§ 63-10-204 — Definitions

Tennessee § 63-10-204

• Jurisdiction: Tennessee
• Title: 63

Text

As used in parts 2-5 of this chapter, unless the context otherwise requires: (1) "Administer" means the direct application of a drug to a patient or research subject by injection, inhalation, ingestion, topical application or by any other means; (2) "Board" means the Tennessee board of pharmacy; (3) "Certification" means a voluntary process by which a practitioner's training, experience and knowledge are identified as meeting or surpassing a standard, defined or approved by the board beyond that required for licensure or registration; (4) "Collaborative pharmacy practice" is the practice of pharmacy whereby one (1) or more licensed pharmacists licensed in this state, jointly and voluntarily work with one (1) or more prescribers licensed in this state, under a collaborative pharmacy practice agreement to provide patient care services, to achieve optimal medication use and desired patient outcomes; (5) "Collaborative pharmacy practice agreement" is a written and signed agreement entered into voluntarily between one (1) or more licensed pharmacists in this state, and one (1) or more prescribers licensed in this state, each of whom is in active practice in this state providing patient care services in this state, that provides for collaborative pharmacy practice, as defined by law; (6) "Compounding" means the preparation, mixing, assembling, packaging or labeling of a drug or device: (A) As the result of a prescription order or initiative based on the prescriber-patient-pharmacist relationship in the course of professional practice; (B) In anticipation of prescription orders based on routine, regularly observed prescribing patterns; (C) For the purpose of, or as an incident to, research, teaching or chemical analysis and not for sale or dispensing; (D) For use in a licensed prescribing practitioner's office for administration to the prescribing practitioner's patient or patients when the product is not commercially available upon receipt of an order from the prescriber; (E) For use in a health care facility for administration to a patient or patients receiving treatment or services provided by that facility when the product is not commercially available upon receipt of an order from an authorized licensed medical practitioner of the facility; (F) For use by emergency medical services for administration to a patient or patients receiving services from them under authorized medical control when the product is not commercially available upon receipt of an order from a licensed prescriber authorized to provide medical control; or (G) For use by a licensed veterinarian for administration to their nonhuman patient or patients or for dispensing to nonhuman patients in the course of the practice of veterinary medicine upon receipt of an order from a veterinarian when the product is not commercially available. (7) "Continuing education" means planned, organized learning experiences and activities beyond the basic educational or preparatory program. These learning experiences and activities are designed to promote the continuous development of skills, attitudes and knowledge necessary to maintain proficiency, provide quality service or products, be responsive to needs and keep abreast of significant change; (8) "Continuous quality improvement program" means a system of standards and procedures to identify and evaluate quality-related events and to improve patient care; (9) "Controlled substance" means a drug, substance or immediate precursor identified, defined or listed in title 39, chapter 17, part 4 and title 53, chapter 11; (10) "Deliver" or "delivery" means the actual, constructive or attempted transfer from one person to another whether or not there is an agency relationship; (11) "Device" means an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent or other similar or related article, including any component part or accessory, that is required under federal or state law to be ordered or prescribed by a person duly authorized; (12) "Dietary supplement" means a product, other than tobacco, intended to supplement the diet that bears or contains one (1) or more of the following ingredients: a vitamin, mineral, herb or other botanical, amino acid, dietary substance for use by humans to supplement the diet by increasing the total dietary intake, or a concentrate, metabolite, constituent, extract or combination of any of these ingredients and any other products designated as dietary supplements by federal or state law; (13) "Director" means the director of the health related boards; (14) "Dispense" means preparing, packaging, compounding or labeling for delivery and actual delivery of a prescription drug, nonprescription drug or device in the course of professional practice to a patient or the patient's agent, to include a licensed health care practitioner or a health care facility providing services or treatment to the patient or patients, by or pursuant to the lawful order of a prescriber; (15) "Distribute" or "distribution" means the sale, purchase, trade, delivery, handling, storage, or receipt of a product or the arrangement of the sale, purchase, trade, delivery, handling, storage, or receipt of a product through third parties; provided, that "distribute" or "distribution" does not include dispensing or administering a product pursuant to a prescription, medical order, or an over-the-counter order. For the purposes of this part, transfers and sales of drugs or devices from one (1) licensed pharmacy to another shall not constitute distribution of drugs or devices; (16) "Distributor" means a person engaged in the distribution of drugs or devices; provided, that "distributor" does not include licensed wholesale distributors or licensed third-party logistics providers; (17) "Division" means the division of health related boards; (18) "Doctor of pharmacy" means a person duly licensed by the board to engage in the practice of pharmacy. "Doctor of pharmacy" and "pharmacist" shall be used interchangeably within parts 4-6 of this chapter and, any other provision of Tennessee Code Annotated and in any rule or regulation promulgated by the state and its agencies; (19) "Drug" means any of the following: (A) Articles recognized as drugs or drug products in any official compendium or supplement thereto; (B) Articles, other than food, intended to affect the structure or function of the body of humans or other animals; (C) Articles, including radioactive substances, intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in humans or other animals; or (D) Articles intended for use as a component of any articles specified in this subdivision (19); (20) "Executive director" means the executive director of the Tennessee board of pharmacy; (21) "Label" means any written, printed or graphic matter on the immediate container of a drug or device; (22) "Labeling" means the process of affixing all labels and other written, printed or graphic matter: (A) Upon any article or any of its containers or wrappers; or (B) Accompanying such article; (23) "Licensure" means the process by which an agency of government grants permission to an individual to engage in a given occupation upon finding that the applicant has attained the minimal degree of competency necessary to ensure that the public health, safety and welfare will be reasonably protected; (24) "Manufacturer" means any person, except a pharmacist compounding in the normal course of professional practice, engaged in the commercial production, preparation, propagation, conversion or processing of a drug, either directly or indirectly, by extraction from substances of natural origin or independently by means of chemical synthesis, or both, and includes any packaging or repackaging of a drug or the labeling or relabeling of its container and the promotion and marketing of such drugs or devices; (25) "Medical order" means a lawful order of a prescriber for a specific patient that may or may not include a prescription order, such orders subject to rules and regulations as may be promulgated from time to time by the respective boards that license the persons who are authorized to prescribe drugs; (26) "Medication therapy management program" means the distinct pharmacist-provided service or group of services that optimize therapeutic outcomes for individual patients. Medication therapy management services are independent of but can occur in conjunction with the provision of a medication product; (27) "Nonprescription device" means a device that may be sold or dispensed without a prescription order and that is labeled and packaged in compliance with applicable state or federal law; (28) "Nonprescription drug" means a drug that may be sold or dispensed without a prescription and that is labeled and packaged in compliance with applicable state or federal law; (29) "Outsourcing facility" means a facility engaged in the compounding of sterile drugs that has elected to register as an outsourcing facility with the U.S. food and drug administration and that complies with all relevant federal laws and regulations; (30) "Patient education" means the communication of information to the patient or caregiver by the pharmacist; (31) "Patient profile" means a written or electronic record of individual patient information, created in a pharmacy practice, for use by a pharmacist in the provision of pharmacy patient care services, including drug use review and patient counseling requirements. The profile may include, but is not limited to, demographic information, medical history, medication and devices utilized, testing results and pharmacist comments; (32) "Peer review committee" or "pharmacist review committee" means any committee, board, commission or other entity of any national, state or local professional association or society, including an impaired pharmacist peer review committee, a drug utilization review committee or a committee of any pharmacy benefits management organization, health care provider network, licensed health care institution or any health care organization, system or foundation, the function of which, or one of the functions of which, is to review, evaluate and improve the quality of pharmacy-related services provided by pharmacists or pharmacy auxiliary personnel, to provide intervention, support or rehabilitative referrals or services or to determine that pharmacy-related services rendered by pharmacists or pharmacy auxiliary personnel were professionally indicated or were performed in compliance with applicable quality standards, or that the cost of pharmacy-related services rendered by pharmacists or pharmacy auxiliary personnel was reasonable; (33) "Person" means any individual, partnership, association, corporation and the state, its departments, agencies and employees, and the political subdivisions of Tennessee and their departments, agencies and employees, except the department of health and local health departments; (34) "Pharmacist" means an individual health care provider licensed by the state, pursuant to parts 4-6 of this chapter, to practice the profession of pharmacy; (35) "Pharmacist-in-charge" means the supervisory pharmacist who has the authority and responsibility for compliance with laws and rules pertaining to the practice of pharmacy at the practice site of the pharmacist-in-charge; (36) "Pharmacy" means a location licensed by this state where drugs are compounded or dispensed under the supervision of a pharmacist, as defined in the rules of the board and where prescription orders are received or processed; (37) "Pharmacy intern" means an individual enrolled in or a graduate of a recognized school or college of pharmacy under rules established by the board who is serving a period of time of practical experience under the supervision of a pharmacist, as defined in the rules of the board; (38) "Pharmacy technician" means an individual who is specifically trained and designated to assist a pharmacist and may perform tasks delegated by the pharmacist, including participation in drug, dietary supplement and device selection, storage, and distribution and administration, consistent with the pharmacy technician's education, training, and experience, as defined by rules promulgated by the board; (39) (A) "Practice of pharmacy" means a patient-oriented health service profession in which pharmacists interact and consult with patients and other health care professionals to enhance patients' wellness, prevent illness, and optimize outcomes. The practice involves: (i) Interpretation, evaluation and implementation of medical orders and prescription orders; (ii) Responsibility for compounding and dispensing prescription orders, including radioactive substances; (iii) Participation in drug, dietary supplement and device selection, storage, distribution and administration; (iv) Drug evaluation, utilization or regimen review; (v) Maintenance of patient profiles and other pharmacy records; (vi) Provision of patient education and counseling; (vii) Provision of patient care services and activities pursuant to a collaborative pharmacy practice agreement; (viii) Drug or drug-related research; and (ix) Those professional acts, professional decisions or professional services necessary to maintain all areas of a patient's pharmacist-provided care; (B) Nothing in this chapter authorizes a pharmacist to order laboratory tests or prescribe any prescription drugs except pursuant to a medical order by the attending prescriber for each patient or pursuant to a collaborative pharmacy practice agreement jointly agreed upon by a pharmacist or pharmacists and a prescriber or prescribers; provided, that pharmacists are authorized to conduct and assist patients with tests approved for home use. Pharmacists may convey orders for laboratory tests when authorized by the attending prescriber and may prescribe prescription drugs when required to carry out a medical order or perform activities pursuant to a collaborative pharmacy practice agreement when authorized by the attending prescriber; (C) Notwithstanding subdivision (39)(B), "practice of pharmacy" includes the issuing of a prescription or medical order of the following drugs, drug categories, or devices, excluding controlled substances, that are issued in accordance with the product's federal food and drug administration-approved labeling or guidelines of the federal centers for disease control and prevention that are limited to: (i) Antivirals for influenza and COVID-19 that are waived under the federal Clinical Laboratory Improvement Amendments of 1988 (CLIA) ( 42 U.S.C. § 263a ), upon completion of a test that is used to guide diagnosis or clinical decision-making; (ii) Agents for active immunization when prescribed for susceptible persons for the protection from communicable disease for individuals who are eighteen (18) years of age and older, and agents for active immunization for influenza and COVID-19 for individuals who are three (3) to seventeen (17) years of age; provided, that pharmacists shall comply with recordkeeping and reporting requirements, including, but not limited to: (a) Informing the patient's primary care provider, if the patient identifies a primary care provider; (b) Submitting the required immunization information to this state's vaccine registry; (c) Complying with requirements related to reporting adverse events; and (d) Reviewing the patient's vaccine history, if any, through this state's vaccine registry or other vaccination records prior to administering a vaccine; (iii) Post-exposure prophylaxis for nonoccupational exposure to HIV infection, and the ordering of lab tests in conjunction with initiation of therapy; (iv) Epinephrine auto-injectors for patients with a documented history of allergies or anaphylactic reactions; (v) Progesterone-only hormonal contraceptives; (vi) Naloxone; (vii) Topical fluoride agents when prescribed according to the American Dental Association's recommendations for persons whose drinking water is proven to have a fluoride content below the United States department of health and human services' recommended concentration; and (viii) Tuberculin purified protein derivative products in compliance with current statutory reporting requirements; (D) The standard of care for a pharmacist providing the services listed in subdivision (39)(C) is the same standard of care as a physician ordering or providing the same service; (E) Issuing a prescription or medical order pursuant to subdivision (39)(C) is not considered the "practice of medicine" as defined in § 63-6-204 ; (40) "Prescriber" means an individual authorized by law to prescribe drugs; (41) "Prescription drug" means a drug that under federal or state law is required to be dispensed only pursuant to a prescription order or is restricted to use by prescribers and that under federal law must be labeled with either the symbol "Rx only" or the statement "Caution: Federal law restricts this drug to use by, or on the order of, a licensed veterinarian"; (42) (A) (i) "Prescription order" means and includes any order, communicated through written, verbal, or electronic means by a physician, certified physician assistant, pharmacist in accordance with a collaborative pharmacy practice agreement pursuant to this section, dentist, veterinarian, optometrist authorized pursuant to § 63-8-102(12) , or other allied medical practitioner, for any drug, device, or treatment; (ii) "Prescription order" means and includes any order, communicated through written, verbal, or electronic means by a nurse authorized pursuant to § 63-6-204 , who is prescribing in collaboration with and under the control and responsibility of a licensed physician, and who meets the requirements pursuant to § 63-7-207(14) ; (B) Nothing in this chapter shall prohibit the verbal communication to a pharmacist of a direct order for a prescription from a physician, registered nurse, licensed practical nurse or physician assistant pursuant to § 63-6-204 , or dentist, veterinarian, optometrist authorized pursuant to § 63-8-102(12) , or other allied medical practitioner by a pharmacist pursuant to § 63-9-113 nor shall this chapter prohibit verbal communication of a direct order for a prescription from one (1) pharmacist to another when ordered pursuant to a collaborative pharmacy practice agreement; (C) Nothing in this chapter shall require an advanced practice registered nurse specializing as a certified registered nurse anesthetist (CRNA) to obtain authorization to prescribe pursuant to § 63-7-123 in order to select, order, or administer appropriate drugs during services ordered by a physician, dentist, or podiatrist and provided by a CRNA in collaboration with the ordering physician, dentist, or podiatrist that are within the scope of practice of the CRNA and authorized by clinical privileges granted by the medical staff of the facility. Such an order by a CRNA for drugs shall only be valid for dispensing for administration at the facility where the anesthesia services are being provided; (43) "Provider" or "necessary health care provider" includes a pharmacist who provides health care services within the scope of pharmacy practice; (44) "Quality assurance program" 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; (45) "Quality-related event" means the inappropriate dispensing or administration of a prescribed medication, including, but not limited to: (A) A variation from the prescriber's medical or prescription order, including, but not limited to: (i) Dispensing an incorrect drug; (ii) Dispensing an incorrect drug strength; (iii) Dispensing an incorrect dosage form; (iv) Dispensing the drug to the wrong patient; and (v) Providing inadequate or incorrect packaging, labeling or directions for use; and (B) Failure to identify, prevent, resolve and manage potential and actual drug and drug-related problems, including, but not limited to: (i) Over-utilization and under-utilization; (ii) Therapeutic duplication; (iii) Drug-age contraindications; (iv) Drug-allergy contraindications; (v) Drug-disease contraindications; (vi) Drug-gender contraindications; (vii) Drug-drug interactions; (viii) Incorrect drug dosage; (ix) Incorrect duration of drug therapy; and (x) Clinical abuse or misuse; (46) "Third-party logistics provider" 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; (47) "Unprofessional conduct" means the conduct of a pharmacist, pharmacy intern or pharmacy technician that is detrimental to patients or to the profession of pharmacy; (48) "Wholesale distribution" means the distribution of a drug or device to persons other than the patient or consumer, or the receipt of a drug or device by persons other than the patient or consumer; provided, that "wholesale distribution" does not include the distribution or receipt of products, transactions, or services that are exempted from this definition by rule. For the purposes of this part, transfers and sales of drugs or devices from one licensed pharmacy to another shall not constitute wholesale distribution of drugs or devices; and (49) "Wholesaler" or "wholesale distributor" means a person primarily engaged in the wholesale distribution of drugs or devices; provided, that "wholesaler" or "wholesale distributor" does not include licensed third-party logistics providers. For the purposes of this part, transfers and sales of drugs or devices from one licensed pharmacy to another shall not constitute wholesale distribution of drugs or devices.

Legislative History

Amended by 2024 Tenn. Acts, ch. 824,s 1, eff. 5/1/2024. Amended by 2022 Tenn. Acts, ch. 812, s 1, eff. 4/8/2022. Amended by 2018 Tenn. Acts, ch. 617, s 1, eff. 7/1/2018. Amended by 2017 Tenn. Acts, ch. 334, s 6, eff. 7/1/2017. Amended by 2016 Tenn. Acts, ch. 980, s 19, eff. 7/1/2016. Amended by 2015 Tenn. Acts, ch. 513, s 1, eff. 5/20/2015. Amended by 2015 Tenn. Acts, ch. 293, s 3, s 4 eff. 4/24/2015. Amended by 2014 Tenn. Acts, ch. 832, s 2, s 3 eff. 7/1/2014. Amended by 2014 Tenn. Acts, ch. 832, s 1, eff. 7/1/2014. Amended by 2013 Tenn. Acts, ch. 266, s 1, s 2 eff. 4/25/2013. Acts 1996, ch. 651, § 4; T.C.A. §63-10-404; Acts 2006, ch. 768, § 1; 2007 , ch. 407, §§ 2, 3.