norml08 - Page 27
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by Congress in 1970. My purpose sim]_ly is to clarify this
Agency's understanding of the law.
A. The Druqas Chemistry Must Be Known and
The ability to recreate a drug in standardized dosages
is fundamental to testing that drug and to using it as a
medicine. Knowing the composition, 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 approvals a drug's chemistry must be known
and reproducible. See 9______ 21 CFR 314 . 50 (d) (1) and
314.126(b) (7) (d); Dorovic v. Richardsont 749 F_2d 242, 251
_+ ......... (7th Cir. 1973). The listing of a d]_ug in a current edition
of one of the official compendia no_nally satisfies this
requirement. 21 U.SoC. 321(j); 21 CFR 314.50(d) (1).
The first element of our eight_point test, namely,
"scientifically determined and accepted knowledge Of its
chemistry, '_ should be clarified to read:
The substance_s chemistry must be scientifically
established to permit 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 Food_ Drug and Cosmetic Acts 21 U.S.C.
321(j)_ is sufficient generally to meet this
Acceptance of this knowledge will be discussed elsewhere.
B_ There Must Be Adequate 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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