MPJE (Multistate Pharmacy Jurisprudence Exam) — Questions and Answers

Question 1: Which entity issues DEA registration to a pharmacy in Illinois for the purpose of handling controlled substances?

Illinois State Police
Illinois Department of Public Health (IDPH)
Illinois Department of Financial and Professional Regulation (IDFPR)
U.S. Drug Enforcement Administration (DEA) (Correct answer)

Correct answer: U.S. Drug Enforcement Administration (DEA)

DEA registration for handling controlled substances is issued by the federal Drug Enforcement Administration, regardless of state.

Question 2: 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
Refuse to dispense, retain the prescription if safe to do so, and notify law enforcement or the prescriber (Correct answer)
Dispense a partial quantity while verifying the prescription's authenticity
Dispense the prescription if the patient has a valid ID and appears legitimate

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 3: A pharmacy technician, under the supervision of a pharmacist, is preparing a non-hazardous, non-sterile topical cream. The technician is wearing a clean lab coat and gloves. According to USP <795> guidelines, which of the following is also a common requirement for personal protective equipment (PPE) to prevent contamination of the preparation?

A face mask. (Correct answer)
A disposable chemotherapy gown.
A full-face respirator.
Sterile gloves.

Correct answer: A face mask.

USP <795> requires appropriate PPE to prevent contamination of the compounded non-sterile preparation (CNSP). In addition to a clean lab coat and gloves, a face mask is typically required to prevent respiratory droplets from contaminating the preparation. Chemotherapy gowns and respirators are for handling hazardous drugs (USP <800>), and sterile gloves are required for sterile compounding (USP <797>).

Question 4: A prescriber phones in an emergency prescription for a 3-day supply of morphine sulfate for a patient in severe pain. The pharmacist immediately reduces the oral prescription to writing. What is the maximum time frame, under federal law, within which the prescriber must provide a written, signed prescription to the pharmacy?

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

Correct answer: 7 days

Federal law under 21 CFR 1306.11(d)(4) requires that a practitioner who issues an emergency oral prescription for a Schedule II controlled substance must deliver a written, signed prescription to the dispensing pharmacist within 7 days after authorizing the emergency prescription.

Question 5: A pharmacist who fails to offer counseling for a new prescription to a Medicaid patient could face consequences under:

State Medicaid agency sanctions for violating OBRA '90 participation requirements (Correct answer)
DEA enforcement action for improper controlled substance handling
FDA enforcement for failing to provide required medication guides
FTC action for deceptive business practices

Correct answer: State Medicaid agency sanctions for violating OBRA '90 participation requirements

OBRA '90 established patient counseling as a condition of Medicaid participation, making violations subject to state Medicaid agency sanctions.

Question 6: What formulations of Schedule 2 may a nurse practitioner prescribe?

No more than 200 milligrams of codeine per 100 milliliters or 100 grams
‥ Can return to the supplier (must use 222 forms if a schedule 2) <br> ‥ Send to a reverse distributor who must complete form 41 <br> ‥ Request disposal by pharmacy, also need to complete form 41
Only oral topical or transdermal for no more than a 30 days supply (Correct answer)
By the end of the month that the order is filled or at the end of the month that the final shipment is made

Correct answer: Only oral topical or transdermal for no more than a 30 days supply

The ability of a nurse practitioner to prescribe Schedule 2 formulations, including oral, topical, or transdermal medications, can vary depending on the jurisdiction and specific regulations in place. In some regions, nurse practitioners may have the authority to prescribe Schedule 2 medications, while in others, their prescribing authority may be more limited. <br> <br> To determine the specific prescribing privileges of a nurse practitioner regarding Schedule 2 formulations in your area, it is best to consult the local regulatory boards, professional organizations, or licensing bodies that govern nurse practitioners. These organizations can provide accurate and up-to-date information regarding the scope of practice and prescribing authority for nurse practitioners in your jurisdiction.

Question 7: 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 pharmacy license is automatically transferred to the next senior pharmacist
The pharmacy may continue operating indefinitely without a PIC
The DEA registration is immediately revoked

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 8: What does an 'AB' rating in the FDA's Orange Book indicate about a generic drug product?

The drug has not yet been evaluated for therapeutic equivalence
The drug has known bioequivalence problems
The drug is approved only for OTC use
The drug is therapeutically equivalent to the reference listed drug (Correct answer)

Correct answer: The drug is therapeutically equivalent to the reference listed drug

An 'AB' rating indicates the generic drug product is therapeutically equivalent to the reference listed drug, meaning it can be substituted without additional clinical evidence.

Question 9: Under the CSA, how long must a retail pharmacy retain records for Schedule II controlled substances?

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

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 10: A retail pharmacy discovers a theft of controlled substances. Under the CSA, the pharmacy must notify the DEA field office within:

Immediately upon discovery by phone, and submit DEA Form 106 within 1 business day (Correct answer)
1 business day of discovery
1 calendar day of discovery
24 hours of discovery

Correct answer: Immediately upon discovery by phone, and submit DEA Form 106 within 1 business day

Significant theft or loss must be reported to the DEA by phone immediately upon discovery, followed by DEA Form 106 within one business day.

Question 11: A pharmacist-in-charge (PIC) who resigns must notify the state board within what typical timeframe?

Only when the replacement PIC is hired
Within the timeframe specified by state law, often 10-15 days (Correct answer)
Within one year of leaving the position
Immediately upon resignation

Correct answer: Within the timeframe specified by state law, often 10-15 days

State pharmacy practice acts typically require notification to the board within a specified short timeframe (commonly 10–15 days) when a PIC position changes.

Question 12: Under federal law, who bears primary responsibility for initiating a drug recall when a product is found to be adulterated or misbranded?

The DEA initiates all drug product recalls
State boards of pharmacy are responsible for all recall actions
The FDA always initiates all recalls by court order
The manufacturer or distributor bears primary responsibility for initiating the recall (Correct answer)

Correct answer: The manufacturer or distributor bears primary responsibility for initiating the recall

Most drug recalls are voluntary and initiated by the manufacturer or distributor, though the FDA can request a recall and mandate one if a company does not act voluntarily.

Question 13: A pharmacist is preparing to dispense a non-sterile compounded magic mouthwash. Which term most accurately describes the date that must be placed on the prescription label to indicate the time after which the preparation should not be used?

Expiration Date
Beyond-Use Date (Correct answer)
Stability Date
Discard Date

Correct answer: Beyond-Use Date

The term 'Expiration Date' is assigned by the manufacturer based on extensive stability testing for a specific product and its packaging. In contrast, a 'Beyond-Use Date' (BUD) is assigned by the dispensing pharmacist for compounded preparations and is based on general guidelines (like USP chapters) or available stability literature for the specific compounded formulation. The BUD is the date after which a compounded preparation should not be used.

Question 14: A pharmacy technician presents a completed prescription bag to a pharmacist for final verification. The pharmacist notices the NDC on the vial does not match the prescription. This is an example of which type of error prevention step?

Prospective DUR screening
Final pharmacist verification (drug utilization review) (Correct answer)
Point-of-sale barcode scan verification
Tech-check-tech program oversight

Correct answer: Final pharmacist verification (drug utilization review)

The pharmacist's final check before dispensing, including verifying NDC against the prescription, is the final pharmacist verification step that catches preparation errors.

Question 15: Under the Ryan Haight Online Pharmacy Consumer Protection Act, prescribing controlled substances via the internet without a valid in-person evaluation generally requires at least how many in-person medical evaluations by the prescribing practitioner?

None if via telemedicine
At least two
At least one (Correct answer)
Three within the prior 12 months

Correct answer: At least one

The Ryan Haight Act requires that a practitioner conduct at least one in-person medical evaluation before prescribing controlled substances via the internet, with limited telemedicine exceptions.

Question 16: Which FD&C Act section grants FDA authority to mandate a Risk Evaluation and Mitigation Strategy (REMS) for a drug?

Section 503(b)
Section 510(k)
Section 502(f)
Section 505-1 (Correct answer)

Correct answer: Section 505-1

Section 505-1 of the FD&C Act authorizes FDA to require a REMS when necessary to ensure that benefits of a drug outweigh its risks.

Question 17: A pharmacist receives a prescription for a Schedule II controlled substance via fax for a patient in a long-term care facility. Under federal law, this is:

Prohibited; Schedule II prescriptions may never be faxed
Permitted; the fax serves as the original prescription (Correct answer)
Permitted; the original must follow within 72 hours
Permitted as an emergency only, with original to follow in 7 days

Correct answer: Permitted; the fax serves as the original prescription

Federal law permits faxed Schedule II prescriptions for LTCF patients, and the fax itself serves as the original.

Question 18: Which of the following statements about an 'AA' rating in the Orange Book is TRUE?

The drug is approved only for abbreviated new drug applications
The drug is therapeutically equivalent to multiple generic versions
The drug has failed bioequivalence testing and requires reformulation
The drug is a conventional dosage form with no bioequivalence concerns and no known equivalent (Correct answer)

Correct answer: The drug is a conventional dosage form with no bioequivalence concerns and no known equivalent

An 'AA' rating is assigned to conventional dosage forms that have no bioequivalence issues—these are typically products where there is no other marketed version to compare against.

Question 19: The following conditions must be met, except one, for a medicine to be declared pharmaceutically equivalent.

Identical strength or concentration
Identical amounts of the same active ingredient
Same exipients (Correct answer)
Same dosage form
Same route of administration

Correct answer: Same exipients

The excipient and active components don't need to be identical for a medicine to be considered a pharmacological equivalent.

Question 20: Which information is NOT required on the outpatient prescription label under federal law?

Patient's name
Directions for use
Prescriber's name
Prescriber's DEA registration number (Correct answer)

Correct answer: Prescriber's DEA registration number

The prescriber's DEA number is not required on the dispensing label; it is required on the original prescription for controlled substances.

Question 21: A pharmacy dispenses a 30-day supply of a Schedule II medication. The patient returns 12 days later requesting an early refill. What is the correct action?

Refuse the refill because Schedule II prescriptions cannot be refilled (Correct answer)
Dispense a full 30-day supply if the prescriber authorizes it verbally
Dispense an emergency 72-hour supply
Transfer the prescription to another pharmacy

Correct answer: Refuse the refill because Schedule II prescriptions cannot be refilled

Schedule II controlled substances are prohibited from being refilled under federal law; a new prescription from the prescriber is required for each dispensing.

Question 22: A pharmacist is compounding a preparation using a substance on the FDA 503A Difficult-to-Compound or Demonstrably Difficult list. This means:

The substance requires enhanced documentation in the compounding record
The pharmacy must obtain a variance from the state board
The substance is prohibited from compounding under 503A (Correct answer)
The pharmacist may still compound it with prescriber authorization

Correct answer: The substance is prohibited from compounding under 503A

Substances on the FDA's 503A 'difficult to compound' or 'demonstrably difficult' categories are prohibited from being compounded under 503A.

Question 23: 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?

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

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 24: Which of the following triggers the 30-month stay on FDA approval of a generic drug's ANDA?

The generic applicant fails to submit required bioequivalence data
FDA places the reference listed drug on the discontinued drug product list
The brand manufacturer files a patent infringement lawsuit within 45 days of receiving the Paragraph IV certification (Correct answer)
The brand manufacturer files a citizen petition with FDA challenging bioequivalence

Correct answer: The brand manufacturer files a patent infringement lawsuit within 45 days of receiving the Paragraph IV certification

A 30-month stay automatically results when the NDA holder sues for patent infringement within 45 days of receiving a Paragraph IV certification notice.

Question 25: A pharmacist receives a prescription for a drug that has a REMS (Risk Evaluation and Mitigation Strategy) with required elements to assure safe use (ETASU). What must the pharmacist do before dispensing?

Dispense the drug and provide the standard medication guide
Verify that all REMS requirements are met, including any required certification or patient enrollment (Correct answer)
Contact the FDA for dispensing authorization on each prescription
Obtain written consent from the patient's primary care physician

Correct answer: Verify that all REMS requirements are met, including any required certification or patient enrollment

REMS programs with ETASU impose specific obligations on pharmacies and pharmacists, including certification, patient enrollment, and documentation, that must be met prior to dispensing.

Question 26: Which Illinois agency is primarily responsible for enforcing the Illinois Pharmacy Practice Act?

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

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

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

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 28: In Illinois, what is the maximum number of refills allowed for a Schedule IV controlled substance prescription?

No refills permitted
3 refills within 6 months
5 refills within 6 months (Correct answer)
Unlimited refills within 1 year

Correct answer: 5 refills within 6 months

Schedule IV prescriptions may be refilled up to 5 times within 6 months of the date of issue under both federal and Illinois law.

Question 29: A patient drops off a prescription for a controlled substance that appears to have been altered. The quantity was changed from 30 to 90 in a different ink color. The pharmacist should:

Fill the prescription for the original quantity of 30 and counsel the patient about the alteration
Fill the prescription as written for 90 since the prescriber can authorize any quantity
Ask the patient to return with a new, unaltered prescription without notifying authorities
Refuse to fill the prescription, retain it if possible, and contact the prescriber and/or law enforcement (Correct answer)

Correct answer: Refuse to fill the prescription, retain it if possible, and contact the prescriber and/or law enforcement

A visibly altered controlled substance prescription must not be filled; the pharmacist should refuse dispensing, retain the prescription if it is safe to do so, and report to the prescriber and/or law enforcement.

Question 30: A pharmacy's security camera footage showing a patient picking up a prescription containing PHI. Under HIPAA, this footage is:

Covered only if the pharmacy specifically uses it for medical record-keeping
Potentially PHI if it links an identifiable individual to receipt of health services (Correct answer)
Not covered by HIPAA since it is video, not medical records
Not PHI because it is collected incidentally, not intentionally

Correct answer: Potentially PHI if it links an identifiable individual to receipt of health services

Video footage can constitute PHI if it contains individually identifiable information related to health services, such as a patient picking up medication.

Question 31: A pharmacist receives a valid, non-refillable prescription for a non-controlled medication. The patient requests to have it filled, but the pharmacist has a deeply held moral objection to the medication's intended use. According to most state laws and professional guidelines regarding 'conscience clauses,' which of the following is the most appropriate action for the pharmacist to take?

Destroy the prescription and inform the patient the pharmacy does not carry the medication.
Refuse to fill the prescription and immediately return it to the patient without further assistance.
Fill the prescription but counsel the patient on the moral objections to its use.
Inform the patient of the refusal and facilitate the timely transfer of the prescription to another local pharmacy that will dispense the medication. (Correct answer)

Correct answer: Inform the patient of the refusal and facilitate the timely transfer of the prescription to another local pharmacy that will dispense the medication.

While some states have 'conscience clause' laws that allow a pharmacist to refuse to dispense a medication based on moral or religious objections, this right is not absolute. The prevailing standard of practice and, in many cases, the law, requires that the pharmacist does not obstruct the patient's access to care. The appropriate action is to step away from the transaction but ensure the patient can still get their medication in a timely manner, typically by transferring the prescription or directing them to another pharmacist on duty who will fill it.

Question 32: A mid-level practitioner (NP) wishes to prescribe Schedule III controlled substances. Under the CSA, which statement is TRUE?

Mid-level practitioners must co-sign prescriptions with a supervising physician
Mid-level practitioners may prescribe only Schedule IV and V substances
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

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 33: A retail pharmacy utilizes a central fill pharmacy, which is under common ownership, to prepare a prescription for zolpidem. According to federal law, which of the following statements regarding the prescription label is correct?

The label must identify only the central fill pharmacy and its address.
The label must identify the retail pharmacy and include a unique identifier for the central fill pharmacy. (Correct answer)
The label is not required to identify the central fill pharmacy if it has the same owner as the retail pharmacy.
The label must identify only the retail pharmacy and its address.

Correct answer: The label must identify the retail pharmacy and include a unique identifier for the central fill pharmacy.

According to 21 CFR 1306.24(b), when a prescription for a controlled substance is filled at a central fill pharmacy, the label must show the retail pharmacy's name and address and a unique identifier (like the DEA number) indicating that the prescription was filled at the central fill pharmacy.

Question 34: Which amendment to the Food, Drug, and Cosmetic Act first required manufacturers to prove both safety AND efficacy before marketing a new drug?

Food, Drug, and Cosmetic Act of 1938
Hatch-Waxman Act of 1984
Kefauver-Harris Amendment of 1962 (Correct answer)
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 35: 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?

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

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

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

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 37: 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 38: A pharmacy intern's registration is typically valid for a maximum period of:

Five years, regardless of school enrollment status
The duration of the pharmacy school program plus one year after graduation (Correct answer)
Two years from the date of issuance
Until the intern passes the NAPLEX

Correct answer: The duration of the pharmacy school program plus one year after graduation

Most states limit intern registration to the duration of the professional pharmacy program plus a limited post-graduation window (commonly one year) to allow time for licensure.

Question 39: Which entity administers the NAPLEX examination used for pharmacist licensure in the United States?

ACPE (Accreditation Council for Pharmacy Education)
The FDA
The DEA
NABP (National Association of Boards of Pharmacy) (Correct answer)

Correct answer: NABP (National Association of Boards of Pharmacy)

NABP develops and administers the NAPLEX on behalf of member boards of pharmacy throughout the US.

Question 40: A pharmacist whose license has lapsed for three years wishes to reinstate it. Most state boards would typically require:

Meeting current reinstatement requirements, which may include CE and/or re-examination (Correct answer)
Retaking only the MPJE
Submitting proof of CE hours completed during the lapse period
Paying a late renewal fee with no additional requirements

Correct answer: Meeting current reinstatement requirements, which may include CE and/or re-examination

Most states require lapsed licensees to meet current reinstatement standards, which commonly include CE completion and may require re-examination depending on the length of lapse.

Question 41: Under the FD&C Act, what is the minimum period for which a brand-name drug manufacturer must provide patent and exclusivity information listed in the 'Orange Book'?

3 years for all new drug products
10 years for biologics, 5 years for small molecules
5 years from date of NDA approval regardless of patent
The duration of the patent or exclusivity period as applicable (Correct answer)

Correct answer: The duration of the patent or exclusivity period as applicable

Orange Book listing reflects the actual remaining patent life and any applicable exclusivity period granted at NDA approval.

Question 42: Which legislation stipulated that new medications must first be deemed secure and efficient for the intended use?

Kefauver-Harris Amendment (Correct answer)
Food, Drug, and Cosmetic Act
Prescription Drug Marketing Act
Durham-Humphrey Amendment
Drug Quality and Security Act

Correct answer: Kefauver-Harris Amendment

According to the Kefauver-Harris Amendment of 1962, new medications had to be demonstrated to be both safe and effective for the intended application. Additionally, it established reasonable manufacturing procedures for producing pharmaceuticals and granted the FDA control over the promotion of prescription medications.

Question 43: A pharmacy wants to transfer a Schedule III–V controlled substance prescription to another pharmacy. How many times may this transfer occur?

Once only, unless pharmacies share a real-time database (Correct answer)
Twice
Up to five times
Unlimited transfers are allowed

Correct answer: Once only, unless pharmacies share a real-time database

A controlled substance prescription for Schedule III–V may be transferred only once between pharmacies, unless both pharmacies share a real-time, online database allowing multiple transfers.

Question 44: A pharmacist is approached by law enforcement who requests patient prescription records without a warrant. What is the pharmacist's MOST appropriate response?

Provide records only after notifying the patient and receiving their signed release
Provide all requested records immediately to cooperate with law enforcement
Refuse all law enforcement requests regardless of documentation provided
Provide records only with patient consent, a valid court order, or a subpoena, or as required by state law (Correct answer)

Correct answer: Provide records only with patient consent, a valid court order, or a subpoena, or as required by state law

HIPAA permits disclosure of PHI to law enforcement under specific conditions including court orders, subpoenas, or where state law mandates reporting, but generally not on informal law enforcement request alone.

Question 45: A drug product is recalled because it was found to contain glass particles. This is classified as a Class __ recall by FDA.

Class I (Correct answer)
Class IV
Class II
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 46: Under Illinois law, what is the required minimum period a pharmacy must keep a pharmacist on duty when the pharmacy is open to the public?

A pharmacist must be on-site at all times the pharmacy is open (Correct answer)
A pharmacist intern may substitute for a pharmacist for up to 4 hours
A pharmacist must be reachable by phone but need not be on-site
A pharmacist must be present at least 50% of open hours

Correct answer: A pharmacist must be on-site at all times the pharmacy is open

Illinois law requires that a licensed pharmacist be on the premises at all times the pharmacy is open and dispensing medications.

Question 47: Under the Combat Methamphetamine Epidemic Act (CMEA), the daily sales limit for ephedrine-containing OTC products is:

7.5 grams per purchaser per day
6 grams per purchaser per month
3.6 grams per purchaser per day (Correct answer)
9 grams per purchaser per 30 days

Correct answer: 3.6 grams per purchaser per day

CMEA limits daily sales to 3.6 grams of ephedrine base per purchaser per day, with a 30-day limit of 9 grams.

Question 48: A pharmacist receives a prescription for a controlled substance for a patient known to have recently completed a drug rehabilitation program. The pharmacist should:

Evaluate the prescription's legitimacy and counsel the patient appropriately (Correct answer)
Contact the rehabilitation facility before dispensing
Refuse to fill the prescription due to the patient's history
Require a urine drug screen before dispensing

Correct answer: Evaluate the prescription's legitimacy and counsel the patient appropriately

A pharmacist must evaluate each prescription on its merits and provide appropriate counseling without discriminating based on a patient's medical history.

Question 49: A pharmacist is asked to fill a prescription for buprenorphine/naloxone (Suboxone) written by a physician. Under federal law, what is required of the prescribing physician?

The physician must be affiliated with a licensed methadone clinic
No special authorization is required beyond a standard DEA registration
The physician must hold a DEA registration with an X suffix (DATA 2000 waiver) or buprenorphine prescribing authorization under the SUPPORT Act (Correct answer)
The physician must file a separate application with the FDA to prescribe buprenorphine

Correct answer: The physician must hold a DEA registration with an X suffix (DATA 2000 waiver) or buprenorphine prescribing authorization under the SUPPORT Act

Physicians prescribing buprenorphine for opioid use disorder must have a DATA 2000 waiver or, under more recent law, specific buprenorphine prescribing authorization reflected in their DEA registration.

Question 50: Under the Drug Price Competition and Patent Term Restoration Act of 1984 (Hatch-Waxman Act), a generic manufacturer must demonstrate:

Manufacturing facilities separate from the brand manufacturer
A novel molecular structure differing from the brand
Bioequivalence to the reference listed drug (Correct answer)
New clinical studies showing independent safety and efficacy

Correct answer: Bioequivalence to the reference listed drug

The Hatch-Waxman Act established the ANDA pathway requiring generic manufacturers to demonstrate bioequivalence, eliminating the need for full new clinical trials.

Question 51: Under USP <800>, which type of hazardous drug preparation requires the use of a Containment Primary Engineering Control (C-PEC)?

Only oral solid reformulation of hazardous drugs
Any compounding of NIOSH Group 1 antineoplastic drugs (Correct answer)
All non-sterile compounding regardless of hazard classification
Hazardous drugs only when prepared in quantities exceeding 100 units

Correct answer: Any compounding of NIOSH Group 1 antineoplastic drugs

USP <800> mandates a C-PEC for compounding NIOSH Group 1 antineoplastic agents and other hazardous drugs requiring containment controls.

Question 52: Which of the following best describes the DEA's authority under the CSA to issue an Immediate Suspension Order (ISO)?

The DEA may suspend a registration only for Schedule I or II violations
The DEA may immediately suspend a registration if it finds an imminent danger to public health or safety (Correct answer)
The DEA may suspend a registration only after a full administrative hearing
The DEA may suspend a registration only with a court order

Correct answer: The DEA may immediately suspend a registration if it finds an imminent danger to public health or safety

The DEA may issue an ISO without prior hearing if it finds that continued registration poses an imminent danger to public health or safety.

Question 53: Which FD&C Act provision allows FDA to require post-market safety studies or clinical trials as a condition of approval?

Post-market requirements under Section 505(o) (Correct answer)
Orphan drug designation under Section 526
Accelerated approval under Section 506(c)
Fast track designation under Section 506(b)

Correct answer: Post-market requirements under Section 505(o)

Section 505(o) authorizes FDA to require post-market studies, clinical trials, or labeling changes when new safety information emerges.

Question 54: 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)
A minimum of three prior prescriptions from a brick-and-mortar pharmacy
Written consent from the patient's state insurance plan

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 55: Under the Controlled Substances Act, which of the following is considered a 'practitioner' authorized to dispense controlled substances?

A registered pharmacist acting independently without a prescription
A hospital licensed under federal law
A wholesale distributor registered with the DEA
A physician, dentist, veterinarian, or other licensed healthcare provider (Correct answer)

Correct answer: A physician, dentist, veterinarian, or other licensed healthcare provider

Under the CSA, 'practitioner' refers to physicians, dentists, veterinarians, and other licensed healthcare providers authorized to prescribe and dispense controlled substances.

Question 56: A pharmacist notices that a colleague appears to be impaired at work. Under most state pharmacy practice acts, the pharmacist's professional obligation is to:

Report the impairment to the state board of pharmacy or a pharmacy assistance program (Correct answer)
Notify the DEA immediately about potential diversion
Document the incident in the pharmacy log and take no further action
Do nothing unless the colleague dispenses an incorrect prescription

Correct answer: Report the impairment to the state board of pharmacy or a pharmacy assistance program

Pharmacists typically have a professional and sometimes legal obligation to report impaired colleagues to the board or a pharmacist assistance program to protect the public.

Question 57: Which federal act requires pharmacists to offer counseling to Medicaid patients receiving new prescriptions?

The Health Insurance Portability and Accountability Act
The Drug Price Competition and Patent Term Restoration Act
OBRA '90 (Omnibus Budget Reconciliation Act of 1990) (Correct answer)
The Poison Prevention Packaging 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 58: Under the Prescription Drug Marketing Act (PDMA), which of the following activities is prohibited?

A manufacturer providing drug samples to licensed practitioners upon written request
A pharmacy transferring a prescription between its own chain locations
A wholesale distributor selling prescription drugs purchased from hospitals back into the retail market (Correct answer)
A pharmacist accepting free product from a manufacturer for patient assistance

Correct answer: A wholesale distributor selling prescription drugs purchased from hospitals back into the retail market

The PDMA prohibits the sale of drug samples and the purchase of prescription drugs by hospitals for resale, to prevent drug diversion and counterfeiting.

Question 59: Under NABP guidelines, which of the following is NOT typically within the authorized scope of a pharmacy technician?

Processing insurance claims for a prescription
Retrieving medication from stock for filling
Performing the final verification of a dispensed prescription (Correct answer)
Entering prescription data into the pharmacy system

Correct answer: Performing the final verification of a dispensed prescription

Final verification of a dispensed prescription is a pharmacist-only function and cannot be delegated to technicians in most states.

Question 60: Which element is specifically required when documenting a patient counseling session per best practice standards?

The date, patient name, medication, information provided, and patient's response or questions (Correct answer)
The prescriber's authorization for the pharmacist to provide counseling
The pharmacist's personal assessment of patient intelligence and ability to understand
A verbatim transcript of all communication between pharmacist and patient

Correct answer: The date, patient name, medication, information provided, and patient's response or questions

Effective counseling documentation includes the date, patient identification, medication involved, information covered, and any patient feedback or questions raised.

Question 61: 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?

5 days
48 hours
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 62: In Illinois, which requirement applies to a collaborative pharmacy practice agreement (CPPA)?

It is only permitted in hospital or health-system settings
It must be filed with and approved by IDFPR before the pharmacist may practice under it
It requires a written agreement signed by the collaborating physician and pharmacist (Correct answer)
It must be approved by the Illinois State Medical Society before implementation

Correct answer: It requires a written agreement signed by the collaborating physician and pharmacist

Illinois law requires a written collaborative pharmacy practice agreement signed by both the collaborating prescriber and the pharmacist.

Question 63: Under the Illinois Pharmacy Practice Act, what is the maximum ratio of pharmacy technicians to pharmacists allowed in a retail pharmacy setting?

4:1
3:1 (Correct answer)
2:1
No statutory limit

Correct answer: 3:1

Illinois law allows a maximum of 3 pharmacy technicians per supervising pharmacist in a retail pharmacy setting.

Question 64: A patient requests that the pharmacy NOT send their prescription refill reminders to their home address because their spouse does not know about their medication. Under HIPAA, the pharmacy must:

Accommodate the reasonable request to use an alternative means of communication (Correct answer)
Notify the prescriber of the patient's unusual request
Require a written explanation from the patient before accommodating
Deny the request since it complicates pharmacy operations

Correct answer: Accommodate the reasonable request to use an alternative means of communication

HIPAA requires covered entities to accommodate reasonable requests by individuals to receive communications of PHI by alternative means or at alternative locations.

Question 65: A compounding record for a non-sterile preparation must be maintained for at least:

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

Correct answer: 2 years

USP <795> and most state boards require compounding records for non-sterile preparations to be retained for a minimum of 2 years.

Question 66: Which FDA form is used by healthcare professionals to voluntarily report adverse drug events through the MedWatch program?

FDA Form 483
DEA Form 222
FDA Form 2253
MedWatch Form 3500 (Correct answer)

Correct answer: MedWatch Form 3500

MedWatch Form 3500 is the voluntary reporting form used by healthcare professionals to report adverse events and product problems to the FDA.

Question 67: Which FD&C Act pathway provides 5 years of new chemical entity (NCE) exclusivity for a newly approved drug?

Pediatric exclusivity under Section 505A
Fast track designation under Section 506(b)
Orphan drug exclusivity under Section 527
Hatch-Waxman new chemical entity exclusivity under Section 505(j) (Correct answer)

Correct answer: Hatch-Waxman new chemical entity exclusivity under Section 505(j)

The Hatch-Waxman Act (which amended the FD&C Act) grants 5 years of NCE exclusivity to drugs containing an active moiety never previously approved by FDA.

Question 68: Which FD&C Act provision requires that drug labeling contain adequate directions for use?

Section 510(k)
Section 505(a)
Section 502(f) (Correct answer)
Section 503(b)

Correct answer: Section 502(f)

Section 502(f) of the FD&C Act deems a drug misbranded if labeling does not bear adequate directions for use.

Question 69: A state board of pharmacy may place a pharmacist license on probation. Which condition is MOST likely to accompany probationary status?

Mandatory practice monitoring and periodic board reporting (Correct answer)
Prohibition from ever supervising technicians
Automatic license revocation after 6 months
Suspension of DEA registration in all states

Correct answer: Mandatory practice monitoring and periodic board reporting

Probation typically includes practice monitoring by a supervisor or board designee and requires the pharmacist to submit periodic reports demonstrating compliance.

Question 70: When a pharmacist detects during counseling that a patient is taking a newly prescribed drug that interacts with a current medication, the pharmacist's primary obligation is to:

Refuse to dispense until the patient sees the prescriber again
Notify the prescriber and counsel the patient about the interaction before dispensing (Correct answer)
Dispense and document without notifying anyone since the prescriber is responsible
Call poison control and file a medication error report

Correct answer: Notify the prescriber and counsel the patient about the interaction before dispensing

The pharmacist's professional duty is to identify the interaction, notify the prescriber, and counsel the patient prior to or instead of dispensing.

Question 71: A pharmacy receives a bulk prescription for methadone 40 mg tablets for a patient with severe chronic pain. Which statement is correct?

Methadone 40 mg tablets are not a valid FDA-approved dosage form for pain management
Methadone for pain can be prescribed by any DEA-registered practitioner on a standard Schedule II prescription (Correct answer)
Methadone for pain can only be dispensed by opioid treatment programs (OTPs)
Methadone for pain requires a special DEA waiver in addition to a standard controlled substance prescription

Correct answer: Methadone for pain can be prescribed by any DEA-registered practitioner on a standard Schedule II prescription

Methadone prescribed for pain (not maintenance therapy) may be written by any DEA-registered practitioner on a standard Schedule II prescription; OTP registration is only required for maintenance treatment of addiction.

Question 72: A 75-year-old patient with severe arthritis tells the pharmacist that she has great difficulty opening her child-resistant prescription vials. She requests that all her future prescriptions from this pharmacy be filled in non-child-resistant containers. According to the Poison Prevention Packaging Act (PPPA), what is the appropriate action for the pharmacist to take?

Inform the patient that a new request must be made for each individual prescription.
Honor the patient's blanket request for all future prescriptions, preferably after obtaining it in writing. (Correct answer)
Tell the patient she must get her prescriber to authorize the use of non-child-resistant containers.
Refuse the request, as only specific drugs are exempt from PPPA requirements.

Correct answer: Honor the patient's blanket request for all future prescriptions, preferably after obtaining it in writing.

The Poison Prevention Packaging Act (PPPA) allows a patient or their agent to make a 'blanket waiver' request for all of their prescriptions to be dispensed in non-child-resistant packaging. While the law does not require this request to be in writing, it is highly recommended that the pharmacy document it with the patient's signature. Prescribers can only request non-child-resistant packaging for an individual prescription and its refills, not a blanket waiver for all of a patient's medications.

Question 73: Under the Combat Methamphetamine Epidemic Act (CMEA), which of the following is a federal requirement for the sale of pseudoephedrine products?

Products must be kept behind the pharmacy counter or in a locked cabinet (Correct answer)
A valid prescription is required for all purchases
Purchasers must be at least 21 years old
Daily purchase limits apply only in states with meth lab problems

Correct answer: Products must be kept behind the pharmacy counter or in a locked cabinet

The CMEA requires pseudoephedrine-containing products to be kept behind the counter or in a locked case regardless of state.

Question 74: When preparing a compounded batch of 'Magic Mouthwash' for the first time, a pharmacist creates a detailed 'recipe' document that includes the ingredients, quantities, mixing instructions, and quality control procedures. Which of the following best describes this document?

Compounding Record
Safety Data Sheet (SDS)
Master Formulation Record (Correct answer)
Standard Operating Procedure (SOP)

Correct answer: Master Formulation Record

The Master Formulation Record is the official 'recipe' or set of instructions for a specific compounded preparation. It contains all the necessary information to create a uniform product. The Compounding Record, in contrast, is the documentation of a specific compounding event, detailing the lot numbers and quantities used for a particular patient or batch.

Question 75: How long may a technician work there before getting their license?

Five years
60 Days (Correct answer)
72 Hours
Four ounces

Correct answer: 60 Days

The duration for which a technician can work in a pharmacy while waiting for their license can vary depending on the jurisdiction and specific regulations in place. In some regions, technicians may be allowed to work for a certain period of time, such as 60 days, while waiting for their license to be processed.

Question 76: A pharmacist receives a prescription for a compounded preparation that is commercially available. Under FDCA Section 503A, this is permissible only if:

The prescriber provides a medical necessity statement
All of the above may be acceptable justifications (Correct answer)
The patient has documented an allergy to the commercial product's excipient
The compound differs from the commercial product in a clinically significant way

Correct answer: All of the above may be acceptable justifications

Section 503A allows compounding a commercially available drug when there is a valid clinical reason such as allergy to an excipient, required dosage form change, or documented medical necessity.

Question 77: In Illinois, which of the following controlled substance prescriptions may be partially filled at the patient's request?

Schedule III and IV, with remainder dispensed within 6 months (Correct answer)
Schedule II only, if the remainder is filled within 72 hours
Schedule II through V, with no time restrictions on the remainder
Partial fills are prohibited for all schedules under Illinois law

Correct answer: Schedule III and IV, with remainder dispensed within 6 months

Under Illinois and federal law, Schedule III and IV prescriptions may be partially filled, with the remaining portions dispensed within 6 months of the original issue date.

Question 78: Despite not being utilized to treat a condition that poses a serious threat to life, a medicine is discovered to be inadequate. What kind of recall is necessary?

Class IV
Class I
No recall will be required
Class II (Correct answer)
Class III

Correct answer: Class II

Products that are unsafe or flawed and may result in significant injury are subject to Class I recalls. Recalls under Class II are made for goods that might momentarily harm consumers' health. Products unlikely to cause any health issues are subject to Class III recalls.

Question 79: Most state boards of pharmacy mandate specific requirements for pharmacists to maintain an active license. Which of the following is most consistently required for biennial license renewal across the majority of states?

A minimum of 1,000 practice hours in the preceding two years.
Completion of a specified number of continuing education (CE) hours. (Correct answer)
Publication of a research article in a peer-reviewed journal.
Active membership in a national pharmacy association.

Correct answer: Completion of a specified number of continuing education (CE) hours.

Virtually every state board of pharmacy requires pharmacists to complete a set number of continuing education (CE) hours during each renewal period (typically every two years) to ensure they stay current with evolving knowledge and practices. While the exact number of hours and specific topic requirements (e.g., law, patient safety) can vary by state, the mandate for CE is a universal standard for licensure maintenance.

Question 80: Under USP <797>, which of the following cleanroom classifications is required for the preparation of Category 2 sterile compounded preparations?

Any classified cleanroom environment with documented cleaning logs
ISO Class 6 buffer room with ISO Class 5 ante-area
ISO Class 5 only, with no additional ante-area requirements
ISO Class 5 primary engineering control within an ISO Class 7 buffer room and ISO Class 8 ante-area (Correct answer)

Correct answer: ISO Class 5 primary engineering control within an ISO Class 7 buffer room and ISO Class 8 ante-area

USP <797> requires Category 2 CSPs to be prepared in an ISO 5 PEC within an ISO 7 buffer room with an ISO 8 ante-room to ensure sterility.

Question 81: A pharmacist is about to dispense a 30-day supply of warfarin. The patient's profile shows a new prescription for fluconazole from a different prescriber. What is the pharmacist's legal and professional obligation?

Conduct a drug utilization review (DUR) and counsel the patient on the significant interaction. (Correct answer)
Dispense both without intervention because prescribers are responsible for drug interactions.
Dispense both; prescribers have already reviewed the combination.
Dispense warfarin only and refuse to fill the fluconazole.

Correct answer: Conduct a drug utilization review (DUR) and counsel the patient on the significant interaction.

OBRA '90 requires pharmacists to perform prospective DUR and offer counseling, especially for significant drug interactions like warfarin-fluconazole.

Question 82: Which statement about compounding for office use under 503A is accurate?

Office-use supply from 503A pharmacies is only permitted for controlled substances
503A pharmacies may furnish reasonable quantities of compounded preparations to practitioners for office administration if permitted by state law (Correct answer)
503A pharmacies may not provide any compounded preparations to practitioners without a patient-specific prescription
Office-use compounding is unlimited under 503A as long as the drug is not on a federal prohibited list

Correct answer: 503A pharmacies may furnish reasonable quantities of compounded preparations to practitioners for office administration if permitted by state law

503A permits limited office-use supply to practitioners in reasonable quantities when authorized by the state board of pharmacy.

Question 83: A patient requests to have their new, unfilled electronic prescription for zaleplon (Schedule IV) transferred from Pharmacy A to Pharmacy B for initial filling. Under the federal rule effective in 2023, which of the following conditions must be met?

The transfer must be communicated directly between two licensed pharmacists. (Correct answer)
The prescription can be transferred multiple times for initial filling.
The transfer must be initiated by the prescriber's agent.
The prescription must be converted to a paper copy and faxed by the pharmacist.

Correct answer: The transfer must be communicated directly between two licensed pharmacists.

The DEA final rule, effective August 28, 2023, allows the one-time transfer of an original, unfilled electronic prescription for a Schedule II-V controlled substance between DEA-registered pharmacies. The rule explicitly requires that the transfer must be communicated directly between two licensed pharmacists.

Question 84: Under the Combat Methamphetamine Epidemic Act (CMEA), what is the daily sales limit per purchaser for ephedrine-containing OTC products?

3.6 grams (Correct answer)
12.0 grams
9.0 grams
7.5 grams

Correct answer: 3.6 grams

CMEA limits retail sales of ephedrine, pseudoephedrine, and phenylpropanolamine to 3.6 grams per day per purchaser.

Question 85: 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 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.
The pharmacy's obligation was not met because counseling is mandatory for all new prescriptions and cannot be refused.

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

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

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 87: Under most state regulations, the pharmacist-in-charge (PIC) is responsible for which of the following?

Personal liability for all prescriber errors
Negotiating contracts with third-party payers
The overall operation of the pharmacy, including compliance with pharmacy laws (Correct answer)
Setting the salary and benefits of all pharmacy staff

Correct answer: The overall operation of the pharmacy, including compliance with pharmacy laws

The PIC bears legal responsibility for the pharmacy's compliance with all applicable federal and state pharmacy laws and regulations governing its operation.

Question 88: Under the FD&C Act, which agency has primary authority to regulate prescription drug advertising?

Centers for Medicare & Medicaid Services (CMS)
Drug Enforcement Administration (DEA)
Federal Trade Commission (FTC)
FDA Office of Prescription Drug Promotion (OPDP) (Correct answer)

Correct answer: FDA Office of Prescription Drug Promotion (OPDP)

FDA's OPDP regulates prescription drug advertising under the FD&C Act, while FTC oversees OTC drug advertising.

Question 89: What is the purpose of a 'drug master file' (DMF) submitted to FDA?

To request accelerated approval for a life-saving drug
To notify FDA of a drug shortage in advance
To provide confidential detailed information about facilities, processes, or articles used in drug manufacturing (Correct answer)
To report adverse events associated with a marketed drug

Correct answer: To provide confidential detailed information about facilities, processes, or articles used in drug manufacturing

A DMF allows manufacturers to share proprietary information with FDA without disclosing it to other parties referencing the DMF.

Question 90: Which of the following best describes the role of a preceptor in pharmacy education?

A faculty member who teaches only didactic coursework
A pharmacist hired exclusively by pharmacy schools to manage rotations
A licensed pharmacist approved to supervise and train pharmacy interns (Correct answer)
A board of pharmacy official who evaluates intern performance

Correct answer: A licensed pharmacist approved to supervise and train pharmacy interns

A preceptor is a licensed pharmacist who has been approved by the state board to supervise pharmacy interns during experiential training.

Question 91: A patient in Illinois requests an emergency refill of a non-controlled maintenance medication and cannot reach their prescriber. Under Illinois law, what is the maximum supply a pharmacist may dispense?

7-day supply
Emergency refills are not permitted in Illinois
30-day supply (Correct answer)
72-hour supply

Correct answer: 30-day supply

Illinois law permits pharmacists to dispense up to a 30-day emergency supply of a non-controlled maintenance medication when the prescriber cannot be reached.

Question 92: A pharmacist in a hospital setting wishes to initiate and adjust the dosage of vancomycin for a specific patient. Under what authority is this action typically permitted?

A verbal order from any physician in the hospital.
A Collaborative Practice Agreement (CPA) specific to the patient or protocol. (Correct answer)
General pharmacist scope of practice as defined by the state pharmacy act.
The hospital's general medication administration policy.

Correct answer: A Collaborative Practice Agreement (CPA) specific to the patient or protocol.

A pharmacist's authority to initiate, modify, or discontinue drug therapy is typically granted through a Collaborative Practice Agreement (CPA) or a similar protocol-based arrangement with a physician or group of physicians. These agreements define the scope of the pharmacist's authority, the specific disease states or medications involved, and the documentation required. General scope of practice does not usually include independently initiating prescription drug therapy.

Question 93: Which of the following describes 'license by endorsement' in pharmacy?

A temporary license granted while awaiting NAPLEX results
A license issued to a new state based on verification of an existing valid license in another state (Correct answer)
A license issued to a pharmacy technician endorsed by their employer
A license granted to a pharmacist who passes an additional specialty exam

Correct answer: A license issued to a new state based on verification of an existing valid license in another state

Licensure by endorsement allows a licensed pharmacist in one state to obtain licensure in another state by verifying their existing license rather than retaking all exams.

Question 94: A pharmacist discovers a discrepancy in the DEA controlled substance inventory during a biennial inventory. What is the required action?

File a report with the state board only, as DEA reporting is optional for small discrepancies
Immediately notify the DEA if theft or significant loss is suspected, filing DEA Form 106 (Correct answer)
Document the discrepancy and continue operations unless theft is confirmed
Wait until the end of the year to report discrepancies in the annual report

Correct answer: Immediately notify the DEA if theft or significant loss is suspected, filing DEA Form 106

Pharmacies must report significant losses or theft of controlled substances to the DEA using Form 106 and notify local law enforcement when theft or significant unexplained loss is discovered.

Question 95: When is a pharmacist generally NOT permitted to substitute a generic drug product?

When the drug appears on the payer's formulary preferred drug list
When the patient has a valid insurance prior authorization on file
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

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 96: Under the National Drug Code (NDC) numbering system, what do the three segments of an NDC number represent?

FDA approval number, active ingredient, and route of administration
DEA schedule, therapeutic category, and lot number
Labeler, product, and package size (Correct answer)
Manufacturer, drug class, and dosage form

Correct answer: Labeler, product, and package size

The NDC number is a 10- or 11-digit code where the three segments identify the labeler (manufacturer/distributor), the product (strength, dosage form, formulation), and the package size.

Question 97: The Durham-Humphrey Amendment to the FD&C Act established the distinction between prescription and over-the-counter (OTC) drugs. Which of the following is a key provision of this amendment?

It established the Good Manufacturing Practices (GMPs) for the pharmaceutical industry.
It required manufacturers to prove drug efficacy in addition to safety.
It authorized the legality of oral prescriptions and prescription refills. (Correct answer)
It created the five schedules for controlled substances.

Correct answer: It authorized the legality of oral prescriptions and prescription refills.

The Durham-Humphrey Amendment of 1951 explicitly authorized the taking of original prescriptions orally (by phone) and the refilling of prescriptions, which were not permitted before this law. Proving efficacy was part of the 1962 Kefauver-Harris Amendments, GMPs were also formalized by Kefauver-Harris, and the scheduling of controlled substances was established by the Controlled Substances Act of 1970.

Question 98: 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 99: Which entity has primary authority to discipline a pharmacist for violations of federal pharmacy law?

The FDA exclusively
The state board of pharmacy exclusively
The DEA for controlled substance violations and the state board for other violations (Correct answer)
The FTC in conjunction with the state board

Correct answer: The DEA for controlled substance violations and the state board for other violations

The DEA enforces federal controlled substance law, while state boards of pharmacy handle state law violations and professional conduct matters.

Question 100: Which statement best describes the 'patient-specific' requirement under FDCA Section 503A?

The requirement only applies to controlled substance compounds
Compounding must be performed pursuant to a valid prescription for an identified individual patient (Correct answer)
Patient-specific means the pharmacist must personally know the patient
A pharmacy may compound batches in advance for anticipated prescriptions without violating 503A

Correct answer: Compounding must be performed pursuant to a valid prescription for an identified individual patient

503A requires compounding to occur pursuant to a valid prescription for a specifically identified individual patient, not in anticipation of future orders.

Question 101: A pharmacist receives a written prescription for a Schedule II controlled substance that was issued 35 days ago. Under federal law, what should the pharmacist do?

Dispense it because federal law has no expiration for Schedule II prescriptions
Refuse to fill it because it is beyond the 30-day limit
Use professional judgment; federal law does not set a specific fill window for Schedule IIs (Correct answer)
Contact the DEA for authorization

Correct answer: Use professional judgment; federal law does not set a specific fill window for Schedule IIs

Federal law does not specify a hard expiration date for Schedule II prescriptions; pharmacists use professional judgment, though many states impose their own time limits.

Question 102: Under the Combat Methamphetamine Epidemic Act, the daily purchase limit for pseudoephedrine is:

2.4 grams
7.5 grams
9.0 grams
3.6 grams (Correct answer)

Correct answer: 3.6 grams

CMEA limits pseudoephedrine purchases to 3.6 grams per day and 9 grams per 30-day period.

Question 103: A label on a compounded sterile preparation (CSP) must include which of the following beyond-use date (BUD) elements?

Date of compounding only
Date and time of compounding or the BUD, whichever applies (Correct answer)
A BUD is not required for CSPs dispensed same-day
Only the expiration date from the bulk drug used

Correct answer: Date and time of compounding or the BUD, whichever applies

USP <797> requires the BUD (date and time) to appear on the label of every compounded sterile preparation.

Question 104: 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?

30 calendar days
45 calendar days
15 calendar days (Correct answer)
7 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 105: A Schedule II prescription is presented to the pharmacist bearing the notation 'Do Not Fill Until 12/1.' Under the CSA, this is:

Permitted—the prescription may be filled on or after the indicated date if otherwise valid (Correct answer)
Permitted only if the prescriber has a DEA note on file authorizing post-dated prescriptions
Prohibited—Schedule II prescriptions cannot contain future fill dates
Prohibited unless the pharmacist telephones the prescriber on the date of filling

Correct answer: Permitted—the prescription may be filled on or after the indicated date if otherwise valid

A Schedule II prescription may be post-dated by the prescriber; the pharmacist may dispense it on or after the date written if the prescription is otherwise valid.

Question 106: A pharmacist counsels a patient on a new antihypertensive medication but omits information about postural hypotension. The patient falls and is injured. Which element of negligence is MOST clearly demonstrated?

Breach of duty (Correct answer)
Damages
Causation
Duty

Correct answer: Breach of duty

By failing to warn about a foreseeable and significant side effect like postural hypotension, the pharmacist breached the standard of care owed to the patient.

Question 107: A pharmacist receives a prescription for hydrocodone/acetaminophen 5/325 mg. Under the CSA, this combination product is classified as:

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

Correct answer: Schedule II

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

Question 108: What is the primary goal of a new drug's Phase 3 clinical trial?

To determine whether the drug can be safely given to humans
To assess the marketability of the drug
To evaluate the drug's safety on laboratory animals
To determine the drug's effectiveness versus the effectiveness of a placebo (Correct answer)
To determine the adverse effects and proper dosage

Correct answer: To determine the drug's effectiveness versus the effectiveness of a placebo

Large patient populations are included in phase 3 trials, often using double-masked techniques. The primary goal is to compare the effectiveness of the medication to that of a placebo-treated control group of patients.

Question 109: An electronic prescription for a Schedule II controlled substance is transmitted to the pharmacy. Under the DEA's EPCS regulations, the prescriber must authenticate using:

A single-factor password only
A handwritten digital signature only
Their DEA number and date of birth
Two-factor authentication including a hard token or biometric (Correct answer)

Correct answer: Two-factor authentication including a hard token or biometric

DEA regulations for electronic prescriptions for controlled substances (EPCS) require two-factor authentication, one of which must be a hard token or biometric.

Question 110: A patient on methadone maintenance therapy asks the pharmacist to provide their dispensing records to their spouse. The pharmacist should:

Provide the records since methadone is not a controlled substance in maintenance programs
Refuse all requests for methadone records as they are permanently sealed
Require written authorization from the patient before releasing the records (Correct answer)
Contact the methadone clinic before releasing any information

Correct answer: Require written authorization from the patient before releasing the records

Substance abuse treatment records are protected by both HIPAA and 42 CFR Part 2, requiring written patient authorization before any disclosure.

Question 111: Which of the following prescribers is federally authorized to prescribe Schedule II controlled substances?

A DEA-registered nurse practitioner in a state that grants full prescriptive authority (Correct answer)
A medical device technician
A pharmacy technician under pharmacist supervision
A pharmacist with a clinical doctorate

Correct answer: A DEA-registered nurse practitioner in a state that grants full prescriptive authority

A nurse practitioner who holds a valid DEA registration and practices in a state granting prescriptive authority for Schedule II substances may legally prescribe them.

Question 112: Which federal act requires pharmacies to maintain written policies and procedures for the pharmacist-in-charge to follow regarding patient counseling?

The Food, Drug, and Cosmetic Act
OBRA '90 (Correct answer)
The Controlled Substances Act
HIPAA Privacy Rule

Correct answer: OBRA '90

OBRA '90 required state Medicaid programs to mandate written policies and procedures for patient counseling at pharmacies.

Question 113: Under the FD&C Act, what is the definition of a 'dietary supplement'?

A food product fortified with vitamins approved by FDA as safe for addition
A product intended to supplement the diet that contains a vitamin, mineral, herb, amino acid, or other dietary ingredient (Correct answer)
A drug product derived from natural plant sources sold without a prescription
Any OTC product that provides nutritional benefits without a prescription

Correct answer: A product intended to supplement the diet that contains a vitamin, mineral, herb, amino acid, or other dietary ingredient

Section 201(ff) of the FD&C Act defines dietary supplements as products intended to supplement the diet, taken by mouth, containing a dietary ingredient.

Question 114: The Controlled Substances Act classifies drugs into schedules primarily based on which criteria?

Manufacturer recommendations and market availability
Abuse potential, accepted medical use, and safety under supervision (Correct answer)
Price, availability, and international treaty obligations
FDA approval status and patent protection

Correct answer: Abuse potential, accepted medical use, and safety under supervision

The CSA scheduling criteria include abuse potential, currently accepted medical use, and safety or dependence liability under medical supervision.

Question 115: A compounding pharmacist prepares a sterile ophthalmic solution. The preparation must be isotonic primarily because:

Isotonicity extends the Beyond-Use Date of the preparation
FDA regulations require a specific tonicity range for all sterile products
It reduces the cost of raw materials used
Hypertonic or hypotonic solutions cause discomfort and potential corneal damage (Correct answer)

Correct answer: Hypertonic or hypotonic solutions cause discomfort and potential corneal damage

Ophthalmic preparations must be isotonic to minimize irritation and prevent osmotic damage to ocular tissues.

Question 116: Which federal agency is responsible for regulating the manufacturing and labeling of prescription drugs?

CDC
DEA
FTC
FDA (Correct answer)

Correct answer: FDA

The FDA regulates drug manufacturing, labeling, safety, and efficacy under the Federal Food, Drug, and Cosmetic Act.

Question 117: A state board of pharmacy revokes a pharmacist's license due to a severe dispensing error that resulted in patient harm, followed by an attempt to cover up the incident. What is the primary purpose of this disciplinary action?

To set a legal precedent for future civil malpractice lawsuits against the pharmacist.
To protect the public health, safety, and welfare from an unprofessional or unqualified practitioner. (Correct answer)
To punish the pharmacist by imposing a significant financial penalty through loss of income.
To recover the costs of the investigation conducted by the board of pharmacy.

Correct answer: To protect the public health, safety, and welfare from an unprofessional or unqualified practitioner.

The primary mission of every state board of pharmacy is to promote, preserve, and protect the public health, safety, and welfare. Disciplinary actions, including license suspension or revocation, are not primarily intended to be punitive but are enacted to remove a practitioner who has been deemed a threat to public safety from practice. While there are secondary effects, the board's fundamental mandate is public protection.

Question 118: Under federal law, which of the following practitioners is NOT authorized to prescribe Schedule II controlled substances?

Registered nurses (RN) (Correct answer)
Medical doctors (MD)
Dentists
Doctors of osteopathy (DO)

Correct answer: Registered nurses (RN)

Registered nurses are not authorized to prescribe controlled substances under federal law; prescribing authority is granted to licensed practitioners such as MDs, DOs, and dentists.

Question 119: A patient presents a valid prescription for morphine sulfate ER 15 mg, quantity of 60 tablets. The patient states they only want to try a 15-day supply (30 tablets) initially to see if they can tolerate it. Under the Comprehensive Addiction and Recovery Act (CARA) provisions, what is the latest the patient can obtain the remaining 30 tablets?

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

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

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

Question 120: Which of the following is TRUE regarding partial filling of a Schedule II prescription?

Partial fills are permitted if the pharmacist cannot supply the full quantity, with the remainder filled within 72 hours (Correct answer)
Partial fills are permitted for any reason, with the remainder filled within 30 days
Partial fills are never permitted for Schedule II drugs
Partial fills require a new written prescription for each fill

Correct answer: Partial fills are permitted if the pharmacist cannot supply the full quantity, with the remainder filled within 72 hours

Schedule II partial fills are allowed when the full quantity cannot be supplied, but the remainder must be dispensed within 72 hours or a new prescription is required.

Question 121: Under the HIPAA Privacy Rule, a covered entity may disclose PHI for public health activities to:

Any government agency upon request
News media reporting on public health emergencies
Insurance companies for actuarial purposes
Public health authorities authorized by law to collect or receive such information (Correct answer)

Correct answer: Public health authorities authorized by law to collect or receive such information

HIPAA permits disclosure of PHI to public health authorities legally authorized to collect or receive information for public health purposes.

Question 122: The 'closed system' of distribution established by the CSA is designed to:

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

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.

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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