18 Va. Admin. Code § 110-20-721 - [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.
Notes
Statutory Authority: §§ 54.1-2400 and 54.1-3307 of the Code of Virginia.
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