Tenn. Comp. R. & Regs. 1140-01-.01 - DEFINITIONS

(1) "ACPE" means the Accreditation Council for Pharmacy Education.

(2) "Alternate or alternative infusion pharmacy practice site" means a pharmacy practice site where parenteral, enteral or respiratory therapies, and ancillary supplies, medications and equipment are provided to patients in a non-institutional setting.

(3) "Accreditation Council for Pharmacy Education (ACPE)" means the national organization for accreditation of professional degree programs in pharmacy and for accreditation of providers of continuing pharmacy education.

(4) "Automated Dispensing System" means a mechanical or electronic system outside the premises of an institutional or long-term care pharmacy that performs operations or activities, other than compounding or administration, relating to pharmacy services, including the storage, dispensing, or distribution of drugs and the collection, control, and maintenance of all transaction information, to provide security and accountability for such drugs.

(5) "Blood" means whole blood collected from a single donor and processed either for transfusion or further manufacturing.

(6) "Blood fraction/component" means that part of blood separated by physical or mechanical means.

(7) "Centralized Prescription Processing" is the filling or refilling of a lawful prescription order written by the patient's authorized prescriber by one (1) pharmacy licensed by the State of Tennessee at the request of another pharmacy licensed by the State of Tennessee for the delivery of the prescription drugs to the patient or patient's agent.

(8) "Certified pharmacy technician" means an individual who is certified by a national or state agency that offers a certification program that is recognized by the board.

(9) "Commercially available" means any marketed FDA-approved drug or biologic product not currently listed on any official shortage list recognized by the Board of Pharmacy.

(10) "Common carrier" means any person or entity who undertakes, whether directly or by any other arrangement, to transport property including prescription drugs and/or devices for compensation. A common carrier is only responsible for transportation. A common carrier has no responsibility to direct the sale or disposition of property.

(11) "Component" means any active ingredient, or any added substance, inactive ingredient, excipient or pharmaceutic ingredient, intended for use in the compounding of a drug product, including those that may not appear on the product label.

(12) "Consultant pharmacist" means a pharmacist retained on a routine basis to consult with organizations, institutional facilities or patients in areas that pertain to the practice of pharmacy.

(13) "Contact hour" means any hour of completed continuing pharmaceutical education programming which is:

(a) Accredited by ACPE (including, but not limited to, live programs, independent study courses, home correspondence courses, and audio or video cassettes); or

(b) Approved by the board (including, but not limited to, attendance at state, district, or local pharmacy association meetings).

(14) "Continuing education unit" means ten (10) hours of participation in an ACPE approved or board-approved continuing pharmaceutical education program under responsible sponsorship, capable direction, and qualified instruction.

(15) "Drug sample" means a unit of a prescription drug that is not intended to be sold and is intended to promote the sale of the prescription drug.

(16) "Electronic medical or prescription order" means a medical or prescription order which is transmitted by computer technology other than by electronic image transmission.

(17) "Facsimile (FAX) medical or prescription order" means a medical or prescription order which is transmitted by an electronic image transmission.

(18) "Foreign pharmacy graduate" means a person whose undergraduate pharmacy degree was conferred by any college or school of pharmacy not accredited by the ACPE but which is listed in the World Health Organization World Directory of Colleges and Schools of Pharmacy, or otherwise approved by the Foreign Pharmacy Graduate Examination Committee (FPGEC) certification program as established by the National Association of Boards of Pharmacy.

(19) "Hazardous product" means any substance that may be cytotoxic, genotoxic, oncogenic, mutagenic, teratogenic, or otherwise pose a potential health hazard.

(20) "Institutional facility" means any organization whose primary purpose is to provide a physical environment for patients to obtain acute or short-term health care services, including but not limited to a(n):

(a) Hospital and associated clinics;

(b) Developmental disability center;

(c) Inpatient psychiatric center;

(d) Sub-acute care facility; and

(e) University health center.

(21) "Institutional pharmacy practice site" means a pharmacy practice site serving patients within an institutional facility.

(22) "Long term care pharmacy practice site" means a pharmacy practice site serving patients within a long term care facility.

(23) "Long term care facility" means any organization whose primary purpose is to provide a physical environment for patients to obtain healthcare services, and where patients spend a majority of their time within the facility, including, but not limited to a(n):

(a) Nursing home

(b) Hospice or residential hospice; and

(c) Assisted living facility.

(24) "Medication assessment" means a consultation between a pharmacist and a patient undertaken for the specific purpose of managing or discussing a course of drug therapy or treatment. Counseling as required by Board Rule 1140-03-.01 shall not be considered a medication assessment for the purposes of this part.

(25) "Medication order" means a prescription order for any prescription drug or device or related material issued by an authorized prescriber to authorized healthcare personnel in an institutional facility or institutional pharmacy practice site.

(26) "National Association of Boards of Pharmacy (NABP)" means the professional organization that represents the individual state boards of pharmacy.

(27) "Nuclear pharmacy practice site" means a pharmacy practice site providing radiopharmaceutical services.

(28) "Outsourcing facility" means a facility engaged in the compounding of sterile drugs which has elected to register as an outsourcing facility with the U.S. Food and Drug Administration and which complies with all relevant federal laws and regulations.

(29) "Oxygen supplier" means any person who sells, delivers, distributes or wholesales medical gases which require a prescription or medical order prior to administration, dispensing or delivery and which are considered legend drugs pursuant to the federal Food, Drug, and Cosmetic Act to any person residing in this state.

(30) "Patient counseling" means communication by the pharmacist of information to the patient or caregiver in order to improve therapeutic outcome.

(31) "Pharmaceutical care" is the responsible provision of drug therapy through, among other things, pharmacists identifying potential and actual drug-related problems and resolving and preventing drug-related problems, for the purpose of achieving definite outcomes that improve a patient's quality of life. The outcomes include but are not limited to cure of a disease, elimination or reduction of a patient's symptomatology, arresting or slowing of a disease process and the preventing of a disease or symptomatology.

(32) "Pharmacy internship" is a period of practical pharmacy experience under the direct supervision of a licensed pharmacist and pursuant to the rules of the board.

(33) "Pharmacy practice site" means any place within this state where prescription drugs or prescription devices are dispensed and where pharmaceutical care is provided, and any place outside of the state where prescription drugs or prescription devices are dispensed and pharmaceutical care is provided to persons residing in this state.

(34) "Preceptor" means an individual who is currently licensed as a pharmacist and who meets the qualifications of a preceptor under the rules of the board and participates in the education of pharmacy interns.

(35) "Prescription department" means the area of a pharmacy practice site in which prescription drugs and devices and related materials are stocked and medical and prescription orders are compounded and dispensed.

(36) "Quality assurance" means a system for identifying problems in patient care that are resolved via administrative, clinical, or educational actions to ensure that final products and outcomes meet applicable specifications.

(37) "Radiopharmaceutical service" means, but is not limited to:

(a) The compounding, dispensing, labeling, and delivering of radiopharmaceuticals;

(b) The participation in radiopharmaceutical selection and radiopharmaceutical utilization reviews;

(c) The proper and safe storage and distribution of radiopharmaceuticals;

(d) The maintenance of radiopharmaceutical quality assurance;

(e) The responsibility for advising, where necessary or where regulated, of the diagnostic and therapeutic value, hazards, and use of radiopharmaceuticals; and

(f) The offering or performing of those acts, services, operations, or transactions necessary in the conduct, operation, management, and control of a nuclear pharmacy practice site.

(38) "Reciprocity" means to issue a license to an applicant who furnishes satisfactory proof of licensing by examination in another state or territory pursuant to the rules of the board.

(39) "Shall" means that compliance is mandatory.

(40) "Sterile product" means any dosage form, drug product, or biological product devoid from all living microorganisms, including but not limited to bacteria and fungus.

(41) "Sterile manufacturing" means the production, propagation, processing, pooling, or repackaging of sterile products for wholesale or any other form of distribution, not pursuant to a prescription or medical order.

(42) "Third-party logistics provider (3PL)" means a person who provides or coordinates warehousing or other logistics services of a drug or device on behalf of a manufacturer, wholesale distributor, or dispenser of the drug or device, but does not take ownership of the drug or device, nor has responsibility to direct the sale or disposition of the drug or device.

(43) "Third party pharmacy program" means any system of providing for the reimbursement of medical or prescription orders and/or pharmaceutical care services under a contractual arrangement or agreement between a provider of such services and the third party program administrator who is not the consumer of those services.

(44) "Third party pharmacy program administrator" means, but is not limited to, insurance companies, managed care organizations, health maintenance organizations, preferred provider organizations, pharmacy benefit managers, and pharmacy services administrative organizations.

(45) "Unit dose packaging" means that packaging which is designed to hold a quantity of a drug product intended for administration as a single dose.

(46) "USP" means the United States Pharmacopeia.

(47) "USP standards" means any applicable standard or standards published in the most current version of United States Pharmacopeia National Formulary guidelines, to the extent that such guidelines do not conflict with state law, rules, or Board Policy Statements and as those guidelines may, from time to time, be amended.

Notes

Tenn. Comp. R. & Regs. 1140-01-.01

Original rule certified June 7, 1974. Repeal and new rule filed February 7, 1983; effective March 9, 1983. Repeal and new rule filed May 11, 1998; effective July 25, 1998. Amendment filed November 24, 2008; effective February 7, 2009. Amendment filed December 23, 2009; effective March 23, 2010. Emergency rule filed January 31, 2014; effective through July 30, 2014. Emergency rule filed January 31, 2014 expired effective July 31, 2014. The rule reverted to its previous status. Amendment filed July 11, 2014; effective October 9, 2014. Amendment filed March 24, 2015; effective June 22, 2015. Amendments filed November 22, 2016; effective February 20, 2017. Amendments filed September 12, 2018; effective 12/11/2018.

Authority: T.C.A. §§ 63-10-101, 63-10-102, 63-10-204, 63-10-214, 63-10-216, 63-10-216, 63-10-301, 63-10-304, 63-10-304(b)(1), 63-10-404(5), (6), (14), (22), (26), (28), and (29), 63-10-504(b)(1), 63-10-306, and Chapter 966 of the Public Acts of 2008, § 1.