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The pharmacy software must have logical access controls that restrict access by name or role The software must store all applicable dispensing information such as the number of units dispensed it must also have an internal audit trail and must perform automated internal audits and provide reports of incidents to the pharmacist 21 CFR 1311 120

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A pharmacy technician may keep the pharmacy dispensing area open if no members of the public are allowed beyond the barrier B secured area of the pharmacy is required to remain open to the public if store in open C store owner may keep the pharmacy dispensing area open D secured area of the pharmacy must be locked and closed to the public

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The automated pharmacy system and accompanying electronic verification process must at a minimum be tested before the first use of the system upon restarting the system and after a modification of the system or electronic verification process which alters the filling stocking or restocking of the system or the electronic verification process

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CHAPTER 639 PHARMACISTS AND PHARMACY GENERAL PROVISIONS 639 67017 Use of automated compounding devices 639 67019 Retention of records 639 6702 639 752 Restrictions on filling or dispensing certain prescriptions 639 753

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