310.502—Certain drugs accorded new drug status through rulemaking procedures.
(a)
The drugs listed in this paragraph have been determined by rulemaking procedures to be new drugs within the meaning of section 201(p) of the act. An approved new drug application under section 505 of the act and part 314 of this chapter is required for marketing the following drugs:
(3)
Amphetamines (amphetamine, dextroamphetamine, and their salts, and levamfetamine and its salts) for human use.
(5)
Certain halogenated salicylanilides (tribromsalan (TBS, 3,4′,5-tribromosalicylanilide), dibromsalan (DBS, 4′, 5-dibromosalicylanilide), metabromsalan (MBS, 3, 5-dibromosalicylanilide), and 3,3′, 4,5′-tetrachlorosalicylanilide (TC-SA)) as an ingredient in drug products.
(8)
Intrauterine devices for human use for the purpose of contraception that incorporate heavy metals, drugs, or other active substances.