"new drug" definition - please help
You may get more responses at "sci.med"
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].
Quote:
> Not sure whether this is the best newsgroup for this post but ...
> 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?
> =================================
> 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.
