norml09 - Page 27
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by Congress in 1970° My purpose simply is to clarify this
Agency's understanding of the law.
A+ _+s Ch@mistr_f__Mq_ Be K own a d
ReproduG_b_e.
The ability to recreate a drug in standardized dosages
is fundamental to testing that drug and to using it as a
medicine° Knowing the compositions properties_ methods of
productions and methods of analysis of a drug is essential
to reproducing it in standardized dosages. To be GRASE or
to receive NDA approval, a drug's chemistry must be known
and reproducible. See e+_ 21 CFR 314+50(d) (1) and
314.126(b) (7) (d); Dorovic v°Richa........................3odson, 749 F°2d 242, 251
(7th Cir+ 1973). The listing of a drug in a current edition
of one of the official compendia normally satisfies this
requirement. 21 U°S°C+ 321(j); 21 CFR 314.50(d) (i).
The first element of our eight-point testp namely_
'_scientifically determined and accepted knowledge Of its
chemistry, t_ should be clarified to read:
The substance's chemistry must be scientifically
established to per_it it to be reproduced into
dosages which can be standardized. The listing of
the substance in a current edition of one of the
official compendia_ as defined by Section 201(j)
of the Foods Drug and Cosmetic Acts 21 U+S.C°
321(j) _ is sufficient generally to meet this
requirement+
Acceptance of this knowledge will be discussed elsewhere_
B. There MDst Be Ade_ate Safety+Studies+
No drug can be considered safe in the abstract° Safety
has meaning only when judged against the intended use of the
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