DEA Recordkeeping, Security & Compliance Audits 2 — Questions and Answers
Question 1: Under 21 CFR 1304, how long must DEA registrants retain executed order forms (DEA Form 222)?
- 1 year
- 2 years (Correct answer)
- 5 years
- 7 years
Correct answer: 2 years
Registrants must retain DEA Form 222 and all related records for a minimum of 2 years from the date of the transaction.
Question 2: A pharmacy discovers that its biennial inventory was not conducted within the required window. What is the maximum allowable variance from the two-year anniversary date?
- 30 days
- 60 days (Correct answer)
- 90 days
- No variance is allowed
Correct answer: 60 days
DEA regulations allow registrants to conduct their biennial inventory within 2 years ± 60 days of the previous inventory date.
Question 3: Which DEA form must a practitioner use to report the theft or significant loss of controlled substances?
- DEA Form 41
- DEA Form 106 (Correct answer)
- DEA Form 222
- DEA Form 224
Correct answer: DEA Form 106
DEA Form 106 (Report of Theft or Significant Loss of Controlled Substances) must be submitted when a registrant discovers theft or significant loss.
Question 4: During a DEA compliance inspection, an auditor finds that a registrant's vault door was left unlocked overnight. Under which regulatory category does this violation fall?
- Recordkeeping deficiency
- Physical security deficiency (Correct answer)
- Dispensing recordkeeping error
- Import/export violation
Correct answer: Physical security deficiency
An unsecured vault constitutes a physical security deficiency under 21 CFR 1301, which governs security requirements for controlled substance storage.
Question 5: A Schedule II controlled substance inventory count reveals a discrepancy of 12 units. At what point is this automatically classified as a 'significant loss' requiring DEA Form 106?
- Any discrepancy over 0 units
- A discrepancy representing more than 3% of total stock
- When the DEA establishes the loss was not due to counting error
- There is no automatic threshold; context and investigation determine significance (Correct answer)
Correct answer: There is no automatic threshold; context and investigation determine significance
DEA policy requires registrants to evaluate all relevant factors — there is no single numerical threshold that automatically classifies a discrepancy as a significant loss.
Question 6: Which of the following is NOT a required element of a DEA-compliant controlled substance dispensing record?
- Date of dispensing
- Patient's Social Security Number (Correct answer)
- Quantity dispensed
- DEA registration number of the prescriber
Correct answer: Patient's Social Security Number
DEA dispensing records do not require the patient's Social Security Number; required elements include date, drug, quantity, and prescriber DEA number.
Question 7: A DEA investigator requests access to a registrant's controlled substance records from 18 months ago. The registrant claims the records were destroyed per internal policy. Is this a violation?
- No, internal policies supersede DEA regulations
- Yes, because records must be retained for at least 2 years (Correct answer)
- No, as long as an inventory was conducted at the time
- Yes, only if the records involved Schedule I substances
Correct answer: Yes, because records must be retained for at least 2 years
Destroying records before the mandatory 2-year retention period expires violates 21 CFR 1304 regardless of internal company policy.
DEA Recordkeeping, Security & Compliance Audits 2
Under 21 CFR 1304, how long must DEA registrants retain executed order forms (DEA Form 222)?