Legend drugs are regulated medications that require a DEA number and are scheduled II-V. Which statement best describes their regulation?

• A. They are exempt from regulation
• B. They require a DEA number and are scheduled II-V
• C. They are available over-the-counter
• D. They are regulated only by state laws

Answer: (B)

Prescription medicines, especially those that are controlled substances, are regulated at the federal level. To legally prescribe or dispense these drugs, the prescriber (and the pharmacy) must have a valid DEA registration number, and the drugs are placed into schedules II through V based on potential for abuse and accepted medical use. That combination—needing a DEA number and belonging to schedules II–V—best captures how these medications are controlled, which is why it’s the correct description. It’s not accurate to say they’re exempt, OTC, or regulated only by state laws, since federal regulation via the DEA applies to controlled substances and often complements state oversight.