[26 Pa.B. 1032]
[Continued from previous Web Page]
STANDARDS § 27.11. Pharmacy permit and pharmacist manager.
* * * * * (b) [No] A pharmacy may not display, advertise or use [another] any name [except] other than the name in which it is registered.
(c) [A change in name or ownership shall require a new application.] A pharmacy may not operate without a licensed pharmacist on duty at all times.
(d) [No person holding a certificate, license, permit or registration as a licensed pharmacy or pharmacist may post or display in public view a current certificate, license, permit or registration or a renewal pertaining thereto of a person not lawfully employed by the licensee.] A change in name or ownership or controlling interest of the pharmacy shall require a new application.
(e) [Applications for a new permit or for a change in location shall be accompanied by at least five photographs, 8 inches by 10 inches, one showing the exterior, one from the inside entrance facing the rear, one from the rear of the pharmacy facing the front and two photos of the prescription area showing its contents, including equipment, sink and refrigerator.] 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 [caution legend] nonproprietary drugs. After 30 days, [no] neither prescription files [or caution legend] nor nonproprietary drugs may be sold, transferred or disposed of without prior permission from the Board. [Signs] When a pharmacy closes or ceases operation, signs, symbols or other indications of a pharmacy [being present] shall immediately [upon closing] be removed from both the interior and exterior of the premises [both inside and outside].
(g) [In the case of a pharmacy permit issued to a person who is not a registered pharmacist, the person shall notify the Board if the pharmacist manager whose name appears on the permit ceases to be the pharmacist manager for that pharmacy, within 15 days from date thereof, together with the name of the new pharmacist manager. If the Board raises no objections within 30 days of notification, the new pharmacist manager may be deemed to be approved. A pharmacy may not operate without a pharmacist manager.] If the pharmacist manager ceases to be the pharmacist manager, the holder of the permit to operate the pharmacy shall inform the Board in writing of this fact and of the new pharmacist manager not more than 15 days after the former pharmacist manager ceased being pharmacist manager. If the Board does not object within 30 days of notification, the new pharmacist manager may be deemed approved. If the holder of the permit 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 new pharmacist manager. 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 new pharmacist manager.
(h) A pharmacist may not be 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 the 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) A satellite pharmacy will require a separate permit under any of the following conditions:
(1) The satellite had a permit to operate as a pharmacy in another institution before that institution was incorporated into the present institution.
(2) The routine activity of the satellite is dispensing drugs to outpatients.
§ 27.12. Practice of pharmacy and delegation of duties.
(a) [It shall be unlawful for a person not licensed as a pharmacist, under the act, to engage or allow another to engage in the practice of pharmacy, including the preparing, compounding, dispensing, selling or distributing at retail to a person a drug, except a pharmacy intern or other authorized personnel under the immediate personal supervision of a pharmacist, who may assist the pharmacist with the preparation of other than Schedule II controlled substances and except personnel engaged in clerical functions, provided that:
(1) Prior to preparing the prescription, a licensed pharmacist shall review the prescription and make necessary professional determinations, which shall include the interpretation of the prescriber's order with respect to the drug name, strength, dosage, quantity and allowable refills.
(2) After the prescription has been prepared, a licensed pharmacist shall thoroughly inspect the prepared prescription to verify the accuracy of the preparation, dosage and number of allowable refills.
(b) In the actual preparation of a prescription, the procedures which require professional skill and training, such as the verification of proper ingredients, the weighing of ingredients and the compounding of other similar processing of ingredients into the final prescription drug shall be performed by a licensed pharmacist or a licensed pharmacist intern under the direct personal supervision of a licensed pharmacist.
(c) Personnel authorized by the pharmacist to assist him may:
(1) Accept written prescriptions.
(2) Convey written prescriptions to the pharmacist.
(3) Carry containers of drugs in and around the pharmacy.
(4) Count pills, tablets or capsules.
(5) After review by the pharmacist, package for delivery and deliver the drugs.
(6) Perform clerical tasks relating to the practice of pharmacy.]
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 the provisions in 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 preparation to determine the name of the drug, strength, dosage, quantity, permissible refills and the other information required under § 27.18(b) (relating to standards of practice).
(2) The pharmacist shall inspect a prescription or drug order after it has been prepared to verify the accuracy of the preparation.
(3) The pharmacist shall provide direct, immediate and personal supervision to pharmacy interns and pharmacy technicians working under him. Direct, immediate and personal supervision means that the supervising pharmacist has reviewed the prescription or drug order prior to its preparation, has verified the final product and is on duty to direct the work of interns and technicians and respond to questions or problems.
(4) 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)(3).
(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 the 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)(3).
(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) Assist in preparing Schedule II controlled substances.
(iii) Enter or be in a pharmacy if a pharmacist is not on duty.
(iv) Perform any act within the practice of pharmacy that involves discretion or independent professional judgment.
(v) 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.
(5) No more than two pharmacy technicians may assist a pharmacist in the practice of pharmacy at any time. The number of pharmacy technicians permitted to assist a pharmacist under this paragraph is in addition to pharmacy interns and clerical and housekeeping personnel.
§ 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 [, and the Board will determine by published regulation and according to reasonable standards what is adequate]. The applicant for a pharmacy permit shall show proof by affidavit that he has ordered or possesses and shall continue to maintain an [adequate] inventory of nonproprietary drugs, devices and equipment appropriate to the practice of that pharmacy. [Until further regulations are promulgated, the applicant shall show proof by affidavit that he has ordered not less than] The inventory shall include at least $5,000 worth of nonproprietary drugs and devices, at cost, from a [registered] licensed wholesaler or manufacturer [in order to supply the prescription needs of his customers. At no time may the prescription] The inventory may not go below this figure at any time.
(b) [A drug which does not meet established legal standards of strength and purity, or which has been improperly stored, or has expired dates for its use, or varies from the purity and strength specified on the label, or is unfit, misbranded or adulterated as defined in the Commonwealth and the Federal statutes for use due to deterioration or other causes may not be sold or given away but shall, within 30 days after the pharmacist knows or upon reasonable effort should know of the drug, be properly disposed of by the pharmacist, except that a caution legend drug be surrendered to a BNDD regional office, or to the Division of Drug Control of the Department of Health or to the Board or returned to the wholesaler or manufacturer to be disposed of in compliance with applicable regulations or, where otherwise permitted by law, destroyed in the presence of an agent of one of the above agencies. The Board will arrange for appropriate storage of a drug at the request and expense of the pharmacist, if the surrendered drug is the subject of litigation or is otherwise required to be preserved. The pharmacist manager shall be responsible for keeping proper records of items surrendered or returned.] 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 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 [miscellaneous] supplies:
(1) [One] A Class A prescription balance [, that is, scale, with weights or automatic balance] or other scale with sensitivity [requirement] of 6 milligrams [with no load] or less.
* * * * * (3) A mechanical refrigerator having the [proper and suitable] appropriate temperature control for the [exclusive] storage of the drugs, vaccines, biologicals or medicaments which require [certain designated] specific temperatures for their stability. [The refrigerator shall either be within the prescription area or reasonably close, in which case it shall be kept locked except when being used.] The refrigerator shall be kept within the prescription area.
(4) [An appropriate source and appliance to generate heat.]
[(5)] At least four graduates assorted to measure 1 [cc] ml to 500[cc (or five minums to one pint)] ml.
[6] (5) ***
[7] (6)***
[(8)] (7) At least two funnels, one [four ounces] 120 ml and the other [16 ounces] 480 ml.
[(9)] (8) One ointment slab of glass or tile or [special ointment] specially treated paper.
[(10)] (9) [One] A book to record sales and transfers of [exempt narcotics and one book to record sales and transfers of] Schedule V controlled substances and poisons. This paragraph does not apply to an institutional pharmacy servicing inpatients.
[(11)] (10) ***
[(12)] (11) [Suitable prescription filing devices] Prescription files for keeping [proper records of regular prescription narcotic and controlled substances prescription] 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 must be retained for 2 years. A pharmacy may make use of a computerized recordkeeping system for keeping track of telephone prescriptions, refills, counselling, and the like if the system has safeguards to prevent accidental erasure and the information can be transferred to hardcopy within 72 hours.
[(13)] (12) ***
[(14)] (13) ***
[(15)] (14) An adequate reference library including two or more of the latest editions of the following, including current supplements:
(i) The [National Formulary and the] United States Pharmacopeia, the National Formulary.
* * * * * (iii) Drug Facts and Comparisons.
(iv) [Remington Practice of Pharmacy] Remington's Pharmaceutical Sciences.
(v) [U. S.] The United States Dispensatory.
(vi) [Pharmaceutical Sciences] Physicians' Generix.
(vii) USPDI [United States Pharmacopeia Dispensing Information].
* * * * * (ix) Goodman and Gilman's Pharmacological Basis of Therapeutics.
(x) AHFS Drug Information: American Hospital Formulary Service.
(xi) [United States Public Health Services] Radiological Health Handbook.
(xii) The Merck Index: An Encyclopedia of Chemicals, Drugs, and Biologicals.
(xiii) [Martindale's] 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.
* * * * * (c) [The walls, ceilings, windows and floors of the pharmacy shall be clean and maintained in good repair and order.
(d)] Waste material may not be permitted [or allowed] to collect upon the [floors, counters] floor, counter or other [portions] area of the pharmacy [, and covered waste receptacles shall be placed in convenient places for the waste material]. The pharmacy shall have a waste removal system adequate to maintain clean and sanitary conditions.
[(e)] (d) ***
[(f)] (e) ***
[(g)] (f) ***
[(h)] (g) ***
§ 27.16. Construction and equipment requirements.
(a) Approval of plans. The following [requirements] requirements [shall be] are applicable to approval of plans:
(1) New pharmacy or change-of-location. Plans for construction of a new pharmacy [or a new building] or new location for an existing pharmacy may be submitted to the Board for approval prior to proceeding with construction. Within 90 days [, or less, if possible, of receipt] of receiving the plans, the Board will notify the applicant of its approval of the planned pharmacy[,] or of its disapproval and the reasons [therefor] 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 [area] immediatelty adjacent [thereto] area.
* * * * * (b) Building standards. The following apply to building standards:
* * * * * (2) [Voluntary guidelines. The experience of the Board indicates a relationship between the size of a store in which a prescription area is located and the level of activity in the practice of pharmacy. Therefore, the voluntary guidelines set forth in the following table are suggested:
Store Area Prescription Area (in square feet) (in square feet) up to 4,000 250 4,001--6,000 350 6,001--8,000 480 8,001--10,000 600 10,001--12,000 750 12,001--14,000 900 14,001--16,000 1,000 16,001--18,000 1,080 over 18,000 1,200] [(3) Adjoining store. A permit may be issued for a self-contained pharmacy having an entrance into an adjoining store which owns the pharmacy or is otherwise affiliated with it. The pharmacy shall have an area of at least 350 square feet. Its separating walls and doors shall afford a degree of security against illegal entry equal to that normally afforded by walls and doors fronting on a public way, and the doors shall be securely locked whenever a licensed pharmacist is not present and on duty. The terms ''pharmacy,'' and ''drugs,'' or words of comparable meaning may only be used in reference to the self-contained pharmacy.]
Self-contained pharmacy.
(i) A self-contained pharmacy is a pharmacy which either is in a larger store or has an entrance into an adjoining store affiliated with the pharmacy and can be securely sealed off from the larger or adjoining store.
(ii) The barrier devices which seal off the self-contained pharmacy shall be capable of providing security for the self-contained 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 larger or adjoining store may not be located in or approached through the self-contained pharmacy unless a pharmacist is on duty whenever staff in the larger or adjoining store need access to these facilities.
(v) If the business hours of the self-contained pharmacy differ from the hours of the larger or adjoining store, the hours of the pharmacy shall be posted at all points of public access.
(vi) Employes of a larger store may enter the larger store only if either the pharmacist is present or if the pharmacy is self-contained and secure. Protocols for access by nonpharmacist staff for bona fide emergencies, such as fires, natural disasters or police matters, may be developed for review and approved by the Board on a case-by-case basis.
(vii) Employes of an adjoining store or of a larger store may not enter an affiliated pharmacy when the pharmacy is closed.
[(4)] (3) Locked compartment. Space shall be provided in the prescription area for a substantially constructed cabinet or safe to contain controlled substances [required to be kept locked in accordance with Federal BNDD regulations] unless the pharmacy disperses controlled substances throughout the stock of noncontrolled substances in a manner as to obstruct 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.
[(5)] (4) Telephone. At least one telephone [--or more if necessary--] shall be [immediately] accessible in the prescription area, and the telephone number shall [coincide with] be the [mandatory] telephone number required to be printed on the label of a prescription.
[(6)] (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. [The sink shall be wholly located within the area designated as the prescription area. Adequate restroom] Restroom facilities for employes of the pharmacy shall be provided reasonably close to, but outside of the prescription area [, or with an entrance for the public located outside of the prescription area].
[(7)] (6) ***
[(8)] (7) ***
[(9)] (8) ***
[(10)] (9) ***
§ 27.18. Standards of practice.
(a) [No drug may be dispensed whether it be on a new prescription or a refill--renewal--except in a new and clean suitable container or in the manufacturer's original container.] 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 capable of reuse. The refill requires a new label containing the information specified in subsection (d). Pharmacies and pharmacists shall comply with the [Federal] Poison Prevention Packaging Act of 1970 (15 U.S.C.A. §§ 1471 [et seq.]--1476.) which includes the use of child resistant containers. [Bottles received originally from manufacturers, wholesalers, distributors or suppliers, shall be destroyed when the container becomes emptied.]
(b) Prescriptions kept on file in the pharmacy shall meet the following requirements:
(1) A prescription 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[, and in addition, when required by statute, the address of the patient, the date the prescription was issued, and the BNDD number of the prescriber].
(2) Prescriptions for controlled substances shall show the DEA number of the prescriber. Prescriptions for Schedule II controlled substances shall be written with ink [or], indelible pencil [or], typewriter, word processor or computer printer and shall be manually signed by the prescriber. The pharmacist is responsible for [seeing that a caution legend drug prescription he fills meets the requirements of] compounding and dispensing nonproprietary drugs consistent with the [Federal] Controlled Substances Act (21 U.S.C.A. § 321 et seq.), 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 [caution legend] non-proprietary drug is refilled, a record of the refill [showing] shall show the date of the refill [and], the name or initials of the dispensing pharmacist and the quantity dispensed[, if]. If the pharmacist dispenses a quantity different from that [shown originally on the face] of the original prescription, the pharmacist shall [be indicated] indicate the changes on the back of the original prescription [or stored in a functionally equivalent information retrieval system] 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. [If a copy is given, the person requesting the copy shall show the pharmacist acceptable identification, such as a driver's license, and it shall be noted in writing as to the date and to whom and by whom the copy was given.]
(c) [No] 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 [legend, caution legend drug] controlled substance or nonproprietary drug or device if [he] 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 [not be required] decline to fill or refill a prescription if, in [his] the pharmacist's professional judgment exercised in the interest of the safety of the patient, [he] the pharmacist believes [it] 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 [with the following] which shall be written in ink, typed or computer generated and shall contain the following information:
(1) [Name] The name, address, telephone number and DEA number of the pharmacy [and the BNDD number assigned to it by that Bureau].
* * * * * (4) The name of the prescriber [and a registration number of the prescriber required to be obtained under applicable Federal statute].
* * * * * (6) The trade or brand name of the drug [and proportion or amount of drug dispensed, unless omission is specifically requested by the prescribing doctor in writing], strength, dosage form and quantity dispensed. If [the name is generic, then] a generic drug is dispensed, the manufacturer's name or suitable abbreviation of manufacturer's name shall also be shown.
* * * * * (r) The following provisions [are applicable] apply to the advertisement and sale of drugs:
* * * * * (7) The patient has the right to request a copy of [his] an original prescription[, and the]. The copy shall clearly indicate on its face that it is a copy and may not be used to obtain a new prescription [order] 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 it is in unit dose. A drug 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, and the diluent and expiration date; and the initials of the pharmacist.
PHARMACISTS § 27.21. Application for examination and registration.
(a) [An application for an examination and registration as a licensed pharmacist shall be submitted on an application form prescribed and provided by the Commissioner, accompanied by the evidence, statements or documents as required, and filed with the Board at its office in Harrisburg at least 30 days before the date fixed for examination.] A person applying to take the National Association of Boards of Pharmacy Licensure Examination (NABPLEX) and the Federal Drug Law Examination (FDLE) shall obtain an application for licensure from the Board, complete the application, and file the application with the Board at least 45 days before the examination.
(b) [An applicant shall use his full legal name in filling out an application.] The applicant shall include with the application proof of graduation with a B.S. or advanced degree in pharmacy granted by an accredited school or college; affidavits of all internship experience gained prior to submitting the application; and the application fee.
(c) [A separate application shall be filed and an examination fee paid for each examination taken.] The applicant shall also complete an examination scheduling form which the applicant shall submit, together with the examination fee, directly to the testing service.
(d) [Internship experience affidavits shall be filed prior to the date set for the practical examination.] Affidavits of internship experience gained after the filing of the application shall be filed before the examination date.
§ 27.23. Time and place for holding examination.
Examinations shall be held at a time and place determined by the [Commissioner] Bureau's examination contract with the testing service which administers the examination.
§ 27.24. Examinations administered and passing grade.
(a) Candidates for licensure by examination are required to pass both the [National Association of Boards of Pharmacy Licensure Examination (NABPLEX)] NABPLEX and the [Federal Drug Law Examination (FDLE)] FDLE, which shall be administered in January [and], June and September of each year.
(b) [Through January 1986, the NABPLEX shall consist of the following five substantive areas: Chemistry, Mathematics, Pharmacy, Pharmacology and the Practice of Pharmacy. Each substantive area shall be graded separately. The minimum passing rate is an average of 75% of the separately graded substantive areas, with at least 60% in Chemistry, Mathematics, Pharmacy and Pharmacology, and at least 75% in the Practice of Pharmacy.
(c) Beginning in June 1986, the NABPLEX shall be an integrated exam, covering the subjects itemized in subsection (b), but with only one grade, rather than separately graded subsections.] The minimum passing [rate] grade for [this integrated exam may be no less than] NABPLEX is 75.
[(d)] (c) The minimum passing grade for the FDLE [may be no less than] is 75.
§ 27.25. [Failure to appear for examination] Licensure by reciprocity.
[The fee paid for investigation and examination of an application for registration as a pharmacist may not be refunded if the applicant fails to qualify for examination, or, if, without good cause as determined by the Board, the applicant fails to appear for examination after notification of the time and place of two consecutive examinations has been mailed by the Board to him at his address as shown on the records of the Board. In this event, a new application shall be filed and a new application fee paid before the applicant shall be eligible for examination.]
(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. [Internship] 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 those individuals with the knowledge and practical experience necessary for functioning competently and effectively upon licensure.
(b) A certificate of registration as a pharmacy intern will only be issued for the purpose of allowing individuals who intend to become registered pharmacists the opportunity to obtain the practical experience required for examination and registration as a pharmacist. If a person desires to work as a pharmacy intern in this Commonwealth, he shall do the following:
(1) Apply for an intern application after having successfully completed his second year in an accredited college which leads to a 5-year course in pharmacy.
(2) Apply to the Board for registration as a pharmacy intern.
(c) A person desiring to register as a pharmacy intern shall complete an application as provided by the Commissioner and in addition shall forward to the Board the following:
(1) A head and shoulders photograph which shall be 3 inches by 4 inches.
(2) The fee.
(3) A letter or transcript certifying that the applicant has in fact successfully completed a minimum of 2 years in an accredited college.
(d) The Board will register an applicant as a pharmacy intern as soon as the Board receives a completed application and the items set forth in subsection (c). Pharmacy internships shall be valid for a period not exceeding 6 years from the date of issue exclusive of time spent in the military service.
(e) The following applies to internship credit: The internship experience may not be less than 1,500 hours, with a maximum of 50 hours in any one week. Credit for internship will not be granted by the Board for periods before registration as an intern.
(f) The following apply to pharmacy intern experience:
(1) Pharmacy school instruction is necessary. After January 1, 1973, a person may not be eligible to become a candidate for registration to practice pharmacy in this Commonwealth unless he receives his instructions 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 Board-approved college.
(2) Internship credit for a maximum of 750 hours may be gained from practical experience obtained in a structured internship program. The credit will be limited to the number of hours of credit for which the structured internship program has been approved by the Board. Internship credit will only be granted when the practical experience is obtained on a full-time basis with no other concurrent required academic load and if the intern obtains a passing grade from the course involved. An accredited school or college of pharmacy which desires to conduct structured internship programs eligible for approval shall make a written request to the Board. Board-approved structured internship programs at the pharmacy schools will be monitored and guided by the Board.]
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 who has completed at least 2 years of pharmacy college or an accredited program leading to transfer into the third year of pharmacy college and is of good moral character. 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 pharmacy college.
(c) The Board will register an applicant after it receives a completed application and other items in subsection (b). A pharmacy intern certificate shall be 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.
* * * * * (h) The requirements for registration as a pharmacist preceptor is as follows:
(1) A pharmacist preceptor may not have been convicted of an offense with respect to observance of Federal, State and municipal statutes and ordinances relating to the practice of pharmacy. A pharmacist may appeal to the Board for a waiver of this provision.
* * * * *
[Pa.B. Doc. No. 96-351. Filed for public inspection March 8, 1996, 9:00 a.m.]
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