DEA Drug Diversion Investigations & Enforcement 3 — Questions and Answers
Question 1: A pain management clinic prescribes the same high-dose opioid regimen to nearly all patients regardless of diagnosis or medical history. This pattern is known as:
- Evidence-based prescribing
- 'Cookie-cutter' prescribing (Correct answer)
- Off-label prescribing
- Compounding prescribing
Correct answer: 'Cookie-cutter' prescribing
'Cookie-cutter' prescribing, where a practitioner issues identical prescriptions to all patients without individualized assessment, is a major red flag for a pill mill operation.
Question 2: A DEA registrant pharmacy discovers that a stock bottle of hydrocodone is missing. Under 21 CFR 1304.11, the registrant must conduct a biennial inventory. For this incident, however, the registrant must also:
- Wait until the next biennial inventory to document the loss
- File DEA Form 106 within one business day of discovering the loss (Correct answer)
- Notify local law enforcement only
- Submit a written report to the state pharmacy board within 30 days
Correct answer: File DEA Form 106 within one business day of discovering the loss
Theft or significant loss of controlled substances requires filing DEA Form 106 within one business day of discovery, separate from biennial inventory requirements.
Question 3: In diversion investigations, 'pill mills' are most accurately defined as:
- Licensed compounding pharmacies that produce bulk controlled substances
- Medical practices that prescribe large quantities of opioids with little or no medical justification (Correct answer)
- Drug manufacturers that sell directly to consumers without prescriptions
- Online pharmacies that operate without a DEA registration
Correct answer: Medical practices that prescribe large quantities of opioids with little or no medical justification
Pill mills are medical practices — often operated by licensed physicians — that prescribe opioids or other controlled substances with minimal or no legitimate medical evaluation.
Question 4: When executing an administrative inspection warrant at a DEA-registered pharmacy, investigators must:
- Obtain a criminal search warrant instead, as administrative warrants are insufficient
- Give 24 hours' advance notice to the registrant before entry
- Limit the inspection to records and not physical premises
- Inspect during business hours and identify themselves as DEA officials (Correct answer)
Correct answer: Inspect during business hours and identify themselves as DEA officials
Administrative inspections must be conducted during business hours, and agents must identify themselves; they allow inspection of premises, equipment, and records of DEA registrants.
Question 5: Which of the following best describes the legal standard for issuing a DEA Order to Show Cause to revoke a practitioner's DEA registration?
- Beyond a reasonable doubt that the practitioner committed a crime
- Probable cause that the practitioner's continued registration is inconsistent with public interest (Correct answer)
- A civil preponderance of evidence standard for malpractice
- A unanimous finding by a DEA review board
Correct answer: Probable cause that the practitioner's continued registration is inconsistent with public interest
DEA may issue an Order to Show Cause to revoke or suspend a registration when there is probable cause that continuation of the registration is inconsistent with the public interest under 21 U.S.C. § 824.
Question 6: An undercover DEA agent successfully purchases a controlled substance from a physician without a physical examination or legitimate medical purpose. This investigative technique is called:
- A reverse sting operation
- A controlled buy (Correct answer)
- A trash cover
- A knock-and-talk
Correct answer: A controlled buy
A controlled buy is an undercover purchase of controlled substances, used to gather evidence that a practitioner is distributing drugs outside the course of legitimate medical practice.
Question 7: Under the DEA's diversion control framework, which entity is primarily responsible for detecting and reporting suspicious orders of controlled substances?
- State pharmacy boards
- DEA field offices
- DEA-registered distributors (Correct answer)
- The FDA's drug safety division
Correct answer: DEA-registered distributors
DEA-registered distributors are required under 21 CFR 1301.74 to design and operate a system to identify suspicious orders and report them to DEA before shipping.
DEA Drug Diversion Investigations & Enforcement 3
A pain management clinic prescribes the same high-dose opioid regimen to nearly all patients regardless of diagnosis or medical history.
This pattern is known as: