norml02 - Page 23

 As the Administrator points out, in the original Controlled
 Substances Act schedules_ Congress appears to have placed all
 NDA-approved drugs into Schedules !I-V and all drugs approved for
 "investigationai use" only, pursuant to 21 U.S.C. 355(i) (1988),
 into Schedule I. The safety and effectiveness of the latter
 drugs had not yet been determined. E d. at i0_504. It also
 appears that Congress placed GRASE drugs into Schedules II-V.
 Id. at 10,503 - 10,504. 7 Congress also placed drugs marketed
 for particular uses since the original enactment of the FDCA in
 1906 into Schedules II-Vo These so-called "grandfathered" drugs
 had been excepted from the safety requirements of the 1938
 version of the FDCA and from the effectiveness requirements of
 the 1962 amendments. I do at i0,504. Et is true that FDCA
 approval for interstate marketing is not a necessary prerequisite
 to placement in Schedules II-V. See NORML v. DEA, 559 F.2d at
 750 n°65 ("[There is] no reason to suppose that Congress intended
 that the NDA institutional check necessarily precede the CSA
 check.") Nevertheless, the FDCA standards for evaluating
 evidence of effectiveness necessarily consider the medical use
 context. It is therefore reasonable for the Administrator to
 rely on those standards when evaluating evidence to determine if
 a drug has an accepted medical use under the Controlled
 Substances Act°
 z In theory, Schedule ! could contain drugs that would
 qualify as GRASE drugs° This is because _=he FDA does not
 normally determine GRASE status unless a party .so requests. Such
 a request usually occurs either in anticipation of marketing a
 product or after a drug has been seized from interstate co_merceo
 !7