Tenn. Comp. R. & Regs. 1140-07-.07 - HAZARDOUS PRODUCTS

(1) Physical Requirements.

(a) If the pharmacy practice site is engaged in the compounding of hazardous drug products, a suitable facility to prepare such products and minimize the risk associated with such products shall be provided.

(b) Such pharmacy practice site shall be designed and equipped for storage and have a procedure for disposal of materials containing hazardous residues in accordance with state and federal laws.

(c) A device must be used to continuously monitor pressure differentials in all hazardous drug compounding areas and all hazardous drug storage areas that require negative pressure. The quantitative results from the pressure monitoring device must be reviewed and documented at least daily on the days when compounding is occurring.

(2) Compounding hazardous drug products shall comply with USP Chapter 800 including all USP chapters and standards incorporated into chapters by reference and including all subsequent amendments and editions of the same.

Notes

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

Original chapter filed October 1, 1987; effective November 15, 1987. Amendment 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-.06, but was renumbered to 1140-07-.07 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.