Federal Requirements practice questions

Fourteen PTCE-style questions on the federal domain, with the reasoning written out. Pick an answer and the explanation opens. Nothing to sign up for.

Every answer links to the guide it comes from, so if one of these catches you out you can read the whole topic rather than memorise a single fact. The full domain is at Federal Requirements.

1. A prescriber's DEA number is AJ5641233. Using the check-digit method, is it valid?

Answer: B. Add the 1st, 3rd and 5th digits: 5 + 4 + 2 = 11. Add the 2nd, 4th and 6th: 6 + 1 + 3 = 10, then double it: 20. Add the two results: 11 + 20 = 31. The last digit of that sum is 1, but the 7th digit of the DEA number is 3. They disagree, so the number is not valid. On the exam the arithmetic is never the hard part — losing track of which digits are which is.
More: How to verify a DEA number

2. In the DEA number AJ5641233 issued to Dr. Thomas Jones, what does the second letter, J, tell you?

Answer: C. The first letter marks the registrant type — A, B, F and G are practitioner-type letters, M marks a mid-level practitioner. The second letter is the first initial of the registrant's last name, which is why J fits Jones. A mismatch between that letter and the prescriber's surname is a classic exam flag for a forged or borrowed number.
More: How to verify a DEA number

3. How does an NPI differ structurally from a DEA number?

Answer: B. A DEA number is two letters followed by seven digits. An NPI is 10 digits with no letters at all, and its 10th digit is a check digit validated with the Luhn 'double-add-double' mod-10 method — the same one used on credit cards. They identify the same prescriber for different purposes, and the exam likes to swap one for the other.
More: How to verify a DEA number

4. A Schedule III prescription is presented. What is the federal refill limit?

Answer: B. Schedule II carries zero refills. Schedules III and IV allow up to five refills within six months of the date written — both halves matter, and running out of either one ends the prescription. Schedule V has no federal refill limit, though state law may impose one. The commonest error is carrying the CIII/CIV rule across the schedule line in either direction.
More: DEA schedules, refills and transfers

5. A prescriber phones in an emergency oral Schedule II prescription. What must follow?

Answer: B. An emergency oral CII is limited to the quantity needed for the emergency period — commonly taught as about 72 hours — and the pharmacist must receive the signed written prescription, or a compliant electronic one, within 7 days. Miss the paperwork and the transaction was never completed. Form 222 is for ordering stock, not for dispensing, which is the trap in the fourth option.
More: What makes a controlled substance prescription valid

6. A patient asks for a partial fill of a Schedule II prescription. Within what period must the remainder be supplied?

Answer: C. A CII may be partially filled at the request of the patient or the prescriber, with the remainder supplied within 30 days. Do not confuse this with the 7-day rule for the written follow-up to an emergency oral CII, or with the 72-hour emergency supply itself — the exam puts all three numbers in the same question set on purpose.
More: DEA schedules, refills and transfers

7. How many line items may the current DEA Form 222 carry?

Answer: B. The legacy triplicate Form 222 was retired in October 2021 and allowed 10 line items. The current single-sheet Form 222 allows up to 20, and the same ordering can be done electronically through CSOS. If a question offers 'triplicate' as an option at all, that is the outdated answer.
More: Ordering, receiving, storing and destroying controlled substances

8. Under the Combat Methamphetamine Epidemic Act, what are the federal pseudoephedrine purchase limits?

Answer: A. CMEA limits a purchaser to 3.6 grams per day, and 9 grams in a 30-day window at retail. The daily limit is the same for retail and mail order. Keep the two numbers the right way round: the smaller one is the daily cap.
More: REMS, iPLEDGE and restricted drug programs

9. USP General Chapter <795> covers which of the following?

Answer: C. <800> is hazardous drugs, <797> is sterile compounding and <795> is nonsterile compounding. The PTCE tests these by number, so the chapter numbers have to be automatic. Worth knowing: nonsterile compounding was removed from the PTCE's own content outline in January 2026, but the chapter numbers still come up as identification.
More: Hazardous drugs and USP <800>

10. Which containment primary engineering control is acceptable for hazardous sterile compounding?

Answer: C. Hazardous sterile work needs a Class II BSC — most commonly Type A2, with Type B2 used for volatile hazardous drugs — or a CACI, externally vented. A horizontal laminar-airflow workbench blows air at the operator and offers no personnel containment at all. A Type A1 is a real containment device but is not acceptable here: its minimum inflow is 75 ft/min against the 100 ft/min a Type A2 provides.
More: Hazardous drugs and USP <800>

11. A product is recalled for a labeling deficiency that is unlikely to cause any adverse health consequence. Which recall class is it?

Answer: C. Class I means exposure could cause serious harm or death. Class II means temporary or medically reversible harm. Class III is primarily a compliance violation with minimal patient risk — a labeling or manufacturing deficiency. The hook that sticks: Class I could kill, Class II could hurt, Class III won't hurt.
More: Drug recalls — Class I, II and III

12. Who initiates most drug recalls in the United States?

Answer: B. Most recalls are voluntary and begin with the manufacturer or distributor. For most human drugs the FDA cannot order a mandatory recall at all — it has that authority for devices, food, biologics and, under the 2018 SUPPORT Act, controlled substances. 'The FDA orders a recall' is a confident-sounding wrong answer.
More: Drug recalls — Class I, II and III

13. Since 27 November 2023, which transaction records does DSCSA require at each handoff?

Answer: B. Transaction History sunset on 27 November 2023, which retired the old 'T3' framing. Two electronic records remain: Transaction Information, identifying product, lot, quantity, dates and trading partners, and the Transaction Statement, the seller's certification that the product was handled compliantly. Older study material still teaches T3 — that is how you spot material written before the change.
More: DSCSA, 503A vs 503B and the drug supply chain

14. One pharmacy borrows stock from another to cover an urgent patient need. Which tracing document does a PTCE-style question expect?

Answer: B. For a pharmacy-to-pharmacy stock replenishment transfer, the expected answer is the transaction statement. Form 222 covers ordering Schedule I and II stock from a supplier and has nothing to do with DSCSA tracing, which is what makes it the attractive wrong answer here.
More: DSCSA, 503A vs 503B and the drug supply chain

Where the rest of the domain is

These questions only sample it. Federal Requirements collects every guide in the domain, written out free.

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