§ 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.

   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)).

   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).

   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).