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 shall be subject to inspection pursuant to Section 4008.
(d) Drugs and devices stored in an ADDS shall be deemed part of the inventory and the responsibility of the pharmacy holding the ADDS license, and drugs and devices dispensed from the ADDS shall be considered to have been dispensed by that pharmacy.
(e) (1) The stocking and restocking of an ADDS shall be performed by a pharmacist, or by a pharmacy technician or intern pharmacist under the supervision of a pharmacist, except for an ADDS located in a health facility licensed pursuant to Section 1250 of the Health and Safety Code, where the stocking and restocking of the ADDS may be performed in compliance with Section 1261.6 of the Health and Safety Code.
(2) Access to the ADDS shall be controlled and tracked using an identification or password system or biosensor.
(3) The ADDS shall make a complete and accurate record of all transactions that includes all users accessing the system and all drugs added to, or removed from, the system.
(f) If drugs or devices are not immediately transferred into an ADDS upon arrival at the ADDS location, the drugs and devices shall be stored for no longer than 48 hours in a secured room within the ADDS location approved by the board under Section 4427.3. Upon retrieval of these drugs and devices from secured storage, an inventory shall be taken to detect any losses or overages.
(Added by Stats. 2018, Ch. 666, Sec. 9. (SB 1447) Effective January 1, 2019. Operative July 1, 2019, pursuant to Section 4427.8.)
Structure California Code