22 Federal Law & Compliance Practice Questions & Answers

1. 1. Under the Controlled Substances Act, what distinguishes a Schedule II drug from a Schedule I drug?

   • A.Schedule II drugs may be refilled five times, while Schedule I drugs are never refilled.
   • B.Schedule II drugs have an accepted medical use, while Schedule I drugs have none.✓ Answer
   • C.Schedule II drugs carry a lower potential for abuse than the drugs in Schedule I.
   • D.Schedule II drugs are approved by the DEA, while Schedule I drugs are cleared by the FDA.

   Schedule placement turns on accepted medical use plus abuse and dependence potential. Schedule I substances have no currently accepted medical use in the United States and cannot be prescribed at all, while Schedule II substances share the same high abuse potential but do have an accepted use, so they may be dispensed under the strictest controls.

   Source: 21 U.S.C. 812(b)(1)-(2); 21 CFR 1308.11-1308.12Report a problem with this question

2. 2. A technician files three new prescriptions. Which line states the correct federal schedule for all three drugs?

   • A.Hydrocodone/acetaminophen III, tramadol III, pregabalin IV
   • B.Hydrocodone/acetaminophen II, tramadol III, pregabalin IV
   • C.Hydrocodone/acetaminophen III, tramadol IV, pregabalin V
   • D.Hydrocodone/acetaminophen II, tramadol IV, pregabalin V✓ Answer

   Hydrocodone combination products were moved from Schedule III to Schedule II, so every hydrocodone product is now a Schedule II drug with no refills. Tramadol was placed in Schedule IV and pregabalin in Schedule V, which is why both still accept refills.

   Source: 21 CFR 1308.12(b)(1); 1308.14(c); 1308.15(e)Report a problem with this question

3. 3. A cough syrup contains 100 mg of codeine phosphate per 100 mL with no other controlled ingredient. What federal schedule and refill rule apply?

   • A.Schedule V, and refills are allowed as often as the prescriber authorizes.✓ Answer
   • B.Schedule III, and refills are capped at five within six months of issue.
   • C.Schedule II, and no refill is permitted without a new written prescription.
   • D.Schedule IV, and refills are capped at five within six months of issue.

   A preparation holding no more than 200 mg of codeine per 100 mL, combined with a non-narcotic ingredient, falls in Schedule V. Federal law caps refills at five in six months only for Schedules III and IV, so a Schedule V product may be refilled as the prescriber authorizes.

   Source: 21 CFR 1308.15(c); 21 CFR 1306.22(a)Report a problem with this question

4. 4. An alprazolam prescription written on March 2 is marked "refill 11 times." What may the pharmacy lawfully dispense under federal law?

   • A.Up to eleven refills, because the prescriber's written authorization controls.
   • B.Up to six refills, and none of them after September 2 of that same year.
   • C.Up to five refills within twelve months of the date the order was written.
   • D.Up to five refills, and none of them after September 2 of that same year.✓ Answer

   Alprazolam is a Schedule IV drug, and a Schedule III or IV prescription may be refilled no more than five times and no later than six months from the date it was written, whichever limit is reached first. A prescriber cannot authorize more than the federal ceiling, so the extra refills are void.

   Source: 21 CFR 1306.22(a); 1308.14(c)Report a problem with this question

5. 5. Which statement about transferring a controlled substance prescription between two retail pharmacies follows federal rules?

   • A.An electronic Schedule II order may be transferred once for initial filling.✓ Answer
   • B.A paper Schedule II order may be transferred once for the initial filling.
   • C.A Schedule IV order loses every remaining refill once it has been transferred.
   • D.A Schedule III order transfers only between pharmacies under common ownership.

   Federal rules now let an electronic prescription in Schedules II through V be transferred one time between retail pharmacies for the initial fill, at the patient's request and pharmacist to pharmacist, if state law allows. A paper Schedule II prescription still cannot be transferred, and a transferred Schedule III or IV prescription carries its remaining refills with it.

   Source: 21 CFR 1306.08(a)-(b); 21 CFR 1306.12(a); 1306.25Report a problem with this question

6. 6. A prescriber telephones an emergency Schedule II order and the pharmacist dispenses it. What does federal law require afterward?

   • A.The pharmacist files the oral order with the nearest DEA field office that week.
   • B.The quantity dispensed is limited to a 7-day supply for every emergency order.
   • C.The prescriber sends an electronic replacement order within 72 hours of the call.
   • D.A written prescription marked "Authorization for Emergency Dispensing" must arrive in 7 days.✓ Answer

   For an emergency oral Schedule II order the pharmacist reduces it to writing immediately and the prescriber must deliver a written cover prescription to the pharmacy within 7 days, bearing that phrase and the date of the oral order. The dispensed quantity is limited to the amount needed for the emergency period rather than to a fixed 7-day supply, and if the written prescription never arrives the pharmacist must notify the nearest DEA field office.

   Source: 21 CFR 1306.11(d)Report a problem with this question

7. 7. A prescriber's DEA number is BW214536X, where X is the check digit. Add digits 1, 3, and 5, then add twice the sum of digits 2, 4, and 6; the last digit of that total must equal digit 7. What is X?

   • A.The check digit is 0.
   • B.The check digit is 9.
   • C.The check digit is 3.✓ Answer
   • D.The check digit is 1.

   The six known digits are 2, 1, 4, 5, 3, 6. Digits 1, 3, and 5 sum to 2 + 4 + 3 = 9; digits 2, 4, and 6 sum to 1 + 5 + 6 = 12, and doubled that is 24. The total is 33, whose last digit is 3, so the valid number ends in 3.

   Source: DEA Diversion Control Division, Pharmacist's Manual: verification of a DEA registration number (check-digit method)Report a problem with this question

8. 8. A chain opens a new pharmacy across town. How does federal law treat DEA registration for that site?

   • A.It may dispense controlled drugs for 90 days while its application is pending.
   • B.It may operate under the chain's existing registration if the owner is the same.
   • C.It registers on DEA Form 222 and renews that registration every single year.
   • D.It must obtain its own registration on DEA Form 224 and must renew it every three years.✓ Answer

   Federal law requires a separate DEA registration for each principal place of business where controlled substances are dispensed, so common ownership does not let a new store borrow another site's registration. A retail pharmacy applies on DEA Form 224 and renews on Form 224a, and pharmacy registrations run on a three-year cycle.

   Source: 21 CFR 1301.12(a); 1301.13(e)(1)(iv)Report a problem with this question

9. 9. A pharmacy orders morphine from a wholesaler, reports a burglary, and destroys expired stock. Which set of DEA forms is correct?

   • A.Order on Form 224, report on Form 106, and destroy on Form 222.
   • B.Order on Form 222, report on Form 41, and destroy on Form 106.
   • C.Order on Form 41, report on Form 224, and destroy on Form 106.
   • D.Order on Form 222, report on Form 106, and destroy on Form 41.✓ Answer

   Schedule I and II purchases move on the single-sheet DEA Form 222 or through its electronic equivalent, the Controlled Substance Ordering System. Theft or significant loss is reported on Form 106, destruction of registrant stock is documented on Form 41, and Form 224 is the registration application rather than a transaction form.

   Source: 21 CFR 1305.03; 1305.20-1305.29 (CSOS); 1301.76(b); 1317.05Report a problem with this question

10. 10. Overnight, a sealed bottle of oxycodone disappears and the pharmacy judges the loss significant. What does federal law require?

    • A.Notify the DEA Field Division in writing within one business day, then file Form 106 within 45 days.✓ Answer
    • B.Notify the local police first and let them decide whether the DEA must be told.
    • C.Note the shortage on the perpetual inventory and report it at the next biennial count.
    • D.File Form 106 with the DEA within 30 days and keep a copy in the pharmacy files.

    Current federal rules split the duty into two deadlines: written notice to the DEA Field Division within one business day of discovering the theft or significant loss, then the completed Form 106 submitted electronically within 45 days of that discovery. The registrant, not the DEA, decides whether a loss is significant, using factors such as the schedule and quantity involved.

    Source: 21 CFR 1301.74(c); 21 CFR 1301.76(b)Report a problem with this question

11. 11. What does federal law require of a pharmacy's ongoing controlled substance inventory?

    • A.A complete inventory every six months, with Schedule II drugs estimated.
    • B.A complete inventory every year, with every schedule estimated to the nearest unit.
    • C.A complete inventory every two years, with all schedules estimated by container volume.
    • D.A complete inventory every two years, with Schedule II drugs counted exactly.✓ Answer

    After the initial inventory taken when the registrant first handles controlled substances, federal law requires a complete inventory at least every two years. Schedule II quantities must be counted exactly because they carry the highest diversion risk, while Schedule III through V containers holding 1,000 dosage units or fewer may be estimated.

    Source: 21 CFR 1304.11(b); 21 CFR 1304.11(e)Report a problem with this question

12. 12. Federal law requires controlled substance records for two years; the state board requires five. Which period governs the pharmacy?

    • A.Five years for Schedule II records and two years for all other schedules.
    • B.Two years, because federal controlled substance law preempts state rules.
    • C.Five years, because the pharmacy must satisfy the stricter of the two rules.✓ Answer
    • D.Whichever period the pharmacy's primary wholesaler specifies in its contract.

    The two-year federal retention period is a floor, not a ceiling, and the Controlled Substances Act does not occupy the field so as to displace stricter state requirements. When federal and state law both apply, the pharmacy follows the stricter rule, which here means holding the records for five years and keeping them readily retrievable.

    Source: 21 CFR 1304.04(a); 21 U.S.C. 903Report a problem with this question

13. 13. Federal limits on pseudoephedrine base are 3.6 g per day and 9 g per 30 days per purchaser. Which sale must be refused?

    • A.2.4 g today to a buyer who bought 3 g eleven days before this visit.
    • B.2.6 g today to a buyer who bought 4 g and then 3 g earlier this month.✓ Answer
    • C.1.8 g today to a buyer who already bought 1.8 g earlier the same morning.
    • D.3.6 g today to a buyer whose only other purchase was 40 days ago.

    The 30-day ceiling counts every purchase in the rolling window, so 4 g plus 3 g plus 2.6 g reaches 9.6 g and exceeds the 9 g limit. The other sales stay inside both ceilings: two 1.8 g purchases in one day total exactly the 3.6 g daily limit, and a purchase 40 days earlier falls outside the 30-day window.

    Source: 21 U.S.C. 830(d)(1); 21 CFR 1314.20Report a problem with this question

14. 14. For a pseudoephedrine sale that is not exempt from logbook rules, what must the seller obtain and keep?

    • A.A prescription from the buyer's physician plus a logbook entry kept two years.
    • B.Photographic identification issued by a government, plus a signed logbook entry kept two years.✓ Answer
    • C.Photographic identification, plus a logbook entry the seller may discard after 90 days.
    • D.Proof of the buyer's insurance coverage plus a logbook entry kept for six months.

    Pseudoephedrine is a nonprescription scheduled listed chemical product, so no prescription is needed federally, but the buyer must show government-issued photo identification and sign a written or electronic logbook. The entry records the product, quantity, buyer name and address, and date and time of sale, and it is retained not fewer than two years; a technician may complete the sale and the entry.

    Source: 21 U.S.C. 830(e)(1)(A); 21 CFR 1314.30Report a problem with this question

15. 15. A drug's REMS includes Elements to Assure Safe Use. What does that add beyond a Medication Guide?

    • A.A counseling session that a pharmacy technician documents in the patient's own profile.
    • B.A requirement that the manufacturer mail safety updates to prescribers every quarter.
    • C.Certification of prescribers and pharmacies plus documented safe-use conditions.✓ Answer
    • D.A prohibition on dispensing the drug to any patient younger than eighteen years old.

    Elements to Assure Safe Use are the most restrictive tier a REMS can carry, and they may require prescriber certification, pharmacy or dispenser certification, dispensing only in certain settings, documented safe-use conditions, patient enrollment in a registry, and authorization before the drug is released. A technician may gather and submit the required documentation, but the pharmacist verifies that the authorization is valid before dispensing.

    Source: 21 U.S.C. 355-1(f); FDA Risk Evaluation and Mitigation Strategies guidanceReport a problem with this question

16. 16. Under the isotretinoin REMS, what applies before the drug is dispensed?

    • A.Prescriber, pharmacy, and patient are all enrolled, and the fill occurs within a 7-day window.✓ Answer
    • B.The pharmacy enrolls once and may then supply automatic refills for up to six months.
    • C.The prescriber alone enrolls, and the pharmacy may fill any quantity within 30 days.
    • D.The patient enrolls after the first fill, and pregnancy testing begins in month two.

    Isotretinoin carries Elements to Assure Safe Use because of severe birth defects, so the prescriber, the dispensing pharmacy, and the patient must all be registered before any quantity moves. Patients who can become pregnant must meet contraception and pregnancy-testing conditions, and the prescription must be filled inside a short window after the qualifying date, which is why automatic refills are not used.

    Source: 21 U.S.C. 355-1(f)(3); FDA iPLEDGE REMS for isotretinoinReport a problem with this question

17. 17. A recall notice says that use of the affected lot could cause death. Which class is it, and what defines that class?

    • A.Class II, because the health consequences are temporary or medically reversible.
    • B.Class I, because there is a reasonable probability of serious harm or death.✓ Answer
    • C.Class III, because the defect is not likely to cause an adverse health effect.
    • D.Class IV, because the product is being withdrawn for a minor labeling violation.

    Recall classes are defined by the health risk the defect creates, not by the size of the recall. A Class I recall means there is a reasonable probability that use or exposure will cause serious adverse health consequences or death, which is why it usually reaches the patient level; there is no Class IV, and a minor violation is handled as a market withdrawal.

    Source: 21 CFR 7.3(m)(1)-(3)Report a problem with this question

18. 18. A wholesaler delivers a case of tablets. What must the pharmacy do with the transaction documents?

    • A.Keep the transaction history for three years and the statement for one year.
    • B.Forward the transaction statement to the FDA within two business days of delivery.
    • C.Keep the transaction information and the transaction statement for six years from that date.✓ Answer
    • D.Pass the transaction information to each patient along with the dispensed drug.

    As a dispenser under the drug supply chain law, a pharmacy must receive and retain transaction information and a transaction statement for six years from the date of the transaction. Those records are not routinely sent anywhere, but the pharmacy must be able to produce them for the FDA or a state within two business days during a recall or investigation, and no transaction document goes to the patient.

    Source: 21 U.S.C. 360eee-1(d)(1) and (d)(3); Drug Supply Chain Security Act dispenser requirementsReport a problem with this question

19. 19. A shipment's serial numbers cannot be verified by the manufacturer, and the product is confirmed illegitimate. What is required?

    • A.Destroy the product at once and record the loss on a DEA Form 106 within 45 days.
    • B.Quarantine the product and notify the FDA and trading partners within 24 hours.✓ Answer
    • C.Return the product to the wholesaler and notify the FDA within five business days.
    • D.Dispense the remaining stock while the manufacturer investigates the serial numbers.

    Product that may be counterfeit, diverted, stolen, or otherwise unfit is suspect product and must be quarantined and investigated, including verification of the package-level product identifier with the manufacturer. Once the investigation shows the product is illegitimate, the pharmacy notifies the FDA and its immediate trading partners within 24 hours using Form FDA 3911 and keeps the product quarantined pending disposition.

    Source: 21 U.S.C. 360eee-1(d)(4)-(5); FDA Form 3911Report a problem with this question

20. 20. A pharmacy must discard expired warfarin tablets, a hazardous pharmaceutical waste. What does federal law require?

    • A.Place them in the regular trash, because expired tablets are no longer drug products.
    • B.Flush them down a sink drain, because pharmacy quantities are exempt from the ban.
    • C.Return them to the manufacturer's representative for burning at the plant site.
    • D.Send them to a permitted hazardous waste facility, and never down the drain.✓ Answer

    Warfarin as the sole active ingredient is an acutely hazardous listed waste, and federal hazardous waste rules for healthcare facilities ban sewering any hazardous waste pharmaceutical, with no small-quantity exception. The tablets must be segregated in a labeled hazardous waste container and shipped to a permitted treatment or disposal facility rather than placed in ordinary trash.

    Source: 40 CFR 266.505; 40 CFR 261.33(e) (P001)Report a problem with this question

21. 21. Who may authorize dispensing a prescription in a container that is not child-resistant?

    • A.The prescriber may waive it for all of a patient's prescriptions at one time.
    • B.The pharmacist may waive it when no young children live in the patient's home.
    • C.The patient may waive it for all prescriptions; the prescriber, one at a time.✓ Answer
    • D.The manufacturer may waive it for the products sold in a unit-of-use container.

    The federal packaging law lets the purchaser make a standing request that all of their prescriptions come in conventional containers, while a prescriber's direction covers only the single prescription for which it is given. The pharmacist cannot decide this on household composition alone, and separate product exemptions such as sublingual nitroglycerin come from the regulation itself.

    Source: 15 U.S.C. 1473(b); 16 CFR 1700.14 and 1700.15Report a problem with this question

22. 22. A prescriber's office calls a pharmacy for a patient's fill history to check adherence. What does the HIPAA Privacy Rule permit?

    • A.Refuse unless the patient is present in the pharmacy to approve the disclosure.
    • B.Release the entire profile, because prescriber requests fall outside the rule.
    • C.Refuse until the patient signs an authorization that names the prescriber's office.
    • D.Release the fill history, because disclosures for treatment need no authorization.✓ Answer

    Protected health information may be disclosed without patient authorization for treatment, payment, and health care operations, and a treating prescriber asking about a patient's own therapy is a treatment disclosure. The minimum necessary standard still shapes what leaves the pharmacy for most uses, although it does not apply to disclosures made to a health care provider for treatment.

    Source: 45 CFR 164.506(c)(2); 45 CFR 164.502(b)(2)(i)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 →