Section 390-2 - DefinitionsAs used in this act:
(1)"Person" includes individual, partnership, corporation, association or any other legal entity.(2)"Board" means the State Board of Pharmacy.(2.1)"Dispense" or "dispensing" means the preparation of a prescription or non-prescription drug in a suitable container appropriately labeled for subsequent administration to or use by a patient or other individual entitled to receive the drug.(3)"Drugs" mean--(i) Articles recognized as drugs in the official United States Pharmacopoeia, official Homeopathic Pharmacopoeia of the United States, or official National Formulary or its successor.(ii) Articles intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in man or other animals.(iii) Articles (other than food) intended to affect the structure or any function of the body of man or other animals.(iv) Articles intended for use as a component of any articles specified in subclauses (i), (ii) or (iii), but not including devices or their component parts or accessories.(4)"Official compendium" shall mean the current revisions of the Pharmacopoeia of the United States, Homeopathic Pharmacopoeia of the United States and National Formulary or its successor.(5)"Device" means an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent or other similar or related article, including any component part or accessory, which is required under Federal or State law to be prescribed by a practitioner and dispensed by a pharmacist.(6)"Federal act" means the Federal Food, Drug and Cosmetic Act (Title 21, USC 301 et seq., 52 Stat. 1040 et seq.).(7)"Controlled substance" means any drug designated as such under the provisions of the act of April 14, 1972 (P.L. 233, No. 64), known as "The Controlled Substance, Drug, Device and Cosmetic Act." (7.1)"Non-proprietary drug" means a drug containing any quantity of any controlled substance or any drug which is required by any applicable Federal or State law to be dispensed only by prescription.(7.2)"Proprietary drug" shall mean non-prescription, non-narcotic medicines or drugs which may be sold without a prescription and which are prepackaged for use by the consumer and labeled in accordance with the requirements of the statutes and regulations of this State and the Federal Government.(8)"Prescription" means a written or oral order issued by a duly licensed medical practitioner in the course of his professional practice for a controlled substance, other drug or device or medication which is dispensed for use by a consumer.(8.1)"Emergency prescription" means a refill of a prescription which is essential to the continuation of therapy in a chronic condition, for which the refill has not been authorized and for which the pharmacist notifies, within seventy-two hours, the prescriber that an emergency prescription has been dispensed.(9)"Medical practitioner" means a physician, dentist, veterinarian or other individual duly authorized and licensed by law to prescribe drugs.(10)"Pharmacist" means an individual duly licensed by the State Board of Pharmacy to engage in the practice of pharmacy.(11)"Practice of pharmacy" means the provision of health care services by a pharmacist, which includes the interpretation, evaluation and implementation of medical orders for the provision of pharmacy services or prescription drug orders; the delivery, dispensing or distribution of prescription drugs; participation in drug and device selection; drug administration; drug regimen review; drug therapy management, including such services provided under the Medicare Prescription Drug, Improvements, and Modernization Act of 2003 ( Public Law 108-173 , 117 Stat. 2066); drug or drug-related research; compounding; proper and safe storage of drugs and devices; management of drug therapy pursuant tosection 9.3 or, if in an institutional setting, consistent with the institution's assignment of clinical duties pursuant to a written agreement or protocol as set forth insection 9.1 ; maintaining proper records; patient counseling; and such acts, services, operations or transactions necessary or incident to the provision of these health care services. The "practice of pharmacy" shall not include the operations of a manufacturer or distributor as defined in "The Controlled Substance, Drug, Device and Cosmetic Act."(12)"Pharmacy" means every place properly issued a permit by the Board of Pharmacy where drugs, devices and diagnostic agents for human or animal consumption are stored, dispensed or compounded, excluding offices or facilities of veterinarians licensed by the State Board of Veterinary Medical Examiners. The term "pharmacy" shall not include the operations of a manufacturer or distributor as defined in "The Controlled Substance, Drug, Device and Cosmetic Act." In an institution, "pharmacy" refers to the organized pharmacy service in the institution under the direct supervision of a licensed pharmacist.(13) The words "drug" and "devices" shall not include surgical or dental instruments or laboratory materials, gas and oxygen, therapy equipment, X-ray apparatus or therapeutic equipment, their component parts or accessories, or equipment, instruments, apparatus or contrivances used to render such articles effective in medical, surgical or dental treatment, or for use or consumption in or for mechanical, industrial, manufacturing or scientific applications or purposes, nor shall the word "drug" include any article or mixture covered by the Pesticide Act of 1957, nor medicated feed intended for and used exclusively as a feed for animals other than man.(14)"Management of drug therapy" means any of the following processes which shall be performed pursuant to a written agreement or protocol as set forth in section 9.1 or pursuant to section 9.3: adjusting a drug regimen; adjusting drug strength, frequency of administration or route; administration of drugs; ordering laboratory tests and ordering and performing other diagnostic tests necessary in the management of drug therapy; monitoring the patient's vital signs; and providing education and training to the patient which is related to the management of drug therapy. The management of drug therapy under section 9.1 shall be performed consistent with the institution's assignment of clinical duties, and ordering of laboratory tests and ordering or performing other diagnostic tests necessary in the management of drug therapy shall be consistent with the testing standards of the institution.(15)"Institution" means a health care facility as defined in section 103 of the act of July 19, 1979 (P.L. 130, No. 48) , known as the "Health Care Facilities Act," which offers care and medical treatment to patients who require food, board and overnight sleeping facilities.(16)"Drug administration" means the direct introduction of or the application of a drug into or on the body of a patient by injection, inhalation, ingestion or any other means and, where required by law, shall occur only pursuant to a medical order.(17)"Physician" means an individual licensed under the laws of this Commonwealth to engage in the practice of medicine and surgery in all its branches within the scope of the act of December 20, 1985 (P.L. 457, No. 112) , known as the "Medical Practice Act of 1985," or in the practice of osteopathic medicine within the scope of the act of October 5, 1978 (P.L. 1109, No. 261), known as the "Osteopathic Medical Practice Act."(18)"Protocol" means a written document that describes the nature and scope of the drug therapy management to be carried out by the pharmacist. (19) "Nonresident pharmacy" means any pharmacy located outside this Commonwealth that ships, mails or delivers, in any manner, legend devices or legend drugs into this Commonwealth pursuant to a prescription order. (20)"Pharmacy technician" means an individual who:(i) Is registered with the board as a pharmacy technician.(ii) May assist in the practice of pharmacy under the direct and immediate personal supervision of a licensed pharmacist after meeting the requirements of this act and the regulations promulgated under this act. The term "pharmacy technician" shall not include an individual performing clerical support with no direct interaction with prescription medication or ability to enter a prescription drug order.(21)"Pharmacy technician trainee" means an individual who has been issued a temporary permit by the board that authorizes the individual to perform the duties of a pharmacy technician under the direct and immediate personal supervision of a licensed pharmacist. (22) "Direct and immediate personal supervision" means:(i) Review by the pharmacist of the prescription or drug order prior to dispensing.(ii) Verification by the pharmacist of the final product.(iii) Immediate availability of the pharmacist on the premises to direct the work of the supervised individual and to respond to questions or problems.(23) "COVID-19" means the novel coronavirus as identified in the proclamation of disaster emergency issued by the Governor on March 6, 2020, published at 50 Pa.B. 1644 (March 21, 2020). Amended by P.L. TBD 2020 No. 140, § 1, eff. 1/29/2021.Amended by P.L. TBD 2015 No. 43, § 1, eff. 12/6/2015.1961, Sept. 27, P.L. 1700, §2. Amended 1985 , Dec. 20, P.L. 433, No. 111, § 1, effective Jan. 1, 1986; 2002, June 29, P.L. 673, No. 102, § 1, effective in 60 days; 2010, June 1, P.L. 201, No. 29, § 1, effective in 60 days [Aug. 2, 2010].