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CHAPTER 27. STATE BOARD OF PHARMACY
GENERAL PROVISIONS Sec.
27.1. Definitions.
27.2. Other definitions.
27.3. Location of office.
27.4. Filing of addresses.
STANDARDS
27.11. Pharmacy permit and pharmacist manager.
27.12. Practice of pharmacy and delegation of duties.
27.13. Inspection reports.
27.14. Supplies.
27.15. Sanitary standards.
27.16. Construction and equipment requirements.
27.17. Security for Schedule II controlled substances.
27.18. Standards of practice.
27.19. Prospective drug review and patient counseling.
27.20. Facsimile machines.
PHARMACISTS
27.21. Application for examination and licensure.
27.22. Application after expulsion from examination.
27.23. Time and place for holding examination.
27.24. Examinations and passing scores.
27.25. Licensure by reciprocity.
27.26. Pharmacy internship.
27.27. [Reserved].
RENEWAL OF PHARMACIST LICENSE AND
PHARMACY PERMIT
27.31. Biennial renewal.
27.32. Continuing education.
INSTITUTIONS
27.41. Qualified institutions.
27.42. Institutional regulation.
ELIGIBILITY OF NONCITIZENS
27.51. Age.
27.52. Graduates of foreign schools and noncitizens.
BRIBERY
27.61. In general.
MISCELLANEOUS
27.71. Revocation and suspension.
APPLICABILITY OF GENERAL RULES
27.81. Applicability of general rules.
FEES
27.91. Schedule of fees.
STATEMENTS OF POLICY
27.101. Radiopharmaceutical prescriptionsstatement of policy.
27.102. Return to stock of undelivered medicationstatement of policy.
27.103. Matters of consciencestatement of policy.
TECHNOLOGY AND AUTOMATION
27.201. Electronically transmitted prescriptions.
27.202. Computerized recordkeeping systems.
27.203. Centralized prescription processing.
27.204. Automated medication systems.
DRUG THERAPY MANAGEMENT
27.301. Written protocol.
PROFESSIONAL LIABILITY INSURANCE
27.311. Certification of professional liability insurance.
ADMINISTRATION OF INJECTABLE MEDICATIONS, BIOLOGICALS AND IMMUNIZATIONS
27.401. Qualifications for authority.
27.402. Application and renewal procedures.
27.403. Conditions for administration.
27.404. Authority and requirements.
27.405. Recordkeeping.
27.406. Notification requirements.
27.407. Education requirements.Authority The provisions of this Chapter 27 issued under section 506 of The Administrative Code of 1929 (71 P. S. § 186); and the Pharmacy Act (63 P. S. § § 390-1390-13), unless otherwise noted.
Source The provisions of this Chapter 27 adopted June 1, 1973, effective June 2, 1973, 3 Pa.B. 1051, unless otherwise noted.
Cross References This chapter cited in 28 Pa. Code § 501.4 (relating to regulations); 28 Pa. Code § 551.52 (relating to ASF responsibilities); 28 Pa. Code § 561.1 (relating to drugs and biologicals); 28 Pa. Code § 601.3 (relating to requirements for home health care agencies); 49 Pa. Code § 41.26 (relating to professional corporations); and 49 Pa. Code § 47.21 (relating to professional corporations).
GENERAL PROVISIONS
§ 27.1. Definitions.
The following words and terms, when used in this chapter, have the following meanings, unless the context clearly indicates otherwise:
ACPEThe American Council of Pharmaceutical Education.
ActThe Pharmacy Act (63 P. S. § § 390-1390-13).
Automated medication system(i) A process that performs operations or activities, other than compounding or administration, relative to the storage, packaging, dispensing and distribution of medications, and which collects, controls and maintains all transaction information.
(ii) The term does not include an automatic counting device or unit-based dispensing cabinet.
Automatic counting deviceA device used in a pharmacy to automatically count medication for dispensing.
BoardThe State Board of Pharmacy.
BureauThe Bureau of Professional and Occupational Affairs of the Department of State of the Commonwealth.
CEUContinuing Education UnitsThe unit of measuring contact hours of continuing education provided by ACPE accredited providers. Ten contact hours are equivalent to 1.0 CEU.
Central fill pharmacyA pharmacy engaging in centralized prescription processing by filling and refilling prescriptions, which includes the preparation and packaging of the medication. A central fill pharmacy may also be the originating or delivering pharmacy.
Centralized prescription processingThe processing, under the direction of a pharmacist, of a request to fill or refill a prescription, to perform functions such as refill authorizations, interventions or other matters related to the practice of pharmacy for subsequent delivery to the delivering pharmacy.
Central processing centerA pharmacy operated under the direction of a pharmacist that processes information related to the practice of pharmacy and that engages solely in centralized prescription processing but from which drugs are not dispensed.
CommissionerThe Commissioner of Professional and Occupational Affairs in the Department.
Contact hoursContinuing 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 educationProfessional education obtained to maintain, improve or expand current skills or knowledge, or to develop new skills or knowledge.
DEAThe Federal Drug Enforcement Administration.
Delivering pharmacyThe pharmacy that receives the processed prescription or the filled or refilled prescription for delivering to the patient or the patients authorized representative. A delivering pharmacy may also be an originating or central fill pharmacy.
DepartmentThe Department of State of the Commonwealth.
Drug orderAn 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.
Drug therapy managementAny of the following processes performed in an institutional setting pursuant to a written agreement, protocol or order as set forth in section 9.1 of the act (63 P. S. § 390-9.1):(i) Adjusting a drug regimen.
(ii) Adjusting drug strength, frequency of administration or route.
(iii) Administration of drugs.
(iv) Ordering laboratory tests and ordering and performing other diagnostic tests necessary in the management of drug therapy, consistent with the testing standards of the institution.
Institutions
(i) A health care facility that offers care and medical treatment to patients who require food, board and overnight sleeping facilities and provides clinically related health services, including, a general or special hospital, including psychiatric hospitals, rehabilitation hospitals, ambulatory surgical facilities, long-term care nursing facilities, cancer treatment centers using radiation therapy on an ambulatory basis, and inpatient drug and alcohol treatment facilities, both profit and nonprofit and including those operated by an agency or State or local government.
(ii) The term also includes a hospice that offers care and medical treatment to patients who require food, board and overnight sleeping facilities.
(iii) The term does not include an office used primarily for the private or group practice by health care practitioners where no reviewable clinically related health service is offered, a facility providing treatment solely on the basis of prayer or spiritual means in accordance with the tenets of any church or religious denomination or a facility conducted by a religious organization for the purpose of providing health care services exclusively to clergy or other persons in a religious profession who are members of the religious denominations conducting the facility.
Long-term care facilityA nursing home, retirement care, mental care or other institution that provides extended health care to resident patients.
Medical practitionerA physician, dentist, veterinarian or other individual authorized and licensed by law to prescribe drugs.
Nonproprietary drugA 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.
OrderAny directive from a medical practitioner.
Originating pharmacy(i) The pharmacy that receives the patients or prescribing practitioners request to fill or refill a prescription and performs functions such as the prospective drug review.
(ii) The term includes a central processing center or a central fill pharmacy if the prescription was transmitted by the prescriber directly to the central processing center or central fill pharmacy or if the patient requested the refill from that pharmacy.
Pharmacist managerThe 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).
PharmacyThe place licensed by the Board where the practice of pharmacy is conducted.
Pharmacy internA 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 technicianAn 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
(i) The provision of health care services by a pharmacist, which includes:
(A) The interpretation, evaluation and implementation of medical orders for the provision of pharmacy services or prescription drug orders.
(B) The delivery, dispensing or distribution of prescription drugs.
(C) Participation in drug and device selection.
(D) Drug administration.
(E) Drug regimen review.
(F) Drug or drug-related research.
(G) Compounding.
(H) Proper and safe storage of drugs and devices.
(I) Managing drug therapy in an institutional setting consistent with the institutions assignment of clinical duties.
(J) Maintaining proper records.
(K) Patient counseling.
(L) Acts, services, operations or transactions necessary or incident to the provision of these health care services.
(ii) The term does not include the operations of a manufacturer or distributor as defined in The Controlled Substance, Drug, Device and Cosmetic Act (35 P. S. § § 780-101780-144).
PrescriptionA 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 areaThat 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 drugA 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 pharmacyA 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.
Authority The provisions of this § 27.1 amended under sections 4(j), 6(k)(1), (9) and 9.2(a) of the Pharmacy Act (63 P. S. § § 390-4(j), 390-6(k)(1) and (9) and 390-9.2(a)).
Source The provisions of this § 27.1 amended December 19, 1986, effective December 20, 1986, 16 Pa.B. 4883; amended June 20, 1997, effective June 21, 1997, 27 Pa.B. 2931; amended September 4, 1998, effective September 5, 1998, 28 Pa.B. 4532; amended May 26, 2006, effective May 27, 2006, 36 Pa.B. 2518; amended June 30, 2006, effective July 1, 2006, 36 Pa.B. 3237. Immediately preceding text appears at serial pages (319631) to (319634).
Cross References This section cited in 6 Pa. Code § 22.62 (relating to conditions of provider participation); 49 Pa. Code § 27.11 (relating to pharmacy permit and pharmacist manager); and 49 Pa. Code § 27.12 (relating to practice of pharmacy and delegation of duties).
§ 27.2. Other definitions.
The definitions contained in the act and also in The Controlled Substance, Drug, Device and Cosmetic Act (35 P. S. § § 780-101780-144), including the term controlled substances and the schedules thereof, apply to this chapter. A requirement contained in this chapter for a controlled substance applies to the lowest schedule of a controlled substance now or subsequently classified as a controlled substance by either BNDD or the Secretary of the Department of Health.
Cross References This section cited in 6 Pa. Code § 22.62 (relating to conditions of provider participation).
§ 27.3. Location of office.
The principal office of the Board is located at 617 Transportation and Safety Building, Harrisburg, Pennsylvania 17120.
Cross References This section cited in 6 Pa. Code § 22.62 (relating to conditions of provider participation).
§ 27.4. Filing of addresses.
A licensed pharmacist and pharmacy in this Commonwealth shall file a current mailing address with the Board at its office and shall notify the Board of changes in the mailing address within 10 days of the changes.
Cross References This section cited in 6 Pa. Code § 22.62 (relating to conditions of provider participation).
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).
Source The provisions of this § 27.11 amended September 4, 1998, effective September 5, 1998, 28 Pa.B. 4532. Immediately preceding text appears at serial page (201793).
Cross References The provisions of this § 27.12 amended September 4, 1998, effective September 5, 1998, 28 Pa.B. 4532. Immediately preceding text appears at serial pages (201793) to (201794).
Cross References This section cited in 6 Pa. Code § 22.62 (relating to conditions of provider participation); and 49 Pa. Code § 27.1 (relating to definitions).
§ 27.13. Inspection reports.
A person to whom a pharmacy or pharmacist certificate, license, permit or registration has been issued shall retain copies of reports or notices issued by inspectors or by the Board, and shall maintain the reports and notices on the licensed premises in such a manner as to make them readily available upon request of the Board or its agents for a period of 2 years from date of issuance of the inspection reports or notices.
Cross References The provisions of this § 27.14 amended under sections 4(j) and 6(k)(1) and (9) of the Pharmacy Act (63 P. S. § § 390-4(j) and 390-6(k)(1) and (9)).
Source The provisions of this § 27.14 adopted June 1, 1973, effective June 2, 1973, 3 Pa.B. 1051; amended June 14, 1991, effective June 15, 1991, 21 Pa.B. 2710; amended September 4, 1998, effective September 5, 1998, 28 Pa.B. 4532; amended March 1, 2002, effective March 2, 2002, 32 Pa.B. 1194; amended May 26, 2006, effective May 27, 2006, 36 Pa.B. 2518. Immediately preceding text appears at serial pages (287427) to (287428) and (290089).
Cross References This section cited in 6 Pa. Code § 22.62 (relating to conditions of provider participation); 28 Pa. Code § 113.12 (relating to supplies); 28 Pa. Code § 561.12 (relating to supplies); and 49 Pa. Code § 43a.9 (relating to schedule of civil penaltiespharmacists and pharmacies).
§ 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.
Source The provisions of this § 27.15 amended September 4, 1998, effective September 5, 1998, 28 Pa.B. 4532. Immediately preceding text appears at serial pages (201796) and (238307).
Cross References The provisions of this § 27.16 amended under sections 4(j) and 6(k)(1) and (9) of the Pharmacy Act (63 P. S. § § 390-4(j) and 390-6(k)(1) and (9)).
Source The provisions of this § 27.16 amended November 28, 1997, effective November 29, 1997, 27 Pa.B. 6218; amended September 4, 1998, effective September 5, 1998, 28 Pa.B. 4532; amended May 26, 2006, effective May 27, 2006, 36 Pa.B. 2518. Immediately preceding text appears at serial pages (290089) to (290090) and (250693) to (250694).
Cross References This section cited in 6 Pa. Code § 22.62 (relating to conditions of provider participation); 28 Pa. Code § 113.14 (relating to space); 28 Pa. Code § 113.15 (relating to locked storage); 28 Pa. Code § 561.14 (relating to space); 28 Pa. Code § 561.15 (relating to locked storage); 49 Pa. Code § 27.203 (relating to centralized prescription processing); and 49 Pa. Code § 43a.9 (relating to schedule of civil penaltiespharmacists and pharmacies).
§ 27.17. Security for Schedule II controlled substances.
(a) From the time that a Schedule II controlled substance is received for storage in the prescription area until the time that controlled substance has been prepared and compounded into an individual prescription, no person except a licensed pharmacist or a licensed pharmacist intern or, in an institution, a licensed physician or registered nurse, may have access to the controlled substances or work in an area where open containers of the controlled substances are shelved or stored. The Board will consider the following measures as adequately controlling access to the controlled substances:
(1) A safe, vault or other storage facility in compliance with storage requirements for BNDD Schedule II drugs.
(2) A chest or cabinet of sound construction secured to a wall or floor and able to be securely locked.
(3) A wire cage with a door able to be securely locked.
(b) The Board may approve alternative security measures proposed by an applicant upon a showing that a degree of security would be provided equal to or greater than that set forth in subsection (a).
(c) The occasional entry of other persons into an area where the controlled substances are accessible in order to clean, deliver or perform other necessary functions shall be allowed only when a licensed person is present and supervising.
(d) The pharmacist manager shall be responsible for assuring that licensed persons, employes and others who enter the prescription area know and abide by the standards of security and that the other measures are taken as may be necessary to insure their enforcement.
Cross References Revocation of a pharmacists license for a violation of 49 Pa. Code § 27.18(u) (relating to violations by a pharmacist of the Federal Controlled Substances Act (21 U.S.C. § 321 et seq.) or the Pennsylvania Controlled Substances, Drug, Devices and Cosmetic Act (35 P. S. § § 780-101780-144)) is not an abuse of discretion. Rosenthal v. State Board of Pharmacy, 457 A.2d 243 (Pa. Cmwlth. 1983).
If a pharmacist has been charged only with violations of the Pharmacy Act (63 P. S. § § 390-1390-13) and the Boards regulations, the Boards authority to revoke or suspend his license is governed by the provisions of section 5(a)(6) of the Pharmacy Act (63 P. S. § 390-5(a)(6)); the provisions of section 23(b) of the Drug Act (35 P. S. § 780-123(b)) are not applicable, even though the violations may also constitute grounds for a criminal prosecution. Moeslein v. State Board of Pharmacy, 432 A.2d 295 (Pa. Cmwlth. 1981).
With regard to the prohibitions of subsection (t), it is irrelevant whether a pharmacist continually fills overlapping prescriptions for the same person, from the same physician, and for the same drug, in the same quantity and dosage, or continually refills a prior prescription; the subsection gives a clear description of what conduct is prohibited such that it satisfies due process requirements. Goldberg v. State Board of Pharmacy, 410 A.2d 413 (Pa. Cmwlth. 1980).
Revocation of a pharmacists license for distributing cocaine and dexedrine without a prescription is not an unduly harsh punishment; the classification of cocaine as a controlled substance is not a denial of equal protection. Carr v. State Board of Pharmacy, 409 A.2d 941 (Pa. Cmwlth. 1980).
Since the petitioner pled guilty to four criminal charges under the Drug Act, only one of which was a felony, the Board has the power to revoke his license but is not obligated to do so, and the case will be remanded if it appears that the Boards decision to revoke his license is based in part on the mistaken belief that a plea of guilty to any offense in connection with the practice of pharmacy is sufficient to revoke a license. Intrieri v. Commissioner of Professional and Occupational Affairs, 396 A.2d 927 (Pa. Cmwlth. 1979).
Source The provisions of this § 27.18 amended September 4, 1998, effective September 5, 1998, 28 Pa.B. 4532. Immediately preceding text appears at serial pages (238310) and (201801) to (201805).
Cross References The provisions of this § 27.20 issued under sections 4(j) and 6(k)(1) and (9) of the Pharmacy Act (63 P. S. § § 390-4(j) and 390-6(k)(1) and (9)).
Source The provisions of this § 27.20 adopted June 20, 1997, effective June 21, 1997, 27 Pa.B. 2931; amended March 1, 2002, effective March 2, 2002, 32 Pa.B. 1194. Immediately preceding text appears at serial pages (247942) and (248955).
PHARMACISTS
§ 27.21. Application for examination and licensure.
(a) A candidate for licensure to practice pharmacy by examination applying to take the North American Pharmacist Licensure Examination (NAPLEX) and the Multistate Pharmacy Jurisprudence Examination (MPJE) shall obtain an application for licensure from the Board, complete the application and file the application with the Board.
(b) The applicant shall include in the application proof of graduation with a B.S. or advanced degree in pharmacy granted by an ACPE accredited school or college; affidavits of all internship experience gained prior to submitting the application; and the application fee.
(c) The applicant shall also complete and submit to the Board with the completed application the examination fees and examination registration forms provided by the test administrator.
(d) Affidavits of internship experience gained after the filing of the application shall be filed before the examination date.
Authority The provisions of this § 27.21 amended under section 812.1 of The Administrative Code of 1929 (71 P. S. § 279.3a); and sections 3, 6(k) and 8.2 of the Pharmacy Act (63 P. S. § § 390-3, 390-6(k) and 8.2).
Source The provisions of this § 27.21 amended May 23, 1997, effective May 24, 1997, 27 Pa.B. 2545; amended October 16, 1998, effective October 17, 1998, 28 Pa.B. 5241. Immediately preceding text appears at serial pages (247943) to (247944).
Cross References This section cited in 49 Pa. Code § 27.52 (relating to graduates of foreign schools and noncitizens).
§ 27.22. Application after expulsion from examination.
An applicant for an examination and registration as a licensed pharmacist who has been expelled from an examination room for cribbing, cheating or other dishonest conduct may not be permitted to file a new application for examination within 1 year thereafter, and shall petition the Board specially for permission to take a subsequent examination.
Cross References This section cited in 49 Pa. Code § 27.52 (relating to graduates of foreign schools and noncitizens).
§ 27.23. Time and place for holding examination.
Examinations shall be held at times and places and determined by the Board in conjunction with the test administrator.
Source The provisions of this § 27.23 amended May 23, 1997, effective May 24, 1997, 27 Pa.B. 2545. Immediately preceding text appears at serial page (201810).
Cross References This section cited in 49 Pa. Code § 27.52 (relating to graduates of foreign schools and noncitizens).
§ 27.24. Examinations and passing scores.
On and after March 1, 1997, but before November 1, 1998, candidates for licensure by examination are required to pass both the North American Pharmacist Licensure Examination (NAPLEX) and the Federal Drug Law Examination (FDLE), developed and administered by the National Association of Boards of Pharmacy (NABP).
(b) On and after November 1, 1998, candidates for licensure by examination are required to pass both the NAPLEX and the Multistate Pharmacy Jurisprudence Examination (MPJE), developed and administered by the NABP.
(c) The minimum passing score on each examination will be as determined by the NABP.
Authority The provisions of this § 27.24 amended under section 812.1 of The Administrative Code of 1929 (71 P. S. § 279.3a); and sections 3, 6(k) and 8.2 of the Pharmacy Act (63 P. S. § § 390-3, 390-6(k) and 390-8.2).
Source The provisions of this § 27.24 amended September 5, 1986, effective September 6, 1986, 16 Pa.B. 3293; amended June 12, 1992, effective June 13, 1992, 22 Pa.B. 3064; corrected June 20, 1992, effective June 13, 1992, 22 Pa.B. 3064; amended May 23, 1997, effective May 24, 1997, 27 Pa.B. 2545; amended October 16, 1998, effective October 17, 1998, 28 Pa.B. 5241. Immediately preceding text appears at serial pages (247944) to (247945).
Cross References This section cited in 49 Pa. Code § 27.52 (relating to graduates of foreign schools and noncitizens).
§ 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.
Source The provisions of this § 27.25 amended May 23, 1997, effective May 24, 1997, 27 Pa.B. 2545; amended September 4, 1998, effective September 5, 1998, 28 Pa.B. 4532. Immediately preceding text appears at serial page (230634).
Cross References The provisions of this § 27.26 amended May 30, 1980, effective May 31, 1980, 10 Pa.B. 2162; amended September 4, 1998, effective September 5, 1998, 28 Pa.B. 4532; corrected October 30, 1998, effective September 5, 1998, 28 Pa.B. 5485. Immediately preceding text appears at serial pages (247945) to (247948).
Cross References This section cited in 49 Pa. Code § 27.1 (relating to definitions); and 49 Pa. Code § 27.52 (relating to graduates of foreign schools and noncitizens).
§ 27.27. [Reserved].
Source The provisions of this § 27.27 adopted August 13, 1982, effective August 14, 1982, 12 Pa.B. 2687; amended August 2, 1985, effective August 3, 1985, 15 Pa.B. 2813; reserved September 30, 1988, effective October 1, 1988, 18 Pa.B. 4416. Immediately preceding text appears at serial pages (114090) to (114091).
RENEWAL OF PHARMACIST LICENSE
AND PHARMACY PERMIT
§ 27.31. Biennial renewal.
(a) A holder of a pharmacy permit shall renew the permit every 2 years, in odd-number years. Renewal requires completion of a form mailed to the holder by the Board in advance of the renewal period, and payment of the specified fee.
(b) A licensed pharmacist shall renew the license every 2 years, in even-numbered years. Renewal requires completion of a form mailed to the pharmacist by the Board in advance of the renewal period, and payment of the specified fee. Beginning with 1988 renewals, a pharmacist shall also submit proof of compliance with the continuing education requirements of § 27.32 (relating to continuing education).
(c) A pharmacist or holder of a pharmacy permit who fails to timely renew shall cease practice or operation until the license or permit is renewed. The holder may be subject to disciplinary action, and will be assessed an additional fee of $5 for each month or part of month after which renewal occurs beyond the date specified by the Board. Notice of lapsed pharmacy permits shall be forwarded to other Commonwealth agencies, including the Department of Health, the Department of Public Welfare and the Department of Aging.
(d) A pharmacist allowing the license to lapse may so notify the Board on the renewal form. Reasons shall be briefly stated, and the pharmacists pocket license and display license shall be surrendered to the Board with the renewal form. A pharmacist who has had a lapsed license for 1 year or more, and who then seeks to reactivate the license, will be required to show current proficiency to practice pharmacy. The full-time practice of pharmacy in another state, during the period of lapsed licensure in this Commonwealth, will be evidence of current proficiency. A holder of a lapsed license who engaged in activities outside the profession of pharmacy during the lapsed period shall complete hours of continuing education equivalent to the hours which he would have been required to take had he held an active license.
Authority The provisions of this § 27.31 amended under section 3.1 of the Pharmacy Act (63 P. S. § 390-3.1).
Source The provisions of this § 27.32 issued under section 3.1 of the Pharmacy Act (63 P. S. § 390-3.1); amended under sections 3.1, 4(a)(i) and (j) and 9.2(a) of the Pharmacy Act (63 P. S. § § 390-3.1, 390-4(a)(i) and (j) and 390-9.2(a)).
Source The provisions of this § 27.32 adopted December 19, 1986, effective December 20, 1986, 16 Pa.B. 4883; amended June 14, 1991, effective June 15, 1991, 21 Pa.B. 2710; amended June 30, 2006, effective July 1, 2006, 36 Pa.B. 3237. Immediately preceding text appears at serial pages (247949) to (247950).
Cross References This section cited in 49 Pa. Code § 27.31 (relating to biennial renewal).
INSTITUTIONS
§ 27.41. Qualified institutions.
Only institutions accredited by the Joint Commission on Accreditation of Hospitals or the Commission on Hospital Accreditation of the American Osteopathic Association or meeting the requirements of the Conditions of Participation for Extended Care Facilities, Federal Health Insurance for the Aged, or licensed by the Department of Welfare or Department of Health, will be considered for an application for a permit to operate a pharmacy. An institution may not be consid-ered for a pharmacy permit unless the pharmacy in that institution is open a minimum of 20 hours per week under the supervision of a registered pharmacist manager.
§ 27.42. Institutional regulation.
Pharmaceutical services in institutions shall always be conducted in accordance with rules and regulations affecting the services which have been or may hereafter be promulgated by the Department of Public Welfare or Department of Health, and the rules and regulations are hereby incorporated automatically. Violation of the rules and regulations constitute a violation of this chapter.
ELIGIBILITY OF NONCITIZENS
§ 27.51. Age.
A person who has reached his 21st birthday and is a graduate of a college of pharmacy accredited by the American Council of Pharmaceutical Education or a college of pharmacy which meets educational qualifications and requirements of and is approved by the Board, and otherwise meets legal requirements shall be eligible for licensure to practice pharmacy in this Commonwealth.
§ 27.52. Graduates of foreign schools and noncitizens.
(a) Graduates of foreign schools and noncitizens are eligible to become licensed to practice in this Commonwealth if they meet the requirements and qualifications of the act and this chapter.
(b) Graduates of foreign schools and noncitizens are advised that licenses obtained in this Commonwealth may not be accepted by other states under present reciprocal arrangements. The Board recommends that graduates of foreign schools and noncitizens who anticipate practicing in another state in the future should make immediate application to that state.
(c) If a graduate of a foreign college has had experience in the practice of pharmacy and demonstrates knowledge of American pharmacy practices and is proficient generally in his ability to communicate in the English language, the Board may approve a special internship program of less than 1,500 hours, but in no case less than 500 hours. The Board may waive the theoretical examination for a graduate, but he will be required to take the practical examination.
(d) Graduates of foreign colleges are subject to the provisions set forth in § § 27.2127.26 (relating to pharmacists).
(e) The Board recognizes those schools or colleges of pharmacy that are accredited by the American Council of Pharmaceutical Education. This body is a national accrediting agency which establishes the standards for colleges of pharmacy and sees that these standards are maintained in the colleges of pharmacy that have been accredited and approved. Since foreign colleges are not accredited by the American Council of Pharmaceutical Education, the Board, with the cooperation and advice of the United States Department of Education and the Pennsylvania Department of Education, may approve foreign colleges of pharmacy and nonaccredited American schools on a case by case basis if they meet the standards and qualifications of the Board. The Board may also, without approving a school, approve individual applications of qualified graduates of schools on a case by case basis.
BRIBERY
§ 27.61. In general.
It shall constitute unprofessional conduct and a violation of this chapter for a licensee of the Board to do the following:
(1) Directly or indirectly to offer or give money or an item of value to an employe of the Commissioner of Professional and Occupational Affairs or any Board or Commission assigned to the administrative jurisdiction of the Commissioner of Professional and Occupational Affairs, except for the payment required by the act and the rules and regulations of the State Board of Professional and Occupational Affairs, in accordance therewith.
(2) To fail to notify in writing the Commissioner at 279 Boas Street, Harrisburg, Pennsylvania 17120 of a demand, solicitation or attempted extortion of money or an item of value by, or on behalf of, an employe of the Commissioner or a board or commission assigned to the administrative jurisdiction of the Commissioner within 5 days thereafter and to furnish the additional information in connection as might reasonably be requested.
MISCELLANEOUS
§ 27.71. Revocation and suspension.
Failure to comply with this chapter shall be grounds for revocation or suspension of licensure under section 5(a)(6) of the act (63 P. S. § 390-5(a)(6)).
Notes of Decisions Since the petitioner pled guilty to four criminal charges under the Drug Act, only one of which was a felony, the Board has the power to revoke his license but is not obligated to do so, and the case will be remanded if it appears that the Boards decision to revoke his license is based in part on the mistaken belief that a plea of guilty to any offense in connection with the practice of pharmacy is sufficient to revoke a license. Intrieri v. Commissioner of Professional and Occupational Affairs, 396 A.2d 927 (Pa. Cmwlth. 1979).
APPLICABILITY OF GENERAL RULES
§ 27.81. Applicability of general rules.
Under 1 Pa. Code § 31.1 (relating to scope of part), 1 Pa. Code Part II (relating to general rules of administrative practice and procedure), are applicable to the activities of and proceedings before the Board.
Source The provisions of this § 27.81 adopted February 7, 1975, effective February 8, 1975, 5 Pa.B. 248.
FEES
§ 27.91. Schedule of fees.
An applicant for a license, certificate, permit or service shall pay the following fees at the time of application:
Application for pharmacy intern certificate $30
Application for pharmacist license $40
Certification of examination scores or internship hours $25
Verification of licensure $15
Assistant pharmacist biennial renewal $120
Registered pharmacist biennial renewal $150
Registered pharmacist late renewal penalty $25
New pharmacy permit application $100
Reinspection of new pharmacy after failure at first inspection $90
Pharmacy permit change without inspection $30
Pharmacy permit change when inspection required $95
Change in pharmacy ownership or Board of Directors $30
Verification of permit $15
Biennial renewal of pharmacy permit $100
Pharmacy permit late renewal penalty $25
Application for approval to administer injectables $30
Biennial renewal of approval to administer injectables $30
Authority The provisions of this § 27.91 issued under sections 3, 4(j), 6(k)(1), 8.2 and 9.2(a) of the Pharmacy Act (63 P. S. § § 390-3, 390-4(j), 390-6(k)(l), 390-8.2 and 390-9.2(a)); amended under section 812.1 of The Administrative Code of 1929 (71 P. S. § 279.3a).
Source The provisions of this § 27.91 adopted September 30, 1988, effective October 1, 1988, 18 Pa.B. 4416; amended March 16, 1990, effective March 17, 1990, 20 Pa.B. 1501; amended November 8, 1991, effective November 9, 1991, 21 Pa.B. 5258; amended December 8, 1995, effective December 9, 1995, and apply retroactively to examination fees charged on and after September 1, 1995, 25 Pa.B. 5587; amended May 23, 1997, effective May 24, 1997, 27 Pa.B. 2545; amended October 16, 1998, effective October 17, 1998, 28 Pa.B. 5241; amended September 8, 2000, effective September 9, 2000, 30 Pa.B. 4734; amended August 19, 2005, effective August 20, 2005, 35 Pa.B. 4711; amended December 2, 2005, effective December 3, 2005, 35 Pa.B. 6531; amended June 30, 2006, effective July 1, 2006, 36 Pa.B. 3237. Immediately preceding text appears at serial pages (315853) to (315854).
Cross References This section cited in 49 Pa. Code § 27.26 (relating to pharmacy internship); and 49 Pa. Code § 27.402 (relating to application and renewal procedures).
STATEMENT OF POLICY
§ 27.101. Radiopharmaceutical prescriptionsstatement of policy.
(a) Definition. The term radiopharmaceutical means a pharmaceutical, biological or drug which contains a radioactive entity.
(b) Unavailable name. When a pharmacist receives a prescription for a radiopharmaceutical for a patient whose name is unavailable at the time the prescription is received and the pharmacist dispenses the radiopharmaceutical, the pharmacist and pharmacy will be considered to have complied with the provisions of § 27.18(b) and (d) (relating to standards of practice) which require the name of the patient if the pharmacist obtains the name of the patient within 72 hours after dispensing the radiopharmaceutical or, if the radiopharmaceutical is not administered to a patient, marks the prescription not used.
§ 27.102. Return to stock of undelivered medicationstatement of policy.
(a) Background and purpose. Section 5(a)(9)(xi) of the act (63 P. S. § 390-5(a)(9)(xi)) prohibits the return to stock of medication once it has left the premises of the pharmacy. However, many prescriptions do not get delivered to patients and, therefore never leave the control of the pharmacy. These prescriptions may be returned to the active stock of the pharmacy. This section sets forth the guidelines that should be considered when returning undelivered medication to the pharmacys active stock. This section will insure that the integrity of the drugs is maintained and patient safety is not compromised.
(b) Guidelines. The following guidelines should be considered when returning undelivered medications to stock to assure that the quality of medications is maintained:
(1) Prescriptions that have not been picked up by or delivered to patients should be checked periodically.
(2) Prescriptions not delivered to patients should be assessed by a pharmacist to determine whether they might safely be returned to stock.
(3) Products deemed eligible for redispensing should never be mixed within stock bottles of different lot numbers or with different expiration dates. Manufacturers stock bottles should never be over-filled. The only safe manner in which drugs can be returned to stock bottles is in those pharmacies in which all medications are tracked by lot numbers and expiration dates.
(4) In those instances in which medication cannot be properly and safely returned to the original stock bottle, the medication may be held in the pharmacy in the container in which it has been repackaged. It is recommended that pharmacies develop an internal manner for so identifying and dating these products.
(5) Medications held for redispensing should be used as soon as possible. Medications held for redispensing, lacking original lot numbers and expiration dates, should only be dispensed to patients up to 6 months from the date the drugs were first prepared for dispensing.
(6) If the manufacturer or the United States Food and Drug Administration orders a recall for a drug product, pharmacists should assume products held in containers without lot numbers are included in the recall and proceed accordingly.
Source