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
Under 21 CFR 1304, how long must DEA registrants retain executed order forms (DEA Form 222)?
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.
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?
Answer: 60 days
DEA regulations allow registrants to conduct their biennial inventory within 2 years ± 60 days of the previous inventory date.
Which DEA form must a practitioner use to report the theft or significant loss of controlled substances?
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.
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?
Answer: Physical security deficiency
An unsecured vault constitutes a physical security deficiency under 21 CFR 1301, which governs security requirements for controlled substance storage.
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?
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.
Which of the following is NOT a required element of a DEA-compliant controlled substance dispensing record?
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.
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?
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.