Gauvin DV
Abstract
Background: There are many misconceptions about conducting research with Schedule 1 (CI) controlled substances to conduct nonclinical research in the US. Research design cannot be driven by financial constraints. Aim: The notion that current regulatory control of CI drugs hamper, hinders, or restricts legitimate nonclinical research in the U.S. may reflect a lack of understanding of the procedures in place to study these drugs. Review: Nonclinical research must comply with the Good Laboratory Practice (GLP) guidelines (21 CFR §58) of the U.S. Food & Drug Administration (FDA). Protocol development under the GLPs provides the information and details required under the Controlled Substances Act (CSA) for submission to the two drug regulating agencies relevant to the approvals required prior to the first dose administration on the study. Under 21 USC § 823(f), the registration applications by practitioners wishing to conduct Schedule I research shall be referred by the Secretary of HHS (FDA), who shall determine the qualifications and competency of each practitioner, as well as the merits of the research protocol. Additionally, a formal verification of the professional standards of the Study Director and the research facility conducting the study will be conducted by the DEA. These additional two requirements differentiate studies conducted with CI drugs and all other schedule-controlled drugs. In the U.S., the security requirements for storage under current DEA administrative regulations are equivalent for both CI and CII drugs. Conclusion: An informed researcher conducting nonclinical studies with CII– CV drugs can easily comply with current drug control requirements to conduct research with CI drugs in the US.