(a) Each emergency medical services agency registered pursuant to § 1301.20 of this chapter (including a hospital-based emergency medical services agency using a hospital registration under § 1301.20(a)(2) of this chapter) must maintain records for each dose of controlled substances administered or disposed of in the course of providing emergency medical services. The following information shall be included in each record:

(1) Name of the substance;

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

(3) Date administered or disposed of;

(4) Identification of the patient (consumer), if applicable;

(5) Amount administered;

(6) Last name or initials of the person who administered the controlled substance;

(7) Last name or initials of the medical director or authorizing medical professional issuing the standing or verbal order;

(8) Whether a standing or verbal order was issued and adopted;

(9) Amount disposed of, if applicable;

(10) Manner disposed of; and

(11) Last name or initials of person who disposed and witness to disposal, if applicable.

(b) For each acquisition of a controlled substance from another registrant, or each distribution of a controlled substance to another registrant, each emergency medical services agency registered pursuant to § 1301.20 of this chapter must maintain records with all of the following information:

(1) For each acquisition of a controlled substance from another registrant:

(i) Name of the substance;

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

(iii) Number of units or volume of finished form in each commercial container;

(iv) Number of commercial containers acquired (e.g., 100-tablet bottle or 3-milliliter vial);

(v) Date of the acquisition;

(vi) Name, address, and registration number of the person from whom the substance was acquired; and

(vii) Name and title of the person acquiring the controlled substance.

(2) For each distribution of a controlled substance to another registrant:

(i) Name of the substance;

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

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

(iv) Number of commercial containers distributed;

(v) Date of the distribution;

(vi) Name, address, and registration number of the person to whom the substance was distributed; and

(vii) Name and title of the person in receipt of the distributed controlled substances.

(3) For each delivery of controlled substances between a designated location and a registered location:

(i) Name of the substance;

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

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

(iv) 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);

(v) Date of the delivery;

(vi) Name and address of the designated location to which the substance is delivered; and

(vii) Name and title of the person in receipt of the controlled substances.

(4) For destruction of a controlled substance:

(i) Name of the substance;

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

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

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

(v) Date of the destruction;

(vi) Manner of disposal of the substance, if applicable;

(vii) Name, address, and registration number of the person to whom the substance was distributed, if applicable; and

(viii) Name and title of the person destroying the controlled substance.

(c) A designated location of an emergency medical services agency that receives controlled substances must notify the agency's registered location within 72 hours of receipt of the controlled substances, in the following circumstances:

(1) An emergency medical services vehicle primarily situated at a designated location of the emergency medical services agency acquires controlled substances from a hospital while restocking following an emergency response;

(2) The designated location of the emergency medical services agency receives controlled substances from another designated location of the same agency.

[91 FR 5241, Feb. 5, 2026]