21 CFR § 299.3
Definitions and interpretations
June 25, 2020
(a) As used in this part 299, act means the Federal Food, Drug, and Cosmetic Act, sections 201-902, 52 Stat. 1040 (21 U.S.C. 321-392), with all amendments thereto.
(b) The definitions and interpretations contained in section 201 of the act shall be applicable to such terms when used in this part 299.
(c) The term official name means, with respect to a drug or ingredient thereof, the name designated in this part 299 under section 508 of the act as the official name.