                                 CODE OF VIRGINIA

AUTOMATED DRUG DISPENSING SYSTEMS AND REMOTE DISPENSING SYSTEMS (§
54.1-3434.02)

A. Hospitals or nursing homes licensed pursuant to Title 32.1, state facilities
as defined in § 37.2-100 established pursuant to Title 37.2, facilities as
defined in § 37.2-100 that are licensed by the Department of Behavioral Health
and Developmental Services and provide site-based crisis stabilization services,
or other facilities authorized by the Board may use automated drug dispensing
systems and remote dispensing systems, as defined in § 54.1-3401, upon meeting
the following conditions:

   1. Drugs are placed in the automated drug dispensing system or remote
   dispensing system in such hospital, nursing home, or facility and are under
   the control of a pharmacy providing services to the hospital, nursing home, or
   facility;

   2. The pharmacist-in-charge of the pharmacy providing services to the
   hospital, nursing home, or facility has established procedures for ensuring
   the accurate stocking and proper storage of drugs in the automated drug
   dispensing system or remote dispensing system and for ensuring accountability
   for and security of all drugs utilized in such system until the time such
   drugs are removed from such system for administration to the patients;

   3. Removal of drugs from any automated drug dispensing system or remote
   dispensing system for administration to patients can only be made pursuant to
   a valid prescription or lawful order of a prescriber;

   4. Adequate security for automated drug dispensing systems or remote
   dispensing systems is provided, as evidenced by written policies and
   procedures, for (i) preventing unauthorized access, (ii) complying with
   federal and state regulations on prescribing and dispensing controlled
   substances, (iii) maintaining patient confidentiality, and (iv) ensuring
   compliance with the requirements of this section;

   5. Accountability for drugs dispensed from automated drug dispensing systems
   or remote dispensing systems is vested in the pharmacist-in-charge of a
   pharmacy located within the hospital, nursing home, or facility or the
   pharmacist-in-charge of the outside pharmacy providing pharmacy services to
   the hospital, nursing home, or facility;

   6. Filling and stocking of all drugs in automated drug dispensing systems or
   remote dispensing systems shall be performed under the direction of the
   pharmacist-in-charge. The task of filling and stocking of drugs into such
   system shall be performed by a pharmacist or a registered pharmacy technician,
   who shall be an employee of the provider pharmacy and shall be properly
   trained in accordance with established standards set forth in a policy and
   procedure manual maintained by the provider pharmacy. The pharmacist stocking
   and filling such system or the pharmacist-in-charge, if such system is stocked
   and filled by a registered pharmacy technician, shall be responsible for the
   proper and accurate stocking and filling of the automated drug dispensing
   system or remote dispensing system; and

   7. Except when the automated drug dispensing system is used exclusively for
   administration of drugs for emergencies, a pharmacy located outside of the
   hospital, nursing home, or facility it services according to this subsection
   shall first obtain a controlled substances registration issued in the name of
   the pharmacy at the address of the hospital, nursing home, or facility and a
   registration from the Drug Enforcement Administration, if required, prior to
   stocking controlled substances in Schedules II through VI.

B. Except as authorized by the Board, drugs placed into and removed from
automated drug dispensing systems or remote dispensing systems for
administration to patients shall be in the manufacturer&#8217;s or
distributor&#8217;s sealed original packaging or in unit-dose containers
packaged by the pharmacy. Drugs in multi-dose packaging or in a liquid,
injectable, or inhaled formulation may be placed in such a device if approved by
the pharmacist-in-charge in consultation with pharmacy, medical, and nursing
staff of the hospital, nursing home, or facility.

C. The pharmacist-in-charge in a pharmacy located within a hospital, nursing
home, or facility or the pharmacist-in-charge of any outside pharmacy providing
pharmacy services to a hospital, nursing home, or facility shall be responsible
for establishing procedures for (i) periodically inspecting and auditing
automated drug dispensing systems and remote dispensing systems to ensure the
proper storage, security, and accountability for all drugs placed in and removed
from automated drug dispensing systems and remote dispensing systems and (ii)
reviewing the operation and maintenance of automated drug dispensing systems and
remote dispensing systems. For hospitals with a pharmacy located within the
hospital, monitoring shall be reviewed by a pharmacist while on the premises of
the hospital and in accordance with the pharmacist-in-charge&#8217;s procedures
and the Board of Pharmacy&#8217;s regulations.

D. The Board of Pharmacy shall promulgate regulations establishing minimum
requirements for random periodic inspections and monthly audits of automated
drug dispensing systems and remote dispensing systems to ensure the proper
storage, security, and accountability of all drugs placed in and removed from
such systems and for reviewing the operation and maintenance of such systems.

E. Notwithstanding this section, the Board shall promulgate regulations for the
use of a remote dispensing system to store drugs previously dispensed and
labeled by the provider pharmacy in compliance with current laws and
regulations. Such regulations shall identify the location where such system may
be placed and requirements to ensure the security of the drug, confidentiality
of protected health information, and appropriate recordkeeping.

HISTORY: 1999, c. 750; 2004, c. 140; 2009, c. 100; 2024, cc. 63, 513.