special handling

Controlled Substances Act (CSA)

This law brings together a number of laws regulating the manufacture and distribution of narcotics, stimulants, depressants, hallucinogens, anabolic steroids, and chemicals used in the illicit production of controlled substances. All substances are placed in one of five schedules, based on medicinal value, harmfulness, and potential for abuse or addiction, with Schedule 1 reserved for the most dangerous drugs that have no recognized medical use.

FD&C

This law applies to research on any product under its regulatory purview. The protection of human subjects is covered in 21 C.F.R. Parts 50 and 56. An exception from informed consent requirements for emergency research was added in October 1996, effective November 1, 1996. See 21 C.F.R. § 50.24.

Federal Policy on Recombinant DNA

Any institution that sponsors recombinant DNA research that is covered by the National Institutes of Health (NIH) guidelines must make sure that the appropriate level of review occurs by the Institutional Biosafety Committee, and that any required petitions are submitted to the NIH.