---
kind: "section"
citation: "21 C.F.R. § 310.502"
title: "21"
number: "310.502"
heading: "Certain drugs accorded new drug status through rulemaking procedures."
url: "https://uscodex.org/cfr/21/310.502"
---

# §310.502. Certain drugs accorded new drug status through rulemaking procedures.

- (a) The drugs listed in this [paragraph (a)](#a) have been determined by rulemaking procedures to be new drugs within the meaning of [section 201(p)](/cfr/21/201.md?p=p) of the Federal Food, Drug, and Cosmetic Act. An approved new drug application under [section 505](/cfr/21/505.md) of the Federal Food, Drug, and Cosmetic Act and [part 314](/cfr/21/part314.md) of this chapter is required for marketing the following drugs:
  - (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]
  - (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.**
- (b) [Reserved]

## Notes

### Amendments

[62 FR 12084, Mar. 14, 1997, as amended at 64 FR 401, Jan. 5, 1999; 84 FR 68334, Dec. 16, 2019]

### Authority

Authority: 21 U.S.C. 321, 331, 351, 352, 353, 355, 360b-360f, 360j, 360hh-360ss, 361(a), 371, 374, 375, 379e, 379k-l; 42 U.S.C. 216, 241, 242(a), 262.

### Amendments

[62 FR 12084, Mar. 14, 1997, as amended at 64 FR 401, Jan. 5, 1999; 84 FR 68334, Dec. 16, 2019]