Controlled Substances Regulations & Scheduling Flashcards

Under 21 CFR Part 1301, which of the following is a valid reason for the DEA to deny or revoke a practitioner's DEA registration?

Answer: The practitioner has been convicted of a felony related to controlled substances

Under 21 U.S.C. § 824, conviction of a felony relating to controlled substances is a statutory ground for DEA registration revocation or denial.

A mid-level practitioner (e.g., nurse practitioner) obtains a DEA registration. Under what authority does this registration operate?

Answer: Under federal authority, but scope is limited by state law defining the practitioner's prescriptive authority

DEA registration grants federal authority to handle controlled substances, but the practitioner's scope is further limited by their state's scope of practice laws.

Which international treaty is the primary basis for U.S. obligations to control narcotic substances and is implemented domestically by the CSA?

Answer: The Single Convention on Narcotic Drugs (1961)

The Single Convention on Narcotic Drugs of 1961 is the foundational international treaty establishing control over narcotics, which the CSA was designed to implement domestically.

A Schedule II controlled substance order form (DEA Form 222) is invalid if which of the following occurs?

Answer: The form contains erasures or alterations

Under 21 CFR 1305.12, DEA Form 222 is void if it contains any alteration, erasure, or change; a new form must be used.

Which scheduling category applies to a substance that has a currently accepted medical use in the U.S. and the lowest potential for abuse relative to other scheduled substances?

Answer: Schedule V

Schedule V substances have accepted medical use and the lowest abuse potential among scheduled substances, such as cough preparations with small amounts of codeine.

Under the CSA, which of the following actions constitutes 'dispensing' as legally defined?

Answer: A pharmacist delivering a controlled substance to an individual patient pursuant to a valid prescription

Under 21 U.S.C. § 802(10), 'dispensing' means delivering a controlled substance to an ultimate user or human research subject pursuant to a lawful order of a practitioner.

A DEA registrant receives a shipment of Schedule II controlled substances and notices a discrepancy between the amount ordered and the amount received. What is the registrant's required action?

Answer: Document the discrepancy and report it to the DEA if the shortage is significant, using DEA Form 106

Registrants must document discrepancies and report significant losses or thefts to the DEA using Form 106 under 21 CFR 1301.76.