[Code of Federal Regulations]
[Title 21, Volume 5]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR310.502]

[Page 22-23]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 310_NEW DRUGS--Table of Contents
 
        Subpart E_Requirements for Specific New Drugs or Devices
 
Sec.  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:
    (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.

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    (10) Parenteral drug products in plastic containers.
    (11) Sterilization of drugs by irradiation.
    (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]