ExCPT Pharmacy Law Practice Test

25 practice questions

Choose an answer, then check it under Show answer.

1. Question 1 of 25Easy

   Which of the following is a required element on all valid prescriptions, including for non-controlled substances?

   1. AA. DEA number of the prescriber
   2. BB. Diagnosis code
   3. CC. Patient's date of birth
   4. DD. Date the prescription was written
   Show answer to question 1

   Answer: D. Date the prescription was written

   The date the prescription is written is a federal requirement for all prescriptions to ensure the prescription is current. A DEA number is only required for controlled substances. Patient date of birth and diagnosis code are not federally mandated, though they may be used for identification or insurance purposes.

   Why the other options are wrong

   • ADEA number is required only for prescriptions for controlled substances.
   • BDiagnosis codes are not required on prescriptions; they may be used for insurance but are not an element of a valid prescription.
   • CPatient date of birth is not a federal requirement on a prescription.

2. Question 2 of 25Easy

   A new drug has just been approved for the treatment of a rare disease. Which federal agency was responsible for reviewing the clinical trial data and approving the drug for marketing?

   1. AA. The state board of pharmacy where the manufacturer is located
   2. BB. The Drug Enforcement Administration
   3. CC. The Food and Drug Administration
   4. DD. The Centers for Medicare and Medicaid Services
   Show answer to question 2

   Answer: C. The Food and Drug Administration

   The FDA reviews clinical trial data on safety and effectiveness and approves new drugs before they can be marketed in the United States.

   Why the other options are wrong

   • AState boards regulate pharmacy practice within a state; they do not approve drugs.
   • BThe DEA schedules and regulates controlled substances; it does not approve new drugs.
   • DCMS runs Medicare and Medicaid coverage and payment, not drug approval.

3. Question 3 of 25Medium

   During a routine inventory check, a pharmacy technician discovers that the perpetual inventory count for a Schedule II controlled substance is 10 tablets less than the physical count. What is the technician's most appropriate immediate action?

   1. AA. Ignore the discrepancy if it is less than 1% of total inventory
   2. BB. Document the discrepancy and report it to the supervising pharmacist
   3. CC. Adjust the perpetual inventory record to match the physical count
   4. DD. Notify the DEA field office within 24 hours
   Show answer to question 3

   Answer: B. Document the discrepancy and report it to the supervising pharmacist

   Any discrepancy in Schedule II records must be documented and reported to the pharmacist-in-charge, who will investigate and determine if a DEA report (Form 106) is required. Technicians cannot adjust records or decide to ignore discrepancies.

   Why the other options are wrong

   • AAll discrepancies, regardless of size, must be investigated and documented; ignoring them is not permitted.
   • CAdjusting inventory records without pharmacist approval is a violation of recordkeeping requirements and could mask a diversion issue.
   • DDEA notification is only required for significant losses (e.g., theft or diversion) after investigation by the pharmacist; a small count discrepancy does not automatically trigger a 24-hour report.

4. Question 4 of 25Medium

   A pharmacy dispenses a medication that is part of a Risk Evaluation and Mitigation Strategy (REMS) program with Elements to Assure Safe Use (ETASU). Which of the following actions is the pharmacy most likely required to perform before dispensing?

   1. AA. Obtain a new prescription from the prescriber each time the patient needs a refill.
   2. BB. Verify that the patient is enrolled in a patient registry and that the prescriber is certified.
   3. CC. Provide the patient with a medication guide and a written warning about side effects.
   4. DD. Dispense the medication only in a hospital setting under direct medical supervision.
   Show answer to question 4

   Answer: B. Verify that the patient is enrolled in a patient registry and that the prescriber is certified.

   REMS with ETASU often require that prescribers be certified and that patients be enrolled in a registry or meet specific safe-use conditions. Pharmacies must verify these elements before dispensing. Examples include isotretinoin (iPLEDGE) and clozapine (Clozapine REMS).

   Why the other options are wrong

   • AREMS programs do not typically require a new prescription for each refill; standard refill procedures apply.
   • CProviding a medication guide may be part of the REMS, but it is not the primary ETASU requirement; the key is verification of enrollment and certification.
   • DWhile some REMS may restrict dispensing to certain settings, most allow outpatient pharmacy dispensing with appropriate safeguards.

5. Question 5 of 25Medium

   According to federal law, how often must a pharmacy conduct a complete inventory of all Schedule II controlled substances?

   1. AA. Every 3 years
   2. BB. Annually
   3. CC. Every 6 months
   4. DD. Every 2 years
   Show answer to question 5

   Answer: D. Every 2 years

   The DEA requires a biennial (every 2 years) inventory of Schedule II controlled substances. Inventories for Schedules III, IV, and V may be done every 2 years as well, but the question specifically asks about Schedule II.

   Why the other options are wrong

   • AEvery 3 years exceeds the DEA's biennial requirement.
   • BAnnual inventory is not required by DEA for Schedule II; it is every 2 years.
   • CEvery 6 months is not a DEA requirement for controlled substance inventories.

6. Question 6 of 25Medium

   A pharmacy technician is organizing the controlled substance inventory. Which medication is categorized as a DEA Schedule IV controlled substance?

   1. AA. Dextroamphetamine
   2. BB. Hydrocodone
   3. CC. Ketamine
   4. DD. Zolpidem
   Show answer to question 6

   Answer: D. Zolpidem

   Zolpidem is a non-benzodiazepine hypnotic agent classified under Schedule IV because of its low potential for abuse relative to Schedule III agents. Ketamine is categorized as a Schedule III substance, while hydrocodone combination products and dextroamphetamine are Schedule II substances.

7. Question 7 of 25Hard

   A pharmacy technician is asked by a pharmacist to assist in verifying the accuracy of a filled prescription. The technician found a dispensing error (wrong strength) and informed the pharmacist. Which action is consistent with the technician's scope of practice?

   1. AA. The technician documents the error and suggests a root cause analysis.
   2. BB. The technician corrects the error by replacing the medication and rechecking the label.
   3. CC. The technician informs the pharmacist, who then corrects the error and documents the incident.
   4. DD. The technician discards the incorrect medication to avoid any issue.
   Show answer to question 7

   Answer: C. The technician informs the pharmacist, who then corrects the error and documents the incident.

   Technicians can identify errors, but only pharmacists are authorized to make final corrections and document errors according to standard operating procedures. The technician's role is supportive.

   Why the other options are wrong

   • ADocumentation and root cause analysis are typically the pharmacist's or quality team's responsibility.
   • BThe technician cannot independently correct an error without pharmacist supervision.
   • DDiscarding evidence is inappropriate and violates error reporting procedures.

8. Question 8 of 25Medium

   In a hospital pharmacy, a technician is preparing a sterile intravenous admixture. Which workflow area is most appropriate for this task?

   1. AA. Inventory management office
   2. BB. Cleanroom with ISO Class 5 environment
   3. CC. Patient counseling area
   4. DD. Receiving and storage area
   Show answer to question 8

   Answer: B. Cleanroom with ISO Class 5 environment

   Sterile IV admixtures must be prepared in a cleanroom that meets ISO Class 5 air quality standards, as outlined in USP <797>, to minimize contamination risk.

   Why the other options are wrong

   • AInventory management office is for administrative tasks.
   • CPatient counseling area is for pharmacist-patient interactions.
   • DReceiving and storage is for unpacking supplies, not sterile compounding.

9. Question 9 of 25Medium

   Under the Omnibus Budget Reconciliation Act of 1990 (OBRA 90), which group of patients must be offered counseling by a pharmacist when a new prescription is dispensed?

   1. AA. Patients with chronic conditions only
   2. BB. Patients covered by Medicaid
   3. CC. Patients covered by Medicare Part D
   4. DD. All patients receiving any prescription
   Show answer to question 9

   Answer: B. Patients covered by Medicaid

   OBRA 90 specifically requires that pharmacists offer to counsel Medicaid patients on their medications. While many states have extended this requirement to all patients, the federal law applies only to Medicaid recipients.

   Why the other options are wrong

   • AOBRA 90 does not restrict counseling to patients with chronic conditions.
   • CMedicare Part D has its own counseling requirements under the Medicare Modernization Act, not OBRA 90.
   • DOBRA 90 does not mandate counseling for all patients; it is limited to Medicaid.

10. Question 10 of 25Medium

    A pharmacy technician accidentally hands a prescription bag containing another patient's medication to a different patient. The patient who received the bag reads the label and sees the other patient's name and drug information. This incident is best classified as:

    1. AA. An acceptable occurrence if the medication is non-controlled
    2. BB. A minor error that requires no action because no harm occurred
    3. CC. A violation of OBRA '90 counseling requirements
    4. DD. A HIPAA breach that must be reported to the patient and possibly to the Department of Health and Human Services
    Show answer to question 10

    Answer: D. A HIPAA breach that must be reported to the patient and possibly to the Department of Health and Human Services

    Unauthorized disclosure of protected health information (PHI) is a HIPAA breach. The pharmacy must notify the affected patient and may need to report to the HHS depending on the number of patients affected.

    Why the other options are wrong

    • AThe controlled status of the medication is irrelevant; any PHI disclosure is a HIPAA violation.
    • BEven without physical harm, a privacy breach requires investigation and notification; it is not minor.
    • COBRA '90 mandates patient counseling for Medicaid patients but does not address privacy breaches.

11. Question 11 of 25Hard

    A pharmacy technician is processing a sale of pseudoephedrine-containing products. The customer has already purchased a total of 9 grams of pseudoephedrine in the last 30 days. According to the Combat Methamphetamine Epidemic Act (CMEA), what should the technician do?

    1. AA. Refuse the sale because the customer has reached the 9-gram monthly limit.
    2. BB. Ask for a prescription to bypass the limit.
    3. CC. Complete the sale because the customer hasn't reached the 10-gram limit.
    4. DD. Refuse the sale because the daily limit is 3.6 grams.
    Show answer to question 11

    Answer: A. Refuse the sale because the customer has reached the 9-gram monthly limit.

    CMEA sets a 9-gram per 30-day limit for pseudoephedrine purchases. The customer already bought 9 grams, so no more can be sold within that period.

    Why the other options are wrong

    • BA prescription would bypass the limit, but pseudoephedrine is an OTC product and not typically prescribed.
    • C9 grams is the limit, not 10; 9 grams includes the purchase, so the limit is reached.
    • DThe daily limit is 3.6 grams, but the customer already exceeded the monthly limit of 9 grams.

12. Question 12 of 25Easy

    A pharmacy technician is asked to perform a task. Which task is within the technician's scope of practice according to typical state regulations?

    1. AA. Entering patient information into the pharmacy system
    2. BB. Counseling a patient on potential side effects
    3. CC. Accepting a new prescription verbally from a prescriber
    4. DD. Performing a final check of a filled prescription
    Show answer to question 12

    Answer: A. Entering patient information into the pharmacy system

    Pharmacy technicians are permitted to perform data entry and other non-clinical tasks under the supervision of a pharmacist. Accepting verbal prescriptions, counseling patients, and performing final verification are responsibilities reserved for the pharmacist due to the need for clinical judgment.

    Why the other options are wrong

    • BPatient counseling requires pharmacist-level clinical knowledge and is outside the technician's scope.
    • COnly a pharmacist can accept a new verbal prescription from a prescriber.
    • DThe final check of a filled prescription must be performed by a pharmacist to ensure accuracy and safety.

13. Question 13 of 25Medium

    According to DEA regulations, how often must a pharmacy take a complete inventory of all controlled substances?

    1. AA. Every 1 year
    2. BB. Every 2 years
    3. CC. Every 5 years
    4. DD. Every 3 years
    Show answer to question 13

    Answer: B. Every 2 years

    The DEA requires a complete inventory of all controlled substances every two years. This applies to all schedules. The initial inventory is taken at the time of registration, and subsequent inventories must be taken every two years thereafter.

    Why the other options are wrong

    • AAnnual inventory is not required by DEA; some states may have more frequent requirements, but federal law is every 2 years.
    • CFive years exceeds the DEA requirement.
    • DThree years is too long; the DEA mandates a two-year cycle.

14. Question 14 of 25Medium

    According to the criteria established by the Durham-Humphrey Amendment, an active drug entity is restricted to prescription-only status if it meets which condition?

    1. AA. It has been commercially marketed in the United States for fewer than seven years
    2. BB. It is not safe for self-medication without supervision by a licensed practitioner
    3. CC. It is synthesized from patented chemical compounds rather than natural sources
    4. DD. It carries a wholesale acquisition cost that exceeds federal pricing limits
    Show answer to question 14

    Answer: B. It is not safe for self-medication without supervision by a licensed practitioner

    Under the Durham-Humphrey Amendment, a drug must be dispensed by prescription if it is habit-forming, toxic, has a high potential for harmful effects, or cannot be used safely without medical supervision by a licensed prescriber. Chemical origin, commercial marketing duration, and wholesale medication costs have no bearing on whether a drug is legally categorized as legend or OTC.

15. Question 15 of 25Easy

    Which of the following regulatory entities is primarily responsible for establishing the licensure requirements, technician-to-pharmacist ratios, and authorized scope of practice for pharmacy technicians?

    1. AA. Centers for Medicare and Medicaid Services
    2. BB. Drug Enforcement Administration
    3. CC. State Board of Pharmacy
    4. DD. Food and Drug Administration
    Show answer to question 15

    Answer: C. State Board of Pharmacy

    The State Board of Pharmacy regulates the daily practice of pharmacy within its specific state, which includes licensing personnel, setting pharmacy technician scopes of practice, and defining operational ratios. The Food and Drug Administration regulates the safety, efficacy, and labeling of pharmaceuticals at the federal level rather than state professional licensing.

16. Question 16 of 25Easy

    The Pure Food and Drug Act of 1906 was primarily enacted to address which public health issue?

    1. AA. False or misleading labeling and interstate sale of contaminated food and drugs
    2. BB. Unregulated distribution of habit-forming narcotics
    3. CC. Lack of proven efficacy before a drug could be prescribed
    4. DD. Absence of a clear distinction between prescription and nonprescription drugs
    Show answer to question 16

    Answer: A. False or misleading labeling and interstate sale of contaminated food and drugs

    The Pure Food and Drug Act of 1906 prohibited interstate commerce of adulterated and misbranded food and drug products, requiring accurate ingredient labeling. It did not mandate that drugs prove efficacy prior to marketing, which was later required by the Kefauver-Harris Amendment of 1962.

17. Question 17 of 25Hard

    A sales representative offers pharmacy staff free registration and lodging at a resort conference in exchange for prioritizing and dispensing their manufacturer's high-cost brand medication to Medicare patients. Which of the following federal laws prohibits this arrangement?

    1. AA. The Federal Food, Drug, and Cosmetic Act
    2. BB. The Poison Prevention Packaging Act
    3. CC. The Anti-Kickback Statute
    4. DD. The Prescription Drug Marketing Act
    Show answer to question 17

    Answer: C. The Anti-Kickback Statute

    The federal Anti-Kickback Statute makes it a criminal offense to knowingly offer, pay, solicit, or receive any remuneration to induce the referral of business payable by federal healthcare programs like Medicare. The Prescription Drug Marketing Act regulates drug sampling and the wholesale distribution of prescription drugs, but it is not the primary statute governing financial inducements for prescribing or dispensing Medicare-covered drugs. The Food, Drug, and Cosmetic Act governs medication safety and labeling.

18. Question 18 of 25Hard

    Under HIPAA regulations, a pharmacy is permitted to disclose protected health information without the patient's authorization or opportunity to agree or object in which of the following scenarios?

    1. AA. Transmitting controlled substance dispensing data to a state prescription drug monitoring program (PDMP)
    2. BB. Providing prescription purchase histories to a pharmaceutical sales representative for marketing analytics
    3. CC. Sharing an employee's medication list with their employer's human resources team for attendance tracking
    4. DD. Releasing therapy notes to a commercial life insurance underwriter during policy application review
    Show answer to question 18

    Answer: A. Transmitting controlled substance dispensing data to a state prescription drug monitoring program (PDMP)

    HIPAA permits covered entities to disclose protected health information without patient authorization for public health activities and when required by law, such as reporting dispensed controlled substances to a state prescription drug monitoring program (PDMP). Disclosures to commercial entities for marketing, employers for workplace attendance, or life insurance underwriters for policy evaluations require the patient's explicit, written authorization.

19. Question 19 of 25Hard

    Under OBRA 90, pharmacies are required to make a reasonable effort to collect and maintain specific patient information in the pharmacy management system. Which details are required under this mandate?

    1. AA. Prescriber National Provider Identifier and federal DEA registration number
    2. BB. Patient credit history, insurance deductible amount, and payment methods
    3. CC. Social Security number, annual household income, and employment history
    4. DD. Known allergies, chronic conditions, and previous drug reactions
    Show answer to question 19

    Answer: D. Known allergies, chronic conditions, and previous drug reactions

    OBRA 90 requires pharmacies to make a reasonable effort to obtain and record patient demographic and clinical data, including known allergies, chronic conditions, and adverse drug reactions. Financial records, Social Security numbers, and prescriber licensing identifiers are not mandated under the OBRA 90 patient profile requirement.

20. Question 20 of 25Medium

    Which of the following medications requires a Risk Evaluation and Mitigation Strategy (REMS) program that includes mandatory patient registry, monthly pregnancy testing, and restricted dispensing?

    1. AA. Lisinopril (Prinivil)
    2. BB. Warfarin (Coumadin)
    3. CC. Metformin (Glucophage)
    4. DD. Isotretinoin (Accutane)
    Show answer to question 20

    Answer: D. Isotretinoin (Accutane)

    Isotretinoin is part of the iPLEDGE REMS program due to its high risk of birth defects. The program requires patient registration, monthly pregnancy tests for females of childbearing potential, and restricted dispensing to certified pharmacies.

    Why the other options are wrong

    • ALisinopril does not have a REMS program.
    • BWarfarin has a REMS but it focuses on patient education and INR monitoring, not monthly pregnancy testing.
    • CMetformin does not have a REMS program.

21. Question 21 of 25Easy

    A pharmacy technician receives a verbal order from a prescriber for a new medication. According to the technician's scope of practice, what is the most appropriate action?

    1. AA. Write down the order and prepare the medication immediately.
    2. BB. Enter the order into the computer system for the pharmacist to verify.
    3. CC. Ask the prescriber to call back and speak with the pharmacist.
    4. DD. Ignore the order because verbal orders are never allowed.
    Show answer to question 21

    Answer: C. Ask the prescriber to call back and speak with the pharmacist.

    Pharmacy technicians cannot accept verbal orders; only a licensed pharmacist may do so. The technician should politely ask the prescriber to speak with the pharmacist.

    Why the other options are wrong

    • ATechnicians are not authorized to accept verbal orders; this would be practicing beyond scope.
    • BEntering an unverified verbal order into the system could lead to errors and is outside the technician's role.
    • DVerbal orders are permitted for non-controlled substances under certain conditions, but only the pharmacist may accept them.

22. Question 22 of 25Medium

    In a hospital pharmacy setting, which of the following tasks is within the scope of practice for a pharmacy technician?

    1. AA. Preparing intravenous (IV) admixtures under the supervision of a pharmacist
    2. BB. Verifying the accuracy of a compounded sterile preparation before dispensing
    3. CC. Approving a non-formulary medication request from a physician
    4. DD. Performing medication reconciliation on a newly admitted patient
    Show answer to question 22

    Answer: A. Preparing intravenous (IV) admixtures under the supervision of a pharmacist

    Pharmacy technicians in hospital settings may prepare IV admixtures using aseptic technique under the direct supervision of a pharmacist. The pharmacist must verify the final product.

    Why the other options are wrong

    • BVerification of any dispensed medication, including sterile preparations, is the pharmacist's responsibility.
    • CFormulary decisions and approvals are made by the pharmacy and therapeutics committee or the pharmacist-in-charge.
    • DMedication reconciliation is a clinical task typically performed by a pharmacist or nurse.

23. Question 23 of 25Hard

    A dietary supplement is discovered to contain a novel synthetic steroid that mimics the effects of testosterone but was not explicitly named in original statutory drug schedules. Under the Designer Anabolic Steroid Control Act, how is this substance handled?

    1. AA. It is automatically classified as a Schedule III controlled substance based on its chemical and pharmacological profile.
    2. BB. It remains unregulated until the DEA completes a formal two-year notice-and-comment rulemaking process.
    3. CC. It is regulated strictly as an adulterated food product under the Federal Food, Drug, and Cosmetic Act.
    4. DD. It is classified as a Schedule I research chemical that cannot be rescheduled under any circumstance.
    Show answer to question 23

    Answer: A. It is automatically classified as a Schedule III controlled substance based on its chemical and pharmacological profile.

    The Designer Anabolic Steroid Control Act expanded Schedule III to include newly created anabolic steroid analogs and designer molecules chemically and pharmacologically related to testosterone, preventing manufacturers from evading regulation simply by altering chemical structures. It does not leave them unregulated, nor does it place them into Schedule I.

24. Question 24 of 25Hard

    A pharmacy receives a written prescription for 60 tablets of methylphenidate, but only 25 tablets are in stock. If the patient accepts the partial quantity, within what timeframe must the remaining 35 tablets be dispensed under federal law before a new prescription is required?

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

    Answer: C. 72 hours

    When a pharmacy cannot supply the full quantity of a Schedule II prescription due to an out-of-stock situation, federal law allows a partial fill provided the remainder is dispensed within 72 hours. If the remaining tablets are not filled within that 72-hour window, the pharmacist must notify the prescriber and a new prescription is needed for any further supply.

25. Question 25 of 25Easy

    Which federal agency is responsible for regulating the manufacturing, distribution, and dispensing of controlled substances?

    1. AA. FDA (Food and Drug Administration)
    2. BB. OSHA (Occupational Safety and Health Administration)
    3. CC. DEA (Drug Enforcement Administration)
    4. DD. HIPAA (Health Insurance Portability and Accountability Act)
    Show answer to question 25

    Answer: C. DEA (Drug Enforcement Administration)

    The DEA is the federal agency that enforces the Controlled Substances Act (CSA) and regulates controlled substances from manufacturing through dispensing. The FDA oversees drug safety and efficacy, but not the scheduling or distribution controls of controlled substances.

    Why the other options are wrong

    • AThe FDA regulates drug approval, labeling, and safety, but does not directly control the distribution of controlled substances.
    • BOSHA regulates workplace safety, not drug control.
    • DHIPAA is a law that protects patient health information privacy, not a regulatory agency for controlled substances.

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