PTCE Federal Requirements Practice Test

25 practice questions

Choose an answer, then check it under Show answer.

1. Question 1 of 25Hard

   A pharmacy technician notices that a coworker has accessed the medication profile of a celebrity patient without a legitimate purpose. Which of the following actions is the technician required to take under HIPAA and pharmacy compliance policies?

   1. AA. Confront the coworker directly and ask them to stop
   2. BB. Ignore the incident because it is a minor privacy breach
   3. CC. Report the incident to the pharmacy's privacy officer immediately
   4. DD. Document the access in the patient's record for future reference
   Show answer to question 1

   Answer: C. Report the incident to the pharmacy's privacy officer immediately

   HIPAA requires that workforce members report any suspected privacy violation to the designated privacy officer. The technician has a duty to report the unauthorized access, which is a breach of PHI. The pharmacy must investigate and take corrective action.

   Why the other options are wrong

   • AConfronting the coworker is not sufficient; the incident must be formally reported to the privacy officer to ensure proper investigation and compliance.
   • BIgnoring the incident is a violation of HIPAA and pharmacy policy; all breaches must be reported.
   • DDocumenting the access in the patient's record is not appropriate; the technician should not alter the patient's record, and the reporting should be done through internal channels.

2. Question 2 of 25Easy

   According to federal law, how long must a pharmacy maintain executed DEA Form 222 records?

   1. AA. 2 years
   2. BB. 1 year
   3. CC. 5 years
   4. DD. 7 years
   Show answer to question 2

   Answer: A. 2 years

   Federal regulations require that all executed, unaccepted, or defective DEA Form 222 documents be kept readily retrievable for at least 2 years. While some individual state laws or Medicare regulations require record retention for 5 or 7 years, federal DEA regulations specifically establish a 2-year minimum requirement. Retaining records for only 1 year does not meet federal compliance guidelines.

3. Question 3 of 25Medium

   A pharmacist receives a valid prescription for a Schedule II controlled substance but only has half the quantity in stock. The patient agrees to a partial fill. According to federal regulations, within how many hours must the remainder of the prescription be dispensed?

   1. AA. 7 days
   2. BB. 72 hours
   3. CC. 24 hours
   4. DD. 48 hours
   Show answer to question 3

   Answer: B. 72 hours

   For Schedule II controlled substances, if a partial fill is necessary because the pharmacy cannot supply the full quantity, the remaining portion must be dispensed within 72 hours. If it is not, the pharmacist must notify the prescriber, and no more may be dispensed without a new prescription (21 CFR 1306.13(a)).

   Why the other options are wrong

   • A7 days is the deadline for the prescriber's written follow-up to an emergency oral Schedule II order, not a partial-fill limit.
   • C24 hours is too short; the regulation allows 72 hours.
   • D48 hours is not the correct timeframe; the rule specifies 72 hours.

4. Question 4 of 25Medium

   Under the DSCSA, how quickly must a pharmacy be able to provide transaction information, history, and statement to the FDA upon request?

   1. AA. Within 2 business days
   2. BB. Within 48 hours
   3. CC. Immediately at the time of the request
   4. DD. Within 10 business days
   Show answer to question 4

   Answer: A. Within 2 business days

   DSCSA requires a dispenser, such as a pharmacy, to provide the transaction information, transaction history and transaction statement to FDA or another appropriate official within 2 business days of a request made during a recall or investigation.

   Why the other options are wrong

   • BThe 48-hour limit belongs to the standard for manufacturers, wholesalers and repackagers (1 business day, not to exceed 48 hours), not dispensers.
   • CThe law gives dispensers 2 business days rather than requiring production at the moment of the request.
   • DTen business days far exceeds the 2-business-day requirement.

5. Question 5 of 25Medium

   A female patient of childbearing potential is prescribed isotretinoin. Under the iPLEDGE REMS program, which of the following must be documented before the pharmacy dispenses the medication?

   1. AA. A signed consent form from the prescriber
   2. BB. Verification of patient's insurance coverage for the medication
   3. CC. Patient enrollment and a valid pregnancy test result within the specified window
   4. DD. Two negative pregnancy tests prior to the first prescription
   Show answer to question 5

   Answer: C. Patient enrollment and a valid pregnancy test result within the specified window

   The iPLEDGE program requires that all patients (male and female) be enrolled, and for females of childbearing potential, a negative pregnancy test must be documented before each prescription is dispensed. The pharmacy must verify the patient's status in the system.

   Why the other options are wrong

   • AA signed consent form is not the primary requirement; the focus is on verification through the iPLEDGE database.
   • BInsurance verification is not part of the iPLEDGE REMS requirements; it's a separate administrative step.
   • DTwo negative tests are required before starting therapy, but not necessarily both before the first pharmacy dispensing; the key is current test and enrollment.

6. Question 6 of 25Medium

   Under federal law, how do Medication Guide requirements generally apply to an institutional hospital pharmacy providing medications to an admitted inpatient?

   1. AA. A Medication Guide is required only if the drug is administered via an intravenous infusion.
   2. BB. A Medication Guide is not required unless the patient or caregiver specifically requests one.
   3. CC. A Medication Guide must be sent to the floor with each individual unit-dose administration.
   4. DD. A Medication Guide must be printed and filed into the patient's permanent medical chart within 24 hours.
   Show answer to question 6

   Answer: B. A Medication Guide is not required unless the patient or caregiver specifically requests one.

   In an inpatient setting where healthcare professionals directly administer medications, pharmacies are generally exempt from providing a Medication Guide with every dose, provided the patient or caregiver does not ask for one. If an inpatient or their caregiver explicitly requests the guide, the pharmacy is legally obligated to provide it. Requiring a guide for every single unit dose administered would be clinically impractical and is not required by federal regulation.

7. Question 7 of 25Medium

   A female patient of childbearing potential is prescribed isotretinoin for severe acne. Which of the following is a mandatory requirement under the iPLEDGE REMS program?

   1. AA. Prescription must be written on tamper-resistant pads
   2. BB. Only a board-certified dermatologist may prescribe isotretinoin
   3. CC. Patient must sign a waiver of liability
   4. DD. Monthly pregnancy testing
   Show answer to question 7

   Answer: D. Monthly pregnancy testing

   iPLEDGE requires female patients of childbearing potential to have two negative pregnancy tests before starting therapy and monthly tests thereafter. This is part of the risk mitigation strategy to prevent fetal exposure.

   Why the other options are wrong

   • ATamper-resistant prescription pads are required for Medicaid prescriptions under federal law, but not specifically for iPLEDGE.
   • BAny prescriber registered with iPLEDGE, not just dermatologists, can prescribe isotretinoin.
   • CA waiver of liability is not part of iPLEDGE; instead, patients must use two forms of contraception and sign a patient consent form.

8. Question 8 of 25Easy

   According to the Combat Methamphetamine Epidemic Act (CMEA), what is the maximum amount of pseudoephedrine that a customer may purchase in a single day from a pharmacy without a prescription?

   1. AA. 3.6 grams
   2. BB. 15 grams
   3. CC. 9 grams
   4. DD. 7.5 grams
   Show answer to question 8

   Answer: A. 3.6 grams

   The CMEA limits daily pseudoephedrine purchases to 3.6 grams and monthly purchases to 9 grams. These limits apply to non-prescription sales of products containing pseudoephedrine.

   Why the other options are wrong

   • B15 grams exceeds both the daily and monthly limits and is not correct.
   • C9 grams is the monthly purchase limit, not the daily limit.
   • D7.5 grams is not a limit established by the CMEA.

9. Question 9 of 25Medium

   Which statement accurately describes the initiation process for the vast majority of prescription drug recalls in the United States?

   1. AA. The Drug Enforcement Administration issues an emergency seizure warrant to retail stores
   2. BB. The local public health department impounds all inventory directly from community pharmacies
   3. CC. The State Board of Pharmacy suspends the national distribution license of the product
   4. DD. The manufacturer initiates the recall voluntarily after discovering a product defect
   Show answer to question 9

   Answer: D. The manufacturer initiates the recall voluntarily after discovering a product defect

   Most prescription drug recalls are initiated voluntarily by the drug manufacturer or distributor upon discovering a manufacturing, packaging, or quality defect, often in consultation with the FDA. While the FDA has legal authority to request or mandate recalls for certain products, most are manufacturer-driven. The DEA enforces controlled substance laws, not safety-related product recalls.

10. Question 10 of 25Medium

    Which of the following health care providers is classified as a mid-level practitioner and must be issued a DEA number that begins with the letter M?

    1. AA. Doctor of Dental Surgery
    2. BB. Certified Nurse Practitioner
    3. CC. Doctor of Podiatric Medicine
    4. DD. Doctor of Veterinary Medicine
    Show answer to question 10

    Answer: B. Certified Nurse Practitioner

    Certified nurse practitioners are classified as mid-level practitioners by the DEA and receive registration numbers starting with the letter M. Dentists, podiatrists, and veterinarians are categorized as individual practitioners and receive numbers beginning with A, B, F, or G.

11. Question 11 of 25Easy

    Under federal law, how many times may a prescription for a Schedule III or IV controlled substance be transferred for refills between two pharmacies that do not share a real-time, online database?

    1. AA. Up to five times
    2. BB. One time only
    3. CC. Zero times, as transfers are prohibited
    4. DD. Up to two times
    Show answer to question 11

    Answer: B. One time only

    Federal regulations permit the transfer of Schedule III, IV, and V prescriptions for the purpose of refill dispensing on a one-time basis between pharmacies that do not share a real-time database. A common misconception is that transfers can occur up to five times because five refills are legally permitted, but the transfer itself is limited to a single occurrence unless the pharmacies share a centralized electronic system.

12. Question 12 of 25Medium

    A pharmacy technician discovers a small spill of a liquid chemotherapy drug on the counter. Which of the following is the correct initial response?

    1. AA. Wipe the spill with paper towels and dispose of them in the regular trash.
    2. BB. Evacuate the pharmacy and call the fire department immediately.
    3. CC. Cover the spill with absorbent material and leave it for the pharmacist to handle later.
    4. DD. Don double gloves and a gown, use a chemotherapy spill kit, and place waste in a hazardous waste container.
    Show answer to question 12

    Answer: D. Don double gloves and a gown, use a chemotherapy spill kit, and place waste in a hazardous waste container.

    Hazardous drug spills require proper PPE (double gloves, gown) and use of a spill kit designed for chemotherapy. All waste must be disposed of in a designated hazardous waste container.

    Why the other options are wrong

    • APaper towels and regular trash are not appropriate; hazardous waste must be segregated and disposed of according to regulations.
    • BEvacuation and fire department are not necessary for a small spill; the spill can be managed in-house with proper training.
    • CLeaving the spill unattended is unsafe and violates protocols; spills must be cleaned promptly.

13. Question 13 of 25Easy

    Which DEA schedule includes drugs with a high potential for abuse and no currently accepted medical use in the United States?

    1. AA. Schedule II
    2. BB. Schedule IV
    3. CC. Schedule I
    4. DD. Schedule III
    Show answer to question 13

    Answer: C. Schedule I

    Schedule I drugs (e.g., heroin, LSD) have a high potential for abuse and no accepted medical use. Schedule II through V drugs have accepted medical uses but varying abuse potentials.

    Why the other options are wrong

    • ASchedule II drugs have high abuse potential but do have accepted medical uses (e.g., morphine, oxycodone).
    • BSchedule IV drugs have even lower abuse potential and accepted medical uses (e.g., alprazolam).
    • DSchedule III drugs have lower abuse potential and accepted medical uses (e.g., Tylenol with codeine).

14. Question 14 of 25Medium

    A patient presents a written prescription for a Schedule II controlled substance. The patient requests a partial fill because they cannot afford the full quantity today. Under federal law, how long does the pharmacy have to dispense the remaining portion of the prescription, assuming the partial fill was properly recorded?

    1. AA. 30 days from the date the prescription was written
    2. BB. 72 hours from the time of the partial fill
    3. CC. 60 days from the date the prescription was written
    4. DD. 21 days from the date of the initial partial fill
    Show answer to question 14

    Answer: A. 30 days from the date the prescription was written

    Under the Comprehensive Addiction and Recovery Act (CARA) of 2016, federal law permits patient-requested partial fills of Schedule II controlled substances. The remaining portion can be filled up to 30 days from the date the prescription was written. This rule applies when the patient requests the partial fill, not due to pharmacy stock shortages.

    Why the other options are wrong

    • BThe 72-hour rule applies only to emergency Schedule II fills or pharmacy stock-shortage partial fills, not to patient-requested partial fills.
    • CFederal law does not allow a 60-day period for filling the remaining portion of a Schedule II prescription after a patient-requested partial fill.
    • DA 21-day timeframe is not a federal standard for this situation; the correct limit is 30 days from the date the prescription was written.

15. Question 15 of 25Hard

    A pharmacy needs to order a Schedule II controlled substance from a distributor. The pharmacy has a valid DEA registration. Which of the following statements about DEA Form 222 is correct?

    1. AA. The form is valid for up to 60 days after execution.
    2. BB. The distributor must retain the copy for 5 years.
    3. CC. The form must be signed by the pharmacist-in-charge.
    4. DD. The pharmacy must submit the original and two copies to the distributor.
    Show answer to question 15

    Answer: A. The form is valid for up to 60 days after execution.

    DEA Form 222 is valid for 60 days from the date of execution. The pharmacy sends the original and one copy (copy 1) to the distributor, retains copy 2. The form must be signed by an authorized individual, not necessarily the PIC. Both parties must retain records for 2 years, not 5.

    Why the other options are wrong

    • BThe distributor must retain the copy for 2 years, not 5 years, as per DEA recordkeeping requirements.
    • CThe form must be signed by the person ordering the controlled substance, who must be authorized by the registrant, but it does not have to be the pharmacist-in-charge specifically.
    • DThe pharmacy submits the original and one copy (copy 1) to the distributor; it keeps copy 2. Sending two copies is incorrect.

16. Question 16 of 25Hard

    In 2014, the Drug Enforcement Administration rescheduled hydrocodone combination products from Schedule III to Schedule II based on which criterion?

    1. AA. A finding that hydrocodone can no longer be safely formulated with acetaminophen
    2. BB. Evidence of high abuse potential leading to severe psychological or physical dependence
    3. CC. A determination that hydrocodone lacks an accepted medical use for pain management
    4. DD. A federal policy requiring all synthetic opioid compounds to be Schedule II
    Show answer to question 16

    Answer: B. Evidence of high abuse potential leading to severe psychological or physical dependence

    The DEA reclassified hydrocodone combination products to Schedule II after data demonstrated that they have a high potential for abuse similar to other Schedule II narcotics and that abuse may lead to severe physical or psychological dependence. The products retain a well-established, accepted medical use in the United States, which rules out any basis for Schedule I or loss of approved indication.

17. Question 17 of 25Medium

    A pharmacy discovers a significant theft of hydrocodone tablets from its inventory. Which DEA form must be used to report this theft to the Drug Enforcement Administration?

    1. AA. DEA Form 106
    2. BB. DEA Form 224
    3. CC. DEA Form 41
    4. DD. DEA Form 222
    Show answer to question 17

    Answer: A. DEA Form 106

    DEA Form 106 is the official form for reporting theft or loss of controlled substances. It must be submitted to the DEA within one business day of discovery for significant losses.

    Why the other options are wrong

    • BDEA Form 224 is the application for retail pharmacy DEA registration, not for incident reporting.
    • CDEA Form 41 is used for the destruction of unwanted or expired controlled substances, not for reporting theft.
    • DDEA Form 222 is used to order Schedule I and II controlled substances from distributors.

18. Question 18 of 25Hard

    A technician scanning an incoming shipment finds that the 2D barcode on several packages will not scan and the printed lot number does not match the accompanying transaction information. The technician sets the packages aside and notifies the pharmacist. What is the correct next step under DSCSA before the pharmacy takes further action with this product?

    1. AA. Notify FDA immediately, since any scanning discrepancy is automatically illegitimate
    2. BB. Destroy the product on site to prevent it from entering the supply chain
    3. CC. Quarantine the product and investigate to determine whether it is illegitimate
    4. DD. Return the product to the reverse distributor without documenting the discrepancy
    Show answer to question 18

    Answer: C. Quarantine the product and investigate to determine whether it is illegitimate

    A barcode that will not scan plus a lot number that conflicts with the transaction information makes the product suspect, not automatically illegitimate. DSCSA requires quarantine and an investigation, which can include verifying the product identifier with the manufacturer, before any further action.

    Why the other options are wrong

    • AFDA notification is required only after an investigation determines the product is illegitimate; a scanning problem alone is not that determination.
    • BDestroying the product skips the required investigation and eliminates evidence needed to resolve the discrepancy.
    • DSuspect product must stay quarantined, and the discrepancy must be documented and investigated, not quietly sent back.

19. Question 19 of 25Easy

    A patient presents a prescription for oxycodone 5 mg tablets, quantity #120, with refills for 0. How many refills are permitted for a CII prescription?

    1. AA. 5
    2. BB. 11
    3. CC. 6
    4. DD. 0
    Show answer to question 19

    Answer: D. 0

    Schedule II (CII) controlled substances cannot be refilled under federal law. Each prescription must be written and dispensed anew. The DEA strictly prohibits any refills for CII medications, regardless of the prescriber's instructions.

    Why the other options are wrong

    • A5 refills are allowed for Schedule III and IV controlled substances, not CII.
    • B11 refills are not recognized under DEA rules; Schedule V may allow refills as authorized by the prescriber, but CII has zero refills.
    • C6 refills are not permitted for any controlled substance; Schedule III and IV allow up to 5 refills within 6 months.

20. Question 20 of 25Hard

    A patient presents a prescription for acetaminophen with codeine 300 mg/30 mg tablets. Under federal law, which schedule is assigned to this combination product?

    1. AA. Schedule II
    2. BB. Schedule V
    3. CC. Schedule IV
    4. DD. Schedule III
    Show answer to question 20

    Answer: D. Schedule III

    Acetaminophen with codeine in solid oral dosage form contains not more than 90 mg of codeine per dosage unit, placing it in Schedule III under the federal Controlled Substances Act. Pure codeine alone is classified as Schedule II, while certain liquid cough syrups containing low concentrations of codeine combined with expectorants fall into Schedule V.

21. Question 21 of 25Hard

    A female patient of childbearing potential is starting isotretinoin therapy under the iPLEDGE program. Which of the following correctly describes the requirements she must meet?

    1. AA. Must have a pregnancy test only before starting treatment
    2. BB. Must use one form of contraception consistently
    3. CC. Must have monthly pregnancy tests and use two forms of contraception
    4. DD. No special requirements if she is not sexually active
    Show answer to question 21

    Answer: C. Must have monthly pregnancy tests and use two forms of contraception

    The iPLEDGE program requires female patients of childbearing potential to have monthly pregnancy tests and use two forms of effective contraception (or abstain) to prevent pregnancy while on isotretinoin.

    Why the other options are wrong

    • AMonthly testing is required throughout therapy, not just at start.
    • BTwo forms of contraception are required, not just one.
    • DEven if not sexually active, monthly pregnancy tests are still required, and abstinence must be documented.

22. Question 22 of 25Easy

    A patient presents a prescription for dextroamphetamine that indicates two authorized refills. Under federal law, how many refills may be dispensed for this Schedule II medication?

    1. AA. Two refills
    2. BB. Up to five refills within six months
    3. CC. Zero refills
    4. DD. One refill
    Show answer to question 22

    Answer: C. Zero refills

    Federal law strictly prohibits any refills on prescriptions for Schedule II controlled substances. Even if the prescriber writes refills on the face of the prescription, the pharmacy cannot dispense any refills. The allowance of up to five refills within six months applies to Schedule III and IV medications, not Schedule II.

23. Question 23 of 25Hard

    A manufacturer discovers that a batch of a blood pressure medication has a labeling error that lists the strength as 5 mg instead of the actual 10 mg. Taking the lower strength could lead to uncontrolled hypertension and stroke. Which FDA recall class applies to this situation?

    1. AA. Class III recall
    2. BB. Market withdrawal
    3. CC. Class II recall
    4. DD. Class I recall
    Show answer to question 23

    Answer: D. Class I recall

    A Class I recall is for situations where there is a reasonable probability that the product will cause serious adverse health consequences or death. The labeling error could lead to uncontrolled hypertension and stroke, which are serious consequences, so this is a Class I recall.

    Why the other options are wrong

    • AClass III recalls are for products that are not likely to cause adverse health consequences; this scenario has a clear risk.
    • BA market withdrawal is a voluntary removal of a product for minor violations or non-health-related reasons, not applicable here.
    • CClass II recalls are for products that may cause temporary or medically reversible adverse effects, but the potential for stroke is not temporary or reversible.

24. Question 24 of 25Medium

    A pharmacy technician is asked by a patient's family member for information about the patient's prescription history. The patient has not provided consent. Which HIPAA principle prohibits the technician from disclosing this information without authorization?

    1. AA. Right to access
    2. BB. Protected health information (PHI) confidentiality
    3. CC. Notice of privacy practices
    4. DD. Minimum necessary standard
    Show answer to question 24

    Answer: B. Protected health information (PHI) confidentiality

    Under HIPAA, protected health information (PHI) is confidential and cannot be disclosed without the patient's authorization except for treatment, payment, or healthcare operations. Family members require patient consent unless the patient is incapacitated or for emergency care.

    Why the other options are wrong

    • ARight to access allows patients to obtain their own records, not family members.
    • CNotice of privacy practices informs patients of their rights, but does not permit disclosure to family without authorization.
    • DThe minimum necessary standard applies when disclosure is permitted, limiting information to what is needed; it does not authorize disclosure without consent.

25. Question 25 of 25Easy

    Which of the following is a Schedule II controlled substance?

    1. AA. Ambien (zolpidem)
    2. BB. Tylenol #3 (codeine/acetaminophen)
    3. CC. Adderall (amphetamine salts)
    4. DD. Xanax (alprazolam)
    Show answer to question 25

    Answer: C. Adderall (amphetamine salts)

    Adderall (amphetamine) is a Schedule II stimulant with high abuse potential and no refills allowed. Xanax is CIV, Ambien is CIV, Tylenol #3 is CIII.

    Why the other options are wrong

    • AAmbien (zolpidem) is a Schedule IV sedative-hypnotic.
    • BTylenol #3 contains codeine and is a Schedule III controlled substance.
    • DXanax is a benzodiazepine, classified as Schedule IV, not Schedule II.

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