Section 1140-07-.03 - PERSONNEL(1) The pharmacist in charge or the person(s) designated by the pharmacist in charge shall be responsible for, at a minimum, the following:(a) Procurement, storage, compounding, labeling, repackaging, dispensing, and distribution of all drugs and devices and related materials necessary in compounding and dispensing compounded drug products;(b) Establishment of policies and procedures for the compounding and dispensing of compounded drug products;(c) Documentation of competency in proper techniques of all pharmacists, pharmacy interns and pharmacy technicians. The proper technique of each person compounding and dispensing compounded drug products shall be observed and evaluated as satisfactory during orientation and training pursuant to standards established by USP chapters 795, 797, 800, and/or 825, pursuant to the compounding pharmacy's site practice, including all USP chapters and standards incorporated into chapters by reference and including all subsequent amendments and editions of the same, governing both the compounded drug products and the physical and environmental conditions under which compounded drug products are prepared, labeled, and dispensed or whenever unacceptable techniques are observed or detected;(d) Establishment of a quality assurance program.(2) All pharmacists, pharmacy interns and pharmacy technicians as defined in 1140-02-.02 responsible for compounding or dispensing compounded drug products shall:(a) Obtain practical and/or academic training in the compounding and dispensing of compounded drug products;(b) Complete education pursuant to the standards established by USP chapters 795, 797, 800, and/or 825, pursuant to the compounding pharmacy's site practice, including all USP chapters and standards incorporated into chapters by reference and including all subsequent amendments and editions of the same, governing both the compounded drug products and the physical and environmental conditions under which compounded drug products are prepared, labeled, and dispensed; and(c) Maintain, in the pharmacy practice site, documentation of completion of the required initial and subsequent training and competency evaluations for (2) years. A written record of initial and subsequent training and competency evaluations shall be maintained in the pharmacy practice site. These records shall contain the following information:1. Name of the person receiving the training or evaluation;2. Date(s) of the training or evaluation;3. General description of the topics covered; and4. Signature of the person receiving the training or evaluation and the pharmacist in charge or the person(s) designated by the pharmacist in charge. The person receiving the training may not self-evaluate.(d) Use proper technique in all drug product compounding as defined by the pharmacy practice site's policies and procedures and in compliance with standards established by USP chapters 795, 797, 800, and/or 825, pursuant to the compounding pharmacy's site practice, including all USP chapters and standards incorporated into chapters by reference and including all subsequent amendments and editions of the same, governing both the compounded drug products and the physical and environmental conditions under which compounded drug products are prepared, labeled, and dispensed.(3) The pharmacist in charge shall be assisted by such additional pharmacists, pharmacy interns, pharmacy technicians as defined by 1140-02-.02 and supportive personnel necessary to operate the pharmacy practice site competently and safely and to provide services in a timely and appropriate manner.(4) All pharmacists, pharmacy interns and pharmacy technicians must be qualified at least annually through an appropriate combination of specific training and experience to operate or manipulate any item of equipment, apparatus, or device to which such pharmacists, interns and technicians will be assigned to use to compound and dispense compounded drug products.(5) Upon request, the Board may waive selected portions of these requirements so long as any waiver granted is consistent with the Board's authority under Tenn. Code Ann. Title 63, Chapters 1 and 10, and Tenn. Code Ann. Title 4, Chapter 5.Tenn. Comp. R. & Regs. 1140-07-.03
Original chapter filed October 1, 1987; effective November 15, 1987. Repeal and new rule filed May 11, 1998; effective July 25, 1998. Rule was previously numbered 1140-07-.02, but was renumbered to 1140-07-.03 with the addition of a new 1140-07-.02. Rule filed July 11, 2014; effective October 9, 2014. Amendments filed November 22, 2016; effective February 20, 2017. Amendments filed December 15, 2023; effective 3/14/2024.Authority: T.C.A. §§ 63-10-216, 63-10-308, and 63-10-310.