Code of Federal Regulations Title 21. Food and Drugs § 21.310.502 Certain drugs accorded new drug status through rulemaking procedures

(1) Aerosol drug products for human use containing 1,1,1-trichloroethane.

(2) Aerosol drug products containing zirconium.

(3)Amphetamines (amphetamine, dextroamphetamine, and their salts, and levamfetamine and its salts) for human use.

(4) Camphorated oil drug products.

(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.

(6) Chloroform used as an ingredient (active or inactive) in drug products.

(7) Cobalt preparations intended for use by man.

(8)Intrauterine devices for human use for the purpose of contraception that incorporate heavy metals, drugs, or other active substances.

(9) Oral prenatal drugs containing fluorides intended for human use.

(10) Parenteral drug products in plastic containers.

(11)[Reserved by 84 FR 68334]

(12) Sweet spirits of nitre drug products.

(13) Thorium dioxide for drug use.

(14) Timed release dosage forms.

(15) Vinyl chloride as an ingredient, including propellant, in aerosol drug products.