20 Federal Law & Compliance Practice Questions & Answers

1. 1. Under the federal Controlled Substances Act, which characteristic defines a Schedule I substance such as heroin or LSD?

   • A.Moderate abuse potential and available for over-the-counter sale
   • B.High potential for abuse but with an accepted medical use under severe restrictions
   • C.High potential for abuse and no currently accepted medical use in the United States✓ Answer
   • D.Low potential for abuse relative to Schedule IV drugs

   Schedule I is uniquely defined by a high potential for abuse combined with no currently accepted medical use and a lack of accepted safety, which is why such drugs cannot be prescribed.

   Source: 21 U.S.C. 812(b)(1) — CSA Schedule I criteriaReport a problem with this question

2. 2. As of the 2014 DEA rescheduling, hydrocodone combination products (e.g., hydrocodone/acetaminophen) are classified in which schedule?

   • A.Schedule III
   • B.Schedule V
   • C.Schedule II✓ Answer
   • D.Schedule IV

   In 2014 the DEA moved hydrocodone combination products from Schedule III to Schedule II because of their high abuse potential, which means no refills are permitted.

   Source: DEA Final Rule, 79 FR 49661 (2014) — hydrocodone reschedulingReport a problem with this question

3. 3. What is the federal controlled-substance schedule of tramadol?

   • A.Schedule IV✓ Answer
   • B.Schedule II
   • C.Non-controlled
   • D.Schedule III

   Tramadol was placed into Schedule IV federally in 2014 because of its abuse and dependence potential; as a C-IV drug it may be refilled up to 5 times within 6 months.

   Source: 21 CFR 1308.14 — tramadol scheduling (2014)Report a problem with this question

4. 4. A prescriber writes 'refill x3' on a prescription for oxycodone, a Schedule II drug. How many refills may the pharmacy legally dispense?

   • A.Three, as written by the prescriber
   • B.Unlimited within one year
   • C.Five refills within six months
   • D.Zero — Schedule II prescriptions may not be refilled✓ Answer

   Federal law prohibits any refills on Schedule II prescriptions; a new written prescription is required each time regardless of what the prescriber writes on the order.

   Source: 21 CFR 1306.12 — no refill of Schedule IIReport a problem with this question

5. 5. After an emergency oral Schedule II prescription is dispensed, within how many days must the prescriber deliver a written, signed prescription to the pharmacy?

   • A.72 hours
   • B.24 hours
   • C.7 days✓ Answer
   • D.30 days

   For an emergency oral C-II, the pharmacist may dispense only the emergency quantity, and the prescriber must furnish a written, signed prescription postmarked or delivered within 7 days.

   Source: 21 CFR 1306.11(d) — emergency Schedule II dispensingReport a problem with this question

6. 6. A prescription for a Schedule IV drug such as alprazolam may be refilled a maximum of how many times and for how long?

   • A.Unlimited refills for up to one year
   • B.No refills are permitted
   • C.Up to 5 refills within 6 months of the date written✓ Answer
   • D.Up to 11 refills within 12 months

   Schedule III, IV, and V prescriptions may be refilled up to 5 times or within 6 months from the date written, whichever limit is reached first.

   Source: 21 CFR 1306.22 — refilling of Schedule III–VReport a problem with this question

7. 7. A patient asks the pharmacy to transfer their remaining oxycodone (Schedule II) prescription to another pharmacy. What is the correct action?

   • A.Transfer it unlimited times because both pharmacies share a database
   • B.Refuse — Schedule II prescriptions may not be transferred between pharmacies✓ Answer
   • C.Transfer it once, as allowed for all controlled substances
   • D.Transfer only the refills but not the original fill

   Schedule II prescriptions cannot be refilled and therefore cannot be transferred; only unfilled refills of Schedule III–V prescriptions are eligible for a one-time transfer.

   Source: 21 CFR 1306.12; DEA transfer rules (C-III–V only)Report a problem with this question

8. 8. A prescriber's DEA number is AP1234563. Using the DEA checksum (add the 1st, 3rd and 5th digits; add the 2nd, 4th and 6th digits and multiply by 2; sum both), what should the 7th 'check' digit be, and is the number valid?

   • A.Check digit 9; the number is invalid
   • B.Check digit 7; the number is invalid
   • C.Check digit 3; the number is valid✓ Answer
   • D.Check digit 5; the number is invalid

   1+3+5 = 9; (2+4+6) x 2 = 24; 9+24 = 33, and the last digit of that sum (3) must equal the 7th digit — it does, so the DEA number is valid.

   Source: DEA registration number checksum formula (DEA Pharmacist's Manual)Report a problem with this question

9. 9. Which DEA form (or its electronic CSOS equivalent) is required for a pharmacy to order Schedule II controlled substances from a supplier?

   • A.DEA Form 41
   • B.DEA Form 224
   • C.DEA Form 106
   • D.DEA Form 222✓ Answer

   Ordering Schedule II substances requires DEA Form 222 (or the electronic CSOS system); Schedule III–V may be ordered on an ordinary invoice, and Form 224 is the pharmacy's registration application.

   Source: 21 CFR 1305 — order forms for Schedule I and IIReport a problem with this question

10. 10. A pharmacy discovers a significant theft of controlled substances. Which DEA form is used to report the loss?

    • A.DEA Form 363
    • B.DEA Form 106✓ Answer
    • C.DEA Form 222
    • D.DEA Form 41

    Significant losses or thefts of controlled substances must be reported to the DEA on Form 106, along with prompt notification of the local DEA field office.

    Source: 21 CFR 1301.76(b) — theft or significant loss reportingReport a problem with this question

11. 11. A registrant needs to document the destruction of expired controlled substances. Which DEA form is used?

    • A.DEA Form 222
    • B.DEA Form 106
    • C.DEA Form 41✓ Answer
    • D.DEA Form 224

    Destruction or disposal of controlled substances by a registrant is documented on DEA Form 41, which serves as the official record of destruction.

    Source: 21 CFR 1317 — destruction; DEA Form 41Report a problem with this question

12. 12. After the initial inventory, how often must a pharmacy take a complete inventory of its controlled substances, and how long must controlled-substance records be retained?

    • A.Monthly; records kept 1 year
    • B.Annually; records kept 5 years
    • C.Every 2 years (biennial); records kept at least 2 years✓ Answer
    • D.Every 3 years; records kept 3 years

    Federal law requires a biennial (every 2 years) controlled-substance inventory, and all controlled-substance records must be kept at least 2 years and be readily retrievable.

    Source: 21 CFR 1304.11 (inventory); 21 CFR 1304.04 (recordkeeping)Report a problem with this question

13. 13. Under the Combat Methamphetamine Epidemic Act (CMEA), what is the maximum amount of pseudoephedrine base a single purchaser may buy in one day?

    • A.3.6 grams✓ Answer
    • B.7.5 grams
    • C.9 grams
    • D.1 gram

    CMEA limits retail sales to 3.6 grams of pseudoephedrine base per purchaser per day; a separate 30-day limit of 9 grams (7.5 grams for mail-order) also applies.

    Source: CMEA 2005; 21 U.S.C. 830(d) — pseudoephedrine sales limitsReport a problem with this question

14. 14. Isotretinoin is dispensed under the iPLEDGE REMS program. Which requirement applies?

    • A.The drug may be refilled up to 5 times like other Schedule IV drugs
    • B.It may be freely substituted with any generic without REMS enrollment
    • C.Patients of childbearing potential must have a negative pregnancy test, and the prescription must be dispensed within a 7-day window with no refills✓ Answer
    • D.No enrollment or pregnancy testing is required for any patient

    The iPLEDGE REMS requires prescriber, pharmacy, and patient enrollment and pregnancy testing because isotretinoin is a potent teratogen; prescriptions have a 7-day dispensing window and cannot be refilled.

    Source: FDA iPLEDGE REMS (isotretinoin)Report a problem with this question

15. 15. The FDA issues a recall for a product where there is a reasonable probability that its use will cause serious adverse health consequences or death. Which recall class is this?

    • A.Class II
    • B.Class I✓ Answer
    • C.Market withdrawal
    • D.Class III

    Class I is the most serious recall class, defined by a reasonable probability of serious adverse health consequences or death, such as a contaminated or wrong-drug product.

    Source: 21 CFR 7.3(m) — FDA recall classificationReport a problem with this question

16. 16. A drug is recalled because of a minor labeling or packaging defect that is unlikely to cause any adverse health consequence. Which recall class applies?

    • A.Class III✓ Answer
    • B.Class II
    • C.Class I and II combined
    • D.Class I

    Class III is the least severe recall class, applied to products unlikely to cause adverse health consequences, such as minor labeling or container defects.

    Source: 21 CFR 7.3(m) — FDA recall classificationReport a problem with this question

17. 17. Under the Drug Supply Chain Security Act (DSCSA), the '3 T's' that must accompany each change of ownership of a prescription drug are Transaction Information, Transaction History, and which third document?

    • A.Transaction Tracking
    • B.Transaction Statement✓ Answer
    • C.Transaction Total
    • D.Transaction Tax

    The three DSCSA documents are Transaction Information (TI), Transaction History (TH), and Transaction Statement (TS); the statement is the seller's attestation of compliance with DSCSA.

    Source: DSCSA, 21 U.S.C. 360eee (Title II of DQSA 2013)Report a problem with this question

18. 18. A pharmacy determines it has received an illegitimate (e.g., counterfeit) prescription product. What does the DSCSA require the pharmacy to do?

    • A.Wait 30 days and then discard it without notifying anyone
    • B.Quarantine the product and notify the FDA (Form FDA 3911) and trading partners within 24 hours of the determination✓ Answer
    • C.Dispense the remaining stock quickly before it expires
    • D.Return it to any patient who requests it

    DSCSA requires illegitimate product to be quarantined and investigated, with notification to the FDA on Form 3911 and to appropriate trading partners within 24 hours of the determination.

    Source: DSCSA, 21 U.S.C. 360eee-1; FDA Form 3911Report a problem with this question

19. 19. Under EPA/RCRA rules, certain drugs such as high-concentration warfarin, nicotine, and physostigmine are classified as acutely hazardous waste. What is this waste category called?

    • A.Non-hazardous pharmaceutical waste
    • B.Trace-chemotherapy waste
    • C.P-list waste✓ Answer
    • D.U-list waste

    P-listed wastes are the acutely hazardous category under RCRA; even 'empty' P-list containers may require special handling, unlike the U-list, which covers other toxic (but not acutely hazardous) wastes.

    Source: 40 CFR 261.33 — RCRA P-list acutely hazardous wasteReport a problem with this question

20. 20. Under the HIPAA Privacy Rule, a pharmacy may disclose protected health information (PHI) without patient authorization for which purpose?

    • A.Treatment, payment, and health care operations (TPO)✓ Answer
    • B.Selling a patient's contact list to a marketing company
    • C.Posting patient names publicly in the pharmacy
    • D.Any purpose, as long as the pharmacist believes it is helpful

    HIPAA permits disclosure of PHI without authorization for treatment, payment, and health care operations (TPO), while the minimum-necessary standard limits other uses and disclosures.

    Source: HIPAA Privacy Rule, 45 CFR 164.506 (TPO)Report a problem with this question

Practice questions based on the PTCB exam content outline. Not affiliated with the PTCB, and not medical advice. About the PTCE →