N.M. Admin. Code § 16.19.14.7

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

Section 16.19.14.7 - DEFINITIONS

A."Device", as used in the New Mexico Drug and Cosmetic Act, is any health care product that does not achieve any of its principal intended purpose through chemical action within or on the body of man or other animal and which is not dependent upon being metabolized for achievement of any of its principal intended purposes.

B."Board" means the New Mexico board of pharmacy.

C."Distribution of medical gases" means the distribution of medical gas, to persons other than consumers or patients.

D."Drug order" means a prescription drug order issued by a licensed prescriber for medical gas.

E."FDA" means the United States Food and Drug Administration.

F."Federal Act" means the Federal Food, Drug and Cosmetic Act.

G."Medical gas" means:

(1) a drug that is manufactured or stored in a liquefied, nonliquefied, or cryogenic state and is administered as a gas; and

(2) that is labeled for medical use in compliance with federal law and is otherwise a designated medical gas as defined at 21 U.S.C. Section 360dd d(1) of the Federal Act, including each of the following that meets the standards set forth in an official compendium: oxygen, nitrogen, nitrous oxide, carbon dioxide, helium, and medical air.

H. "Medical gas repackager" means a person that manufactures or repackages a medical gas, which includes producing, cascading, distributing, filling, mixing, purifying, separating, transferring, and transfilling medical gases. This includes original manufacturers as defined by the FDA that repackage medical gas and have a valid registration as a drug establishment with the FDA. A medical gas manufacturer shall be issued the license type medical gas repackager.

I."Medical gas seller" means a person licensed to distribute a medical gas to a person other than a consumer or patient, or to supply medical gases on drug orders to a patient or ultimate user.

J."Repackage" means persons or entities manufacturing bulk medical gases or transferring gas or liquefied gas product from one container to another (e.g., liquid to gas, gas to gas, liquid to liquid).

N.M. Admin. Code § 16.19.14.7

03-07-80...08-27-90; 16.19.14.7 NMAC - Rn, 16 NMAC 19.14.7, 03-30-02, Adopted by New Mexico Register, Volume XXXIV, Issue 04, February 28, 2023, eff. 2/28/2023