective date
26 of this act, as terms expire or vacancies occur thereafter, the
27 board shall consist of:
28 (1) The Commissioner of Professional and Occupational
29 Affairs.
30 (2) The Director of the Bureau of Consumer Protection in
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1 the Office of Attorney General or a designee of the director.
2 (3) Two persons representing the public at large.
3 (4) Seven persons who are licensed to practice pharmacy
4 in this Commonwealth. Of the seven appointees under this
5 paragraph:
6 (i) Two pharmacists shall be appointed from
7 independent retail pharmacies.
8 (ii) Two pharmacists shall be appointed who are
9 employees of retail chain pharmacies which operate five
10 or more pharmacies licensed within this Commonwealth.
11 (iii) One pharmacist shall be appointed from an
12 acute care institutional pharmacy.
13 (iv) One pharmacist shall be appointed who is
14 practicing primarily in long-term care pharmacy that
15 provides services to long-term care facilities
16 (consulting or pharmacy services).
17 (v) One pharmacist shall be appointed from an
18 alternative pharmacy position that represents any other
19 area of pharmacy practice not otherwise represented on
20 the board.
21 Section 303. Qualification.
22 (a) Pharmacist members.--Each pharmacist member of the board
23 shall at the time of appointment:
24 (1) Be a resident of this Commonwealth for not less than
25 one year.
26 (2) Must have been registered as a pharmacist in this
27 Commonwealth for at least five years immediately preceding
28 appointment.
29 (b) Public members.--The public members of the board:
30 (1) Shall have been residents of this Commonwealth for
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1 not less than two years at the time of their appointment.
2 (2) Shall have attained the age of majority.
3 (3) Shall not be, nor shall ever have been, a
4 pharmacist, the spouse of a pharmacist or a person who has
5 ever had any material financial interest in the provision of
6 pharmacy services or who has engaged in any activity directly
7 related to the practice of pharmacy.
8 Section 304. Appointment.
9 Nominations for appointment to the board may be made to the
10 Governor by any individual, any professional pharmacy
11 association within this Commonwealth or any other entity. All
12 professional and public members of the board shall be appointed
13 by the Governor with the advice and consent of a majority of the
14 members elected to the Senate.
15 Section 305. Terms of office.
16 (a) Regular term.--Except as provided in subsection (b), the
17 terms of each professional member and each public member of the
18 board shall be six years, or until a successor has been
19 appointed and qualified, but not longer than six months beyond
20 the six-year period. In the event that any member shall die or
21 resign or otherwise become disqualified during that member's
22 term, a successor shall be appointed in the same way and with
23 the same qualifications as the original member and shall hold
24 office for the unexpired portion of the term.
25 (b) Terms to be staggered.--The terms of the professional
26 and public members of the board shall be staggered, so that the
27 terms of no more than three members shall expire in any year.
28 Each member shall serve until a successor is appointed and
29 qualified as provided in subsection (a).
30 (c) Existing board members.--The present members of the
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1 board on the effective date of this act shall serve the balance
2 of their terms.
3 (d) Reappointment.--No professional or public member of the
4 board shall be eligible for appointment to serve more than two
5 consecutive full terms. The completion of the unexpired portion
6 of a full term shall not constitute a full term for purposes of
7 this subsection. Any present board member appointed initially
8 for a term of less than four years shall be eligible to serve
9 for two additional full terms.
10 (e) Vacancies.--A vacancy that occurs in the membership of
11 the board for any reason shall be filled by the Governor in the
12 manner provided for appointment of board members in section 304.
13 Section 306. Removal.
14 (a) Grounds for removal.--A board member may be removed
15 pursuant to the procedure set forth in subsection (b), upon one
16 or more of the following grounds:
17 (1) The refusal or inability for any reason of a board
18 member to perform the duties as a member of the board in an
19 efficient, responsible and professional manner.
20 (2) The misuse of office by a board member to obtain
21 personal, pecuniary or material gain or advantage for that
22 board member or another person through such office.
23 (3) The violation by a board member of the laws
24 governing the practice of pharmacy or the distribution of
25 drugs or devices.
26 (4) The failure of a board member to attend three
27 consecutive board meetings unless the Commissioner of
28 Professional and Occupational Affairs, upon written request
29 from that member, finds that the board member should be
30 excused from a meeting because of illness of the death of a
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1 family member, or other valid reason.
2 (5) The failure of a public member to attend two
3 consecutive statutorily mandated training seminars under
4 section 813(e) of the act of April 9, 1929 (P.L.177, No.175),
5 known as The Administrative Code of 1929, unless the
6 Commissioner of Professional and Occupational Affairs, upon
7 written request from the public member, finds that the public
8 member should be excused from a meeting because of illness or
9 death of a family member, or other valid reason.
10 (b) Procedure.--Removal of a board member shall be in
11 accordance with 2 Pa.C.S. Ch. 5 Subch. A (relating to practice
12 and procedure of Commonwealth agencies).
13 Section 307. Organization.
14 (a) Officers.--The board shall elect from its members a
15 chairperson and any other officers deemed appropriate and
16 necessary to conduct the business of the board. The chairperson
17 shall preside at all meetings of the board and shall be
18 responsible for the performance of all of the duties and
19 functions of the board required or permitted by this act. Each
20 additional officer elected by the board shall perform those
21 duties normally associated with that position and any other
22 duties assigned by the board.
23 (b) Terms of office for officers.--Officers elected by the
24 board shall serve terms of one year commencing with the day of
25 their election and ending upon election of their successors and
26 shall serve no more than two consecutive full terms in each
27 office to which they are elected.
28 Section 308. Compensation of board members.
29 Each board member, except the Commissioner of Professional
30 and Occupational Affairs and the Director of the Bureau of
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1 Consumer Protection, shall receive $250 per day when actually
2 attending to the work of the board. Members shall also receive
3 timely reimbursement for reasonable traveling, lodging and other
4 necessary expenses incurred in the performance of their duties
5 in accordance with Commonwealth regulations.
6 Section 309. Meetings.
7 (a) Regular meetings.--The board shall meet at least once
8 every two months and at any additional times that may be
9 necessary to conduct the business of the board. Any additional
10 meetings may be called by the chairperson or by two-thirds of
11 the members of the board.
12 (b) Place of meeting.--The board shall meet at such place as
13 it may, from time to time, determine. The place for each meeting
14 shall be determined prior to giving notice of that meeting to
15 each member. The place of a meeting may not be changed after
16 notice is given without adequate prior notification to all
17 members of the board.
18 (c) Quorum.--A majority of the members of the board serving
19 in accordance with law shall constitute a quorum for the
20 purposes of conducting the business of the board. Except for
21 temporary and automatic suspensions under this act, a member may
22 not be counted as part of a quorum or vote on any issue unless
23 that member is physically in attendance at the meeting.
24 (d) Open meetings.--All board meetings and hearings shall be
25 open to the public. The board may, in its discretion and
26 according to law, conduct any portion of its meeting in
27 executive session, closed to the public. Executive sessions may
28 not be utilized during hearings or discussion of current
29 regulations or development of regulations.
30 Section 310. Executive director.
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1 (a) Selection.--The board shall select and employ, with the
2 approval of the Commissioner of Professional and Occupational
3 Affairs, an executive director who shall be a full-time employee
4 and who shall be a pharmacist licensed in this Commonwealth. The
5 executive director shall be paid such compensation as determined
6 by the board to be commensurate with the level of compensation
7 paid other executive directors to professional licensing boards
8 in this Commonwealth.
9 (b) Duties.--The executive director shall have the following
10 duties:
11 (1) To establish guidelines and information, with the
12 concurrence of the board, for training of inspectors within
13 the Department of State who are responsible for inspecting
14 pharmacies.
15 (2) To assist the board in revising and promulgating
16 regulations.
17 (3) To review recorded minutes and proceedings of all
18 board meetings and to be the custodian of such documents.
19 (4) To maintain a record of policies set by the board
20 and to disseminate that information to all board licensees.
21 (5) To perform any other duties the board may request.
22 (c) Assistance.--The executive director shall be provided
23 adequate facilities, staff and pharmacy inspectors to perform
24 the functions listed in this section.
25 Section 311. Employees.
26 The board may, in its discretion, employ persons in addition
27 to the executive director in such other positions or capacities
28 as it deems necessary for the proper conduct of board business
29 and to fulfill the board's responsibilities as defined by this
30 act.
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1 Section 312. Rules and regulations.
2 The board shall, within 180 days of the effective date of
3 this act and at times necessary thereafter promulgate, adopt,
4 amend the repeal rules or regulations as deemed necessary by the
5 board for the proper administration and enforcement of this act.
6 Rules and regulations shall be promulgated in accordance with
7 the procedures specified in the act of July 31, 1968 (P.L.769,
8 No.240), referred to as the Commonwealth Documents Law, and the
9 act of June 25, 1982 (P.L.633, No.181), known as the Regulatory
10 Review Act.
11 Section 313. Powers and responsibilities.
12 The board shall have sole responsibility for the control and
13 regulation of the practice of pharmacy in this Commonwealth,
14 including, but not limited to, the following:
15 (1) To determine the nature of examinations for any
16 applicant for a pharmacist license.
17 (2) To determine, inspect and investigate all
18 applications and all applicants for licensure as pharmacists,
19 pharmacies or pharmacy interns or registration as pharmacy
20 technicians and to grant certificates of licensure or
21 registration to all applicants whom it shall judge to be
22 properly qualified.
23 (3) To renew licenses to engage in the practice of
24 pharmacy and to operate a pharmacy.
25 (4) To establish and enforce compliance with
26 professional standards of conduct of pharmacies engaged in
27 the practice of pharmacy. The board shall also have the
28 authority to review prospective and innovative pilot programs
29 in the practice of pharmacy and to make a determination as to
30 whether to approve or disapprove the programs. Approval for
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1 such programs, if granted, shall be for a temporary period of
2 time. At the conclusion of the time period, the administrator
3 of such a program shall, upon inspection or upon a
4 presentation to the members of the pharmacy board,
5 demonstrate the results of the pilot program. If the
6 administrator can prove to the board that positive outcomes
7 for the patient or pharmacy were achieved as a result of the
8 program and that patient safety was maintained, then the
9 board shall have the authority to approve the continuance of
10 the program on an indefinite basis.
11 (5) To determine and issue standards for recognition and
12 approval of degree programs of schools and colleges of
13 pharmacy whose graduates shall be eligible for licensure in
14 this Commonwealth and to specify and enforce requirements for
15 practical training, including internship.
16 (6) To enforce the provisions of this act relating to
17 the conduct or competence of pharmacists practicing in this
18 Commonwealth and to suspend, revoke or restrict licenses to
19 engage in the practice of pharmacy.
20 (7) To prepare position descriptions, to employ a
21 minimum of eight pharmacy inspectors or more of such
22 inspectors if the board deems necessary who shall be
23 pharmacists licensed in this Commonwealth.
24 (8) To retain appropriate consultants to assist it for
25 any purpose which it may deem necessary, subject to the
26 limitation that the board may not delegate any of its final
27 decision-making responsibilities to any consultant.
28 (9) To investigate or cause to be investigated all
29 violations of this act and its regulations and to cause
30 prosecutions to be instituted in the courts upon advice from
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1 the Office of Attorney General.
2 (10) To inspect any pharmacy licensed by this
3 Commonwealth at reasonable hours for the purpose of
4 determining if any provisions of the laws governing the legal
5 distribution of drugs or devices for the practice of pharmacy
6 are being violated. The board, its officers, inspectors and
7 representatives shall cooperate with all agencies charged
8 with the enforcement of the laws of the United States, of
9 this Commonwealth and of all other states relating to drugs,
10 devices and the practice of pharmacy.
11 (11) To make or order inspections of other places in
12 which drugs or devices are stored, held, compounded,
13 dispensed or sold to a customer and to take and analyze any
14 drugs or devices and to seize and condemn any drugs or
15 devices which are adulterated, misbranded or stored, held,
16 dispensed, distributed or compounded in violation of the
17 provisions of this act or the provisions of the act of April
18 14, 1972 (P.L.233, No.64), known as The Controlled Substance,
19 Drug, Device and Cosmetic Act.
20 (12) To establish minimum specifications for the
21 physical facilities, technical equipment, environment,
22 supplies, personnel and procedures for the storage,
23 compounding or dispensing of drugs or devices and for the
24 monitoring of drug therapy.
25 (13) To establish minimum standards for maintaining the
26 integrity and confidentiality of prescription information and
27 other patient care information.
28 (14) To conduct hearings for the revocation or
29 suspension of licenses, permits or registrations for which
30 hearings the board shall have the power to subpoena
19990H1946B4165 - 21 -
1 witnesses.
2 (15) To assist the regularly constituted enforcement
3 agencies of this Commonwealth in enforcing all laws
4 pertaining to drugs, controlled substances and the practice
5 of pharmacy.
6 (16) To have authority to issue subpoenas, upon
7 application of an attorney responsible for representing the
8 Commonwealth in disciplinary matters before the board, for
9 the purpose of investigating alleged violations of the
10 disciplinary provisions administered by the board.
11 (17) To subpoena witnesses, to administer oaths, to
12 examine witnesses and to take such testimony or compel the
13 production of such books, records, papers and documents as it
14 may deem necessary or proper in and pertinent to any
15 proceeding, investigation or hearing held or had by it,
16 subject to the following:
17 (i) Patient records may not be subpoenaed without
18 the consent of the patient or without order of a court of
19 competent jurisdiction on a showing that the records are
20 reasonably necessary for the conduct of the
21 investigation.
22 (ii) The court may impose such limitations on the
23 scope of the subpoena as are necessary to prevent
24 unnecessary intrusion into a patient confidential
25 situation.
26 (18) To apply to Commonwealth Court to enforce its
27 subpoena.
28 (19) In addition to its appropriation from the
29 Commonwealth, to receive and expend funds from parties other
30 than the Commonwealth, subject to the following restrictions:
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1 (i) The funds are awarded for the pursuit of a
2 specific objective which the board is authorized to
3 accomplish by this act or which the board is qualified to
4 accomplish by reason of its jurisdiction or professional
5 expertise.
6 (ii) Activities connected with or occasioned by the
7 expenditure of these funds do not interfere with the
8 performance of the board's duties and responsibilities
9 and do not conflict with the exercise of the board's
10 powers as specified by this act.
11 (iii) The funds are kept in a separate special
12 account and periodic reports are made to the Commissioner
13 of Professional and Occupational Affairs concerning the
14 board's receipt and expenditure of the funds. The powers
15 and duties of the board, as enumerated in this
16 subparagraph, shall not be applicable to manufacturers or
17 distributors as defined in The Controlled Substance,
18 Drug, Device and Cosmetic Act.
19 Section 314. Communication to licensees.
20 The board shall at least every six months and more frequently
21 if necessary convey relevant information concerning this act,
22 rules or regulations promulgated thereunder and the practice of
23 pharmacy to all pharmacists and pharmacies registered in this
24 Commonwealth and any nonresident pharmacies licensed by the
25 board.
26 Section 315. Annual report.
27 The board shall submit annually a report to the Consumer
28 Protection and Professional Licensure Committee of the Senate
29 and the Professional Licensure Committee of the House of
30 Representatives containing a description of the types of
19990H1946B4165 - 23 -
1 complaints received, the status of cases, any board action which
2 has been taken and the length of time from the initial complaint
3 to final board resolution.
4 CHAPTER 5
5 PHARMACISTS AND PHARMACIES
6 Section 501. Declaration.
7 The practice of pharmacy in this Commonwealth is hereby
8 declared to be a health care professional practice in which the
9 pharmacist is considered a health care provider affecting the
10 public health, safety and welfare and is subject to regulation
11 and control in the public interest.
12 Section 502. Licensing of pharmacists.
13 Except as otherwise provided in this act, it shall be
14 unlawful for any individual to engage in the practice of
15 pharmacy within this Commonwealth unless that individual is
16 currently licensed to practice pharmacy pursuant to this act.
17 Section 503. Prerequisites for pharmacist license.
18 (a) Application.--The board may license as a pharmacist any
19 person who has filed an application therefore, subscribed by the
20 person under oath or affirmation, containing such information as
21 the board may by regulation require, and who:
22 (1) Has satisfied the board that the applicant is of
23 good moral and professional character and not unfit or unable
24 to practice pharmacy by reason of the extent or manner of the
25 applicant's use of alcoholic beverages or controlled
26 substances or by reason of a physical or mental disability.
27 (2) Holds an entry-level practice degree in pharmacy
28 granted by a school or college of pharmacy which is
29 accredited by an accrediting body recognized by the board.
30 (3) Has completed an internship or other equivalent
19990H1946B4165 - 24 -
1 program which has been approved by the board or has
2 demonstrated experience in the practice of pharmacy which
3 meets or exceeds the minimum internship requirements of the
4 board.
5 (4) Has satisfactorily passed such examinations as
6 required by the board.
7 (5) Has paid the fee specified by the board for the
8 examination and any related materials and has paid for the
9 issuance of the license.
10 (6) Has not been convicted of any felonious act
11 prohibited by the act of April 14, 1972 (P.L.233, No.64),
12 known as The Controlled Substance, Drug, Device and Cosmetic
13 Act, or convicted of a felony relating to a controlled
14 substance in a court of law of the United States or any other
15 state, territory or country unless all of the following
16 criteria are satisfied:
17 (i) At least ten years have elapsed from the date of
18 conviction.
19 (ii) The applicant satisfactorily demonstrates to
20 the board that the applicant has made significant
21 progress in personal rehabilitation since the conviction
22 such that licensure of that applicant should not be
23 expected to create a substantial risk of harm to the
24 health and safety of patients or the public or a
25 substantial risk of further criminal violations.
26 (iii) The applicant otherwise satisfies the
27 qualifications contained in or authorized by this act.
28 (b) Statement of absence of conviction.--An applicant's
29 statement on the application declaring the absence of a
30 conviction shall be deemed satisfactory evidence of the absence
19990H1946B4165 - 25 -
1 of a conviction, unless the board has evidence to the contrary.
2 Section 504. Examinations.
3 (a) Schedule of examinations.--The board shall, at least
4 once each year, examine in the practice of pharmacy all
5 applicants who:
6 (1) Have completed their education requirements.
7 (2) Make application for examination pursuant to
8 regulations promulgated by the board.
9 (3) Shall be otherwise eligible for licensure.
10 (b) Content of examination.--The examination shall be
11 prepared to measure the competence of the applicant to engage in
12 the practice of pharmacy. The board may employ, cooperate with
13 or contract with any organization or consultant or professional
14 testing organization for the preparation, administration and
15 grading of the examination, but the board shall retain the sole
16 discretional responsibility for determining which applicants
17 have successfully passed an examination.
18 (c) Reexamination.--In case of failure at first examination,
19 the applicant shall have within two years the privilege of a
20 second and third examination. In case of failure with the third
21 examination, the applicant shall have the privilege of
22 examination only after satisfactorily completing additional
23 preparation as directed and approved by the board.
24 Section 505. Internship.
25 (a) Requirement.--To ensure proficiency in the practical
26 aspects of pharmacy, the board shall, by regulation, prescribe
27 internship requirements which must be satisfactorily completed
28 prior to the issuance of a pharmacist license.
29 (b) Supervision of intern.--To assure adequate practical
30 instruction, pharmacist internship experience as required under
19990H1946B4165 - 26 -
1 this act shall be obtained under the immediate supervision of a
2 pharmacist meeting the requirements established by the board.
3 (c) Examination to obtain pharmacist license.--A pharmacist
4 intern applying for examination shall pay to the board an
5 examination fee established by the board through regulation.
6 Upon passing the required examination and complying with all the
7 rules and regulations of the board and this act, the board shall
8 grant the applicant licensure as a pharmacist and issue a
9 license qualifying the applicant to enter into the practice of
10 pharmacy. This license may not be issued until a fee established
11 by the board through regulation shall be paid to the board.
12 Section 506. Qualifications for reciprocal license transfer.
13 (a) Procedure.--The board may, without examination, license
14 as a pharmacist any individual who, at the time of filing an
15 application for licensure, is licensed as a pharmacist in any
16 other state, territory or possession of the United States
17 provided that that individual shall meet those standards
18 established by the board by regulation and meet all of the
19 following criteria:
20 (1) Produce evidence satisfactory to the board of having
21 had the required secondary and professional education and
22 training, including internship.
23 (2) Be of good character and morals as required of
24 applicants for licensure under this act.
25 (3) At the time of initial licensure as a pharmacist,
26 have all the qualifications necessary to have been eligible
27 for licensure as a pharmacist in this Commonwealth at the
28 time of licensure.
29 (4) Have presented to the board proof of initial
30 licensure by examination and proof that such license is in
19990H1946B4165 - 27 -
1 good standing.
2 (5) Not be eligible for reciprocal license transfer
3 unless the state in which that individual is licensed shall
4 under similar conditions grant reciprocal licensure as a
5 pharmacist without examination to pharmacists duly licensed
6 by examination in this Commonwealth.
7 (b) Fee.--An application under this subsection shall be
8 accompanied by a fee established by the board through regulation
9 for the application and expense of investigation by the board. A
10 fee established by the board through regulation shall be paid
11 for the license and certificate prior to its approval and
12 issuance by the board.
13 Section 507. Renewal of licenses.
14 The board shall provide for, regulate and require all
15 individuals licensed as pharmacists to renew their licenses
16 biennially. The board shall prescribe the form of the renewal
17 application and the information required to be submitted by all
18 applicants, including proof of continuing education. The
19 applicant shall file with the board the renewal application
20 accompanied by a biennial license fee established by the board
21 through regulation. An additional fee established by the board
22 through regulation shall be paid for late licensure renewal of a
23 pharmacist.
24 Section 508. Continuing pharmacy education.
25 (a) General rule.--Continuing pharmacy education as the
26 board may require shall be a prerequisite for licensure renewal.
27 (b) Requirements.--The board shall:
28 (1) Define, by regulation, the requirements for
29 continuing education.
30 (2) Approve programs of continuing education.
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1 (3) Adopt rules and regulations necessary to carry out
2 and enforce this section, which shall include the methods of
3 determining approved programs and any required fees.
4 Section 509. Reporting multiple licensure.
5 A licensed pharmacist of this Commonwealth who is also
6 licensed to practice pharmacy in any other state, territory or
7 country shall report this information to the board on the
8 biennial registration application. Any disciplinary action in
9 any other state, territory and country shall be reported to the
10 board on the biennial renewal application or within 90 days of
11 final disposition, whichever is sooner. Multiple licensure shall
12 be noted by the board on the pharmacist's record, and such
13 state, territory or country shall be notified by the board of
14 any disciplinary actions taken against said pharmacist in this
15 Commonwealth.
16 Section 521. Licensing of pharmacies.
17 (a) General rule.--The board shall issue a permit to any
18 person to conduct a pharmacy:
19 (1) Who has filed an application to operate a pharmacy.
20 (2) Who has subscribed the application under oath or
21 affirmation.
22 (3) Who provides all information the board may require.
23 (4) Who pays any fee established by the board by
24 regulation.
25 (5) Whose proposed pharmacy complies with all
26 regulations of the board and with all requirements of this
27 act.
28 (b) Additional information.--An applicant for a permit shall
29 provide sufficient evidence to the board that the proposed
30 pharmacy:
19990H1946B4165 - 29 -
1 (1) Has the necessary reference materials, current
2 supplements to these reference materials and the professional
3 equipment, technical equipment and other pharmaceutical
4 equipment which such reference materials, supplements and
5 equipment have been determined by the board as necessary to
6 meet the needs of the practice of pharmacy for the area and
7 type of practice to protect the health and welfare of the
8 citizens of this Commonwealth.
9 (2) Has sufficient physical facilities, including
10 equipment, size, space and sanitation, for adequately
11 providing for the practice of pharmacy, including
12 distributing and dispensing drugs and devices consistent with
13 the protection of the public health, safety and welfare as
14 the board may by regulation establish.
15 (3) Contains a suitable book or file in which shall be
16 preserved, for a period of not less than two years, every
17 prescription compounded or dispensed therein.
18 (4) Will be under the immediate supervision of a
19 pharmacist licensed in this Commonwealth at all times that
20 the pharmacy is open for business.
21 (c) Criminal history and character.--
22 (1) If the applicant is an individual or partnership,
23 that the individual or copartner, if not a pharmacist, has
24 not previously been found or pleaded guilty or nolo
25 contendere to any crime concerning the practice of pharmacy
26 or involving moral turpitude.
27 (2) If the applicant is an individual or partnership and
28 a pharmacist, that the pharmacist is presently licensed by
29 the board.
30 (3) If the applicant is an association, that no director
19990H1946B4165 - 30 -
1 or officer has been found or pleaded guilty or nolo
2 contendere to said crimes or had a pharmacy or pharmacist's
3 license revoked or renewal refused for cause.
4 (4) If the applicant is a corporation, that no director,
5 officer or person having a beneficial interest of more than
6 10% of the stock has been found guilty or pleaded guilty or
7 nolo contendere to said crimes or had a pharmacy or
8 pharmacist's license revoked or renewal refused for cause.
9 (5) An applicant shall be of good moral and professional
10 character. In determining this qualification, the board may
11 take into consideration, among other things, the conduct and
12 operation of other pharmacies conducted by the applicant.
13 (d) Supervision.--Each pharmacy shall be under the
14 supervision and management of a pharmacist duly licensed in this
15 Commonwealth.
16 (e) Display of license.--A license or permit issued under
17 this act shall be displayed in a conspicuous place in the
18 pharmacy for which it is issued.
19 (f) 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 (g) Fees.--An application for a permit to conduct a pharmacy
26 shall be accompanied by an initial registration fee established
27 by the board by regulation.
28 (h) Expiration.--A permit issued under this section, unless
29 sooner revoked or suspended, shall expire on the date set forth
30 on the permit. The board may promulgate regulations authorizing
19990H1946B4165 - 31 -
1 the application by a personal representative of a deceased
2 permittee for an extension of the deceased permittee's permit
3 for a period not to exceed one year from the date of death.
4 Section 522. Renewal of pharmacy permit.
5 The board shall renew a permit for the succeeding biennium,
6 unless the board shall have given ten days' previous notice to
7 the applicant for the permit of objections to the renewal based
8 upon a finding or plea of guilty or nolo contendere by the
9 applicant, its partners or officers, to a violation of any of
10 the laws of the United States or of this Commonwealth relating
11 to the practice of pharmacy or to the enforcement of controlled
12 substances or involving moral turpitude, upon payment of a fee
13 established by the board by regulation for each pharmacy. The
14 application for renewal shall be made on or before September 1
15 of each odd-numbered year.
16 Section 523. Permit required for operation.
17 No person shall operate a pharmacy until that person has been
18 granted a pharmacy permit by the board.
19 Section 524. Display of ownership information.
20 The full name or names of the proprietor, or if a
21 partnership, the partners, or if an association or corporation,
22 the name of the pharmacist manager, must be conspicuously
23 displayed in the pharmacy along with any corporate association
24 or duly registered fictitious name.
25 Section 525. Extraterritorial pharmacy permits.
26 (a) Permit required.--A person, entity, pharmacy or
27 pharmacist located outside of this Commonwealth who ships,
28 mails, distributes, dispenses or delivers prescription drugs or
29 devices to individuals within this Commonwealth shall be
30 required to obtain a pharmacy permit from the board.
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1 (b) Waiver.--If the person, entity, pharmacy or pharmacist
2 holds a valid pharmacy permit issued by the state in which that
3 pharmacy is operated, the board may waive any requirements
4 imposed upon pharmacies within this Commonwealth if the waiver
5 of these requirements will not endanger the public health,
6 safety or welfare of the citizens of this Commonwealth.
7 (c) Effect of nonlicensure.--If the person or entity does
8 not hold a valid pharmacy permit from the jurisdiction in which
9 the person or entity is operating, then the person or entity
10 shall satisfy all requirements imposed upon pharmacies in this
11 Commonwealth prior to shipping, mailing, dispensing,
12 distributing or delivering prescription drugs or devices within
13 this Commonwealth.
14 (d) Registered agent.--
15 (1) Each person, entity, pharmacy or pharmacist located
16 outside of this Commonwealth who ships, mails, dispenses,
17 distributes or delivers prescription drugs or devices in this
18 Commonwealth shall designate a registered agent in this
19 Commonwealth for service of process.
20 (2) Any such person, entity, pharmacy or pharmacist who
21 does not so designate a registered agent shall be deemed to
22 have designated the Secretary of State 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,
25 pharmacy or pharmacist growing out of or arising from such
26 shipping, mailing, dispensing, distributing or delivery.
27 (3) A copy of any such service of process shall be
28 mailed to such person, entity, pharmacy or pharmacist by the
29 board by certified mail, return receipt requested, postage
30 prepaid, at the address designated on the application for
19990H1946B4165 - 33 -
1 licensure in this Commonwealth.
2 (4) If any such person, entity, pharmacy or pharmacist
3 is not licensed by the board, service on the Secretary of
4 State only shall be sufficient service for legal purposes.
5 Section 526. Regulatory power over pharmacies.
6 The board may promulgate regulations designed to insure
7 methods of operation and conduct which protect the public health
8 and welfare.
9 CHAPTER 7
10 ENFORCEMENT
11 Section 701. Refusal to grant, revocation and suspension of
12 licenses and permits.
13 The board may refuse to grant, refuse to renew, suspend,
14 revoke or restrict the license of any pharmacist or pharmacist
15 intern upon any of the following grounds:
16 (1) Unprofessional conduct as that term is defined by
17 the rules of the board.
18 (2) Unfit to practice pharmacy because of the
19 intemperance in the use of alcoholic beverages, controlled
20 substances or any other substance which impairs the intellect
21 and judgment to such an extent as to impair the performance
22 of professional duties.
23 (3) Unfit or unable to practice pharmacy by reason of a
24 physical or mental disease or disability. In enforcing this
25 paragraph, the board shall, upon probable cause, compel a
26 pharmacist or a pharmacist intern to submit to a mental or
27 physical examination by physicians or psychologists approved
28 by the board. Failure to submit to such examination when
29 directed by the board, unless such failure is due to
30 circumstances beyond the individual's control, shall
19990H1946B4165 - 34 -
1 constitute an admission of the allegations against that
2 individual, consequent upon which a default and final order
3 may be entered without the taking of testimony or
4 presentation of evidence. A pharmacist or a pharmacist intern
5 affected under this paragraph shall at reasonable intervals
6 be afforded an opportunity to demonstrate that the pharmacist
7 or pharmacist intern can resume a competent practice of
8 pharmacy with reasonable skill and safety to patients.
9 (4) Procured a license through fraud, misrepresentation
10 or deceit.
11 (5) Been found guilty, pleaded guilty, entered a plea of
12 nolo contendere or received probation without verdict,
13 disposition in lieu of trial or an Accelerated Rehabilitative
14 Disposition in the disposition of one or more of the
15 following:
16 (i) A felony.
17 (ii) An offense involving moral turpitude or gross
18 immorality.
19 (iii) Violation of the pharmacy or drug laws of this
20 Commonwealth or rules and regulations pertaining thereto;
21 or of pharmacy laws, rules and regulations of the Federal
22 Government or of any other state.
23 (6) Violated or knowingly permitted the violation of any
24 provision of this act or regulation of the board.
25 (7) Knowingly allowed, aided or abetted an individual to
26 engage in the practice of pharmacy without a license.
27 (8) Knowingly aided or abetted an individual to assist
28 in the practice of pharmacy without having registered with
29 the board or falsely used the title of pharmacist or
30 pharmacist intern. Nothing contained in this paragraph shall
19990H1946B4165 - 35 -
1 be construed to prohibit pharmacist interns or registered
2 pharmacy technicians from assisting in the practice of
3 pharmacy under the immediate supervision of a licensed
4 pharmacist provided such assistance is consistent with proper
5 pharmacy practices and with board regulations.
6 (9) 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 (10) 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 (11) Public assertion or implication of professional
15 superiority in the practice of pharmacy.
16 (12) 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 (13) Entering into an agreement with a licensed medical
22 practitioner for the compounding or dispensing of secret
23 formula (coded) prescriptions.
24 (14) 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 (15) Displaying or permitting the display of the
30 pharmacist's or pharmacist intern's certificate of licensure
19990H1946B4165 - 36 -
1 or current registration document in a pharmacy of which that
2 pharmacist or pharmacist intern is not the proprietor or is
3 not employed.
4 (16) For any holder of a current pocket registration
5 card to fail, when practicing, to have the card available for
6 inspection by an authorized agent of the board.
7 (17) The acceptance back and redistribution of any
8 unused drug or part thereof as defined by regulations.
9 (18) Accept employment as a pharmacist, or share or
10 receive compensation in any form arising out of or incidental
11 to that pharmacist's professional activities from any person
12 who orders that pharmacist, directly or indirectly, to engage
13 in any aspect of the practice of pharmacy in contravention of
14 any provision of this act or regulation of the board.
15 (19) 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 (20) Acted in such a manner as to present an immediate
20 and clear danger to the public health or safety.
21 (21) 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 (22) 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.
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1 (23) Engaging in any conduct which subverts or attempts
2 to subvert any licensing examination or the administration of
3 any licensing exam.
4 (24) Failing to pay the costs assessed in a disciplinary
5 hearing.
6 Section 702. Temporary suspension.
7 (a) Authorization.--
8 (1) A license duly issued under this act may be
9 temporarily suspended under circumstances as determined by
10 the board to be an immediate and clear danger to the public
11 health and safety.
12 (2) The board shall issue an order to that effect
13 without a hearing, but upon due notice to the licensee
14 concerned at the licensee's last known address, which shall
15 include a written statement of all allegations against the
16 licensee.
17 (3) The case of a temporary suspension pursuant to this
18 section, hearings, appeals from and rulings resulting
19 therefrom need not comply with the provisions of 2 Pa.C.S. §
20 103 (relating to administrative agency law).
21 (b) Commencement of formal proceedings.--The board shall
22 thereupon commence formal action to suspend, revoke or restrict
23 the license of the person concerned, as otherwise provided for
24 in this act. All actions shall be taken promptly and without
25 delay.
26 (c) Preliminary hearing.--
27 (1) Within 30 days following the issuance of an order
28 temporarily suspending a license, the board shall conduct or
29 cause to be conducted a preliminary hearing to determine that
30 there is a prima facie case supporting the suspension.
19990H1946B4165 - 38 -
1 (2) The licensee whose license has been temporarily
2 suspended may be present at the preliminary hearing and may
3 be represented by counsel, cross-examine witnesses, inspect
4 physical evidence, call witnesses, offer evidence and
5 testimony and make record of the proceedings.
6 (3) If it is determined that there is not a prima face
7 case, the suspended licensee shall be immediately restored.
8 (d) Duration of temporary suspension.--The temporary
9 suspension shall remain in effect until vacated by the board,
10 but in no event longer than 180 days.
11 Section 703. Automatic suspension.
12 (a) Conditions for.--A pharmacist license or a pharmacist
13 intern license issued under this act shall be automatically
14 suspended upon any of the following:
15 (1) The legal commitment to an institution of a licensee
16 or registrant because of mental incompetency from any cause
17 upon filing with the board a certified copy of such
18 commitment.
19 (2) The conviction of a felony under the act of April
20 14, 1972 (P.L.233, No.64), known as The Controlled Substance,
21 Drug, Device and Cosmetic Act, or conviction of an offense
22 under the laws of another jurisdiction, which if committed in
23 this Commonwealth would be a felony under The Controlled
24 Substance, Drug, Device and Cosmetic Act.
25 (b) Stay prohibited and restoration.--Automatic suspension
26 under this section shall not be stayed pending any appeal of
27 conviction. Restoration of such license or registration shall be
28 made as provided in this act in the case of revocation or
29 suspension of such license or registration.
30 Section 704. Impaired licensee.
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1 (a) Board action.--When an impaired pharmacist or pharmacist
2 intern is subject to disciplinary action, the board may defer
3 and ultimately dismiss any of the types of corrective action set
4 forth in this act for an impaired professional so long as the
5 pharmacist or pharmacist intern is progressing satisfactorily in
6 an approved treatment program and in an impaired professional
7 support group recognized by the board.
8 (b) Information disclosure to board.--If an impaired
9 pharmacist or pharmacist intern enters an approved treatment
10 program and an impaired professional support group, the approved
11 program provider shall, upon request, disclose to a professional
12 consultant appointed and employed by the board as described in
13 section 908, such information the program provider possesses or
14 controls regarding the impaired pharmacist or pharmacist intern
15 in treatment, unless the program provider is prohibited from
16 disclosing such information by an act of the United States, this
17 Commonwealth or another state.
18 (c) Agreement by licensee.--An impaired pharmacist or
19 pharmacist intern who enrolls in an approved treatment program
20 shall enter into either:
21 (1) An agreement with the peer assistance group which
22 will monitor the licensee's progress, monitor compliance with
23 the terms of the agreement and monitor adherence to any
24 limitations on the practice of pharmacy as required by the
25 terms of the agreement so as to protect the public.
26 (2) An agreement with the board under which the
27 pharmacist's or pharmacist intern's license shall be
28 suspended or revoked, and which provides that enforcement of
29 the suspension or revocation shall be stayed for the length
30 of time the impaired pharmacist or pharmacist intern remains
19990H1946B4165 - 40 -
1 in the treatment program and makes satisfactory progress,
2 complies with the terms of the agreement and adheres to any
3 limitations on his or her practice imposed by the board to
4 protect the public.
5 (d) Disqualification from program.--Failure to enter into
6 one of the agreements required by subsection (c) shall
7 disqualify the impaired professional from the impaired
8 pharmacist or pharmacist intern program and shall activate an
9 immediate investigation and disciplinary proceeding by the
10 board.
11 (e) Lack of satisfactory progress.--
12 (1) If, in the opinion of the professional consultant
13 after consultation with the program provider, the peer
14 assistance group, or both, an impaired pharmacist or
15 pharmacist intern who is enrolled in an approved treatment
16 program or the peer assistance program and has entered into
17 an agreement under subsection (a) has not progressed
18 satisfactorily, the professional consultant shall disclose to
19 the board all information in the consultant's possession
20 regarding said pharmacist or pharmacist intern.
21 (2) After the disclosure, the board shall institute
22 proceedings to determine if the stay of the enforcement of
23 the suspension or revocation of the impaired pharmacist's or
24 pharmacist intern's license shall be vacated if the licensee
25 has executed a board agreement.
26 (3) If the licensee has not executed a board agreement,
27 but has executed an agreement with the peer assistance
28 program, the board shall immediately institute proceedings to
29 determine if the impaired pharmacist's or pharmacist intern's
30 license should be revoked or suspended.
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1 Section 705. Reinstatement.
2 (a) Petition.--A person whose license to practice pharmacy
3 in this Commonwealth has been suspended, revoked or restricted
4 pursuant to this act, whether voluntarily or by action of the
5 board, shall have the right, after any statutorily mandated
6 period of time, or, if no statutory limitation exists, at
7 reasonable intervals, to petition the board for reinstatement of
8 such license.
9 (b) Forms.--The petition shall be made in writing and in the
10 form prescribed by the board.
11 (c) Board procedures.--Upon investigation and hearing, the
12 board may, in its discretion, grant or deny the petition, or it
13 may modify its original findings to reflect any circumstances
14 which have changed sufficiently to warrant such modifications.
15 The board, at its discretion, may also require such person to
16 pass an examination for reentry into the practice of pharmacy.
17 (d) No reinstatement for revocation.--
18 (1) Unless ordered to do so by Commonwealth Court or an
19 appeal therefrom, the board may not reinstate the license of
20 a person to the practice of pharmacy pursuant to this act
21 which license has been revoked.
22 (2) A person whose license has been revoked may apply
23 for reinstatement after a period of five years from the date
24 of revocation, but must meet all of the licensing
25 qualifications of this act for the license applied for, to
26 include the examination requirement.
27 Section 706. No bar to criminal action.
28 Nothing in this act shall be construed as barring criminal
29 prosecutions for violations of this act.
30 Section 707. Administrative Agency Law.
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1 A final decision of the board shall be subject to judicial
2 review pursuant to 2 Pa.C.S. § 103 (relating to Administrative
3 Agency Law).
4 Section 708. Board action.
5 When the board finds that the license of a pharmacist or
6 pharmacist intern may be refused, revoked or suspended under the
7 terms of this section, the board may:
8 (1) Deny the application for a license.
9 (2) Administer a public reprimand.
10 (3) Revoke, suspend, limit or otherwise restrict the
11 license as determined by the board.
12 (4) Require the licensee to submit to the care,
13 counseling or treatment of a physician or a psychologist
14 designated by the board or enter into an appropriate
15 treatment program as determined by the board.
16 (5) Suspend enforcement of its findings thereof and
17 place the licensee on probation with the right to vacate the
18 probationary order for noncompliance unless such suspension
19 is otherwise prohibited by this act.
20 Section 709. Pharmacy permits.
21 The board shall refuse, revoke or suspend the permit of any
22 pharmacy upon proof satisfactory to it that any of the following
23 occurred:
24 (1) The permit was procured through fraud,
25 misrepresentation or deceit.
26 (2) The holder of the pharmacy permit or partner or
27 officer thereof has violated any of the provisions of this
28 act, regulations of the board or any provisions of the
29 Federal act, or the act of April 14, 1972 (P.L.233, No.64),
30 known as The Controlled Substance, Drug, Device and Cosmetic
19990H1946B4165 - 43 -
1 Act, or has ordered a pharmacist, pharmacist intern or
2 pharmacy technician in the employ of that pharmacy to engage
3 in any aspect of the practice of pharmacy in contravention of
4 any provisions of the aforesaid acts or regulations.
5 (3) The holder of the pharmacy permit sold, dispensed or
6 caused or allowed to be sold or dispensed any controlled
7 substance or nonproprietary drug, except by a licensed
8 pharmacist.
9 (4) Upon the suspension or revocation of a license of a
10 pharmacist or pharmacist intern employed by the pharmacy, it
11 is shown that the illegal acts of the pharmacist or
12 pharmacist intern where within the knowledge of or should
13 have been within the knowledge of the holder of the pharmacy
14 permit, or partner or officer thereof.
15 (5) The holder of the pharmacy permit, after issuance of
16 a permit, fails to continue to comply with all requirements
17 of Subchapter C of Chapter 5.
18 Section 710. Return of license or permit.
19 An individual or entity whose license to practice pharmacy or
20 registration to assist in the practice of pharmacy is revoked,
21 suspended or not renewed shall return the license or
22 registration certificate to the offices of the board within ten
23 days after receipt of notice of such action.
24 Section 711. Hearings.
25 (a) Notice of determination.--Upon refusal of the board to
26 issue a license or permit, written notices of the grounds
27 supporting such decision shall be given the applicant, either
28 personally or by registered or certified mail, return receipt
29 requested, and the board shall accord the applicant the
30 opportunity of a hearing, upon written request received within
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1 15 days from the date of giving the written notice.
2 (b) Investigation.--The board may, upon its own motion, and
3 shall, promptly, upon the verified complaint in writing of a
4 person setting forth specifically the wrongful act or acts
5 complained of, investigate any alleged violations of this act by
6 any persons, and shall have the power temporarily to suspend or
7 permanently revoke licenses or permit issued by the board under
8 this act at any time when, after due proceedings as provided, it
9 shall find the holder thereof to have been guilty of any
10 violation of this act or the rules or regulations of the board.
11 (c) Conduct of hearings.--Hearings, appeals and rulings
12 resulting therefrom, unless otherwise provided in this act,
13 shall be in accordance with the provisions of 2 Pa.C.S. § 103
14 (relating to Administrative Agency Law).
15 (d) Presence of board member.--A majority of the board shall
16 designate the member or members to be present at each hearing.
17 Subsequent to each hearing, the notes of testimony shall be
18 transcribed, and a copy of the transcription shall be given to
19 each member of the board who shall review the same prior to
20 voting thereon. All decisions shall be reached by a majority
21 vote of the entire board. The board shall, by regulation,
22 establish and publish procedural rules concerning the conduct of
23 hearings.
24 Section 712. Docket and other records.
25 (a) Duty to maintain.--
26 (1) The board shall maintain in its office a docket or
27 other record of the rulings and decisions upon all complaints
28 filed with it and all investigations instituted by it.
29 (2) The board shall give immediate written notice of a
30 ruling or decision to the licensee affected thereby and,
19990H1946B4165 - 45 -
1 where the investigation shall have been instituted by
2 complaint filed, to the party or parties by whom the
3 complaint was made.
4 (3) If a ruling or decision may operate to the prejudice
5 or shall injuriously affect the licensee, the board shall
6 also state in the notice the date upon which the ruling shall
7 become effective.
8 (b) Publication.--
9 (1) If the licensee, at such time, cannot be found, the
10 licensee's whereabouts being unknown, such notice may be
11 given by the board by advertisement inserted in one issue of
12 a newspaper of general circulation published within the
13 county which was designated by the licensee as the licensee's
14 mailing address.
15 (2) When any revocation or suspension shall become
16 final, the board shall publish notice thereof in one issue of
17 one or more newspapers of general circulation published
18 within the county in which the licensee was engaged in the
19 practice of pharmacy at the time of such revocation or
20 suspension.
21 CHAPTER 9
22 PHARMACIST PRACTICE
23 Section 901. Practice of pharmacy.
24 The practice of pharmacy in this Commonwealth is hereby
25 declared a health care professional practice in which the
26 pharmacist is considered a health care provider affecting the
27 public health, safety and welfare and is subject to regulation
28 and control in the public interest. It is declared to be a
29 matter of public interest and concern that the practice of
30 pharmacy, as defined in this act, merit and receive the
19990H1946B4165 - 46 -
1 confidence of the public and that only qualified persons be
2 permitted to engage in the practice of pharmacy in this
3 Commonwealth.
4 Section 902. Pharmacy health care service.
5 The practice of pharmacy is the provision of health care
6 services by a pharmacist, including, but not limited to:
7 (1) The interpretation, evaluation and implementation of
8 medical orders.
9 (2) The delivering, dispensing or distributing of
10 prescription drugs.
11 (3) Participation in drug and device selection.
12 (4) Drug administration.
13 (5) Drug regimen review.
14 (6) Drug or drug-related research.
15 (7) Compounding.
16 (8) Proper and safe storage of drugs and devices.
17 (9) Managing drug therapy.
18 (10) Such acts, services, operations or transactions
19 necessary or incident to the provision of these health care
20 services.
21 Section 903. Drug regimen review.
22 In all practice care settings a pharmacist shall:
23 (1) Perform a drug regimen review prior to dispensing a
24 prescription.
25 (2) Maintain a patient history in compliance with
26 regulations of the board for each patient for whom
27 prescriptions are dispensed.
28 (3) Provide drug information to the patient, caregiver
29 or patient's agent in compliance with regulations of the
30 board. The offer to provide this information shall be made by
19990H1946B4165 - 47 -
1 the pharmacist or the pharmacist's designee.
2 Section 904. Managing drug therapy.
3 (a) Written authorization.--A pharmacist shall be permitted
4 to enter into a written agreement or protocol authorizing the
5 delegation of the management of drug therapy.
6 (b) Licensed prescriber.--The licensed prescriber who is a
7 party to a written agreement or protocol authorizing the
8 delegation of the management of drug therapy shall be in active
9 practice and the delegation shall be within the scope of the
10 licensed prescriber's current practice.
11 (c) Voluntary utilization.--Participation in a written
12 agreement or protocol authorizing the delegation of the
13 management of drug therapy shall be voluntary, and no licensed
14 prescriber, pharmacist or patient shall be required to
15 participate.
16 (d) Insurance protection.--A party to a written agreement or
17 protocol authorizing the delegation of the management of drug
18 therapy shall maintain a minimum agreement and malpractice
19 insurance policy in an amount of not less than $1,000,000.
20 (e) Regulations.--The board shall adopt regulations to
21 assure for the protection of the health and welfare of patients
22 treated pursuant to a written agreement or protocol authorizing
23 the delegation of the management of drug therapy.
24 Section 905. Pharmacy technicians.
25 (a) Use.--A pharmacy technician may be utilized to assist a
26 pharmacist in the preparation of prescriptions and drug orders
27 in compliance with regulations adopted by the board.
28 (b) Training.--A technician may be trained at any licensed
29 pharmacy or trained thorough educational programs provided by
30 colleges, universities, professional associations, private
19990H1946B4165 - 48 -
1 schools or other entities.
2 (c) Registration.--A pharmacy technician must register with
3 the board on a form prescribed by the board and pay a
4 registration fee as determined by the board.
5 (d) Pharmacist supervision.--A pharmacy technician shall
6 work only under the immediate supervision of a licensed
7 pharmacist.
8 (e) Prohibited activities.--A pharmacy technician shall be
9 prohibited from performing those functions requiring the skill
10 and competence of a licensed pharmacist, including, but not
11 limited to:
12 (1) Performing drug regimen reviews.
13 (2) Providing drug information, or patient counseling,
14 or both, to patients or caregivers.
15 (3) Monitoring of drug therapy.
16 (f) Construction.--Nothing in this section shall be
17 construed to preclude or prevent a pharmacy technician from
18 assisting a pharmacist by making an offer to the patient or
19 caregiver or agent of the patient to have a pharmacist provide
20 drug information, patient counseling or both.
21 Section 906. Prescriptions.
22 (a) Transmission.--Prescriptions and drug orders may be:
23 (1) written by the health practitioner;
24 (2) transmitted by telephone to the pharmacy by the
25 health practitioner or the practitioner's agent;
26 (3) transmitted to the pharmacy by facsimile, provided
27 there is no prohibition in Federal or State law prohibiting
28 facsimile transmission of prescription or drug orders for the
29 specific drug involved;
30 (4) transmitted by electronic data transmission from the
19990H1946B4165 - 49 -
1 health practitioner directly to the pharmacy.
2 (b) Regulations.--The board shall establish regulations
3 governing the use of facsimile or electronic data transmission
4 to assure for the protection of the public health and safety and
5 to provide adequate security to assure confidentiality of the
6 information and data.
7 (c) Transfer between pharmacies.--A prescription may be
8 transferred between pharmacies in this Commonwealth pursuant to
9 the following requirements and any regulations of the board:
10 (1) The prescription is for a drug which is lawfully
11 refillable.
12 (2) The drug is not a Schedule II controlled substance
13 under act of April 14, 1972 (P.L.233, No.64), known as The
14 Controlled Substance, Drug, Device and Cosmetic Act.
15 (3) An original or new prescription is not required from
16 the prescriber by law.
17 (4) The pharmacist transferring the prescription cancels
18 the original prescription in the pharmacist's records and
19 indicates on the prescription records to whom the
20 prescription was transferred, including the name of the
21 pharmacy, the date of the transfer and the name or initials
22 of the transferring pharmacist.
23 (5) The pharmacist receiving the transferred
24 prescription:
25 (i) Notes on the prescription that it is a
26 transferred prescription.
27 (ii) Records all of the following on the
28 prescription records in addition to other information
29 required by law:
30 (A) Date of issuance of original prescription.
19990H1946B4165 - 50 -
1 (B) Date of original filling of prescription and
2 date of last refill.
3 (C) Original number of refills authorized on
4 prescription.
5 (D) Number of valid refills remaining.
6 (iii) Notes the location and file number of the
7 original prescription.
8 (iv) Notes the name of the pharmacy and pharmacist
9 from whom the prescription was transferred.
10 (6) A pharmacist may transfer a prescription to another
11 pharmacist employed by the same corporation without regard to
12 the requirements of this subsection, provided that both
13 pharmacists have access to the same computerized prescription
14 transfer system which contains the prescription refill
15 records and incorporates procedures to prevent unauthorized
16 refills.
17 Section 907. Emergency refills.
18 A pharmacist shall be permitted to provide an emergency
19 refill of a prescription that would otherwise not be legally
20 refillable only if all of the following terms and conditions are
21 satisfied:
22 (1) The pharmacist first attempts to obtain an
23 authorization from the authorized prescriber but cannot
24 contact the prescriber.
25 (2) The drug which is the subject of the refill is
26 essential to the continuation of therapy and, in the
27 pharmacist's professional judgment, the interruption of the
28 therapy might reasonably produce an undesirable health
29 consequence, be detrimental to the patient's welfare or cause
30 physical or mental discomfort.
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1 (3) The drug which is the subject of the refill is not a
2 controlled substance.
3 (4) The pharmacist enters on the back of the
4 prescription or on another appropriate, uniformly maintained
5 and readily retrievable record, the date and quantity of the
6 refill and the pharmacist must verify the prescription.
7 (5) The pharmacist provides no more than a 72-hour
8 emergency supply of the medication in conformity with the
9 prescribed directions for use.
10 (6) Within 72 hours of dispensing the refill, the
11 pharmacist notified the prescriber that an emergency
12 prescription had been dispensed and the quantity of drug
13 provided to the patient.
14 Section 908. Impaired pharmacist or pharmacist intern.
15 (a) Board power.--In addition to the power set forth in
16 section 704, the board, with the approval of the Commissioner of
17 Professional and Occupational Affairs, shall appoint and fix
18 compensation of a professional consultant who is a licensee of
19 the board with education and experience in the identification,
20 treatment and rehabilitation of persons with chemical, physical
21 and mental impairments. The consultant shall be accountable to
22 the board and shall act as a liaison between the board and
23 treatment programs, such as alcohol and drug treatment programs
24 licensed by the Department of Health, psychological counseling
25 and impaired professional support groups approved by the board
26 and which provide services to licensees under this act.
27 (b) Required reporting.--A hospital or health care facility,
28 peer or colleague who has substantial evidence that a pharmacist
29 or pharmacist intern has an active, addictive disease for which
30 the pharmacist or pharmacist intern is not receiving treatment,
19990H1946B4165 - 52 -
1 is diverting a controlled substance for personal use or is
2 mentally or physically incompetent to carry out the duties of
3 the pharmacist's or pharmacist's intern's license or certificate
4 shall make or cause to be made a report to the board, except
5 that any person or facility who acts in a treatment capacity to
6 an impaired pharmacist in an approved treatment program is
7 exempt from the mandatory reporting requirements of this
8 subsection.
9 (c) Immunity.--Any person or facility who reports in good
10 faith and without malice under this section shall be immune from
11 any civil or criminal liability resulting from such report.
12 (d) Penalty.--Failure to provide the report within a
13 reasonable time from receipt of such knowledge of impairment
14 shall subject the person or facility to a fine not to exceed
15 $1,000. The board shall levy the penalty only after affording
16 the accused party the opportunity for a hearing, as provided in
17 2 Pa.C.S. (relating to administrative law and procedure).
18 (e) Report by provider.--An approved program provider who
19 makes disclosure to the board pursuant to the requirements of
20 this act shall not be subject to civil liability for such
21 disclosure or its consequences.
22 CHAPTER 11
23 UNLAWFUL ACTIVITIES
24 Section 1101. Unlawful acts.
25 It shall be unlawful for:
26 (1) A person to procure or attempt to procure a license,
27 permit or certificate for that person or for any other person
28 by making or causing to be made any false representations.
29 (2) A person not duly licensed as a pharmacist pursuant
30 to this act to engage in the practice of pharmacy, except a
19990H1946B4165 - 53 -
1 pharmacy intern or such other authorized personnel under the
2 immediate personal supervision of a pharmacist. Nothing in
3 this section shall be construed to prevent a duly licensed
4 medical practitioner from administering any drug to the
5 practitioner's own patients after diagnosis or treatment of
6 the patient or to prevent any person from selling or
7 distributing at retail household remedies or proprietary
8 medicines when the same are offered for sale or sold in the
9 original manufacturer's package which was prepared for sale
10 to consumers.
11 (3) An unlicensed person to operate or conduct or to
12 have charge or to supervise any pharmacy. For a violation of
13 this section, the owner of the pharmacy shall be equally
14 liable as the principal party involved in the violation.
15 (4) A person to represent that person as licensed under
16 this act when in fact that person is not so licensed.
17 (5) A person to knowingly prevent or refuse to permit
18 any member of the board or its duly authorized agents to
19 enter a pharmacy or any other place where drugs or devices
20 are kept, stored, dispensed or distributed to a patient or
21 consumer for the purpose of lawful inspection or other
22 purposes in accordance with this act and regulations pursuant
23 thereto.
24 (6) A person whose license, permit or certification has
25 been revoked, suspended or refused renewal to fail to deliver
26 the license, permit or certificate to the board within ten
27 days after receipt of notice of such action.
28 (7) A person to sell at auction drugs or devices in bulk
29 or in open or unopened packages, unless such sale has been
30 approved in advance by the board and unless such sale shall
19990H1946B4165 - 54 -
1 be under the personal supervision of a licensed pharmacist
2 appointed by the board and whose fee shall be paid by the
3 seller.
4 (8) A person, firm or corporation to use the title
5 "pharmacist," "pharmacist care," "pharmacy care,"
6 "pharmaceutical care," "assistant pharmacist," "druggist,"
7 "apothecary" or similar terms except a person duly licensed
8 as a pharmacist in this Commonwealth.
9 (9) A person to conduct or transact business under a
10 name which contains as part thereof the words "drug store,"
11 "pharmacy," "drugs," "medicine store," "medicines," "drug
12 shop," "apothecary," "pharmaceutical" or any term having a
13 similar meaning, or in any manner by advertisement, display
14 or show globes or otherwise describe or refer to the place of
15 the conducted business or person unless the place is a
16 pharmacy duly issued a permit by the board.
17 (10) A person who buys, sells or causes to be sold or
18 offers for sale any drug or device which bears or which
19 package bears or originally did bear the inscription "sample"
20 or "not for resale" or "for investigational or experimental
21 use only" or other similar words, except where a cost is
22 incurred in the bona fide acquisition of an investigational
23 or experimental drug.
24 (11) A person using to that person's own advantage or
25 revealing to anyone other than the board, its duly authorized
26 representatives or to the courts when relevant to any
27 judicial proceeding under this act, any information acquired
28 under authority of this act or concerning any method or
29 process which is a trade secret.
30 (12) A pharmacist or owner of a pharmacy advertising or
19990H1946B4165 - 55 -
1 promoting prices for drugs and pharmaceutical services to the
2 public which do not conform to Federal and State laws and
3 regulations.
4 (13) A person who knowingly and willfully:
5 (i) forges or counterfeits upon any goods, wares or
6 merchandise the private stamps or labels of any mechanic
7 or manufacturer with intent to defraud the purchasers or
8 manufacturers of any goods, wares or merchandise;
9 (ii) keeps in possession or conceals any goods,
10 wares or merchandise or keeps in control, custody or
11 possession any punch plate, stone or other thing in the
12 likeness of any punch plate or stone designated for the
13 printing or imprinting of the private stamps or labels of
14 any mechanic or manufacturer; or
15 (iii) vends any goods, wares or merchandise having
16 thereon any forged or counterfeited stamps or labels
17 purporting to be the stamps or labels of any mechanic or
18 manufacturer, knowing the same to be forged or
19 counterfeited.
20 (14) A person acting alone or through another person to
21 procure or attempt to procure for himself or another person
22 any drug:
23 (i) By fraud, deceit, misrepresentation or
24 subterfuge.
25 (ii) By the forgery or alteration of a prescription
26 or any written order.
27 (iii) By the concealment of material facts.
28 (iv) By the use of a false statement and a
29 prescription order or report.
30 (15) A person to deliver a prescription medication by
19990H1946B4165 - 56 -
1 mail or otherwise to a patient within this Commonwealth
2 unless the prescription is filled or refilled in a pharmacy
3 licensed by the board.
4 (16) A licensed prescriber to have a proprietary or
5 beneficial interest in a pharmacy sufficient to permit that
6 prescriber to exercise supervision or control over a
7 pharmacist working in the pharmacy in the pharmacist's
8 professional responsibilities and duties.
9 Section 1102. Criminal penalties.
10 A person who violates any of the provisions of section 1101
11 commits a misdemeanor and shall, upon conviction, be sentenced
12 to pay a fine of not more than $5,000, or to imprisonment for
13 not more than one year, or both and for each subsequent offense,
14 shall be sentenced to pay a fine or not more than $15,000, or to
15 imprisonment for not more than three years, or both.
16 Section 1103. Additional civil penalty.
17 In addition to any other civil remedy or criminal penalty
18 provided for in this act, the board may levy a civil penalty of
19 up to $1,000 on any current licensee who violates any provision
20 of this act or on any person who practices pharmacy without
21 being properly licensed to do so under this act. The board shall
22 levy such penalty only after affording the accused party the
23 opportunity for a hearing, as provided in 2 Pa.C.S. (relating to
24 administrative law and procedure).
25 CHAPTER 13
26 FISCAL AFFAIRS
27 Section 1301. Setting of fees.
28 (a) General rule.--All fees required under this act shall be
29 fixed by the board by regulation and shall be subject to the act
30 of June 25, 1982 (P.L.633, No.181), known as the Regulatory
19990H1946B4165 - 57 -
1 Review Act. If the revenues raised by fees, fines and civil
2 penalties imposed under this act are not sufficient to meet
3 expenditures over a two-year period, the board shall increase
4 those fees by regulation, so that the projected revenues will
5 meet or exceed projected expenditures.
6 (b) Increase in fees.--If the bureau determines that the
7 fees, fines and civil penalties established by the board under
8 subsection (a) are inadequate to meet the minimum enforcement
9 efforts required by this act, then the bureau, after
10 consultation with the board and subject to the Regulatory Review
11 Act, shall increase the fees by regulation in an amount such
12 that adequate revenues are raised to meet the required
13 enforcement effort.
14 Section 1302. Pharmacy Professional Development Fund.
15 There is hereby established in the State Treasury the
16 Pharmacy Professional Development Fund. All fees, fines and
17 civil penalties imposed in accordance with this act shall be
18 paid into the fund. The funds shall be used by the board for
19 professional development and for enforcement efforts mandated by
20 this act.
21 Section 1303. Annual submissions.
22 (a) Estimate to department.--The board shall submit annually
23 to the Department of State an estimate of the financial
24 requirements of the board for its administrative, investigative,
25 legal and miscellaneous expenses.
26 (b) Report to the General Assembly.--The board shall submit
27 annually to the Appropriations Committee of the Senate and the
28 Appropriations Committee of the House of Representatives, 15
29 days after the Governor has submitted the budget to the General
30 Assembly, a copy of the budget request for the upcoming fiscal
19990H1946B4165 - 58 -
1 year which the board previously submitted to the Department of
2 State.
3 Section 1304. Hiring of pharmacy inspectors.
4 The board shall employ at least eight pharmacy inspectors who
5 shall be licensed pharmacists in this Commonwealth. If the board
6 determines that additional pharmacy inspectors are necessary to
7 protect the health and safety of the citizens of this
8 Commonwealth, the board shall hire such additional inspectors.
9 Pharmacy inspectors shall be under the authority of the board,
10 shall report to the executive director and shall inspect all
11 licensed locations at the direction of the board or executive
12 director.
13 CHAPTER 15
14 MISCELLANEOUS PROVISIONS
15 Section 1501. Existing board members.
16 Members of the board appropriately confirmed as of the
17 effective date of this act shall continue to serve as members of
18 the board until their present terms expire or until a successor
19 has been appointed and qualified, but not longer than six months
20 after present terms have expired.
21 Section 1502. Existing rules, regulations and fees.
22 The rules and regulation of the board in effect on the
23 effective date of this act, not inconsistent with this act,
24 shall remain in effect until repealed or amended by the board.
25 Each fee of the board in effect on the effective date of this
26 act, and not inconsistent with this act, shall remain in effect
27 until repealed or amended in accordance with this act.
28 Section 1503. Current licensees.
29 A person who holds a valid license issued by the board on the
30 effective date of this act shall, on and after the effective
19990H1946B4165 - 59 -
1 date of this act, be deemed to be licensed by the board as
2 provided for in this act.
3 Section 1504. Severability.
4 The provisions of this act are severable. If any provision of
5 this act or its application to any person or circumstance is
6 held invalid, the invalidity shall not affect other provisions
7 or applications of this act which can be given effect without
8 the invalid provision or application.
9 Section 1505. Repeals.
10 (a) Absolute.--The following acts and parts of acts are
11 repealed:
12 Act of September 27, 1961 (P.L.1700, No.699), known as the
13 Pharmacy Act.
14 (b) Inconsistent.--The act of April 9, 1929 (P.L.177,
15 No.175), known as The Administrative Code of 1929, is repealed
16 insofar as it is inconsistent with this act.
17 (c) General.--All other acts and parts of acts are repealed
18 insofar as they are inconsistent with this act.
19 Section 1506. Effective date.
20 This act shall take effect January 1, 2000 or immediately,
21 whichever occurs later.
22 SECTION 1. SECTION 2(11) OF THE ACT OF SEPTEMBER 27, 1961 <--
23 (P.L.1700, NO.699), KNOWN AS THE PHARMACY ACT, AMENDED DECEMBER
24 20, 1985 (P.L.433, NO.111), IS AMENDED AND THE SECTION IS
25 AMENDED BY ADDING CLAUSES TO READ:
26 SECTION 2. DEFINITIONS.--AS USED IN THIS ACT:
27 * * *
28 (11) "PRACTICE OF PHARMACY" MEANS THE [PRACTICE OF THAT
29 PROFESSION CONCERNED WITH THE ART AND SCIENCE OF THE EVALUATION
30 OF PRESCRIPTION ORDERS AND THE PREPARING, COMPOUNDING AND
19990H1946B4165 - 60 -
1 DISPENSING OF DRUGS AND DEVICES, WHETHER DISPENSED ON THE
2 PRESCRIPTION OF A MEDICAL PRACTITIONER OR LEGALLY DISPENSED OR
3 PROVIDED TO A CONSUMER, AND SHALL INCLUDE THE PROPER AND SAFE
4 STORAGE AND DISTRIBUTION OF DRUGS, THE MAINTENANCE OF PROPER
5 RECORDS, THE PARTICIPATION IN DRUG SELECTION AND DRUG
6 UTILIZATION REVIEWS, AND THE RESPONSIBILITY OF RELATING
7 INFORMATION AS REQUIRED CONCERNING SUCH DRUGS AND MEDICINES AND
8 THEIR THERAPEUTIC VALUES AND USES IN THE TREATMENT AND
9 PREVENTION OF DISEASE:] PROVISION OF HEALTH CARE SERVICES BY A
10 PHARMACIST, WHICH INCLUDES THE INTERPRETATION, EVALUATION AND
11 IMPLEMENTATION OF MEDICAL ORDERS OR PRESCRIPTION DRUG ORDERS;
12 THE DELIVERY, DISPENSING OR DISTRIBUTION OF PRESCRIPTION DRUGS;
13 PARTICIPATION IN DRUG AND DEVICE SELECTION; DRUG ADMINISTRATION;
14 DRUG REGIMEN REVIEW; DRUG OR DRUG-RELATED RESEARCH; COMPOUNDING;
15 PROPER AND SAFE STORAGE OF DRUGS AND DEVICES; MANAGING DRUG
16 THERAPY IN AN INSTITUTIONAL SETTING; MAINTAINING PROPER RECORDS;
17 PATIENT COUNSELING; AND SUCH ACTS, SERVICES, OPERATIONS OR
18 TRANSACTIONS NECESSARY OR INCIDENT TO THE PROVISION OF THESE
19 HEALTH CARE SERVICES. [PROVIDED, HOWEVER, THAT] THE "PRACTICE OF
20 PHARMACY" SHALL NOT INCLUDE THE OPERATIONS OF A MANUFACTURER OR
21 DISTRIBUTOR AS DEFINED IN "THE CONTROLLED SUBSTANCE, DRUG,
22 DEVICE AND COSMETIC ACT."
23 * * *
24 (14) "MANAGING DRUG THERAPY" MEANS ANY OF THE FOLLOWING
25 PROCESSES WHICH SHALL BE PERFORMED IN AN INSTITUTIONAL SETTING
26 ONLY: ADJUSTING A DRUG REGIMEN; ADJUSTING DRUG STRENGTH,
27 FREQUENCY OF ADMINISTRATION OR ROUTE; ADMINISTRATION OF DRUGS;
28 AND ORDERING AND PERFORMING OF LABORATORY OR OTHER DIAGNOSTIC
29 TESTS NECESSARY IN THE MANAGEMENT OF DRUG THERAPY. MANAGING DRUG
30 THERAPY SHALL BE PERFORMED PURSUANT TO A WRITTEN AGREEMENT OR
19990H1946B4165 - 61 -
1 PROTOCOL AS SET FORTH IN SECTION 9.1 OF THIS ACT, AUTHORIZING
2 THE DELEGATION OF MANAGEMENT OF DRUG THERAPY FROM A LICENSED
3 PHYSICIAN TO A PHARMACIST, IN ACCORDANCE WITH SECTION 17 OF THE
4 ACT OF DECEMBER 20, 1985 (P.L.457, NO.112), KNOWN AS THE
5 "MEDICAL PRACTICE ACT OF 1985," WHICH AUTHORIZES A MEDICAL
6 DOCTOR TO DELEGATE DUTIES TO HEALTH CARE PRACTITIONERS, AND
7 SECTION 3 OF THE ACT OF OCTOBER 5, 1978 (P.L.1109, NO.261),
8 KNOWN AS THE "OSTEOPATHIC MEDICAL PRACTICE ACT," WHICH
9 AUTHORIZES SERVICES AND ACTS RENDERED BY ALLIED MEDICAL PERSONS
10 UNDER THE SUPERVISION, DIRECTION OR CONTROL OF A LICENSED
11 PHYSICIAN.
12 (15) "INSTITUTION" MEANS AN EXTENDED CARE FACILITY, NURSING
13 HOME, NURSING CARE FACILITY, CONVALESCENT HOME, RESIDENT CARE
14 FACILITY, HOSPITAL OR ANY OTHER PLACE WHICH OFFERS MEDICAL
15 TREATMENT TO PATIENTS WHO REQUIRE FOOD, BOARD AND OVERNIGHT
16 SLEEPING FACILITIES AND CARE.
17 (16) "DRUG ADMINISTRATION" MEANS THE DIRECT INTRODUCTION OF
18 OR THE APPLICATION OF A DRUG INTO OR ON THE BODY OF A PATIENT BY
19 INJECTION, INHALATION, INGESTION OR ANY OTHER MEANS, AND WHERE
20 REQUIRED BY LAW, SHALL OCCUR ONLY PURSUANT TO A MEDICAL ORDER.
21 (17) "MEDICAL ORDER" MEANS A LAWFUL ORDER BY A SPECIFICALLY
22 IDENTIFIED MEDICAL PRACTITIONER FOR A SPECIFICALLY IDENTIFIED
23 PATIENT.
24 (18) "PHYSICIAN" MEANS AN INDIVIDUAL LICENSED UNDER THE LAWS
25 OF THIS COMMONWEALTH TO ENGAGE IN THE PRACTICE OF MEDICINE AND
26 SURGERY IN ALL ITS BRANCHES WITHIN THE SCOPE OF THE ACT OF
27 DECEMBER 20, 1985 (P.L.457, NO.112), KNOWN AS THE "MEDICAL
28 PRACTICE ACT OF 1985," OR IN THE PRACTICE OF OSTEOPATHIC
29 MEDICINE WITHIN THE SCOPE OF THE ACT OF OCTOBER 5, 1978
30 (P.L.1109, NO.261), KNOWN AS THE "OSTEOPATHIC MEDICAL PRACTICE
19990H1946B4165 - 62 -
1 ACT."
2 (19) "PROTOCOL" MEANS A WRITTEN DOCUMENT THAT DESCRIBES THE
3 NATURE AND SCOPE OF THE DRUG THERAPY MANAGEMENT TO BE CARRIED
4 OUT BY THE PHARMACIST.
5 SECTION 2. THE ACT IS AMENDED BY ADDING SECTIONS TO READ:
6 SECTION 9.1. DRUG THERAPY PROTOCOLS.--(A) A PHARMACIST
7 SHALL BE PERMITTED TO ENTER INTO A WRITTEN AGREEMENT OR PROTOCOL
8 WITH A LICENSED PHYSICIAN AUTHORIZING THE DELEGATION OF THE
9 MANAGEMENT OF DRUG THERAPY IN AN INSTITUTIONAL SETTING.
10 (B) THE LICENSED PHYSICIAN WHO IS A PARTY TO A WRITTEN
11 AGREEMENT OR PROTOCOL AUTHORIZING THE DELEGATION OF THE
12 MANAGEMENT OF DRUG THERAPY SHALL BE IN ACTIVE PRACTICE AND THE
13 DELEGATION SHALL BE WITHIN THE SCOPE OF THE LICENSED PHYSICIAN'S
14 CURRENT PRACTICE.
15 (C) PARTICIPATION IN A WRITTEN AGREEMENT OR PROTOCOL
16 AUTHORIZING THE DELEGATION OF THE MANAGEMENT OF DRUG THERAPY
17 SHALL BE VOLUNTARY, AND NO LICENSED PHYSICIAN SHALL BE REQUIRED
18 TO PARTICIPATE.
19 (D) (1) A PHARMACIST WHO IS A PARTY TO A WRITTEN AGREEMENT
20 OR PROTOCOL AUTHORIZING THE DELEGATION OF THE MANAGEMENT OF DRUG
21 THERAPY SHALL OBTAIN AND MAINTAIN, TO THE SATISFACTION OF THE
22 BOARD, PROFESSIONAL LIABILITY INSURANCE COVERAGE IN THE MINIMUM
23 AMOUNT OF ONE MILLION DOLLARS ($1,000,000). THE PROFESSIONAL
24 LIABILITY INSURANCE COVERAGE SHALL REMAIN IN EFFECT AS LONG AS
25 THAT PHARMACIST IS A PARTY TO A WRITTEN AGREEMENT OR PROTOCOL
26 AUTHORIZING THE DELEGATION OF THE MANAGEMENT OF DRUG THERAPY.
27 FAILURE TO MAINTAIN INSURANCE COVERAGE AS REQUIRED UNDER THIS
28 SUBSECTION SHALL BE ACTIONABLE UNDER SECTION 5 OF THIS ACT.
29 (2) THE BOARD SHALL ACCEPT FROM PHARMACISTS AS SATISFACTORY
30 EVIDENCE OF INSURANCE COVERAGE UNDER THIS SUBSECTION, ANY AND
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1 ALL OF THE FOLLOWING: SELF-INSURANCE, PERSONALLY PURCHASED
2 PROFESSIONAL LIABILITY INSURANCE, PROFESSIONAL LIABILITY
3 INSURANCE COVERAGE PROVIDED BY THE PHARMACIST'S EMPLOYER OR ANY
4 SIMILAR TYPE OF COVERAGE.
5 (3) THE BOARD SHALL ADOPT, BY REGULATION, STANDARDS AND
6 PROCEDURES ESTABLISHED BY THE INSURANCE COMMISSIONER FOR SELF-
7 INSURANCE. IN THE ABSENCE OF THESE STANDARDS AND PROCEDURES, THE
8 BOARD, AFTER CONSULTATION WITH THE INSURANCE COMMISSIONER, SHALL
9 ESTABLISH STANDARDS AND PROCEDURES BY REGULATION FOR SELF-
10 INSURANCE UNDER THIS SUBSECTION.
11 (E) WITHIN EIGHTEEN MONTHS OF THE EFFECTIVE DATE OF THIS
12 SECTION, THE BOARD SHALL ADOPT REGULATIONS ESTABLISHING THE
13 PARAMETERS OF WRITTEN AGREEMENTS OR PROTOCOLS AUTHORIZED BY THIS
14 SECTION. SUCH PARAMETERS SHALL INCLUDE, BUT NOT BE LIMITED TO,
15 THE REQUIREMENT THAT WRITTEN AGREEMENTS OR PROTOCOLS:
16 (1) BE IN WRITING.
17 (2) REQUIRE THAT DRUG THERAPY REGIMENS BE INITIATED BY A
18 LICENSED PHYSICIAN FOR PATIENTS REFERRED TO A PHARMACIST FOR
19 DRUG THERAPY.
20 (3) PROVIDE FOR NOTIFICATION OF THE ROLE OF THE PHARMACIST
21 BY A LICENSED PHYSICIAN TO EACH REFERRED PATIENT WHOSE DRUG
22 THERAPY MANAGEMENT MAY BE AFFECTED BY THE AGREEMENT.
23 (4) BE AVAILABLE AS FOLLOWS:
24 (I) AT THE PRACTICE SITE OF ANY LICENSED PHYSICIAN WHO IS A
25 PARTY TO THE AGREEMENT.
26 (II) AT THE PRACTICE SITE OF ANY LICENSED PHARMACIST WHO IS
27 A PARTY TO THE AGREEMENT.
28 (III) TO ANY PATIENT WHOSE DRUG THERAPY MANAGEMENT IS
29 AFFECTED BY THE AGREEMENT.
30 (IV) UPON REQUEST, TO INVESTIGATORS OF THE STATE BOARD OF
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1 MEDICINE, THE STATE BOARD OF OSTEOPATHIC MEDICINE AND THE STATE
2 BOARD OF PHARMACY.
3 (5) IDENTIFY, BY NAME, EACH LICENSED PHYSICIAN AND EACH
4 LICENSED PHARMACIST WHO ARE PARTIES TO THE AGREEMENT.
5 (6) BE SIGNED AND DATED BY EACH LICENSED PHYSICIAN.
6 (7) SPECIFY THE FUNCTIONS AND TASKS WHICH ARE THE SUBJECT OF
7 THE DELEGATION.
8 (8) PROVIDE FOR EXECUTION OF THE AGREEMENT WHEN ANY LICENSED
9 PHYSICIAN OR LICENSED PHARMACIST MAY BE TEMPORARILY ABSENT FROM
10 A PRACTICE SETTING OR TEMPORARILY UNAVAILABLE TO PARTICIPATE IN
11 ITS EXECUTION.
12 (9) ESTABLISH AN APPROPRIATE TIME FRAME, NOT TO EXCEED
13 SEVENTY-TWO HOURS, WITHIN WHICH THE LICENSED PHARMACIST MUST
14 NOTIFY THE LICENSED PHYSICIAN OF ANY CHANGES IN DOSE, DURATION
15 OR FREQUENCY OF MEDICATION PRESCRIBED.
16 (10) BE FILED WITH THE STATE BOARD OF PHARMACY AND THE STATE
17 BOARD OF MEDICINE AND/OR THE STATE BOARD OF OSTEOPATHIC
18 MEDICINE.
19 (11) REMAIN IN EFFECT FOR A PERIOD NOT TO EXCEED TWO YEARS
20 UPON THE CONCLUSION OF WHICH, OR SOONER, THE PARTIES SHALL
21 REVIEW THE AGREEMENT AND MAKE A DETERMINATION AS TO ITS RENEWAL,
22 NECESSARY MODIFICATIONS OR TERMINATION.
23 (12) ALLOW FOR TERMINATION OF THE AGREEMENT AT THE REQUEST
24 OF ANY PARTY TO IT AT ANY TIME.
25 (F) MANAGING DRUG THERAPY WITHIN AN INSTITUTIONAL SETTING
26 MAY OCCUR WITHOUT THE REQUIREMENTS OF SUBSECTION (E) PROVIDED IT
27 IS PURSUANT TO A MEDICAL ORDER BY A LICENSED PHYSICIAN FOR
28 MANAGING DRUG THERAPY PROTOCOL OR GUIDELINE APPROVED BY THE
29 MEDICAL STAFF OF THE INSTITUTION.
30 SECTION 9.2. AUTHORITY TO ADMINISTER INJECTABLE MEDICATIONS,
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1 BIOLOGICALS AND IMMUNIZATIONS.--(A) WITHIN EIGHTEEN MONTHS FROM
2 THE EFFECTIVE DATE OF THIS SECTION, THE BOARD SHALL BY
3 REGULATION ESTABLISH EDUCATION AND TRAINING STANDARDS AND
4 PRACTICE GUIDELINES PURSUANT TO WHICH PHARMACISTS SHALL BE
5 AUTHORIZED TO ADMINISTER INJECTABLE MEDICATIONS, BIOLOGICALS AND
6 IMMUNIZATIONS TO PERSONS WHO ARE MORE THAN EIGHTEEN YEARS OF
7 AGE. SUCH STANDARDS AND GUIDELINES SHALL INCLUDE, BUT NOT BE
8 LIMITED TO, THE FOLLOWING:
9 (1) SATISFACTORY COMPLETION OF AN ACADEMIC AND PRACTICAL
10 CURRICULUM APPROVED BY THE BOARD THAT INCLUDES THE CURRENT
11 GUIDELINES AND RECOMMENDATIONS OF THE CENTERS FOR DISEASE
12 CONTROL AND PREVENTION IN THE PUBLIC HEALTH SERVICE OF THE
13 UNITED STATES DEPARTMENT OF HEALTH AND HUMAN SERVICES, THE
14 AMERICAN COUNCIL ON PHARMACEUTICAL EDUCATION OR A SIMILAR HEALTH
15 AUTHORITY OR PROFESSIONAL BODY, AND INCLUDES, BUT IS NOT LIMITED
16 TO, DISEASE EPIDEMIOLOGY, VACCINE CHARACTERISTICS, INJECTION
17 TECHNIQUE, EMERGENCY RESPONSE TO ADVERSE EVENTS AND RELATED
18 TOPICS.
19 (2) MAINTENANCE OF A CURRENT CARDIO-PULMONARY RESUSCITATION
20 (CPR) CERTIFICATE ACCEPTABLE TO THE BOARD.
21 (3) THAT THE ADMINISTRATION OF INJECTABLE MEDICATIONS,
22 BIOLOGICALS AND IMMUNIZATIONS BE IN ACCORDANCE WITH A DEFINITIVE
23 SET OF TREATMENT GUIDELINES ESTABLISHED BY A PHYSICIAN AND
24 APPROVED BY THE BOARD.
25 (4) THAT A MINIMUM OF TWO HOURS OF THE THIRTY-HOUR
26 REQUIREMENT FOR CONTINUING EDUCATION FOR LICENSE RENEWAL BE
27 DEDICATED TO THIS AREA OF PRACTICE.
28 (B) A PHARMACIST'S AUTHORITY TO ADMINISTER INJECTABLE
29 MEDICATIONS, BIOLOGICALS AND IMMUNIZATIONS SHALL NOT BE
30 DELEGATED TO ANY OTHER PERSON.
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1 SECTION 3. THIS ACT SHALL TAKE EFFECT IN 60 DAYS.
I2L63DMS/19990H1946B4165 - 67 -