[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: 21CFR310.3]

[Page 6-7]
 
                        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 A_General Provisions
 
Sec.  310.3  Definitions and interpretations.


    As used in this part:
    (a) The term act means the Federal Food, Drug, and Cosmetic Act, as 
amended (secs. 201-902, 52 Stat. 1040 et seq., as amended; 21 U.S.C. 
321-392).
    (b) Department means the Department of Health and Human Services.
    (c) Secretary means the Secretary of Health and Human Services.
    (d) Commissioner means the Commissioner of Food and Drugs.
    (e) The term person includes individuals, partnerships, 
corporations, and associations.
    (f) The definitions and interpretations of terms contained in 
section 201 of the act shall be applicable to such terms when used in 
the regulations in this part.

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    (g) New drug substance means any substance that when used in the 
manufacture, processing, or packing of a drug, causes that drug to be a 
new drug, but does not include intermediates used in the synthesis of 
such substance.
    (h) The newness of a drug may arise by reason (among other reasons) 
of:
    (1) The newness for drug use of any substance which composes such 
drug, in whole or in part, whether it be an active substance or a 
menstruum, excipient, carrier, coating, or other component.
    (2) The newness for a drug use of a combination of two or more 
substances, none of which is a new drug.
    (3) The newness for drug use of the proportion of a substance in a 
combination, even though such combination containing such substance in 
other proportion is not a new drug.
    (4) The newness of use of such drug in diagnosing, curing, 
mitigating, treating, or preventing a disease, or to affect a structure 
or function of the body, even though such drug is not a new drug when 
used in another disease or to affect another structure or function of 
the body.
    (5) The newness of a dosage, or method or duration of administration 
or application, or other condition of use prescribed, recommended, or 
suggested in the labeling of such drug, even though such drug when used 
in other dosage, or other method or duration of administration or 
application, or different condition, is not a new drug.
    (i) [Reserved]
    (j) The term sponsor means the person or agency who assumes 
responsibility for an investigation of a new drug, including 
responsibility for compliance with applicable provisions of the act and 
regulations. The ``sponsor'' may be an individual, partnership, 
corporation, or Government agency and may be a manufacturer, scientific 
institution, or an investigator regularly and lawfully engaged in the 
investigation of new drugs.
    (k) The phrase related drug(s) includes other brands, potencies, 
dosage forms, salts, and esters of the same drug moiety, including 
articles prepared or manufactured by other manufacturers: and any other 
drug containing a component so related by chemical structure or known 
pharmacological properties that, in the opinion of experts qualified by 
scientific training and experience to evaluate the safety and 
effectiveness of drugs, it is prudent to assume or ascertain the 
liability of similar side effects and contraindications.
    (l) Special packaging as defined in section 2(4) of the Poison 
Prevention Packaging Act of 1970 means packaging that is designed or 
constructed to be significantly difficult for children under 5 years of 
age to open or obtain a toxic or harmful amount of the substance 
contained therein within a reasonable time and not difficult for normal 
adults to use properly, but does not mean packaging which all such 
children cannot open or obtain a toxic or harmful amount within a 
reasonable time.
    (m) [Reserved]
    (n) The term radioactive drug means any substance defined as a drug 
in section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act which 
exhibits spontaneous disintegration of unstable nuclei with the emission 
of nuclear particles or photons and includes any nonradioactive reagent 
kit or nuclide generator which is intended to be used in the preparation 
of any such substance but does not include drugs such as carbon-
containing compounds or potassium-containing salts which contain trace 
quantities of naturally occurring radionuclides. The term ``radioactive 
drug'' includes a ``radioactive biological product'' as defined in Sec.  
600.3(ee) of this chapter.

[39 FR 11680, Mar. 29, 1974, as amended at 39 FR 20484, June 11, 1974; 
40 FR 31307, July 25, 1975; 46 FR 8952, Jan. 27, 1981; 50 FR 7492, Feb. 
22, 1985]