PRINTER'S NO. 2031
No. 1717 Session of 1981
INTRODUCED BY SERAFINI, STEWART, McMONAGLE, MAIALE, ARTY, NAHILL
AND SWEET, JUNE 29, 1981
REFERRED TO COMMITTEE ON HEALTH AND WELFARE, JUNE 29, 1981
AN ACT
1 Amending the act of September 27, 1961 (P.L.1700, No.699),
2 entitled "An act relating to the regulation of the practice
3 of pharmacy, including the sales, use and distribution of
4 drugs and devices at retail; and amending, revising,
5 consolidating and repealing certain laws relating thereto,"
6 adding a legislative declaration and purpose; changing and
7 adding definitions; providing for the licensing and permit
8 requirements to practice pharmacy or conduct a pharmacy,
9 including fees, and for revocation and suspension of licenses
10 and permits; changing the composition and powers and duties
11 of the Pennsylvania State Board of Pharmacy; providing for
12 continuing education of pharmacists; further providing for
13 unlawful acts; and making editorial changes.
14 The General Assembly of the Commonwealth of Pennsylvania
15 hereby enacts as follows:
16 Section 1. The act of September 27, 1961 (P.L.1700, No.699),
17 known as the "Pharmacy Act," is amended by adding sections to
18 read:
19 Section 1.1. Legislative Declaration.--The practice of
20 pharmacy in the Commonwealth of Pennsylvania is declared a
21 professional practice affecting the public health, safety and
22 welfare and is subject to regulation and control in the public
23 interest. It is further declared to be a matter of public
1 interest and concern that the practice of pharmacy, as defined
2 in this act, merit and receive the confidence of the public and
3 that only qualified persons be permitted to engage in the
4 practice of pharmacy in the Commonwealth of Pennsylvania. This
5 act shall be liberally construed to carry out these objects and
6 purposes.
7 Section 1.2. Statement of Purpose.--It is the purpose of
8 this act to promote, preserve and protect the public health,
9 safety and welfare by and through the effective control and
10 regulation of the practice of pharmacy and of the issuing of
11 permits to pharmacies engaged in the sale and distribution of
12 drugs, medications, devices and such other materials as may be
13 used in the diagnosis and treatment of injury, illness and
14 disease.
15 Section 2. Section 2 of the act is amended to read:
16 Section 2. Definitions.--As used in this act:
17 (1) "Person" includes individual, partnership, corporation,
18 [and] association or any other legal entity.
19 (2) "Board" means the Pennsylvania State Board of Pharmacy.
20 (2.1) "Dispense" or "Dispensing" shall mean the preparation
21 and delivery of a prescription or non-prescription drug in a
22 suitable container appropriately labeled for subsequent
23 administration to or use by a patient or other individual
24 entitled to receive the drug.
25 (3) "Drugs" mean--
26 (i) Articles recognized as drugs in the official United
27 States Pharmacopoeia, official Homeopathic Pharmacopoeia of the
28 United States, or official National Formulary or its successor.
29 (ii) Articles intended for use in the diagnosis, cure,
30 mitigation, treatment or prevention of disease in man or other
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1 animals.
2 (iii) Articles (other than food) intended to affect the
3 structure or any function of the body of man or other animals;
4 and
5 (iv) Articles intended for use as a component of any
6 articles specified in subclauses (i), (ii) or (iii), but not
7 including devices or their component parts or accessories.
8 (4) "Official compendium" shall mean the current revisions
9 of the United States Pharmacopoeia [of the United States],
10 Homeopathic Pharmacopoeia of the United States and National
11 Formulary or their successors.
12 (5) [The term "device" means instruments, apparatus and
13 contrivances, including their components, parts and accessories,
14 intended (i) for use in the diagnosis, cure, mitigation,
15 treatment or prevention of disease in man or other animals, or
16 (ii) to affect the structure or any function of the body of man
17 or other animals.] "Device" means an instrument, apparatus,
18 implement, machine, contrivance, implant, in vitro reagent or
19 other similar or related article, including any component part
20 or accessory, which is required under Federal or State law to be
21 prescribed by a practitioner and dispensed by a pharmacist.
22 (6) The term "Federal act" means the Federal Food, Drug and
23 Cosmetic Act (Title 21, USC 301 et seq., 52 Stat. 1040 et seq.).
24 (7) ["Narcotic drug," "dangerous drug,"] "Controlled
25 substance," "non-proprietary drug"--any drug designated as such
26 under the provisions of [the Drug, Device, and Cosmetic Act of
27 Pennsylvania] the act of April 14, 1972 (P.L.233, No.64) known
28 as "The Controlled Substance, Drug, Device and Cosmetic Act."
29 (8) "Prescription" means a written or oral order [for drugs]
30 issued by a duly licensed medical practitioner in the course of
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1 his professional practice for a controlled substance, other drug
2 or device or medication which is dispensed for use by a
3 consumer, but shall not include an order for a controlled
4 substance, other drug or device or medication which is dispensed
5 for immediate administration to a bed patient in an institution.
6 (9) "Medical practitioner" means a physician, dentist,
7 veterinarian or other [person] individual duly authorized and
8 licensed by law to prescribe drugs.
9 (10) "Pharmacist" means [a person] an individual duly
10 licensed by the State Board of Pharmacy to engage in the
11 practice of pharmacy.
12 (11) "Practice of pharmacy" means the practice of that
13 profession concerned with the art and science of the
14 interpretation and evaluation of prescription orders, the
15 preparing, compounding, [and] dispensing and administering of
16 drugs and devices, whether dispensed on the prescription of a
17 medical practitioner or legally dispensed or [sold directly to
18 the ultimate consumer] provided to a patient, and shall include
19 the proper and safe storage and distribution of drugs, the
20 maintenance of proper records therefor, the participation in
21 drug selection and drug utilization reviews, and the
22 responsibility of relating information as required concerning
23 such drugs and medicines and their therapeutic values and uses
24 in the treatment and prevention of disease: Provided, however,
25 That "practice of pharmacy" shall not include the operations of
26 a manufacturer or wholesaler as defined in [the Drug, Device and
27 Cosmetic Act] the act of April 14, 1972 (P.L.233, No.64), known
28 as "The Controlled Substance, Drug, Device and Cosmetic Act."
29 (12) "Pharmacy" means every place properly [licensed] issued
30 a permit by the Board of Pharmacy where [the practice of
19810H1717B2031 - 4 -
1 pharmacy is conducted] drugs, radiopharmaceuticals and
2 diagnostic agents for human or animal consumption are stored,
3 dispensed or compounded. The term "pharmacy" shall not include
4 the operations of a manufacturer or wholesaler as defined in
5 "The Controlled Substance, Drug, Device and Cosmetic Act." In an
6 institution, "pharmacy" refers to the total organized pharmacy
7 service in the institution under the direct control of a
8 licensed pharmacist.
9 (12.1) "Nuclear Pharmacy" means a pharmacy providing
10 radiopharmaceutical services.
11 [(13) The words "drug" and "devices" shall not include
12 surgical or dental instruments or laboratory materials, gas and
13 oxygen, therapy equipment, X-ray apparatus or therapeutic
14 equipment, their component parts or accessories, or equipment,
15 instruments, apparatus or contrivances used to render such
16 articles effective in medical, surgical or dental treatment, or
17 for use or consumption in or for mechanical, industrial,
18 manufacturing or scientific applications or purposes, nor shall
19 the word "drug" include any article or mixture covered by the
20 Pesticide Act of 1957, nor medicated feed intended for and used
21 exclusively as a feed for animals other than man.]
22 Section 3. Section 3 of the act, repealed insofar as
23 inconsistent, July 1, 1978 (P.L.700, No.122) and amended
24 November 1, 1979 (P.L.454, No.91), is reenacted and amended to
25 read:
26 Section 3. Licensing of Pharmacists.--(a) The State Board
27 of Pharmacy may license as a pharmacist any person who has filed
28 an application therefor, subscribed by the person under oath or
29 affirmation, containing such information as the board may by
30 regulation require, and who--
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1 (1) Is not less than twenty-one years of age [and a citizen
2 of the United States];
3 (2) Has satisfied the board that he is of good moral and
4 professional character, [that he will properly carry out the
5 duties and responsibilities required of a pharmacist] that he
6 has not been convicted of a drug or alcohol related felony or
7 misdemeanor, and that he is not unfit or unable to practice
8 pharmacy by reason of the extent or manner of his use of
9 alcoholic beverages, [narcotic drugs or dangerous drugs] or
10 controlled substances or by reason of a physical or mental
11 disability;
12 (3) Holds a first professional degree in pharmacy granted by
13 a school or college of pharmacy which is accredited by the
14 American Council of Pharmaceutical Education or its successor;
15 (4) [Has completed the internship requirements as prescribed
16 by the board pursuant to this act;] Has completed an internship
17 or other program which has been approved by the Board of
18 Pharmacy, or demonstrated to the board's satisfaction experience
19 in the practice of pharmacy which meets or exceeds the minimum
20 internship requirements of the board.
21 (5) Has satisfactorily passed such examinations given by the
22 board.
23 (b) The State Board of Pharmacy shall, at least once in
24 every six months, examine in the practice of pharmacy all
25 pharmacy interns, who have completed their educational
26 requirements, who shall make applications for said examination
27 pursuant to regulations promulgated by the board. [The said
28 examination shall consist of two parts: the first part being a
29 theoretical examination, the second part consisting of a
30 practical examination which shall be given to all pharmacy
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1 interns who have satisfactorily completed their internship
2 requirements.] The board shall determine the content and subject
3 matter of each examination, the place, time and date of
4 administration of the examination, and those persons who shall
5 have successfully passed the examination. In case of failure at
6 a first examination, the applicant shall have within two years
7 the privilege of a second and third examination. In case of
8 failure in a third examination, the applicant shall have the
9 privilege of examination only after satisfactorily completing
10 additional preparation as directed and approved by the board.
11 (c) To insure proficiency in the practical aspects of
12 pharmacy, the board shall, by regulation, prescribe internship
13 requirements which must be satisfactorily completed prior to
14 issuance of a pharmacist license. The board shall specify the
15 period of time [of not less than six months nor more than one
16 year and when] and in what manner the internship shall be
17 served, and shall include an internship program in conformity
18 with standards as approved by the board by regulation.
19 (d) The board may, by regulation, accept in lieu of the
20 experience as a registered pharmacy intern as herein required
21 other equivalent experience obtained prior to January 1, [1962]
22 1980.
23 (e) Any person enrolled as a student of pharmacy in an
24 accredited college shall, [before] upon the commencement of his
25 or her third from last year of college, file with the State
26 Board of Pharmacy an application for registration as a pharmacy
27 intern in which said application he shall be required to furnish
28 such information as the board may, by regulation, prescribe and,
29 simultaneously with the filing of said application, shall pay to
30 the board a fee [of ten dollars ($10)] established by the board
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1 through regulation. All certificates issued to pharmacy interns
2 shall be valid for a period not exceeding six years from the
3 date of issue exclusive of time spent in the military service.
4 (f) To assure adequate practical instruction, pharmacy
5 internship experience as required under this act shall be
6 obtained [by employment in any licensed pharmacy] under the
7 direct supervision of a pharmacist meeting the requirements
8 [promulgated by regulation of the board] established by the
9 board through regulation, and shall include such instruction in
10 the practice of pharmacy as the board by regulation shall
11 prescribe.
12 [(g) All pharmacy apprentice certificates shall, within one
13 year from the effective date of this act, be returned to the
14 board and, upon receipt thereof, the board shall issue therefor
15 a pharmacy intern certificate.]
16 (h) The board may, without examination, license as a
17 pharmacist any person who, at the time of filing application
18 therefor, is and, for at least one year next preceding, has been
19 licensed as a pharmacist in any other state, territory or
20 possession of the United States or have met the internship
21 requirements of this Commonwealth within the one year period
22 immediately previous to the date of such application: Provided,
23 That the said person shall produce evidence satisfactory to the
24 board of having had the required secondary and professional
25 education and training and is possessed of good character and
26 morals as required of applicants for registration under the
27 provisions of this act: Provided, That persons of good character
28 and morals who have become registered as pharmacists by
29 examination in other states prior to the time this act takes
30 effect shall be required to satisfy only the requirements which
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1 existed in this Commonwealth at the time they became licensed in
2 such other states: Further provided, That the state in which
3 said person is licensed shall under similar conditions grant
4 reciprocal registration as pharmacist without examination to
5 pharmacists duly licensed by examination in this Commonwealth.
6 Every application under this subsection shall be accompanied by
7 a fee [of fifty dollars ($50)] established by the board through
8 regulation for the application and expense of investigation by
9 the Pennsylvania Board of Pharmacy. A fee [of twenty-five
10 dollars ($25)] established by the board through regulation shall
11 be paid for the registration and certificate prior to its
12 approval and issuance by the board.
13 (i) Each pharmacy intern applying for examination shall pay
14 to the State Board of Pharmacy an examination fee [of fifteen
15 dollars ($15)] established by the board through regulation. Upon
16 passing the required examinations and complying with all the
17 rules and regulations of the board and the provisions of this
18 act, the board shall grant the applicant registration as a
19 pharmacist and issue to him a certificate qualifying him to
20 enter into the practice of pharmacy. Said certificate shall not
21 be issued until a fee [of twenty dollars ($20)] established by
22 the board through regulation shall be paid to the board.
23 (j) The board shall provide for, regulate and require all
24 [persons registered] individuals licensed as pharmacists or
25 assistant pharmacists to renew their registration biennially,
26 and shall prescribe the form of such registration and
27 information required to be submitted by all applicants including
28 proof of continuing education as required by the board through
29 regulation. Unless the board shall have given ten days' previous
30 notice to the applicant for renewal of registration of
19810H1717B2031 - 9 -
1 objections to the renewal of his license based upon a final
2 conviction of or plea of guilty or nolo contendere of any charge
3 based upon the laws of the United States or of this Commonwealth
4 relating to the practice of pharmacy, [narcotics or dangerous
5 drugs] controlled substances, the license of a licensee shall be
6 renewed when the applicant shall file with the board his
7 application accompanied by a biennial registration fee [of five
8 dollars ($5)] established by the board through regulation.
9 (k) An additional fee [not to exceed twenty-five dollars
10 ($25)] established by the board through regulation shall be paid
11 for late registration of a pharmacist.
12 (l) Assistant pharmacist--(1) Any [person] individual duly
13 registered as an assistant pharmacist prior to the date of this
14 act may continue to act as such.
15 (2) From the date of this act, no [person] individual who is
16 not already licensed as an assistant pharmacist shall be so
17 licensed.
18 Section 4. The act is amended by adding a section to read:
19 Section 3.1. Continuing Pharmacy Education.--(a) The
20 General Assembly makes the following findings and declarations:
21 (1) Because of the continuous introduction of new
22 therapeutic and diagnostic agents and the changing concepts in
23 the delivery of health-care services in the practice of
24 pharmacy, it is essential that a pharmacist undertake a
25 continuing education program in order to maintain his
26 professional competency and improve his professional skills; and
27 (2) To assure the continued competency of the pharmacist and
28 to maintain uniform qualifications for registration and
29 licensure in the profession for the protection of the health and
30 welfare of the citizens, the General Assembly of this
19810H1717B2031 - 10 -
1 Commonwealth deems it in the public interest to adopt a
2 continuing professional education program.
3 (b) Commencing with appropriate regulations of the board, no
4 annual renewal license shall be issued to a pharmacist until
5 such pharmacist shall have submitted proof to the board that he
6 has satisfactorily completed an accredited program of continuing
7 professional education during the previous two years to help
8 assure his continued competence to engage in the practice of
9 pharmacy. The board shall from time to time determine the amount
10 of continuing education to be required.
11 (c) The board shall adopt rules and regulations necessary to
12 carry out the stated objectives and purposes and to enforce the
13 provisions of this section, which shall include the methods of
14 determining accredited programs, any fees and such other rules
15 and regulations consistent with this section as the board shall
16 determine.
17 Section 5. Section 4 of the act, repealed in part insofar as
18 inconsistent, July 1, 1978 (P.L.700, No.124), is reenacted and
19 amended to read:
20 Section 4. [Licensing of Pharmacies] Permit to Conduct a
21 Pharmacy.--(a) The State Board of Pharmacy shall [license]
22 issue a permit to any person to conduct a pharmacy who has filed
23 an application therefor, subscribed by the applicant under oath
24 or affirmation, and containing such information as the board may
25 require, and whose proposed pharmacy complies with all
26 requirements of this act, including the following:
27 (1) Possesses a copy of the latest revision of the United
28 States Pharmacopoeia [of the United States], the latest edition
29 of the National Formulary, or its successor and, if homeopathic
30 remedies are compounded or dispensed, a copy of the latest
19810H1717B2031 - 11 -
1 revision of the Homeopathic Pharmacopoeia of the United States,
2 the current supplements to them, and such other pharmaceutical
3 equipment, reference books, professional and technical equipment
4 as the board may by regulation establish;
5 (2) Has sufficient physical facilities, including equipment,
6 size, space and sanitation for adequately distributing and
7 dispensing drugs and devices consonant with the protection of
8 the public health, safety and welfare as the board may by
9 regulation establish;
10 (3) Contains a suitable book, [or] file, or equivalent
11 information retrieval system, in which shall be preserved, for a
12 period of not less than [five] two years, every prescription
13 compounded or dispensed therein;
14 (4) Has insured that a pharmacist duly [registered] licensed
15 in Pennsylvania shall be in charge of said pharmacy at all times
16 that the pharmacy is open and shall have total responsibility
17 for professional policies and activities in the pharmacy;
18 (5) Complies with the regulations of the board setting up
19 minimum requirements regarding adequate facilities for safe
20 storage of drugs, and protection from theft of or improper
21 access to [dangerous drugs and narcotics] controlled substances,
22 equipment for compounding and dispensing of prescriptions, and
23 size, space and sanitation requirements of pharmacies;
24 (6) If an individual or partnership is the applicant, that
25 the individual or copartner if not a pharmacist, has not
26 previously been found or pleaded guilty or nolo contendere to
27 any crime concerning the practice of pharmacy or involving moral
28 turpitude; or if a pharmacist, that he is presently licensed by
29 the board; if an association that no director or officer or if a
30 corporation that no director, officer or person having a
19810H1717B2031 - 12 -
1 beneficial interest [in] of more than ten per [centum] cent of
2 the stock has been found or pleaded guilty or nolo contendere to
3 said crimes or had a pharmacy or pharmacist's license revoked or
4 renewal refused, for cause.
5 (b) All applicants shall be of good moral and professional
6 character: in determining this qualification, the board may take
7 into consideration among other things the conduct and operation
8 of other pharmacies conducted by said applicant.
9 (c) Every pharmacy shall, at all times when open, be under
10 the constant direct and personal supervision and management of a
11 pharmacist duly [registered] licensed in Pennsylvania who shall
12 have personal supervision of not more than one pharmacy at the
13 same time.
14 (d) All licenses and permits issued under the provisions of
15 this act shall be displayed in a conspicuous place in the
16 pharmacy for which it was issued.
17 (e) Separate applications and permits shall be required for
18 each [establishment] pharmacy, and each permit shall be issued
19 bearing the name of the pharmacist who will be in charge of
20 [the] that pharmacy and who will be responsible for all
21 operations involving the practice of pharmacy in that pharmacy.
22 (f) All [registrations prior to approval] applications for a
23 permit to conduct a pharmacy shall be accompanied by an initial
24 [registration fee of fifty dollars ($50)] fee established by the
25 board through regulation. The board shall renew each permit for
26 the succeeding biennium unless the board shall have given ten
27 days' previous notice to the applicant for renewal of
28 [registration] the permit, of objections to the renewal [of
29 registration] based upon a finding or plea of guilty or nolo
30 contendere by the [registrant] applicant, its partners, officers
19810H1717B2031 - 13 -
1 or directors of any of the laws of the United States or of this
2 Commonwealth relating to the practice of pharmacy[, narcotics or
3 dangerous drugs] or controlled substances, upon payment of a fee
4 [of ten dollars ($10)] established by the board through
5 regulation, for each pharmacy. [and such] Such application for
6 renewal shall be made on or before September 1 of each odd-
7 numbered year.
8 (g) All [licenses] permits granted under this section,
9 unless sooner revoked or suspended, shall expire on the date set
10 forth therein: Provided, however, That the board may promulgate
11 regulations authorizing the application by a personal
12 representative of a deceased [licensee] grantee for an extension
13 of deceased [licensee's permit] grantee's permit for a period
14 not to exceed one year from date of death.
15 (h) No person shall operate or advertise a pharmacy until
16 the person has been granted a pharmacy permit by the board.
17 (i) The full name or names of the proprietor, or if a
18 partnership, the partners, or if an association or a
19 corporation, the name of the pharmacist manager, must be
20 conspicuously displayed [so as to be visible from the exterior
21 of] in the pharmacy along with any corporate association or duly
22 registered fictitious name.
23 (j) The board may promulgate regulations in accordance with
24 the above requirements and, in addition, shall have the power to
25 promulgate rules and regulations governing standards of practice
26 and operation of community pharmacies, institutional pharmacies
27 and nuclear pharmacies including, but not limited to, rules and
28 regulations governing the method of advertising, promotion and
29 standards for [filling and refilling] dispensing prescriptions,
30 such regulations to be designed to insure methods of operation
19810H1717B2031 - 14 -
1 and conduct which protect the public health, safety and welfare
2 and prevent practices or operations which may tend to lower
3 professional standards of conduct, so as to endanger the public
4 health and welfare.
5 Section 6. Section 5 of the act, clause (8) of subsection
6 (a) repealed insofar as inconsistent, November 24, 1976
7 (P.L.1163, No.259), is reenacted and amended to read:
8 Section 5. Revocation and Suspension.--(a) The board shall
9 have the power to revoke or suspend the license of any
10 pharmacist upon proof satisfactory to it that the pharmacist:
11 (1) [His] Procured his or her personal license [was
12 procured] through fraud, misrepresentation or deceit;
13 (2) [He has] Has been found guilty, pleaded guilty or
14 entered a plea of nolo contendere to any offense in connection
15 with the practice of pharmacy or involving moral turpitude
16 before any court of record of any jurisdiction;
17 (3) [He is] Is unfit to practice pharmacy because of
18 [habitual] intemperance in the use of alcoholic beverages,
19 [narcotics, dangerous drugs] controlled substances or any other
20 substance which impairs the intellect and judgment to such an
21 extent as to impair the performance of professional duties;
22 (4) [He is] Is unfit or unable to practice pharmacy by
23 reason of a physical or mental disease or disability;
24 (5) [His] Has had a license to practice pharmacy issued by
25 any other properly constituted licensing authority of any other
26 state [has been] suspended or revoked;
27 (6) [He has] Has violated or knowingly permitted the
28 violation of any provision of this act or regulation of the
29 board;
30 (7) [He has engaged in the practice of pharmacy with an
19810H1717B2031 - 15 -
1 unlicensed person or has] Has knowingly allowed any unlicensed
2 person to take charge of a pharmacy or engage in the
3 compounding, distribution or dispensing of prescriptions,
4 [dangerous drugs or narcotics, except a pharmacy intern in the
5 presence of and under the immediate] or controlled substances,
6 except pharmacy interns or such other authorized personnel
7 consistent with proper pharmaceutical practices who may assist
8 the pharmacist in the pharmacy under the direct and immediate
9 personal supervision of a licensed pharmacist;
10 (8) [He has] Has compounded, dispensed, sold or caused the
11 compounding, dispensing or sale of any drug or device which
12 contains more or less than the proportionate quantity of
13 ingredient or ingredients specified by the person who prescribed
14 such drug or device or which is of a brand or trade name other
15 than that specified by the person prescribing such brand or
16 trade name product or which contains an ingredient or
17 ingredients of a brand or trade name other than that specified
18 by the person prescribing such drug or device, unless the
19 consent of the prescriber is first obtained to each such
20 specific prescription: Provided, however, That nothing herein
21 shall be construed to prevent the addition of such inert
22 ingredients as may be required in the art of compounding,
23 preparing, mixing or otherwise producing drug or devices: This
24 clause shall not apply to proper substituting of generically
25 equivalent drugs as stipulated under the act of November 24,
26 1976 (P.L.1163, No.259), referred to as the Generic Equivalent
27 Drug Law, and that reductions in quantities dispensed are in
28 accordance with limits imposed by virtue of the consumer's
29 membership in a third party plan;
30 (9) [He is] Is guilty of grossly unprofessional conduct. The
19810H1717B2031 - 16 -
1 following acts on the part of a pharmacist are hereby declared
2 to constitute grossly unprofessional conduct of a pharmacist:
3 (i) Willfully deceiving or attempting to deceive the State
4 Board of Pharmacy or its agents with respect to any material
5 matter under investigation by the board;
6 (ii) [The advertising to the public of prices for
7 prescriptions, dangerous or non-proprietary drugs, or any
8 reference to the price of said drugs or prescriptions either
9 specifically or as a percentile of prevailing prices]
10 Advertising of prices for drugs and pharmaceutical services to
11 the public which does not conform to Federal and State laws or
12 regulations;
13 (iii) The public assertion or implication of professional
14 superiority in the [compounding of prescriptions] practice of
15 pharmacy;
16 (iv) The engaging by any means in untrue, false, misleading
17 or deceptive advertising of drugs or devices;
18 (v) Paying rebates to physicians or any other persons, or
19 the entering into any agreement with a medical practitioner or
20 any other person for the payment or acceptance of compensation
21 in any form for the recommending of the professional services of
22 either party;
23 (vi) The entering into of any agreement with a licensed
24 medical practitioner for the compounding or dispensing of secret
25 formula (coded), prescriptions or any authorization to a
26 pharmacist or pharmacy not accruing equally to other pharmacists
27 or pharmacies;
28 (vii) The misbranding or adulteration of any drug or device
29 and the sale, distribution or dispensing of any misbranded or
30 adulterated drug or device as defined in [the Drug, Device and
19810H1717B2031 - 17 -
1 Cosmetic Act] the act of April 14, 1972 (P.L.233, No.64), known
2 as "The Controlled Substance, Drug, Device and Cosmetic Act";
3 (viii) Engaging in the sale or purchase of drugs or devices
4 whose package bears the inscription "sample" or "not for
5 resale;"
6 (ix) Displaying or permitting the display of his [license]
7 certificate of licensure and biennial registration document in a
8 pharmacy of which he is not the proprietor or in which he is not
9 employed;
10 (x) Any holder of a [license or certificate to fail to
11 display same while actually engaged in the practice of pharmacy]
12 biennial pocket registration card who fails to have same
13 available for inspection by an authorized agency or authority
14 when he is practicing;
15 (xi) The acceptance back and redistribution of any unused
16 drug, or a part thereof, after it has left the premises of any
17 pharmacy, whether issued by mistake or otherwise, unless in the
18 original sealed unit dose or manufacturer's sealed container;
19 (xii) To accept employment as a pharmacist, or share or
20 receive compensation in any form arising out of, or incidental
21 to, his professional activities from any medical practitioner or
22 any other person or corporation in which one or more medical
23 practitioners have a proprietary or beneficial interest
24 sufficient to permit them to exercise supervision or control
25 over the pharmacist in his professional responsibilities and
26 duties;
27 (xiii) To accept employment as a pharmacist, or share or
28 receive compensation in any form arising out of, or incidental
29 to, his professional activities from any person who orders said
30 pharmacist, directly or indirectly, to engage in any aspect of
19810H1717B2031 - 18 -
1 the practice of pharmacy in contravention of any provision of
2 this act.
3 (b) The board shall have the power to revoke or suspend the
4 permit of any pharmacy upon proof satisfactory to it that:
5 (1) The [license] permit was procured through fraud,
6 misrepresentation or deceit;
7 (2) The holder or partner, officer or director thereof has
8 violated any of the provisions of this act or regulations of the
9 board applicable to him or any provision of [the Drug, Device
10 and Cosmetic Act] "The Controlled Substance, Drug, Device and
11 Cosmetic Act" or the Federal act, or has ordered a pharmacist in
12 his employ to engage in any aspect of the practice of pharmacy
13 in contravention of any provisions of the aforesaid acts or
14 regulations thereunder;
15 (3) The holder or partner, officer or director thereof sold,
16 dispensed or caused or allowed to be sold or dispensed any
17 [narcotic drug, dangerous drug] controlled substance or non-
18 proprietary drug, except by a licensed pharmacist;
19 (4) The holder or partner, officer or director thereof,
20 after issuance of a permit, fails to continue to comply with all
21 requirements of section 4 hereof;
22 (4.1) The holder, partner, officer or director thereof
23 discourages the pharmacist from providing the patient with
24 pharmaceutical services;
25 (5) Upon the suspension or revocation of a license of a
26 pharmacist employed by said person, it is shown that the illegal
27 acts of the pharmacist were within the knowledge or should have
28 been within the knowledge of the permit holder or partner,
29 officer or director.
30 Section 7. Section 6 of the act, clause (7) of subsection
19810H1717B2031 - 19 -
1 (h) repealed insofar as inconsistent, October 15, 1980 (P.L.950,
2 No.164), is reenacted and amended to read:
3 Section 6. Board of Pharmacy.--(a) The State Board of
4 Pharmacy, hereinafter designated as the "board," established by
5 section 415, act of April 9, 1929 (P.L.177, No.175), known as
6 "The Administrative Code of 1929," is continued.
7 (b) The board shall consist of the [Superintendent of Public
8 Instruction] Commissioner of Professional and Occupational
9 Affairs, ex officio, two consumer members, and five members who
10 shall be [citizens] residents of Pennsylvania and registered as
11 pharmacists [in Pennsylvania] for a period of at least ten years
12 previous to their appointment[, and must at the time of
13 appointment be engaged in the practice of pharmacy] with the
14 immediate five years experience prior to appointment having been
15 gained as a licensed pharmacist in Pennsylvania.
16 (c) The Governor shall, upon the expiration of the term of
17 office of any member, appoint a person with the above-specified
18 qualifications for a term of six years, or until a successor is
19 appointed and qualified. Vacancies shall be filled in like
20 manner. [A list of at least six persons with the above specified
21 qualifications may be submitted to the Governor by the executive
22 committee of the Pennsylvania Pharmaceutical Association.]
23 Nominations for appointment to the board may be made to the
24 Governor by any interested individual, association or any other
25 entity provided that such nomination shall be supported by a
26 nominating petition executed by at least one hundred individuals
27 who shall be qualified to vote in the State elections of this
28 State. Such nominations shall be recommendations only and shall
29 not be binding in any manner upon the Governor.
30 (d) No person may serve more than two full terms as a member
19810H1717B2031 - 20 -
1 of said board. An interim term or the appointment to fill an
2 unexpired term shall not be considered as part of a full term.
3 (d.1) The terms of the members of the board shall be
4 staggered, so that the term of no more than one member shall
5 expire in any year.
6 (e) [Three] Five members of the board shall constitute a
7 quorum for the transaction of all business, except as otherwise
8 specified in this act.
9 (f) The board shall meet prior to December 30 of each year
10 for the purpose of organizing for the following year. At such
11 organization meeting, the board shall elect a chairman and a
12 vice-chairman for the ensuing calendar year. The board shall
13 meet at least once every thirty days at the board offices and/or
14 at such other times and places as the chairman deems necessary.
15 The members of the board shall be paid by the Department of
16 [Public Instruction thirty dollars ($30) per diem] State a per
17 diem in an amount to be determined biennially by the
18 commissioner consistent with fees paid such boards in addition
19 to expenses incurred when actually engaged in official meeting
20 or [otherwise] in the performance of their official duties as
21 directed by the chairman.
22 (g) The board shall elect an administrative secretary who
23 shall not be a member of the board but who shall be a pharmacist
24 duly licensed in Pennsylvania. Upon the approval of the
25 Governor, said administrative secretary shall be installed and
26 shall serve [during] at the pleasure of the board. Said
27 administrative secretary shall [receive compensation of nine
28 thousand five hundred dollars ($9500) per year from the
29 Department of Public Instruction. The secretary shall be a full-
30 time employe of the Department of Public Instruction, and shall:
19810H1717B2031 - 21 -
1 (1) Be responsible for the administration of all
2 professional and public affairs as directed by the board;
3 (2) Report to and proceed with the instructions of the
4 board;
5 (3) Carry out all policies and instructions emanating from
6 said board;
7 (4) Make, keep and be in charge of all records and record
8 books required to be kept by the board, including a register of
9 all registrants who are required to be registered;
10 (5) Attend to the correspondence of the board and perform
11 all other duties as the board may require;
12 (6) Receive and receipt for all fees collected under
13 provisions of this act.] be a full-time employe of the board and
14 shall receive compensation commensurate with the duties and
15 responsibilities of the position. Specifications outlining the
16 duties and responsibilities of the administrative secretary
17 shall be prepared by the board, based on the needs of the board.
18 (h) The board shall have the power, and it shall be its
19 duty:
20 (1) To regulate the practice of pharmacy;
21 (2) To prepare, grade and administer or to determine the
22 nature of and supervise the grading and administration of
23 examinations for all applicants for pharmacists' licenses;
24 (3) To examine, inspect and investigate all applications and
25 all applicants for [registration] licensure as pharmacists,
26 pharmacies or registration as pharmacy interns and to grant
27 certificates of licensure or registration to all applicants whom
28 it shall judge to be properly qualified;
29 (4) To [employ inspectors, chemists and other agents to
30 assist it for any purpose which it may deem necessary] prepare
19810H1717B2031 - 22 -
1 position description and employ inspectors, who shall be
2 licensed pharmacists and appropriate consultants to assist it
3 for any purposes which it may deem necessary;
4 (5) To investigate or cause to be investigated any and all
5 violations of the provisions of this act and its regulations and
6 to cause prosecutions to be instituted in the courts upon advice
7 from the Attorney General;
8 (6) To make or order inspections of all pharmacies and other
9 places in which drugs or devices are stored, held, compounded,
10 dispensed or sold to [the ultimate] a consumer, to take and
11 analyze any drugs or devices and to seize and condemn any drugs
12 or devices which are adulterated, misbranded or stored, held,
13 dispensed, distributed or compounded in violation of the
14 provisions of this act or the provisions of [the Drug, Device
15 and Cosmetic Act] the act of April 14, 1972 (P.L.233, No.64),
16 known as "The Controlled Substance, Drug, Device and Cosmetic
17 Act";
18 (7) To conduct hearings for the revocation or suspension of
19 licenses, permits or registrations, with the approval of the
20 [Attorney General] Office of General Counsel, for which hearings
21 the board shall have the power to subpoena witnesses;
22 (8) To assist the regularly constituted enforcement agencies
23 of this Commonwealth in enforcing all laws pertaining to drugs,
24 [narcotics] controlled substances, and practice of pharmacy;
25 (9) To promulgate rules and regulations to effectuate the
26 purposes of this act and to regulate the distribution of drugs
27 and devices and the practice of pharmacy for the protection and
28 promotion of the public health, safety and welfare.
29 (h.1) All fees paid to the board and all fines collected for
30 violations of the provisions of this act, shall be paid into the
19810H1717B2031 - 23 -
1 State Treasury for the exclusive use of the board to aid in the
2 enforcement of the act and in the payment of other costs
3 incurred in the administration of this act.
4 (i) The powers and duties of the board, as enumerated in
5 subsection (h) of this section, shall not be applicable to
6 manufacturers and wholesalers as defined in [the Drug, Device
7 and Cosmetic Act] "The Controlled Substance, Drug, Device and
8 Cosmetic Act" or to their operations as such.
9 Section 8. Section 8 of the act is amended to read:
10 Section 8. Unlawful Acts.--It shall be unlawful for:
11 (1) Any person to procure or attempt to procure a license,
12 permit or certificate for himself or for any other person by
13 making or causing to be made any false representations.
14 (2) Any person not duly licensed as a pharmacist, pursuant
15 to section 3 hereof, to engage in the practice of pharmacy,
16 including the preparing, compounding, dispensing, selling or
17 distributing at retail to any person any drug, except by a
18 pharmacy intern or such other authorized personnel under the
19 direct and immediate personal supervision of a pharmacist:
20 Provided, however, That nothing herein shall be construed to
21 prevent a duly licensed medical practitioner from dispensing,
22 compounding or otherwise giving any drug to his own patients
23 after diagnosis or treatment of said patient, if such
24 compounding, preparing and dispensing is done by said licensee
25 himself, nor shall anything herein prevent any person from
26 selling or distributing at retail household remedies or
27 proprietary medicines when the same are offered for sale or sold
28 in the original packages which have been put up ready for sale
29 to consumers, provided household remedies or proprietary
30 medicines shall not include any [narcotic drug, dangerous drug]
19810H1717B2031 - 24 -
1 controlled substances or non-proprietary drug under [the Drug,
2 Device and Cosmetic Act] the act of April 14, 1972 (P.L.233,
3 No.64), known as "The Controlled Substance, Drug, Device and
4 Cosmetic Act."
5 (3) Any unlicensed person to operate or conduct, or to have
6 charge of or to supervise any pharmacy, for a violation of this
7 section, the owner of said pharmacy shall be equally liable as
8 principal.
9 (4) Any person representing himself to be licensed under
10 this act when in fact he is not.
11 (5) Any person to knowingly prevent or refuse to permit any
12 member of the board, or its duly authorized agents, to enter a
13 pharmacy or any other place where drugs or devices are kept,
14 stored, dispensed or distributed to [the ultimate] a consumer,
15 for the purpose of lawful inspection or other purposes in
16 accordance with the provisions of this act and regulations
17 pursuant thereto.
18 (6) Any person whose license, permit or certificate has been
19 revoked, suspended or refused renewal to fail to deliver the
20 license permit or certificate to the board upon demand.
21 (7) Any person to sell at auction drugs or devices in bulk
22 or in open or unopened packages, unless such sale has been
23 approved in advance by the board and unless such sale shall be
24 under the personal supervision of a licensed pharmacist
25 appointed by the board and whose fee shall be paid by the seller
26 thereof.
27 (8) Any person, firm or corporation to use the title
28 "pharmacist", "assistant pharmacist", "druggist", "apothecary",
29 except a person duly licensed as a pharmacist in Pennsylvania,
30 or any person to conduct or transact business under a name which
19810H1717B2031 - 25 -
1 contains as part thereof the words "drug store", "pharmacy",
2 "drugs", "medicine store", "medicines", "drug shop",
3 "apothecary", or any term having a similar meaning, or in any
4 manner by advertisement, display of show globes or otherwise
5 describe or refer to the place of the conducted business or
6 person, unless the place is a pharmacy duly [licensed] issued a
7 permit by the State Board of Pharmacy.
8 (9) Any person who buys, sells or causes to be sold or
9 offers for sale any drug or device which bears or which package
10 bears, or originally did bear, the inscription "sample" or "not
11 for resale" or "for investigational or experimental use only" or
12 other similar words, except where a cost is incurred in the bona
13 fide acquisition of the investigational or experimental drug.
14 (10) Any person using to his own advantage or revealing to
15 anyone other than the board, its duly authorized
16 representatives, or to the courts, when relevant to any judicial
17 proceeding under this act, any information acquired under
18 authority of this act or concerning any method or process which
19 is a trade secret.
20 (11) Any pharmacist or owner of a pharmacy advertising or
21 promoting [dangerous drugs, narcotics or drugs containing either
22 by name or prices therefor to the general public] prices for
23 drug and pharmaceutical services to the public which do not
24 conform to Federal and State laws or regulations.
25 (12) Any person who knowingly and willfully forges or
26 counterfeits upon any goods, wares or merchandise the private
27 stamps or labels of any mechanic or manufacturer, with intent to
28 defraud the purchasers or manufacturers of any goods, wares or
29 merchandise, or keeps in possession or conceals any goods, wares
30 or merchandise bearing forged or counterfeited private stamps or
19810H1717B2031 - 26 -
1 labels of any mechanic or manufacturer, with intent to defraud
2 the purchasers or manufacturers of any goods, wares or
3 merchandise, or keeps in control, custody or possession any
4 punch plate, stone or other thing in the likeness of any punch
5 plate or stone designated for the printing or imprinting of the
6 private stamps or labels of any mechanic or manufacturer, or who
7 vends any goods, wares or merchandise having thereon any forged
8 or counterfeited stamps or labels purporting to be the stamps
9 or labels of any mechanic or manufacturer, knowing the same to
10 be forged or counterfeited, without disclosing the fact to the
11 purchaser.
12 (13) Any person by himself or through another to procure or
13 attempt to procure for himself or another any drug:
14 (i) by fraud, deceit, misrepresentation or subterfuge;
15 (ii) by the forgery or alteration of a prescription or any
16 written order;
17 (iii) by the concealment of a material fact;
18 (iv) by use of a false statement in any prescription, order
19 or report.
20 (14) Any person to advertise the filling or refilling of
21 prescriptions for any consumer or patient in Pennsylvania if
22 said person is not licensed under this act or the said
23 prescription is not filled or refilled in a pharmacy licensed by
24 the board.
25 (14.1) Any medical practitioner to have a proprietary or
26 beneficial interest sufficient to permit him to exercise
27 supervision or control over the pharmacist in his professional
28 responsibilities and duties.
29 (14.2) Any person to employ a pharmacist and order him to
30 engage in any conduct in contravention of any provision of this
19810H1717B2031 - 27 -
1 act.
2 (15) Any person who violates any of the provisions of this
3 section 8 is guilty of a misdemeanor, and upon conviction
4 thereof, shall be sentenced to undergo imprisonment for not more
5 than one year or pay a fine of not more than five thousand
6 dollars ($5000), or both, and for each subsequent offense, shall
7 be sentenced to undergo imprisonment of not more than three
8 years or to pay a fine of not more than fifteen thousand dollars
9 ($15,000), or both.
10 Section 9. (a) Section 216, act of July 1, 1978 (P.L.700,
11 No.124), known as the "Bureau of Professional and Occupational
12 Affairs Fee Act," is repealed.
13 (b) All other acts or parts of acts, which are inconsistent
14 with this act are hereby repealed.
15 Section 10. This act shall take effect in 60 days.
F15L35JJR/19810H1717B2031 - 28 -