Prelicensure Inspection at Proposed Location of an Automated Drug Delivery System (ADDS) - Business and Professions Code sections 4119.11(a)(9) and BPC 4427.2(e)
A California licensed pharmacy applying for an ADDS license for a proposed location or relocation of an ADDS will not be subject to the required prelicensure inspection at the proposed location provided the pharmacy submits the following:
- A description of the proposed ADDS location with pictures, video and/or a floor plan with the surrounding areas labeled and how the ADDS is secured.
- A copy of the pharmacy’s policies and procedures to operate the ADDS regarding security, safety, accuracy, accountability, patient confidentiality, maintenance, maintaining the quality, potency and purity of the dangerous drugs and devices, restocking, record keeping and quality assurance.
- Proof of training or plans for training pharmacy staff and personnel at the pharmacy applying for the proposed ADDS location on the policies and procedures.
- A statement that a copy of the policies and procedures will be maintained as required by BPC section 4427.3(c).
If the ADDS is an Automated Patient Dispensing System (APDS), the pharmacy must also provide the following with its application (see BCP section 4427.6):
- Policies and procedures that include all of the following: criteria used to determine which drugs are placed in the APDS; methods of ensuring patients are aware that consultation is available; a description of assignments of responsibility; training on using the APDS; plans for orienting participating patients; plans for ensuring delivery of drugs when the APDS is disabled or malfunctioning; and plans for handling of complaints, errors, omissions and other incidents with the use of the APDS.
- A statement explaining how a written consent from participating patients is obtained and what means are used to identify the patient or patient’s agent before releasing the drug.
- A statement confirming the APDS has a two-way audio and video for consultation; records are maintained for all transactions; child resistant containers are used; drug warning labels are used for drugs causing risk of overdose, addiction, impairment while operating a vehicle, and risk if alcohol is consumed; a sign is prominently posted on the APDS with the pharmacy’s name, address and phone number; the prescription label meets the patient-centered labeling requirements; and translation and interpretive services are available.
Effective: November 20, 2020
Expiration: October 31, 2021, or until 30 days after the emergency declaration is lifted, whichever is sooner.