A manufacturer recalls a batch of medication because it could cause serious, life-threatening health consequences. How does the FDA classify this recall?
A. Class III recall
B. Class I recall
C. Class II recall
D. There is no formal classification system for drug recalls
Show answer and reasoning
Correct answer: B. Class I recall
Correct. Under 21 CFR § 7.3(m), a Class I recall is used when there is a reasonable probability that use of the product will cause serious adverse health consequences or death.
- A: Wrong. A Class III recall involves a situation not likely to cause adverse health consequences, the opposite of this scenario.
- C: Wrong. A Class II recall involves a situation where use may cause temporary or reversible health consequences, less severe than the life-threatening scenario described.
- D: Wrong. The FDA does maintain a formal three-tier recall classification system (Class I, II, III) based on the severity of health risk.
Source: FDA recall classification, 21 CFR § 7.3(m)
On the PTCE, which knowledge domain carries the largest single weighting of exam content?
A. Medications, covering generic/brand names, classifications, interactions, dosage forms, and storage
B. Federal Requirements, covering controlled substance schedules and recordkeeping
C. Order Entry and Processing, covering prescription and medication order entry
D. Patient Safety and Quality Assurance, covering error prevention and reporting
Show answer and reasoning
Correct answer: A. Medications, covering generic/brand names, classifications, interactions, dosage forms, and storage
Correct. The PTCB Certification Exam Content Outline weights the Medications domain at 35%, the largest of the four domains, covering drug names, classifications, interactions, dosing, and storage.
- B: Wrong. Federal Requirements is weighted at 18.75% under the current outline, less than half the weight of the Medications domain.
- C: Wrong. Order Entry and Processing is weighted at 22.5%, smaller than the Medications domain.
- D: Wrong. Patient Safety and Quality Assurance is weighted at 23.75%, still smaller than the Medications domain.
Source: PTCB Certification Exam Content Outline (2026), Domain 1: Medications
A pharmacy technician receives a request to refill a patient's Schedule II oxycodone prescription that has zero refills remaining. What is the correct action?
A. Process the refill if the pharmacist verbally approves it over the phone
B. Inform the patient that Schedule II prescriptions cannot be refilled and a new prescription is required
C. Add one refill automatically since the patient has an established relationship with the pharmacy
D. Dispense a partial quantity to hold the patient over until a new prescription arrives
Show answer and reasoning
Correct answer: B. Inform the patient that Schedule II prescriptions cannot be refilled and a new prescription is required
Correct. Under 21 CFR § 1306.11 and 21 U.S.C. § 829(a), Schedule II controlled substances cannot be refilled; a new prescription is required for each dispensing, with narrow partial-fill exceptions that do not apply here.
- A: Wrong. No verbal approval, even from a pharmacist, can create a refill for a Schedule II drug because federal law prohibits refills on Schedule II prescriptions entirely.
- C: Wrong. An established patient relationship does not override the federal prohibition on Schedule II refills.
- D: Wrong. Dispensing any additional quantity without a new valid prescription is not permitted for a Schedule II drug with no refills left.
Source: 21 CFR § 1306.11 / 21 U.S.C. § 829(a)
A patient's Schedule IV prescription for alprazolam was written 4 months ago with 2 refills authorized. Under federal law, is it still fillable?
A. No, because Schedule IV drugs can never be refilled under any circumstances
B. Yes, but only if the prescriber re-authorizes it every 30 days
C. Yes, because Schedule III-V prescriptions may be refilled up to 5 times within 6 months of the date issued, if authorized
D. No, because all controlled substance prescriptions expire after 90 days regardless of schedule
Show answer and reasoning
Correct answer: C. Yes, because Schedule III-V prescriptions may be refilled up to 5 times within 6 months of the date issued, if authorized
Correct. 21 CFR § 1306.22 permits Schedule III, IV, and V prescriptions to be refilled up to five times within six months of the date of issuance, so a 4-month-old prescription with 2 authorized refills remaining is still fillable.
- A: Wrong. Unlike Schedule II drugs, Schedule III-V drugs may be refilled when the prescriber has authorized refills, subject to the 5-refill/6-month federal limit.
- B: Wrong. No monthly re-authorization is required by federal law for Schedule III-V refills within the 6-month/5-refill limit.
- D: Wrong. The federal expiration rule for Schedule III-V refills is 6 months from issuance, not a flat 90 days for all schedules.
Source: 21 CFR § 1306.22
A technician is entering a new controlled substance prescription and notices the prescriber's DEA number on the script. What is the purpose of verifying this number's format?
A. To calculate the patient's insurance copay
B. To determine which pharmacy the prescription must be filled at
C. To identify which state issued the patient's driver's license
D. To help confirm the prescriber is registered with the DEA to prescribe controlled substances
Show answer and reasoning
Correct answer: D. To help confirm the prescriber is registered with the DEA to prescribe controlled substances
Correct. Practitioners who prescribe controlled substances must be registered with the DEA under 21 CFR § 1301.11, and the DEA number format (including its check-digit structure) is one tool used to help verify that registration.
- A: Wrong. The DEA number has no relationship to insurance copay calculation.
- B: Wrong. A prescriber's DEA number does not restrict which pharmacy may fill the prescription.
- C: Wrong. The DEA number identifies the registered prescriber, not the patient or the patient's state of licensure.
Source: 21 CFR § 1301.11
