18 Va. Admin. Code § 110-20-721

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

Section 18VAC110-20-721 - [Effective until 2/19/2026] Additional recordkeeping requirements for EMS agencies

A. Each EMS agency holding a controlled substances registration or serving as a designated location of an EMS agency or regional EMS council, including a hospital-owned EMS agency operating under a hospital registration, responsible for administering a drug must maintain written standing protocols signed by the operational medical director for the EMS agency that authorize the administration. Oral orders authorizing the administration shall be reduced to writing by the EMS provider and shall be signed by a medical practitioner and maintained by the EMS entity responsible for administering the drug.

B. A record for each dose of drug in Schedules II through VI administered and destruction of partially administered drug in the course of providing emergency medical services must also be maintained. 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. Except as indicated in 18VAC110-20-591 for emergency drug kits provided by a pharmacy, documentation shall be maintained in the EMS agency or the designated location of an EMS agency or regional EMS council for a period of two years from the date of destruction.

C. The following records shall be maintained for each acquisition of a drug in Schedules II through VI from another registrant of the board or each distribution of a drug in Schedules II through VI to another registrant of the board:

1. For each acquisition of a drug from another registrant:

a. Name of the drug;

b. Finished form of the drug (e.g., 10-milligram tablet or 10-milligram concentration per fluid ounce or milliliter);

c. Number of units or volume of finished form in each commercial container (e.g., 100-tablet bottle or 3-milliliter vial);

d. Number of commercial containers acquired;

e. Date of the acquisition;

f. Name, address, and registration number of the person from whom the substance was acquired; and

g. Name and title of the person acquiring the drug.

2. For each distribution of drug in Schedules II through VI to another registrant:

a. Name of the drug;

b. Finished form of the drug (e.g., 10-milligram tablet or 10-milligram concentration per fluid ounce or milliliter);

c. Number of units or volume of finished form in each commercial container (e.g., 100-tablet bottle or 3-milliliter vial);

d. Number of commercial containers distributed;

e. Date of the distribution;

f. Name, address, and registration number of the person to whom the substance was distributed; and

g. Name and title of the person in receipt of the distributed drugs.

3. For each delivery of drug in Schedules II through VI between a designated location and a registered location:

a. Name of the drug;

b. Finished form of the drug (e.g., 10-milligram tablet or 10-milligram concentration per fluid ounce or milliliter);

c. Number of units or volume of finished form in each commercial container (e.g., 100-tablet bottle or 3-milliliter vial);

d. Number of units or volume of finished form in each commercial container and number of commercial containers delivered (e.g., 100-tablet bottle or 3-milliliter vial);

e. Date of the delivery;

f. Name and address of the designated location to which the substance was delivered; and

g. Name and title of the person in receipt of the controlled substances.

4. For destruction of a drug in Schedules II through VI, unless otherwise authorized under federal law, expired or unwanted drugs shall be transferred to another person or entity authorized to possess or provide for proper disposal of such drugs.

D. A designated location of an EMS agency that receives drugs in Schedules II through V must notify the EMS agency's registered location within 72 hours of receipt of the drugs in the following circumstances:

1. An EMS vehicle or other EMS vehicle primarily situated at a designated location of the EMS agency acquires drug from a hospital while restocking following a response; or

2. The designated location of the EMS agency receives drugs from another designated location of the same agency.

E. To the extent permitted by federal law, registered EMS agency headquarters, regional EMS councils, or designated locations of the EMS agency or regional EMS council in which the repackaging or prepackaging of over-the-counter drugs is performed shall maintain adequate control records for a period of one year or until the expiration of the drugs, whichever is greater.

1. The records shall show the name of the drugs used; strength, if any; date repackaged; quantity prepared; initials of the pharmacist, EMS responsible party, or designee authorized to administer drugs verifying the process; the assigned lot or control number; the manufacturer or distributor name and lot or control number; and an expiration date.

2. Any subsequently repackaged units shall show the name of the drug; strength, if any; the assigned lot or control number or the manufacturer or distributor name and lot or control number; and an appropriate expiration date determined by the pharmacist, EMS responsible party, or designee authorized to administer drugs in accordance with USP guidelines.

3. Repackaging of drugs shall be performed in compliance with USP-NF standards.

18 Va. Admin. Code § 110-20-721

Derived from 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.