1. (1) There shall be a documented, ongoing quality assurance program that monitors process validation; pharmacist(s), pharmacy intern(s), and pharmacy technician(s) performance; equipment; and environment.
2. (2) The program shall be designed to assure that the pharmacy practice site is capable of consistently compounding quality sterile products.
3. (3) All quality assurance programs shall follow applicable USP standards.
4. (4) As part of its quality assurance program, any licensed facility which engages in sterile compounding shall perform a gap analysis pursuant to guidelines adopted by the Board of Pharmacy. Any exceptions or serious deficiencies noted in this analysis shall be reported to the Board of Pharmacy.
5. (5) Failure by any licensee or registrant to comply with its quality assurance program shall be considered a violation of a duly promulgated rule of the Board of Pharmacy and may be considered dishonorable, immoral, unethical or unprofessional conduct within the meaning of T.C.A. § 63-10-305(6).

Authority: T.C.A. §§ 63-10-204, 63-10-216, 63-10-301, 63-10-304, 63-10-306, 63-10-404(26), (28), (29), and (30), and 63-10-504(b)(1), (2). Administrative History: Original rule filed March 30, 1994; effective June 13, 1994. Repeal and new rule filed May 11, 1998; effective July 25, 1998. Emergency rules filed January 31, 2014; effective through July 30, 2014. Emergency rules expired effective July 31, 2014, and the rules reverted to their previous statuses. Rule was previously numbered 1140-07-.08, but was renumbered to 1140-07-.09 with the addition of a new 1140-07-.02 filed July 11, 2014; effective October 9, 2014. Amendments filed July 11, 2014; effective October 9, 2014. 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.