MPJE (Multistate Pharmacy Jurisprudence Exam) — Questions and Answers

Question 1: 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 authorized the legality of oral prescriptions and prescription refills. (Correct answer)
It created the five schedules for controlled substances.
It required manufacturers to prove drug efficacy in addition to safety.
It established the Good Manufacturing Practices (GMPs) for the pharmaceutical industry.

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 2: Under federal law, what is the maximum number of refills allowed for a Schedule IV controlled substance?

5 refills within 6 months (Correct answer)
Unlimited refills within 12 months
No refills are permitted for Schedule IV substances
3 refills within 6 months

Correct answer: 5 refills within 6 months

Schedule IV controlled substances may be refilled up to 5 times within 6 months of the original prescription date under federal law.

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

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: According to federal law, which of the following is a required element on the prescription label for a dispensed Schedule IV controlled substance?

The pharmacy's DEA number.
A 'Caution: Federal law prohibits the transfer...' statement. (Correct answer)
The patient's date of birth.
The lot number and expiration date of the drug.

Correct answer: A 'Caution: Federal law prohibits the transfer...' statement.

Federal law, specifically 21 CFR 290.5, requires that the label of any dispensed Schedule II, III, or IV controlled substance must contain the statement: 'CAUTION: Federal law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed.'

Question 5: 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
20 contact hours per renewal cycle
30 contact hours per renewal cycle (Correct answer)

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 6: A prescriber writes a prescription for 'Zolpidem CR 12.5 mg – dispense #30, 3 refills.' Zolpidem is a Schedule IV controlled substance. Under federal law, what is the maximum number of refills permitted?

No refills are permitted for Schedule IV substances
5 refills within 6 months of the original prescription date (Correct answer)
Refills are unlimited within 12 months for Schedule IV
3 refills as written by the prescriber

Correct answer: 5 refills within 6 months of the original prescription date

Federal law limits Schedule III–V prescriptions to a maximum of 5 refills within 6 months of the date issued, so the prescriber's 3 refills are within the allowable maximum.

Question 7: When a patient declines counseling, the pharmacist should:

Report the refusal to the prescriber immediately
Refuse to dispense the prescription until counseling is accepted
Document the declination and dispense the prescription (Correct answer)
Require a signed waiver before dispensing

Correct answer: Document the declination and dispense the prescription

If a patient declines the offer to counsel, the pharmacist should document the refusal and proceed with dispensing the prescription.

Question 8: 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 recover the costs of the investigation conducted by the board of pharmacy.
To protect the public health, safety, and welfare from an unprofessional or unqualified practitioner. (Correct answer)
To set a legal precedent for future civil malpractice lawsuits against the pharmacist.
To punish the pharmacist by imposing a significant financial penalty through loss of income.

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

The drug is therapeutically equivalent to the reference listed drug (Correct answer)
The drug has known bioequivalence problems
The drug has not yet been evaluated for therapeutic equivalence
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 10: Narrow therapeutic index (NTI) drugs require special consideration during generic substitution because:

They are always more expensive than other drug products
They require a DEA registration number for dispensing
They are excluded from the Orange Book rating system
Small differences in blood drug levels can result in therapeutic failure or serious toxicity (Correct answer)

Correct answer: Small differences in blood drug levels can result in therapeutic failure or serious toxicity

NTI drugs have a narrow margin between therapeutic and toxic blood concentrations, meaning even minor bioequivalence differences can have significant clinical consequences.

Question 11: 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 date the drug's patent is set to expire.
The pharmacy's current inventory level of the medication.
Common severe side effects or adverse effects. (Correct answer)
The manufacturer's wholesale acquisition cost.

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

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

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 13: Under HIPAA, a pharmacist may disclose a patient's protected health information without authorization to:

Another treating provider involved in the patient's care (Correct answer)
The patient's employer upon request
The patient's adult child without the patient's consent
A law firm representing the patient's insurer

Correct answer: Another treating provider involved in the patient's care

HIPAA's Treatment exception permits disclosure to other treating providers without patient authorization.

Question 14: A pharmacist fills a prescription for warfarin and fails to warn the patient about significant drug-food interactions. The patient suffers a serious bleeding event. What legal doctrine most directly applies?

Strict liability
Pharmacy malpractice / professional negligence (Correct answer)
Respondeat superior
Negligence per se

Correct answer: Pharmacy malpractice / professional negligence

Failure to provide adequate drug interaction counseling constitutes professional negligence (malpractice) because the pharmacist breached the standard of care owed to the patient.

Question 15: The biennial inventory for controlled substances must be taken at what time of the business day?

At the start or close of business on the inventory date (Correct answer)
At any time during business hours with no restriction
At the end of the business day only
Exactly at midnight on the inventory date

Correct answer: At the start or close of business on the inventory date

Federal DEA regulations require the biennial inventory to be taken at the opening or close of business on the selected inventory date.

Question 16: Which examination must be passed in addition to the NAPLEX to obtain a pharmacist license in most US states?

The NCLEX-RN for pharmacists in hospital settings
The MPJE or a state-specific pharmacy law exam (Correct answer)
The USMLE Step 2
The PTCE if supervising technicians

Correct answer: The MPJE or a state-specific pharmacy law exam

Most states require passage of the MPJE (or an equivalent state law exam) in addition to the NAPLEX for initial pharmacist licensure.

Question 17: 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
Hypertonic or hypotonic solutions cause discomfort and potential corneal damage (Correct answer)
It reduces the cost of raw materials used

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 18: A patient discovers that their pharmacy shared their medication information with their employer. This would most likely violate:

HIPAA's Privacy Rule prohibition on unauthorized disclosures (Correct answer)
State pharmacy practice act minimum standards
The Controlled Substances Act confidentiality provisions
OBRA '90 counseling requirements

Correct answer: HIPAA's Privacy Rule prohibition on unauthorized disclosures

HIPAA's Privacy Rule prohibits covered entities from disclosing PHI to employers without the patient's written authorization.

Question 19: An institutional practitioner may dispense a Schedule II controlled substance for immediate administration to an ultimate user. Which of the following is a valid method for this to occur under federal law?

Pursuant to a standing order for any patient on a specific unit.
Pursuant to a patient's chart order from a medical resident using their personal DEA number.
Pursuant to an order for medication made by an individual practitioner. (Correct answer)
Pursuant to an oral order from a registered nurse.

Correct answer: Pursuant to an order for medication made by an individual practitioner.

According to 21 CFR 1306.11(c), an institutional practitioner may administer or dispense a Schedule II controlled substance directly to an ultimate user pursuant to a written prescription signed by the prescribing individual practitioner or to an order for medication made by an individual practitioner that is dispensed for immediate administration.

Question 20: Under the Poison Prevention Packaging Act, child-resistant containers are NOT required for which of the following?

Oral solid medications dispensed in quantities greater than 50
Oral antibiotic suspensions
Oral iron supplements containing 250 mg or more of elemental iron
Nitroglycerin sublingual tablets (Correct answer)

Correct answer: Nitroglycerin sublingual tablets

Nitroglycerin sublingual tablets are specifically exempt from PPPA child-resistant packaging requirements.

Question 21: A 503B outsourcing facility differs from a 503A compounding pharmacy primarily in that a 503B facility:

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

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

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

Question 22: A pharmacist discovers a significant loss of alprazolam (Schedule IV) during a monthly review. The pharmacy immediately notifies the local DEA Field Division Office in writing within one business day. According to federal regulations effective in 2023, what is the maximum time frame the pharmacy has to complete and electronically submit the DEA Form 106?

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

Correct answer: 45 calendar days

A DEA final rule effective July 24, 2023, amended the regulations for reporting theft or significant loss. While the initial written notification to the local DEA field office is still required within one business day of discovery, registrants now have 45 calendar days from the discovery of the loss to complete their investigation and electronically submit the DEA Form 106.

Question 23: A pharmacy technician asks a pharmacist whether they can independently counsel a patient on a new prescription. What is the correct response?

Yes, as long as the technician reads from the package insert.
Yes, if the technician has completed a counseling training program.
No; patient counseling on prescription drugs must be performed by a licensed pharmacist. (Correct answer)
Yes, if the pharmacist is present in the pharmacy.

Correct answer: No; patient counseling on prescription drugs must be performed by a licensed pharmacist.

Patient counseling on prescription medications is within the scope of pharmacist practice and cannot be delegated to pharmacy technicians under OBRA '90 and most state laws.

Question 24: Which of the following statements about an 'AA' rating in the Orange Book is TRUE?

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

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 25: A state board of pharmacy may place conditions on a pharmacist's license renewal for which of the following reasons?

Practicing in a neighboring state under a compact license
Switching employers without notifying the board
A finding of substance use disorder by the board (Correct answer)
Failure to join a professional pharmacy organization

Correct answer: A finding of substance use disorder by the board

Boards of pharmacy are authorized to impose conditions such as drug testing or monitoring programs when a pharmacist has been found to have a substance use disorder.

Question 26: A pharmacist receives an oral prescription for a Schedule III controlled substance from a physician. Which action is required?

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

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

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

Question 27: Which of the following is correct regarding compounded preparations dispensed pursuant to a prescription?

Compounded preparations must be labeled with the name and strength of the active ingredient(s), beyond use date, and pharmacist's name (Correct answer)
Compounded preparations are exempt from all state Board of Pharmacy labeling requirements
Compounded preparations must carry the same labeling as FDA-approved manufactured drugs
Compounded preparations require an NDC number before dispensing

Correct answer: Compounded preparations must be labeled with the name and strength of the active ingredient(s), beyond use date, and pharmacist's name

Compounded prescriptions must be labeled with the active ingredient(s) and strength, the beyond-use date, and the dispensing pharmacist's or pharmacy's identifying information.

Question 28: Which of the following practitioners is NOT eligible to obtain a DEA registration to dispense Schedule II controlled substances?

Physician
Medical laboratory technician (Correct answer)
Dentist
Veterinarian

Correct answer: Medical laboratory technician

DEA registration for dispensing controlled substances is granted to practitioners such as physicians, dentists, and veterinarians—not laboratory technicians.

Question 29: 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
Contact the FDA for dispensing authorization on each prescription
Verify that all REMS requirements are met, including any required certification or patient enrollment (Correct answer)
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 30: A Schedule V cough preparation containing less than 200 mg of codeine per 100 mL may be sold OTC in states that permit it under which condition?

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

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

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

Question 31: Which entity has primary authority to discipline a pharmacist for violations of federal pharmacy law?

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

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 32: Which of the following is a pharmacist's responsibility under HIPAA when a patient requests access to their own prescription records?

Deny access to protect third-party prescriber information
Charge any fee deemed appropriate for record retrieval
Require the patient to submit the request to their health plan instead
Provide access within 30 days of the request (Correct answer)

Correct answer: Provide access within 30 days of the request

HIPAA grants patients the right to access their protected health information, and covered entities must respond within 30 days (with one possible 30-day extension).

Question 33: The 'corresponding responsibility' doctrine under federal controlled substance law holds that:

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

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

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

Question 34: The Drug Addiction Treatment Act of 2000 (DATA 2000) allowed qualifying physicians to prescribe which controlled substance for the office-based treatment of opioid use disorder?

Buprenorphine (Correct answer)
Methadone
Naltrexone
Naloxone

Correct answer: Buprenorphine

DATA 2000 allowed qualifying physicians to obtain a waiver to prescribe buprenorphine (Schedule III) in office-based settings for opioid use disorder treatment.

Question 35: A pharmacist is compounding a preparation using a substance on the FDA 503A Difficult-to-Compound or Demonstrably Difficult list. This means:

The pharmacy must obtain a variance from the state board
The substance requires enhanced documentation in the compounding record
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 36: An 'abbreviated new drug application' (ANDA) relies on which type of existing FDA approval?

A drug master file (DMF) submitted by the API manufacturer
An investigational new drug (IND) application
A biological license application (BLA)
A reference listed drug (RLD) with an approved NDA (Correct answer)

Correct answer: A reference listed drug (RLD) with an approved NDA

An ANDA references the safety and efficacy data of an approved RLD rather than submitting independent clinical trials.

Question 37: An Illinois pharmacy wants to dispense prescription drugs via a kiosk or automated dispensing machine located in a clinic without a pharmacist on-site. What is required?

IDFPR approval of the kiosk location as a satellite pharmacy with a supervising pharmacist available via telepharmacy (Correct answer)
The clinic must hold its own retail pharmacy license
No special permit; any licensed pharmacy may operate off-site automated dispensing
FDA approval of the dispensing device under 510(k) clearance

Correct answer: IDFPR approval of the kiosk location as a satellite pharmacy with a supervising pharmacist available via telepharmacy

Illinois requires IDFPR approval for telepharmacy or remote automated dispensing operations, and a licensed pharmacist must be available for supervision via real-time audiovisual technology.

Question 38: A pharmacist holds an active license in State A and moves to State B. To practice in State B, the pharmacist must:

File a reciprocity application with State B's board of pharmacy (Correct answer)
Retake the NAPLEX examination in State B
Simply notify State B that they hold a valid license in State A
Obtain a federal interstate pharmacy permit

Correct answer: File a reciprocity application with State B's board of pharmacy

Licensure by reciprocity (or endorsement) requires a formal application to the new state's board of pharmacy.

Question 39: Under the Illinois Controlled Substances Act, which of the following is classified as a Schedule I substance?

Alprazolam
Hydrocodone
Tramadol
Heroin (diacetylmorphine) (Correct answer)

Correct answer: Heroin (diacetylmorphine)

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

Question 40: A pharmacist working at a hospital is asked to also manage a retail pharmacy kiosk in another building on the same campus under a single DEA registration. This arrangement is:

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

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

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

Question 41: Which of the following is an example of an 'imminent hazard' that allows FDA to immediately suspend a drug's approval under the FD&C Act?

A drug with a label that omits the phone number for adverse event reporting
A drug that has exceeded its expiration date by 30 days
A drug linked to sudden cardiac death with no known safe dose (Correct answer)
A drug manufactured in a facility with minor cGMP deviations

Correct answer: A drug linked to sudden cardiac death with no known safe dose

An imminent hazard justifying immediate suspension exists when continued marketing presents an unreasonable risk of serious injury or death to consumers.

Question 42: A pharmacist who also holds a valid nurse practitioner license wants to prescribe and dispense medications from the same practice location. Most state boards would require:

No additional steps since both licenses are valid
Compliance with any conflict-of-interest or self-prescribing regulations applicable to both professions (Correct answer)
Approval from both the medical board and the pharmacy board
The pharmacist to surrender one of the two licenses

Correct answer: Compliance with any conflict-of-interest or self-prescribing regulations applicable to both professions

Dual-licensed practitioners must comply with all regulations of both licensing boards, including self-prescribing prohibitions and conflict-of-interest rules.

Question 43: 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?

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

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

A license granted to a pharmacist who passes an additional specialty exam
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)
A temporary license granted while awaiting NAPLEX results

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

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

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

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

Question 46: 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 full-face respirator.
Sterile gloves.
A disposable chemotherapy gown.
A face mask. (Correct answer)

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

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

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

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

Correct answer: It lacks adequate directions for use

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

Question 49: When a controlled substance is administered to a patient in a hospital setting, the record must be maintained for how many years under federal DEA regulations?

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

Correct answer: 2 years

DEA regulations require controlled substance records, including administration records, to be maintained for at least 2 years.

Question 50: 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
DEA registration number linked to each shipment
Serialized National Drug Code (sNDC) with transaction history (Correct answer)
FDA establishment registration number

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 51: A pharmacist in a retail setting dispenses a prescription for amoxicillin 500 mg but accidentally fills it with ampicillin 500 mg. The patient takes the drug with no ill effect. Which of the following BEST describes the pharmacist's obligations?

Report the error only to the state board of pharmacy within 24 hours
No action is needed since no patient harm occurred
Document the error internally only, as no harm occurred
Disclose the error to the patient, document it, and follow pharmacy and state error reporting protocols (Correct answer)

Correct answer: Disclose the error to the patient, document it, and follow pharmacy and state error reporting protocols

Ethical standards and many state laws require pharmacists to disclose dispensing errors to patients and document them, regardless of whether harm occurred, and to follow applicable error reporting requirements.

Question 52: Under pharmacy law, the standard of care for a pharmacist is BEST defined as:

Care defined by the prescribing physician's instructions on the prescription
The minimum care required to avoid criminal prosecution
The care that a reasonably prudent pharmacist would provide under similar circumstances (Correct answer)
The highest possible level of pharmaceutical care achievable

Correct answer: The care that a reasonably prudent pharmacist would provide under similar circumstances

The standard of care in pharmacy negligence cases is what a reasonably prudent pharmacist would do under the same or similar circumstances.

Question 53: Under the FD&C Act, which of the following best describes a 'new drug application' (NDA)?

An application to list a drug in the Orange Book
A request to the DEA for Schedule II prescribing authority
A state-level application for pharmacy dispensing licensure
A formal submission to the FDA seeking approval to market a new drug in the US (Correct answer)

Correct answer: A formal submission to the FDA seeking approval to market a new drug in the US

An NDA is the vehicle through which drug sponsors formally propose that the FDA approve a new pharmaceutical for sale and marketing in the United States.

Question 54: Under the Illinois Pharmacy Practice Act, a pharmacist's license renewal period is how long?

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

Correct answer: 2 years

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

Question 55: Which element distinguishes written counseling information (e.g., patient package inserts) from verbal counseling under OBRA '90?

Written information alone satisfies OBRA '90 counseling requirements
Verbal counseling offers the interactive opportunity to address patient-specific questions (Correct answer)
OBRA '90 prohibits written information as a substitute for verbal counseling
Written information is more legally protective for the pharmacy

Correct answer: Verbal counseling offers the interactive opportunity to address patient-specific questions

Verbal counseling allows the pharmacist to tailor information and answer specific patient questions, which written materials cannot fully replace.

Question 56: Which DEA form is used by a pharmacy to destroy outdated or damaged controlled substances?

DEA Form 222
DEA Form 41 (Correct answer)
DEA Form 106
DEA Form 363

Correct answer: DEA Form 41

DEA Form 41 is submitted when a registrant destroys controlled substances, documenting the drugs destroyed and method used.

Question 57: Under most state regulations, the pharmacist-in-charge (PIC) is responsible for which of the following?

The overall operation of the pharmacy, including compliance with pharmacy laws (Correct answer)
Negotiating contracts with third-party payers
Personal liability for all prescriber errors
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 58: 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 controlled substances if authorized by state law and registered with the DEA (Correct answer)
Mid-level practitioners may never prescribe controlled substances under federal law
Mid-level practitioners may prescribe only Schedule IV and V substances

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 59: A patient presents a valid prescription for sublingual nitroglycerin tablets. According to the Poison Prevention Packaging Act (PPPA) of 1970, which of the following is the most accurate statement regarding the dispensing of this medication?

The medication can only be dispensed in non-child-resistant packaging if the prescriber explicitly requests it on the prescription.
The medication must be dispensed in child-resistant packaging unless the patient provides a blanket waiver for all their prescriptions.
The medication is exempt from child-resistant packaging requirements. (Correct answer)
The medication must always be dispensed in a container with a safety cap, regardless of patient preference.

Correct answer: The medication is exempt from child-resistant packaging requirements.

The Poison Prevention Packaging Act (PPPA) of 1970 requires child-resistant packaging for most oral prescription drugs. However, there are specific exemptions for medications where rapid access may be critical. Sublingual nitroglycerin is one of the key exemptions to the PPPA, meaning it is not required to be dispensed in child-resistant packaging due to its need for immediate access during an angina attack.

Question 60: 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 61: A patient presents a prescription for amoxicillin 500 mg #30. The pharmacist has only 250 mg capsules in stock. Which action is most appropriate?

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

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

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

Question 62: Which of the following information is NOT required on a prescription label for a non-controlled legend drug under federal law?

Directions for use
Name and address of the dispensing pharmacy
Name of the patient
Prescriber's DEA registration number (Correct answer)

Correct answer: Prescriber's DEA registration number

A prescriber's DEA number is not required on a non-controlled drug prescription label; it is only relevant for controlled substance prescriptions.

Question 63: Which HIPAA provision specifically allows a pharmacist to discuss a patient's prescription information with the patient's adult child who is present at the counter?

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

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

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

Question 64: A pharmacy discovers that a Schedule II drug was stolen. Under DEA regulations, the pharmacy must notify the DEA field office within:

72 hours of discovery
24 hours of discovery (Correct answer)
1 business day of discovery
30 days 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 65: Which information is NOT required on the outpatient prescription label under federal law?

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

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 66: Which of the following tasks is generally considered outside the scope of practice for a registered or certified pharmacy technician?

Reconstituting an oral antibiotic suspension after the prescription has been verified.
Entering prescription information into the computer system from a written prescription.
Recommending an over-the-counter (OTC) medication for a patient's allergy symptoms. (Correct answer)
Accepting a new written prescription from a patient at the drop-off window.

Correct answer: Recommending an over-the-counter (OTC) medication for a patient's allergy symptoms.

Recommending an OTC product for a patient's specific symptoms requires clinical assessment and constitutes patient counseling, which is a professional function reserved for pharmacists. Pharmacy technicians' duties are technical and non-judgmental. While they can locate an OTC product for a patient, they cannot make a therapeutic recommendation. The other tasks are generally considered within a technician's scope of practice under the supervision of a pharmacist.

Question 67: What FDA publication identifies which generic drug products are therapeutically equivalent to their brand-name counterparts?

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

Correct answer: The Orange Book

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

Question 68: A prescription reads 'Metformin 500 mg – dispense as written.' The pharmacist's wholesaler only has the generic in stock. What is the pharmacist's obligation?

Dispense the brand name by ordering it specifically to fulfill the DAW instruction (Correct answer)
Dispense the generic, as DAW instructions on non-controlled drugs are unenforceable
Contact the prescriber to discuss alternatives before dispensing the generic
Refuse to fill the prescription until the brand name is available

Correct answer: Dispense the brand name by ordering it specifically to fulfill the DAW instruction

A 'dispense as written' (DAW) instruction requires the pharmacist to dispense the brand-name product, which may require special ordering.

Question 69: Under federal law, a valid prescription must include all of the following EXCEPT:

Patient address
Drug name, strength, and quantity
Date issued
Prescriber's National Provider Identifier (NPI) number (Correct answer)

Correct answer: Prescriber's National Provider Identifier (NPI) number

Federal law does not require a prescriber's NPI number on a prescription; required elements include patient name/address, date, drug information, and prescriber signature/DEA number for controlled substances.

Question 70: Which of the following information is NOT required on a prescription label for a non-controlled drug?

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

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 71: Under the FD&C Act, which section establishes the requirement for current Good Manufacturing Practice (cGMP)?

Section 503(b)(1)
Section 501(a)(2)(B) (Correct answer)
Section 505(c)
Section 502(b)

Correct answer: Section 501(a)(2)(B)

Section 501(a)(2)(B) deems a drug adulterated if it was not manufactured in conformance with cGMP regulations.

Question 72: Under federal law, how long must a pharmacy retain Schedule II controlled substance records?

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

Correct answer: 2 years

Federal law requires Schedule II controlled substance records to be maintained for a minimum of 2 years from the date of the transaction.

Question 73: Under federal law, which of the following is an acceptable method for a DEA-registered pharmacy to destroy expired controlled substances?

Incineration by facility maintenance staff without DEA notification
Flushing down the sink if a take-back program is unavailable
Placing in a DEA-authorized collector or using a DEA-authorized reverse distributor (Correct answer)
Disposal in regular trash with bleach

Correct answer: Placing in a DEA-authorized collector or using a DEA-authorized reverse distributor

Pharmacies must use a DEA-authorized collector or reverse distributor to destroy controlled substances; improper disposal violates the Controlled Substances Act.

Question 74: Under the National Drug Code (NDC) numbering system, what do the three segments of an NDC number represent?

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

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

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

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 76: What is the proper sequencing for the three NDC code segments?

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

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 77: A pharmacy technician asks whether they can independently counsel a patient on a new prescription when the pharmacist is temporarily unavailable. The pharmacist should respond that:

Technicians may counsel on non-controlled OTC products only
Technicians may never counsel patients; only pharmacists may provide prescription counseling (Correct answer)
Technicians may provide basic administration instructions but not clinical counseling
Technicians may counsel if they hold a PharmD degree

Correct answer: Technicians may never counsel patients; only pharmacists may provide prescription counseling

Patient counseling on prescription medications is a pharmacist-only function; pharmacy technicians are not authorized to perform counseling regardless of their training level.

Question 78: A patient presents a prescription for oxycodone 30 mg #120 written by an out-of-state physician. The prescription appears legitimate. Under federal law, what may the pharmacist do?

Fill the prescription if it meets all federal and state requirements for a valid Schedule II prescription (Correct answer)
Require the patient to get a new prescription from an in-state physician
Fill only a 30-day emergency supply and require an in-state prescription for the rest
Refuse to fill any out-of-state Schedule II prescription

Correct answer: Fill the prescription if it meets all federal and state requirements for a valid Schedule II prescription

Federal law does not prohibit filling out-of-state Schedule II prescriptions; pharmacists must verify the prescription meets all legal requirements including validity and prescriber authority.

Question 79: A pharmacist receives a faxed prescription for a Schedule II controlled substance from a physician. Under federal law, when may this fax serve as the original prescription?

Never; Schedule II prescriptions must always be written originals
When the patient is in a long-term care facility, hospice, or the substance is a compounded product for home infusion (Correct answer)
When the prescriber provides a verbal authorization within 7 days
When the pharmacy is located in a rural health shortage area

Correct answer: When the patient is in a long-term care facility, hospice, or the substance is a compounded product for home infusion

Federal DEA regulations permit a faxed Schedule II prescription to serve as the original when the patient is in a LTCF, enrolled in hospice, or for a compounded Schedule II product for home infusion therapy.

Question 80: 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 Drug Supply Chain Security Act (DSCSA) electronic tracing system (Correct answer)
The National Drug Code (NDC) directory
The FDA's MedWatch reporting program

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

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

Correct answer: 5 refills

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

Question 82: Under Illinois law, a pharmacy technician trainee may perform which of the following without direct pharmacist oversight?

Final verification of prescriptions
Data entry of prescription information (Correct answer)
Counseling patients on OTC medications
Compound sterile preparations

Correct answer: Data entry of prescription information

Pharmacy technician trainees in Illinois may perform data entry tasks but all dispensing functions require pharmacist oversight.

Question 83: A pharmacist receives a telephone call from a known local physician for an emergency supply of hydromorphone for a patient in severe pain. Which of the following is a federal requirement for this emergency dispensing situation?

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

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

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

Question 84: Which of the following best describes the pharmacist's responsibility under the MPJE regarding patient counseling documentation in most states?

Pharmacists should maintain a record of the counseling offer and outcome for each dispensed prescription (Correct answer)
Documentation is only required for Schedule II controlled substances
Documentation is optional because counseling is a professional courtesy, not a legal mandate
Pharmacists must document only when the patient refuses counseling

Correct answer: Pharmacists should maintain a record of the counseling offer and outcome for each dispensed prescription

Most state practice acts require pharmacists to maintain documentation of the counseling offer and its outcome for all dispensed prescriptions.

Question 85: Under federal law, which of the following is NOT a requirement for a pharmacist to dispense a Schedule V substance without a prescription, where permitted by state law?

The purchaser must be at least 18 years of age.
A bound record book must be maintained with details of the sale.
The dispensing must be done only by a pharmacist.
The pharmacist must obtain authorization from the patient's primary physician. (Correct answer)

Correct answer: The pharmacist must obtain authorization from the patient's primary physician.

Federal law (21 CFR 1306.26) outlines several requirements for dispensing certain C-V substances over-the-counter. These include that the dispensing is done by a pharmacist, the purchaser is at least 18, and the sale is recorded in a bound book. There is no federal requirement to obtain authorization from the patient's physician for such a transaction.

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

Counterfeit
Adulterated
Investigational
Misbranded (Correct answer)

Correct answer: Misbranded

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

Question 87: Which FDA form is used by healthcare professionals to voluntarily report adverse drug events through the MedWatch program?

DEA Form 222
FDA Form 483
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 88: How long may a technician work there before getting their license?

60 Days (Correct answer)
Five years
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 89: 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
Call poison control and file a medication error report
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 90: The Drug Supply Chain Security Act (DSCSA) requires that pharmacies maintain transaction records for prescription drug products for a minimum of:

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

Correct answer: 3 years

The DSCSA requires pharmacies to maintain transaction information, transaction history, and transaction statements for at least 3 years.

Question 91: Which of the following practitioners is NOT eligible to obtain a DEA registration to prescribe controlled substances?

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

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

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

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 93: A pharmacist applying for licensure discloses a felony conviction on the application. The state board is MOST likely to:

Automatically deny the application without review
Refer the application to the DEA for a decision
Grant the license if more than five years have elapsed since conviction
Conduct an individualized assessment of the conviction's nature, recency, and relevance to pharmacy practice (Correct answer)

Correct answer: Conduct an individualized assessment of the conviction's nature, recency, and relevance to pharmacy practice

Most state boards conduct individualized assessments of criminal history, considering the nature of the offense, time elapsed, rehabilitation evidence, and relevance to pharmacy practice before making a licensure decision.

Question 94: Which of the following substances is correctly matched with its DEA schedule?

Cocaine – Schedule I
Methamphetamine – Schedule III
Testosterone – Schedule III (Correct answer)
Heroin – Schedule II

Correct answer: Testosterone – Schedule III

Testosterone is a Schedule III anabolic steroid; heroin is Schedule I, cocaine is Schedule II, and methamphetamine is Schedule II.

Question 95: When counseling a patient on a new antihypertensive medication, which component is MOST critical to include per standard counseling guidelines?

Signs and symptoms of adverse effects requiring medical attention (Correct answer)
How the drug compares to other drugs in its class
The cost of the medication compared to alternatives
The prescriber's rationale for choosing this specific drug

Correct answer: Signs and symptoms of adverse effects requiring medical attention

Informing patients about adverse effects requiring medical attention is essential for patient safety and is a core counseling element.

Question 96: A pharmacist who breaches patient confidentiality without authorization may face disciplinary action under:

Medicare Part D regulations only
The Federal Food, Drug, and Cosmetic Act only
The Controlled Substances Act only
State pharmacy practice acts and HIPAA (Correct answer)

Correct answer: State pharmacy practice acts and HIPAA

Unauthorized disclosure of patient information can trigger both state pharmacy board sanctions and federal HIPAA penalties.

Question 97: Which of the following BEST describes a mid-level practitioner (MLP) under DEA regulations?

A nurse, physician assistant, or similar professional who may prescribe controlled substances only to the extent permitted by state law (Correct answer)
A hospital pharmacist who supervises controlled substance distribution
A practitioner licensed in any profession who can prescribe without state authorization
Any healthcare professional with a DEA registration number

Correct answer: A nurse, physician assistant, or similar professional who may prescribe controlled substances only to the extent permitted by state law

DEA defines MLPs as individual practitioners other than physicians, dentists, or vets; they may prescribe controlled substances only within the scope granted by state law.

Question 98: A preceptor pharmacist overseeing a pharmacy intern must generally hold:

An active pharmacist license in the state where training occurs (Correct answer)
DEA Schedule II prescriptive authority
A specialty board certification in addition to a pharmacist license
At least a PharmD degree

Correct answer: An active pharmacist license in the state where training occurs

Preceptors must hold an active, unrestricted pharmacist license in the state where the internship is being conducted; additional certifications are generally not required by state law.

Question 99: A pharmacy intern, under the direct supervision of a licensed pharmacist, receives a new verbal prescription over the phone from a prescriber's office. The supervising pharmacist is busy counseling another patient but is physically present in the pharmacy. According to most state pharmacy laws, which action is the intern permitted to perform?

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

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

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

Question 100: Which of the following prescribers is federally authorized to prescribe Schedule II controlled substances?

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

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

The pharmacy license is automatically transferred to the next senior pharmacist
The pharmacy may continue operating indefinitely without a PIC
A new PIC must be designated and reported to the board within a specified timeframe (Correct answer)
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 102: A Schedule III controlled substance prescription may be refilled up to how many times within 6 months of the date issued?

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

Correct answer: 5 times

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

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

Only the expiration date from the bulk drug used
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

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: Which schedule of controlled substances has NO currently accepted medical use in the United States?

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

Correct answer: Schedule I

Schedule I substances have no currently accepted medical use, a high abuse potential, and lack accepted safety under medical supervision.

Question 105: Foreign pharmacy graduates seeking licensure in the US must typically obtain evaluation of their credentials through:

The NABP Foreign Pharmacy Graduate Examination Committee (FPGEC) (Correct answer)
The FDA's Office of International Programs
The American Pharmacists Association directly
The Joint Commission's international division

Correct answer: The NABP Foreign Pharmacy Graduate Examination Committee (FPGEC)

The NABP FPGEC program evaluates the education and credentials of foreign pharmacy graduates seeking US licensure.

Question 106: Which of the following is TRUE regarding DEA Schedule V controlled substances dispensed without a prescription (OTC)?

They may only be sold to patients with a valid prescription on file
They may be purchased in unlimited quantities per transaction
Any employee of the pharmacy may sell them
The purchaser must be at least 18 years old and the sale must be recorded in a bound log (Correct answer)

Correct answer: The purchaser must be at least 18 years old and the sale must be recorded in a bound log

Federal law requires that OTC Schedule V purchases be made by individuals 18 or older and that the pharmacist or designee record the sale in a bound logbook.

Question 107: A pharmacy compounds a drug product using bulk active pharmaceutical ingredients (APIs) that are not FDA-approved. Under 503A, this is permissible only if the API is:

Listed on an FDA-approved bulk drug substances list or subject to a clinical need exemption (Correct answer)
Used only in oral dosage forms
Accompanied by a Certificate of Analysis from any lab
Obtained from a licensed supplier in any foreign country

Correct answer: Listed on an FDA-approved bulk drug substances list or subject to a clinical need exemption

503A permits compounding from bulk APIs only if the substance appears on the FDA's positive list of bulk drug substances that can be used in compounding.

Question 108: A drug product is recalled because it was found to contain glass particles. This is classified as a Class __ recall by FDA.

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

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 109: The FDA Adverse Event Reporting System (FAERS) database is primarily used for which post-market purpose?

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

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

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

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

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

Question 111: Under the federal Omnibus Budget Reconciliation Act of 1990 (OBRA '90), which of the following statements is accurate regarding the patient counseling requirement for a new Medicaid prescription?

The offer to counsel must be made, but the patient or their caregiver has the right to refuse it. (Correct answer)
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.
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 112: A pharmacy needs to destroy a small quantity of expired and damaged hydrocodone/acetaminophen tablets (Schedule II) from its inventory. According to federal law, which of the following is the correct procedure for recording this destruction?

Complete a DEA Form 106 and have it signed by the pharmacist-in-charge.
Dispose of the tablets in a collection receptacle and notate the disposal in the biennial inventory.
Transfer the substances to a DEA-registered reverse distributor using a DEA Form 222.
Document the destruction on a DEA Form 41, which must be signed by two authorized employees who witnessed the destruction, and maintain it in the pharmacy's records. (Correct answer)

Correct answer: Document the destruction on a DEA Form 41, which must be signed by two authorized employees who witnessed the destruction, and maintain it in the pharmacy's records.

Federal regulations require that when a DEA registrant destroys a controlled substance, the destruction must be recorded on a DEA Form 41. This form must be completed and signed by two authorized employees who personally witnessed the destruction, which must render the substance non-retrievable. The completed form is to be maintained with the pharmacy's records and does not need to be sent to the DEA unless requested.

Question 113: 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
Deny the request since it complicates pharmacy operations
Require a written explanation from the patient before accommodating

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 114: A pharmacy orders 10 bottles of oxycodone 10 mg tablets using a DEA Form 222. The supplier ships 7 bottles and annotates the form accordingly. According to federal law, what is the maximum time the supplier has to send the remaining 3 bottles before the order form becomes invalid for that line item?

14 business days from the partial shipment
60 days from the date the form was executed (Correct answer)
90 days from the date the form was executed
30 days from the date of the partial shipment

Correct answer: 60 days from the date the form was executed

According to 21 CFR 1305.13(b), if a supplier cannot fill an entire order for a Schedule II substance, they may fill it in part and supply the remaining balance through additional shipments within 60 days of the date on the DEA Form 222. After 60 days, the form is no longer valid for that order.

Question 115: The pharmacist-in-charge at a community pharmacy discovers a significant loss of zolpidem (Schedule IV) tablets during a routine count. According to federal regulations, what is the initial reporting requirement?

Notify the nearest DEA Diversion Field Office in writing within one business day of discovery. (Correct answer)
File a report with the State Board of Pharmacy within 10 business days.
Complete and submit DEA Form 41 within 24 hours.
Notify the local police department within 72 hours.

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

Federal regulations (21 C.F.R. §1301.76(b)) require that upon discovery of a theft or significant loss of any controlled substance, the registrant must notify the local DEA Diversion Field Office, in writing, within one business day. Following this initial notification, the registrant must complete a DEA Form 106.

Question 116: 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.

Question 117: Under the Health Insurance Portability and Accountability Act (HIPAA), which of the following disclosures of Protected Health Information (PHI) by a pharmacy requires prior written authorization from the patient?

Reporting a suspected case of child abuse discovered during a patient interaction to a public health authority as required by state law.
Disclosing a patient's name and address to a pharmaceutical company for the purpose of marketing a new medication. (Correct answer)
Submitting a claim to a patient's insurance company for reimbursement of a filled prescription.
Providing a patient's prescription history to their primary care physician for continuity of care.

Correct answer: Disclosing a patient's name and address to a pharmaceutical company for the purpose of marketing a new medication.

HIPAA permits the disclosure of PHI without patient authorization for treatment, payment, and healthcare operations (TPO). Disclosing information to a physician for treatment or to an insurer for payment falls under TPO. Disclosures required by law, such as to public health authorities, are also permitted without authorization. However, using PHI for marketing purposes that are not related to the patient's direct care requires explicit written authorization from the patient.

Question 118: A pharmacist dispenses a 30-day supply of lisinopril and mistakenly gives the patient atenolol. The error is discovered after the patient has left. Which step is the MOST immediate priority?

Document the error in the dispensing record and notify the prescriber at the next opportunity
Pull the remaining stock of atenolol to determine if additional errors occurred
Contact the patient immediately to inform them of the error and provide guidance on next steps (Correct answer)
File a MedWatch report with the FDA before contacting the patient

Correct answer: Contact the patient immediately to inform them of the error and provide guidance on next steps

Patient safety requires immediately contacting the patient to disclose the dispensing error and provide guidance on what to do with the wrong medication.

Question 119: Which scenario represents a valid emergency oral prescription for a Schedule II controlled substance?

A patient calls the pharmacy directly to request their own controlled substance prescription
A prescriber calls in morphine for a terminally ill patient with a bona fide emergency and provides a written prescription within 7 days (Correct answer)
A nurse practitioner's receptionist calls in oxycodone for a non-emergency chronic pain patient
A pharmacist dispenses a 30-day supply based on a previous refillable Schedule II prescription

Correct answer: A prescriber calls in morphine for a terminally ill patient with a bona fide emergency and provides a written prescription within 7 days

Federal law permits oral Schedule II prescriptions only in genuine emergencies, provided the prescriber submits a written prescription within 7 days and the quantity is limited to the emergency period.

Question 120: 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?

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

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

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

Correct answer: A licensed pharmacist

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

Question 122: Who is the legitimate owner of a prescription once it has been filled and administered?

The pharmacist
The state board of pharmacy
The customer
The pharmacy (Correct answer)
The prescription must be shredded immediately

Correct answer: The pharmacy

It is legally owned by the pharmacy and should not be given to the patient. A copy of the prescription should be offered if the patient requests it.

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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