Section 1140-07-.04 - PHYSICAL REQUIREMENTS(1) Any facility that compounds drug products shall comply 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.(2) 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-.04
Original rule 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-.03, but was renumbered to 1140-07-.04 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.