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Recordkeeping, Security & Compliance Audits Flashcards

7 cards from real DEA practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.

Read the first 7 Recordkeeping, Security & Compliance Audits flashcards as text
  1. Under DEA regulations, which Schedule requires the most stringent physical security storage requirements, typically a steel safe or vault?

    Answer: Schedule II

    Schedule II controlled substances require the highest level of physical security, including storage in an approved safe, vault, or steel cabinet with specific construction standards.

  2. A hospital pharmacy conducts a compliance audit and discovers that its CSOS (Controlled Substance Ordering System) logs have not been archived for 14 months. Under 21 CFR 1305, what is the record retention requirement for CSOS records?

    Answer: 2 years

    CSOS electronic records, like paper DEA Form 222 records, must be retained for a minimum of 2 years under 21 CFR 1305.

  3. A DEA Diversion Investigator arrives unannounced at a registered pharmacy during business hours. The pharmacist asks for a warrant. Under the Controlled Substances Act, can the DEA conduct an administrative inspection without a warrant?

    Answer: Yes, DEA investigators may conduct warrantless administrative inspections of registered premises

    The CSA authorizes DEA Diversion Investigators to conduct administrative inspections of DEA-registered premises during business hours without a warrant.

  4. Which of the following scenarios correctly describes the use of a 'running inventory' for Schedule III–V substances?

    Answer: It is an optional method that satisfies the biennial inventory requirement when maintained accurately

    A perpetual (running) inventory for Schedule III–V substances, if maintained accurately, can satisfy the DEA's biennial inventory requirement.

  5. A veterinary practice registered with the DEA fails to conduct a biennial inventory. Which entity has primary enforcement authority over this violation?

    Answer: DEA Diversion Control Division

    The DEA Diversion Control Division has primary federal enforcement authority over all DEA registrants' compliance with controlled substance recordkeeping, including veterinary practices.

  6. A registrant stores controlled substances in a locked cabinet that does not meet DEA specifications. A subsequent inspection finds no diversion occurred. Can the DEA still take administrative action?

    Answer: Yes, failure to meet storage requirements is an independent violation

    Non-compliant storage is a standalone regulatory violation under 21 CFR 1301; actual diversion does not need to be proven for the DEA to take administrative action.

  7. When a DEA registrant goes out of business, which form must be filed to surrender any remaining controlled substances?

    Answer: DEA Form 41

    DEA Form 41 (Registrant Record of Controlled Substances Destroyed) is used when a registrant surrenders or arranges for the destruction of controlled substances.