18 Va. Admin. Code § 110-20-710

Current through Register Vol. 41, No. 6, November 4, 2024

Section 18VAC110-20-710 - [Effective until 2/19/2026] Requirements for storage and security for controlled substances registrants

A. Drugs shall be stored under conditions that meet USP-NF specifications or manufacturer's suggested storage for each drug.

B. Any drug that has exceeded the expiration date shall not be administered; it shall be separated from the stock used for administration and maintained in a separate, locked area until properly disposed.

C. If a controlled substances registrant wishes to dispose of unwanted or expired Schedules II through VI drugs, the controlled substances registrant shall transfer the drugs to another person or entity authorized to possess and to provide for proper disposal of such drugs.

D. Drugs shall be maintained in a lockable cabinet, cart, device, or other area that shall be locked at all times when not in use. The keys or access code shall be restricted to the supervising practitioner and persons designated access in accordance with 18VAC110-20-700 C.

E. A registered EMS agency headquarters or regional EMS council may store controlled substances in an automated dispensing device that is located at a secured site at the registered location or designated location of the EMS agency or regional EMS council that is (i) installed and operated by the EMS agency or regional EMS council, (ii) not used to directly dispense controlled substances to an ultimate user, and (iii) is in compliance with the requirements of state law.

F. In a facility not staffed 24 hours a day, the drugs shall be stored in a fixed and secured room, cabinet, or area that has a security device for the detection of breaking that meets the following conditions:

1. The device shall be a sound, microwave, photoelectric, ultrasonic, or any other generally accepted and suitable device.

2. The installation and device shall be based on accepted alarm industry standards.

3. The device shall be maintained in operating order, have an auxiliary source of power, be monitored in accordance with accepted industry standards, be maintained in operating order; and shall be capable of sending an alarm signal to the monitoring entity if breached and the communication line is not operational.

4. The device shall fully protect all areas where prescription drugs are stored and shall be capable of detecting breaking by any means when activated.

5. Access to the alarm system shall be restricted to only designated and necessary persons, and the system shall be activated whenever the drug storage areas are closed for business.

6. An alarm system is not required for researchers; animal control officers; humane societies; alternate delivery sites as provided in 18VAC110-20-275; registered EMS agencies or regional EMS councils, or designated locations of registered EMS agency headquarters or regional EMS councils stocking only Schedule VI drugs or temporarily securing a secured drug kit that may contain Schedules II through VI drugs when the EMS vehicle or other EMS vehicle cannot maintain appropriate drug storage temperature or is out of service; persons authorized by the Department of Behavioral Health and Developmental Services to train individuals on the administration of naloxone and to dispense naloxone for opioid overdose reversal; and teaching institutions possessing only Schedule VI drugs.

G. A registered EMS agency headquarters or regional EMS council may store controlled substances at any of the following secured locations:

1. A registered location of the EMS agency or regional EMS council;

2. A designated location of the EMS agency or regional EMS council of which the board has been notified and DEA has granted approval if stocking drugs in Schedules II through V;

3. In an EMS vehicle or other EMS vehicle situated at a registered location or designated location of the EMS agency or regional EMS council; or

4. In an EMS vehicle or other EMS vehicle used by the EMS agency that is traveling from or returning to a registered location or designated location of the EMS agency or EMS council in the course of responding to an emergency or otherwise actively in use by the EMS agency.

H. Drugs secured in an EMS agency, regional EMS council, EMS vehicle, or other EMS vehicle shall be stored at an appropriate temperature pursuant to manufacturer's directions at all times. If the EMS vehicle or other EMS vehicle cannot maintain appropriate temperature or is out of service, the drug kit may be temporarily maintained within the building of the EMS agency. The drug kit shall be stored in compliance with this section.

18 Va. Admin. Code § 110-20-710

Derived from Virginia Register Volume 15, Issue 26, eff. October 13, 1999; amended, Virginia Register Volume 20, Issue 23, eff. August 25, 2004; Volume 22, Issue 21, eff. September 10, 2006; Volume 25, Issue 24, eff. September 2, 2009; Volume 28, Issue 5, eff. December 22, 2011; Volume 29, Issue 25, eff. September 26, 2013; Amended, Virginia Register Volume 35, Issue 09, eff. 1/23/2019; Amended, Virginia Register Volume 41, Issue 2, eff. 8/20/2024, exp. 2/19/2026 (Emergency).

Statutory Authority: §§ 54.1-2400 and 54.1-3307 of the Code of Virginia.