1 DEA Schedules and Regulatory Framework Free Online FlashCards

What federal law governs controlled substances in the United States?

The Controlled Substances Act (CSA) is the federal law governing controlled substances in the United States.

What factors guide federal controlled-substance scheduling?

Federal scheduling considers a substance’s potential for abuse, accepted medical use, and risks of dependence.

What defines Schedule I substances?

Schedule I substances have high abuse potential, no currently accepted medical use in the United States, and a lack of accepted safety for use under medical supervision.

What defines Schedule II substances?

Schedule II substances have high abuse potential and accepted medical use; abuse may lead to severe psychological or physical dependence.

What defines Schedule III substances?

Schedule III substances have lower abuse potential than Schedules I and II and accepted medical use; abuse may lead to moderate or low physical dependence, or high psychological dependence.

What defines Schedule IV substances?

Schedule IV substances have lower abuse potential than Schedule III, accepted medical use, and comparatively limited dependence risk.

What defines Schedule V substances?

Schedule V substances have lower abuse potential than Schedule IV, accepted medical use, and limited dependence risk relative to Schedule IV.

How does abuse potential generally change across the five schedules?

In general, abuse potential decreases from Schedule I to Schedule V.

Why can a product’s formulation matter to its schedule?

The exact substance and formulation matter; ingredients or concentration can affect a product’s classification.

Who generally must register with the DEA to handle controlled substances?

People and organizations that manufacture, distribute, or dispense controlled substances generally must register with the DEA, subject to statutory exceptions.

Does DEA registration authorize handling every controlled substance in every setting?

DEA registration authorizes only activities within its terms; it is not blanket permission to handle every controlled substance in every setting.

When is a separate DEA registration generally required?

A separate DEA registration is generally required for each principal place of business or professional practice where controlled substances are handled.