Tenn. Comp. R. & Regs. 1140-09-.06 - MINIMUM REQUIREMENTS FOR STERILE PRODUCT OPERATION

(1) Any manufacturer, outsourcing facility or wholesaler/distributor licensed pursuant to this chapter that also holds an active sterile compounding registration from the Board of Pharmacy and that holds a license or registration from the Federal Food and Drug Administration, shall comply with all applicable federal laws, regulations, and guidelines including, but not limited to:

(a) FDA Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs 21 CFR § 210;

(b) FDA Current Good Manufacturing Practice for Finished Pharmaceuticals 21 CFR § 211;

(c) DEA regulations relating to controlled substances 21 CFR §§ 1300-99.

(2) Any manufacturer, outsourcing facility or wholesaler/distributor licensed pursuant to this chapter who also holds an active sterile compounding registration from the Board of Pharmacy and who does not hold a license or registration from the federal Food and Drug Administration shall comply with all applicable USP standards.

(3) Any manufacturer, outsourcing facility or wholesaler/distributor licensed pursuant to this chapter who also holds an active sterile compounding registration from the Board of Pharmacy shall comply with all other applicable Board of Pharmacy rules and all other applicable laws of this State.

(4) The Board of Pharmacy may waive any applicable USP standards upon a showing by the applicant that good cause exists and that a waiver would better promote public health, safety, and welfare.

Notes

Tenn. Comp. R. & Regs. 1140-09-.06

Emergency rule filed January 31, 2014; effective through July 30, 2014. Emergency rules filed January 31, 2014 expired effective July 31, 2014. The rules reverted to reserved status. Original rule filed July 11, 2014; effective October 9, 2014. Repeal and new rule filed March 24, 2015; effective 6/22/2015.

Authority: T.C.A. §§ §§ 63-10-204, 63-10-216, 63-10-304, 63-10-305, and 63-10-306..