49 Pa. Code § 27.1

Current through Register Vol. 54, No. 50, December 14, 2024

Section 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 Accreditation Council for Pharmacy 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.

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.

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.

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.

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-

(i) 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.

(ii) 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.

FDA-The United States Food and Drug Administration, a division of the United States Department of Health and Human Services.

FDLE- Federal Drug Law Examination.

Institution- A health care facility as defined in section 103 of the Health Care Facilities Act (35 P. S. § 448.103) which offers care and medical treatment to patients who require food, board and overnight sleeping facilities.

Licensed person- A person holding a license issued by the Board.

Long-term care facility- A nursing home, retirement care, mental care or other institution that provides extended health care to resident patients.

MJPE- Multistate Pharmacy Jurisprudence Examination.

Management of drug therapy-

(i) Any of the following processes performed under a written protocol as set forth in section 9.1 of the act (63 P. S. § 390-9.1) or under a collaborative agreement as set forth in section 9.3 of the act (63 P. S. § 390-9.3):

(A) Adjusting a drug regimen.

(B) Adjusting drug strength, frequency of administration or route.

(C) Administration of drugs.

(D) Ordering laboratory tests and ordering and performing other diagnostic tests necessary in the management of drug therapy.

(E) Monitoring the patient's vital signs.

(F) Providing education and training to the patient that is related to the management of the drug therapy.

(ii) The term excludes medication therapy management services in the practice of pharmacy provided under the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (Pub. L. No. 108-173, 117 Stat. 2066).

Medical practitioner- A physician, dentist, veterinarian or other individual authorized and licensed by law to prescribe drugs.

Non-institutional setting- A setting other than an institution as defined in the act and this section.

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.

PDR- Prospective drug review performed to assure that a drug dispensed under a prescription is not likely to have an adverse medical result 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.

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-

(i) 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).

(ii) 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) Management of drug therapy under a written collaborative agreement as set forth in section 9.3 of the act or, if in an institutional setting, consistent with the institution's assignment of clinical duties under a written protocol as set forth in section 9.1 of the act.

(J) Maintaining proper records.

(K) Patient counseling.

(L) Acts, services, operations or transactions necessary or incident to the provision of these health care services.

(M) Drug therapy management, including services provided under the Medicare Prescription Drug, Improvement, and Modernization Act of 2003.

(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, electronic 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-

(i) That area of the pharmacy used for compounding, legend drug storage and other activities necessary to the practice of pharmacy.

(ii) 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-

(i) 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.

(ii) The term does not include a pharmacy serving the public on the premises of an 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.

USP-The United States Pharmacopeia-A compendium of drug information published by the United States Pharmacopeial Convention.

49 Pa. Code § 27.1

The provisions of this § 27.1 amended December 19, 1986, effective 12/20/1986, 16 Pa.B. 4883; amended June 20, 1997, effective 6/21/1997, 27 Pa.B. 2931; amended September 4, 1998, effective 9/5/1998, 28 Pa.B. 4532; amended May 26, 2006, effective 5/27/2006, 36 Pa.B. 2518; amended June 30, 2006, effective 7/1/2006, 36 Pa.B. 3237; amended December 24, 2009, effective 12/26/2009, 39 Pa.B. 7205; amended February 12, 2010, effective 2/13/2010, 40 Pa.B. 842; corrected October 7, 2011, effective 5/27/2006, 41 Pa.B. 5365; amended August 21, 2015, effective 8/22/2015, 45 Pa.B. 4911; amended June 21, 2019, effective 6/22/2019, 49 Pa.B. 3210.

The provisions of this § 27.1 amended under sections 4(j), 6(k)(1) and (9) and 9.3 of the Pharmacy Act (63 P. S. §§ 390-4(j), 390-6(k)(1) and (9) and 390-9.3).

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).