MPJE Federal Controlled Substances Act 5 — Questions and Answers
Question 1: Under the CSA, a DEA registrant must conduct a biennial inventory of all controlled substances. When must this inventory be taken?
- Exactly every 2 years from the date of the previous inventory, at opening or closing of business (Correct answer)
- Every January 1st and July 1st
- On the anniversary date of initial DEA registration
- Within 30 days of any change in pharmacy ownership
Correct answer: Exactly every 2 years from the date of the previous inventory, at opening or closing of business
A biennial inventory must be taken every two years from the date of the prior inventory, either at the opening or close of business on that date.
Question 2: A Schedule II prescription is presented to the pharmacist bearing the notation 'Do Not Fill Until 12/1.' Under the CSA, this is:
- Prohibited—Schedule II prescriptions cannot contain future fill dates
- Permitted—the prescription may be filled on or after the indicated date if otherwise valid (Correct answer)
- Permitted only if the prescriber has a DEA note on file authorizing post-dated prescriptions
- Prohibited unless the pharmacist telephones the prescriber on the date of filling
Correct answer: Permitted—the prescription may be filled on or after the indicated date if otherwise valid
A Schedule II prescription may be post-dated by the prescriber; the pharmacist may dispense it on or after the date written if the prescription is otherwise valid.
Question 3: Under the Controlled Substances Act, which of the following is considered a 'practitioner' authorized to dispense controlled substances?
- A registered pharmacist acting independently without a prescription
- A hospital licensed under federal law
- A physician, dentist, veterinarian, or other licensed healthcare provider (Correct answer)
- A wholesale distributor registered with the DEA
Correct answer: A physician, dentist, veterinarian, or other licensed healthcare provider
Under the CSA, 'practitioner' refers to physicians, dentists, veterinarians, and other licensed healthcare providers authorized to prescribe and dispense controlled substances.
Question 4: A pharmacist suspects a patient is obtaining controlled substances fraudulently. Under the CSA, the pharmacist's corresponding responsibility means:
- The pharmacist must dispense all valid-appearing prescriptions regardless of suspicion
- The pharmacist shares responsibility for the proper prescribing and dispensing of controlled substances (Correct answer)
- The pharmacist must report suspicions to the DEA before refusing to fill
- The pharmacist is only responsible for verifying the prescriber's DEA number
Correct answer: The pharmacist shares responsibility for the proper prescribing and dispensing of controlled substances
The corresponding responsibility doctrine holds pharmacists equally responsible with prescribers for ensuring controlled substances are dispensed for a legitimate medical purpose.
Question 5: Under the CSA, which of the following is NOT a valid purpose for which a Schedule II controlled substance may be prescribed?
- Treatment of moderate-to-severe pain
- Maintenance treatment of opioid use disorder at a DEA-registered opioid treatment program
- Detoxification treatment outside a licensed opioid treatment program by a general practitioner (Correct answer)
- Treatment of narcolepsy with a stimulant
Correct answer: Detoxification treatment outside a licensed opioid treatment program by a general practitioner
Under the CSA, treating opioid dependence with opioids outside of a licensed/registered opioid treatment program by a general practitioner is prohibited (with limited exceptions for DATA-waivered providers).
Question 6: Which of the following best describes the DEA's authority under the CSA to issue an Immediate Suspension Order (ISO)?
- The DEA may suspend a registration only after a full administrative hearing
- The DEA may immediately suspend a registration if it finds an imminent danger to public health or safety (Correct answer)
- The DEA may suspend a registration only with a court order
- The DEA may suspend a registration only for Schedule I or II violations
Correct answer: The DEA may immediately suspend a registration if it finds an imminent danger to public health or safety
The DEA may issue an ISO without prior hearing if it finds that continued registration poses an imminent danger to public health or safety.
Question 7: A pharmacist is asked to fill a prescription for buprenorphine/naloxone (Suboxone) written by a physician. Under federal law, what is required of the prescribing physician?
- No special authorization is required beyond a standard DEA registration
- The physician must hold a DEA registration with an X suffix (DATA 2000 waiver) or buprenorphine prescribing authorization under the SUPPORT Act (Correct answer)
- The physician must be affiliated with a licensed methadone clinic
- The physician must file a separate application with the FDA to prescribe buprenorphine
Correct answer: The physician must hold a DEA registration with an X suffix (DATA 2000 waiver) or buprenorphine prescribing authorization under the SUPPORT Act
Physicians prescribing buprenorphine for opioid use disorder must have a DATA 2000 waiver or, under more recent law, specific buprenorphine prescribing authorization reflected in their DEA registration.
Under the CSA, a DEA registrant must conduct a biennial inventory of all controlled substances.
When must this inventory be taken?