PharmacyAutomated Drug Delivery System
Section § 4427
This law section clarifies that when it mentions "drugs" or "dangerous drugs," and "devices" or "dangerous devices," it refers to the definitions given in another part of the law, specifically Section 4022. So, to understand what dangerous drugs or devices mean here, you need to look at that section.
Section § 4427.1
This law states that ADDS, which stands for Automated Drug Delivery System, can't be set up or used in California unless it follows specific rules laid out in the article.
Section § 4427.2
This section requires that Automatic Drug Dispensing Systems (ADDS) in California must be licensed by the board. Only pharmacies with a valid California license can have an ADDS license, and each ADDS needs its own application and license. Before issuing a license, certain conditions must be met, like security of the ADDS and proper inventory controls. The board will inspect the ADDS location before licensing it. If the pharmacy's license lapses, the ADDS license gets canceled too. ADDS licenses need to be renewed every year, and they can't be transferred if the ADDS is moved. Hospital pharmacies may have different rules if they use automated systems just for administering drugs to patients. Some systems within the secure area of a pharmacy don't need an ADDS license at all.
Section § 4427.3
Automated Drug Delivery Systems (ADDS) must be installed indoors at an approved location with a specific address. The ADDS can be placed next to the pharmacy's secured area or in specific healthcare facilities like licensed clinics, hospitals, or correctional clinics. Before installation, the pharmacy and facility where the ADDS is installed must create and follow safety and security policies, ensuring drug quality and privacy. These guidelines should be accessible at both the pharmacy and the ADDS location.
Section § 4427.4
Section § 4427.5
Section § 4427.6
This law outlines additional requirements for Automated Prescription Dispensing Systems (APDS) used by pharmacies. Pharmacies must develop policies to safeguard the APDS and determine which medications are suitable for it. Patients must be informed about pharmacist consultations available for APDS use, and staff must be trained appropriately. APDS use requires patient consent, and each system must track individual patient prescriptions. Pharmacists must oversee all dispensing, including reviewing prescriptions for issues. Initial use of APDS for any prescription requires a video consultation with a pharmacist. The APDS must display the owning pharmacy's contact details, and the pharmacy must review any incidents involving complaints or errors. A pharmacy can have a limited number of APDS licenses, and records must be maintained for three years after stopping APDS use.
Section § 4427.65
This law allows automated systems for dosing drugs (called AUDS) to be placed in various state-licensed facilities, jails, and detention centers. Pharmacies must create and follow detailed rules to ensure these systems are safe, accurate, and secure. They must also track all transactions and ensure only authorized personnel access the drugs. For emergencies, pharmacists must review and approve any drug orders before use. Lastly, only pharmacists and supervised assistants can stock these systems, which have to be routinely checked for safety and accuracy.
Section § 4427.7
This law requires pharmacies with an Automated Drug Delivery System (ADDS) license to conduct a self-assessment on how well they follow pharmacy laws concerning ADDS use. This assessment must cover every aspect of operation, maintenance, and any issues like errors or complaints. Additionally, these pharmacies must keep records according to pharmacy laws, storing them separately from other records within the licensed facility.
Section § 4427.8
This law became active on July 1, 2019, and outlines that by January 1, 2025, the board must submit a report to the Legislature. This report is part of the board's sunset evaluation and has to cover how ADDS units are used across the healthcare system, the number of inspections done each year, and any public safety concerns identified regarding ADDS use.