Tenn. Comp. R. & Regs. 1140-07-.05 - POLICY AND PROCEDURE MANUAL

(1) A policy and procedure manual related to drug product compounding shall be available for inspection at the pharmacy practice site. The manual shall include policies and procedures for compounding pursuant to USP standards, and shall, at a minimum, include:

(a) Security;

(b) Equipment;

(c) Sanitation;

(d) Reference materials;

(e) Prescription drug and device and related material storage;

(f) Prescription drug and device and related material compounding and dispensing;

(g) Prescription drug and device and related material labeling and relabeling;

(h) Prescription drug and device and related material destruction and returns;

(i) Dispensing of compounded drug products;

(j) Record keeping;

(k) Quality assurance;

(l) Quality control;

(m) Duties for pharmacist(s), pharmacy intern(s), pharmacy technician(s) and supportive personnel;

(n) Public safety relative to harmful compounded drug products, including the active notification of patients if they may be affected by a product found to have a defect or an out-of-specification result including any recall policy and procedures;

(o) Attire;

(p) Pharmacist, pharmacy intern, and pharmacy technician training;

(q) Compliance with the 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; and

(r) Response to adverse events, outbreaks, and other public health threats associated with products compounded, dispensed, manufactured, propagated, distributed, or otherwise processed at the facility, including procedures for the rapid compilation and dissemination of records to appropriate authorities.

(2) Any licensed facility which engages in drug product compounding shall conduct an annual review of its policy and procedure manual, and shall update its policy and procedure manual as necessary.

(3) Failure by any licensee or registrant to comply with its policy and procedure manual, or any part of this rule shall be considered a violation of a duly promulgated rule of the Board of Pharmacy and may be considered dishonorable, immoral, unethical or unprofessional conduct within the meaning of T.C.A. § 63-10-305(6).

Notes

Tenn. Comp. R. & Regs. 1140-07-.05

Original rule filed October 1, 1987; effective November 15, 1987. Amendment filed November 16, 1992; effective January 8, 1993. 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. Amendments filed July 11, 2014; effective October 9, 2014. Rule was previously numbered 1140-07-.04, but was renumbered to 1140-07-.05 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.