1140-07-.09
Quality Assurance
Cite as Tenn. Comp. R. & Regs. 1140-07-.09
(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 sterile products.
(3)
All quality assurance programs shall follow applicable USP standards.
(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)
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).