Policy And Procedure Manual

(1) A policy and procedure manual related to sterile product compounding shall be available for inspection at the pharmacy practice site. The manual shall include policies and procedures for sterile compounding pursuant to USP standards, and shall, at a minimum, include: (a) Security; (b) Equipment; (c) Sanitation; (d) Reference materials; STERILE PRODUCT PREPARATION IN PHARMACY PRACTICE CHAPTER 1140-07 (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 sterile 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 sterile 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 all applicable USP standards; 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 sterile 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).