MPJE (Multistate Pharmacy Jurisprudence Exam) — Questions and Answers

Question 1: Under federal law, which statement must appear on the label of every dispensed prescription drug container?

Store at room temperature.
Shake well before use.
This medication may cause drowsiness.
Federal law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed. (Correct answer)

Correct answer: Federal law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed.

Federal law (21 CFR 290.5) requires the transfer-prohibition statement on all dispensed prescription containers.

Question 2: A pharmacist notices a colleague frequently making dispensing errors, exhibiting mood swings, and appearing disheveled. The pharmacist suspects the colleague may be impaired due to substance abuse. What is the pharmacist's primary professional and ethical obligation?

Anonymously inform other staff members to see if they have noticed similar behavior.
Report the suspicions to the appropriate authority, such as the pharmacy manager, the State Board of Pharmacy, or a pharmacist recovery program. (Correct answer)
Ignore the behavior to avoid conflict and protect the colleague's job.
Confront the colleague directly during a busy shift to demand an explanation.

Correct answer: Report the suspicions to the appropriate authority, such as the pharmacy manager, the State Board of Pharmacy, or a pharmacist recovery program.

A pharmacist's primary duty is to protect public health and safety. If a colleague is suspected of being impaired, this poses a significant risk to patients. The ethical and, in many states, legal obligation is to report these concerns to an appropriate entity. This could be the pharmacist's supervisor, the state's pharmacist recovery network (PRN), or the Board of Pharmacy. The goal is to intervene to protect patients and get the colleague the help they need.

Question 3: A pharmacist receives a faxed prescription for a Schedule III controlled substance. Under federal law, which statement is correct?

Faxed Schedule III prescriptions are never permitted under any circumstances
Faxed Schedule III prescriptions are only permitted in long-term care facilities
Faxed Schedule III prescriptions are permitted and may serve as the original (Correct answer)
Faxed Schedule III prescriptions require a follow-up oral confirmation within 72 hours

Correct answer: Faxed Schedule III prescriptions are permitted and may serve as the original

Federal law (21 CFR 1306.21) permits Schedule III–V prescriptions to be transmitted by fax, and the fax may serve as the original prescription.

Question 4: Which federal law established the requirement for Medication Guides (MedGuides) to be dispensed with certain prescription drugs?

FDA Modernization Act (FDAMA)
Kefauver-Harris Amendment
Food, Drug, and Cosmetic Act as amended with REMS authority (Correct answer)
Omnibus Budget Reconciliation Act (OBRA-90)

Correct answer: Food, Drug, and Cosmetic Act as amended with REMS authority

FDA regulations under the FDCA authority (21 CFR 208) require Medication Guides for drugs with serious risks, and REMS authority formalized their role.

Question 5: Under the FD&C Act, what is the maximum penalty for a first-offense misdemeanor violation?

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

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

The Controlled Substances Act
OBRA '90 (Correct answer)
The Food, Drug, and Cosmetic 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 7: A DEA registration for a retail pharmacy is valid for how long before renewal is required?

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

Correct answer: 3 years

DEA registrations for retail pharmacies are valid for three years and must be renewed before expiration.

Question 8: A pharmacist is found to have knowingly dispensed a medication based on a fraudulent prescription. This action is discovered, and the State Board of Pharmacy initiates disciplinary proceedings. What is a potential consequence of this action on the pharmacist's license in other states?

The pharmacist's licenses in other states are automatically and immediately revoked without a separate hearing.
Disciplinary action taken in one state must be reported and can serve as a basis for disciplinary action against the pharmacist's licenses in other states. (Correct answer)
There is no impact, as each state's Board of Pharmacy is an independent entity.
The pharmacist will receive a warning letter from other states but no further action.

Correct answer: Disciplinary action taken in one state must be reported and can serve as a basis for disciplinary action against the pharmacist's licenses in other states.

Disciplinary action taken by one state's Board of Pharmacy is not isolated. Pharmacists are typically required to report any such action to all other states where they hold a license. This reported action can, and often does, form the basis for the other states to open their own investigations and take reciprocal disciplinary action, which may include suspension, revocation, or other restrictions. While action isn't usually automatic without a hearing, the initial disciplinary finding is a serious matter that all other licensing boards will address.

Question 9: 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 10: Which of the following is NOT required on a prescription label for a controlled substance dispensed in the US?

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

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 11: What FDA recall classification indicates the most serious health hazard where use or exposure will cause serious adverse health consequences or death?

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

Correct answer: Class I

A Class I recall involves a reasonable probability that use of the product will cause serious adverse health consequences or death.

Question 12: 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?

Safety Data Sheet (SDS)
Compounding Record
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 13: What is the proper sequencing for the three NDC code segments?

Labeler Code, Product Segment, Package Segment (Correct answer)
Labeler Code, Package Segment, Product Segment
Product Segment, Labeler Code, Package Segment
Package Segment, Product Segment, Labeler Code
Package Segment, Labeler Code, Product Segment

Correct answer: Labeler Code, Product Segment, Package Segment

Each drug has a unique 10-digit identification code called the NDC. There are three sections: The labeler code indicates the business that makes or sells the medication. The strength, dosing form, and formulation are specified in the Product section. The size and shape of the package are specified in the Package section.

Question 14: Under the Medication Guides rule (21 CFR 208), when must a pharmacist distribute an FDA-required Medication Guide?

Only when a prescriber specifically orders it
Only on the first fill of a new prescription
Only when the patient requests written information
Each time the drug is dispensed to the patient (Correct answer)

Correct answer: Each time the drug is dispensed to the patient

FDA requires Medication Guides to be dispensed with each prescription fill for drugs with a Medication Guide requirement, not just the first dispensing.

Question 15: In Illinois, which of the following prescribers is NOT authorized to prescribe Schedule II controlled substances?

Advanced Practice Registered Nurse with prescriptive authority
Doctor of Osteopathic Medicine (DO)
Licensed physician (MD)
Optometrist holding a therapeutic license (Correct answer)

Correct answer: Optometrist holding a therapeutic license

Illinois optometrists may prescribe certain therapeutic agents but are not authorized to prescribe Schedule II controlled substances.

Question 16: Which of the following is the correct DEA schedule for tramadol?

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

Correct answer: Schedule IV

Tramadol was placed in Schedule IV by the DEA effective August 18, 2014.

Question 17: Under federal law, who bears primary responsibility for initiating a drug recall when a product is found to be adulterated or misbranded?

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)
The DEA initiates all drug product recalls

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

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

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 19: Under the FD&C Act, which of the following is required on the labeling of all prescription drug products?

The statement 'Rx only' (or 'Caution: Federal law prohibits dispensing without a prescription') (Correct answer)
A QR code linking to the manufacturer's website
The National Drug Code (NDC) in barcode format only
The retail price suggested by the manufacturer

Correct answer: The statement 'Rx only' (or 'Caution: Federal law prohibits dispensing without a prescription')

Federal law requires prescription drug labeling to bear the statement 'Rx only,' indicating that the drug may only be dispensed pursuant to a valid prescription.

Question 20: Which program is specifically designed to monitor adverse events related to vaccines in the United States?

REMS
VAERS (Vaccine Adverse Event Reporting System) (Correct answer)
FAERS
MedWatch

Correct answer: VAERS (Vaccine Adverse Event Reporting System)

VAERS (Vaccine Adverse Event Reporting System) is a national program co-managed by CDC and FDA specifically for monitoring vaccine safety.

Question 21: Which federal agency is primarily responsible for overseeing drug recalls for prescription medications?

State Board of Pharmacy
CDC
FDA (Correct answer)
DEA

Correct answer: FDA

The FDA oversees drug recalls for prescription medications, including monitoring voluntary recalls initiated by manufacturers and ordering mandatory recalls when necessary.

Question 22: Which of the following BEST describes a pharmacist's 'corresponding responsibility' under the CSA?

The obligation to match every prescription against a patient's medication history
The duty to report all Schedule II prescriptions to the DEA monthly
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)

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 23: Under which federal legal authority did the FDA gain explicit power to require a REMS program for a drug?

Prescription Drug Marketing Act (PDMA)
Dietary Supplement Health and Education Act (DSHEA)
Controlled Substances Act (CSA)
FDCA Section 505-1, added by the FDA Amendments Act of 2007 (FDAAA) (Correct answer)

Correct answer: FDCA Section 505-1, added by the FDA Amendments Act of 2007 (FDAAA)

FDCA Section 505-1, added by FDAAA 2007, explicitly grants the FDA authority to require a REMS when necessary to ensure a drug's benefits outweigh its risks.

Question 24: Under the Pharmacy Compounding Accreditation Board (PCAB) and most state regulations, who bears primary responsibility for the quality of a compounded preparation?

The prescriber who ordered it
The pharmacist who performed or supervised the compounding (Correct answer)
The pharmacy technician who physically prepared it
The patient who requested it

Correct answer: The pharmacist who performed or supervised the compounding

The pharmacist who supervises or performs compounding is legally and professionally responsible for the quality, safety, and accuracy of the compounded preparation.

Question 25: 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
The raw materials are too expensive to obtain through licensed suppliers
Compounding these products presents risks that cannot be adequately mitigated in a pharmacy setting (Correct answer)

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

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

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 27: The term 'legend drug' refers to a drug that:

Has been approved by the FDA for more than 10 years
Is listed in a state formulary
Is available without a prescription in limited quantities
Requires a prescription because it is not safe for self-medication (Correct answer)

Correct answer: Requires a prescription because it is not safe for self-medication

A legend drug bears the federal legend 'Rx only' because it is not safe for use without professional supervision and therefore requires a prescription.

Question 28: 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?

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

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 29: 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 106
DEA Form 224
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 30: The FDA Adverse Event Reporting System (FAERS) database is primarily used for which post-market purpose?

Approving new drug applications
Post-marketing safety surveillance and pharmacovigilance (Correct answer)
Issuing and renewing pharmacy licenses
Setting drug reimbursement rates

Correct answer: Post-marketing safety surveillance and pharmacovigilance

FAERS is used for post-marketing safety surveillance, helping the FDA identify new safety signals and monitor known risks for approved drugs and therapeutic biologics.

Question 31: 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.
Passing the Multistate Pharmacy Jurisprudence Examination (MPJE) for State B. (Correct answer)
Providing proof of residency in State B for at least one year.
Completing a new 1,500-hour internship in State B.

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

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

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 33: A prescription label for a dispensed medication must include directions for use. If the prescriber wrote 'use as directed,' how should the pharmacist handle the label?

Obtain clarification from the prescriber and include specific directions on the label (Correct answer)
Print 'use as directed' on the label as written by the prescriber
Leave the directions blank and counsel the patient verbally
Dispense only if the patient demonstrates knowledge of the directions

Correct answer: Obtain clarification from the prescriber and include specific directions on the label

Pharmacists should obtain specific directions from the prescriber so the label can include clear, unambiguous instructions for the patient's safety.

Question 34: Under the Ryan Haight Act, an online pharmacy that dispenses controlled substances must hold a DEA registration AND comply with which additional requirement?

Have a licensed pharmacist on call 24 hours per day
Accept only faxed prescriptions
Conduct at least one in-person medical evaluation before prescribing (Correct answer)
Operate only in states that allow telepharmacy

Correct answer: Conduct at least one in-person medical evaluation before prescribing

The Ryan Haight Act requires at least one valid in-person medical evaluation before a controlled substance may be prescribed via the internet.

Question 35: 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 with patient consent, a valid court order, or a subpoena, or as required by state law (Correct answer)
Provide all requested records immediately to cooperate with law enforcement
Refuse all law enforcement requests regardless of documentation provided
Provide records only after notifying the patient and receiving their signed release

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

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

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 37: 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 patient cannot provide a photo ID for a non-controlled prescription
The pharmacist believes the prescription is not for a legitimate medical purpose (Correct answer)
The prescription was phoned in rather than written

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

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

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

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

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 40: A 'market withdrawal' under FDA regulations refers to which situation?

A recall for a life-threatening Class I health hazard
Suspension of a drug's NDA approval
Removal of a product involving a minor violation not subject to legal action (Correct answer)
An FDA-mandated removal by court order

Correct answer: Removal of a product involving a minor violation not subject to legal action

A market withdrawal involves a product removed due to a minor violation that would not be subject to legal action, distinguishing it from a formal recall.

Question 41: 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?

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

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 42: A pharmacist is presented with a prescription for a high-dose opioid from a prescriber they are unfamiliar with, for a patient who traveled 50 miles to their pharmacy. Which of the following concepts best describes the pharmacist's legal obligation in this situation?

The Learned Intermediary Doctrine
The Durham-Humphrey Amendment
Respondeat Superior
Corresponding Responsibility (Correct answer)

Correct answer: Corresponding Responsibility

The concept of 'Corresponding Responsibility' is a federal law (21 C.F.R. § 1306.04) that places a duty on the pharmacist to ensure that a controlled substance prescription is issued for a legitimate medical purpose. The presence of several 'red flags' (e.g., unfamiliar prescriber, long travel distance, high dose) requires the pharmacist to take affirmative steps to validate the prescription's legitimacy before dispensing. The responsibility is shared between the prescriber and the pharmacist.

Question 43: A pharmacy technician notices that the DEA registration certificate has expired. Which action is MOST appropriate?

Cease dispensing all controlled substances until the registration is renewed (Correct answer)
Continue dispensing until the renewed certificate arrives
Only dispense Schedule III–V drugs until renewal
Contact the state board for a temporary exemption

Correct answer: Cease dispensing all controlled substances until the registration is renewed

A pharmacy must not dispense controlled substances without a valid, current DEA registration; all controlled substance dispensing must stop.

Question 44: Under the CSA, which DEA form must a practitioner use to report the theft or significant loss of controlled substances?

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

Correct answer: DEA Form 106

DEA Form 106 is required to report theft or significant loss of controlled substances to the DEA.

Question 45: Under federal law, what is the maximum number of refills permitted for a Schedule III controlled substance?

No refills allowed
Unlimited refills with prescriber authorization
Up to 12 refills within 1 year
Up to 5 refills within 6 months (Correct answer)

Correct answer: Up to 5 refills within 6 months

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

Question 46: 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 II Recall
Market Withdrawal
Class I Recall (Correct answer)
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 47: Under the Model State Pharmacy Act, who holds ultimate responsibility for the legal operation of a pharmacy?

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

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 48: A pharmacy technician trainee is working at a pharmacy. Which statement is MOST accurate regarding their scope of practice?

They may perform all technician duties immediately upon hire
They may independently verify other technicians' work
They must work under direct supervision until licensed or registered (Correct answer)
They have the same authority as a certified technician

Correct answer: They must work under direct supervision until licensed or registered

Technician trainees must work under direct pharmacist supervision and are limited in their duties until they obtain the required state registration or licensure.

Question 49: Which FD&C Act pathway provides 5 years of new chemical entity (NCE) exclusivity for a newly approved drug?

Orphan drug exclusivity under Section 527
Fast track designation under Section 506(b)
Pediatric exclusivity under Section 505A
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 50: Under Illinois law, what is the minimum continuing education (CE) requirement for a pharmacist to renew their license?

15 contact hours per renewal cycle
40 contact hours per renewal cycle
30 contact hours per renewal cycle (Correct answer)
20 contact hours per renewal cycle

Correct answer: 30 contact hours per renewal cycle

Illinois requires pharmacists to complete 30 contact hours of approved continuing education per 2-year renewal cycle.

Question 51: Under federal law, which individual may serve as the designated representative for a DEA-registered pharmacy?

The pharmacy owner if not a licensed pharmacist
Any licensed healthcare provider on staff
The pharmacist-in-charge or another responsible pharmacist (Correct answer)
Any licensed pharmacy technician

Correct answer: The pharmacist-in-charge or another responsible pharmacist

The DEA requires that a pharmacist-in-charge or another responsible pharmacist serve as the designated representative accountable for controlled substance compliance.

Question 52: Under the Omnibus Budget Reconciliation Act of 1990 (OBRA '90), what must a pharmacist offer to Medicaid patients at the point of sale?

A printed medication guide
A copy of the prescriber's notes
A drug interaction printout
A verbal or written offer to counsel (Correct answer)

Correct answer: A verbal or written offer to counsel

OBRA '90 requires pharmacists to offer prospective drug utilization review and counseling to Medicaid patients, typically fulfilled by a verbal or written offer to counsel.

Question 53: Under the Durham-Humphrey Amendment, which category of drugs requires a prescription from a licensed practitioner before dispensing?

All Schedule I–V controlled substances only
Any drug with a narrow therapeutic index
Drugs with FDA Black Box Warnings only
Drugs that are habit-forming, not safe for self-medication, or require professional supervision (Correct answer)

Correct answer: Drugs that are habit-forming, not safe for self-medication, or require professional supervision

The Durham-Humphrey Amendment defines legend drugs as those habit-forming, unsafe for self-diagnosis/treatment, or requiring practitioner supervision.

Question 54: A pharmacist fills a prescription for a Schedule II medication. In addition to standard prescription label information (pharmacy name/address, patient name, etc.), which specific cautionary statement is federally required to be on the label?

"Store in a cool, dry place away from children."
"Take with food to avoid stomach upset."
"CAUTION: Federal law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed." (Correct answer)
"May cause drowsiness; do not operate heavy machinery."

Correct answer: "CAUTION: Federal law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed."

Federal law (21 CFR 290.5) requires that the label of any dispensed Schedule II, III, or IV controlled substance must contain the specific cautionary statement: "CAUTION: Federal law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed." The other statements are common and important auxiliary labels but are not explicitly mandated by federal law for all Schedule II drugs.

Question 55: Under the FD&C Act, which agency has primary authority to regulate prescription drug advertising?

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

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 56: Under federal law, how long must a pharmacy retain dispensing records for Schedule II controlled substances?

3 years from the date of dispensing
5 years from the date of dispensing
2 years from the date of dispensing (Correct answer)
7 years from the date of dispensing

Correct answer: 2 years from the date of dispensing

Federal DEA regulations (21 CFR 1304.04) require that Schedule II controlled substance records be maintained for a minimum of 2 years.

Question 57: Upon discovering a significant loss of a Schedule IV controlled substance, a pharmacy is required to take which of the following actions within one business day?

Notify the state board of pharmacy and the local police.
Notify the local DEA Diversion Field Office in writing. (Correct answer)
Conduct a complete physical inventory of all controlled substances.
Complete and submit a DEA Form 106 to the local DEA office.

Correct answer: Notify the local DEA Diversion Field Office in writing.

According to 21 CFR §1301.76(b), a registrant must notify the local DEA Diversion Field Office, in writing, of any theft or significant loss of any controlled substances within one business day of discovery. While completing a DEA Form 106 is also required, the initial notification must happen within one business day, and the form itself has a longer submission deadline (45 days).

Question 58: A pharmacist receives a prescription for a compounded preparation that is commercially available. Under FDCA Section 503A, this is permissible only if:

The patient has documented an allergy to the commercial product's excipient
The prescriber provides a medical necessity statement
All of the above may be acceptable justifications (Correct answer)
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 59: 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:

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

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 60: 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?

7 days (Correct answer)
72 hours
24 hours
48 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 61: 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)
Discard Date
Stability 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 62: A pharmacist discovers during a weekly inventory check that a full stock bottle of zolpidem 10mg tablets is missing and cannot be accounted for, constituting a significant loss. What is the first action the pharmacy must take according to federal law?

Immediately report the loss to the local police department.
Complete and submit a DEA Form 106 online within 24 hours.
Notify the local DEA Diversion Field Office in writing within one business day of discovery. (Correct answer)
Conduct a thorough internal investigation before contacting any external agencies.

Correct answer: Notify the local DEA Diversion Field Office in writing within one business day of discovery.

Upon discovery of a theft or significant loss of controlled substances, a DEA registrant must first notify the local DEA Diversion Field Office in writing (which can include email or fax) within one business day. After this initial notification, the registrant must then conduct an investigation and submit a DEA Form 106 within 45 days.

Question 63: 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 student practitioner DEA registration
A temporary pharmacist permit
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 64: Which of the following is NOT a required element of patient counseling under OBRA '90 for new prescriptions?

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

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 65: Under Illinois law, a pharmacy technician must complete how many hours of practical experience before being eligible for a pharmacy technician license?

180 hours
400 hours
500 hours
Illinois has no statutory hour requirement for technician licensure (Correct answer)

Correct answer: Illinois has no statutory hour requirement for technician licensure

Illinois requires pharmacy technicians to pass a national certification exam (PTCE or ExCPT) but does not specify a minimum practical hour requirement by statute for initial licensure.

Question 66: During a medication therapy management (MTM) consultation, a pharmacist identifies that a patient is taking a medication for a condition not listed in their medical history. The pharmacist should:

Refuse to continue the MTM session until complete records are provided
Ignore the discrepancy to avoid embarrassing the patient
Immediately contact all of the patient's prescribers without the patient's consent
Document the medication and counsel the patient to ensure safety and comprehensiveness (Correct answer)

Correct answer: Document the medication and counsel the patient to ensure safety and comprehensiveness

Comprehensive MTM requires complete medication reconciliation; documenting and counseling ensures patient safety without violating confidentiality.

Question 67: What is the purpose of a 'drug master file' (DMF) submitted to FDA?

To report adverse events associated with a marketed drug
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)

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 68: A new pharmacy is preparing to open. The designated Pharmacist-in-Charge (PIC) is responsible for many initial setup tasks. Which of the following is a critical personnel-related duty for the PIC before the pharmacy can legally operate?

Ordering the initial inventory of over-the-counter medications.
Ensuring all employed pharmacy technicians are registered or licensed with the State Board as required. (Correct answer)
Setting up the pharmacy's billing system with insurance companies.
Designing the pharmacy's logo and branding.

Correct answer: Ensuring all employed pharmacy technicians are registered or licensed with the State Board as required.

The PIC is responsible for ensuring that all pharmacy personnel meet the legal requirements to practice in that state. This includes verifying that pharmacy technicians have the appropriate and current registration or license from the Board of Pharmacy before they are allowed to perform any technician duties. The other tasks are important business functions but are not a direct regulatory requirement related to personnel licensure that falls under the PIC's legal responsibility.

Question 69: The Ryan Haight Online Pharmacy Consumer Protection Act of 2008 sets requirements for prescribing controlled substances via the internet. Generally, what is the primary requirement a practitioner must meet before they can legally issue a prescription for a controlled substance to a patient based on a telemedicine encounter?

The practitioner must have conducted at least one prior in-person medical evaluation of the patient. (Correct answer)
The practitioner must record the entire telemedicine encounter and store it for two years.
The practitioner must obtain a special telemedicine registration from the DEA.
The patient must sign a specific consent form acknowledging the risks of remote prescribing.

Correct answer: The practitioner must have conducted at least one prior in-person medical evaluation of the patient.

The Ryan Haight Act generally requires that a prescribing practitioner must have conducted at least one in-person medical evaluation of the patient before issuing a prescription for a controlled substance via the internet or telemedicine. While there are exceptions and temporary waivers (such as those enacted during the COVID-19 public health emergency), the baseline federal requirement is a prior in-person visit.

Question 70: A pharmacy receives a drug product with labeling that lacks the required National Drug Code (NDC) number. Under the FD&C Act, this drug is considered:

Misbranded (Correct answer)
Counterfeit
Investigational
Adulterated

Correct answer: Misbranded

Absence of required labeling information such as the NDC number renders the drug misbranded under the FD&C Act.

Question 71: Under the Illinois Pharmacy Practice Act, which of the following activities constitutes the practice of pharmacy?

Interpreting and evaluating a prescription drug order (Correct answer)
Receiving and logging incoming drug shipments
Stocking shelves with non-prescription merchandise
Selling OTC vitamins and supplements

Correct answer: Interpreting and evaluating a prescription drug order

Interpreting and evaluating a prescription drug order falls within the statutory definition of pharmacy practice in Illinois.

Question 72: Which federal regulation governs the requirements for pharmacy compounding under Section 503A of the FDCA?

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
Compounded preparations under 503A are exempt from all USP standards
Compounding is only permissible for licensed outsourcing facilities registered with the FDA

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 73: When a prescriber writes 'Dispense as Written' (DAW) on a prescription, the pharmacist must:

Use professional judgment to select the most cost-effective product
Dispense the brand-name drug exactly as written without generic substitution (Correct answer)
Obtain prior authorization from the payer before dispensing
Dispense directions in written form only, without verbal counseling

Correct answer: Dispense the brand-name drug exactly as written without generic substitution

A 'Dispense as Written' instruction obligates the pharmacist to dispense the specific brand-name product as written, overriding state drug product selection laws that would otherwise permit substitution.

Question 74: Under federal law, a traditional 503A pharmacy may compound a drug product in limited quantities before the receipt of a prescription for an individual patient. This practice is known as:

Anticipatory compounding (Correct answer)
Outsourcing
Office-use compounding
cGMP manufacturing

Correct answer: Anticipatory compounding

Section 503A of the FD&C Act permits a pharmacy to compound in limited quantities before receiving a patient-specific prescription, provided it is based on a history of receiving valid prescriptions for that specific compounded product. This practice is known as anticipatory compounding. Office-use compounding (compounding for prescribers to have as stock) is generally not permitted for 503A pharmacies under federal law and is the domain of 503B outsourcing facilities.

Question 75: A prescription for amoxicillin 500 mg is written for 'qty: 30 capsules, no refills.' Three weeks later the patient calls requesting a refill. What should the pharmacist do?

Dispense up to a 72-hour emergency supply and notify the prescriber
Dispense a one-time courtesy refill as amoxicillin is not a controlled substance
Contact the prescriber for a new prescription or refill authorization before dispensing (Correct answer)
Refuse any dispensing as the prescription is expired

Correct answer: Contact the prescriber for a new prescription or refill authorization before dispensing

When a prescription has no refills authorized, the pharmacist must obtain a new prescription or authorization from the prescriber before dispensing additional medication.

Question 76: Which of the following actions could be grounds for a State Board of Pharmacy to suspend or revoke a pharmacist's license?

Failing to complete the required number of continuing education hours for license renewal. (Correct answer)
Refusing to fill a prescription due to a suspected forgery.
Working as a pharmacist for more than 12 consecutive hours in an emergency situation.
Reporting a suspected adverse drug reaction to the FDA's MedWatch program.

Correct answer: Failing to complete the required number of continuing education hours for license renewal.

State boards of pharmacy establish continuing education (CE) requirements to ensure pharmacists maintain their competency. Failure to complete and report the required CE hours is a common reason for disciplinary action, which can include fines, license suspension, or non-renewal. The other actions are examples of professional responsibility (refusing a forgery, reporting an ADR) or are often permissible under specific circumstances (extended hours during an emergency).

Question 77: Which of the following information is NOT required on a prescription label for a non-controlled drug?

Name and address of the dispensing pharmacy
Directions for use
Patient's date of birth (Correct answer)
Name of the prescribing practitioner

Correct answer: Patient's date of birth

Federal law does not require the patient's date of birth on a prescription label, though other identifying information such as the patient's name is required.

Question 78: A patient requests an early refill of a Schedule III controlled substance because they will be traveling. The pharmacist may:

Dispense an early refill if the prescriber authorizes it and state law permits (Correct answer)
Automatically refill up to 5 days early under federal law
Dispense up to a 30-day emergency supply at their discretion
Deny all early refills without exception for Schedule III drugs

Correct answer: Dispense an early refill if the prescriber authorizes it and state law permits

Early refills of Schedule III–V may be dispensed if the prescriber authorizes it and state law does not prohibit the practice.

Question 79: Act on controlled substances.

A pharmacy can partially fill a schedule 2 med as long as the remainder is filled within
This law gave the FDA authority to determine schedule of controlled substances (Correct answer)
How many schedule 2 prescriptions can a doctor write for a patient at once
When should the supplier forward the green copy 2 of the dea form to the DEA

Correct answer: This law gave the FDA authority to determine schedule of controlled substances

The Controlled Substances Act (CSA) is a federal law in the United States that was enacted in 1970. It establishes a framework for the regulation of controlled substances, including drugs and substances that have the potential for abuse and dependence. The CSA aims to prevent the misuse and illegal distribution of these substances while ensuring access to them for legitimate medical and scientific purposes.

Question 80: What does an 'AB' rating in the FDA's Orange Book indicate about a generic drug product?

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

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

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

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 82: 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?

Counseling is only required if the patient explicitly asks for it.
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.

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 83: When a patient is brought to the hospital, she cannot identify the prescriptions she takes at home. To get a list of prescriptions, the hospital pharmacist calls the patient's outpatient pharmacy. Which statement is accurate?

This is a HIPAA violation unless the patient has given written and verbal consent for the information to be given to the hospital pharmacy
This is a HIPAA violation unless the patient has given verbal consent for the information to be given to the hospital pharmacy
This is not a HIPAA violation because the information is being given to the hospital pharmacy for treatment purposes (Correct answer)
This is not a HIPAA violation because HIPAA does not apply to patients being treated in a hospital setting
This is a HIPAA violation unless the patient has given signed consent for the information to be given to the hospital pharmacy

Correct answer: This is not a HIPAA violation because the information is being given to the hospital pharmacy for treatment purposes

HIPAA permits the use of protected health information (PHI) for treatment purposes. This information can be given to anyone involved in the patient’s care, and does not require written or verbal consent.

Question 84: 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 85: A pharmacist has been designated as the Pharmacist in Charge (PIC) for a community pharmacy. Which of the following statements BEST describes the ultimate responsibility of the PIC?

The PIC is responsible for the pharmacy's overall compliance with all state and federal laws and regulations. (Correct answer)
The PIC is solely responsible for counseling every patient who receives a new prescription.
The PIC's primary responsibility is to manage the work schedules of all pharmacy staff.
The PIC is only liable for their own dispensing errors and not those of staff pharmacists or technicians.

Correct answer: The PIC is responsible for the pharmacy's overall compliance with all state and federal laws and regulations.

The Pharmacist in Charge (PIC) is the individual who accepts responsibility for the operation of a pharmacy in conformance with all laws and regulations pertinent to the practice of pharmacy. While they may delegate tasks like counseling or scheduling, they hold the ultimate accountability for the legal and professional conduct of the entire pharmacy, including the actions of all personnel.

Question 86: A pharmacist's license has lapsed for 3 years. Which requirement is MOST commonly imposed by state boards before reinstatement?

Retaking the MPJE examination
Completion of continuing education hours (Correct answer)
Payment of a reinstatement fee only
Retaking the NAPLEX examination

Correct answer: Completion of continuing education hours

Most state boards require completion of a specified number of continuing education hours as a primary condition for reinstatement of a lapsed pharmacist license.

Question 87: Which of the following describes 'license by endorsement' in pharmacy?

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

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 88: Under federal law, which controlled substance schedule requires a written prescription and cannot be called in to the pharmacy by a physician (except in emergencies)?

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

Correct answer: Schedule II

Schedule II controlled substances require a written or electronic prescription and may only be telephoned in during a documented emergency.

Question 89: Under the Controlled Substances Act, an emergency oral Schedule II prescription must be dispensed in what quantity?

A maximum of a 72-hour supply
Any quantity at the pharmacist's professional judgment
A full 30-day supply
Only the quantity adequate to treat the patient during the emergency period (Correct answer)

Correct answer: Only the quantity adequate to treat the patient during the emergency period

An emergency oral Schedule II prescription may only be dispensed in the quantity necessary to treat the patient during the emergency period.

Question 90: Under USP <795>, a non-sterile compounded preparation with an aqueous oral dosage form that uses no preservatives has a default BUD of:

30 days at any temperature
6 months
14 days refrigerated (Correct answer)
35 days at controlled room temperature

Correct answer: 14 days refrigerated

USP <795> assigns a default BUD of 14 days refrigerated for non-preserved aqueous oral non-sterile preparations.

Question 91: Which of the following best describes a pharmacist's 'corresponding responsibility' for controlled substance prescriptions?

The pharmacist is responsible for billing the correct insurance for controlled substance dispensing
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

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 92: Which of the following practitioners is NOT eligible to obtain a DEA registration to prescribe controlled substances?

Nurse practitioner with prescriptive authority
Pharmacist practicing in a long-term care facility (Correct answer)
Physician assistant with appropriate state authority
Veterinarian

Correct answer: Pharmacist practicing in a long-term care facility

Pharmacists are not practitioners eligible for a DEA prescriber registration; they may obtain a dispensing registration but cannot prescribe.

Question 93: 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'?

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

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 94: A pharmacist is required to document patient counseling refusals because:

Insurance companies require documentation of counseling completion for reimbursement
Documentation provides evidence that the offer to counsel was made, protecting the pharmacy legally (Correct answer)
Refusals must be reported to state pharmacy boards within 30 days
State and federal law requires documentation of all patient interactions

Correct answer: Documentation provides evidence that the offer to counsel was made, protecting the pharmacy legally

Documenting counseling refusals provides a legal record that the pharmacist fulfilled their duty to offer counseling even when the patient declined.

Question 95: 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)
Automatic FDA approval without bioequivalence testing
Permanent patent rights over the generic formulation
A 5-year data exclusivity period

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 96: The Combat Methamphetamine Epidemic Act (CMEA) limits the sale of pseudoephedrine to no more than how many grams per day per customer?

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

Correct answer: 3.6 grams

The CMEA limits pseudoephedrine sales to 3.6 grams per day per purchaser.

Question 97: Which of the following actions requires a pharmacist's professional judgment and CANNOT be delegated to a pharmacy technician?

Counting tablets for a prescription
Performing the final verification of a dispensed prescription (Correct answer)
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 98: A pharmacy intern's registration is typically valid for a maximum period of:

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
Five years, regardless of school enrollment status

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 99: A pharmacist is counseling a patient on a new prescription for warfarin. According to the principles established by OBRA '90, which of the following points of information is the pharmacist expected to cover during the counseling session?

The pharmacy's current inventory level of the medication.
Common severe side effects or adverse effects. (Correct answer)
The manufacturer's wholesale acquisition cost.
The date the drug's patent is set to expire.

Correct answer: Common severe side effects or adverse effects.

OBRA '90 suggests several topics for counseling to ensure safe and effective medication use. These include the name of the drug, dosage, route of administration, and critically, information on common severe side effects, adverse effects, or interactions, and what action to take if they occur. Financial details, inventory levels, and patent information are not part of the required counseling points for patient safety.

Question 100: Under FD&C Act Section 503A, which of the following is a requirement for a compounded drug to be exempt from NDA and labeling requirements?

The drug must be compounded based on a valid prescription for an identified individual patient (Correct answer)
The drug must be on the FDA's shortage list
The compounding pharmacy must be licensed in at least 10 states
The drug must be compounded in advance and kept in a large stock inventory

Correct answer: The drug must be compounded based on a valid prescription for an identified individual patient

Section 503A exemptions apply to patient-specific compounding by licensed pharmacists based on valid prescriptions.

Question 101: According to federal law, which of the following is a requirement for a pharmacy's biennial controlled substance inventory?

The inventory record must be submitted to the DEA within 45 days of completion.
An exact count is required for all Schedule III, IV, and V substances.
The inventory must be taken on the same date every two years.
An exact physical count of all Schedule II controlled substances is mandatory. (Correct answer)

Correct answer: An exact physical count of all Schedule II controlled substances is mandatory.

Federal law requires an actual physical count of all Schedule II controlled substances during an inventory. For Schedule III, IV, and V substances, an estimated count is permissible unless the container holds more than 1,000 tablets or capsules, in which case an exact count is required.

Question 102: In Illinois, which of the following controlled substance prescriptions may be partially filled at the patient's request?

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

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 103: A pharmacist receives a fax of a Schedule II prescription. Under federal law, which statement is CORRECT?

Faxed Schedule II prescriptions are valid if the prescriber's signature is original on the fax
Faxed Schedule II prescriptions are valid for all dispensing purposes
Faxed Schedule II prescriptions are never valid under federal law
Faxed Schedule II prescriptions may serve as the original only for specific exceptions such as compounded preparations for home infusion patients (Correct answer)

Correct answer: Faxed Schedule II prescriptions may serve as the original only for specific exceptions such as compounded preparations for home infusion patients

Federal law generally requires original written or electronic Schedule II prescriptions, but faxes may serve as the original for limited exceptions including home infusion, hospice patients, and compounded Schedule II substances.

Question 104: The FD&C Act's Drug Quality and Security Act (DQSA) established which system to track prescription drug products through the supply chain?

The Drug Enforcement Administration's ARCOS system
The FDA's MedWatch reporting program
The Drug Supply Chain Security Act (DSCSA) electronic tracing system (Correct answer)
The National Drug Code (NDC) directory

Correct answer: The Drug Supply Chain Security Act (DSCSA) electronic tracing system

The DSCSA, enacted as Title II of DQSA, established requirements for an electronic, interoperable system to identify and trace prescription drugs as they are distributed in the US.

Question 105: A pharmacy discovers that a Schedule II drug was stolen. Under DEA regulations, the pharmacy must notify the DEA field office within:

30 days of discovery
72 hours of discovery
24 hours of discovery (Correct answer)
1 business day of discovery

Correct answer: 24 hours of discovery

Pharmacies must notify the nearest DEA field office by telephone within 24 hours upon discovery of a significant theft or loss of controlled substances.

Question 106: Under the Combat Methamphetamine Epidemic Act (CMEA), what is the daily sales limit per purchaser for ephedrine-containing OTC products?

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

Correct answer: 3.6 grams

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

Question 107: A pharmacist dispensing a drug with a REMS Medication Guide requirement must provide the Medication Guide at which point?

Only when specifically requested by the patient
Only when the prescriber includes a written request
Each time the drug is dispensed, including refills (Correct answer)
Only for the first dispensing of a new prescription

Correct answer: Each time the drug is dispensed, including refills

FDA regulations require that a Medication Guide be dispensed with every fill of the applicable drug, including refills, to ensure patients have consistent access to safety information.

Question 108: 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 IV
Schedule V
Schedule III

Correct answer: Schedule II

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

Question 109: Which of the following constitutes a 'serious' adverse event under FDA adverse event reporting definitions?

Any event reported by a patient regardless of severity
Any side effect requiring a dose adjustment
An event resulting in death, hospitalization, persistent disability, or congenital anomaly (Correct answer)
Any event requiring an OTC medication for treatment

Correct answer: An event resulting in death, hospitalization, persistent disability, or congenital anomaly

Under FDA definitions, a serious adverse event includes outcomes such as death, inpatient hospitalization, persistent or significant disability, congenital anomaly, or other medically important conditions.

Question 110: The FD&C Act's Drug Supply Chain Security Act (DSCSA) provisions require trading partners to track and trace drugs using which identifier?

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

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

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

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 112: Under the pharmacy practice act in most states, which action by a pharmacist would most likely result in mandatory license revocation rather than discretionary discipline?

Failing to counsel a patient on a new prescription
Dispensing a prescription with a labeling error
Failing to submit continuing education records on time
A second conviction for diverting controlled substances (Correct answer)

Correct answer: A second conviction for diverting controlled substances

Many states mandate revocation upon a second controlled substance diversion conviction, whereas most other violations are subject to discretionary discipline.

Question 113: Under the FD&C Act, 'homeopathic' drug products are regulated as:

Dietary supplements exempt from all drug approval requirements
Biologics requiring a BLA
Medical devices requiring 510(k) clearance
Drugs subject to the same adulteration and misbranding provisions as other drugs (Correct answer)

Correct answer: Drugs subject to the same adulteration and misbranding provisions as other drugs

Homeopathic products are regulated as drugs under the FD&C Act and must comply with adulteration and misbranding requirements.

Question 114: 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
7 calendar days
15 calendar days (Correct answer)
45 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 115: What does the FD&C Act require for a drug to qualify for the 'Rx-to-OTC switch' pathway?

Adequate safety data showing it can be used without practitioner supervision (Correct answer)
DEA scheduling must be removed before the switch
A new NDA must be submitted as if the drug were entirely new
FDA must hold a public hearing with mandatory comment period

Correct answer: Adequate safety data showing it can be used without practitioner supervision

An Rx-to-OTC switch requires demonstrating that consumers can safely self-select and use the drug without a prescriber's supervision.

Question 116: 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 117: When a DEA-registered pharmacy closes permanently, what must happen to its remaining controlled substance inventory?

Destroy on-site without notifying the DEA
Transfer to the state board of pharmacy for redistribution
Transfer to another DEA registrant or return to the manufacturer with DEA approval (Correct answer)
Donate to a local hospital without restriction

Correct answer: Transfer to another DEA registrant or return to the manufacturer with DEA approval

Upon permanent closure, a pharmacy must transfer remaining controlled substances to another DEA registrant or return them to the manufacturer, following DEA disposal regulations.

Question 118: The Secure and Responsible Drug Disposal Act of 2010 allows ultimate users to dispose of their unwanted pharmaceutical controlled substances. Which of the following is NOT a DEA-authorized method for an ultimate user to dispose of these medications?

Giving them to law enforcement during a take-back event.
Depositing them in an authorized collection receptacle at a local pharmacy that is registered as a collector.
Using a mail-back package provided by a DEA-authorized collector.
Returning them to the pharmacy where they were originally dispensed for destruction if the pharmacy is not a registered collector. (Correct answer)

Correct answer: Returning them to the pharmacy where they were originally dispensed for destruction if the pharmacy is not a registered collector.

The Secure and Responsible Drug Disposal Act and its implementing regulations expand disposal options for ultimate users to include take-back events, mail-back programs, and collection receptacles at authorized locations. A pharmacy cannot accept controlled substances back from a patient for disposal unless it has modified its DEA registration to become an authorized collector. Simply being the original dispensing pharmacy does not grant this authority.

Question 119: Under the Prescription Drug Marketing Act (PDMA), which of the following activities is prohibited?

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
A manufacturer providing drug samples to licensed practitioners upon written request

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 120: When a pharmacist-in-charge (PIC) accepts responsibility for a new pharmacy, they become liable for:

All prior violations at that pharmacy regardless of when they occurred
Violations related to controlled substances only
Only violations that occur after they assume the PIC role (Correct answer)
Violations that the previous PIC failed to report to the board

Correct answer: Only violations that occur after they assume the PIC role

A PIC assumes legal responsibility for compliance from the date they accept the role; they are not retroactively responsible for prior violations.

Question 121: 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?

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

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

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

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.

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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