Reading 2 Flashcards
Definition of the official compendium
-USP
-NF
-HPUS
Definition of a prescription drug
A drug intended for use by man which because of its toxicity or other potentiality for harmful effect, or the method of its use, is not safe for use except under the supervision of a practitioner licensed by law to administer such drug or is limited by an approved application under section 355 of this title to use under the professional supervision of practitioner licensed by law to administer such drug
Definition of an over-the-counter drug
Not a prescription drug
Definition of a new drug
A drug not generally recognized as safe and effective for the condition, in the dosage form it would be prescribed under, or a drug that has been recognized as safe and effective but has not been used in the condition or the dosage form for a sufficient amount of time
Definition of established name
Generic name
Definition of a device
An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is (1) recognized in the United States Pharmacopeia, National Formulary, or any supplement of them, and (2) intended for use in the diagnosis of disease or other condition, or in the cure, mitigation, treatment, or prevention of disease in man or other animal, and (3) intended to affect the structure or an function of the body in man or other animal, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purpose
Definition of adulteration
