PTCB pharmacy law practice questions

21 practice questions on DEA schedules and refill rules, DEA forms, controlled substance records, and the federal drug laws the exam names, with the answer and a short explanation for each.

Federal Requirements is 18.75% of the PTCB exam under PTCB’s PTCE Content Outline, in effect since January 6, 2026. The PTCE has 90 multiple-choice questions and a 1 hour 50 minute time limit.

Pick an answer to check it. The answer and explanation are under each question.

1. Question 1

   Which DEA schedule includes drugs with high abuse potential and accepted medical use, such as oxycodone, fentanyl, and amphetamine salts?

   1. ASchedule I
   2. BSchedule II
   3. CSchedule IV
   4. DSchedule III
   Show answer and explanation

   Answer: B. Schedule II

   Schedule II includes drugs with high abuse potential but accepted medical use; prescriptions cannot be refilled and require a new written order each time they are dispensed.

   From the Federal Requirements flashcards.

2. Question 2

   How many refills are permitted for a Schedule III or IV controlled substance prescription under federal law?

   1. AA maximum of 11 refills within 12 months
   2. BNo refills are permitted within 6 months
   3. CA maximum of 5 refills within 6 months
   4. DA maximum of 3 refills within 12 months
   Show answer and explanation

   Answer: C. A maximum of 5 refills within 6 months

   Schedule III and IV prescriptions may be refilled up to 5 times within 6 months from the date the prescription was originally written by the authorized prescriber.

   From the Federal Requirements flashcards.

3. Question 3

   Under federal law, how long after signing must an ordinary Schedule II prescription be filled?

   1. ANo federal fill-by time limit
   2. B7 days under federal law
   3. C90 days under federal law
   4. D12 months under federal law
   Show answer and explanation

   Answer: A. No federal fill-by time limit

   There is no federal fill-by time limit; the pharmacist must still determine that the prescription is needed.

   From the Federal Requirements flashcards.

4. Question 4

   What number must appear on a controlled substance prescription?

   1. APrescriber DEA number
   2. BPharmacy NPI number
   3. CPatient insurance ID
   4. DPrescriber tax ID number
   Show answer and explanation

   Answer: A. Prescriber DEA number

   From the Federal Requirements flashcards.

5. Question 5

   What DEA form is used to order Schedule I and Schedule II controlled substances?

   1. ADEA Form 224
   2. BDEA Form 222
   3. CDEA Form 41
   4. DDEA Form 106
   Show answer and explanation

   Answer: B. DEA Form 222

   DEA Form 222 (or the electronic equivalent, CSOS).

   From the Pharmacy Law & Regulations flashcards.

6. Question 6

   What DEA form must be completed when a pharmacy discovers a theft or significant loss of controlled substances?

   1. ADEA Form 41
   2. BDEA Form 224
   3. CDEA Form 222
   4. DDEA Form 106
   Show answer and explanation

   Answer: D. DEA Form 106

   DEA Form 106 (Report of Theft or Significant Loss of Controlled Substances).

   From the Pharmacy Law & Regulations flashcards.

7. Question 7

   What DEA form is used to document the destruction or disposal of controlled substances?

   1. ADEA Form 224
   2. BDEA Form 106
   3. CDEA Form 222
   4. DDEA Form 41
   Show answer and explanation

   Answer: D. DEA Form 41

   DEA Form 41 (Registrants Inventory of Drugs Surrendered).

   From the Pharmacy Law & Regulations flashcards.

8. Question 8

   What is the DEA registration number format, and what does the second letter indicate?

   1. ATwo letters and seven digits, with surname or business initial second
   2. BTwo letters and seven digits, with registration state initial second
   3. CTwo letters and seven digits, with authorized schedule initial second
   4. DTwo letters and seven digits, with drug class initial second
   Show answer and explanation

   Answer: A. Two letters and seven digits, with surname or business initial second

   Two letters followed by seven digits; the second letter is the first letter of the registrant's last name (or business name).

   From the Pharmacy Law & Regulations flashcards.

9. Question 9

   How long must Schedule II controlled substance records be kept on file at a pharmacy?

   1. AThe federal minimum is 1 year
   2. BThe federal minimum is 2 years
   3. CThe federal minimum is 5 years
   4. DThe federal minimum is 3 years
   Show answer and explanation

   Answer: B. The federal minimum is 2 years

   A minimum of 2 years (federal requirement; state law may require longer).

   From the Pharmacy Law & Regulations flashcards.

10. Question 10

    Under federal law, how often must a pharmacy conduct a complete inventory of all controlled substances?

    1. AFederal required interval: every 5 years
    2. BFederal required interval: every 1 year
    3. CFederal required interval: every 2 years
    4. DFederal required interval: every 3 years
    Show answer and explanation

    Answer: C. Federal required interval: every 2 years

    At least every 2 years (biennial inventory).

    From the Pharmacy Law & Regulations flashcards.

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12. Question 11

    Which schedule of controlled substances requires a separate inventory count that is exact, rather than an estimated count?

    1. ASchedule II requires an exact count
    2. BSchedule III requires an exact count
    3. CSchedule V requires an exact count
    4. DSchedule IV requires an exact count
    Show answer and explanation

    Answer: A. Schedule II requires an exact count

    Schedule II controlled substances require an exact (actual) count.

    From the Pharmacy Law & Regulations flashcards.

13. Question 12

    What is the maximum supply of a Schedule II controlled substance that may be dispensed via an emergency oral prescription?

    1. AOnly the amount needed during the emergency
    2. BOnly the amount in a fixed 30-day supply
    3. COnly the amount in a fixed 14-day supply
    4. DOnly the amount in a fixed 24-hour supply
    Show answer and explanation

    Answer: A. Only the amount needed during the emergency

    Enough to cover the emergency period only; a follow-up prescription must be delivered within 7 days.

    From the Pharmacy Law & Regulations flashcards.

14. Question 13

    Which amendment to the FDCA established the distinction between prescription (Rx) and over-the-counter (OTC) drugs?

    1. AHatch-Waxman Act of 1984
    2. BOBRA of 1990
    3. CKefauver-Harris Amendment of 1962
    4. DDurham-Humphrey Amendment of 1951
    Show answer and explanation

    Answer: D. Durham-Humphrey Amendment of 1951

    The Durham-Humphrey Amendment of 1951.

    From the Pharmacy Law & Regulations flashcards.

15. Question 14

    Which federal law requires drug manufacturers to prove both safety AND efficacy before a new drug can be approved?

    1. AFederal Food, Drug, and Cosmetic Act, 1938
    2. BPrescription Drug User Fee Act, 1992
    3. CKefauver-Harris Amendment, 1962
    4. DDurham-Humphrey Amendment, 1951
    Show answer and explanation

    Answer: C. Kefauver-Harris Amendment, 1962

    The Kefauver-Harris Amendment of 1962 (passed in response to the thalidomide tragedy).

    From the Pharmacy Law & Regulations flashcards.

16. Question 15

    What federal law created the legal framework for generic drug approval by allowing manufacturers to file an Abbreviated New Drug Application (ANDA)?

    1. APrescription Drug User Fee Act of 1992
    2. BHatch-Waxman Act of 1984
    3. CKefauver-Harris Amendment of 1962
    4. DDrug Quality and Security Act of 2013
    Show answer and explanation

    Answer: B. Hatch-Waxman Act of 1984

    The Hatch-Waxman Act (Drug Price Competition and Patent Term Restoration Act) of 1984.

    From the Pharmacy Law & Regulations flashcards.

17. Question 16

    Which federal law requires child-resistant packaging for most prescription and OTC drugs?

    1. AFederal Hazardous Substances Act of 1960
    2. BPoison Prevention Packaging Act of 1970
    3. CConsumer Product Safety Improvement Act of 2008
    4. DDrug Quality and Security Act of 2013
    Show answer and explanation

    Answer: B. Poison Prevention Packaging Act of 1970

    The Poison Prevention Packaging Act (PPPA) of 1970.

    From the Pharmacy Law & Regulations flashcards.

18. Question 17

    Which federal law established the Risk Evaluation and Mitigation Strategy (REMS) program to ensure benefits of certain drugs outweigh their risks?

    1. AFDA Amendments Act of 2007
    2. BFDA Modernization Act of 1997
    3. CDrug Quality and Security Act of 2013
    4. DPrescription Drug User Fee Act of 1992
    Show answer and explanation

    Answer: A. FDA Amendments Act of 2007

    The Food and Drug Administration Amendments Act (FDAAA) of 2007.

    From the Pharmacy Law & Regulations flashcards.

19. Question 18

    Under the FDA's drug recall system, which class of recall involves a situation where use of the product will cause serious adverse health consequences or death?

    1. AA market withdrawal
    2. BClass III recall
    3. CClass II recall
    4. DClass I recall
    Show answer and explanation

    Answer: D. Class I recall

    Class I recall.

    From the Pharmacy Law & Regulations flashcards.

20. Question 19

    A technician is working at the pharmacy counter when a patient requests pseudoephedrine 120 mg extended-release tablets. The patient has already purchased pseudoephedrine twice this month at different pharmacies. What federal law governs the sale of pseudoephedrine, and what is the daily purchase limit per individual?

    1. AControlled Substances Act with a 2.4 g daily limit
    2. BCombat Methamphetamine Epidemic Act with a 3.6 g daily limit
    3. CDrug Quality and Security Act with a 4.8 g daily limit
    4. DOmnibus Budget Reconciliation Act with a 5.0 g daily limit
    Show answer and explanation

    Answer: B. Combat Methamphetamine Epidemic Act with a 3.6 g daily limit

    The Combat Methamphetamine Epidemic Act of 2005 governs pseudoephedrine sales, limiting purchases to 3.6 grams per day and requiring purchaser identification, logbook entry, and behind-the-counter placement of the product.

    From the Pharmacy Law & Regulations flashcards.

21. Question 20

    Which DEA schedule includes anabolic steroids and buprenorphine/naloxone (Suboxone)?

    1. ASchedule IV
    2. BSchedule V
    3. CSchedule III
    4. DSchedule II
    Show answer and explanation

    Answer: C. Schedule III

    Schedule III. These substances have moderate to low potential for physical dependence but accepted medical uses.

    From the Drug Classifications flashcards.

22. Question 21

    What schedule was hydrocodone combination products (e.g., Vicodin) reclassified to in 2014, and what was their prior schedule?

    1. ASchedule IV, previously Schedule III
    2. BSchedule II, previously Schedule IV
    3. CSchedule III, previously Schedule II
    4. DSchedule II, previously Schedule III
    Show answer and explanation

    Answer: D. Schedule II, previously Schedule III

    In 2014, hydrocodone combination products were reclassified from Schedule III to Schedule II by the DEA, meaning they now require a written/electronic prescription and cannot be refilled.

    From the Drug Classifications flashcards.

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