According to the investigative drug protocol, how is an investigation drug treated?

An investigative drug is treated as a controlled substance II according to the investigative drug protocol. This classification is significant as it denotes a high potential for abuse, with the potential for severe psychological or physical dependence. Investigational new drugs (INDs) are often under research for their efficacy and safety, and they can include substances that are similar to controlled substances. Therefore, until they are fully studied and approved, they need to comply with strict regulatory requirements similar to those for controlled substances to ensure proper handling, distribution, and administration during trials.

The nature of these drugs necessitates careful monitoring and regulation to prevent misuse and to ensure that they are only used in controlled clinical settings, reflecting their status as controlled substances, particularly under Schedule II. This classification helps researchers maintain compliance with federal and state regulations regarding prescribing, dispensing, and administering these potentially dangerous substances.