MPJE (Multistate Pharmacy Jurisprudence Exam) — Questions and Answers

Question 1: A 503B outsourcing facility differs from a 503A compounding pharmacy primarily in that a 503B facility:

Is exempt from CGMP requirements
Must compound only for individual patient prescriptions
Cannot compound sterile preparations
Can compound large batches without patient-specific prescriptions (Correct answer)

Correct answer: Can compound large batches without patient-specific prescriptions

503B outsourcing facilities may produce large sterile batches for healthcare facilities without patient-specific prescriptions but must comply with CGMP.

Question 2: Under the DEA's Disposal Regulations (21 CFR Part 1317), which of the following is an authorized method for ultimate users to dispose of unwanted controlled substances?

Dropping medications in any hospital dumpster
Flushing medications down the toilet at home
Returning medications to a DEA-authorized collector at a take-back location (Correct answer)
Mailing medications to the prescriber for destruction

Correct answer: Returning medications to a DEA-authorized collector at a take-back location

DEA-authorized collector take-back programs are the preferred lawful method for ultimate users to dispose of unwanted controlled substances.

Question 3: An Illinois pharmacy wishes to compound sterile preparations for office use by a physician. Which registration is required?

503B outsourcing facility registration from the FDA (Correct answer)
Both 503A from IDFPR and a separate IDPH sterile compounding permit
Standard retail pharmacy license only
503A compounding pharmacy registration from IDFPR

Correct answer: 503B outsourcing facility registration from the FDA

Pharmacies compounding sterile preparations in large quantities for office use (not patient-specific) must register as a 503B outsourcing facility with the FDA.

Question 4: A pharmacist may dispense a Schedule III controlled substance refill up to how many times within 6 months of the original prescription date?

Up to 12 times
Up to 5 times (Correct answer)
No refills are permitted
Up to 3 times

Correct answer: Up to 5 times

Schedule III and IV controlled substances may be refilled up to 5 times within 6 months of the original issue date.

Question 5: Under the Federal Food, Drug, and Cosmetic Act, a prescription drug dispensed by a pharmacist is exempt from certain manufacturer labeling requirements, but the dispensed vial's label must contain specific information. Which of the following is NOT a federally mandated requirement for the prescription label?

The name of the prescribing practitioner.
The serial number of the prescription.
The discard date or 'beyond-use date'. (Correct answer)
The name and address of the dispenser.

Correct answer: The discard date or 'beyond-use date'.

While including a beyond-use date (BUD) or discard date is a standard of practice and required by most state laws, it is not explicitly required by the federal FD&C Act for a dispensed prescription label. The FD&C Act does require the name and address of the dispenser (pharmacy), the serial (prescription) number, the date of the prescription or of its filling, and the name of the prescriber.

Question 6: Which amendment to the Food, Drug, and Cosmetic Act first required manufacturers to prove both safety AND efficacy before marketing a new drug?

Kefauver-Harris Amendment of 1962 (Correct answer)
Food, Drug, and Cosmetic Act of 1938
Hatch-Waxman Act of 1984
Durham-Humphrey Amendment of 1951

Correct answer: Kefauver-Harris Amendment of 1962

The Kefauver-Harris Amendment of 1962 established the dual requirement that new drugs be proven both safe and effective, triggered by the thalidomide tragedy in Europe.

Question 7: A drug is considered 'misbranded' under the FD&C Act if:

It was approved via the 505(b)(2) pathway
It lacks adequate directions for use (Correct answer)
It contains only GRAS (generally recognized as safe) ingredients
It is manufactured in a state-licensed facility

Correct answer: It lacks adequate directions for use

A drug is misbranded if its labeling is false or misleading, or if it lacks adequate directions for use, among other labeling deficiencies listed in the FD&C Act.

Question 8: Which Illinois agency is primarily responsible for enforcing the Illinois Pharmacy Practice Act?

Illinois Department of Financial and Professional Regulation (IDFPR) (Correct answer)
Illinois State Board of Pharmacy
Illinois Department of Public Health
Illinois Department of Human Services

Correct answer: Illinois Department of Financial and Professional Regulation (IDFPR)

The Illinois Department of Financial and Professional Regulation (IDFPR) is the primary agency responsible for enforcing the Illinois Pharmacy Practice Act.

Question 9: Under the federal Omnibus Budget Reconciliation Act of 1990 (OBRA '90), which of the following statements is accurate regarding the patient counseling requirement for a new Medicaid prescription?

The law mandates that written information, like a patient leaflet, is a sufficient substitute for a verbal offer to counsel.
The offer to counsel must be made, but the patient or their caregiver has the right to refuse it. (Correct answer)
A pharmacy technician may provide the full counseling session if the pharmacist is unavailable.
Counseling is only required if the patient explicitly asks for it.

Correct answer: The offer to counsel must be made, but the patient or their caregiver has the right to refuse it.

OBRA '90 requires that a pharmacist (or their agent, depending on state law) make an 'offer to counsel' for Medicaid beneficiaries on new prescriptions. It does not mandate that the patient must accept the counseling; the patient or their caregiver retains the right to refuse. While written information is a useful supplement, it does not replace the requirement for a verbal offer.

Question 10: Under the FD&C Act, which labeling element is specifically required on the immediate container of a prescription drug dispensed to a patient?

Full package insert approved by FDA at time of NDA
Manufacturer's name and country of origin
Name and address of the dispenser, prescription serial number, date, prescriber name, and patient name (Correct answer)
NDC number, lot number, and expiration date only

Correct answer: Name and address of the dispenser, prescription serial number, date, prescriber name, and patient name

Section 503(b)(2) requires the prescription container to bear the dispenser's name/address, serial number, date of dispensing, prescriber name, and patient name.

Question 11: A caregiver picks up a new prescription for an elderly patient. The pharmacy technician at the counter completes the sale and asks, "Do you have any questions for the pharmacist today?" The caregiver replies, "No, we're all set," and leaves. Which statement best describes the pharmacy's fulfillment of its patient counseling obligations under the Omnibus Budget Reconciliation Act of 1990 (OBRA '90)?

The pharmacy's obligation was not met because counseling is mandatory for all new prescriptions and cannot be refused.
The pharmacy's obligation was met because an offer to counsel was made and subsequently refused by the patient's agent. (Correct answer)
The pharmacy's obligation was not met because the pharmacist must personally make the offer to counsel.
The pharmacy's obligation was met because the technician is a designated agent of the pharmacist for all non-clinical tasks.

Correct answer: The pharmacy's obligation was met because an offer to counsel was made and subsequently refused by the patient's agent.

Under OBRA '90, a pharmacist must make an 'offer to counsel' a patient or their agent on new prescriptions. While the counseling itself must be performed by a pharmacist, the offer can often be made by ancillary personnel like a technician. Since the caregiver, acting as the patient's agent, refused the offer, the pharmacy has met its legal obligation. Counseling is not mandatory if a patient or their agent refuses the offer.

Question 12: Under Illinois law, which of the following is a valid reason for a pharmacist to refuse to dispense a prescription?

The prescription is written by an out-of-state licensed prescriber
The prescription was phoned in rather than written
The pharmacist believes the prescription is not for a legitimate medical purpose (Correct answer)
The patient cannot provide a photo ID for a non-controlled prescription

Correct answer: The pharmacist believes the prescription is not for a legitimate medical purpose

A pharmacist has both the right and professional responsibility to refuse dispensing when there is a reasonable belief the prescription lacks a legitimate medical purpose.

Question 13: Which of the following is an acceptable method for a prescriber to communicate a new Schedule II prescription to a pharmacy?

Oral telephone order with written prescription to follow within 7 days
Unsigned fax transmitted by office staff
Text message from the prescriber's personal cell phone
Written prescription signed by the prescriber (Correct answer)

Correct answer: Written prescription signed by the prescriber

Schedule II prescriptions must be written and signed by the prescriber; oral orders are only permitted in true emergencies with a written follow-up.

Question 14: Under USP <795>, which factor does NOT influence the assigned Beyond-Use Date of a non-sterile compounded preparation?

Container-closure system used
Presence or absence of a preservative
Physical and chemical stability of the active ingredient
Geographic location of the pharmacy (Correct answer)

Correct answer: Geographic location of the pharmacy

USP <795> BUD is determined by stability data, storage conditions, container type, and preservative status, not the pharmacy's geographic location.

Question 15: Under OBRA '90, pharmacists are required to offer counseling to Medicaid patients. Which statement best describes the scope of this requirement?

Counseling must be offered verbally; written materials alone do not satisfy the requirement (Correct answer)
Counseling may be provided by technicians trained in medication information
Counseling must include the medication's cost compared to generic alternatives
Counseling is only required for new prescriptions, not refills

Correct answer: Counseling must be offered verbally; written materials alone do not satisfy the requirement

OBRA '90 requires pharmacists to offer verbal counseling to Medicaid patients; merely providing written information does not fulfill the obligation.

Question 16: Under Illinois law, what information must appear on the label of every dispensed prescription drug?

Drug name, quantity dispensed, prescriber's license number, and pharmacy's DEA registration number
Patient's date of birth, prescriber's DEA number, drug lot number, and expiration date
Patient's name, pharmacy name and address, prescriber's name, drug name and strength, directions, and date dispensed (Correct answer)
National Drug Code (NDC), drug manufacturer name, prescriber's NPI, and patient's insurance ID

Correct answer: Patient's name, pharmacy name and address, prescriber's name, drug name and strength, directions, and date dispensed

Illinois prescription labels must include patient name, pharmacy name and address, prescriber's name, drug name and strength, directions for use, and date dispensed, among other required elements.

Question 17: A pharmacy technician certification (e.g., CPhT from PTCB) is BEST described as which type of credential?

A state-issued license required to practice in all states
A credential that replaces the need for state registration
A federal DEA registration for handling controlled substances
A voluntary national certification that some states also require for registration (Correct answer)

Correct answer: A voluntary national certification that some states also require for registration

PTCB and ExCPT certifications are national voluntary credentials, though many states have incorporated them as a requirement or pathway for state technician registration.

Question 18: Drug manufacturers are required to submit expedited adverse event reports to the FDA within how many calendar days for serious and unexpected adverse drug reactions?

7 calendar days
45 calendar days
15 calendar days (Correct answer)
30 calendar days

Correct answer: 15 calendar days

Under 21 CFR 314.81, manufacturers must submit expedited safety reports to the FDA within 15 calendar days for serious and unexpected adverse drug reactions.

Question 19: Under USP <797>, what is the beyond-use date (BUD) for a low-risk compounded sterile preparation stored at controlled room temperature?

72 hours
24 hours
48 hours (Correct answer)
14 days

Correct answer: 48 hours

USP <797> assigns a 48-hour beyond-use date for low-risk CSPs stored at controlled room temperature when prepared under ISO 5 conditions.

Question 20: A DEA registrant who wishes to surrender their registration for retirement must:

Simply allow the registration to expire without renewal
Transfer all controlled substances to another registrant and submit DEA Form 104 (Correct answer)
Submit DEA Form 101 and await DEA confirmation
Notify only the state board of pharmacy

Correct answer: Transfer all controlled substances to another registrant and submit DEA Form 104

A registrant surrendering their registration must transfer inventory to another DEA registrant and submit a DEA Form 104 (Surrender for Cause) or coordinate with the DEA for voluntary surrender.

Question 21: A patient presents a valid, original paper prescription for a Schedule III controlled substance with two authorized refills. After the initial fill, the patient requests to transfer the remaining refills to a different pharmacy across town that is not part of the same chain. Assuming the pharmacies do not share a real-time, online database, how many times can this prescription be transferred?

As many times as there are refills remaining.
Only one time. (Correct answer)
It cannot be transferred as it is a Schedule III substance.
Twice.

Correct answer: Only one time.

According to 21 CFR 1306.25(a), the transfer of original prescription information for a controlled substance listed in Schedule III, IV, or V for the purpose of refill dispensing is permissible between pharmacies on a one-time basis only, unless the pharmacies electronically share a real-time, online database.

Question 22: Under the provisions of the Comprehensive Addiction and Recovery Act (CARA) amending the Controlled Substances Act, a patient may request a partial fill of a Schedule II prescription. If a partial fill is dispensed, any remaining quantity must be filled no later than:

30 days from the date the prescription was written. (Correct answer)
60 days from the date of the partial fill.
72 hours from the date the prescription was written.
7 days from the date of the partial fill.

Correct answer: 30 days from the date the prescription was written.

The Comprehensive Addiction and Recovery Act (CARA) amended the CSA to allow for partial filling of Schedule II prescriptions at the request of the patient or prescriber. The law specifies that the remaining portions of a partially filled prescription must be filled no later than 30 days after the date on which the prescription was written.

Question 23: The Drug Enforcement Administration (DEA) Form 222 is used for:

Requesting a waiver to dispense buprenorphine for OUD
Registering a new pharmacy with the DEA
Ordering Schedule I and II controlled substances (Correct answer)
Reporting theft or significant loss of controlled substances

Correct answer: Ordering Schedule I and II controlled substances

DEA Form 222 (or its electronic equivalent CSOS) is the official order form used to purchase or transfer Schedule I and II controlled substances.

Question 24: Under the Illinois Controlled Substances Act, Schedule II prescriptions must be filled within how many days of the written date to be valid?

30 days (Correct answer)
7 days
14 days
90 days

Correct answer: 30 days

Illinois requires Schedule II prescriptions to be filled within 90 days of the date written.

Question 25: A pharmacy receives a suspicious order for a controlled substance from a supplier. Under DEA regulations, the pharmacist must:

Report the order to the DEA before filling it (Correct answer)
Report it to the state board of pharmacy only
Fill the order and report it to the DEA within 72 hours
Refuse the order and immediately call the DEA hotline

Correct answer: Report the order to the DEA before filling it

DEA regulations require registrants to report suspicious orders to the DEA prior to shipping or filling them.

Question 26: A pharmacist discovers that 50 tablets of oxycodone are unaccounted for during a routine inventory. What is the FIRST required action?

Notify the state board of pharmacy within 72 hours
File DEA Form 41 within 30 days
Wait until the end of the month to complete the biennial inventory
Notify the DEA and local law enforcement immediately if theft is suspected (Correct answer)

Correct answer: Notify the DEA and local law enforcement immediately if theft is suspected

Suspected theft of controlled substances must be reported to the DEA and local law enforcement immediately upon discovery.

Question 27: Under the Hatch-Waxman Act, when a brand drug manufacturer receives a Paragraph IV certification from a generic applicant, it may:

Immediately recall the brand-name product to prevent competition
File a patent infringement lawsuit within 45 days to trigger an automatic 30-month stay of generic approval (Correct answer)
File a citizen petition that automatically blocks the generic indefinitely
Request FDA to permanently deny the generic application

Correct answer: File a patent infringement lawsuit within 45 days to trigger an automatic 30-month stay of generic approval

Filing a patent infringement suit within 45 days of receiving a Paragraph IV certification triggers an automatic 30-month stay of FDA approval of the generic, allowing time to litigate the patent dispute.

Question 28: A pharmacist discovers that a batch of hydrochlorothiazide tablets from a manufacturer was stored at an improper temperature in the pharmacy's storeroom, potentially altering the drug's efficacy and safety. The drug has not yet been dispensed. Under the Federal Food, Drug, and Cosmetic Act, this batch of medication is considered:

A counterfeit drug
Subject to a Class I recall
Misbranded
Adulterated (Correct answer)

Correct answer: Adulterated

A drug is considered adulterated if it has been held under insanitary conditions or under conditions where it may have been contaminated or rendered injurious to health. Storing a drug at an improper temperature that could affect its strength, quality, or purity meets this definition. Misbranding relates to labeling issues, counterfeit refers to fraudulent imitation, and the recall class would be determined by the FDA based on the level of hazard.

Question 29: A pharmacy receives a prescription for Schedules III–V drugs. Under federal law, this prescription may be refilled:

Never; all controlled substance prescriptions are non-refillable
As many times as the prescriber authorizes, with no federal limit
Up to 12 times within 12 months of the date issued
Up to 5 times within 6 months of the date issued (Correct answer)

Correct answer: Up to 5 times within 6 months of the date issued

Schedule III and IV prescriptions may be refilled no more than 5 times within 6 months of the issue date; Schedule V is also limited to 5 refills in 6 months under federal law.

Question 30: Under federal law, which of the following must appear on the label of a dispensed controlled substance in Schedule II?

The patient's date of birth
The quantity originally prescribed
The prescriber's DEA number
A warning that the drug is a controlled substance and has potential for abuse (Correct answer)

Correct answer: A warning that the drug is a controlled substance and has potential for abuse

Federal regulations require that Schedule II through V labels include a transfer warning and abuse potential notice as specified by the CSA.

Question 31: Under the Poison Prevention Packaging Act (PPPA), which of the following medications is EXEMPT from child-resistant packaging requirements?

Methotrexate tablets
Hydrocodone/acetaminophen tablets
Oral contraceptives dispensed in manufacturer's mnemonic packaging when the prescriber or patient requests non-CRP (Correct answer)
Warfarin sodium tablets

Correct answer: Oral contraceptives dispensed in manufacturer's mnemonic packaging when the prescriber or patient requests non-CRP

Oral contraceptives dispensed in their original mnemonic (cycle) packaging are exempt from PPPA child-resistant requirements when a waiver is requested by the patient or prescriber.

Question 32: A pharmacist receives an oral order for a Schedule II controlled substance. Under which circumstance is this permitted by federal law?

Never; all CII prescriptions must be written
In a genuine emergency when the prescriber cannot provide a written prescription (Correct answer)
When the prescriber is a DEA-registered physician and the patient is a minor
When the pharmacy's computer system is down

Correct answer: In a genuine emergency when the prescriber cannot provide a written prescription

Federal law permits oral orders for Schedule II substances only in genuine emergencies, with a written prescription to follow within 7 days.

Question 33: A pharmacist's license is revoked by the state board. The pharmacist seeks to have the revocation reversed. The appropriate first step is to:

Submit a petition to NABP for license restoration
Request a hearing before the state board or an administrative law judge (Correct answer)
Appeal directly to federal district court
File a complaint with the DEA

Correct answer: Request a hearing before the state board or an administrative law judge

Administrative due process requires the pharmacist to exhaust administrative remedies, beginning with a board hearing, before seeking judicial review.

Question 34: Under federal law, what is the minimum period that original prescription records and controlled substance inventory records must be maintained by a pharmacy?

One year
Two years (Correct answer)
Ten years
Five years

Correct answer: Two years

The Code of Federal Regulations (CFR) and the Controlled Substances Act mandate that pharmacies must maintain all records, including prescriptions and inventories, for a minimum of two years from the date of such record or inventory. State laws may require a longer retention period, and if so, the stricter law must be followed.

Question 35: Under most state pharmacy practice acts, which of the following is the MOST common continuing education requirement for pharmacist license renewal?

30 contact hours per renewal period (Correct answer)
15 contact hours per renewal period
10 contact hours per year
40 contact hours per renewal period

Correct answer: 30 contact hours per renewal period

Most states require 30 contact hours (3 CEUs) of continuing pharmacy education per renewal period, typically every two years, consistent with ACPE standards.

Question 36: Which of the following is a primary reason the FDA has listed certain drug products on the 503A 'Demonstrably Difficult to Compound' list?

They are controlled substances subject to DEA quotas
The drugs are widely available commercially, so compounding provides no advantage
Compounding these products presents risks that cannot be adequately mitigated in a pharmacy setting (Correct answer)
The raw materials are too expensive to obtain through licensed suppliers

Correct answer: Compounding these products presents risks that cannot be adequately mitigated in a pharmacy setting

The 'demonstrably difficult to compound' designation reflects FDA's finding that safe preparation cannot be reliably achieved in a compounding pharmacy environment.

Question 37: Which piece of information must a DEA Form 222 contain when ordering Schedule I or II controlled substances?

The patient's insurance information
The name, address, and DEA registration number of the purchaser (Correct answer)
The wholesale acquisition cost of the drug
The lot number of the controlled substance

Correct answer: The name, address, and DEA registration number of the purchaser

DEA Form 222 must include the name, address, and DEA registration number of the purchaser to ensure proper accountability in the controlled substance ordering process.

Question 38: Under the Model State Pharmacy Act, who holds ultimate responsibility for the legal operation of a pharmacy?

The pharmacy owner or permit holder
The DEA field office supervisor
The state board of pharmacy inspector
The pharmacist-in-charge (PIC) (Correct answer)

Correct answer: The pharmacist-in-charge (PIC)

The pharmacist-in-charge is legally responsible for the day-to-day compliance, operations, and professional standards of the pharmacy under most state acts.

Question 39: A pharmacist discovers that a dispensed prescription contained the wrong drug. Under federal regulations, which action is MOST critical as an immediate next step?

Restock the correct drug and continue dispensing
Shred the original prescription to avoid liability
Notify the patient and prescriber and document the medication error (Correct answer)
Wait to see if the patient reports adverse effects

Correct answer: Notify the patient and prescriber and document the medication error

Patient safety requires immediately notifying the patient and prescriber of a dispensing error and documenting the incident to allow for appropriate clinical management and error reporting.

Question 40: Which of the following best describes a 'new animal drug' requiring FDA approval under the FD&C Act?

Any antibiotic used in livestock feed operations
Any drug intended for use in animals not generally recognized as safe and effective (Correct answer)
Any drug derived from natural sources used in animals
Any OTC veterinary product not previously marketed

Correct answer: Any drug intended for use in animals not generally recognized as safe and effective

A new animal drug is one not generally recognized as safe and effective (GRASE) for its intended animal use and requires an approved NADA.

Question 41: Which of the following practitioner types is NOT eligible to obtain a DEA registration to prescribe Schedule II–V controlled substances?

Veterinarian
Nurse practitioner with prescriptive authority
Dentist
Pharmacist filling prescriptions (Correct answer)

Correct answer: Pharmacist filling prescriptions

Pharmacists dispense controlled substances under the pharmacy's DEA registration; they do not obtain individual prescriber DEA registrations.

Question 42: The Orange Book (Approved Drug Products with Therapeutic Equivalence Evaluations) is used to determine:

Maximum allowable quantities for controlled substance dispensing
Drug pricing benchmarks for Medicare Part D
Recommended storage conditions for temperature-sensitive drugs
Therapeutic equivalence ratings for generic drug substitution (Correct answer)

Correct answer: Therapeutic equivalence ratings for generic drug substitution

The Orange Book provides FDA therapeutic equivalence ratings (e.g., AB-rated) used to guide generic substitution decisions.

Question 43: A patient presents a prescription for amoxicillin 500 mg #30. The pharmacist has only 250 mg capsules in stock. Which action is most appropriate?

Dispense the 250 mg strength without altering the directions.
Refuse to fill and refer the patient to another pharmacy.
Dispense 60 capsules of 250 mg with directions to take 2 capsules per dose and notify the prescriber. (Correct answer)
Dispense the 30 capsules of 250 mg and tell the patient to return for the rest.

Correct answer: Dispense 60 capsules of 250 mg with directions to take 2 capsules per dose and notify the prescriber.

A pharmacist may make a therapeutic equivalent substitution in strength by adjusting quantity and directions after notifying the prescriber, as it constitutes the same drug.

Question 44: Which of the following pharmacy personnel may legally counsel a patient on the proper use of a new prescription medication?

A pharmacy intern under supervision is prohibited from counseling
A certified pharmacy technician with 5 years of experience
Any pharmacy employee who has completed a counseling training course
A licensed pharmacist (Correct answer)

Correct answer: A licensed pharmacist

Patient counseling on prescription medications is a professional act that must be performed by a licensed pharmacist.

Question 45: Which of the following is NOT required on a prescription label for a controlled substance dispensed in the US?

Patient's full address
Date of dispensing
Directions for use
Pharmacy's DEA number (Correct answer)

Correct answer: Pharmacy's DEA number

The pharmacy's DEA registration number is not required on the prescription label; it appears on the pharmacy's DEA registration certificate but not on individual labels.

Question 46: When can items from Schedule 1 be used?

‥ Patient address ‥ Drug strength ‥ Drug quantity ‥ Directions for use
No not even for destruction
Medically under an investigational protocol (Correct answer)
Five refills or 6 months

Correct answer: Medically under an investigational protocol

Schedule I substances have no accepted medical use and high abuse potential, so they can only be used medically under an approved investigational research protocol. They are not available for routine prescribing or refills, which is why the other options are incorrect.

Question 47: What FDA publication identifies which generic drug products are therapeutically equivalent to their brand-name counterparts?

The Blue Book
The Red Book
The Green Book
The Orange Book (Correct answer)

Correct answer: The Orange Book

The Orange Book (Approved Drug Products with Therapeutic Equivalence Evaluations) is the FDA publication that identifies therapeutically equivalent generic drug products.

Question 48: Under the iPLEDGE REMS program, females of childbearing potential must use how many forms of contraception and obtain monthly pregnancy tests for how long before receiving isotretinoin?

One form of contraception; no pregnancy test required
Two forms of contraception; monthly negative pregnancy tests required throughout therapy (Correct answer)
No contraception required if patient is unmarried
One form of contraception; one pregnancy test before starting only

Correct answer: Two forms of contraception; monthly negative pregnancy tests required throughout therapy

iPLEDGE requires females of childbearing potential to use two forms of contraception simultaneously and obtain a negative pregnancy test each month before a prescription can be dispensed.

Question 49: Which of the following scenarios would MOST likely trigger a mandatory report to the state board of pharmacy?

A pharmacist is convicted of a drug-related felony (Correct answer)
A pharmacy hires a new technician
A pharmacist changes their home address
A pharmacist takes a vacation for two weeks

Correct answer: A pharmacist is convicted of a drug-related felony

A felony conviction, especially drug-related, triggers mandatory self-reporting obligations to the board of pharmacy in virtually every U.S. state.

Question 50: Which of the following scenarios represents an impermissible disclosure under HIPAA without patient authorization?

Releasing medication records to a patient's attorney without the patient's authorization (Correct answer)
Providing minimum necessary information for insurance billing purposes
Sharing prescription information with another treating provider for care coordination
Disclosing information to public health authorities for disease surveillance

Correct answer: Releasing medication records to a patient's attorney without the patient's authorization

Disclosing PHI to a patient's attorney is not within the treatment, payment, or operations exceptions and requires explicit patient authorization.

Question 51: Under FDA regulations, a Risk Evaluation and Mitigation Strategy (REMS) with Elements to Assure Safe Use (ETASU) may require which of the following?

A mandatory generic substitution program
DEA co-signature on all prescriptions
Dispensing only through certified pharmacies or healthcare settings (Correct answer)
Monthly urine drug screening of all patients

Correct answer: Dispensing only through certified pharmacies or healthcare settings

REMS with ETASU can restrict distribution to certified pharmacies or healthcare settings to manage serious drug risks.

Question 52: Which FD&C Act provision requires manufacturers to report serious and unexpected adverse drug experiences to the FDA?

Postmarket safety reporting requirements (21 CFR Part 314) (Correct answer)
The Drug Listing Act
The Poison Prevention Packaging Act
The Prescription Drug User Fee Act (PDUFA)

Correct answer: Postmarket safety reporting requirements (21 CFR Part 314)

Post-approval safety reporting regulations (implementing FD&C Act Section 505) require NDA holders to submit expedited and periodic reports of serious and unexpected adverse drug experiences.

Question 53: Which of the following describes the NABP's Pharmacist Licensure Compact (PLC)?

A DEA reciprocal registration program for Schedule II prescribing
A multi-state agreement allowing eligible pharmacists to obtain licensure privileges in member states (Correct answer)
A NABP program replacing the MPJE with a single national law exam
A federal law allowing pharmacists to practice in all 50 states with one license

Correct answer: A multi-state agreement allowing eligible pharmacists to obtain licensure privileges in member states

The Pharmacist Licensure Compact is a voluntary interstate compact allowing eligible licensed pharmacists to obtain practice privileges in other member states without full re-licensure.

Question 54: A Schedule III controlled substance prescription may be refilled up to how many times within 6 months of the date issued?

2 times
3 times
5 times (Correct answer)
6 times

Correct answer: 5 times

Schedule III and IV controlled substance prescriptions may be refilled up to 5 times within 6 months of the date issued.

Question 55: A pharmacist has been licensed and practicing in State A for 10 years. They wish to obtain a license to practice in State B through licensure transfer (reciprocity). They have already passed the NAPLEX. Which of the following will MOST LIKELY be required by the State B Board of Pharmacy?

Retaking the NAPLEX because more than two years have passed.
Providing proof of residency in State B for at least one year.
Completing a new 1,500-hour internship in State B.
Passing the Multistate Pharmacy Jurisprudence Examination (MPJE) for State B. (Correct answer)

Correct answer: Passing the Multistate Pharmacy Jurisprudence Examination (MPJE) for State B.

Licensure transfer (reciprocity) allows a pharmacist licensed in one state to obtain a license in another. While the NAPLEX score is transferable, the new state needs to ensure the pharmacist knows its specific laws and regulations. Therefore, passing the MPJE for the new state (State B) is a standard and near-universal requirement. Retaking the NAPLEX or completing a new internship is typically not required for an actively practicing pharmacist, and residency is not a condition for licensure.

Question 56: What is the name of a drug created primarily to address a rare medical condition?

Orphan drug (Correct answer)
Type 3 drug
Targeted drug
Type N drug
Subsidized drug

Correct answer: Orphan drug

Orphan medications are prescribed for uncommon disorders affecting fewer than 200,000 Americans—the Orphan Drug Act of 1983 aims to motivate businesses to provide medicines for specific illnesses.

Question 57: A pharmacist receives a prescription for hydrocodone/acetaminophen 5/325 mg. Under the CSA, this combination product is classified as:

Schedule V
Schedule III
Schedule IV
Schedule II (Correct answer)

Correct answer: Schedule II

In 2014, the DEA reclassified all hydrocodone combination products from Schedule III to Schedule II.

Question 58: A patient requests that all of their prescriptions be dispensed in non-child-resistant containers. Which of the following is the correct procedure?

The pharmacist must deny the request to protect public safety
A physician must authorize the request in writing
A pharmacist supervisor must approve each such request
The pharmacist may comply with a signed patient request on file (Correct answer)

Correct answer: The pharmacist may comply with a signed patient request on file

Under PPPA, adult patients may waive child-resistant packaging for their own prescriptions with a signed request maintained on file.

Question 59: A patient requests an emergency oral Schedule II prescription. Under federal law, the pharmacist may dispense the emergency supply if the prescriber provides a written prescription within how many days?

5 days
7 days (Correct answer)
10 days
3 days

Correct answer: 7 days

DEA regulations require the prescribing practitioner to furnish a written Schedule II prescription to the pharmacist within 7 days of authorizing an emergency oral prescription.

Question 60: A drug product is recalled because it was found to contain glass particles. This is classified as a Class __ recall by FDA.

Class II
Class IV
Class I (Correct answer)
Class III

Correct answer: Class I

Class I recall involves a situation where use of or exposure to the product will cause serious adverse health consequences or death.

Question 61: Under the Ryan Haight Online Pharmacy Consumer Protection Act, prescribing a controlled substance via telemedicine generally requires:

Prior DEA special registration only
At least one in-person medical evaluation of the patient before the prescription is issued (Correct answer)
Written consent from the patient's state insurance plan
A minimum of three prior prescriptions from a brick-and-mortar pharmacy

Correct answer: At least one in-person medical evaluation of the patient before the prescription is issued

The Ryan Haight Act requires that a valid patient-prescriber relationship, including at least one in-person evaluation, exist before controlled substances may be prescribed via the internet.

Question 62: In a community pharmacy, which of the following activities can be legally performed by an unlicensed pharmacy clerk or cashier with no technician registration?

Clarifying the spelling of a patient's last name with the prescriber's office over the phone.
Asking a patient if they have any questions for the pharmacist when they pick up a prescription. (Correct answer)
Returning a bottle of medication to the stock shelf after it was returned to stock.
Entering new prescription information from a written script into the computer system.

Correct answer: Asking a patient if they have any questions for the pharmacist when they pick up a prescription.

The role of unlicensed personnel is strictly non-technical and non-professional; they may perform clerical duties. Asking a patient if they have questions for the pharmacist is a required part of the transaction process (the "offer to counsel") and does not require a license. Entering prescription data, handling stock medication, and communicating with a prescriber's office about prescription details are all functions reserved for licensed or registered personnel (pharmacists, interns, or technicians) under pharmacist supervision.

Question 63: A pharmacy uses a three-file system for its hardcopy prescriptions. A pharmacist receives new prescriptions for oxycodone (Schedule II), alprazolam (Schedule IV), and lisinopril (non-controlled). How must these prescriptions be filed to comply with federal law?

Oxycodone in file one; alprazolam and lisinopril together in file two.
Oxycodone in file one; alprazolam in file two; lisinopril in file three. (Correct answer)
Oxycodone and alprazolam together in file one; lisinopril in file two.
All three prescriptions can be filed together in one file as long as the controlled substance prescriptions are marked with a red 'C'.

Correct answer: Oxycodone in file one; alprazolam in file two; lisinopril in file three.

Federal law allows for either a two-file or three-file system for paper prescriptions. In a three-file system, Schedule II prescriptions are filed alone, Schedule III-V prescriptions are in a second file, and non-controlled prescriptions are in a third file.

Question 64: A pharmacist is employed at two different pharmacies owned by two different corporations. Which of the following is true regarding their DEA registration?

The pharmacist does not need a personal DEA registration; each pharmacy holds its own (Correct answer)
The pharmacist must hold separate DEA registrations for each employer
A DEA waiver is required to work at multiple locations
One DEA registration covers all employment locations for an individual pharmacist

Correct answer: The pharmacist does not need a personal DEA registration; each pharmacy holds its own

Individual pharmacists do not hold DEA registrations; the pharmacy entity holds the registration, so multiple employers each have their own.

Question 65: What location should ephedrine products be kept in?

(behind the pharmacy counter). If convenience packages are sold by retailers they must be displayed behind the store counter or in a locked case (Correct answer)
‥ Citizenship ‥ Completion of 400 hours of apprenticeship ‥ Board exam of 75% ‥ Graduation from an accredited program
‥ The first four are the manufacturer ‥ The second four are the drug identifier ‥ The last 2 are the package identifier
It is only 30 milliliters and contains warnings that its only for emergencies from poisonings and other warnings about how to use it

Correct answer: (behind the pharmacy counter). If convenience packages are sold by retailers they must be displayed behind the store counter or in a locked case

The placement of ephedrine products can vary depending on the regulations and policies of different countries and regions. However, in many places, ephedrine products are considered controlled substances due to their potential for misuse and abuse. As a result, they are often subject to stricter regulations and may require specific placement measures.

Question 66: A pharmacy student who has not yet graduated but is enrolled in an ACPE-accredited pharmacy program may obtain which credential to gain supervised practice experience?

A temporary pharmacist permit
A student practitioner DEA registration
A pharmacy intern registration (Correct answer)
A limited pharmacy technician certification

Correct answer: A pharmacy intern registration

Students enrolled in ACPE-accredited pharmacy programs apply to their state board of pharmacy for an intern registration that allows them to practice under pharmacist supervision.

Question 67: A pharmacist suspects that a prescription for oxycodone was forged. Which action is most appropriate?

Return the prescription to the patient and advise them to see another pharmacy
Dispense a partial quantity while verifying the prescription's authenticity
Dispense the prescription if the patient has a valid ID and appears legitimate
Refuse to dispense, retain the prescription if safe to do so, and notify law enforcement or the prescriber (Correct answer)

Correct answer: Refuse to dispense, retain the prescription if safe to do so, and notify law enforcement or the prescriber

When a controlled substance prescription is suspected to be forged, the pharmacist should refuse to fill it, retain the prescription if possible, and report to the prescriber and/or law enforcement.

Question 68: An Illinois pharmacy dispenses a generic drug when the prescriber wrote 'brand medically necessary' on the prescription. Which statement is correct?

The pharmacist may substitute a generic and notify the prescriber within 48 hours
Generic substitution requires prescriber verbal approval but not written notation
The pharmacist may still substitute a generic if it costs less for the patient
The pharmacist must dispense the brand as written and may not substitute (Correct answer)

Correct answer: The pharmacist must dispense the brand as written and may not substitute

When a prescriber indicates 'brand medically necessary' (or equivalent language) in Illinois, the pharmacist must dispense the brand-name drug and may not substitute a generic.

Question 69: A pharmacy intern, under the direct supervision of a licensed pharmacist, receives a new verbal prescription over the phone from a prescriber's office. The supervising pharmacist is busy counseling another patient but is physically present in the pharmacy. According to most state pharmacy laws, which action is the intern permitted to perform?

Independently transfer a copy of the prescription to another pharmacy.
Transcribe the verbal order to writing and perform the final verification of the filled prescription.
Transcribe the verbal order to writing for the pharmacist's final verification. (Correct answer)
Counsel the patient on the new medication without the pharmacist's final approval.

Correct answer: Transcribe the verbal order to writing for the pharmacist's final verification.

Pharmacy interns are authorized to perform many pharmacist functions, but only under the direct supervision of a licensed pharmacist. This generally includes transcribing new verbal orders. However, the final verification of a prescription and patient counseling are ultimate responsibilities of the pharmacist. Transferring prescriptions often has specific rules that may restrict intern involvement or require more direct pharmacist action. Therefore, transcribing the order for the pharmacist's review and final verification is the appropriate and legally permissible action.

Question 70: A Schedule V cough preparation containing less than 200 mg of codeine per 100 mL may be sold OTC in states that permit it under which condition?

Without any pharmacist involvement or record-keeping requirement
Only with a written prescription from a physician
Only to patients over age 18 with a valid photo ID and no log required
By a pharmacist or pharmacy intern only, with a log entry of the purchaser's name and address (Correct answer)

Correct answer: By a pharmacist or pharmacy intern only, with a log entry of the purchaser's name and address

Federal law allows OTC sale of Schedule V exempt preparations only by a pharmacist or intern, and requires maintaining a bound log with purchaser information.

Question 71: In Illinois, a pharmacist who receives an oral prescription for a Schedule III controlled substance must reduce it to writing within how many hours?

48 hours
12 hours
72 hours (Correct answer)
24 hours

Correct answer: 72 hours

Illinois law requires that oral Schedule III controlled substance prescriptions be reduced to writing within 72 hours.

Question 72: What is the maximum validity period for a Schedule V prescription under federal law?

6 months (Correct answer)
18 months
12 months
There is no federal expiration limit for Schedule V prescriptions

Correct answer: 6 months

Schedule V prescriptions, like Schedules III and IV, are valid for refills for up to 6 months from the date issued.

Question 73: Under Illinois law, how soon must a pharmacist provide patient counseling after a patient's first fill of a new prescription?

Counseling is only required for controlled substances
Counseling is mandatory for new prescriptions unless the patient declines (Correct answer)
At every dispensing encounter
Before dispensing upon patient request only

Correct answer: Counseling is mandatory for new prescriptions unless the patient declines

Illinois law requires pharmacists to offer counseling on new prescriptions; the pharmacist must document if the patient declines.

Question 74: A pharmacist receives an oral prescription for a Schedule III controlled substance from a physician. Which action is required?

Require a written order before dispensing.
Fill the prescription but note DEA must be notified within 7 days.
Reduce the oral order to writing and dispense. (Correct answer)
Refuse to fill; oral orders are prohibited for all controlled substances.

Correct answer: Reduce the oral order to writing and dispense.

Schedule III–V controlled substances may be prescribed orally, but the pharmacist must promptly reduce the order to writing.

Question 75: Which of the following best defines 'adulteration' of a drug product under the FD&C Act?

Dispensing a drug without a valid prescription
Selling a drug without FDA approval
Marketing a drug for an unapproved indication
A product that fails to meet established quality, strength, or purity standards (Correct answer)

Correct answer: A product that fails to meet established quality, strength, or purity standards

Under the FD&C Act, adulteration refers to a drug that does not meet quality, strength, purity, or composition standards.

Question 76: Which of the following is a pharmacist's obligation when detecting a potential drug-drug interaction on a new prescription during prospective DUR?

Refuse to fill the prescription and require the prescriber to rewrite it
Automatically substitute a safer therapeutic alternative without prescriber consultation
Evaluate the clinical significance, contact the prescriber if warranted, and counsel the patient appropriately (Correct answer)
Dispense as written since the prescriber assumes full responsibility

Correct answer: Evaluate the clinical significance, contact the prescriber if warranted, and counsel the patient appropriately

Prospective DUR requires pharmacists to evaluate interaction severity, use professional judgment about prescriber contact, and ensure patients receive appropriate counseling.

Question 77: The 'closed system' of distribution established by the CSA is designed to:

Require all prescriptions to be filled within 24 hours
Limit the number of pharmacies that can dispense controlled substances
Prohibit importation of controlled substances from other countries
Track controlled substances from manufacture to dispensing to prevent diversion (Correct answer)

Correct answer: Track controlled substances from manufacture to dispensing to prevent diversion

The CSA's closed system creates a chain of accountability from manufacturer to patient to prevent diversion of controlled substances.

Question 78: Under the Controlled Substances Act, a pharmacist may dispense a Schedule III controlled substance with a verbal (oral) prescription. Within how many days must the oral prescription be reduced to writing?

48 hours
72 hours
24 hours
7 days (Correct answer)

Correct answer: 7 days

Federal law requires that oral prescriptions for Schedule III and IV controlled substances be promptly reduced to writing, generally documented within 7 days.

Question 79: Which of the following best describes a pharmacist's 'corresponding responsibility' for controlled substance prescriptions?

The pharmacist must confirm the diagnosis before dispensing any Schedule II medication
The pharmacist shares legal responsibility with the prescriber for ensuring a controlled substance prescription is issued for a legitimate medical purpose (Correct answer)
The pharmacist must co-sign all Schedule II prescriptions to accept responsibility for dispensing
The pharmacist is responsible for billing the correct insurance for controlled substance dispensing

Correct answer: The pharmacist shares legal responsibility with the prescriber for ensuring a controlled substance prescription is issued for a legitimate medical purpose

Under 21 CFR 1306.04, both the prescriber and the pharmacist share corresponding responsibility for ensuring a controlled substance prescription serves a legitimate medical purpose.

Question 80: A pharmacist receives a verbal order for a Schedule III controlled substance. How many days does the prescriber have to provide a written follow-up?

48 hours
5 days
7 days (Correct answer)
10 days

Correct answer: 7 days

For Schedule III–V controlled substances received verbally, the prescriber must provide a written or electronic prescription within 7 days.

Question 81: Under the Ryan Haight Online Pharmacy Consumer Protection Act, a practitioner may not prescribe a controlled substance via telemedicine unless:

The patient is physically located in the same state as the prescriber
The patient is enrolled in a certified telehealth program
The practitioner has conducted at least one in-person medical evaluation of the patient (Correct answer)
The prescription is limited to Schedule IV or V substances only

Correct answer: The practitioner has conducted at least one in-person medical evaluation of the patient

The Ryan Haight Act generally requires at least one in-person medical evaluation before prescribing controlled substances via telemedicine.

Question 82: When is a pharmacist generally NOT permitted to substitute a generic drug product?

When the prescriber has written 'Dispense as Written' or equivalent restrictive language (Correct answer)
When the generic drug costs significantly less than the brand-name product
When the patient has a valid insurance prior authorization on file
When the drug appears on the payer's formulary preferred drug list

Correct answer: When the prescriber has written 'Dispense as Written' or equivalent restrictive language

A pharmacist cannot substitute a generic when the prescriber has restricted substitution through 'Dispense as Written,' 'Brand Medically Necessary,' or equivalent notation, as prescriber authority overrides state substitution laws.

Question 83: A pharmacist suspects a patient is obtaining controlled substances fraudulently. Under the CSA, the pharmacist's corresponding responsibility means:

The pharmacist must dispense all valid-appearing prescriptions regardless of suspicion
The pharmacist shares responsibility for the proper prescribing and dispensing of controlled substances (Correct answer)
The pharmacist is only responsible for verifying the prescriber's DEA number
The pharmacist must report suspicions to the DEA before refusing to fill

Correct answer: The pharmacist shares responsibility for the proper prescribing and dispensing of controlled substances

The corresponding responsibility doctrine holds pharmacists equally responsible with prescribers for ensuring controlled substances are dispensed for a legitimate medical purpose.

Question 84: A patient counseling session should include information about what to do if a dose is missed. Under MPJE standards, this counseling element falls under:

Storage and disposal information
Drug-disease interactions
Instructions for use of the medication (Correct answer)
Common adverse effects

Correct answer: Instructions for use of the medication

Instructions for use, including missed-dose procedures, are a core counseling element under OBRA '90 and state pharmacy practice standards.

Question 85: Under the FD&C Act, what is the maximum penalty for a first-offense misdemeanor violation?

3 years imprisonment and/or $10,000 fine
1 year imprisonment and/or $1,000 fine (Correct answer)
5 years imprisonment and/or $50,000 fine
10 years imprisonment and/or $100,000 fine

Correct answer: 1 year imprisonment and/or $1,000 fine

A first-offense misdemeanor under the FD&C Act carries up to 1 year imprisonment and/or a $1,000 fine.

Question 86: A pharmacist receives a drug sample that is not labeled with an expiration date. Under the FD&C Act, this product is considered:

Investigational
Counterfeit
Misbranded (Correct answer)
Adulterated

Correct answer: Misbranded

Failure to include an expiration date on drug labeling violates FD&C Act labeling requirements, making the product misbranded.

Question 87: A pharmacist working at a hospital is asked to also manage a retail pharmacy kiosk in another building on the same campus under a single DEA registration. This arrangement is:

Generally not permissible; each pharmacy location requires its own DEA registration (Correct answer)
Allowed as long as the pharmacist is physically present at one location at all times
Permitted only for non-controlled substance dispensing at the kiosk
Permissible if both locations are under the same hospital license

Correct answer: Generally not permissible; each pharmacy location requires its own DEA registration

Each pharmacy location must have its own DEA registration; a single registration cannot cover multiple separate dispensing locations.

Question 88: When a pharmacist-in-charge (PIC) resigns, which action must typically occur under state law?

A new PIC must be designated and reported to the board within a specified timeframe (Correct answer)
The DEA registration is immediately revoked
The pharmacy license is automatically transferred to the next senior pharmacist
The pharmacy may continue operating indefinitely without a PIC

Correct answer: A new PIC must be designated and reported to the board within a specified timeframe

State pharmacy laws generally require that a new PIC be designated and the board be notified within a specific period (commonly 30 days) to maintain the pharmacy's operating permit.

Question 89: Under the FD&C Act, which of the following is the correct definition of 'adulterated' as applied to a drug?

The drug contains a filthy or decomposed substance rendering it unfit for use (Correct answer)
The drug is sold without a valid prescription
The drug's expiration date has passed
The drug's labeling is false or misleading

Correct answer: The drug contains a filthy or decomposed substance rendering it unfit for use

Under the FD&C Act, a drug is adulterated if it consists in whole or in part of any filthy, putrid, or decomposed substance, or if it has been prepared under unsanitary conditions.

Question 90: Keep out of children's reach.

Illinois requires an additional state controlled substance license with the following requirements
The pharmacist can be the PIC at mutiple stores as long as they work how many hours per week at each location
What is the fine for not reporting schedule medications to the online prescription drug monitoring program
Over the counter products containing salicylates must have this warning (excluding para aminosalycilate and effervesscent preparations) (Correct answer)

Correct answer: Over the counter products containing salicylates must have this warning (excluding para aminosalycilate and effervesscent preparations)

The warning "Keep out of children's reach" is commonly included on the packaging or labeling of over-the-counter products containing salicylates. Salicylates are a class of medications that include substances like aspirin (acetylsalicylic acid) and its derivatives. While salicylates can be used for various purposes, including pain relief and fever reduction, they can also pose risks if consumed inappropriately or in excessive amounts, especially in children.

Question 91: A mid-level practitioner (NP) wishes to prescribe Schedule III controlled substances. Under the CSA, which statement is TRUE?

Mid-level practitioners may prescribe controlled substances if authorized by state law and registered with the DEA (Correct answer)
Mid-level practitioners may never prescribe controlled substances under federal law
Mid-level practitioners may prescribe only Schedule IV and V substances
Mid-level practitioners must co-sign prescriptions with a supervising physician

Correct answer: Mid-level practitioners may prescribe controlled substances if authorized by state law and registered with the DEA

Mid-level practitioners (NPs, PAs, etc.) may obtain DEA registration and prescribe controlled substances if their state law grants them that authority.

Question 92: A patient requests a 90-day supply of a Schedule III medication. The prescription was written for 30 days. What is the maximum number of refills permitted?

Unlimited refills within 6 months
No refills are allowed for Schedule III
2 refills
5 refills (Correct answer)

Correct answer: 5 refills

Schedule III and IV controlled substances may be refilled up to 5 times within 6 months of the date issued.

Question 93: Which of the following actions requires a pharmacist's professional judgment and CANNOT be delegated to a pharmacy technician?

Performing the final verification of a dispensed prescription (Correct answer)
Counting tablets for a prescription
Entering prescription data into the dispensing system
Affixing labels to prescription containers

Correct answer: Performing the final verification of a dispensed prescription

Final prescription verification—the clinical check ensuring accuracy, appropriateness, and safety—is a pharmacist-only function and cannot be delegated to technicians.

Question 94: Which of the following is NOT a required element of patient counseling under OBRA '90 for new prescriptions?

The price comparison with generic alternatives (Correct answer)
Common severe side effects and interactions
Name and description of the medication
Proper storage of the medication

Correct answer: The price comparison with generic alternatives

OBRA '90 mandates counseling on drug name, indication, side effects, interactions, storage, and monitoring, but does not require price comparisons.

Question 95: The 'corresponding responsibility' doctrine under federal controlled substance law holds that:

Prescribers bear sole legal liability for illegitimate prescriptions
Manufacturers are responsible for all downstream drug diversion
DEA must investigate every suspicious order before a pharmacy can dispense
A pharmacist shares responsibility for ensuring a controlled substance prescription is issued for a legitimate medical purpose (Correct answer)

Correct answer: A pharmacist shares responsibility for ensuring a controlled substance prescription is issued for a legitimate medical purpose

Corresponding responsibility means a pharmacist who knowingly fills an illegitimate controlled substance prescription shares legal liability with the prescriber.

Question 96: A pharmacist is discussing a patient's sensitive diagnosis and complex medication history with a pharmacy technician in the breakroom. The technician was not involved in preparing this specific patient's prescription. Which HIPAA principle is most directly violated in this scenario?

The Patient's Right to Access.
The Minimum Necessary Standard. (Correct answer)
The Notice of Privacy Practices.
The Breach Notification Rule.

Correct answer: The Minimum Necessary Standard.

The HIPAA Minimum Necessary Standard requires that workforce members only access, use, or disclose the minimum amount of PHI needed to perform their job duties. Since the technician was not involved with the patient's prescription, there was no job-related need for them to know the details of the patient's PHI. Discussing this information, even in a private breakroom, constitutes an unnecessary disclosure and violates this core principle.

Question 97: Under the Illinois Controlled Substances Act, which of the following is classified as a Schedule I substance?

Heroin (diacetylmorphine) (Correct answer)
Tramadol
Hydrocodone
Alprazolam

Correct answer: Heroin (diacetylmorphine)

Heroin (diacetylmorphine) is classified as a Schedule I controlled substance under both the Illinois Controlled Substances Act and federal law.

Question 98: Which of the following BEST describes a pharmacist's 'corresponding responsibility' under the CSA?

The requirement to correspond with insurance companies before dispensing controlled substances
The shared responsibility with the prescriber to ensure a controlled substance prescription is issued for a legitimate medical purpose (Correct answer)
The obligation to match every prescription against a patient's medication history
The duty to report all Schedule II prescriptions to the DEA monthly

Correct answer: The shared responsibility with the prescriber to ensure a controlled substance prescription is issued for a legitimate medical purpose

The CSA's corresponding responsibility doctrine holds pharmacists jointly responsible with prescribers for ensuring controlled substance prescriptions are for legitimate medical purposes.

Question 99: Which DEA form is required for a pharmacy to order Schedule II controlled substances like fentanyl and methylphenidate from a distributor?

DEA Form 222 (Correct answer)
DEA Form 224
DEA Form 106
DEA Form 41

Correct answer: DEA Form 222

DEA Form 222 is the official order form for Schedule I and II controlled substances. A pharmacy must use this form (or its electronic equivalent, CSOS) to purchase these substances. DEA Form 41 is for disposal, Form 106 is for reporting theft or loss, and Form 224 is the registration application for pharmacies.

Question 100: Under the Illinois Pharmacy Practice Act, a pharmacist's license renewal period is how long?

4 years
2 years (Correct answer)
1 year
3 years

Correct answer: 2 years

Illinois pharmacist licenses are renewed on a 2-year cycle, with renewal deadlines determined by the IDFPR.

Question 101: A prescription written with a brand name followed by the notation 'or equivalent' indicates:

The pharmacist may dispense a therapeutically equivalent generic product (Correct answer)
The pharmacist must dispense the brand-name drug as written
The prescriber will contact the pharmacy to confirm the final product selected
The patient must approve any substitution in writing before it is made

Correct answer: The pharmacist may dispense a therapeutically equivalent generic product

When a prescriber writes 'or equivalent,' it constitutes explicit consent for the pharmacist to substitute a therapeutically equivalent product as listed in the Orange Book.

Question 102: A pharmacy wants to implement central recordkeeping for certain documents to save space at the registered location. Which of the following records MUST be maintained on-site at the pharmacy and cannot be stored at a central location?

Shipping and financial records
All prescription records older than one year
Unused DEA Form 222s
Executed DEA Form 222s, prescriptions, and inventory records (Correct answer)

Correct answer: Executed DEA Form 222s, prescriptions, and inventory records

Federal regulations allow pharmacies to store certain records, such as shipping and financial data, at a central location after notifying the DEA. However, executed DEA Form 222s, all prescriptions, and all inventory records must be kept at the registered pharmacy location and cannot be moved to a central recordkeeping site.

Question 103: Under the Omnibus Budget Reconciliation Act of 1990 (OBRA-90), which of the following is a required component of a pharmacist's prospective drug review for Medicaid patients?

Mandatory consultation with the prescriber before dispensing any new medication
Evaluation for therapeutic duplication, drug-disease contraindications, and incorrect dosage (Correct answer)
Review of the patient's credit history for billing purposes
Verification of the patient's insurance eligibility

Correct answer: Evaluation for therapeutic duplication, drug-disease contraindications, and incorrect dosage

OBRA-90 requires pharmacists to conduct prospective drug use review including screening for therapeutic duplication, drug-disease contraindications, incorrect dosage, and drug interactions.

Question 104: Which HIPAA provision specifically allows a pharmacist to discuss a patient's prescription information with the patient's adult child who is present at the counter?

The patient's implied authorization based on the circumstances (Correct answer)
The incidental disclosure allowance
The minimum necessary standard
The treatment, payment, and operations exception

Correct answer: The patient's implied authorization based on the circumstances

HIPAA allows disclosure when a patient's conduct implies authorization, such as bringing a family member to the pharmacy counter.

Question 105: Under the CSA, how long must a retail pharmacy retain records for Schedule II controlled substances?

5 years
3 years
1 year
2 years (Correct answer)

Correct answer: 2 years

The CSA requires that records for controlled substances be maintained for a minimum of 2 years from the date of the record.

Question 106: Under the CSA, a DEA registrant must conduct a biennial inventory of all controlled substances. When must this inventory be taken?

On the anniversary date of initial DEA registration
Every January 1st and July 1st
Within 30 days of any change in pharmacy ownership
Exactly every 2 years from the date of the previous inventory, at opening or closing of business (Correct answer)

Correct answer: Exactly every 2 years from the date of the previous inventory, at opening or closing of business

A biennial inventory must be taken every two years from the date of the prior inventory, either at the opening or close of business on that date.

Question 107: Under the FD&C Act, which term describes a drug whose labeling fails to bear required warnings?

Unapproved
Counterfeit
Misbranded (Correct answer)
Adulterated

Correct answer: Misbranded

A drug is misbranded if its labeling is false or misleading or omits required information such as warnings.

Question 108: Which of the following statements about transferring a Schedule III controlled substance prescription between pharmacies is correct?

Schedule III prescriptions may be transferred only within the same pharmacy chain
Schedule III prescriptions may never be transferred between pharmacies
Schedule III prescriptions may be transferred an unlimited number of times within the authorized refills
Schedule III prescriptions may be transferred only once between pharmacies (Correct answer)

Correct answer: Schedule III prescriptions may be transferred only once between pharmacies

Federal law allows Schedule III–V prescriptions to be transferred between pharmacies only once, unless the pharmacies share a real-time electronic database allowing multiple transfers.

Question 109: A pharmacy technician provides medication information to a patient waiting for a prescription. This practice is:

Acceptable if the technician has completed a certified training program
Generally considered practicing pharmacy without a license (Correct answer)
Permitted if a pharmacist is available to answer follow-up questions
Acceptable for general health information but not medication-specific information

Correct answer: Generally considered practicing pharmacy without a license

Providing patient-specific medication counseling is within the scope of pharmacy practice and generally cannot be delegated to pharmacy technicians.

Question 110: Which of the following pieces of information is required by federal law to be on the prescription label for a Schedule III controlled substance dispensed to an outpatient?

The patient's date of birth.
The name of the practitioner issuing the prescription. (Correct answer)
The medication's beyond-use date.
The pharmacy's DEA number.

Correct answer: The name of the practitioner issuing the prescription.

According to 21 CFR 1306.24, the label for a dispensed Schedule III, IV, or V controlled substance must include the pharmacy name and address, prescription number, date of initial filling, patient's name, practitioner's name, and directions for use, along with any cautionary statements. While a pharmacy's DEA number is required for records and transfers, it is not explicitly required on the patient's label by this federal regulation. Patient's date of birth and beyond-use date may be required by state law but are not federal requirements for the label.

Question 111: Under federal law, a DEA registration is required for which of the following pharmacy personnel?

The pharmacy as an entity, not individual pharmacists (Correct answer)
Every pharmacy technician who handles Schedule II drugs
Both the PIC and each individual pharmacist employed
Each individual pharmacist who dispenses controlled substances

Correct answer: The pharmacy as an entity, not individual pharmacists

Under federal law, the DEA registration is issued to the pharmacy (the registrant), not to individual pharmacists or technicians.

Question 112: Which of the following is an example of a 'misbranded' drug under the FD&C Act?

A drug that has not undergone clinical trials
A drug that contains less active ingredient than stated
A drug manufactured in an unsanitary facility
A drug with a label that omits required adequate directions for use (Correct answer)

Correct answer: A drug with a label that omits required adequate directions for use

Misbranding refers to labeling defects, including missing required information such as adequate directions for use.

Question 113: The 'first-to-file' provision of the Hatch-Waxman Act rewards the first generic manufacturer to challenge a brand drug patent with:

180 days of marketing exclusivity before other generics may enter the market (Correct answer)
A 5-year data exclusivity period
Permanent patent rights over the generic formulation
Automatic FDA approval without bioequivalence testing

Correct answer: 180 days of marketing exclusivity before other generics may enter the market

Under Hatch-Waxman, the first generic manufacturer to file a Paragraph IV patent certification receives 180 days of marketing exclusivity as an incentive to challenge brand drug patents.

Question 114: A pharmacist receives a telephone call from a known local physician for an emergency supply of hydromorphone for a patient in severe pain. Which of the following is a federal requirement for this emergency dispensing situation?

The prescriber must provide a written prescription, postmarked within 7 days of the oral order. (Correct answer)
The pharmacist must receive a written, signed prescription from the prescriber within 30 days.
The pharmacist must notify the local DEA field office within 48 hours of dispensing.
The quantity dispensed can be for a maximum of a 30-day supply.

Correct answer: The prescriber must provide a written prescription, postmarked within 7 days of the oral order.

Federal regulation 21 CFR 1306.11(d) stipulates that in an emergency situation, a pharmacist may dispense a Schedule II substance upon oral authorization. However, the prescribing practitioner must provide a written prescription for the emergency quantity to the dispensing pharmacist within 7 days. It can be delivered in person or postmarked within the 7-day period.

Question 115: Under OBRA '90, which patients are specifically entitled to pharmacist counseling offers for new prescriptions?

Only patients purchasing brand-name medications
Only patients with chronic diseases
All patients regardless of payer source
Medicaid outpatients receiving new prescriptions (Correct answer)

Correct answer: Medicaid outpatients receiving new prescriptions

OBRA '90 mandated that pharmacists offer counseling to Medicaid outpatients for new prescriptions as a condition of Medicaid participation.

Question 116: A pharmacy wishes to destroy returned controlled substances on-site. Which DEA form must be submitted to document the destruction of Schedule II substances?

DEA Form 106
DEA Form 363
DEA Form 41 (Correct answer)
DEA Form 224

Correct answer: DEA Form 41

DEA Form 41 (Registrant Record of Controlled Substances Destroyed) is used to document the on-site destruction of controlled substances by registrants.

Question 117: Which federal regulation governs the requirements for pharmacy compounding under Section 503A of the FDCA?

Compounding is only permissible for licensed outsourcing facilities registered with the FDA
Compounded preparations under 503A are exempt from all USP standards
Compounding under 503A is permitted for individual patient prescriptions and must be based on a valid patient-specific prescription (Correct answer)
Pharmacies may compound any FDA-approved drug in unlimited quantities for office use

Correct answer: Compounding under 503A is permitted for individual patient prescriptions and must be based on a valid patient-specific prescription

Section 503A of the FDCA permits traditional pharmacy compounding for individual patients based on valid prescriptions, subject to specific requirements.

Question 118: A pharmacist-in-charge (PIC) resigns from a pharmacy. Who bears primary responsibility for ensuring the DEA registration is updated?

The state board of pharmacy on notification
The incoming pharmacist-in-charge or pharmacy owner (Correct answer)
The DEA automatically updates upon license change
The outgoing PIC only

Correct answer: The incoming pharmacist-in-charge or pharmacy owner

When a PIC changes, the pharmacy or new PIC must notify the DEA and update the registration to reflect the responsible party.

Question 119: Which federal act requires pharmacists to offer counseling to Medicaid patients receiving new prescriptions?

The Drug Price Competition and Patent Term Restoration Act
The Poison Prevention Packaging Act
OBRA '90 (Omnibus Budget Reconciliation Act of 1990) (Correct answer)
The Health Insurance Portability and Accountability Act

Correct answer: OBRA '90 (Omnibus Budget Reconciliation Act of 1990)

OBRA '90 mandates that pharmacists offer prospective drug use review and counseling to Medicaid outpatients receiving new prescriptions.

Question 120: A manufacturer issues a voluntary recall for a widely used blood pressure medication because some bottles may contain a small glass fragment, which could cause serious or life-threatening harm if ingested. How would the FDA MOST likely classify this recall?

Class I Recall (Correct answer)
Class II Recall
Market Withdrawal
Class III Recall

Correct answer: Class I Recall

A Class I recall is the most serious type, used in situations where there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. The presence of a glass fragment poses such a risk. A Class II recall is for temporary or reversible health consequences, and a Class III recall is for situations not likely to cause adverse health consequences.

Question 121: The FD&C Act's Drug Supply Chain Security Act (DSCSA) provisions require trading partners to track and trace drugs using which identifier?

FDA establishment registration number
DEA registration number linked to each shipment
Universal Product Code (UPC) barcode only
Serialized National Drug Code (sNDC) with transaction history (Correct answer)

Correct answer: Serialized National Drug Code (sNDC) with transaction history

DSCSA requires a serialized identifier on each smallest saleable unit and electronic transaction information (TI, TH, TS) to track drugs through the supply chain.

Question 122: Under the FD&C Act, the 'substantial evidence' standard for drug approval requires:

A single published peer-reviewed study
One well-controlled clinical investigation plus confirmatory evidence (Correct answer)
Anecdotal reports from at least 10 licensed physicians
Sales data demonstrating consumer acceptance

Correct answer: One well-controlled clinical investigation plus confirmatory evidence

The FD&C Act requires substantial evidence of effectiveness, typically consisting of adequate and well-controlled investigations, which the FDA generally interprets as at least two pivotal trials.

MPJE (Multistate Pharmacy Jurisprudence Exam)

The MPJE (Multistate Pharmacy Jurisprudence Exam) exam validates essential knowledge and skills required for certification or licensure in this field.

120

Questions

150 min

Time Limit

75%

To Pass

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