REGULATION OF AUTOMATED DRUG DISTRIBUTION SYSTEMS

To work with the Drug Enforcement Administration and other agencies to seek regulatory and policy changes to accommodate automated drug distribution in health systems.

Rationale

In 2021, ASHP published guidelines on the safe use of automated dispensing cabinets, including requirements for controlled storage, secure operations, and technology infrastructure including interfaces. Those guidelines contain recommendations regarding diversion surveillance, monitoring, and detection guidance. In the same year, the National Association of Boards of Pharmacy (NABP) published Model State Pharmacy Act and Model Rules concerning automated pharmacy systems. NABP provides guidance on system documentation, oversight, security systems, record/data keeping, and pharmacist-in-charge responsibilities. In 2020, the DEA revised its Pharmacist’s Manual to assist pharmacists in understanding of the Federal Controlled Substances Act. The council recognized the policy reflects automated systems for drug distribution and the regulatory jurisdiction of additional federal and state agencies beyond the Drug Enforcement Administration.