A. Hospitals licensed pursuant to Title 32.1 or Title 37.2 may use automated drug dispensing systems, as defined in § 54.1-3401, upon meeting the following conditions:
1. Drugs are placed in the automated drug dispensing system in a hospital and are under the control of a pharmacy providing services to the hospital;
2. The pharmacist-in-charge of the pharmacy providing services to the hospital has established procedures for assuring the accurate stocking and proper storage of drugs in the automated drug dispensing system and for ensuring accountability for and security of all drugs utilized in the automated drug dispensing system until the time such drugs are removed from the automated drug dispensing system for administration to the patients;
3. Removal of drugs from any automated drug 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 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) assuring compliance with the requirements of this section;
5. Accountability for drugs dispensed from automated drug dispensing systems is vested in the pharmacist-in-charge of a pharmacy located within the hospital or the pharmacist-in-charge of any outside pharmacy providing pharmacy services to the hospital;
6. Filling and stocking of all drugs in automated drug dispensing systems shall be performed under the direction of the pharmacist-in-charge. The task of filling and stocking of drugs into an automated drug dispensing 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 the automated drug dispensing system or the pharmacist-in-charge, if the automated drug dispensing 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.
B. Drugs placed into and removed from automated drug 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, other than those administered orally, may be placed in such a device if approved by the pharmacist-in-charge in consultation with a standing hospital committee comprised of pharmacy, medical, and nursing staff.
C. The pharmacist-in-charge in a pharmacy located within a hospital or the pharmacist-in-charge of any outside pharmacy providing pharmacy services to a hospital shall be responsible for establishing procedures for (i) periodically inspecting and auditing automated drug dispensing systems to assure the proper storage, security, and accountability for all drugs placed in and removed from automated drug dispensing systems, and (ii) reviewing the operation and maintenance of automated drug dispensing systems. This 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 to assure the proper storage, security, and accountability of all drugs placed in and removed from automated drug dispensing systems and for reviewing the operation and maintenance of automated drug dispensing systems.
1999, c. 750; 2004, c. 140; 2009, c. 100.
Structure Code of Virginia
Title 54.1 - Professions and Occupations
§ 54.1-3403. Chapter not applicable to economic poisons
§ 54.1-3405. Access to and copies of records; inspections
§ 54.1-3406. Records confidential; disclosure of information about violations of federal law
§ 54.1-3407. Analysis of controlled substances
§ 54.1-3408. Professional use by practitioners
§ 54.1-3408.01. Requirements for prescriptions
§ 54.1-3408.02. Transmission of prescriptions
§ 54.1-3408.03. Dispensing of therapeutically equivalent drug product permitted
§ 54.1-3408.04. Dispensing of interchangeable biosimilars permitted
§ 54.1-3408.05. Use of FDA-approved substance upon publication of final rule
§ 54.1-3408.1. Prescription in excess of recommended dosage in certain cases
§ 54.1-3408.3. Certification for use of cannabis oil for treatment
§ 54.1-3408.5. Epinephrine required in certain public places
§ 54.1-3409. Professional use by veterinarians
§ 54.1-3410. When pharmacist may sell and dispense drugs
§ 54.1-3410.1. Requirements for radiopharmaceuticals
§ 54.1-3411. When prescriptions may be refilled
§ 54.1-3411.1. Prohibition on returns, exchanges, or re-dispensing of drugs; exceptions
§ 54.1-3411.2. Prescription drug disposal programs
§ 54.1-3411.2:1. Guidelines for disposal of unused drugs
§ 54.1-3412. Date of dispensing; initials of pharmacist; automated data processing system
§ 54.1-3413. Manufacturing and administering Schedule I drugs
§ 54.1-3414. Official orders for Schedule II drugs
§ 54.1-3415. Distribution of drugs in Schedules II through VI by manufacturers and wholesalers
§ 54.1-3415.1. Delivery of medical devices on behalf of a medical equipment supplier
§ 54.1-3416. No prescription for preparations listed pursuant to Schedule V
§ 54.1-3417. Disposing of stocks of Schedules II through V drugs
§ 54.1-3418. Sale of aqueous or oleaginous solutions
§ 54.1-3419. Dispensing of insulin preparations
§ 54.1-3420. Distribution of certain drugs; written request or confirmation of receipt
§ 54.1-3420.1. Identification required for filling prescriptions
§ 54.1-3420.2. Delivery of prescription drug order
§ 54.1-3426. Regulations for special packaging
§ 54.1-3427. Dispensing drugs without safety closure container
§ 54.1-3428. Dissemination of information
§ 54.1-3429. Revocation of permit issued to manufacturer, wholesaler or distributor
§ 54.1-3430. Display of permit; permits nontransferable; renewal
§ 54.1-3431. Admission into evidence of certain certificates of analysis
§ 54.1-3432. Supervision by pharmacist
§ 54.1-3433. Certain advertising and signs unlawful
§ 54.1-3434. Permit to conduct pharmacy
§ 54.1-3434.01. Notice of pharmacy closing; change of ownership; penalty
§ 54.1-3434.02. Automated drug dispensing systems
§ 54.1-3434.03. Continuous quality improvement program
§ 54.1-3434.04. Automatic review of certain case decisions
§ 54.1-3434.05. Permit to act as an outsourcing facility
§ 54.1-3434.1. Nonresident pharmacies to register with Board
§ 54.1-3434.2. Permit to be issued
§ 54.1-3434.3. Denial, revocation, suspension of registration, summary proceedings
§ 54.1-3434.4. Prohibited acts
§ 54.1-3434.5. Nonresident outsourcing facilities to register with the Board
§ 54.1-3435. License to act as wholesale distributor; renewal; fee
§ 54.1-3435.01. Registration of nonresident wholesale distributors; renewal; fee
§ 54.1-3435.02. Certain permitted pharmacies and medical equipment suppliers exempted
§ 54.1-3435.2. Permit to act as medical equipment supplier; storage; limitation; regulations
§ 54.1-3435.3. Inspection and audit
§ 54.1-3435.3:1. Registration of nonresident medical equipment suppliers; renewal; fee
§ 54.1-3435.4. Permit to act as warehouser; regulations
§ 54.1-3435.4:01. Registration to act as a nonresident warehouser; regulations
§ 54.1-3435.4:1. Permitting of third-party logistics provider; renewal
§ 54.1-3435.4:2. Registration of nonresident third-party logistics provider; renewal
§ 54.1-3436.1. Prescription drug price transparency
§ 54.1-3437. Permit to manufacture drugs
§ 54.1-3437.1. Limited permit for repackaging drugs
§ 54.1-3438. Manufacturing, etc., of drugs or proprietary medicines, to be supervised by pharmacist
§ 54.1-3439. Application for nonrestricted manufacturing permit; fee
§ 54.1-3440. Persons to whom nonrestricted permit is granted
§ 54.1-3442. When permit not to be granted; regulations
§ 54.1-3442.01. Registration of nonresident manufacturer; renewal
§ 54.1-3442.02. Prescription drug price transparency
§ 54.1-3442.4. Limitation of liability
§ 54.1-3442.6. Permit to operate pharmaceutical processor or cannabis dispensing facility
§ 54.1-3442.7. Dispensing cannabis products; report
§ 54.1-3442.8. Criminal liability; exceptions
§ 54.1-3443. Board to administer article
§ 54.1-3444. Controlled substances included by whatever name designated
§ 54.1-3445. Placement of substance in Schedule I
§ 54.1-3447. Placement of substance in Schedule II
§ 54.1-3449. Placement of substance in Schedule III
§ 54.1-3451. Placement of substance in Schedule IV
§ 54.1-3453. Placement of substance in Schedule V
§ 54.1-3456. Controlled substance analog
§ 54.1-3456.1. Drugs of concern
§ 54.1-3460. Poisonous or deleterious substance, or color additive
§ 54.1-3461. Adulterated drug or device
§ 54.1-3462. Misbranded drug or device
§ 54.1-3463. Exemption of drugs dispensed by filling or refilling prescription
§ 54.1-3464. Adulterated cosmetics
§ 54.1-3465. Misbranded cosmetics
§ 54.1-3468. Conditions to dispensing device, item, or substance; records
§ 54.1-3469. Storage, usage, and disposition of controlled paraphernalia
§ 54.1-3470. Obtaining controlled paraphernalia by fraud, etc.
§ 54.1-3471. Issuance of permits to certain persons other than registered pharmacists