MCQ Quiz: The Closed System of Controlled Substances

The “closed system” is the cornerstone of controlled substance regulation in the United States, established by the Controlled Substances Act (CSA) and enforced by the Drug Enforcement Administration (DEA). This framework is designed to track high-risk medications from manufacture to dispensing to prevent diversion. A deep understanding of these regulations, a core component of the Principles of Pharmacy Law and Ethics course “, is a non-negotiable responsibility for every practicing pharmacist. This quiz will test your knowledge on the key components of the closed system, including drug schedules, prescription requirements, and record-keeping.

1. The “closed system of distribution” for controlled substances was established by which federal law?

• a. The Food, Drug, and Cosmetic Act
• b. The Health Insurance Portability and Accountability Act (HIPAA)
• c. The Controlled Substances Act (CSA)
• d. The Omnibus Budget Reconciliation Act of 1990 (OBRA ’90)

Answer: c. The Controlled Substances Act (CSA)

2. Which federal agency is primarily responsible for enforcing the Controlled Substances Act?

• a. The Food and Drug Administration (FDA)
• b. The Centers for Disease Control and Prevention (CDC)
• c. The Drug Enforcement Administration (DEA)
• d. The National Institutes of Health (NIH)

Answer: c. The Drug Enforcement Administration (DEA)

3. Drugs with a high potential for abuse, a currently accepted medical use, and a high potential for severe psychological or physical dependence are classified as:

• a. Schedule I
• b. Schedule II
• c. Schedule III
• d. Schedule IV

Answer: b. Schedule II

4. Which of the following drugs is a Schedule I controlled substance, meaning it has no currently accepted medical use in the United States?

• a. Oxycodone
• b. Morphine
• c. Heroin
• d. Fentanyl

Answer: c. Heroin

5. A pharmacy must use which DEA form to register with the DEA as a dispenser?

• a. DEA Form 41
• b. DEA Form 106
• c. DEA Form 222
• d. DEA Form 224

Answer: d. DEA Form 224

6. The principles of pharmacy law are a core course in the curriculum.

• a. True
• b. False

Answer: a. True

7. Which DEA form is required for a pharmacy to order Schedule II controlled substances?

• a. DEA Form 41
• b. DEA Form 106
• c. DEA Form 222
• d. DEA Form 224

Answer: c. DEA Form 222

8. Prescriptions for Schedule II medications are generally valid for how long from the date of issue (may vary by state law)?

• a. They have no expiration date.
• b. 30 days
• c. 6 months
• d. 1 year

Answer: b. 30 days

9. How many refills are permitted on a prescription for a Schedule II medication like oxycodone?

• a. Zero
• b. One
• c. Up to 5 refills in 6 months
• d. Unlimited refills for one year

Answer: a. Zero

10. A prescription for a Schedule III or IV medication may be refilled:

• a. As many times as the patient wants.
• b. Up to 5 times within 6 months from the date of issue.
• c. Only once.
• d. For up to one year.

Answer: b. Up to 5 times within 6 months from the date of issue.

11. A pharmacist’s ability to handle controlled substances in compliance with the law is a key part of their experiential education.

• a. True
• b. False

Answer: a. True

12. A pharmacist partially fills a prescription for a C-II medication for a community patient because they are out of stock. The remaining quantity must be filled within:

• a. 24 hours
• b. 72 hours
• c. 30 days
• d. 60 days

Answer: b. 72 hours

13. A biennial inventory of all controlled substances must be conducted by the pharmacy every:

• a. 6 months
• b. 1 year
• c. 2 years
• d. 5 years

Answer: c. 2 years

14. A pharmacy experiences a significant theft of controlled substances. This must be reported to the local DEA office using which form?

• a. DEA Form 41
• b. DEA Form 106
• c. DEA Form 222
• d. DEA Form 224

Answer: b. DEA Form 106

15. A pharmacist has expired controlled substances that need to be destroyed. They must document this destruction on which form?

• a. DEA Form 41
• b. DEA Form 106
• c. DEA Form 222
• d. DEA Form 224

Answer: a. DEA Form 41

16. Which of the following is NOT required on a prescription for a controlled substance?

• a. Patient’s full name and address.
• b. Prescriber’s full name, address, and DEA number.
• c. Drug name, strength, dosage form, quantity, and directions.
• d. The patient’s social security number.

Answer: d. The patient’s social security number.

17. The “closed system” is designed to create a paper trail to track controlled substances and prevent:

• a. Diversion
• b. High prices
• c. Drug interactions
• d. Side effects

Answer: a. Diversion

18. A prescriber wants to issue multiple prescriptions for a C-II medication on the same day to be filled sequentially. This is:

• a. Never allowed.
• b. Allowed, provided the total quantity does not exceed a 90-day supply and each subsequent prescription has an “earliest fill date.”
• c. Allowed for up to a 6-month supply.
• d. Only allowed for terminally ill patients.

Answer: b. Allowed, provided the total quantity does not exceed a 90-day supply and each subsequent prescription has an “earliest fill date.”

19. Which of the following is a Schedule V medication that can be sold without a prescription in some states, according to specific state laws?

• a. Oxycodone
• b. Diazepam
• c. Codeine-containing cough syrup
• d. Heroin

Answer: c. Codeine-containing cough syrup

20. The pharmacist’s “corresponding responsibility” means:

• a. The pharmacist is not responsible for the validity of a prescription.
• b. The pharmacist shares a responsibility with the prescriber to ensure a controlled substance prescription is for a legitimate medical purpose.
• c. The pharmacist must correspond with every patient by mail.
• d. The pharmacist is only responsible for prescriptions from their own state.

Answer: b. The pharmacist shares a responsibility with the prescriber to ensure a controlled substance prescription is for a legitimate medical purpose.

21. A pharmacy must keep all controlled substance records (invoices, inventory, prescriptions) for at least:

• a. 6 months
• b. 1 year
• c. 2 years
• d. 5 years

Answer: c. 2 years

22. An oral prescription (called in by a prescriber) is permissible for which of the following?

• a. Schedule II medications in any situation.
• b. Schedule III, IV, and V medications.
• c. Only non-controlled medications.
• d. Schedule I medications.

Answer: b. Schedule III, IV, and V medications.

23. The “C” that must be stamped in red ink on a C-III-V prescription applies when a pharmacy uses which filing system?

• a. A three-file system (C-II, C-III-V, non-controlled).
• b. A two-file system (C-II, all others).
• c. A one-file system.
• d. It is always required.

Answer: b. A two-file system (C-II, all others).

24. A prescriber’s DEA number starts with the letter “B”. What does this signify?

• a. The prescriber is a mid-level practitioner.
• b. The prescriber is a hospital or clinic.
• c. The prescriber is a physician (MD/DO).
• d. The prescriber is a distributor.

Answer: c. The prescriber is a physician (MD/DO).

25. Which of the following is a key feature of the electronic DEA Form 222 (CSOS)?

• a. It can be used to order any prescription drug.
• b. It allows for faster and more efficient ordering of C-IIs compared to the paper form.
• c. It does not require a digital certificate.
• d. It is less secure than the paper form.

Answer: b. It allows for faster and more efficient ordering of C-IIs compared to the paper form.

26. A pharmacist may dispense a partial fill of a C-II prescription for a patient in a Long-Term Care Facility (LTCF) for up to:

• a. 72 hours
• b. 30 days
• c. 60 days from the issue date
• d. 6 months

Answer: c. 60 days from the issue date

27. The Controlled Substances Act (CSA) is a ____ law.

• a. state
• b. federal
• c. local
• d. international

Answer: b. federal

28. If a state law regarding controlled substances is stricter than the federal law, the pharmacist must follow:

• a. The federal law.
• b. The state law.
• c. Whichever law is less strict.
• d. They can choose which law to follow.

Answer: b. The state law.

29. The total number of dosage units for a C-V substance that can be dispensed to a single purchaser without a prescription in a 48-hour period is limited by:

• a. The pharmacist’s discretion only.
• b. Both federal and state law.
• c. The patient’s insurance plan.
• d. There are no limits.

Answer: b. Both federal and state law.

30. Which of the following is an example of a “red flag” that might indicate a fraudulent or illegitimate controlled substance prescription?

• a. A regular patient receiving their monthly opioid prescription from their pain management doctor.
• b. A patient presenting prescriptions for the same opioid from multiple doctors filled at multiple pharmacies.
• c. A prescription written for an acute injury.
• d. A prescription sent electronically from the prescriber’s office.

Answer: b. A patient presenting prescriptions for the same opioid from multiple doctors filled at multiple pharmacies.

31. The transfer of an original prescription for a C-III, IV, or V medication is permissible:

• a. An unlimited number of times.
• b. Only on a one-time basis between two licensed pharmacists (unless they share a real-time online database).
• c. It is not allowed.
• d. Only if the patient requests it in writing.

Answer: b. Only on a one-time basis between two licensed pharmacists (unless they share a real-time online database).

32. An emergency oral prescription for a Schedule II drug is permitted, but the prescriber must provide a written “cover” prescription to the pharmacy within:

• a. 24 hours
• b. 72 hours
• c. 7 days
• d. 30 days

Answer: c. 7 days

33. The principles of pharmacy law are a foundational part of the PharmD curriculum.

• a. True
• b. False

Answer: a. True

34. The State Prescription Drug Monitoring Program (PDMP) is a tool pharmacists should use to:

• a. Check a patient’s controlled substance fill history to prevent diversion and ensure patient safety.
• b. Order C-II medications.
• c. Report medication errors.
• d. Check for drug interactions with non-controlled substances.

Answer: a. Check a patient’s controlled substance fill history to prevent diversion and ensure patient safety.

35. A pharmacist is responsible for all activities performed by their pharmacy technicians.

• a. True
• b. False

Answer: a. True

36. Who can legally sign a DEA Form 222?

• a. Any pharmacy technician.
• b. The person who signed the last DEA registration (DEA Form 224) or someone to whom they have granted Power of Attorney.
• c. The pharmacy delivery driver.
• d. Any pharmacist on duty.

Answer: b. The person who signed the last DEA registration (DEA Form 224) or someone to whom they have granted Power of Attorney.

37. Upon receiving a C-II order, the pharmacist must record the number of packages and the date received on:

• a. A separate sheet of paper.
• b. Copy 3 of the DEA Form 222.
• c. The patient’s profile.
• d. No documentation is needed.

Answer: b. Copy 3 of the DEA Form 222.

38. The role of the pharmacist is critical in preventing the diversion and abuse of controlled substances.

• a. True
• b. False

Answer: a. True

39. Which of the following is NOT a Schedule II drug?

• a. Morphine
• b. Methylphenidate
• c. Hydrocodone/acetaminophen
• d. Alprazolam

Answer: d. Alprazolam

40. A pharmacist’s professional judgment is a key component in determining the legitimacy of a controlled substance prescription.

• a. True
• b. False

Answer: a. True

41. The term “diversion” refers to:

• a. The transfer of a controlled substance from a legal to an illegal channel of distribution or use.
• b. A type of drug interaction.
• c. A patient assistance program.
• d. A route of administration.

Answer: a. The transfer of a controlled substance from a legal to an illegal channel of distribution or use.

42. A pharmacy must secure its controlled substances by:

• a. Storing them in a locked cabinet or safe.
• b. Dispersing them throughout the stock of non-controlled drugs.
• c. Both a and b are acceptable methods.
• d. Storing them on an open shelf.

Answer: c. Both a and b are acceptable methods.

43. A pharmacist providing a patient with naloxone is participating in:

• a. A harm reduction strategy.
• b. The dispensing of a controlled substance.
• c. A medication error.
• d. A violation of the law.

Answer: a. A harm reduction strategy.

44. A key part of the closed system is that every transfer of a controlled substance must be documented.

• a. True
• b. False

Answer: a. True

45. What must be done when conducting a biennial inventory of controlled substances?

• a. An exact count must be made for all Schedule II drugs.
• b. An estimated count is acceptable for C-III, IV, and V drugs if the stock bottle contains less than 1000 units.
• c. The inventory must be taken either at the beginning or close of business.
• d. All of the above.

Answer: d. All of the above.

46. Which of the following is a valid DEA number for Dr. John Smith?

• a. AJ 1234567
• b. SJ 1234563
• c. AS 1234567
• d. BS 1234568

Answer: d. BS 1234568

47. The “three-file” prescription storage system consists of separate files for:

• a. C-IIs, C-IIIs, and all others.
• b. C-IIs, C-IVs, and all others.
• c. C-IIs, C-IIIs-Vs, and non-controlled drugs.
• d. Brand, generic, and compounded drugs.

Answer: c. C-IIs, C-IIIs-Vs, and non-controlled drugs.

48. Handling controlled substances is a key competency evaluated during pharmacy practice experiences.

• a. True
• b. False

Answer: a. True

49. The overall purpose of the closed system of distribution is to:

• a. Make it difficult for legitimate patients to get their medications.
• b. Create more paperwork for pharmacies.
• c. Provide an accountability trail for all controlled substances to prevent diversion.
• d. Increase the cost of controlled substances.

Answer: c. Provide an accountability trail for all controlled substances to prevent diversion.

50. The ultimate reason a pharmacist must master the laws of the closed system is to:

• a. Protect the public health and safety while ensuring legitimate patient access to medications.
• b. Avoid going to jail or losing their license.
• c. Pass the MPJE (pharmacy law exam).
• d. All of the above.

Answer: d. All of the above.