856 IAC 1-30-9 Personnel

Sec. 9. (a) Each pharmacist, pharmacist intern, pharmacist extern, and pharmacy technician engaged in preparing sterile pharmaceuticals must be trained in the specialized functions of preparing and dispensing compounded, sterile pharmaceuticals, including the principles of aseptic technique and quality assurance. Documentation of such training or experience shall be made available for inspection by the board or its representatives. (b) The qualifying pharmacist shall be responsible for the following: (1) Purchasing, storage, compounding, repackaging, dispensing, and distribution of all sterile pharmaceuticals. (2) Development and continuing review of all: (A) policies and procedures; (B) training manuals; and (C) quality assurance programs. (c) The qualifying pharmacist shall: (1) assure the environmental control of all products shipped, as controllable by the pharmacist to the extent such aspect of shipping is controllable by the pharmacist; and (2) be responsible for adherence to all current USP Standards related to sterile compounding, personnel cleansing and gowning; or (3) reject or cause to be rejected any such shipment or drugs as prepared in violation of applicable USP Standards.