norml08 - Page 27

 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
 Reproducible.
 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
 requirements
 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
 27