RULES AND REGULATIONS
Title 49--PROFESSIONAL AND VOCATIONAL STANDARDS
STATE BOARD OF PHARMACY
[49 PA. CODE CH. 27]
General Revisions
[28 Pa.B. 4532] The State Board of Pharmacy (Board) amends Chapter 27 (relating to State Board of Pharmacy) to read as set forth in Annex A. The amendments delete dated and redundant language and clarify standards of practice and licensure requirements.
A. Effective Date
The amendments will be effective upon publication in the Pennsylvania Bulletin.
B. Statutory Authority
The amendments are authorized under sections 3(f), 4(j) and 6(k)(1) and (9) of the Pharmacy Act (act) (63 P. S. §§ 390-3(f), 390-4(j) and 390-6(k)(1) and (9)).
C. Background and Purpose
The amendments are designed to maintain health and safety standards in the delivery of pharmacy services to Pennsylvanians consistent with current business and professional practices.
The amendments generally revise, clarify and update various provisions of the Board's regulations. Outdated language has been deleted, as has redundant language. Amendments define a ''pharmacy technician'' and enlarge the scope of technician utilization. They define a ''satellite pharmacy'' and clarify when institutions will be required to obtain separate permits for pharmacies in the system. Amendments further clarify and update provisions pertaining to sanitary standards, construction and equipment requirements and standards of practice. Provisions related to pharmacy internships and licensure by reciprocity are also clarified.
D. Summary of Comments on Proposed Rulemaking and Board Responses
Notice of proposed rulemaking was published at 26 Pa.B. 1032 (March 9, 1996). The Board received comments from 25 public commentators, including the Pennsylvania Society of Health-System Pharmacists, the Hospital and Healthsystem Association of Pennsylvania, individual community, chain and hospital pharmacies and pharmacists, health system pharmacists, educators and Legislators. The House Professional Licensure Committee (House Committee) and the Independent Regulatory Review Commission (IRRC) also provided comments and recommendations which the Board has considered in final rulemaking.
Pharmacy Technicians
The vast majority of commentators expressed concern that the proposed amendments would unduly restrict the utilization of pharmacy technicians in the delivery of cost-effective pharmaceutical services. Specifically, commentators objected to the requirement in proposed rulemaking that a pharmacist supervise no more than two pharmacy technicians at any time. (§ 27.12(d)(5)). Commentators suggested that certain dispensing functions involving automation and remote order entries could be safely performed with ratios higher than two-to-one, while other functions could require one-to-one supervision. The commentators recommended that a pharmacist be permitted the latitude to exercise professional judgment in determining the number of technicians the pharmacist may effectively supervise. They further contended that the use of more technicians to perform routine functions such as counting pills, stocking pharmacy shelves, preparing prescription labels and certain recordkeeping, will free pharmacists for other important activities requiring professional judgment. These activities include verifying the accuracy and appropriateness of a prescription or drug order prior to its being dispensed and providing patient counseling services. Concurring with these comments, IRRC recommended that the ratio in § 27.12(d)(5) be deleted in final rulemaking.
The Board notes that the purpose of the proposed ratio was a recognition that public health and safety issues are implicated when unlicensed persons such as technicians are performing pharmacy services. Indeed, most jurisdictions limit the number of pharmacy technicians a pharmacist may supervise at any given time. However, in view of the objections raised, and in light of the fact that the ratio represents only one factor in determining appropriate supervision of pharmacy technicians, the Board in final rulemaking has deleted § 27.12(d)(5). The Board is satisfied that other provisions in the regulation which outline the parameters of technician practice, list prohibited duties, set out supervisory responsibilities of pharmacists and require written protocols in various pharmacy settings provide adequate notice to pharmacists of their supervisory responsibilities over technicians and ultimate responsibility for all pharmacy services rendered.
Several commentators objected to the requirement that a pharmacist review a prescription or drug order prior to its preparation and again prior to its being dispensed. The commentators suggested that the review by a pharmacist of a prescription or drug order only prior to its being dispensed to verify the accuracy of the preparation would provide more efficient management of the pharmacist's time. Likewise, the commentators perceived the proposed rulemaking to require a pharmacist to be ''hovering'' over a technician to direct the technicians every move. This, the commentators suggested, was an inefficient and costly proposition. IRRC, on the other hand, suggested that the act requires the Board to adopt a more stringent standard than that proposed.
The Board has reviewed sections 5(a)(7) and 8(2) of the act (63 P. S. §§ 390-5(a)(7) and 390-8(2)), which provide that ''other authorized personnel . . . may assist the pharmacist in the pharmacy under the direct and immediate personal supervision of a licensed pharmacist . . .'' The Board does not agree that the act requires constant pharmacist supervision of all technician activities. Rather, the Board agrees with the public commentators that an ''on-premises'' supervision standard is not only consistent with consumer safety and efficient practice, but also tracks the language of the statute. The Board also agrees that a review of a prescription or drug order prior to its being dispensed to verify the final product is cost-effective and sufficient to satisfy consumer safety concerns. Accordingly, in final rulemaking, § 27.12(b)(1)--(3) has been amended to accomplish this goal.
Two commentators as well as IRRC acknowledged that written protocols are appropriate to define the duties of a pharmacy technician because the technician is an unlicensed person assisting in the practice of pharmacy, but sought more specific guidance as to what the contents of a written protocol should include. The Board notes that § 27.12 outlines the duties which a pharmacy technician may perform and identifies the responsibilities of the supervising pharmacist. The Board suggests that the written protocol identify the specific tasks which the pharmacy technician will be permitted to perform in the particular pharmacy practice, the supervision which the pharmacist will provide, the training the technician must have and the tasks which the technician may not perform. The Board likens the written protocol to a training or operations manual currently utilized in pharmacy practice. The Board declines to further expand upon the relatively detailed provisions already contained in § 27.12 in an effort to avoid unnecessary regulation inconsistent with Executive Order 1996-1.
A commentator representing hospital pharmacists expressed concern that proposed § 27.12(d)(3)(ii), prohibiting pharmacy technicians from assisting in the preparation of Schedule II controlled substances, would result in significant additional costs to institutions where technicians perform such tasks as delivering controlled drugs to nursing unit stock, stocking automated dispensing machines and performing some inventory functions. The Board has reviewed this provision, and has determined that the prohibition is unnecessary to safe pharmacy practice. The written protocols required in § 27.12(d)(4), together with the supervising pharmacist's acceptance of responsibility for prescriptions and drug orders which are dispensed, are sufficient to provide safe and efficient pharmaceutical care. Accordingly, in final rulemaking, the Board has deleted § 27.12(d)(3)(ii).
With regard to public comments, IRRC suggested that uniform certification of pharmacy technicians by the National Pharmacy Technician Certification Board could satisfy many concerns. Although the Board believes that the registration of pharmacy technicians may aid in tracking and reviewing technician utilization, State recognition of both certification and registration would require authorization from the General Assembly.
Errata
IRRC pointed out that § 27.18(d)(7)(v) as published requires a drug dispensed in unit dose to be labeled to indicate the patient's name, drug name, drug strength, dosing instructions and lot number. IRRC agreed with several commentators that this labeling requirement is simply not practical because unit doses are prepackaged single dosages often no larger than 1 square inch. The Board has noted that a drafting error changed the language which should have read ''a drug NOT in unit dose shall be labeled to indicate the patient name, drug name, drug strength, dosing instructions and lot number.'' The Board has made the correction and added further clarifying language in this section in final rulemaking.
Pharmacy Internships
IRRC suggested that the Board's qualifications for pharmacy internship registration exactly track the statutory provisions in section 3(e) of the act. The Board has, in final rulemaking, amended § 27.26(b) and (b)(2) as recommended.
The House Committee questioned why the Board proposed to allow a pharmacist desirous of becoming a preceptor to seek a waiver of the prohibition against his having once been convicted of ''an offense with respect to observance of Federal, State and municipal statutes and ordinances relating to the practice of pharmacy.'' (§ 27.26(h)(1)). The waiver provision was intended to allow the Board some flexibility in registering as a preceptor a pharmacist whose only infraction had been a minor recordkeeping, facility or building code violation, or the like. Upon reflection, however, the Board has determined that a waiver procedure could prove unwieldy and generate potential equal protection concerns absent specific standards. Likewise, the Board finds that the requirements for registration as a pharmacist preceptor need further clarification.
In final rulemaking, § 27.26(h) has been amended to clarify that a pharmacist seeking to serve as a preceptor: (1) may not have been convicted of a criminal offense relating to the practice of pharmacy; (2) currently holds a license without restriction to practice pharmacy in this Commonwealth; and (3) is working full-time in a pharmacy approved for intern training. In this way, the public health and safety will continue to be protected through the exclusion from service as preceptors those pharmacists convicted of criminal activity involving the practice of pharmacy, while preserving the Board's ability to register as preceptors pharmacists who have been the subject of minor civil or administrative infractions.
Satellite Pharmacies
Commentators expressed confusion over the provisions in proposed rulemaking in §§ 27.1 and 27.11(i) related to satellite pharmacies. The Board has clarified these provisions to codify in regulatory form its longstanding policy that nonsatellite pharmacies must be separately permitted.
Sections 2(12) and 4(e) of the act (63 P. S. §§ 390-2(12) and 390-4(e)) require that any place where drugs are stored, compounded or dispensed must hold a pharmacy permit, have a designated pharmacist in charge and meet the drug safety and security requirements of the Board.
The Board intends by its definition of a ''satellite pharmacy'' in § 27.1 (relating to definitions) to refer to places in large multidisciplinary hospitals where drugs are routinely stored from the inventory of the central institutional pharmacy for the convenience of various medical departments of the hospital. Satellite pharmacies are not required to be separately permitted. § 27.11(i) (relating to pharmacy permit and pharmacist manager). Satellites are not, however, pharmacies established by hospitals to sell pharmaceuticals to the public in the nature of retail sales. Furthermore, satellites are not institutional pharmacy activities occurring in multiple geographic locations within a health care system. These two categories of pharmacy activity require separate permits.
The purpose of the rule is twofold. First, it notifies hospitals and other institutions that if they intend to function as retail pharmacies, they must be regulated as such. In other words, they must have facilities physically separate from the institutional pharmacy and must separately meet the drug safety and security requirements and practice standards of the Board. Second, it notifies health systems that satellites are permissible only on the premises of a hospital which has a permitted institutional pharmacy. Separate permits are required for separate hospitals because the pharmacy activities which take place there require separate security, separate drug safety measures and separate clinical supervision.
With respect to the first category, Federal law at 15 U.S.C.A. § 13 prohibits institutions from unfairly competing with retail pharmacies by reselling to consumers pharmaceuticals purchased for institutional use. Institutional uses include drugs for inpatients, emergency patients, outpatients (when the drug is to be used on the premises), discharged patients (when the drug is for personal use and the prescription cannot be refilled), hospital employes, students or staff physicians and their dependents. Sales to former patients through renewal or refill of prescriptions, to staff physicians for dispensing in the course of their clinical private practices, or to walk-in customers do not constitute institutional uses. See, Abbott Labs v. Portland Retail Druggist, 425 U. S. 1 (1976).
The second category is grounded in the Board's primary responsibility to protect the health and safety of the public. The Board has determined that a pharmacist manager located in one facility of a health system with several institutions where acute care is provided, cannot adequately maintain supervision over drug dispensing, inventory and other pharmacy services throughout the entire system. Accordingly, remote institutional pharmacy activities, even if operated by the same entity which operates an institution's central pharmacy, must be separately permitted.
To the extent that further refinements can be made to the satellite pharmacy provisions following their adoption without compromising public health and safety, the Board pledges to work cooperatively with the Department of Health and other interested parties to develop overall standards and policies for health system-wide pharmaceutical care delivery. The amendments are not meant to inhibit innovation in the delivery of pharmaceutical care. The Board intends the amendments to establish outside parameters for public health and safety. It will continue to make judgment calls in conjunction with the Department of Health on the basis of individual institutional needs. For example, by these amendments, the Board does not intend to require a pharmacy in a long term care facility where the population is residential, where patient conditions are stable and where routine maintenance drug therapy is involved. On the other hand, where two or more acute care institutions are located miles apart and where patient conditions may change dramatically and intensive drug monitoring is necessary, a single shared pharmacy would not likely protect the public health.
Pharmacies in Retail Establishments
IRRC and the House Committee also suggested that the provisions related to a self-contained pharmacy be reorganized in the amendments. The Board has considered this comment and reviewed the entire section concerning self-contained pharmacies, and determined that the phrase ''self-contained'' does not accurately identify the provisions in question. Accordingly, the Board has revised entirely § 27.16(b)(2) (relating to construction and equipment requirements) to accurately reflect the Board's intent that pharmacies located within retail establishments whose business hours differ from the pharmacies' hours are required to maintain certain standards of security.
Miscellaneous
In accordance with the suggestions of IRRC and the House Committee, the Board has amended § 27.11(g) to specify a 30-day time limit within which changes in name or ownership or controlling interest of a pharmacy must be reported to the Board and an application for new permit filed.
The House Committee questioned why the Board has deleted the requirement in § 27.14(c)(3) (relating to supplies) that a pharmacy refrigerator be used exclusively for the storage of drugs. The deletion relates to sanitary considerations which would not prohibit, for example, a sealed beverage or food container from being stored in the pharmacy refrigerator.
In addition to adopting a number of recommendations made by IRRC and the House Committee to clarify provisions of the regulations, the Board has also attempted, in final rulemaking, to remove redundancies and clarify, where possible, language unnecessary to the understanding of the regulations consistent with Executive Order 1996-1 and within the scope of proposed rulemaking. For the same reason, the Board has declined to unduly burden the regulation in § 27.25(a) (relating to licensure by reciprocity) by reiterating the requirements of section 3(g) of the act.
E. Compliance with Executive Order 1996-1
In accordance with the requirements of Executive Order 1996-1 (February 6, 1996), the Board has sought in final rulemaking to achieve clear and, where possible, nontechnical language. The Board has also refined the regulations to achieve cost effective methods of addressing compelling public health and safety concerns in the delivery of pharmaceutical services in this Commonwealth. Likewise, it has reviewed and incorporated many of the comments received on proposed rulemaking from various individuals and organizations representing the regulated community.
F. Fiscal Impact and Paperwork Requirements
The amendments will have a positive fiscal impact on Commonwealth institutions and institutions operated by political subdivisions. Pharmacies which utilize pharmacy technicians will be required to prepare written protocols if they have not already done so. The expanded ability of pharmacies to utilize technicians will reduce overall costs. The cost for a new permit when changes in controlling interests of a pharmacy occur will increase only by the cost of the permit. Pharmacies should achieve overall savings in monetary cost and paperwork through the implementation of practice standards which recognize technological advances in drug distribution and electronic data collection and maintenance.
G. Sunset Date
The Board continuously monitors its regulations. Therefore, no sunset date has been assigned.
H. Regulatory Review
Under section 5.1(a) of the Regulatory Review Act (71 P. S. § 745.5a(a)), on April 6, 1998, the Board submitted within the required 2-year period from the conclusion of the public comment period, the text of these final-form regulations together with the Board's responses to comments received on proposed rulemaking, a copy of the notice of proposed rulemaking, published at 26 Pa.B. 1032 and other required documentation, to IRRC and the Chairpersons of the House Professional Licensure Committee and the Senate Consumer Protection and Professional Licensure Committee for review and comment. In compliance with section 5(c) of the Regulatory Review Act, the Board also provided IRRC and the Committees with copies of all comments received, as well as other documentation. Under section 5.1(b) of the Regulatory Review Act, the Board copied all commentators with the final-form regulations and this explanation of changes to proposed rulemaking on the same date.
In preparing these final-form regulations the Board has considered comments received from IRRC, the Committees and the public.
The final-form regulations were reviewed by the House Committee on April 22, 1998, and tabled with a recommendation for revision concerning pharmacist preceptor registration requirements. The Board requested disapproval from IRRC to allow it to make revisions consistent with the House Committee's recommendation. On May 7, 1998, IRRC disapproved the final-form regulations under section 5.1(e) of the Regulatory Review Act. The disapproval order was received by the Board on May 8, 1998. In addition to the reason for which the Board sought disapproval, the order also cited concerns about satellite pharmacy provisions raised by representatives of health systems on May 7, 1998.
On May 14, 1998, the Board submitted written notice to the Governor, the House and Senate Committees and IRRC, under section 7(a) of the Regulatory Review Act (71 P. S. § 745.7(a)), of its intention to resubmit the regulation with modifications in accordance with section 7(c) of the Regulatory Review Act. Modifications were made to § 27.26(h) relating to requirements for registration as a pharmacy preceptor as outlined in Paragraph D of this Preamble.
On June 15, 1998, the Board delivered the modified final-form regulations, together with the section 7(c) report, to the Governor, the House and Senate Committees and IRRC. On July 9, 1998, IRRC disapproved the report, barring publication of the final-form regulations, on the grounds that the definition of a ''satellite pharmacy'' ''violates [IRRC's] criteria of clarity, and raises serious questions of need, cost-effectiveness and economic impact.'' The disapproval order was delivered to the House and Senate Committees on July 16, 1998.
The Board's final-form regulations were subsequently deemed approved by the House and Senate Committees on July 30, 1998, clearing the way to final promulgation under section 7(d) of the Regulatory Review Act.
I. Public Information
Interested persons may obtain information regarding the amendments by writing to State Board of Pharmacy, 116 Pine Street, P. O. Box 2649, Harrisburg, PA 17105-2649.
J. Findings
The Board finds that:
(1) Public notice of proposed rulemaking was given under sections 201 and 202 of the act of July 31, 1968 (P. L. 769, No. 240) (45 P. S. §§ 1201 and 1202) and the regulations promulgated thereunder at 1 Pa. Code §§ 7.1 and 7.2.
(2) A public comment period was provided as required by law and all comments were considered.
(3) These amendments do not enlarge the purpose of proposed rulemaking published at 26 Pa.B. 1032.
(4) These amendments are necessary and appropriate for administration and enforcement of the authorizing act identified in Part B of this Preamble.
K. Order
The Board, acting under its authorizing statute, orders that:
(a) The regulations of the Board, 49 Pa. Code Chapter 27, are amended by amending §§ 27.1, 27.11, 27.12, 27.14--27.16, 27.18, 27.25 and 27.26, to read as set forth in Annex A, with ellipses referring to the existing text of the regulations.
(b) The Board shall submit this order and Annex A to the Office of General Counsel and to the Office of Attorney General as required by law.
(c) The Board shall certify this order and Annex A and deposit them with the Legislative Reference Bureau as required by law.
(d) This order shall take effect on publication in the Pennsylvania Bulletin.
PAULA L. CASTOR, R.Ph.,
Chairperson(Editor's Note: For the text of the order of the Independent Regulatory Review Commission relating to this document, see 28 Pa.B. 3558 (July 25, 1998).)
Fiscal Note: Fiscal Note 16A-542 remains valid for the final adoption of the subject regulations.
Annex A
TITLE 49. PROFESSIONAL AND
VOCATIONAL STANDARDS
PART I. DEPARTMENT OF STATE
Subpart A. PROFESSIONAL AND
OCCUPATIONAL AFFAIRS
CHAPTER 27. STATE BOARD OF PHARMACY
GENERAL REVISIONS § 27.1. Definitions.
The following words and terms, when used in this chapter, have the following meanings, unless the context clearly indicates otherwise:
ACPE--The American Council of Pharmaceutical Education.
Act--The Pharmacy Act (63 P. S. §§ 390-1--390-13).
Board--The State Board of Pharmacy.
CEU--Continuing Education Units--The unit of measuring contact hours of continuing education provided by ACPE accredited providers. Ten contact hours are equivalent to 1.0 CEU.
Commissioner--The Commissioner of Professional and Occupational Affairs in the Department.
Contact hours--Continuing education units of measure equivalent to 50 to 60 minutes of participation in an approved organized learning experience, including home study with approved educational materials.
Continuing education--Professional education obtained to maintain, improve or expand current skills or knowledge, or to develop new skills or knowledge.
DEA--The Federal Drug Enforcement Administration.
Department--The Department of State of the Commonwealth.
Drug order--An oral or written order issued by a medical practitioner which is either written on or entered by computer into the medical record of a patient in an institution for the dispensing of a drug or device for administration to the patient. The term does not include an order for a drug for a patient in an institution which the patient will self-administer which will be considered a prescription.
Institutions--Extended care facilities, nursing homes, nursing care facilities, convalescent homes, resident care facilities, hospitals or another place which offers medical treatment to patients who require food, board and overnight sleeping facilities and care.
Long-term care facility--A nursing home, retirement care, mental care or other institution that provides extended health care to resident patients.
Medical practitioner--A physician, dentist, veterinarian or other individual authorized and licensed by law to prescribe drugs.
Nonproprietary drug--A drug containing any quantity of a controlled substance or a drug which is required by an applicable Federal or state law to be dispensed only by prescription.
Pharmacist manager--The pharmacist named in the permit to operate a pharmacy who is in charge of a pharmacy and responsible for operations involving the practice of pharmacy under section 4 of the act (63 P. S. § 390-4).
Pharmacy--The place licensed by the Board where the practice of pharmacy is conducted.
Pharmacy intern--A person registered by the Board as a pharmacy intern under section 3(e) of the act (63 P. S. § 390-3(e)) and § 27.26 (relating to pharmacy internship).
Pharmacy technician--An unlicensed person working in a pharmacy to assist a pharmacist in the practice of pharmacy in accordance with § 27.12 (relating to practice of pharmacy and delegation of duties). The term does not include a pharmacy intern or clerical or housekeeping personnel.
Practice of pharmacy--The practice of that profession concerned with the art and science of preparing, compounding and dispensing drugs and devices, whether dispensed on the prescription of a medical practitioner or legally dispensed or sold directly to the ultimate consumer. The term includes the proper and safe storage and distribution of drugs, the maintenance of proper records therefor and the responsibility of relating information as required concerning the drugs and medicines and their therapeutic values and uses in the treatment and prevention of disease.
Prescription--A written or oral order issued by a licensed medical practitioner in the course of professional practice for a controlled substance, other drug or device or medication which is dispensed for use by a consumer.
Prescription area--That area of the pharmacy used for compounding, legend drug storage and other activities necessary to the practice of pharmacy. The term does not include waiting counters or display space attached to the waiting counters.
Proprietary drug--A nonprescription, nonnarcotic medicine or drug which may be sold without a prescription and which is prepackaged for use by the consumer and labeled in accordance with the requirements of Federal and State statutes and regulations.
Satellite pharmacy--A pharmacy in an institution which provides specialized services for the patients of the institution and which is dependent upon the centrally located pharmacy for administrative control, staffing and drug procurement. The term does not include a pharmacy serving the public on the premises of the institution nor does it include a pharmacy located off premises from the centrally located pharmacy of the institution regardless of whether the pharmacy is owned by the same person or entity which owns the institution.
STANDARDS § 27.11. Pharmacy permit and pharmacist manager.
(a) A permit to conduct a pharmacy issued under section 4 of the act (63 P. S. § 390-4) shall show the name and address of the pharmacy, the name of the current owner and the name of the current pharmacist manager.
(b) A pharmacy may not display, advertise or use any name other than the name in which it is registered.
(c) A pharmacy may not be open without a licensed pharmacist on duty at all times.
(d) A change in name or ownership or controlling interest of the pharmacy shall require a new permit. Applications for new permits shall be filed within 30 days of the change in name, ownership or controlling interest.
(e) A person or entity holding a certificate, license, permit or registration as a licensed pharmacist or pharmacy may not post or display in public view a current certificate, license, permit, registration or renewal of a person not lawfully employed by the licensee.
(f) A pharmacy which closes or otherwise ceases operation shall immediately return to the Board its current permit and shall immediately inform the Board of the disposition of the prescription files and nonproprietary drugs. After 30 days, neither prescription files nor nonproprietary drugs may be sold, transferred or disposed of without prior permission from the Board. When a pharmacy closes or ceases operation, signs, symbols or other indications of a pharmacy shall immediately be removed from both the interior and exterior of the premises.
(g) If the pharmacist manager ceases to hold that position, the pharmacy permit holder shall inform the Board in writing of this fact and of the new pharmacist manager not more than 15 days later. If the Board does not object within 30 days of notification, the new pharmacist manager may be deemed approved. If the permit holder is unable to replace the pharmacist manager within those 15 days, the permit holder may request in writing an extension of up to 30 additional days to obtain a replacement. A pharmacy may not operate without a pharmacist manager for more than 15 days unless the pharmacy first obtains from the Board an extension of time for obtaining a replacement.
(h) A pharmacist may not serve as the pharmacist manager of more than one pharmacy at any given time. The holder of a permit to operate a pharmacy which has lost the services of a pharmacist manager and cannot obtain a suitable replacement may apply in writing to the Board for a temporary waiver of this subsection. The Board may grant a waiver which would authorize a pharmacist manager to serve as pharmacist manager of more than one pharmacy for up to 60 days after the initial 15 days permitted under subsection (g).
(i) Each pharmacy in this Commonwealth will require a separate permit regardless of ownership unless the pharmacy is a satellite pharmacy as defined in § 27.1 (relating to definitions).
§ 27.12. Practice of pharmacy and delegation of duties.
(a) General. It is unlawful for a person not licensed as a pharmacist by the Board to engage or allow another person to engage in the practice of pharmacy as defined in § 27.1 (relating to definitions) and section 2 of the act (63 P. S. § 390-2) except in accordance with this section.
(b) Delegation. A pharmacist may delegate aspects of the practice of pharmacy to a pharmacy intern or pharmacy technician, as defined in § 27.1, subject to the following conditions:
(1) The pharmacist shall review every prescription or drug order prior to its being dispensed to determine the name of the drug, strength, dosage, quantity, permissible refills and other information required under § 27.18(b) (relating to standards of practice) to verify the accuracy of the preparation.
(2) The pharmacist shall provide direct, immediate and personal supervision to pharmacy interns and pharmacy technicians working with the pharmacist. Direct, immediate and personal supervision means that the supervising pharmacist has reviewed the prescription or drug order prior to its being dispensed, has verified the final product and is immediately available on the premises to direct the work of interns and technicians and respond to questions or problems.
(3) The pharmacist shall ensure that the label of the container in which a nonproprietary drug is dispensed or sold pursuant to a prescription complies with the labeling requirements of § 27.18(d).
(c) Pharmacy interns.
(1) A pharmacy intern may work only under the direct, immediate, personal supervision of a pharmacist in accordance with subsection (b)(2).
(2) A pharmacy intern may neither accept nor transcribe an oral order or telephone prescription.
(3) A pharmacy intern may neither enter nor be in a pharmacy if a pharmacist is not on duty.
(4) A pharmacy intern working under the direct, immediate, personal supervision of a pharmacist may perform procedures which require professional skill and training. Examples of these procedures include: verifying ingredients, weighing ingredients, compounding ingredients and other similar processing of ingredients.
(d) Pharmacy technicians.
(1) A pharmacy technician may work only under the direct, immediate, personal supervision of a pharmacist in accordance with subsection (b)(2).
(2) The following are examples of the types of activities which a pharmacy technician may perform:
(i) Carry containers of drugs in and around the pharmacy.
(ii) Count pills, tablets and capsules and put them in a container.
(iii) Type or print, or both, labels.
(iv) Maintain records which are related to the practice of pharmacy.
(v) Assist the pharmacist in preparing and reconstituting parenteral products and other medications. After the parenteral product or other medication has been prepared, the supervising pharmacist shall initial the label of the product or medication to document his final inspection and to accept total responsibility for its preparation.
(vi) Enter prescription, drug order or patient information in a patient profile.
(3) A pharmacy technician may not:
(i) Accept or transcribe an oral order or telephone prescription.
(ii) Enter or be in a pharmacy if a pharmacist is not on duty.
(iii) Perform any act within the practice of pharmacy that involves discretion or independent professional judgment.
(iv) Perform a duty until the technician has been trained and the duty has been specified in a written protocol.
(4) The pharmacist manager shall create and maintain a written protocol for each pharmacy technician employed in the pharmacy. The protocol shall specify each duty which the pharmacy technician may perform. The pharmacist manager and the pharmacy technician shall date and sign the protocol and each amendment to the protocol. The pharmacist manager shall make the protocol available to agents of the Board upon demand.
§ 27.14. Supplies.
(a) A pharmacy shall maintain a supply of drugs and devices adequate to meet the needs of the health professions and the patients it is intended to serve. The applicant for a pharmacy permit shall show proof by affidavit that the applicant has ordered or possesses and shall continue to maintain an inventory of nonproprietary drugs, devices and equipment appropriate to the practice of that pharmacy. The inventory shall include at least $5,000 worth of nonproprietary drugs and devices, at cost, from a licensed wholesaler or manufacturer. The inventory may not go below this figure at any time.
(b) Drugs which must be removed from active stock shall be removed in accordance with the following provisions:
(1) The pharmacist manager is responsible for removing from the active stock of the pharmacy and disposing of the following:
(i) A drug whose expiration date has passed.
(ii) A drug which does not meet legal standards of strength and purity.
(iii) A drug which varies from the strength and purity indicated on the label of the commercial container.
(iv) A drug which has been improperly stored.
(v) A drug which has deteriorated.
(vi) A drug which is unfit, misbranded or adulterated under Federal or State statutes.
(2) Drugs which have been removed from active stock in accordance with this subsection may not be sold or given away. The drugs shall be returned to the wholesaler or manufacturer for disposal or disposed of by the pharmacy according to Federal or State statutes or regulations.
(3) A pharmacy desiring to or required to dispose of a controlled substance shall contact the nearest DEA office for authority and instructions to dispose of the substance.
(4) The pharmacist manager shall be responsible for keeping proper records of controlled substances which have been disposed of. These records shall include the name of the substance, the number of units or the volume of the substance or the number of commercial containers and the date and manner of disposal.
(c) A pharmacy shall maintain at least the following equipment and supplies:
(1) A Class A prescription balance or other scale with a no-load sensitivity of 6 milligrams or less.
(2) Both an apothecary set of weights from 1/2 grain to 1 ounce and a set of metric weights from 10 milligrams to 50 grams.
(3) A mechanical refrigerator having the appropriate temperature control for the storage of the drugs, vaccines, biologicals or medicaments which require specific temperatures for their stability. The refrigerator shall be kept within the prescription area.
(4) At least four graduates assorted to measure 1 ml to 500 ml.
(5) At least two mortars and pestals, glass or wedgewood.
(6) At least three spatulas of assorted sizes, metallic-rust resistant and rubber or nonmetalic composition.
(7) At least two funnels, one 120 ml and the other 480 ml.
(8) One glass or tile slab or specially treated paper for use in compounding ointments.
(9) A book to record sales and transfers of Schedule V controlled substances and poisons. This paragraph does not apply to an institutional pharmacy servicing only inpatients.
(10) An adequate supply of filter paper and powder papers and an adequate supply of empty capsules, prescription containers, prescription and poison and other applicable identification labels used in dispensing of prescription drugs and medication.
(11) Prescription files for keeping prescriptions of nonproprietary drugs in accordance with the act and, for controlled substance prescriptions, the regulations of the DEA at 21 CFR 1304.04(h) (relating to maintenance of records and inventories). The original prescription shall be retained for 2 years. A pharmacy may make use of a computerized recordkeeping system for keeping track of telephone prescriptions, refills, counseling, and the like, if the system has safeguards to prevent accidental erasure and the information can be transferred to hard copy within 72 hours.
(12) Current copies of the act and this chapter.
(13) Federal and Commonwealth statutes and regulations pertaining to the practice of pharmacy.
(14) An adequate reference library including two or more of the latest editions of the following, including current supplements:
(i) The United States Pharmacopeia, The National Formulary.
(ii) Physicians Desk Reference.
(iii) Drug Facts and Comparisons.
(iv) Remington's Pharmaceutical Sciences.
(v) The United States Dispensatory.
(vi) Physicians' Generix.
(vii) USPDI (United States Pharmacopeia Dispensing Information).
(viii) American Drug Index.
(ix) Goodman and Gilman's Pharmacological Basis of Therapeutics.
(x) AHFS Drug Information.
(xi) Radiological Health Handbook.
(xii) The Merck Index: An Encyclopedia of Chemicals, Drugs, and Biologicals.
(xiii) Martindale: The Extra Pharmacopeia.
§ 27.15. Sanitary standards.
(a) The pharmacy and equipment shall be maintained in a clean and orderly condition and in good repair.
(b) The pharmacy shall comply with the health and sanitation statutes of the Commonwealth and of the municipality and county in which the pharmacy is located.
(c) Waste material may not be permitted to collect upon the floor, counter or other area of the pharmacy. The pharmacy shall have a waste removal system adequate to maintain clean and sanitary conditions.
(d) The prescription area shall be dry and well ventilated, free from rodents, insects, dirt and foreign material, and well lighted.
(e) Plumbing shall be in good repair and working order.
(f) The prescription area shall contain only appliances, instruments, equipment, materials, drugs, medicines, chemicals and supplies necessary for the practice of pharmacy, as set forth in section 2(11) of the act (63 P. S. § 390-2(11)), and other equipment and supplies deemed reasonable for the operation and management of a pharmacy as established by the Board.
(g) Persons working in the prescription area shall be required to keep themselves and their apparel in a clean, sanitary and professional manner.
§ 27.16. Construction and equipment requirements.
(a) Approval of plans. The following requirements are applicable to approval of plans:
(1) New pharmacy or change-of-location. Plans for construction of a new pharmacy or new location for an existing pharmacy may be submitted to the Board for approval prior to proceeding with construction. Within 90 days of receiving the plans, the Board will notify the applicant of its approval of the planned pharmacy or of its disapproval and the reasons for disapproval. The plans, including dimensions, shall demonstrate compliance with applicable regulations and shall show the layout and fixtures for the prescription area and the immediately adjacent area.
(2) Alterations. The practice of pharmacy shall cease while substantial alterations in the layout or fixtures of an approved pharmacy are being made unless:
(i) The pharmacy makes the alterations and takes adequate precautions so that the health and safety of professionals, employes and the public is protected during the continuing operation of the pharmacy.
(ii) The plans for the alterations and a description of the precautions are submitted to the Board at least 30 days before the beginning of alteration work. If the Board raises no objection during that time, the pharmacy is authorized to proceed with the alterations as planned.
(b) Building standards. The following apply to building standards:
(1) Minimum size. The minimum size of the prescription area shall be at least 250 square feet, and shall be large enough, considering the level of activity, to carry on the practice of pharmacy in a manner that protects the health and safety of professionals, employes and the public. Within the prescription area, there shall be a prescription working counter of at least 10 linear feet in length and 2 linear feet in width. If more than two pharmacists are on duty simultaneously, the minimum counter length shall be increased by 5 linear feet for an additional pharmacist. Institutions with special considerations may apply to the Board for a waiver.
(2) Pharmacies in retail establishments. Pharmacies located within retail establishments whose business hours differ shall adhere to the following standards:
(i) The pharmacy can be securely sealed off from the remainder of the retail establishment.
(ii) The barrier devices which seal off the pharmacy shall be capable of providing security for the pharmacy. The barrier devices shall reach from floor to ceiling, shall be impenetrable by hand or the use of a reach extender, and shall be securely locked whenever a licensed pharmacist is not present and on duty.
(iii) The pharmacy shall be closed whenever a licensed pharmacist is not present and on duty.
(iv) Safes, electrical equipment or other facilities of the retail establishment may not be located in or approached through the pharmacy unless a pharmacist is on duty whenever staff from the retail establishment need access to these facilities.
(v) The hours of the pharmacy shall be posted at all points of public access.
(vi) Protocols for access to the pharmacy when it is closed by nonpharmacist staff for bona fide emergencies, such as fires, natural disasters or police matters, shall include notification to the pharmacist manager.
(3) Locked compartment. Space shall be provided in the prescription area for a substantially constructed cabinet or safe to contain controlled substances unless the pharmacy disperses controlled substances throughout the stock of noncontrolled substances in a manner that obstructs the theft of controlled substances. If the pharmacy stocks Schedule I controlled substances, these substances shall be stored in a securely locked, substantially constructed cabinet or safe.
(4) Telephone. At least one telephone shall be accessible in the prescription area, and the telephone number shall be the telephone number printed on the prescription label.
(5) Sanitary facilities. Pharmacies shall be equipped with a sink within the prescription area to be used solely for pharmaceutical purposes. The sink shall measure at least 200 square inches exclusive of drainboard area. The sink shall be connected properly to supply hot and cold water. Restroom facilities for employes of the pharmacy shall be provided reasonably close to, but outside of the prescription area.
(7) Lighting and ventilation. The pharmacy shall be well lighted and ventilated.
(7) No television set. A television set may not be placed within the prescription area or so situated in the pharmacy that its viewing screen may be seen when looking at it from within the prescription area.
(8) Physical arrangement. The prescription area shall be arranged so that prescription drugs and devices are inaccessible to an unlicensed or unauthorized person. The prescription area may not be used for storage of merchandise or other items other than those used in the preparation, dispensing or delivery of drugs. No animals may be allowed in a prescription area except for security reasons.
(9) Existing pharmacies. Existing pharmacies licensed by the Board prior to the effective date of this chapter may continue if they reasonably conform, or are made to reasonably conform, to the intent of this chapter. The Board will determine what constitutes reasonable conformity consonant with the public interest, health, safety and welfare.
§ 27.18. Standards of practice.
(a) A pharmacist shall dispense a new prescription in a new and clean container or in the manufacturer's original container. In refilling a prescription, the pharmacist may reuse the original container of that prescription if the container is clean and reuseable. The refill requires a new label containing the information specified in subsection (d). Pharmacies and pharmacists shall comply with the Poison Prevention Packaging Act of 1970 (15 U.S.C.A. §§ 1471--1476) which includes the use of child resistant containers.
(b) Prescriptions kept on file in the pharmacy shall meet the following requirements:
(1) Prescriptions on file shall show the name and address of the patient; the name and address or other identifier of the prescriber; the date the prescription was issued, if the prescription is for a controlled substance or if it was written with a PRN or ad lib refill designation; the name and quantity of the drug prescribed; directions for its use; cautions communicated to the ultimate consumer by means of auxiliary labels or other means when dispensed to the ultimate consumer; the date the prescription was compounded and dispensed; and the name or initials of the dispensing pharmacist.
(2) Prescriptions for controlled substances shall show the DEA number of the prescriber. Prescriptions for Schedule II controlled substances shall be written with ink, indelible pencil, typewriter, word processor or computer printer and shall be manually signed by the prescriber. The pharmacist is responsible for compounding and dispensing nonproprietary drugs consistent with the Federal Controlled Substances Act (21 U.S.C.A. §§ 801--904), The Controlled Substance, Drug, Device and Cosmetic Act (35 P. S. §§ 780-101--780-144) and the regulations promulgated under these acts.
(3) If a prescription for a nonproprietary drug is refilled, a record of the refill shall show the date of the refill, the name or initials of the dispensing pharmacist and the quantity dispensed. If the pharmacist dispenses a quantity different from that of the original prescription, the pharmacist shall indicate the changes on the back of the original prescription or shall enter the changes in the computerized files of the pharmacy.
(4) Original prescriptions shall be kept for 2 years.
(5) In an institution, Schedule II controlled substances which the pharmacy dispensed and which were ultimately received by the patient shall be recorded and the record kept for 2 years.
(c) A pharmacist may decline to fill or refill a prescription if the pharmacist knows or has reason to know that it is false, fraudulent or unlawful, or that it is tendered by a patient served by a public or private third-party payor who will not reimburse the pharmacist for that prescription. A pharmacist may not knowingly fill or refill a prescription for a controlled substance or nonproprietary drug or device if the pharmacist knows or has reason to know it is for use by a person other than the one for whom the prescription was written, or will be otherwise diverted, abused or misused. In addition, a pharmacist may decline to fill or refill a prescription if, in the pharmacist's professional judgment exercised in the interest of the safety of the patient, the pharmacist believes the prescription should not be filled or refilled. The pharmacist shall explain the decision to the patient. If necessary the pharmacist shall attempt to discuss the decision with the prescriber.
(d) The container in which a prescription drug or device is sold or dispensed to the ultimate consumer shall bear a label which shall be written in ink, typed or computer generated and shall contain the following information:
(1) The name, address, telephone number and DEA number of the pharmacy.
(2) The name of the patient.
(3) Full directions for the use of its contents.
(4) The name of the prescriber.
(5) The serial number of the prescription and the date originally filled.
(6) The trade or brand name of the drug, strength, dosage form and quantity dispensed. If a generic drug is dispensed, the manufacturer's name or suitable abbreviation of the manufacturer's name shall also be shown.
(7) On controlled substances, the statement: ''Caution: Federal law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed.''
* * * * * (j) Prescriptions for Schedule II controlled substances may not be refilled. No controlled substance in Schedule III, IV or V may be filled or refilled more than five times in the 6-month period from the date of the prescription. Other nonproprietary drugs which may be renewed for a longer period of time or for a greater number of refills shall be in specific numbers, such as, ''may be renewed ten times'' and shall be in the original handwriting of the prescriber. A nonproprietary drug which is refillable by statute may not be refilled on the basis of preprinted designations or ''ad lib,'' P.R.N., or similar instructions more than five times in the 6-month period from the date of the prescription.
* * * * * (r) The following provisions apply to the advertisement and sale of drugs:
* * * * * (7) The patient has the right to request a copy of an original prescription. The copy shall clearly indicate on its face that it is a copy and may not be used to obtain a new prescription or refill. Before a pharmacist provides a copy of a written prescription to a patient or an authorized agent of the patient, the person requesting the copy shall show the pharmacist acceptable authorization and identification, such as a driver's license. The pharmacist shall record in writing the date, to whom and by whom the copy was given.
* * * * * (v) A drug order in an institution is not required to conform to the labeling requirements of subsection (d) as long as the drug is dispensed in unit dose. A drug not in unit dose shall be labeled to indicate the patient name, drug name, drug strength, dosing instructions and lot number. The label of a parenteral, enteral or total parenteral nutrition product shall contain the name of the patient; the ingredients, including the name, strength, quantity of each, the diluent and expiration date; and the initials of the pharmacist.
PHARMACISTS § 27.25. Licensure by reciprocity.
(a) An applicant for licensure by reciprocity shall comply with section 3(g) of the act (63 P. S. § 390-3(g)).
(b) An applicant for licensure by reciprocity who received a license to practice pharmacy in any other state, territory or possession of the United States after January 26, 1983, shall be required to demonstrate that he passed the FDLE.
§ 27.26. Pharmacy internship.
(a) Pharmacy internship means the supervised practical experience required for licensure as a registered pharmacist. The purpose of the pharmacy internship program is to provide a registered intern with the knowledge and practical experience necessary for functioning competently under the act and this chapter.
(b) A certificate of registration as a pharmacy intern will be available to an individual of good moral character who has completed at least 2 years of pharmacy college or an accredited program leading to transfer into the third year of a pharmacy college in which the individual is enrolled or accepted. A person desiring to register as a pharmacy intern shall do the following:
(1) Apply to the Board for registration including the fee specified in § 27.91 (relating to schedule of fees) for registering as a pharmacy intern.
(2) Forward to the Board a letter or transcript certifying that the applicant has successfully completed 2 years of pharmacy college or an accredited program leading to transfer into the third year of a pharmacy college in which the applicant is enrolled or accepted.
(c) The Board will register an applicant after it receives a completed application and other items in subsection (b). A pharmacy intern certificate is valid for 6 years from the date of issue exclusive of time spent in the military.
(d) The following applies to internship credit:
(1) An intern shall serve at least 1,500 hours.
(2) A maximum of 50 hours may be credited in 1 week.
(3) An intern shall serve at least 750 of the 1,500 hours in a pharmacy.
(4) An intern may earn up to 750 of the 1,500 hours in an internship program sponsored or approved by the pharmacy college subject to the following conditions:
(i) The Board will determine the maximum number of hours available for each internship program sponsored or approved by a pharmacy college.
(ii) The Board will grant internship credit to an individual in an internship program sponsored or approved by a pharmacy college only if the following applies:
(A) The internship program is full-time.
(B) There is no concurrent academic courseload.
(C) The individual achieves a passing grade in the program.
(iii) A pharmacy college which desires to sponsor or approve an internship program shall request approval from the Board.
(iv) The Board will monitor internship programs which are sponsored or approved by a pharmacy college.
(5) The Board may grant internship credit for hours that an individual served in a pharmacy before the individual registered as an intern only if the individual shows good cause for failing to register in timely fashion.
(6) The Board will not grant internship credit for hours which an individual served in a pharmacy if the supervising pharmacist was not registered as a preceptor. An exception to the requirement that the supervising pharmacist register as a preceptor will be made for internship hours acquired in an internship program sponsored or approved by a pharmacy college.
(e) The Board will grant internship credit only for activities related to the practice of pharmacy. The following are examples of these activities: scrutinizing prescriptions or drug orders, compounding medications and filling prescriptions. The Board will not grant internship credit for activities which are not related to the practice of pharmacy. The following are examples of these activities: retail sales unrelated to pharmacy items, shelving or clerical functions unrelated to pharmacy.
(f) A person may not be eligible to become a candidate for registration to practice pharmacy unless the person receives instruction in practical pharmacy and pharmaceutical technique from an instructor, professor, or faculty member who is a registered pharmacist or from a faculty member who is a registered pharmacist at a pharmacy college.
(g) The following requirements are applicable to a pharmacy approved for intern training:
(1) A pharmacy may not have been or be in violation of Federal, State or municipal statutes and ordinances governing any phase of activity in which it is engaged. A pharmacy may appeal to the Board for a waiver of this provision.
(2) A pharmacy shall be managed so that the emphasis is on activities connected with the distribution of articles and services pertaining to medical care, including drugs, medicines, prescriptions, medical supplies and materials.
(3) A pharmacy shall be kept in a sanitary, orderly and clean condition, and the prescription department shall meet the requirements in the statutes and regulations as they affect prescription departments.
(4) A pharmacy shall compound and dispense a sufficient number of prescriptions including renewals so as to provide the pharmacy intern with ample opportunity to scrutinize prescriptions and to compound and dispense under the supervision of a licensed pharmacist.
(5) A pharmacy shall have in its employ a licensed pharmacist who is registered as a pharmacist preceptor.
(6) A pharmacy which meets the qualifications of this section shall be approved by the Board after proper notification by the owner or manager of willingness to cooperate in the development of the internship program. Whenever a new intern is accepted for training in the pharmacy, the pharmacist preceptor shall notify the Board of the name of the intern and his anticipated period of internship in the pharmacy.
(h) The requirements for registration as a pharmacist preceptor are as follows:
(1) A pharmacist preceptor may not have been convicted of a criminal offense relating to the practice of pharmacy.
(2) An applicant shall hold a license without restriction to practice pharmacy in this Commonwealth and shall be engaged in the active practice of pharmacy in this Commonwealth.
(3) The applicant shall be working on a full-time basis in a pharmacy approved for intern training.
[Pa.B. Doc. No. 98-1444. Filed for public inspection September 4, 1998, 9:00 a.m.]
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