DEA DEA Diversion Control 2 — Questions and Answers
Question 1: Under the DEA registration system, which type of registrant is authorized to manufacture controlled substances?
- A DEA-registered manufacturer holding a Schedule I or II manufacturer registration (Correct answer)
- Any DEA registrant with a practitioner registration
- A pharmacist holding an active state pharmacy license
- A DEA registrant with a researcher registration
Correct answer: A DEA-registered manufacturer holding a Schedule I or II manufacturer registration
Manufacturers must hold a specific DEA manufacturing registration that authorizes production of the specific scheduled substances listed on the registration certificate.
Question 2: What is 'drug diversion through pharmacy theft' and what DEA form documents it?
- Employees stealing controlled substances from pharmacy stock, documented on DEA Form 106 (Correct answer)
- Pharmacies selling controlled substances without prescriptions, documented on DEA Form 41
- Patients stealing from pharmacy counters, documented on DEA Form 224
- Wholesalers short-shipping orders, documented on DEA Form 222
Correct answer: Employees stealing controlled substances from pharmacy stock, documented on DEA Form 106
Employee pilferage of pharmacy controlled substances is a common diversion method; registrants report all significant losses including theft on DEA Form 106.
Question 3: What is the role of DEA's Automation of Reports and Consolidated Orders System (ARCOS)?
- A federal database that tracks the distribution of Schedule I and II controlled substances from manufacturer to retail dispensing, allowing DEA to detect diversion (Correct answer)
- A system for managing DEA agent personnel records
- A tool used to electronically file DEA registrations
- A database of all individuals convicted of drug offenses
Correct answer: A federal database that tracks the distribution of Schedule I and II controlled substances from manufacturer to retail dispensing, allowing DEA to detect diversion
ARCOS collects transaction data from manufacturers, distributors, and dispensers of Schedules I–V substances, creating a supply chain audit trail that reveals suspicious distribution patterns.
Question 4: A 'corresponding responsibility' in DEA pharmacy regulations refers to:
- The pharmacist's legal duty to ensure a prescription is issued for a legitimate medical purpose before dispensing a controlled substance (Correct answer)
- The prescriber's responsibility to check the PDMP before writing a prescription
- The distributor's obligation to verify a pharmacy's DEA registration
- The patient's responsibility to use medications only as prescribed
Correct answer: The pharmacist's legal duty to ensure a prescription is issued for a legitimate medical purpose before dispensing a controlled substance
Under 21 C.F.R. § 1306.04, pharmacists share legal responsibility with prescribers for ensuring controlled substance prescriptions are issued for legitimate medical purposes.
Question 5: Under DEA regulations, how often must a DEA-registered pharmacy conduct a controlled substance inventory?
- At least every two years (biennial inventory) (Correct answer)
- Monthly
- Annually
- Only when applying for registration renewal
Correct answer: At least every two years (biennial inventory)
21 C.F.R. § 1304.11 requires all DEA registrants to take a complete physical inventory of all controlled substances at least every two years.
Question 6: What action can DEA take against a distributor that fails to report suspicious orders of controlled substances?
- Revoke or suspend the distributor's DEA registration and pursue civil or criminal penalties (Correct answer)
- Issue a written warning for a first offense only
- Refer the matter to the state pharmacy board exclusively
- Require additional PDMP reporting for 90 days
Correct answer: Revoke or suspend the distributor's DEA registration and pursue civil or criminal penalties
Distributors have a statutory duty to report suspicious orders and maintain effective controls against diversion; failure to comply can result in registration revocation and significant civil monetary penalties.
DEA DEA Diversion Control 2
Under the DEA registration system, which type of registrant is authorized to manufacture controlled substances?