MPJE Controlled Substances Regulations 5 — Questions and Answers
Question 1: Which of the following is a TRUE statement about transferring a Schedule III–V prescription between pharmacies?
- Transfers are unlimited as long as both pharmacies are DEA-registered
- A Schedule III–V prescription may be transferred only once, unless the pharmacies share a real-time electronic database (Correct answer)
- Transfers are prohibited for all controlled substances under federal law
- Schedule IV prescriptions may be transferred twice; Schedule III and V only once
Correct answer: A Schedule III–V prescription may be transferred only once, unless the pharmacies share a real-time electronic database
Federal law allows one transfer of a Schedule III–V prescription between pharmacies, but pharmacies sharing a real-time database may transfer it up to the refill limit.
Question 2: Under the Controlled Substances Act, which entity has primary authority to schedule, reschedule, or deschedule a controlled substance?
- The FDA alone
- The DEA, with input from HHS/FDA (Correct answer)
- The U.S. Congress exclusively
- The state boards of pharmacy collectively
Correct answer: The DEA, with input from HHS/FDA
The DEA Administrator, after receiving a scientific and medical evaluation from HHS/FDA, has the authority to schedule, reschedule, or deschedule substances.
Question 3: A practitioner who is DEA-registered to prescribe controlled substances moves to a new office location within the same state. What must the practitioner do?
- Apply for a new DEA registration at the new address before prescribing any controlled substances
- Notify the DEA of the address change at least 30 days before moving
- No action is needed; the DEA number is valid regardless of address changes
- Submit DEA Form 224a to modify the registration and may continue prescribing during processing (Correct answer)
Correct answer: Submit DEA Form 224a to modify the registration and may continue prescribing during processing
A practitioner must notify the DEA of an address change using the appropriate form and may continue prescribing while the modification is processed.
Question 4: Under 21 CFR Part 1306, which of the following is NOT a required element on a valid controlled substance prescription?
- Date the prescription was issued
- Patient's date of birth (Correct answer)
- Drug name, strength, and quantity
- Prescriber's manual or electronic signature
Correct answer: Patient's date of birth
Federal law does not require a patient's date of birth on a controlled substance prescription, although some states do require it.
Question 5: A nurse practitioner in a state that grants full prescriptive authority wishes to prescribe Schedule II controlled substances. Which DEA form must be submitted to obtain registration?
- DEA Form 224 (Correct answer)
- DEA Form 225
- DEA Form 363
- DEA Form 106
Correct answer: DEA Form 224
Individual practitioners—including nurse practitioners—apply for DEA registration using DEA Form 224.
Question 6: When a controlled substance is administered to a patient in a hospital setting, the record must be maintained for how many years under federal DEA regulations?
- 1 year
- 2 years (Correct answer)
- 5 years
- 7 years
Correct answer: 2 years
DEA regulations require controlled substance records, including administration records, to be maintained for at least 2 years.
Question 7: Which action is required when a pharmacy discovers an unresolvable discrepancy between the perpetual inventory record and the actual count of a Schedule II drug?
- Correct the perpetual record and make an internal note
- Report the discrepancy to the DEA as a theft or significant loss using DEA Form 106 (Correct answer)
- Conduct a second count and average the two results
- Document the discrepancy in the pharmacy's internal log with no DEA notification required
Correct answer: Report the discrepancy to the DEA as a theft or significant loss using DEA Form 106
An unresolvable discrepancy for a Schedule II drug is considered a significant loss and must be reported to the DEA on Form 106.
MPJE Controlled Substances Regulations 5
Which of the following is a TRUE statement about transferring a Schedule III–V prescription between pharmacies?