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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
 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
 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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