Virginia Code 54.1-3434.02: Automated drug dispensing systems and remote dispensing systems.
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:
Terms Used In Virginia Code 54.1-3434.02
- Automated drug dispensing system: means a mechanical or electronic system that performs operations or activities, other than compounding or administration, relating to pharmacy services, including the storage, dispensing, or distribution of drugs and the collection, control, and maintenance of all transaction information, to provide security and accountability for such drugs. See Virginia Code 54.1-3401
- Board: means the Board of Pharmacy. See Virginia Code 54.1-3401
- Device: means instruments, apparatus, and contrivances, including their components, parts, and accessories, intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or animals or to affect the structure or any function of the body of man or animals. See Virginia Code 54.1-3401
- Distributor: means a person who distributes. See Virginia Code 54.1-3401
- Drug: means (i) articles or substances recognized in the official United States Pharmacopoeia National Formulary or official Homeopathic Pharmacopoeia of the United States, or any supplement to any of them; (ii) articles or substances intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or animals; (iii) articles or substances, other than food, intended to affect the structure or any function of the body of man or animals; (iv) articles or substances intended for use as a component of any article specified in clause (i), (ii), or (iii); or (v) a biological product. See Virginia Code 54.1-3401
- Manufacturer: means every person who manufactures, a manufacturer's co-licensed partner, or a repackager. See Virginia Code 54.1-3401
- Pharmacist-in-charge: means the person who, being licensed as a pharmacist, signs the application for a pharmacy permit and assumes full legal responsibility for the operation of the relevant pharmacy in a manner complying with the laws and regulations for the practice of pharmacy and the sale and dispensing of controlled substances; the "pharmacist-in-charge" shall personally supervise the pharmacy and the pharmacy's personnel as required by § Virginia Code 54.1-3401
- Prescriber: means a practitioner who is authorized pursuant to §§ Virginia Code 54.1-3401
- Prescription: means an order for drugs or medical supplies, written or signed or transmitted by word of mouth, telephone, telegraph, or other means of communication to a pharmacist by a duly licensed physician, dentist, veterinarian, or other practitioner authorized by law to prescribe and administer such drugs or medical supplies. See Virginia Code 54.1-3401
- Remote dispensing system: means a profile-driven automated drug dispensing system that performs operations or activities relative to the storage, packaging, labeling, or dispensing of medications employing bidirectional audio-visual technology to facilitate pharmacist communication with a patient, authorized agent of the patient, or person licensed to administer drugs, and collects, controls, and maintains all information online. See Virginia Code 54.1-3401
- State: when applied to a part of the United States, includes any of the 50 states, the District of Columbia, the Commonwealth of Puerto Rico, Guam, the Northern Mariana Islands, and the United States Virgin Islands. See Virginia Code 1-245
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‘s or distributor‘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’s procedures and the Board of Pharmacy’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.
1999, c. 750; 2004, c. 140; 2009, c. 100; 2024, cc. 63, 513.