DEA Recordkeeping, Security & Compliance Audits 2

Question 1

Under 21 CFR 1304, how long must DEA registrants retain executed order forms (DEA Form 222)?

Accepted Answer

2 years

Answer

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?

Accepted Answer

60 days

Answer

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?

Accepted Answer

DEA Form 106

Answer

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?

Accepted Answer

Physical security deficiency

Answer

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?

Accepted Answer

There is no automatic threshold; context and investigation determine significance

Answer

DEA policy requires registrants to evaluate all relevant factors — there is no single numerical threshold that automatically classifies a discrepancy as a significant loss.

(DEA) Certified Drug Enforcement Administration Specialist Practice Test

(DEA) Certified Drug Enforcement Administration Specialist Practice Test

DEA Recordkeeping, Security & Compliance Audits 2