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
A DEA registrant's compliance audit reveals a pattern of dispensing to the same patient by multiple prescribers — a potential red flag for diversion. Under the CSA, what is the registrant's affirmative obligation?
Answer: Exercise corresponding responsibility and refuse or investigate suspicious prescriptions
Under the corresponding responsibility doctrine (21 CFR 1306.04), pharmacists share legal responsibility with prescribers to ensure controlled substance prescriptions are issued for legitimate medical purposes.
A hospital's controlled substance audit reveals that a nurse withdrew 10 mg morphine but patient records indicate only 4 mg was administered. The remaining 6 mg is unaccounted for. This is classified as:
Answer: A potential diversion requiring investigation and possible DEA reporting
Unaccounted controlled substance wasting that cannot be reconciled suggests potential diversion, which must be investigated and may require a DEA Form 106 report if deemed a significant loss.
Under 21 CFR 1301.13, how often must a DEA registration be renewed for a retail pharmacy?
Answer: Every 3 years
DEA registrations for practitioners and pharmacies must be renewed every 3 years under 21 CFR 1301.13.
A compliance officer discovers that a Schedule IV medication was inadvertently stored in a Schedule III cabinet. No loss or diversion is found. What is the MOST appropriate corrective action?
Answer: Document the error, relocate the substance, and implement a corrective action plan
Storage classification errors with no diversion are typically handled through internal corrective action documentation and physical remediation, without triggering mandatory DEA reporting.
Which of the following best describes the DEA's 'readily retrievable' standard for controlled substance records?
Answer: Records must be producible within 2 business days upon DEA request
The DEA defines 'readily retrievable' as records that can be produced upon request within 2 business days; they need not be stored at the registered location as long as they meet this standard.
A DEA diversion investigator finds that a mid-level practitioner (MLP) has been issuing Schedule III prescriptions without physician supervision as required by state law. The DEA's jurisdiction in this case covers:
Answer: Both federal CSA compliance and state supervision rules that affect the validity of the prescription
Under 21 CFR 1306.04, a valid prescription must be issued for a legitimate medical purpose by a practitioner acting within the usual course of professional practice, which incorporates state law authority.
A DEA registrant receives a subpoena from a plaintiff's attorney requesting controlled substance dispensing records for a civil lawsuit. The registrant should:
Answer: Consult legal counsel, as disclosure may still require compliance with DEA regulations and state privacy laws
Civil subpoenas for controlled substance records require careful legal review because DEA regulations, HIPAA, and state law all intersect and may impose disclosure conditions or restrictions.