Tenn. Comp. R. & Regs. 1140-07-.09 - NONSTERILE SIMPLE COMPOUNDING PREPARATIONS

(1) The combining of commercially manufactured ready-to-use products shall be exempt from the 'Compounding Facilities' requirements in the USP 795 compounding standards if all of the following conditions are met:

(a) Only commercially manufactured ready-to-use products (that have not been manipulated) are used. Manipulation occurs when a change of a commercially available drug product occurs for patient-specific needs beyond United States Food and Drug Administration approved labeling. Crushing, using a surfactant, diluting or using a dosage form that exists as a granule or powder is manipulating for the purpose of this section.

(b) Compounding is not prepared in anticipation of medication orders.

(c) Beyond Use Dates are assigned in accordance with the current standards of USP 795.

(d) The label complies with the labeling requirements as set forth in Tenn. Comp. R. and Regs. 1140-07-.06.

(e) The compounding record complies with the requirements as set forth in Tenn. Comp. R. and Regs. 1140-07-.02.

(2) Solely adding flavoring to medications is not considered compounding.

(3) 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.

Notes

Tenn. Comp. R. & Regs. 1140-07-.09

Original chapter 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. 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.