What is required for a drug to be classified as a 'controlled substance'?

For a drug to be classified as a 'controlled substance,' it must have a potential for abuse and lead to dependence. This classification is critical as it helps regulate drugs that have a significant likelihood of being misused, which can lead to addiction or other adverse consequences. The specific criteria for control often consider factors such as the substance's medicinal use, safety, and its potential for abuse, which are evaluated during the scheduling process by the Drug Enforcement Administration (DEA) and other regulatory bodies.

In contrast, while a prescription-only status, FDA approval, or being manufactured in a licensed facility apply to many medications, these criteria alone do not determine whether a drug is classified as a controlled substance. Being prescription-only can include non-controlled medications, and FDA approval is necessary for safety and efficacy but is not a direct measure of a substance's potential for abuse. Thus, the essence of the controlled substance classification centers around the risk of abuse and the potential for dependence, making that the definitive criterion in this context.