subpart_subject: "Requirements for Specific New Drugs or Devices"
section_number: "310.502"
section_subject: "Certain drugs accorded new drug status through rulemaking procedures."
cfr_reference: "21 CFR 310.502"
title_name: "Title 21"
title_subject: "Food and Drugs"
parts_covered: "Parts 300 to 499"
revised_date: "Revised as of April 1, 2019"
publication_date: "As of April 1, 2019"
contains_description: "Containing a codification of documents of general applicability and future effect"
publication_info: "Published by the Office of the Federal Register National Archives and Records Administration as a Special Edition of the Federal Register"
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(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:
(1)Aerosol drug products for human use containing 1,1,1-trichloroethane.
(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.