2020 California Code
Business and Professions Code - BPC
DIVISION 2 - HEALING ARTS
CHAPTER 9 - Pharmacy
ARTICLE 25 - Automated Drug Delivery System
Section 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 license shall only be issued when the following conditions are met:

(1) Use of the ADDS is consistent with legal requirements.

(2) The proposed location for installation of the ADDS meets the requirements of Section 4427.3 and the ADDS is secure from access and removal by unauthorized individuals.

(3) The pharmacy’s policies and procedures related to the ADDS include appropriate security measures and monitoring of the inventory to prevent theft and diversion.

(4) The pharmacy’s policies and procedures include provisions for reporting to the board drug losses from the ADDS inventory, as required by law.

(e) Prior to issuance of the license, the board shall conduct a prelicensure inspection, within 30 days of a completed application for an ADDS license, at the proposed location of the ADDS. Relocation of the ADDS shall require a new application for licensure. Replacement of an ADDS shall require notification to the board within 30 days.

(f) The ADDS 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 ADDS license may be submitted to the board.

(g) The holder of an ADDS license shall advise the board in writing within 30 days if use of the ADDS is discontinued.

(h) The ADDS license shall be renewed annually, and the renewal date shall be the same as the underlying pharmacy license.

(i) An AUDS operated by a licensed hospital pharmacy, as defined in Section 4029, and used solely to provide doses administered to patients while in a licensed general acute care hospital facility or a licensed acute psychiatric hospital facility, as defined in subdivisions (a) and (b) of Section 1250 of the Health and Safety Code, shall be exempt from the requirement of obtaining an ADDS license pursuant to this section if the licensed hospital pharmacy owns or leases the AUDS and owns the dangerous drugs and dangerous devices in the AUDS. The AUDS shall comply with all other requirements for an ADDS in this article. The licensed hospital pharmacy shall maintain a list of the locations of each AUDS it operates and shall make the list available to the board upon request.

(j) An ADDS license is not required for technology, installed within the secured licensed premises area of a pharmacy, used in the selecting, counting, packaging, and labeling of dangerous drugs and dangerous devices.

(Added by Stats. 2018, Ch. 666, Sec. 9. (SB 1447) Effective January 1, 2019. Operative July 1, 2019, pursuant to Section 4427.8.)