Part XI. Other Institutions and Facilities
18VAC110-20-570. Drugs in infirmaries or first-aid rooms.
A. Prescription drugs purchased by an institution, agency, or business within the Commonwealth, having been purchased in the name of a practitioner licensed by the Commonwealth of Virginia and who is employed by an institution, agency, or business which does not hold a pharmacy permit, shall be used only for administering to those persons at that institution, agency, or business.
B. All prescription drugs shall be maintained and secured in a suitable locked storage area, the key to which will be in the possession of the practitioner or nurse who is under the direction and supervision of the practitioner.
C. Such institution, agency, or business shall adopt a specific protocol for the administration of prescription drugs, listing the inventory of such drugs maintained, and authorizing the administering of such drugs in the absence of a practitioner in an emergency situation when the timely prior verbal or written order of a prescriber is not possible. Administering of such drugs shall be followed by written orders.
1. For the purpose of this chapter, "emergency" means a circumstance requiring administration of prescription drugs necessary to preserve life or to prevent significant or permanent injury or disability.
2. The protocol shall be maintained for inspection and documentation purposes.
Statutory Authority
§§ 54.1-2400 and 54.1-3307 of the Code of Virginia.
Historical Notes
Derived from VR530-01-1 § 12.1, eff. October 25, 1989; amended, Virginia Register Volume 9, Issue 4, eff. December 16, 1992; Volume 10, Issue 1, eff. November 4, 1993; Volume 11, Issue 21, eff. August 9, 1995; Volume 12, Issue 21, eff. August 7, 1996; Volume 15, Issue 8, eff. February 3, 1999; Volume 25, Issue 24, eff. September 2, 2009.
18VAC110-20-580. Animal shelters.
An animal shelter, after having obtained the proper registrations pursuant to state and federal laws, may purchase, possess and administer controlled substances in accordance with provisions of § 54.1-3423 of the Code of Virginia provided that these procedures are followed:
1. Drugs ordered by a public or private animal shelter, as defined in § 3.2-6500 of the Code of Virginia, shall only be stored and administered at the address of the shelter.
2. A veterinarian shall provide general supervision for the facility and shall provide and certify training in accordance with guidelines set forth by the State Veterinarian to the persons responsible for administration of the drugs. Certification of training signed by the veterinarian providing the training shall be maintained at the facility for each person administering drugs and must be retained for not less than two years after the person ceases administering.
3. The person in charge of administration of drugs for the facility shall obtain the required permit and controlled substances registration from the board and shall be responsible for maintaining proper security and required records of all controlled substances obtained and administered.
a. If that person ceases employment with the facility or relinquishes his position, he shall immediately return the registration to the board and shall take a complete and accurate inventory of all drugs in stock.
b. An application for a new registration shall be filed with the required fee within 14 days on a form provided by the board. At that time, the new responsible person shall take a complete and accurate inventory of all drugs in stock.
4. Drugs shall be stored in a secure, locked place and only the person responsible for administering may have access to the drugs.
5. All invoices and order forms shall be maintained for a period of two years.
6. Complete and accurate records shall be maintained for two years on the administration of the drug. The record shall show the name and strength of the drug, date of administration, the species of the animal, the weight of animal, the amount of drug administered and the signature of the person administering the drug.
Statutory Authority
§§ 54.1-2400 and 54.1-3307 of the Code of Virginia.
Historical Notes
Derived from VR530-01-1 § 12.2, eff. October 25, 1989; amended, Virginia Register Volume 9, Issue 4, eff. December 16, 1992; Volume 10, Issue 1, eff. November 4, 1993; Volume 11, Issue 21, eff. August 9, 1995; Volume 15, Issue 8, eff. February 3, 1999; Volume 25, Issue 24, eff. September 2, 2009; Volume 36, Issue 6, eff. December 11, 2019.
18VAC110-20-590. Drugs in correctional facilities.
A. All prescription drugs at any correctional facility shall be subject to the following conditions:
1. Notwithstanding the allowances in subsections B, C, and D of this section, prescription drugs shall be obtained only on an individual prescription basis.
2. All prepared drugs shall be maintained in a suitable locked storage area with only the person responsible for administering the drugs having access.
3. Complete and accurate records shall be maintained of all drugs received, administered and discontinued. The administration record shall show the:
a. Patient name;
b. Drug name and strength;
c. Number of dosage units received;
d. Prescriber's name; and
e. Date, time and signature of the person administering the individual dose of drug.
4. All unused or discontinued drugs shall be sealed and the amount in the container at the time of the sealing shall be recorded on the drug administration record. Schedule VI drugs shall be returned to the provider pharmacy or to a secondary pharmacy along with the drug administration record, a copy of the drug administration record, or other form showing substantially the same information, within 30 days of discontinuance.
a. The provider or secondary pharmacy shall conduct random audits of returned drug administration records for accountability.
b. The drug administration records shall be filed in chronological order by the provider or secondary pharmacy and maintained for a period of one year or, at the option of the facility, the records may be returned by the pharmacy to the facility.
c. Drugs may be returned to pharmacy stock in compliance with the provisions of 18VAC110-20-400.
d. Other drugs shall be disposed of or destroyed by the provider pharmacy in accordance with local, state, and federal regulations.
5. After performing the audit required by subdivision 4 a of this subsection and ensuring the proper maintenance of the administration records, drugs in Schedules II through V shall be destroyed at the site of the correctional facility using a method of destruction that renders the drug unrecoverable.
a. The destruction shall be performed by a nurse, pharmacist, or physician and witnessed by the nurse supervisor, a pharmacist, or a physician.
b. Destruction of drugs shall occur within 30 days of discontinuance.
c. A complete and accurate record of the drugs destroyed shall be made. The original of the record of destruction shall be signed and dated by the persons witnessing the destruction and maintained at the correctional facility for a period of two years. A copy of the destruction record shall be maintained at the provider pharmacy for a period of two years.
B. Emergency and stat-drug box. An emergency box and a stat-drug box may be prepared for a correctional facility served by the pharmacy pursuant to 18VAC110-20-540 and 18VAC110-20-550 provided that the facility employs one or more full-time physicians, registered nurses, licensed practical nurses, or physician assistants.
C. A correctional facility may maintain a stock of intravenous fluids, irrigation fluids, sterile water, and sterile saline to be accessed only by those persons licensed to administer drugs and shall be administered only by such persons pursuant to a valid prescription or lawful order of a prescriber. Such stock shall be limited to a listing to be determined by the provider pharmacist in consultation with the medical and nursing staff of the institution.
D. Except for drugs in an emergency box, stat-drug box, or a stock of intravenous fluids, irrigation fluids, sterile water, and sterile saline, prescription drugs, including vaccines, may be floor-stocked only at a medical clinic or surgery center that is part of a correctional facility and that is staffed by one or more prescribers during the hours of operation, provided the clinic first obtains a controlled substances registration and complies with the requirements of 18VAC110-20-690, 18VAC110-20-700, 18VAC110-20-710, and 18VAC110-20-720.
Statutory Authority
§§ 54.1-2400 and 54.1-3307 of the Code of Virginia.
Historical Notes
Derived from VR530-01-1 § 12.3, eff. October 25, 1989; amended, Virginia Register Volume 9, Issue 4, eff. December 16, 1992; Volume 10, Issue 1, eff. November 4, 1993; Volume 11, Issue 21, eff. August 9, 1995; Volume 15, Issue 8, eff. February 3, 1999; Volume 20, Issue 23, eff. August 25, 2004; Volume 25, Issue 24, eff. September 2, 2009; Volume 31, Issue 20, eff. July 16, 2015; Volume 33, Issue 24, eff. September 7, 2017.
18VAC110-20-591. Allowances for emergency medical services agencies to obtain drugs.
A. This section contains specific provisions by which an EMS agency may obtain drugs for administration.
B. Unless prohibited by federal law, a pharmacy may prepare a kit for an EMS agency, provided:
1. The PIC of the pharmacy shall be responsible for all prescription drugs contained in this kit. Except as authorized in 18VAC110-20-505, a pharmacist shall (i) check each kit after filling and (ii) initial the filling record certifying the accuracy and integrity of the contents of the kit.
2. The kit containing drugs in Schedules II through V is sealed, secured, and stored in such a manner that will deter theft or loss of drugs and aid in detection of theft or loss. Kits containing only drugs in Schedule VI are not required to be sealed but must be secured in a manner to deter theft or loss.
a. The pharmacy shall have a method of sealing the kits such that once the seal is broken, it cannot be reasonably resealed without the breach being detected.
b. If a seal is used, it shall have a unique numeric or alphanumeric identifier to preclude replication or resealing. The pharmacy shall maintain a record of the seal identifiers when placed on a kit and maintain the record for a period of one year.
c. In lieu of a seal, a kit with a built-in mechanism preventing resealing or relocking once opened except by the provider pharmacy may be used.
3. A current copy of the signed standing protocol shall be maintained by the pharmacy participating in the kit exchange. The EMS provider shall make a record of all drugs administered to a patient.
4. When the drug kit has been opened, the kit shall be returned to the pharmacy and exchanged for an unopened kit. The record of the drugs administered shall accompany the opened kit when exchanged. An accurate record shall be maintained by the pharmacy on the exchange of the drug kit for a period of one year. A pharmacist, pharmacy technician, or nurse shall reconcile the Schedule II, III, IV, or V drugs in the kit at the time the opened kit is returned. A record of the reconciliation, to include any noted discrepancies, shall be maintained by the pharmacy for a period of two years from the time of exchange. The theft or any other unusual loss of any Schedule II, III, IV, or V controlled substance shall be reported in accordance with § 54.1-3404 of the Code of Virginia.
5. Accurate records of the following shall be maintained by the pharmacy on the exchange of the drug kit for a period of one year:
a. The record of filling and verifying the kit, to include the drug contents of the kit, the initials of the pharmacist verifying the contents, the date of verification, a record of an identifier if a seal is used, and the assigned expiration date for the kit, which shall be no later than the expiration date associated with the first drug scheduled to expire.
b. The record of the exchange of the kit, to include the date of exchange and the name of EMS agency and EMS provider receiving the kit.
6. Destruction of partially used Schedules II, III, IV, and V drugs shall be accomplished by two persons, one of whom shall be the EMS provider and the other shall be a pharmacist, nurse, prescriber, pharmacy technician, or a second EMS provider. Documentation shall be maintained in the pharmacy for a period of two years from the date of destruction.
7. The record of the drugs administered shall be maintained as a part of the pharmacy records pursuant to state and federal regulations for a period of not less than two years.
8. Intravenous and irrigation solutions provided by a pharmacy to an emergency medical services agency may be stored separately outside the kit.
9. Any drug showing evidence of damage or tampering shall be immediately removed from the kit and replaced.
10. In lieu of exchange by a hospital pharmacy, the PIC of the hospital pharmacy may authorize the exchange of the kit by the emergency department. Exchange of the kit in the emergency department shall only be performed by a pharmacist, nurse, prescriber, or pharmacy technician if the kit contents include Schedule II, III, IV, or V drugs.
11. Drug kits shall be secured on the EMS vehicle or other EMS vehicle at all times, unless the vehicle is incapable of maintaining appropriate drug storage temperature or is out of service. The EMS agency is not required to obtain a controlled substances registration pursuant to § 54.1-3423 D of the Code of Virginia to participate in a pharmacy kit exchange in accordance with this section unless the EMS agency needs to temporarily store a secured drug kit within the EMS building when a vehicle is incapable of maintaining appropriate drug storage temperature or is out of service and the EMS agency does not otherwise serve as a designated location of a current, active controlled substances registration. An alarm system consistent with requirements in 18VAC110-20-710 is not required under these conditions.
C. An EMS agency or regional EMS council that has been issued a controlled substances registration pursuant to 18VAC110-20-690 G and a registration from DEA in accordance with federal law may receive drugs in Schedules II through VI and deliver or transfer the drugs to any designated location of the registered EMS agency headquarters or regional EMS council. Delivery of the drugs shall not constitute wholesale distribution.
D. For sites that are not designated locations of the entity providing the drug, nothing shall preclude a hospital, EMS agency, or regional EMS council from transferring or distributing drugs in Schedule VI to another EMS agency, regional EMS council, or a designated location of either entity during a shortage of drugs or in an emergency.
E. A hospital, EMS agency, regional EMS council, and designated locations may deliver drugs in Schedules II through V to each other consistent with federal law in the event of shortages of such drugs, a public health emergency, or a mass casualty event. All entities transferring, delivering, and receiving drugs shall comply with recordkeeping requirements listed in 18VAC110-20-721.
F. In compliance with federal law, a hospital pharmacy may provide drugs to a hospital-owned EMS agency operating as an extension of the hospital pharmacy's DEA registration.
G. If an EMS agency that is not hospital owned has obtained a controlled substances registration and a DEA registration in accordance with federal law, a pharmacy may provide that EMS agency drugs for restocking an EMS vehicle or other EMS vehicle, provided all of the following criteria are met:
1. The registered or designated location of the agency operating the EMS vehicle or other EMS vehicle maintains the record of receipt of drugs in accordance with state and federal law.
2. The pharmacy maintains a record of the delivery to the EMS agency in accordance with state and federal law.
3. If the EMS vehicle or other EMS vehicle is primarily situated at a designated location of an EMS agency, the designated location notifies the registered location of the agency within 72 hours of the EMS vehicle or other EMS vehicle receiving drugs in Schedules II through V.
4. Pursuant to § 54.1-3434.02 of the Code of Virginia, the EMS provider may directly obtain Schedule VI drugs from an automated drug dispensing device.
5. If such drugs are obtained from a nurse, pharmacist, or prescriber, it shall be in accordance with the procedures established by the pharmacist-in-charge, which shall include a requirement to record the date of exchange, name of licensed person providing the drug, name of the EMS agency and provider receiving the drug, and assigned expiration date. Such record shall be maintained by the pharmacy for one year from the date of exchange.
6. If an EMS agency is performing a one-to-one exchange of Schedule VI drugs, such Schedule VI drugs shall remain in a separate container.
H. Schedule VI drugs stored on an EMS vehicle or other EMS vehicle are not required to be stored in a sealed kit, but must be stored in a manner to deter theft or loss. Drugs in Schedules II through V stored on a ground EMS vehicle, other EMS vehicle, or EMS vehicle that is a licensed fixed-wing aircraft shall be stored in a sealed, secured kit or device within a locked cabinet that is accessible from the patient compartment of the vehicle. Drugs in Schedules II through V stored on an EMS vehicle that is a licensed rotary aircraft shall be stored in a sealed, secured kit or device to deter theft or loss.
1. The method of sealing the kits shall ensure that once the seal is broken, it cannot be reasonably resealed without the breach being detected.
2. If a seal is used, it shall have a unique numeric or alphanumeric identifier to preclude replication or resealing. The EMS registered agency headquarters, regional EMS council, or designated location sealing and resealing the kit shall maintain a record of the seal identifiers when placed on a kit and maintain the record for a period of one year.
3. In lieu of a seal, a kit with a built-in mechanism preventing resealing or relocking once opened except by EMS personnel may be used.
I. Registered EMS agency headquarters, regional EMS councils, and designated locations of the registered EMS agency headquarters or regional EMS councils shall implement a process to review expiration dates no less often than every three months to ensure drugs are not administered beyond the expiration date.
J. Registered EMS agency headquarters, regional EMS councils, and designated locations of the registered EMS agency headquarters or regional EMS councils shall perform drug inventories and report drug theft or unusual loss to the board in accordance with § 54.1-3404 of the Code of Virginia.
K. Registered EMS agency headquarters and regional EMS councils shall audit the security of the drug storage location and perform a random audit of Schedules II through V drugs and required recordkeeping for accuracy at least every six months at each designated location under the controlled substances registration. Documentation verifying the completion of the audit for each designated location shall be maintained at the registered EMS agency headquarters or regional EMS council for two years from the date performed.
Statutory Authority
§§ 54.1-2400 and 54.1-3307 of the Code of Virginia.
Historical Notes
Derived from Virginia Register Volume 42, Issue 9, eff. January 14, 2026.