(a) A pharmacy located in the state may provide pharmacy services to the patients of a âcovered entity,â as defined in Section 256b of Title 42 of the United States Code, through the use of an automated patient dispensing system located on the premises of the covered entity or on the premises of medical professional practices under contract to provide medical services to covered entity patients, which need not be the same location as the pharmacy, if all of the following conditions are met: (1) The pharmacy obtains a license from the board to operate the automated patient dispensing system at the covered entity or affiliated site. As part of the application, the pharmacy shall provide the address at which the automated patient dispensing system shall be placed and identify the covered entity. A separate license shall be required for each location and shall be renewed annually concurrent with the pharmacy license. (2) The pharmacy providing the pharmacy services to the patients of the covered entity, including, unless otherwise prohibited by any other law, patients enrolled in the Medi-Cal program, shall be under contract with that covered entity as described in Section 4126 to provide those pharmacy services through the use of the automated patient dispensing system. (3) Drugs stored in an automated patient dispensing system shall be part of the inventory of the pharmacy providing pharmacy services to the patients of the covered entity and drugs dispensed from the automated patient dispensing system shall be considered to have been dispensed by that pharmacy. (4) The pharmacy shall maintain records of the acquisition and disposition of dangerous drugs stored in the automated patient dispensing system separate from other pharmacy records. (5) The pharmacy shall be solely responsible for the security, operation, and maintenance of the automated patient dispensing system. (6) The pharmacy shall provide training regarding the operation and use of the automated patient dispensing system to both pharmacy and covered entity personnel using the system. (7) The operation of the automated patient dispensing system shall be under the supervision of a licensed pharmacist acting on behalf of the pharmacy providing services to the patients of the covered entity. The pharmacist need not be physically present at the site of the automated patient dispensing system and may supervise the system electronically. (8) Notwithstanding Section 4107, the board may issue a license for the operation of an automated patient dispensing system at an address for which it has issued another site license. (9) The board, within 30 days after receipt of an application for an automated patient dispensing system license, shall conduct a prelicensure inspection at the proposed location of the automated patient dispensing system. Relocation of the automated patient dispensing system shall require a new application for licensure. Replacement of an automated patient dispensing system shall require notice to the board within 30 days. (10) The automated patient dispensing system license shall be canceled by operation of law if the underlying pharmacy license is not current, valid, and active. Upon reissuance or reinstatement of the underlying pharmacy license, a new application for an automated patient dispensing system license may be submitted to the board. (11) A pharmacy that holds an automated patient dispensing system license shall advise the board in writing within 30 days if use of the automated patient dispensing system is discontinued. (b) For purposes of this section, the following definitions shall apply: (1) An âautomated drug delivery systemâ (ADDS) means a mechanical system that performs operations or activities, other than compounding or administration, relative to the storage, dispensing, or distribution of drugs. An ADDS shall collect, control, and maintain all transaction information to accurately track the movement of drugs into and out of the
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