Tenn. Comp. R. & Regs. 1140-07-.08 - QUALITY ASSURANCE

(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) The program shall be designed to assure that the pharmacy practice site is capable of consistently compounding quality compounded drug products.

(3) All quality assurance programs shall comply with 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.

(4) Any recall or an event that results in the halting of compounding due to a quality assurance issue by a compounding facility, in addition to an event that resulted in a Corrective Action Preventative Action, shall be reported to the Board of Pharmacy immediately.

(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).

Notes

Tenn. Comp. R. & Regs. 1140-07-.08

Original chapter filed October 1, 1987; effective November 15, 1987. Amendment filed March 30, 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-.07, but was renumbered to 1140-07-.08 with the addition of a new 1140-07-.02. Rule filed July 11, 2014; effective October 9, 2014. Amendments filed December 15, 2023; effective 3/14/2024.

Authority: T.C.A. §§ 63-10-216, 63-10-308, and 63-10-310.