norml08 - Page 25



Page 25 Previous , Next , Original Image
Return to Index

 ............
 Drugs recognized under the FDCA for research use only,
 not for use in treatments such as alphacety!methadol and
 marijuana, were placed by Congress into Schedule I.
 Unfortunately, Federal records are not complete enough
 to do a comprehensive mathematical mapping; tracing every
 drug in the initial Controlled Substances Act schedules back
 to its legal status under the FDCA. Nevertheless_
 determining legislative intent does :not require mathematical
 certainty. Probability based on circumstantial evidence, on
 samplings, and on inductive reasonin_ can suffice,
 especially when there is nowhere els_ to turn.
 The pattern of initial scheduling of drugs in the
 Controlled Substances Act, viewed in light of the prior
 legal status of these drugs under th_a FDCA_ convinces me
 that Congress equated the term _currently accepted medical
 use in treatment in the United States" as used in the
 Controlled Substances Act with the core FDCA standards for
 acceptance of drugs for medical use.
 This is not to say that every FDCA requirement for
 GRASE status_ or for NDA approval_ is pertinent to
 scheduling determinations under the Controlled Substances
 Act. There are differences_ But the core FDCA criteria
 appear to have guided the Congress in the decisions it made
 concerning the initial scheduling of drugs in the Act.
 These same core FDCA criteria served as the basis for
 _ ........... an eight-point test used by my predecessor as Administrator
 25




Previous , Next , Return to Index