3.0 Applicability

Controlled substances must be used only in research locations and situations described in the registrant's DEA and IBPE registrations. The researcher must address specific aspects of controlled substance utilization as stated in the research project justification.

Typical examples of research situations where controlled substances are used include: (a) animal anesthesia, analgesia, restraint, or experimentation; (b) analysis including quantitation and/or characterization; and (c) synthetic chemistry involving development of new drugs.

This guidance document on controlled substances management includes: (a) registration; (b) purchasing; (c) storage and security; (d) dispensation and disposal; (e) dispensation and disposal records; (f) inventory and self-audit; and (g) retention of documentation.