(a) In addition to the locations authorized in Section 4427.3, an automated unit dose system (AUDS) may also be located and operated in either of the following locations: (1) A facility licensed by this state with the statutory authority to provide pharmaceutical services. (2) Jail, youth detention facility, or other correctional facility where drugs are administered within the facility under the authority of the medical director. (b) The pharmacy operating the AUDS shall develop and implement, and review annually, written policies and procedures pertaining to the device. (c) The pharmacy shall operate the AUDS in compliance with the following requirements: (1) Transaction information shall be made readily available in a written format for review and inspection by individuals authorized by law. These records shall be maintained in the facility for a minimum of three years. (2) Individualized and specific access to automated drug delivery systems shall be limited to facility and contract personnel authorized by law to administer drugs. (3) (A) The facility and the pharmacy shall develop and implement written policies and procedures to ensure safety, accuracy, accountability, security, patient confidentiality, and maintenance of the quality, potency, and purity of stored drugs. Policies and procedures shall define access to the automated drug delivery system and limits to access to equipment and drugs. (B) All policies and procedures shall be maintained at the pharmacy operating the automated drug delivery system and the location where the automated drug delivery system is being used. (4) When used as an emergency pharmaceutical supplies container, drugs removed from the automated drug delivery system shall be limited to the following: (A) A new drug order given by a prescriber for a patient of the facility for administration prior to the next scheduled delivery from the pharmacy, or 72 hours, whichever is less. The drugs shall be retrieved only upon authorization by a pharmacist and after the pharmacist has reviewed the prescriberâs order and the patientâs profile for potential contraindications and adverse drug reactions. (B) Drugs that a prescriber has ordered for a patient on an as-needed basis, if the utilization and retrieval of those drugs are subject to ongoing review by a pharmacist. (C) Drugs designed by the patient care policy committee or pharmaceutical service committee of the facility as emergency drugs or acute onset drugs. These drugs may be retrieved from an automated drug delivery system pursuant to the order of a prescriber for emergency or immediate administration to a patient of the facility. Within 48 hours after retrieval under this paragraph, the case shall be reviewed by a pharmacist. (5) When used to provide pharmacy services pursuant to Section 4017.3 and this article, the automated drug delivery system shall be subject to all of the following requirements: (A) Drugs removed from the automated drug delivery system for administration to a patient shall be in properly labeled units of administration containers or packages. (B) A pharmacist shall review and approve all orders prior to a drug being removed from the automated drug delivery system for administration to a patient. The pharmacist shall review the prescriberâs order and the patientâs profile for potential contraindications and adverse drug reactions. (C) The pharmacy providing services to the facility pursuant to this article shall control access to the drugs stored in the automated drug delivery system. (D) Access to the automated drug delivery system shall be controlled and tracked using an identification or password system or biosensor. (E) The automated drug delivery system shall make a complete and accurate record of all transactions that will include all users accessing the system and all drugs added to, or removed from, the system. (F) After the pharmacist reviews the prescriberâs order, access by licensed personnel to the auto
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