Section 4427.4.
4427.4. (a) The ADDS shall be owned or leased by the pharmacy holding the license for the ADDS. (b) Each ADDS shall only be operated under the supervision of the pharmacy holding the ADDS license. (c) An ADDS shall be considered an extension and part of the pharmacy holding the ADDS license, regardless of the ADDS location, and […]
Section 4427.5.
4427.5. Prior to installation, and annually thereafter, the pharmacy holding the ADDS license shall provide training on the operation and use of the ADDS to pharmacy personnel and to personnel using the ADDS at the location where the ADDS is placed pursuant to subdivision (b) of Section 4427.3. (Added by Stats. 2018, Ch. 666, Sec. […]
Section 4427.6.
4427.6. In addition to any other requirements imposed by this article, an APDS shall additionally meet the following requirements: (a) The pharmacy shall develop and implement, and review annually, written policies and procedures pertaining to the APDS, including all of the following: (1) Maintaining the security of the APDS and the dangerous drugs and dangerous devices within […]
Section 4427.65.
4427.65. (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 […]
Section 4427.7.
4427.7. (a) A pharmacy holding an ADDS license shall complete a self-assessment, performed pursuant to Section 1715 of Title 16 of the California Code of Regulations, evaluating the pharmacy’s compliance with pharmacy law relating to the use of the ADDS. All information regarding operation, maintenance, compliance, error, omissions, or complaints pertaining to the ADDS shall be […]
Section 4427.8.
4427.8. (a) This article shall become operative on July 1, 2019. (b) On or before January 1, 2024, as part of the board’s sunset evaluation process, and notwithstanding Sections 9795 and 10231.5 of the Government Code, the board shall report to the appropriate committees of the Legislature on the regulation of ADDS units as provided in this […]
Section 4427.
4427. As used in this article, “drugs” or “dangerous drugs” shall have the same meaning as “dangerous drug” as provided in Section 4022 and “devices” or “dangerous devices” shall have the same meaning as “dangerous device” as provided in Section 4022. (Added by Stats. 2018, Ch. 666, Sec. 9. (SB 1447) Effective January 1, 2019. […]
Section 4427.1.
4427.1. An ADDS shall not be installed or operated in California unless it meets the requirements of this article. (Added by Stats. 2018, Ch. 666, Sec. 9. (SB 1447) Effective January 1, 2019. Operative July 1, 2019, pursuant to Section 4427.8.)
Section 4427.2.
4427.2. (a) An ADDS installed, leased, owned, or operated in California shall be licensed by the board. (b) An ADDS license shall only be issued to the holder of a current, valid, and active pharmacy license of a pharmacy located and licensed in California. (c) A separate application and license shall be required for each ADDS. (d) An ADDS […]
Section 4427.3.
4427.3. (a) An ADDS shall be placed and operated inside an enclosed building, with a premises address, at a location approved by the board. (b) An ADDS shall be placed and operated in one of the following locations: (1) Adjacent to the secured pharmacy area of the pharmacy holding the ADDS license. (2) A health facility licensed pursuant to […]