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ID MPJE practice questions

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Question 1Federal drug laws and regulations (FDCA, CSA, DSCSA, REMS)

Under the federal Controlled Substances Act, a prescription for a Schedule II controlled substance may be refilled in which of the following circumstances?

  1. Never; Schedule II prescriptions may not be refilled under any circumstances Correct answer.
  2. Up to five times within six months of the issue date
  3. Once, if the prescriber authorizes a single refill in writing
  4. Up to three times within one month of the issue date

Explanation

The CSA prohibits refilling a Schedule II prescription; each dispensing requires a new prescription, with narrow exceptions such as an emergency oral order followed by a written prescription. Schedule III–IV prescriptions may be refilled up to five times within six months if authorized.

Question 2Federal drug laws and regulations (FDCA, CSA, DSCSA, REMS)

A pharmacy receives an oral emergency order for a Schedule II controlled substance. Under DEA regulations, within what period must the prescriber furnish a written prescription?

  1. 30 days
  2. 14 days
  3. 7 days Correct answer.
  4. 72 hours

Explanation

DEA regulations permit emergency oral Schedule II orders for limited quantities, but the prescriber must deliver a written prescription within seven days. If it is not received, the pharmacist must notify DEA.

Question 3Federal drug laws and regulations (FDCA, CSA, DSCSA, REMS)

Which of the following best describes the CSA requirement for a prescription for a Schedule II controlled substance transmitted by fax?

  1. Faxes are permitted only for certain exceptions such as compounded infusions or long-term care patients Correct answer.
  2. Faxes are permitted only when the patient signs a written consent
  3. Faxes are never permitted for any controlled substance prescription
  4. Faxes are permitted for any Schedule II prescription if the prescriber signs the cover sheet

Explanation

DEA permits faxed Schedule II prescriptions only in limited situations, such as compounded narcotic infusions, long-term care facility patients, and hospice patients. Otherwise an original written or qualifying electronic prescription is required.

Question 4Federal drug laws and regulations (FDCA, CSA, DSCSA, REMS)

A retail pharmacy discovers that a Schedule II controlled substance was stolen from stock. To which authority must the pharmacy report the theft, and how quickly?

  1. DEA Headquarters by telephone within thirty days of discovery
  2. The DEA Field Division office in writing within one business day of discovery
  3. The state board of pharmacy only, at the next license renewal
  4. DEA and state authorities immediately upon discovery, with a written DEA Form 106 filed thereafter Correct answer.

Explanation

DEA regulations require notification of the Field Division office in the area and state authorities immediately upon discovery of a theft or significant loss. A DEA Form 106 is then submitted; it must be filed within one business day of discovery.

Question 5Federal drug laws and regulations (FDCA, CSA, DSCSA, REMS)

Which statement correctly describes the DEA Form 222 (single-sheet) order form for Schedule I and II controlled substances?

  1. It may be executed by any employee of the purchaser who is at least 18 years old
  2. It must be signed by a person who holds a valid power of attorney authorizing that person to order Correct answer.
  3. It may be transmitted electronically without any registration or certification
  4. It may be signed by the pharmacist-in-charge without any separate authorization document

Explanation

Only a registrant or a person holding a valid power of attorney may execute a DEA Form 222. The power of attorney must be executed on DEA Form 222a and retained by the supplier, and the purchaser keeps a record.

Question 6Federal drug laws and regulations (FDCA, CSA, DSCSA, REMS)

A pharmacy wants to destroy expired Schedule II controlled substances on site. Which practice is consistent with DEA regulations?

  1. Destroying them by flushing down the sink without documentation
  2. Seeking DEA authorization for on-site destruction and documenting the destruction Correct answer.
  3. Transferring them to a reverse distributor without any records
  4. Returning them to the prescriber without a DEA Form 41

Explanation

On-site destruction of controlled substances requires DEA authorization and documentation, typically on DEA Form 41, and destruction must render the substances non-retrievable. Reverse distribution is an alternative but still requires records.

Question 7Federal drug laws and regulations (FDCA, CSA, DSCSA, REMS)

Which of the following is required for a prescription for a Schedule III controlled substance to be refilled?

  1. Refills are prohibited for Schedule III substances
  2. Each refill requires a new written prescription from the prescriber
  3. The prescriber must authorize refills on the prescription and the total quantity dispensed may not exceed five refills within six months Correct answer.
  4. Refills may continue indefinitely as long as the prescriber is notified

Explanation

Schedule III and IV prescriptions may be refilled if the prescriber authorizes it, up to five times, and no later than six months from the date of issue. Schedule II prescriptions cannot be refilled.

Question 8Federal drug laws and regulations (FDCA, CSA, DSCSA, REMS)

A patient presents a prescription for a Schedule II opioid written by an out-of-state prescriber. Which statement reflects current federal authority for a pharmacist to fill it?

  1. Federal law requires the out-of-state prescriber to obtain a DEA registration in the patient's state
  2. Federal law permits a pharmacist to fill a valid Schedule II prescription from an out-of-state prescriber if state law allows it Correct answer.
  3. Federal law prohibits filling any Schedule II prescription from an out-of-state prescriber
  4. Federal law requires the prescription to be transferred to an in-state prescriber before dispensing

Explanation

DEA rules and the SUPPORT Act confirm that a pharmacist may fill a valid Schedule II prescription issued by a prescriber registered in another state, provided the prescription is otherwise valid and state law permits it. The prescriber does not need a separate registration in the patient's state for this purpose.

Question 9Federal drug laws and regulations (FDCA, CSA, DSCSA, REMS)

Which of the following best describes the CSA definition of a "readily retrievable" record for controlled substances?

  1. Records maintained only in an electronic format approved by DEA
  2. Records kept in a locked cabinet accessible only to the pharmacist-in-charge
  3. Records stored off-site at a secure warehouse
  4. Records that can be produced within a reasonable time using an automated system or manual method Correct answer.

Explanation

Readily retrievable records are those that can be produced promptly, either manually or through an automated data processing system, for inspection by DEA. Physical proximity alone does not define the term.

Question 10Federal drug laws and regulations (FDCA, CSA, DSCSA, REMS)

Under the FDCA, which of the following is an example of a "prescription drug" that may be dispensed only upon prescription?

  1. A dietary supplement marketed with a structure/function claim
  2. A cosmetic intended to alter appearance
  3. A drug that is labeled with adequate directions for use by a layperson
  4. A drug that is not safe for use except under the supervision of a practitioner licensed by law to administer it Correct answer.

Explanation

The FDCA defines prescription drugs to include those not safe for use except under professional supervision because of toxicity or method of use, and those restricted to prescription dispensing by new drug application. Adequate directions for lay use indicates an OTC drug.

Question 11Federal drug laws and regulations (FDCA, CSA, DSCSA, REMS)

A manufacturer wants to market a new drug in the United States. Which approval pathway is generally required before interstate commercial distribution?

  1. Registration with the DEA alone
  2. A state pharmacy license
  3. An approved new drug application or an abbreviated new drug application Correct answer.
  4. A certificate of free sale from the manufacturer's country

Explanation

The FDCA requires an approved new drug application (NDA) or abbreviated new drug application (ANDA) before a new drug may be introduced into interstate commerce. DEA registration and state licensure are separate requirements and do not substitute for FDA approval.

Question 12Federal drug laws and regulations (FDCA, CSA, DSCSA, REMS)

Which of the following describes the FDCA prohibition on adulterated drugs?

  1. A drug is adulterated if it is prepared, packed, or held under insanitary conditions that may render it injurious to health Correct answer.
  2. A drug is adulterated only if it lacks a National Drug Code
  3. A drug is adulterated only if it is misbranded
  4. A drug is adulterated only if it fails its expiration date

Explanation

The FDCA deems a drug adulterated when it is manufactured under insanitary conditions, contains filthy or decomposed substances, or fails to conform to compendial standards, among other grounds. Misbranding is a separate violation category.

Question 13Federal drug laws and regulations (FDCA, CSA, DSCSA, REMS)

A drug's label fails to bear the established name of the drug and the quantity of each active ingredient. Under the FDCA, this most directly constitutes which violation?

  1. Unapproved new drug
  2. Misbranding Correct answer.
  3. Adulteration
  4. Counterfeiting

Explanation

The FDCA deems a drug misbranded when its labeling lacks required information such as the established name, active ingredient quantities, and adequate directions for use. Adulteration concerns physical composition and manufacturing conditions.

Question 14Federal drug laws and regulations (FDCA, CSA, DSCSA, REMS)

Which statement about the FDA's authority over compounded human drug products under section 503A of the FDCA is correct?

  1. A 503A compounder may compound any commercially available drug in any quantity without restriction
  2. A 503A compounder is exempt from all FDCA requirements including labeling
  3. A 503A compounder must obtain an NDA for each compounded preparation
  4. A 503A compounder must comply with applicable USP monographs and may not compound a drug that is essentially a copy of a commercially available product Correct answer.

Explanation

Section 503A conditions the exemption on compliance with USP standards, use of bulk ingredients from registered establishments, and a prohibition on regularly compounding copies of commercially available drugs. It does not exempt compounders from all FDCA requirements.

Question 15Federal drug laws and regulations (FDCA, CSA, DSCSA, REMS)

Which of the following is a key requirement of the Drug Supply Chain Security Act (DSCSA) for trading partners?

  1. All trading partners must obtain a DEA registration before shipping any drug
  2. Pharmacies must verify the legitimacy of every product at the point of dispensing using a national database
  3. Transaction information, transaction history, and a transaction statement must be captured and maintained for each transaction Correct answer.
  4. Manufacturers must publish wholesale acquisition costs for all products

Explanation

DSCSA requires trading partners to exchange and keep transaction information, transaction history, and transaction statements documenting the chain of custody. Verification is required upon suspect product identification, not for every unit at dispensing.

Question 16Federal drug laws and regulations (FDCA, CSA, DSCSA, REMS)

Under DSCSA, a pharmacy identifies a product that it has reason to believe is counterfeit. What is the appropriate initial action?

  1. Destroy the product immediately and take no further action
  2. Dispense the product and report it only if a patient complains
  3. Return the product to the wholesaler without documentation
  4. Quarantine the product and investigate, and if it is illegitimate, notify FDA and trading partners Correct answer.

Explanation

DSCSA requires trading partners to quarantine suspect product, conduct an investigation, and, if the product is determined to be illegitimate, notify FDA and immediate trading partners. Records of the investigation must be retained.

Question 17Federal drug laws and regulations (FDCA, CSA, DSCSA, REMS)

Which of the following best describes the DSCSA requirement for product tracing at the package level?

  1. Each package must be labeled with the DEA registration number of the manufacturer
  2. Each package must include a paper pedigree signed by every prior owner
  3. Each package must be marked with a product identifier that includes the NDC, serial number, lot number, and expiration date Correct answer.
  4. Each package must carry a certificate of analysis

Explanation

DSCSA requires a standardized product identifier on packages, containing the NDC, a unique serial number, lot number, and expiration date, in human-readable and machine-readable form. Paper pedigrees and certificates of analysis are not the DSCSA package-level tracing mechanism.

Question 18Federal drug laws and regulations (FDCA, CSA, DSCSA, REMS)

A wholesaler wants to sell a drug to a pharmacy. Under DSCSA, which condition must be met before the wholesaler may transfer ownership?

  1. The wholesaler must be licensed by the state and must provide the required transaction information, history, and statement Correct answer.
  2. The wholesaler must hold a DEA registration for all products sold
  3. The wholesaler must obtain written patient consent
  4. The wholesaler must be a manufacturer

Explanation

DSCSA requires trading partners to be authorized and to exchange transaction information, transaction history, and a transaction statement at the time of transfer. State licensure is part of being an authorized trading partner.

Question 19Federal drug laws and regulations (FDCA, CSA, DSCSA, REMS)

Which of the following is a purpose of an FDA Risk Evaluation and Mitigation Strategy (REMS)?

  1. To set the wholesale price of a drug
  2. To replace the need for a new drug application
  3. To manage a serious safety concern by imposing elements to assure safe use, such as restricted distribution or prescriber certification Correct answer.
  4. To authorize compounding of a drug

Explanation

REMS is a safety program required when FDA determines it is necessary to ensure the benefits of a drug outweigh its risks. It may include medication guides, communication plans, and elements to assure safe use such as restricted distribution systems.

Question 20Federal drug laws and regulations (FDCA, CSA, DSCSA, REMS)

A drug has a REMS with elements to assure safe use that requires prescriber certification. Which statement is correct for a pharmacy dispensing that drug?

  1. The pharmacy must verify that the prescriber is certified and that the patient meets any required conditions before dispensing Correct answer.
  2. The pharmacy may dispense if the drug is in stock
  3. The pharmacy may dispense without verification if the patient signs a general consent
  4. The pharmacy must obtain a DEA registration specific to that drug

Explanation

When a REMS includes elements to assure safe use, dispensing sites must confirm that the prescriber and, where applicable, the patient meet the program requirements before the drug is dispensed. A general consent does not substitute for REMS verification.

Question 21Federal drug laws and regulations (FDCA, CSA, DSCSA, REMS)

Which of the following statements about the FDA's REMS authority is correct?

  1. REMS requirements may be imposed only by state boards of pharmacy
  2. REMS may be used to require a drug to be sold only through pharmacies owned by the manufacturer
  3. REMS requirements apply only to generic drugs
  4. FDA may require a REMS at the time of approval or later if new safety information emerges Correct answer.

Explanation

FDA may require a REMS when approving a new drug or afterward upon becoming aware of new safety information. REMS is a federal risk-management tool and is not limited to generics or imposed by states.

Question 22Federal drug laws and regulations (FDCA, CSA, DSCSA, REMS)

A pharmacy receives a prescription for isotretinoin. Which REMS-related step is required before dispensing?

  1. Confirming that the patient has a valid DEA registration
  2. Obtaining a DEA Form 222
  3. Checking the drug's National Drug Code against a wholesaler catalog
  4. Verifying that the prescriber and patient are registered in the iPLEDGE program and that a negative pregnancy test is documented where required Correct answer.

Explanation

Isotretinoin is subject to a REMS with elements to assure safe use that require prescriber and patient registration and pregnancy testing for patients who can become pregnant. A pharmacy must complete the program's verification steps before dispensing.

Question 23Federal drug laws and regulations (FDCA, CSA, DSCSA, REMS)

Under the FDCA, which of the following statements about the Orange Book therapeutic equivalence rating is correct?

  1. An "AB" rating indicates that a product may be dispensed without a prescription
  2. An "AB" rating indicates that a product is a controlled substance
  3. An "AB" rating indicates that a generic product is considered therapeutically equivalent to the reference listed drug Correct answer.
  4. An "AB" rating indicates that a product is adulterated

Explanation

The Orange Book assigns therapeutic equivalence codes; an "AB" rating means the product is considered therapeutically equivalent to the reference drug. This rating supports substitution decisions where state law permits.

Question 24Federal drug laws and regulations (FDCA, CSA, DSCSA, REMS)

A pharmacist wants to refill a Schedule IV prescription that was issued eight months ago and authorized five refills. Which statement is correct?

  1. Refills may continue indefinitely if the prescriber is contacted
  2. Refills may continue until all five are used
  3. No further refills may be dispensed because the six-month limit from the issue date has passed Correct answer.
  4. Refills may continue for one year from the issue date

Explanation

Schedule III and IV prescriptions may be refilled up to five times but not later than six months after the date of issue. Because eight months have elapsed, no further refills may be dispensed.

Question 25Federal drug laws and regulations (FDCA, CSA, DSCSA, REMS)

A pharmacy's automated dispensing system dispenses a Schedule II drug. Which recordkeeping practice best satisfies DEA requirements?

  1. Keep records only in the prescriber's file
  2. Maintain records for six months only
  3. Rely on the wholesaler to retain all records
  4. Maintain records that identify the receipt, dispensing, and disposition of the drug and that are readily retrievable for at least two years Correct answer.

Explanation

DEA requires registrants to keep complete and accurate records of controlled substances for at least two years and to make them readily retrievable for inspection. Automated systems must capture the same accountability information.

Question 26Federal drug laws and regulations (FDCA, CSA, DSCSA, REMS)

A pharmacy technician discovers that a sealed bottle of a Schedule II controlled substance has expired. The pharmacy has no reverse distributor arrangement and will destroy the drug on site. Under DEA regulations, which practice is required for this destruction?

  1. Destruction is prohibited unless a DEA special agent is physically present
  2. Destruction must be reported to FDA in a MedWatch submission before the drug is discarded
  3. Destruction may be performed by a single pharmacist without any written record
  4. Destruction must be witnessed and documented by two employees, and the record must be kept for two years Correct answer.

Explanation

DEA regulations require that destruction of controlled substances in a registrant's inventory be witnessed by two responsible employees and documented in a record showing the drug, quantity, date, and witnesses, retained for at least two years. A single unwitnessed act with no record fails this requirement.

Question 27Federal drug laws and regulations (FDCA, CSA, DSCSA, REMS)

A prescriber issues a Schedule III prescription with no refills indicated. Under the CSA regulations, how long is that prescription valid for dispensing?

  1. Six months from the date of issue Correct answer.
  2. Thirty days from the date of issue
  3. One year from the date of issue
  4. Three months from the date of issue

Explanation

Under 21 CFR 1306.22, a prescription for a Schedule III or IV controlled substance may not be filled or refilled more than six months after the date of issue. Schedule II prescriptions, by contrast, may not be refilled at all.

Question 28Federal drug laws and regulations (FDCA, CSA, DSCSA, REMS)

A patient brings in a Schedule II prescription written by a physician licensed in a neighboring state. Which statement best reflects the federal rule on dispensing such a prescription?

  1. A Schedule II prescription from an out-of-state prescriber is valid only after the pharmacist calls DEA for authorization
  2. A Schedule II prescription from an out-of-state prescriber is always invalid and must be refused
  3. A Schedule II prescription from an out-of-state prescriber is valid only if the patient resides in the prescriber's state
  4. A Schedule II prescription may be filled only if the prescriber is registered with DEA in the state where the pharmacy is located or meets an exception Correct answer.

Explanation

Federal law generally requires the prescriber to be registered with DEA in the state where the controlled substance is dispensed, but exceptions exist, such as for certain federal facilities and for prescribers in states with reciprocal registration or in specific statutory exceptions. The pharmacist must verify the prescriber's registration status before dispensing.

Question 29Federal drug laws and regulations (FDCA, CSA, DSCSA, REMS)

A pharmacy maintains a computerized record system for controlled substances. Which statement best describes what makes a record "readily retrievable" under DEA regulations?

  1. The record is kept in a locked cabinet accessible only to the pharmacist-in-charge
  2. The record can be produced during an inspection without undue delay, such as through an on-site printer or terminal Correct answer.
  3. The record is stored on a backup server that can be accessed within 30 days
  4. The record is archived off-site and retrievable by written request

Explanation

DEA defines readily retrievable records as those that can be produced promptly during an inspection, either as a printout or through an on-site computer terminal. Records requiring a written request or lengthy retrieval do not meet the standard.

Question 30Federal drug laws and regulations (FDCA, CSA, DSCSA, REMS)

A pharmacist receives a prescription for a Schedule II stimulant written by a prescriber who is registered with DEA. Which of the following is a valid way to transmit the prescription to the pharmacy under federal law?

  1. An electronic prescription transmitted through a DEA-compliant application Correct answer.
  2. A photocopy of a prescription mailed by the patient
  3. A faxed copy of a handwritten prescription
  4. An oral telephone order from the prescriber to the pharmacist

Explanation

Schedule II prescriptions may be transmitted electronically only through an application and process that meets DEA requirements, including identity proofing and digital signing. Oral orders, faxes, and photocopies are not generally valid for Schedule II under federal rules, except for limited emergency situations.

Question 31Federal drug laws and regulations (FDCA, CSA, DSCSA, REMS)

A pharmacist receives a prescription for a Schedule II controlled substance that was issued 45 days ago. The patient is stable and the prescriber is reachable. Which statement best reflects the federal rule?

  1. The prescription is automatically void after 30 days under federal law
  2. The pharmacist must obtain a new prescription from DEA
  3. The prescription may be refilled once to cover the gap
  4. The pharmacist may dispense only if the prescription is still valid under applicable state law and the pharmacist exercises professional judgment Correct answer.

Explanation

Federal law does not impose a uniform expiration date for Schedule II prescriptions; validity is governed by state law and professional judgment. A pharmacist must confirm that the prescription remains valid under state rules before dispensing.

Question 32Federal drug laws and regulations (FDCA, CSA, DSCSA, REMS)

A pharmacy receives a prescription for a Schedule II opioid for a patient in hospice care. Which statement best reflects the federal partial-filling rules?

  1. Partial filling is allowed only if the prescriber is physically present
  2. Partial filling is allowed only for Schedule III and IV prescriptions
  3. The pharmacist may partially fill the prescription at the patient's request or the prescriber's request, with the remainder filled within 60 days Correct answer.
  4. Partial filling is prohibited for all Schedule II prescriptions

Explanation

The SUPPORT Act and DEA regulations allow partial filling of Schedule II prescriptions at the request of the patient or prescriber, with the remaining portions filled within 60 days of the date of issue. After that period, the remaining portion cannot be dispensed.

Question 33Federal drug laws and regulations (FDCA, CSA, DSCSA, REMS)

A pharmacy is filling a Schedule II prescription that the prescriber transmitted by fax because of an emergency. Which statement best reflects the federal requirement?

  1. The prescriber must call DEA to confirm the emergency within 24 hours
  2. The pharmacy must report the emergency to the state board within 30 days
  3. The pharmacy must destroy the fax after dispensing
  4. The prescriber must deliver a written or electronic original prescription to the pharmacy within seven days Correct answer.

Explanation

In an emergency oral or faxed Schedule II situation, the prescriber must provide a written or electronic original prescription to the pharmacy within seven days. If the original is not received, the pharmacist must notify DEA.

Question 34Federal drug laws and regulations (FDCA, CSA, DSCSA, REMS)

A pharmacist is reviewing a prescription for a Schedule IV controlled substance that was issued eight months ago and authorized five refills. Which statement best reflects the federal rule?

  1. The prescription may be refilled because the prescriber authorized five refills
  2. The prescription may be refilled once as a courtesy
  3. The prescription may not be refilled because more than six months have passed since the date of issue Correct answer.
  4. The prescription may be refilled only if the patient is terminally ill

Explanation

Under 21 CFR 1306.22, Schedule III and IV prescriptions may not be filled or refilled more than six months after the date of issue. After that period, the prescription is no longer valid for refilling.

Question 35Federal drug laws and regulations (FDCA, CSA, DSCSA, REMS)

A pharmacy uses an automated dispensing system to store and dispense Schedule II drugs. Which recordkeeping practice best satisfies DEA requirements?

  1. The system must be emptied and restocked manually each day
  2. The system must be connected to the state prescription monitoring program
  3. The system must be inspected annually by DEA
  4. The system must maintain a perpetual inventory and produce a transaction record that is readily retrievable Correct answer.

Explanation

Automated dispensing systems for controlled substances must maintain accurate perpetual inventory and transaction records that are readily retrievable during an inspection. The records must identify the drug, quantity, date, and personnel involved.

Question 36Federal drug laws and regulations (FDCA, CSA, DSCSA, REMS)

A manufacturer is preparing to market a new prescription drug. Which pathway generally requires the manufacturer to demonstrate substantial evidence of effectiveness through adequate and well-controlled investigations?

  1. A new drug application under section 505(b)(1) of the FDCA Correct answer.
  2. A cosmetic labeling exemption
  3. A generally recognized as safe determination
  4. An over-the-counter monograph listing

Explanation

A 505(b)(1) new drug application requires the applicant to submit full reports of investigations showing the drug is safe and effective, including adequate and well-controlled studies. Other pathways, such as 505(b)(2) or ANDA, rely on different evidence structures.

Question 37Federal drug laws and regulations (FDCA, CSA, DSCSA, REMS)

A generic manufacturer wants to market a generic version of an approved brand drug. Which statement best describes the ANDA pathway?

  1. The applicant must repeat the full clinical trials conducted for the brand drug
  2. The applicant must obtain a new chemical entity exclusivity period
  3. The applicant must show bioequivalence to the reference listed drug and rely on the brand's safety and efficacy findings Correct answer.
  4. The applicant must file a 505(b)(2) application with new clinical investigations

Explanation

An abbreviated new drug application under section 505(j) requires the applicant to demonstrate bioequivalence to the reference listed drug and to rely on the agency's prior findings of safety and effectiveness for that drug. Full clinical trials are not repeated.

Question 38Federal drug laws and regulations (FDCA, CSA, DSCSA, REMS)

A drug's labeling omits the established name of the drug and the quantity of each active ingredient. Under the FDCA, which statement best describes the consequence?

  1. The drug may be deemed misbranded Correct answer.
  2. The drug becomes an unapproved new drug
  3. The drug is automatically adulterated
  4. The drug is exempt from FDA oversight

Explanation

Under section 502 of the FDCA, a drug is misbranded if its label fails to bear the established name and the quantity of each active ingredient. Adulteration, by contrast, concerns manufacturing conditions and contamination.

Question 39Federal drug laws and regulations (FDCA, CSA, DSCSA, REMS)

A pharmacy compounds a sterile injectable product for a specific patient under section 503A. Which statement best describes the federal framework?

  1. The compounder is exempt from all federal labeling requirements
  2. The compounder must comply with applicable USP standards and the prescription must be for an identified individual patient Correct answer.
  3. The compounder may use bulk drug substances that are not on any FDA list without restriction
  4. The compounder may mass-produce the product for interstate distribution without an FDA approval

Explanation

Section 503A conditions the exemption from certain FDCA requirements on compliance with USP compounding standards, use of acceptable bulk substances, and dispensing pursuant to a prescription for an identified individual patient. Mass production and interstate distribution without approval are inconsistent with that framework.

Question 40Federal drug laws and regulations (FDCA, CSA, DSCSA, REMS)

A pharmacist is reviewing a drug that has a REMS with elements to assure safe use requiring that the patient enroll in a registry before dispensing. Which statement best reflects the pharmacist's obligation?

  1. The pharmacist may dispense if the prescriber verbally assures enrollment
  2. The pharmacist must verify that the patient is enrolled and that other ETASU requirements are met before dispensing Correct answer.
  3. The pharmacist may dispense first and document enrollment afterward
  4. The pharmacist may substitute a different drug without notifying the prescriber

Explanation

When a REMS includes elements to assure safe use, the dispenser must confirm that the applicable requirements, such as patient enrollment or prescriber certification, are satisfied before dispensing. Dispensing first and documenting later defeats the safety purpose.

Question 41Federal drug laws and regulations (FDCA, CSA, DSCSA, REMS)

A manufacturer markets a drug with a REMS that includes a medication guide. Which statement best describes the purpose of the medication guide?

  1. It certifies the prescriber to prescribe the drug
  2. It replaces the professional package insert
  3. It provides patient-directed information about serious risks and safe use Correct answer.
  4. It authorizes the pharmacist to refill without a prescription

Explanation

A medication guide is a patient-directed document required under a REMS to communicate serious risks and safe-use information. It supplements, rather than replaces, the professional labeling and does not authorize refills or certify prescribers.

Question 42Federal drug laws and regulations (FDCA, CSA, DSCSA, REMS)

A trading partner is verifying a drug product before a transaction under DSCSA. Which statement best describes the required product identifier?

  1. It includes the product's NDC, serial number, lot number, and expiration date Correct answer.
  2. It includes the prescriber's DEA number and the patient's name
  3. It includes the pharmacy's NPI and the dispensing date
  4. It includes only the drug's brand name and strength

Explanation

Under DSCSA, the product identifier must include the NDC, serial number, lot number, and expiration date, encoded in a standardized format. This identifier supports verification and tracing throughout the supply chain.

Question 43Federal drug laws and regulations (FDCA, CSA, DSCSA, REMS)

A pharmacy receives a shipment of drug products from a wholesaler and is required to verify the transaction under DSCSA. Which statement best describes the transaction information the pharmacy should receive?

  1. It includes the manufacturer's marketing materials
  2. It includes the product name, strength, dosage form, NDC, container size, lot number, and transaction dates Correct answer.
  3. It includes the patient's prescription number and diagnosis
  4. It includes only the invoice total and the wholesaler's name

Explanation

DSCSA transaction information must include the product name, strength, dosage form, NDC, container size, lot number, and the dates of the transaction, among other elements. This information supports product tracing and verification.

Question 44Federal drug laws and regulations (FDCA, CSA, DSCSA, REMS)

A pharmacy identifies a product that it suspects is counterfeit and has reason to believe it is illegitimate. Under DSCSA, which action is most appropriate?

  1. Discard the product without documentation
  2. Dispense the product while investigating
  3. Quarantine the product and notify the manufacturer and FDA Correct answer.
  4. Return the product to the wholesaler for resale

Explanation

Under DSCSA, a trading partner that suspects a product is counterfeit, diverted, or otherwise illegitimate must quarantine the product and notify the manufacturer and FDA. The product must not be returned to the supply chain or dispensed.

Question 45Federal drug laws and regulations (FDCA, CSA, DSCSA, REMS)

A drug is adulterated under the FDCA when which condition exists?

  1. The drug is manufactured under conditions that fail to conform to current good manufacturing practice Correct answer.
  2. The drug is dispensed without a prescription
  3. The drug's label omits the established name
  4. The drug is sold at a discount

Explanation

Under section 501 of the FDCA, a drug is adulterated if it is manufactured under conditions that do not conform to current good manufacturing practice or if it contains filthy or decomposed substances, among other conditions. Labeling omissions relate to misbranding.

Question 46Federal drug laws and regulations (FDCA, CSA, DSCSA, REMS)

A pharmacist is reviewing a prescription for a controlled substance that the prescriber has authorized to be refilled. Which statement best describes the federal requirement for refill records?

  1. The pharmacist must record the refill date, quantity, and the identity of the dispensing pharmacist Correct answer.
  2. The pharmacist must report refills to the state board monthly
  3. The pharmacist must notify DEA each time a refill is dispensed
  4. The pharmacist must obtain a new prescription for every refill

Explanation

Federal regulations require that refills of controlled substances be recorded, including the date, quantity, and the dispensing pharmacist's identity. These records must be maintained and be readily retrievable for inspection.

Question 47Federal drug laws and regulations (FDCA, CSA, DSCSA, REMS)

A pharmacy is registered with DEA and dispenses controlled substances. Which statement best describes the federal requirement for its DEA registration renewal?

  1. The registration must be renewed every three years Correct answer.
  2. The registration must be renewed every five years
  3. The registration never expires once issued
  4. The registration must be renewed every year

Explanation

DEA registrations for pharmacies are issued for a three-year period and must be renewed before expiration. Renewal requires updating registration information and paying the applicable fee.

Question 48Federal drug laws and regulations (FDCA, CSA, DSCSA, REMS)

A pharmacy discovers that a controlled substance was lost through a break-in. Which statement best describes the federal reporting requirement?

  1. The pharmacy must notify FDA rather than DEA
  2. The pharmacy must notify DEA at the next renewal cycle
  3. The pharmacy must notify DEA in writing within one business day of discovery of the theft or significant loss Correct answer.
  4. The pharmacy must notify DEA only if the loss exceeds 1,000 dosage units

Explanation

Under 21 CFR 1301.74(c), a registrant must notify the DEA field division office in writing within one business day of discovery of a theft or significant loss of controlled substances. The notification must include the circumstances and a list of the substances involved.

Question 49Federal drug laws and regulations (FDCA, CSA, DSCSA, REMS)

A pharmacy is evaluating whether a prescription for a Schedule V controlled substance may be refilled. Which statement best reflects the federal rule?

  1. A Schedule V prescription may be refilled only with a new prescription each time
  2. A Schedule V prescription may be refilled as authorized by the prescriber, subject to the same six-month limit applicable to Schedules III and IV Correct answer.
  3. A Schedule V prescription may never be refilled
  4. A Schedule V prescription may be refilled indefinitely

Explanation

Schedule V prescriptions may be refilled if authorized by the prescriber, and the six-month limit in 21 CFR 1306.22 applies to refills of Schedule III, IV, and V prescriptions. The refill must be recorded.

Question 50Federal drug laws and regulations (FDCA, CSA, DSCSA, REMS)

A pharmacist receives a controlled substance prescription that appears to have been altered. Which statement best reflects the pharmacist's responsibility?

  1. The pharmacist should dispense a partial quantity to avoid waste
  2. The pharmacist should alter the prescription to match the patient's request
  3. The pharmacist should dispense the prescription because the prescriber's signature appears valid
  4. The pharmacist should decline to dispense and may report the suspected forgery to the appropriate authorities Correct answer.

Explanation

A pharmacist who suspects that a controlled substance prescription has been altered or forged must exercise professional judgment and should not dispense. Reporting the suspected forgery to DEA or local law enforcement is appropriate and consistent with the corresponding responsibility doctrine.