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 1301.76, which of the following employees is a registrant generally required to screen before granting access to controlled substances?
Answer: Any employee who may have access to controlled substances
21 CFR 1301.76 requires registrants to screen all employees who will have access to controlled substances to prevent hiring individuals with drug-related convictions.
A mid-size distributor implements an electronic record system for Schedule II orders. Under DEA e-commerce regulations, what digital security feature is MANDATORY for these records?
Answer: A digital signature meeting DEA's PKI requirements
DEA's CSOS (21 CFR 1305) requires that electronic Schedule II orders bear a DEA-compliant digital signature using Public Key Infrastructure (PKI) technology.
How must a DEA registrant document the destruction of expired Schedule II controlled substances on-site?
Answer: Complete DEA Form 41 and retain it for 2 years
On-site destruction of Schedule II substances requires completion of DEA Form 41, which must be retained by the registrant for 2 years.
A DEA audit reveals a pharmacy has been recording controlled substance dispensing in a system separate from its main pharmacy management software. Is this permissible?
Answer: Yes, if the separate records are readily retrievable and meet DEA requirements
DEA regulations permit separate recordkeeping systems as long as records are readily retrievable within 2 business days and comply with all content requirements.
A retail pharmacy that dispenses controlled substances must keep Schedule II records separate from all other records. Which regulation establishes this requirement?
Answer: 21 CFR 1304.04
21 CFR 1304.04 requires that Schedule II records be maintained separately from all other DEA records and from non-DEA business records.
During a DEA compliance inspection, the investigator asks for records relating to a specific transaction from 20 months ago. The registrant must produce the records within:
Answer: 2 business days
DEA regulations require that controlled substance records be 'readily retrievable,' defined as producible within 2 business days of a DEA request.
A pharmaceutical manufacturer installs a new access control system for its controlled substance vault. Under 21 CFR 1301, which feature is specifically required for Schedule I and II storage vaults above a certain size?
Answer: An alarm system that notifies local police or a central station upon unauthorized entry
21 CFR 1301.72 requires that vaults storing Schedule I and II substances be equipped with an alarm system connected to a central station or law enforcement that activates upon unauthorized entry.