Drugs, medical device defined--Promulgation of rules

For the purpose of this chapter, "drugs" are:

(1) Articles recognized in the official United States Pharmacopoeia or the official National Formulary, as adopted by the board through rules promulgated pursuant to chapter 1-26 , or recognized in the official Homeopathic Pharmacopoeia of the United States as in effect on January 1, 1993;

(2) Articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in humans or other animals;

(3) Articles, other than food, intended to affect the structure or any functions of the human body; and

(4) Articles intended for use as a component of any articles specified in this section.

The term "drugs" excludes medical devices.

For the purposes of this section, "medical device" means an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, that is intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease in humans or animals, or is intended to affect the structure or any function of the body of humans or animals, that does not achieve any of its principal intended purposes through chemical action within or on the body of humans or animals and that is not dependent upon being metabolized for achievement of any of its principal intended purposes.

Source: SL 1993, ch 278, § 3; SL 2025, ch 154, § 3.