21 CFR 310.502
Certain drugs accorded new drug status through rulemaking procedures
21 CFR 310.502 is the regulation titled “Certain drugs accorded new drug status through rulemaking procedures” in 21 CFR Part 310, New Drugs. Since 2021, 1 FDA warning letter has cited it.
- Letters citing it
- 1 since 2021
- Jan 1 to Oct 30, 2026
- 0 against 0 on the same dates in 2025
- Most often cited with
- 21 CFR 201.128, in 1 letter
- Closed out
- 0% of these letters have a published close-out
Letters citing it, by year issued
It is a drug letter. 2026 runs to Oct 30, 2026. Pick a year to see its letters.
- 02021
- 02022
- 12023
- 02024
- 02025
- 02026
The regulation
Read the text of 21 CFR 310.502 (eCFR, as of Sep 1, 2026)
(a) The drugs listed in this paragraph (a) have been determined by rulemaking procedures to be new drugs within the meaning of section 201(p) of the Federal Food, Drug, and Cosmetic Act. An approved new drug application under section 505 of the Federal Food, Drug, and Cosmetic Act and part 314 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]
[62 FR 12084, Mar. 14, 1997, as amended at 64 FR 401, Jan. 5, 1999; 84 FR 68334, Dec. 16, 2019]
Text from eCFR as of Sep 1, 2026.
Cited alongside it
Regulations that appear in the same letters as 21 CFR 310.502.
- 21 CFR 201.128Meaning of “intended uses”1 letter cites both
- 21 CFR 201.66Format and content requirements for over-the-counter (OTC) drug product labeling1 letter cites both
- 21 CFR 207.29What are the requirements for reviewing and updating registration information?1 letter cites both
- 21 CFR 207.57What information must registrants submit when updating listing information and when?1 letter cites both
- 21 CFR 211.100Written procedures; deviations1 letter cites both
- 21 CFR 211.166Stability testing1 letter cites both
- 21 CFR 211.22Responsibilities of quality control unit1 letter cites both
- 21 CFR 211.63Equipment design, size, and location1 letter cites both
Latest letters citing it
The letter citing 21 CFR 310.502 that FDA posted most recently.
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