Where can I find the definition of "new drug" in the FD&C Act?
I need to confirm bullet point (3) below.

The text below is taken from the following article ...
http://www.***.com/

What Does New Drug Mean?
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Its important to have a clear perception of what a new drug is, and how a drug
is determined to be new. The term is defined in the Federal Food, Drug, and
Cosmetic Act, as amended in 1962 (1). Written in legalese, the Act takes two
paragraphs, totaling 194 words, to define new drug. Stripping the jargon-laden
definition down to its essentials, the term new drug means:

1)    It is a human drug.

2)    Its composition is not generally recognized, among qualified experts, as
safe and effective under the conditions recommended in its labeling.

3)    Even if it has been so recognized, if the drug has not been used to a
material extent or for a material (i.e., significant) time it is still a new
drug.

The second point of the definition requires the following clarification:

1)    The experts referred to above must be qualified by scientific training
and experience to evaluate the safety and effectiveness of {*filter*}.

2)    A {*filter*} safety and effectiveness can only be expressed in relation to the
claims made in the sponsors labeling. No drug is safe or effective without
further qualification.

It follows from the definition that any previously unknown substance, whether
synthesized or isolated from a culture or other biological system, is
unquestionably a new drug. With regard to known substances, gray areas exist,
but these are not pertinent to this article.

Bullet point (3) below seems correct.

Definitions can be found in the following link:
SEC. 201. [21 U.S.C. 321]
CHAPTER IIDEFINITIONS 1
http://www.***.com/
ctFDCAct/FDCActChaptersIandIIShortTitleandDefinitions/ucm086297.htm

The term "new drug" means

(1) Any drug (except a new animal drug or an animal [10] feed bearing or
containing a new animal drug) the composition [20] of which is such that such
drug is not generally [30] recognized, among experts qualified by scientific
training and experience to [40] evaluate the safety and effectiveness of {*filter*},
as safe and [50] effective for use under the condition prescribed, recommended,
or suggested [60] in the labeling thereof, except that such a drug not [70] so
recognized shall not be deemed to be a "new [80] drug" if at any time prior to
the enactment of [90] this Act [enacted June 25, 1938] it was subject to [100]
the cooking.net">food and {*filter*} Act of June 30, 1906, as [110] amended, and if at such time
its labeling contained the [120] same representations concerning the conditions
of its use; or

(2) Any [130] drug (except a new animal drug or an animal feed [140] bearing or
containing a new animal drug) the composition of [150] which is such that such
drug, as a result of [160] investigations to determine its safety and
effectiveness for use under [170] such conditions, has become so recognized, but
which has not [180], otherwise than in such investigations, been used to a
material [190] extent or for a material time under such conditions [199].