N.M. Admin. Code § 16.19.14.19

Current through Register Vol. 35, No. 21, November 5, 2024

Section 16.19.14.19 - PRESCRIPTION REQUIREMENT

A. Prescription requirement, in general: A designated medical gas shall be subject to the requirements of 21 U.S.C. section 353(b)(1) unless the Secretary of the FDA exercises the authority provided in section 353(b)(3) to remove such medical gas from the requirements of section 353(b)(1), the gas is approved for use without a prescription pursuant to an application under 21 U.S.C. section 355 or 360b, or the use in question is authorized pursuant to another provision of this part relating to use of medical products in emergencies.

B. Oxygen, no prescription required for certain uses: oxygen may be provided without a prescription for the following uses:

(1) for use in the event of depressurization or other environmental oxygen deficiency; and

(2) for oxygen deficiency or for use in emergency resuscitation, when administered by properly trained personnel.

(3) Labeling - For oxygen provided pursuant to this Subsection B., the requirements of section 353(b)(4) of 21 U.S.C. shall be deemed to have been met if its labeling bears a warning that the oxygen can be used for emergency use only and for all other medical applications a prescription is required.

C. Prescription requirement. Except as provided above, medical gas sellers shall not supply medical gas to a patient or consumer without a drug order.

(1) An original or copy of a prescription drug order must be kept at the licensed location supplying the medical gas.

(2) A prescription drug order shall be valid for a period of time consistent with the indication for which it was prescribed. Prescription drug orders shall be maintained for three years and be readily retrievable and available at inspection.

N.M. Admin. Code § 16.19.14.19

Adopted by New Mexico Register, Volume XXXIV, Issue 04, February 28, 2023, eff. 2/28/2023