1. (1) The pharmacist in charge or pharmacist designee shall be responsible for, at a minimum, the following:

   1. (a) Procurement, storage, compounding, labeling, repackaging, dispensing, and distribution of all prescription drugs and devices and related materials necessary in compounding and dispensing sterile products;
   2. (b) Establishment of policies and procedures for the compounding and dispensing of sterile products;
   3. (c) Documentation of competency in aseptic techniques of all pharmacists, pharmacy interns and pharmacy technicians. The aseptic technique of each person compounding and dispensing sterile products shall be observed and evaluated as satisfactory during orientation and training and at least on an annual basis or whenever unacceptable techniques are observed or detected;
   4. (d) Establishment of a quality assurance program;
   5. (e) Reviewing and updating annually all policies and procedures; and
   6. (f) Provision of sterile products on a twenty four (24) hour a day basis.

2. (2) All pharmacists, pharmacy interns and pharmacy technicians as defined in 1140-02-.02 responsible for compounding or dispensing sterile products shall:

   1. (a) Obtain practical and/or academic training in the compounding and dispensing of sterile products;
   2. (b) Complete annual continuing education related to sterile product compounding and dispensing and utilization; and
   3. (c) Maintain, in the pharmacy practice site, documentation of completion of the required training and continuing education.
   4. (d) Use proper aseptic technique in all sterile product compounding as defined by the pharmacy practice site’s policies and procedures.
3. (3) A pharmacist shall be available to respond to patients' and other health care practitioners' information needs on a twenty four (24) hour a day basis.
4. (4) 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.
5. (5) All pharmacists, pharmacy interns and pharmacy technicians must be qualified 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 sterile products.

6. (6) A written record of initial and subsequent training and competency evaluations shall be maintained in the pharmacy practice site and contain the following information:

   1. (a) Name of the person receiving the training or evaluation;
   2. (b) Date(s) of the training or evaluation;
   3. (c) General description of the topics covered; and
   4. (d) Signature of the person receiving the training or evaluation and the pharmacist in charge or pharmacist designee of the pharmacist in charge.
7. (7) 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.

Authority: T.C.A. §§ 63-10-204, 63-10-304, 63-10-404(4), (5), (8), (11), (14), (16), (26), (27), (29), and (30), and 63-10-504(b)(1), (2). Administrative History: Original rule 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 filed July 11, 2014; effective October 9, 2014. Amendments filed November 22, 2016; effective February 20, 2017. Amendments filed December 15, 2023; effective March 14, 2024. Amendments expired pursuant to Chapter 827, § 1 of the 2024 Public Acts, effective May 1, 2024, and the rules reverted to their previous statuses.