DEA Recordkeeping, Security & Compliance Audits 3 — Questions and Answers
Question 1: Under DEA regulations, which Schedule requires the most stringent physical security storage requirements, typically a steel safe or vault?
- Schedule III
- Schedule IV
- Schedule II (Correct answer)
- All schedules require identical storage
Correct 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.
Question 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pharmacy conducts a compliance audit and discovers that its CSOS (Controlled Substance Ordering System) logs have not been archived for 14 months.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?
- 1 year
- 2 years (Correct answer)
- 3 years
- 5 years
Correct 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.
Question 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?
- No, a warrant is always required
- Yes, DEA investigators may conduct warrantless administrative inspections of registered premises (Correct answer)
- Yes, but only if a complaint was filed
- No, unless the inspection is for Schedule I substances only
Correct 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.
Question 4: Which of the following scenarios correctly describes the use of a 'running inventory' for Schedule III–V substances?
- It is prohibited; only biennial inventories are allowed
- It is an optional method that satisfies the biennial inventory requirement when maintained accurately (Correct answer)
- It is required for all schedules
- It replaces DEA Form 222 for ordering purposes
Correct 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.
Question 5: A veterinary practice registered with the DEA fails to conduct a biennial inventory. Which entity has primary enforcement authority over this violation?
- State veterinary licensing board
- FDA Center for Veterinary Medicine
- DEA Diversion Control Division (Correct answer)
- USDA Animal and Plant Health Inspection Service
Correct 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.
Question 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?
- No, action requires proof of actual diversion
- Yes, failure to meet storage requirements is an independent violation (Correct answer)
- No, if the registrant corrects the issue before the next inspection
- Yes, but only if the substances were Schedule I or II
Correct 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.
Question 7: When a DEA registrant goes out of business, which form must be filed to surrender any remaining controlled substances?
- DEA Form 41 (Correct answer)
- DEA Form 106
- DEA Form 224
- DEA Form 363
Correct 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.
DEA Recordkeeping, Security & Compliance Audits 3
Under DEA regulations, which Schedule requires the most stringent physical security storage requirements, typically a steel safe or vault?