1. (1) Any facility that compounds sterile products shall comply with applicable USP standards.
2. (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.

Authority: T.C.A. §§ 63-10-204, 63-10-216, 63-10-301, 63-10-304, and 63-10-306. Administrative History: 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 filed July 11, 2014; effective October 9, 2014. Amendments 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.