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 prescriptions—statement of policy.
27.102.    Return to stock of undelivered medication—statement of policy.
27.103.    Matters of conscience—statement 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. § §  390-1—390-13), 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:

   ACPE—The American Council of Pharmaceutical Education.

   Act—The Pharmacy Act (63 P. S. § §  390-1—390-13).

   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 device—A device used in a pharmacy to automatically count medication for dispensing.

   Board—The State Board of Pharmacy.

   Bureau—The Bureau of Professional and Occupational Affairs of the Department of State of the Commonwealth.

   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.

   Central fill pharmacy—A 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 processing—The 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 center—A 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.

   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.

   Delivering pharmacy—The pharmacy that receives the processed prescription or the filled or refilled prescription for delivering to the patient or the patient’s authorized representative. A delivering pharmacy may also be an originating or central fill pharmacy.

   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.

   Drug therapy management—Any 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 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.

   Order—Any directive from a medical practitioner.

   Originating pharmacy

     (i)   The pharmacy that receives the patient’s or prescribing practitioner’s 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 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

     (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 institution’s 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. § §  780-101—780-144).

   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.

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. § §  780-101—780-144), 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

   This section cited in 6 Pa. Code §  22.62 (relating to conditions of provider participation); and 49 Pa. Code §  43a.9 (relating to schedule of civil penalties—pharmacists and pharmacies).

§ 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.

Source

   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

   This section cited in 6 Pa. Code §  22.62 (relating to conditions of provider participation).

§ 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 must 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. A central processing center is not required to maintain $5,000 worth of nonproprietary drugs and devices under §  27.203(b) (relating to centralized prescription processing).

 (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)  Except for a pharmacy operating as a central processing center, 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 nonmetallic 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, State and Federal laws and regulations. The original prescription or image of the original prescription shall be retained for 2 years from the date of the most recent filling. A pharmacy may make use of a computerized recordkeeping system for keeping track of telephone prescriptions, refills, counseling, and the like in accordance with §  27.202 (relating to computerized recordkeeping systems).

   (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 which meets the following standards:

     (i)   Enables a pharmacy to prepare and dispense prescriptions properly, consistent with its scope of practice.

     (ii)   Includes reference sources appropriate to the type of pharmacy practice at that particular location. A pharmacy shall include in the pharmacy’s library current material regarding the technical, clinical and professional aspects of practice with emphasis in the area in which the pharmacy specializes.

     (iii)   Enables the pharmacist to compound medications in a safe and effective manner consistent with accepted standards of pharmacy practice.

     (iv)   Lists the possible drug interactions and possible adverse effects of medications dispensed by the pharmacy.

     (v)   Lists the therapeutic equivalents for medications.

     (vi)   Lists the therapeutic usage and dosages of medications dispensed by the pharmacy.

     (vii)   Provides guidelines for the counseling of patients.

     (viii)   A pharmacy that specializes in nuclear or parenteral prescriptions may limit the library it maintains under subparagraph (ii) relating to the pharmacy’s own specialization.

     (ix)   Maintains the latest editions including current supplements of each of its reference sources.

 (d)  A pharmacy operating as a central processing center shall maintain equipment, supplies and access to a reference library recognized by the pharmacy community in this Commonwealth as meeting minimum standards of practice as a central processing center.

Authority

   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 penalties—pharmacists 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

   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 §  561.14 (relating to space); and 49 Pa. Code §  43a.9 (relating to schedule of civil penalties—pharmacists and pharmacies).

§ 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.

     (i)   The minimum size of the prescription area must 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, employees and the public. Within the prescription area, there must 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.

     (ii)   A pharmacy operating as a central processing center need not conform to the minimum space requirements in subparagraph (i).

   (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. Except for pharmacies operating as central processing centers, pharmacies must be equipped with a sink within the prescription area to be used solely for pharmaceutical purposes. The sink must measure at least 200 square inches exclusive of drainboard area. The sink must be connected properly to supply hot and cold water. Restroom facilities for employees of the pharmacy shall be provided reasonably close to, but outside of the prescription area.

   (6)  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.

Authority

   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 penalties—pharmacists 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

   This section cited in 6 Pa. Code §  22.62 (relating to conditions of provider participation); 28 Pa. Code §  113.15 (relating to locked storage); and 28 Pa. Code §  561.15 (relating to locked storage).

§ 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.’’

 (e)  No pharmacist may enter into an arrangement or agreement with a nonlicensed person whereby prescription orders or prescription drugs and devices may be regularly left with, picked up from, solicited by, accepted by or delivered to the nonlicensed person or whereby a pharmacist pays or has an arrangement or agreement with the nonlicensed person to perform these functions. Nothing in this section shall prohibit a licensee from picking up a prescription or delivering a prescription drug or device, at the request of the patient, at the office or home of the prescriber or patient, at an institution in which the patient is confined, at another place as the patient designates for his safety and convenience, or by means of an employe, the mails or common carrier.

 (f)  No pharmacist or pharmacy may dispense, dispose of, or sell a Schedule V cough preparation containing codeine, dilaudid or other narcotic cough preparation without a prescription, except that this subsection does not apply to a preparation used within an institution.

 (g)  Sales of Schedule V narcotic preparations are required to have affixed to the bottle or container at the time of sale a label indicating the name and address of the pharmacy and the initials of the pharmacist and the date of sale.

 (h)  No prescription may be knowingly filled or refilled for a patient which prescription was written for prior use by a prescriber who is deceased or no longer in practice.

 (i)  [Reserved]

 (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.

 (k)  Prepacking and labeling in convenient quantities for subsequent use shall be done under the direct personal supervision of a registered pharmacist. A container shall have a label containing the name of the drug and, if the name is generic, the name of the manufacturer, its strength, the manufacturer’s control number or other code control number and the expiration date, if any. A log shall be kept in the pharmacy stating the name of the drug and, if the name is generic, the name of the manufacturer, its strength, the manufacturer’s control number or other code control number, the expiration date, if any, and the date and quantity prepacked.

 (l)  Prescriptions sent through the mail to a pharmacy shall be compounded and dispensed in the following manner:

   (1)  Prescription medication shall be sent only in first class mail or common carrier, except where the purchaser is advised in advance that a slower means of transportation will be used and agrees thereto.

   (2)  The mailing of antibiotics which have been reconstituted is prohibited.

   (3)  The mailing of a medication or prescription drug or device generally accepted and recognized to be subject to significant deterioration of the original content due to heat, cold, fermentation or prolonged agitation is prohibited.

 (m)  Prescription drugs, medications and devices which are delivered shall be sent in such containers as are reasonably necessary, considering the nature of the drug, medication or device, to insure its safety and effectiveness for the patient.

 (n)  A prescription by means of an oral order, telephone or otherwise, shall be received and transcribed only by a registered pharmacist.

 (o)  Except as provided under the definition of order, an oral prescription shall be reduced to writing immediately by the pharmacist and shall be filled by, or under the direction of the pharmacist. An order entered on the chart or medical record of a patient in an institution for the diagnostic care and treatment of a patient on an overnight basis, or on the chart or medical record of a patient under emergency treatment in an institution by or on the order of a practitioner authorized by statute to prescribe drugs or devices, shall be considered to be a prescription if the medication is to be furnished directly to the patient for self-administration. It is the responsibility of the prescriber to see that the chart or medical record contains the information required for a prescription and that it is signed by the prescriber himself at the time the drug is given or if he is not present, then on his next visit to the institution. No registered pharmacist may compound, prepare, dispense, fill, sell or give away a drug or device on the basis of a prescription or order in an institution or hospital unless the prescription or order is an original prescription or order or direct copy thereof issued by the authorized prescriber or practitioner who may be using electronic or computerized equipment.

 (p)  The pharmacist has the responsibility to make his professional service available under the following conditions:

   (1)  A pharmacist practicing in a hospital, institution or similar place or specialized ambulatory care unit may not be required to extend pharmaceutical services to other than registered patients of that hospital or institution.

   (2)  A pharmacist shall offer complete pharmaceutical service by compounding or dispensing prescriptions which may reasonably be expected to be compounded or dispensed by pharmacists to meet the needs of persons who would usually attempt to utilize the services.

   (3)  A pharmacist shall safeguard the storage and distribution of prescription drugs and devices under Commonwealth and Federal statutes, maintaining proper records therefor and shall, upon request, advise concerning contents, therapeutic values and uses of the drugs, devices and articles.

   (4)  No pharmacy or pharmacist may discriminate against a person on account of race, creed, religion, national origin or sex.

 (q)  No pharmacist, pharmacy owner or pharmacist manager may be permitted to provide a medical practitioner or a person authorized to prescribe drugs or devices with prescription blanks bearing a pharmacist’s name or the name or address of the pharmacy thereon.

 (r)  The following provisions are applicable to the advertisement and sale of drugs:

   (1)  No person may advertise the filling or refilling of prescriptions for a consumer or patient in the Commonwealth if that person is not licensed under the act or the prescription is not filled or refilled in a pharmacy licensed by the Board.

   (2)  No person may promote to the public the sale of Schedule II controlled substances or barbiturates and their compounds.

   (3)  Advertisements of prescription drugs and devices may not be false or misleading, and shall be truthful, reasonable, informative and understandable to the public.

   (4)  A drug or device misbranded or adulterated in Federal law is misbranded and adulterated in Commonwealth law.

   (5)  An advertisement of a prescription shall be for a commercially reasonable quantity. If the price of a quantity of a prescription drug is advertised, the price of one dosage unit or of the smallest saleable quantity shall be shown in close proximity thereto.

   (6)  A pharmacist or pharmacy advertising special prices for prescriptions, dangerous drugs, proprietary or nonproprietary drugs, preparations or products, devices and appliances, if using a percentile number such as 10% off, 20% off, and the like, as to selected items, shall state or publish a price list from which the percentile prices are derived, so the consumer or patient knows exactly what the cost is.

   (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.

   (8)  A violation of the Unfair Trade Practices and Consumer Protection Law (73 P. S. § §  201-1—201-9.2) is a violation of this chapter.

 (s)  The following provisions are applicable to paraphernalia and accessories:

   (1)  Sale of accessories, such as empty capsules, quinine, sugar of milk or a similar product found in illegal traffic when sold in unusually large quantities shall be immediately reported to the Board. A pharmacist who sells, gives away or otherwise disposes of accessories, chemicals or proprietary products when the pharmacist knows or has reason to know of their intended use for illegal purposes shall be guilty of unprofessional conduct and in violation of this chapter.

   (2)  Sales of needles and syringes shall be made by the pharmacist only to persons showing a prescription issued by a licensed practitioner. The prescription shall be in force for a maximum of 1 year from date of its issuance. This subsection shall take effect 3 months after the other provisions of this chapter take effect in order to give the public ample notice.

 (t)  A pharmacist may only renew a prescription at a reasonable time prior to the time when the contents of the prescription shall be consumed according to prescriber’s directions.

 (u)  A violation by a pharmacist of the Federal Controlled Substances Act (21 U.S.C.A. §  321 et seq.) or The Controlled Substance, Drug, Device and Cosmetic Act (35 P. S. § §  780-101—780-144) or the rules and regulations promulgated thereunder constitutes a violation of this chapter and of the act.

 (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.

Notes of Decisions

   Revocation of a pharmacist’s 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. § §  780-101—780-144)) 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. § §  390-1—390-13) and the Board’s regulations, the Board’s 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 pharmacist’s 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 Board’s 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

   This section cited in 6 Pa. Code §  11.142 (relating to labeling of medications); 6 Pa. Code §  22.62 (relating to conditions of provider participation); 6 Pa. Code §  22.63 (relating to other provisions for providing services by mail); 6 Pa. Code §  22.82 (relating to false or fraudulent claims by providers); 28 Pa. Code §  113.25 (relating to drug distribution systems); 49 Pa. Code §  27.12 (relating to practice of pharmacy and delegation of duties); 49 Pa. Code §  27.101 (relating to radiopharmaceutical prescriptions—statement of policy); 49 Pa. Code §  27.201 (relating to electronically transmitted prescriptions); 49 Pa. Code §  27.202 (relating to computerized recordkeeping systems); and 49 Pa. Code §  43a.9 (relating to schedule of civil penalties—pharmacists and pharmacies).

§ 27.19. Prospective drug review and patient counseling.

 (a)  Definitions. The following words and terms, when used in this section, have the following meanings, unless the context clearly indicates otherwise:

   Caregiver—A person who has assumed responsibility for the care of a patient. The following will be presumed to be caregivers: the spouse, parent, adult child, guardian, legal representative or nurse of the patient.

   Mail order pharmacy—A pharmacy whose primary patient population consists of patients who send their prescriptions to the pharmacy through the mail and receive nonproprietary drugs and devices from the pharmacy through the mail, common carrier or express courier serivce.

   PDR—Prospective Drug Review.

 (b)  General. This section requires a pharmacist to perform a PDR before filling, delivering or sending a new retail or outpatient prescription. The PDR requires that the pharmacist review a profile of the patient maintained in the pharmacy in accordance with subsection (g) prior to dispensing the medication to the patient or caregiver and that the pharmacist or designee of the pharmacist make an offer to counsel the patient or caregiver.

 (c)  Purpose. The purpose of the PDR is to help assure that a drug dispensed under a prescription is not likely to have an adverse medical result. The PDR accomplishes this by attempting to identify potential drug therapy problems that might result from therapeutic duplication, drug-drug interactions, incorrect dosage, incorrect duration of drug treatment, drug-allergy interactions, and clinical abuse or misuse.

 (d)  Scope.

   

   (1)  The PDR is required for retail or outpatient prescriptions. The PDR does not extend to the following:

     (i)   An order for a drug for an inpatient of an institution, as the term ‘‘institution’’ is defined in this chapter.

     (ii)   A drug dispensed in an emergency room.

     (iii)   A drug dispensed by a medical practitioner.

     (iv)   A drug dispensed by a pharmacist to a medical practitioner which the practitioner will administer to a patient.

   (2)  The following are examples of situations in which a PDR is required:

     (i)   A patient visits a physician in the physician’s office and receives a prescription. The patient has the prescription filled in a retail pharmacy.

     (ii)   A pharmacist fills a prescription for a patient who lives in a personal care home.

     (iii)   A pharmacist in a hospital pharmacy fills an outpatient prescription for a hospital employe.

     (iv)   A patient is treated on a nonemergency basis in an outpatient clinic of a hospital and is given a prescription. The patient has the prescription filled either in the hospital pharmacy or in a retail pharmacy.

   (3)  The following are examples of situations in which a PDR is not required:

     (i)   A pharmacist fills a prescription for a patient in a nursing home.

     (ii)   A pharmacist in a hospital dispenses a drug which will be administered to a patient in the hospital.

     (iii)   A physician dispenses a drug to a patient being treated in the emergency room.

     (iv)   A pharmacist dispenses a radiopharmaceutical to a physician who will administer it to a patient.

 (e)  The offer to counsel.

   (1)  An offer to counsel shall be made to each patient or caregiver when the pharmacist fills, delivers or sends a new retail or outpatient prescription.

   (2)  The pharmacist or designee of the pharmacist shall orally make the offer in person if a patient or caregiver comes to the pharmacy. If the pharmacist in the exercise of professional judgment in the interest of a patient believes that an oral offer would be less effective than a written offer, the pharmacist may substitute a written offer. The following are examples of situations in which a pharmacist might substitute a written offer:

     (i)   The patient or caregiver is hearing impaired.

     (ii)   The patient or caregiver is not an English speaker.

   (3)  If neither the patient nor caregiver comes to the pharmacy, the offer to counsel shall be made in one of the following ways;

     (i)   The pharmacist or designee may telephone the patient or caregiver.

     (ii)   The pharmacy delivery person may orally make the offer to the patient or caregiver.

     (iii)   The pharmacist may send a written offer to counsel together with the filled prescription which is delivered or sent to the patient.

   (4)  A written offer to counsel shall include the telephone number of the pharmacy.

   (5)  A pharmacy shall provide toll-free telephone service if its primary patient population is beyond the local or toll-free exchange.

   (6)  A mail order pharmacy shall make the offer to counsel either by telephone or by sending a written offer together with the filled prescription. The written offer shall include a toll-free telephone number of the pharmacy which a patient or caregiver may use to obtain counselling.

   (7)  The obligation to make an offer to counsel will be fulfilled by making one offer in accordance with this subsection.

 (f)  The counselling.

   (1)  Only a pharmacist may counsel.

   (2)  If a patient or caregiver who comes to the pharmacy indicates that he wants counselling, the pharmacist shall counsel the patient or caregiver in person, or, at the discretion of the patient or caregiver, by telephone.

   (3)  If the filled prescription is sent or delivered to the patient or caregiver, counselling shall be by telephone.

   (4)  The following are examples of matters which a pharmacist in the exercise of professional judgment might deem significant and discuss with the patient or caregiver:

     (i)   The name and description of the medication.

     (ii)   The route of administration, dosage form and duration of drug therapy.

     (iii)   Special directions and precautions for preparation, administration and use by the patient.

     (iv)   Common severe side effects or interactions and therapeutic contraindications that may be encountered, including their avoidance, and the action required if they occur.

     (v)   Techniques for self-monitoring drug therapy.

     (vi)   Proper storage.

     (vii)   Prescription refill information.

     (viii)   Action to be taken in the event of a missed dose.

   (5)  If a pharmacist discovers a specific problem with a medication during the course of a PDR, the pharmacist shall intervene to attempt to resolve the problem.

 (g)  The patient profile.

   (1)  The pharmacist or designee of the pharmacist shall make a reasonable effort to obtain, record and maintain the following information about each patient:

     (i)   The name, address, telephone number, date of birth (or age) and gender.

     (ii)   Individual history, if significant, including known allergies and drug reactions, and a list of medications and relevant devices, as provided by the patient or caregiver.

     (iii)   Pharmacist comments relative to the individual’s drug therapy.

   (2)  The patient profile may be maintained electronically or manually.

   (3)  The pharmacist or designee of the pharmacist shall begin a patient profile when the pharmacist fills a prescription for a new patient or for a current patient for whom a profile had not previously been maintained.

   (4)  The patient profile shall be maintained for at least 2 years after the last entry.

   (5)  The Board will consider a single request for information for a patient profile made to a patient or caregiver a reasonable effort to obtain the information outlined in this subsection.

 (h)  Refusal to accept counselling or to provide information.

   (1)  A pharmacist is not required to provide counselling or obtain information for the patient profile if the patient or caregiver refuses the offer to counsel or refuses to divulge information for the patient profile. If a patient or caregiver fails to respond to an offer to counsel or a request for information, the failure to respond will be deemed a refusal.

   (2)  The pharmacist or designee shall document the refusal of a patient or caregiver to accept counselling or provide information. The documentation shall include the name or initials of the pharmacist or designee noting the refusal. The following kinds of documentation are acceptable:

     (i)   A notation made by the pharmacist or designee on the prescription or patient profile or the electronic records of the pharmacy.

     (ii)   A writing signed by the patient or caregiver.

 (i)  Confidentiality.

   (1)  Information gained by a pharmacist, pharmacy or employe of a pharmacy about a patient under this section shall be regarded as confidential. The information shall be maintained in accordance with section 8(10) of the act (63 P. S. §  390-8(10)).

   (2)  The pharmacist or pharmacy may reveal the information if one of the following circumstances occurs:

     (i)   The patient consents to the disclosure.

     (ii)   The Board or its authorized agents require the information for any proceeding under the act.

     (iii)   State or Federal law or regulations require or authorize the disclosure.

     (iv)   A court orders the disclosure.

Source

   The provisions of this §  27.19 adopted March 4, 1994, effective March 5, 1994, 24 Pa.B. 1180.

Cross References

   This section cited in 49 Pa. Code §  27.203 (relating to centralized prescription processing).

§ 27.20. Facsimile machines.

 (a)  Schedule II controlled substances.

   (1)  A pharmacist may fill a prescription for a Schedule II controlled substance which was received on a facsimile machine if the original prescription signed by the medical practitioner is presented to the pharmacist for review prior to the actual dispensing of the controlled substance. The original prescription shall be maintained as the original pharmacy record.

   (2)  There are three exceptions to the requirement that the pharmacist review the original of the prescription received on a facsimile machine before dispensing a Schedule II controlled substance. A pharmacist may fill and dispense a prescription for a Schedule II controlled substance which was received on a facsimile machine and may use the facsimile as the original pharmacy record of the following:

     (i)   A prescription for a Schedule II controlled narcotic substance to be compounded for the direct administration to a patient by parenteral, intravenous, intramuscular, subcutaneous or intraspinal infusion in the patient’s home.

     (ii)   A prescription for a Schedule II controlled substance for a resident of a long-term care facility.

     (iii)   A prescription for a Schedule II controlled narcotic substance for a patient enrolled in a hospice care program.

 (b)  Schedule III, IV and V controlled substances and other nonproprietary drugs. A pharmacist may fill and dispense a prescription signed by a medical practitioner for a Schedule III, IV or V controlled substance or other nonproprietary drug which was received on a facsimile machine. The pharmacist may use the facsimile as the original pharmacy record.

 (c)  General.

   (1)  A pharmacist shall exercise professional judgment regarding the accuracy and authenticity of the facsimile copy of a prescription.

   (2)  Unless the original prescription will be maintained as the original pharmacy record, the quality of paper on which a facsimile copy of a prescription is printed shall be of a type that the facsimile copy can be maintained as a record for at least 2 years, as required under section 4(a)(3) of the act (63 P. S. §  390-4(a)(3)).

   (3)  A pharmacist or pharmacy may not contribute in any way to the installation of a facsimile machine in the office of a medical practitioner or in an institution.

   (4)  For purposes of this section, a prescription does not include an order for medication which is dispensed for immediate administration to a patient in an institution.

Authority

   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

   This section cited in 49 Pa. Code §  27.52 (relating to graduates of foreign schools and noncitizens).

§ 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)  An applicant shall be working on a full-time basis in a pharmacy approved for intern training.

   (4)  A pharmacist preceptor may not direct the training of more than two pharmacy interns at any one time, unless the program has been approved by the Board for a greater number.

   (5)  A pharmacist preceptor shall be willing to cooperate with the Board in developing an intern program and shall apply to the Board signifying the desire to do so.

   (6)  A pharmacist preceptor shall certify to the commencement and completion of intern training and may make recommendations to the Board concerning the competency of the intern under his supervision.

   (7)  A pharmacist preceptor shall report to the Board, as required by the Board, on the progress of an intern under the pharmacist’s supervision.

   (8)  A pharmacist preceptor shall be charged with the responsibility for seeing that his intern receive proper pharmaceutical training and experience, always keeping in mind the objections of the practical training program.

 (i)  Credit shall be granted for practical experience gained in pharmacies outside this Commonwealth upon presentation of evidence satisfactory to the Board to indicate that the experience gained is substantially equivalent to that required by this chapter.

 (j)  The pharmacy internship may not be deemed satisfactorily completed until the intern has filed affidavits with the Board certifying that the intern has obtained a total of 1,500 hours of practical experience since registration as a pharmacy intern.

 (k)  When a candidate receives his first certificate and identification card to practice as a pharmacist, his certificate as an intern terminates.

Source

   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 pharmacist’s 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 §  27.31 amended December 19, 1986, effective December 20, 1986, 16 Pa.B. 4883. Immediately preceding text appears at serial page (101310).

§ 27.32. Continuing education.

 (a)  The Board will renew the license of a pharmacist who has completed a minimum of 30 contact hours (3 CEU) of continuing education during the preceding biennial renewal period. For licensees with authority to administer injectable medications, biologicals and immunizations in accordance with section 9.2 of the act (63 P. S. §  390-9.2) and §  27.301 (relating to qualifications for authority), at least 2 of the required 30 hours shall concern the administration of injectable medications, biologicals and immunizations, including disease epidemiology, vaccine characteristics, injection technique, emergency response to adverse events and related topics. Programs offered by providers accredited by the ACPE are approved by the Board.

 (b)  A pharmacist shall prove compliance with the requirements of subsection (a) by completing and submitting a form provided to the pharmacist by the Board for that purpose with the renewal application. The certificates provided upon completion of an approved program shall be retained by a pharmacist for 2 years after renewal, and shall be produced upon demand by the Board or its auditing agents. The Board will utilize a random audit of 5% of renewals to determine compliance with the requirements of subsection (a), and may expand the audit if rates of noncompliance at 20% or more of the sample are revealed by the initial audit. Individuals selected for the audit will be required to produce certificates proving the information they provided to the Board on the form submitted with the renewal application.

 (c)  Both live and correspondence courses will be accepted by the Board as long as they are offered by approved providers.

 (d)  An excess of completed contact hours in one renewal period will not be carried over into the next renewal period.

 (e)  A newly graduated licensee will be exempt from the requirements in subsection (a) for the license renewal immediately following licensure. A reciprocally licensed pharmacist will be required to show compliance with the requirements in subsection (a), but will have the number of hours required to be completed prorated, on a quarterly basis, from the date of licensure to the next date of renewal. For this purpose, each quarter will consist of 3 months, and will be credited for 3.75 contact hours (.375 CEU). The pharmacist will be required to begin accumulating contact hours at the beginning of the next quarter following licensure.

 (f)  A pharmacist whose license has been suspended or revoked for disciplinary reasons shall comply with continuing education requirements during the period of suspension or revocation, if the pharmacist wants to resume practice or petition for licensure reinstatement at the conclusion of the disciplinary period.

 (g)  The Board will consider renewing a license without timely filing of the required hours of continuing education on a case by case basis, upon a showing of incapacity, acute illness or other circumstances which reasonably precluded timely compliance. Pharmacists whose licenses are renewed under this subsection will be required to make up the missing hours of continuing education on a schedule determined by the Board, and to pay applicable fees and fines.

 (h)  Continuing education program providers which are not ACPE approved may apply to the Board for approval, and shall make a showing of program accreditation substantially similar to ACPE accreditation standards. The Board will maintain a list of programs approved under this subsection.

 (i)  A pharmacist who fails to comply with this section, or who submits fraudulent contact hour reports, will be subject to disciplinary action.

Authority

   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 § §  27.21—27.26 (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 Board’s 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 prescriptions—statement 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 medication—statement 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 pharmacy’s 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

   The provisions of this §  27.102 adopted October 17, 2003, effective October 18, 2003, 33 Pa.B. 5202.

§ 27.103. Matters of conscience—statement of policy.

 (a)  Background and purpose. This statement of policy is not intended to supersede relevant laws, rules or regulations. Questions have been raised relating to the professional obligations of licensed pharmacists with respect to providing services to which they may be religiously, morally or ethically opposed. Pharmacists have a professional responsibility to offer complete pharmaceutical service by compounding or dispensing prescriptions which may reasonably be expected to be compounded or dispensed by pharmacists to meet the needs of patients who would usually attempt to utilize the services. However, pharmacists may also 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. When a pharmacist recognizes that religious, moral or ethical beliefs will result in the refusal to fill a prescription that is otherwise available in a pharmacy, the pharm