BIOETYKA / ETYKA MEDYCZNA

BIOETYKA / ETYKA MEDYCZNA - Przeglądy aktów prawnych

Federal Food, Drug, and Cosmetic Act (FD&C Act) Federalna Ustawa o Żywności, Lekach i Kosmetykach – 1938

§321. Definitions; generally

(…)

g)(1) The term “drug” means (A) articles recognized in the official United States Pharmacopoeia, official Homoeopathic Pharmacopoeia of the United States, or official National Formulary, or any supplement to any of them; and (B) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and (C) articles (other than food) intended to affect the structure or any function of the body of man or other animals; and (D) articles intended for use as a component of any article specified in clause (A), (B), or (C). (…)

§355 New drugs

(a) Necessity of effective approval of application

No person shall introduce or deliver for introduction into interstate commerce any new drug, unless an approval of an application filed pursuant to subsection (b) or (j) of this section is effective with respect to such drug (…).