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NE MPJE practice questions

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Question 1Federal and state pharmacy law and regulations

Under federal law, a prescription for a Schedule II controlled substance may be refilled under which circumstance?

  1. Only if the prescriber authorizes refills in writing
  2. Up to five times within six months
  3. Never; refilling is prohibited Correct answer.
  4. Once within 30 days of issuance

Explanation

Federal regulations prohibit refilling a Schedule II prescription under any circumstances; the patient must obtain a new prescription from the prescriber for additional medication. The prescriber may issue multiple prescriptions authorizing sequential fills, but each is a separate dispensing, not a refill.

Question 2Federal and state pharmacy law and regulations

A pharmacist receives an oral prescription for a Schedule III controlled substance. Which action is permitted under federal law?

  1. Dispensing it only after the prescriber mails a written copy
  2. Reducing the quantity to the nearest package size
  3. Refilling it indefinitely as long as the prescriber approves
  4. Taking the order by telephone and reducing it to writing promptly Correct answer.

Explanation

Federal law permits oral prescriptions for Schedule III, IV, and V substances, provided the pharmacist reduces the order to writing promptly or records it in a permanent electronic or written file. Schedule II oral orders are restricted to genuine emergencies with a follow-up written prescription.

Question 3Federal and state pharmacy law and regulations

A prescriber issues an emergency oral order for a Schedule II controlled substance. Within how many days must the prescriber furnish a written prescription to the pharmacy?

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

Explanation

When a pharmacist dispenses a Schedule II substance on an emergency oral order, the prescriber must deliver a written prescription within seven days. If the written prescription is not received, the pharmacist must notify DEA.

Question 4Federal and state pharmacy law and regulations

Which federal statute establishes the legal framework for classifying controlled substances into schedules and imposes registration duties on dispensers?

  1. Durham-Humphrey Amendment
  2. Controlled Substances Act Correct answer.
  3. Food, Drug, and Cosmetic Act
  4. Public Health Service Act

Explanation

The Controlled Substances Act (Title II of the Comprehensive Drug Abuse Prevention and Control Act of 1970) creates the five schedules and the registration, recordkeeping, and security obligations enforced by DEA. The Food, Drug, and Cosmetic Act governs drug approval and labeling rather than scheduling.

Question 5Federal and state pharmacy law and regulations

Which record must a pharmacy retain for at least two years under federal controlled substance regulations?

  1. DEA Form 222 records for Schedule II acquisitions Correct answer.
  2. Third-party payer remittance records
  3. Biennial inventory of all legend drugs
  4. Patient counseling logs

Explanation

Federal regulations require registrants to keep records and inventories of controlled substances, including executed and voided DEA Form 222 documents and receipts for Schedule II purchases, for at least two years. These records must be maintained separately or be readily retrievable.

Question 6Federal and state pharmacy law and regulations

A pharmacy discovers that a bottle of oxycodone tablets is missing. What is the federal reporting obligation?

  1. Report the theft or significant loss to the DEA field office in writing upon discovery Correct answer.
  2. Report the loss only in the next biennial inventory filing
  3. Report the loss to the state board only if the value exceeds $500
  4. Report the loss to DEA on Form 106 within one business day of discovery

Explanation

A registrant that discovers a theft or significant loss of controlled substances must notify the DEA field division office in writing upon discovery and complete a DEA Form 106. The registrant must also notify local law enforcement as required.

Question 7Federal and state pharmacy law and regulations

A DEA Form 222 is used to accomplish which transaction?

  1. Reporting a theft of controlled substances
  2. Transferring a controlled substance between pharmacies for destruction
  3. Ordering Schedule II controlled substances from a distributor Correct answer.
  4. Registering a new pharmacy with DEA

Explanation

DEA Form 222 (now also available electronically through the CSOS system) is the order form used to procure Schedule II controlled substances. It provides a paper trail linking the supplier and purchaser for each Schedule II transaction.

Question 8Federal and state pharmacy law and regulations

A patient presents a prescription for a Schedule II stimulant written 45 days ago. Which federal rule applies?

  1. The prescription is invalid because Schedule II prescriptions expire 30 days after issuance
  2. The prescription must be filled only if the prescriber re-dates it
  3. The prescription remains valid because federal law sets no expiration date for Schedule II prescriptions Correct answer.
  4. The prescription is valid for 90 days under the emergency-fill provision

Explanation

Federal law does not impose an expiration date on Schedule II prescriptions; however, many states impose their own time limits, and pharmacists must follow the stricter applicable rule. A pharmacist should verify state law before refusing or filling based on age of the prescription.

Question 9Federal and state pharmacy law and regulations

A pharmacy technician receives a new prescription for a Schedule II opioid and prepares it for dispensing. Under federal rules, who must verify the prescription before dispensing?

  1. Any registered pharmacy intern
  2. The pharmacist on duty Correct answer.
  3. The pharmacy manager only
  4. The technician who entered the data

Explanation

Federal law requires that a pharmacist personally verify the accuracy of a controlled substance prescription before dispensing. Technicians may perform data entry and preparation tasks, but the pharmacist retains responsibility for verification and dispensing.

Question 10Federal and state pharmacy law and regulations

Which statement correctly describes the federal requirement for a pharmacy's initial inventory of controlled substances?

  1. It must be taken on the date the pharmacy first engages in dispensing and kept for two years Correct answer.
  2. It must be taken within 30 days of opening and discarded after one year
  3. It is required only for Schedule II substances
  4. It may be replaced by the distributor's invoice records

Explanation

A registrant must take an initial inventory of all controlled substances on hand on the date it first engages in business and retain that record for at least two years. Thereafter, a biennial inventory is required every two years.

Question 11Federal and state pharmacy law and regulations

A prescriber writes a prescription for a Schedule II drug with three sequential fill dates noted, each 30 days apart, totaling 90 dosage units. Which statement is correct under DEA policy?

  1. The pharmacist may fill each installment only on or after the date specified Correct answer.
  2. The prescription is invalid because multiple fills are prohibited
  3. The pharmacist may fill all three at once because the total quantity is authorized
  4. The pharmacist must obtain a new DEA Form 222 for each installment

Explanation

DEA permits a prescriber to issue multiple prescriptions authorizing sequential fills of a Schedule II medication, provided each is filled no earlier than the date specified. The pharmacist must ensure the total quantity does not exceed 90 days and must follow state rules, which may be stricter.

Question 12Federal and state pharmacy law and regulations

A pharmacy receives a faxed prescription for a Schedule II controlled substance. Under federal rules, which statement is accurate?

  1. A fax may serve as the original only for Schedule II drugs that may be orally ordered Correct answer.
  2. A fax is acceptable only if the prescriber signs it in blue ink
  3. A fax may serve as the original prescription for all Schedule II drugs
  4. A fax is never acceptable for Schedule II prescriptions

Explanation

DEA allows a fax to serve as the original prescription for Schedule II substances that may also be ordered orally, such as certain narcotics for home infusion or hospice patients. For other Schedule II drugs, a fax may be used to provide information but the original signed prescription must follow.

Question 13Federal and state pharmacy law and regulations

A pharmacist dispenses a Schedule IV drug and the patient asks to return the unused tablets because of an adverse reaction. What should the pharmacist do?

  1. Refuse the return because dispensed controlled substances cannot be returned to stock Correct answer.
  2. Accept the return and destroy the tablets in the pharmacy sink
  3. Accept the return only if the patient signs a release
  4. Accept the return and place the tablets back into stock

Explanation

Dispensed controlled substances generally may not be returned to the pharmacy for restocking or resale. Patients should be directed to an authorized take-back program or collector, and the pharmacy should handle any permitted destruction according to DEA and state rules.

Question 14Federal and state pharmacy law and regulations

Which federal requirement applies to the labeling of a dispensed prescription for a controlled substance?

  1. The label must carry the federal transfer warning required for all controlled substances
  2. The label must state the pharmacy's DEA number
  3. The label must state the schedule number and the DEA registration number of the prescriber Correct answer.
  4. The label must state the patient's diagnosis code

Explanation

Federal law requires that the label on a dispensed controlled substance bear the pharmacy's name and address, the prescription number, the date, the patient's name, directions for use, and the prescriber's name, and the dispensing pharmacist must note the schedule and the prescriber's DEA number on the record of dispensing. The label itself must include the required information in the manner federal and state rules prescribe.

Question 15Federal and state pharmacy law and regulations

A pharmacy's DEA registration expires on June 30. The pharmacy submits a renewal application on July 10. What is the pharmacy's status?

  1. The registration is expired and the pharmacy must cease controlled substance activity until reinstated Correct answer.
  2. The registration remains valid if the pharmacy posts a copy of the renewal application
  3. The registration remains valid because renewal was filed within 30 days
  4. The registration is automatically extended for 60 days

Explanation

A DEA registration expires on its stated date, and controlled substance activity must stop unless a renewal application is filed before expiration. DEA does not provide a grace period for late renewal, and dispensing after expiration can expose the registrant to enforcement action.

Question 16Federal and state pharmacy law and regulations

Which of the following is a valid reason for a pharmacist to refuse to fill a controlled substance prescription?

  1. The prescription was written by a nurse practitioner
  2. The prescriber's office is outside the pharmacist's county
  3. The pharmacist believes the prescription is not for a legitimate medical purpose Correct answer.
  4. The patient's insurance requires a prior authorization

Explanation

A pharmacist has a corresponding responsibility to ensure that a controlled substance prescription is issued for a legitimate medical purpose in the usual course of professional practice. If the pharmacist has unresolved concerns, the prescription should not be filled and the prescriber should be contacted.

Question 17Federal and state pharmacy law and regulations

A pharmacy wants to transfer an unfilled electronic prescription for a Schedule II drug to another pharmacy. Which statement reflects DEA policy?

  1. Transfer is allowed only if both pharmacies use the same software vendor
  2. Electronic Schedule II prescriptions may be transferred between pharmacies for initial filling
  3. Electronic Schedule II prescriptions may not be transferred for initial filling Correct answer.
  4. Transfer is allowed only with a handwritten copy sent by mail

Explanation

DEA does not permit the transfer of electronic prescriptions for Schedule II substances between pharmacies for initial filling. Once a Schedule II prescription has been filled, transfers are not permitted at all. Schedule III through V prescriptions may be transferred under specified conditions.

Question 18Federal and state pharmacy law and regulations

Under the federal Combat Methamphetamine Epidemic Act, which product must be sold from behind the counter or in a locked cabinet with a written or electronic logbook?

  1. Pseudoephedrine tablets Correct answer.
  2. Diphenhydramine capsules
  3. Ranitidine tablets
  4. Guaifenesin syrup

Explanation

The CMEA imposes sales restrictions, daily and monthly purchase limits, logbook requirements, and identification checks on scheduled listed chemical products, which include pseudoephedrine and ephedrine. These products must be kept behind the counter or in a locked cabinet and sold only after the purchaser provides identification and signs the logbook.

Question 19Federal and state pharmacy law and regulations

A patient purchases a 96-count box of pseudoephedrine 30 mg tablets. What is the federal daily limit for an individual purchaser?

  1. 1.2 grams
  2. 9 grams
  3. 3.6 grams Correct answer.
  4. 7.5 grams

Explanation

The CMEA sets a daily limit of 3.6 grams of pseudoephedrine base per purchaser and a 30-day limit of 9 grams. The 3.6-gram daily cap applies regardless of the package size sold.

Question 20Federal and state pharmacy law and regulations

Which federal law requires that a prescription drug be dispensed only upon a prescription when it is not safe for self-medication?

  1. Kefauver-Harris Amendment
  2. Waxman-Hatch Act
  3. Durham-Humphrey Amendment Correct answer.
  4. Poison Prevention Packaging Act

Explanation

The Durham-Humphrey Amendment of 1951 created the prescription-only category of drugs and established that certain drugs may be dispensed only upon a prescription. It also permitted oral prescriptions and refills under specified conditions.

Question 21Federal and state pharmacy law and regulations

A manufacturer issues a recall for a prescription drug already dispensed to patients. Which federal agency is responsible for overseeing the recall?

  1. Federal Trade Commission
  2. Centers for Medicare & Medicaid Services
  3. Food and Drug Administration Correct answer.
  4. Drug Enforcement Administration

Explanation

The FDA oversees recalls of drugs and other regulated products, including classification of the recall into Class I, II, or III and monitoring the effectiveness of the recall. DEA handles controlled substance diversion issues, not general drug recalls.

Question 22Federal and state pharmacy law and regulations

A pharmacist dispenses a drug with a Medication Guide required under FDA regulations. What is the pharmacist's obligation?

  1. Provide the Medication Guide only for controlled substances
  2. Provide the Medication Guide only on the first dispensing
  3. Provide the Medication Guide to the patient with each dispensing Correct answer.
  4. Provide the Medication Guide only if the patient requests it

Explanation

When a Medication Guide is required for a drug, the pharmacist must provide it to the patient with each dispensing unless the patient is an inpatient receiving care from a health professional. The guide is intended to help patients use the product safely.

Question 23Federal and state pharmacy law and regulations

A pharmacy compounds a sterile injectable for a patient. Which federal standard governs the pharmacy's sterile compounding practices?

  1. United States Pharmacopeia Chapter 1181
  2. United States Pharmacopeia Chapter 797 Correct answer.
  3. United States Pharmacopeia Chapter 800
  4. United States Pharmacopeia Chapter 795

Explanation

USP Chapter 797 sets standards for sterile compounding, including facility design, environmental monitoring, personnel training, and beyond-use dating. Chapter 795 addresses nonsterile compounding, and Chapter 800 addresses hazardous drug handling.

Question 24Federal and state pharmacy law and regulations

A prescriber requests that a pharmacist dispense a drug for an unapproved indication. Which statement is accurate under federal law?

  1. The pharmacist must report the prescriber to FDA
  2. The pharmacist may dispense because off-label prescribing is permitted by the FDCA Correct answer.
  3. The pharmacist may dispense only if the patient signs an informed consent
  4. The pharmacist must refuse because the indication is not FDA-approved

Explanation

The FDCA regulates marketing and labeling by manufacturers, not the practice of medicine, so prescribers may prescribe and pharmacists may dispense for off-label uses. The pharmacist should ensure the prescription is valid and may counsel on evidence, but federal law does not prohibit dispensing for an unapproved indication.

Question 25Federal and state pharmacy law and regulations

A patient asks a pharmacist to fill a prescription for a Schedule II drug written by a prescriber in another state. Which factor is most important in determining whether the pharmacist may fill it?

  1. Whether the prescriber's state has legalized the drug for recreational use
  2. Whether the drug is on the pharmacy's formulary
  3. Whether the patient has previously filled a prescription at the pharmacy
  4. Whether the prescriber holds a valid DEA registration and the prescription meets applicable state requirements Correct answer.

Explanation

A prescriber must hold a valid DEA registration to prescribe controlled substances, and the pharmacist must comply with the prescription requirements of the state where the dispensing occurs. Cross-state prescriptions are common, but the pharmacist must verify registration status and state-law validity.

Question 26Federal and state pharmacy law and regulations

Under the federal Controlled Substances Act, into which schedule is a drug placed when it has a currently accepted medical use in the United States but a high potential for abuse that may lead to severe psychological or physical dependence?

  1. Schedule III
  2. Schedule IV
  3. Schedule V
  4. Schedule II Correct answer.

Explanation

Schedule II is defined by three elements: high abuse potential, a currently accepted medical use in the United States, and use that may lead to severe psychological or physical dependence. Schedule III also requires accepted medical use but specifies moderate or low physical dependence or high psychological dependence.

Question 27Federal and state pharmacy law and regulations

A pharmacy's DEA registration is in effect and the pharmacist-in-charge wants to order a Schedule II controlled substance from a wholesaler. Which document must the pharmacy complete for each such distribution?

  1. A state board of pharmacy inspection form
  2. A DEA Form 106
  3. A DEA Form 222 or its electronic equivalent Correct answer.
  4. A DEA Form 41

Explanation

The DEA Form 222 (single-sheet or electronic CSOS version) is the order form required for each distribution of a Schedule I or II controlled substance between registrants. It documents the transaction and must be retained and accounted for by both parties.

Question 28Federal and state pharmacy law and regulations

A pharmacist receives a telephone order for a Schedule III analgesic from a prescriber. Which statement best describes the federal rule on oral orders for this schedule?

  1. Oral orders are permitted with no follow-up prescription required.
  2. Oral orders are permitted, and the prescriber must furnish a written or electronic prescription within 7 days. Correct answer.
  3. Oral orders are prohibited for Schedule III drugs.
  4. Oral orders are permitted only if the prescriber signs the record within 24 hours.

Explanation

Federal regulations allow an oral prescription for a Schedule III, IV, or V drug, but the prescriber must provide a written or electronic prescription within 7 days. If the follow-up does not arrive, the pharmacist must notify the DEA.

Question 29Federal and state pharmacy law and regulations

A pharmacy technician is asked to perform a final verification of a new prescription before it reaches the patient. Under state law, which statement reflects the typical restriction on this task?

  1. Technicians may verify prescriptions when the pharmacist is at lunch.
  2. Final verification of a new prescription is a pharmacist-only function in most states. Correct answer.
  3. Technicians may verify any prescription if a pharmacist supervises them.
  4. Technicians may verify prescriptions only for Schedule V drugs.

Explanation

Final verification of a new prescription is generally reserved to the pharmacist as part of the pharmacist's counseling and clinical responsibility. Technician duties are usually limited to tasks delegated by the pharmacist and defined by state board rules.

Question 30Federal and state pharmacy law and regulations

A patient asks the pharmacist whether a prescription is required for a drug that FDA has approved as a prescription-only product. Which federal standard governs this?

  1. The drug may be sold without a prescription if the pharmacist counsels the patient.
  2. The drug may be sold without a prescription if the state board permits it.
  3. The drug may be sold without a prescription if the patient signs a waiver.
  4. The drug must be dispensed only on prescription because it is not safe for self-medication. Correct answer.

Explanation

The federal Food, Drug, and Cosmetic Act requires that a drug be dispensed only upon prescription when it is not safe for use except under professional supervision because of its toxicity or method of use. This federal status is independent of pharmacist counseling or patient waiver.

Question 31Federal and state pharmacy law and regulations

A pharmacy receives a shipment containing a controlled substance that was not ordered and that the pharmacy does not want. Which action is consistent with federal rules on returning controlled substances to a registered supplier?

  1. Destroy it on site and record it on DEA Form 41.
  2. Report it as a theft on DEA Form 106.
  3. Ship it back with an ordinary invoice and no DEA form.
  4. Return it to the supplier using a DEA Form 222 or CSOS order form executed in reverse. Correct answer.

Explanation

A registrant returning a Schedule II controlled substance to the supplier uses the DEA Form 222 (or CSOS equivalent) in the reverse direction. The supplier must be registered and the transaction documented on the order form.

Question 32Federal and state pharmacy law and regulations

A pharmacist wants to fill a prescription for a Schedule II drug that was issued by a prescriber in another state. Which consideration is most relevant to whether the pharmacist may fill it?

  1. The prescription may be filled only if the drug is not a controlled substance.
  2. The prescription may be filled if the prescriber is licensed and the prescription meets the pharmacy's state requirements. Correct answer.
  3. The prescription may be filled only if the patient is a resident of the pharmacy's state.
  4. The prescription may be filled only if the prescriber is located in the same state as the pharmacy.

Explanation

Federal law does not require the prescriber to be in the same state as the pharmacy, but the prescription must satisfy the requirements of the state where it is dispensed. The pharmacist should verify the prescriber's license and the prescription's compliance with state law.

Question 33Federal and state pharmacy law and regulations

A pharmacy receives a written prescription for a Schedule II drug but the prescriber's DEA number is missing. Which statement best describes the pharmacist's obligation?

  1. The pharmacist may fill it if the pharmacy already has the prescriber on file.
  2. The pharmacist may fill it if the patient confirms the prescriber's identity.
  3. The pharmacist should not fill it until the prescriber's DEA number is obtained and verified. Correct answer.
  4. The pharmacist may fill it because the DEA number is not required on a prescription.

Explanation

A prescription for a controlled substance must include the prescriber's DEA registration number. A pharmacist should resolve the missing information before dispensing rather than rely on patient or file confirmation.

Question 34Federal and state pharmacy law and regulations

A patient presents a prescription for a Schedule II opioid that was written 45 days ago. Which federal rule applies?

  1. The prescription may be filled because federal law sets no expiration date for Schedule II prescriptions. Correct answer.
  2. The prescription may be filled if the pharmacist documents the reason for the delay.
  3. The prescription may be filled only after the prescriber issues a new prescription.
  4. The prescription is invalid because Schedule II prescriptions expire after 30 days under federal law.

Explanation

Federal law does not impose an expiration date on Schedule II prescriptions, though many states do. The pharmacist must still apply state law and professional judgment about the prescription's validity.

Question 35Federal and state pharmacy law and regulations

A pharmacy's controlled substance inventory is conducted every two years. Which statement correctly describes the federal requirement for a biennial inventory?

  1. The inventory must be taken every two years and destroyed after the next inventory.
  2. The inventory must be taken every two years and kept as a written, typewritten, or printed record. Correct answer.
  3. The inventory must be taken every two years and filed with DEA within 30 days.
  4. The inventory must be taken on a specific date set by DEA each year.

Explanation

Federal regulations require a biennial inventory of controlled substances, taken on any date chosen by the registrant within two years of the prior inventory. The record must be maintained and made available to DEA.

Question 36Federal and state pharmacy law and regulations

A pharmacist suspects that a prescriber is issuing prescriptions for controlled substances outside the usual course of professional practice. Which action is most consistent with the pharmacist's corresponding responsibility?

  1. Fill the prescription because the prescriber is licensed.
  2. Fill the prescription and report the prescriber to DEA after dispensing.
  3. Resolve the concern before dispensing and, if unresolved, decline to fill. Correct answer.
  4. Fill the prescription but limit the quantity dispensed.

Explanation

A pharmacist shares responsibility for ensuring that a controlled substance prescription is issued for a legitimate medical purpose by an individual acting in the usual course of professional practice. The pharmacist should resolve red flags before dispensing and may decline if the concern cannot be resolved.

Question 37Federal and state pharmacy law and regulations

A pharmacy discovers that a bottle of oxycodone tablets is missing. Which federal reporting obligation applies?

  1. Report the loss to DEA on Form 106 regardless of quantity.
  2. Report the loss to DEA on Form 41 within 24 hours.
  3. Report the loss to DEA on Form 106 only if the loss is significant. Correct answer.
  4. Report the loss to DEA on Form 222 within 7 days.

Explanation

A registrant must notify DEA of the theft or significant loss of any controlled substance using DEA Form 106. Isolated small discrepancies are documented in records but do not necessarily require a formal report unless the loss is significant.

Question 38Federal and state pharmacy law and regulations

A pharmacy dispenses a Schedule IV drug, and the patient later asks to return the unused tablets because of an adverse reaction. Which statement best describes the federal rule?

  1. The pharmacy may accept the return only with a DEA Form 222.
  2. The pharmacy may accept the return and place the tablets back in stock.
  3. The pharmacy may not accept the return of the dispensed controlled substance from the patient. Correct answer.
  4. The pharmacy may accept the return and destroy the tablets on site.

Explanation

Once a controlled substance has been dispensed to a patient, federal law does not permit the pharmacy to accept it back into inventory. Disposal options for the patient include authorized collection sites and mail-back programs.

Question 39Federal and state pharmacy law and regulations

A pharmacy wants to transfer an unfilled electronic prescription for a Schedule II drug to another pharmacy. Which statement best describes the federal rule?

  1. The transfer is permitted only if the patient signs a written consent.
  2. The transfer is permitted only if the prescription is converted to a paper prescription.
  3. The transfer is prohibited because Schedule II prescriptions cannot be transferred.
  4. The transfer is permitted if both pharmacies are DEA registrants and the transfer is documented. Correct answer.

Explanation

Federal rules allow the transfer of electronic prescriptions for Schedule II-V drugs between retail pharmacies, provided the transfer is documented and the requirements for electronic prescriptions are met. State law may impose additional conditions.

Question 40Federal and state pharmacy law and regulations

A pharmacy sells a product containing pseudoephedrine. Which federal requirement applies under the Combat Methamphetamine Epidemic Act?

  1. The product may be sold only in quantities of 24 tablets or fewer.
  2. The product must be kept in a locked cabinet at all times.
  3. The product may be sold only to patients with a prescription.
  4. The product must be sold from behind the counter or in a locked cabinet, and sales must be logged. Correct answer.

Explanation

The CMEA requires that scheduled listed chemical products be sold from behind the counter or in a locked cabinet and that the seller maintain a written or electronic logbook of sales. It also imposes daily and monthly purchase limits.

Question 41Federal and state pharmacy law and regulations

A patient purchases a 96-count box of pseudoephedrine 30 mg tablets. Which statement best describes the federal daily limit for an individual purchaser?

  1. The daily limit is 3.6 grams of pseudoephedrine base. Correct answer.
  2. The daily limit is 1.44 grams of pseudoephedrine base.
  3. The daily limit is 9 grams of pseudoephedrine base.
  4. The daily limit is 7.5 grams of pseudoephedrine base.

Explanation

The CMEA sets a daily limit of 3.6 grams of pseudoephedrine base for an individual purchaser and a 30-day limit of 9 grams. A 96-count box of 30 mg tablets contains 2.88 grams, which is within the daily limit.

Question 42Federal and state pharmacy law and regulations

A manufacturer issues a recall for a prescription drug already dispensed to patients. Which federal agency is responsible for the recall classification and oversight?

  1. The Food and Drug Administration Correct answer.
  2. The Centers for Disease Control and Prevention
  3. The Drug Enforcement Administration
  4. The Federal Trade Commission

Explanation

FDA oversees recalls of drugs and assigns recall classifications based on the health hazard presented. DEA handles controlled substances, CDC handles public health surveillance, and FTC handles advertising and consumer protection.

Question 43Federal and state pharmacy law and regulations

A pharmacist dispenses a drug for which FDA requires a Medication Guide. Which obligation does the pharmacist have?

  1. Provide the Medication Guide to the patient with each dispensing. Correct answer.
  2. Provide the Medication Guide only when the prescriber asks.
  3. Provide the Medication Guide only on the first dispensing.
  4. Provide the Medication Guide only if the patient requests it.

Explanation

FDA regulations require that a Medication Guide be provided to the patient with each dispensing of a drug for which one is required. The guide is part of the approved labeling and supports safe use.

Question 44Federal and state pharmacy law and regulations

A prescriber asks a pharmacist to dispense a drug for an unapproved indication. Which statement is accurate under federal law?

  1. Dispensing for an unapproved indication is permitted only with an FDA investigational new drug approval.
  2. Dispensing for an unapproved indication is permitted because FDA does not regulate off-label use. Correct answer.
  3. Dispensing for an unapproved indication is prohibited by federal law.
  4. Dispensing for an unapproved indication is permitted only if the drug is a controlled substance.

Explanation

FDA regulates the approval and labeling of drugs but does not prohibit prescribers from using approved drugs for unapproved indications. Off-label use is a recognized part of medical practice, though manufacturers cannot promote it.

Question 45Federal and state pharmacy law and regulations

A prescriber writes a prescription for a Schedule II drug with three sequential fill dates noted, each 30 days apart, to be filled over three months. Which statement best describes the federal rule?

  1. Federal law permits multiple fill dates only if the patient has a terminal illness.
  2. Federal law permits multiple fill dates on a Schedule II prescription if the total quantity is specified.
  3. Federal law prohibits multiple fill dates on a Schedule II prescription; the prescriber must issue a new prescription for each fill. Correct answer.
  4. Federal law permits multiple fill dates only for Schedule II drugs with a quantity of 90 units or more.

Explanation

A Schedule II prescription may not authorize multiple fills; each fill requires a new prescription. Some states have limited exceptions, but the federal default is one fill per prescription.

Question 46Federal and state pharmacy law and regulations

A pharmacy's DEA registration expires on June 30. The pharmacy submits a renewal application on July 10. Which statement best describes the pharmacy's authority to dispense controlled substances?

  1. The pharmacy may not dispense controlled substances until the registration is renewed. Correct answer.
  2. The pharmacy may continue dispensing because DEA registration is not required for pharmacies.
  3. The pharmacy may continue dispensing because the renewal was filed within 30 days.
  4. The pharmacy may continue dispensing only for Schedule III-V drugs.

Explanation

A DEA registration expires on its stated date, and a late renewal application does not extend the authority to dispense controlled substances. The registrant must wait for the renewed registration before resuming controlled substance dispensing.

Question 47Federal and state pharmacy law and regulations

A pharmacist learns that a patient is obtaining the same Schedule II opioid from multiple prescribers and pharmacies. Which action best reflects the pharmacist's professional and legal obligations?

  1. Fill the prescription and report the patient to DEA.
  2. Fill the prescription but reduce the quantity dispensed.
  3. Decline to fill until the concern is resolved and document the decision. Correct answer.
  4. Fill the prescription and counsel the patient about the risk.

Explanation

A pharmacist with a reasonable belief that a prescription is not for a legitimate medical purpose should resolve the concern before dispensing and may decline to fill. Documentation supports the decision and the corresponding responsibility standard.

Question 48Federal and state pharmacy law and regulations

A state board of pharmacy adopts a rule that is more restrictive than federal law regarding the refill of Schedule III prescriptions. Which principle determines whether the state rule controls?

  1. Federal law always preempts state law in pharmacy practice.
  2. Federal law controls only for Schedule II drugs.
  3. State law controls only if the state rule is identical to federal law.
  4. State law controls because pharmacy practice is regulated by the states, provided the state rule is not less strict than federal law. Correct answer.

Explanation

States regulate the practice of pharmacy, and a state may impose requirements stricter than federal law. Federal law sets a floor, and state rules that are more restrictive generally apply within the state.

Question 49Federal and state pharmacy law and regulations

A pharmacy's DEA registration expired 20 days ago and the pharmacy has continued to dispense Schedule II through V controlled substances while its renewal application is pending. The renewal was first filed after expiration, and DEA granted no extension. Which statement best describes the pharmacy's federal authority to dispense during this period?

  1. Dispensing is lawful only if DEA grants an extension upon written request before the expiration date.
  2. Dispensing is lawful because a timely renewal application preserves the registration during DEA review.
  3. Dispensing is unlawful because the registration lapsed and no valid registration exists until renewed. Correct answer.
  4. Dispensing is lawful for Schedule III through V but not for Schedule II while renewal is pending.

Explanation

Because the renewal was filed after expiration and DEA granted no extension, the registration lapsed and the pending application does not authorize dispensing. An eligible registration continues automatically when renewal is filed at least 45 days before expiration and DEA has not acted. That continuation does not apply here.

Question 50Federal and state pharmacy law and regulations

A pharmacist receives a telephone order from a prescriber for a Schedule III analgesic for a new patient. Which federal requirement governs the pharmacist's documentation of this oral prescription?

  1. The prescriber must deliver a written or electronic prescription within 72 hours. Correct answer.
  2. The prescriber must deliver a written or electronic prescription within 7 days.
  3. The prescriber must deliver a written or electronic prescription within 30 days.
  4. No follow-up prescription is required for Schedule III oral orders.

Explanation

Under DEA regulations, a prescription for a Schedule III or IV controlled substance may be communicated orally, but the prescriber must provide a written or electronic prescription within 72 hours. If that follow-up does not arrive, the pharmacist may not dispense further quantities on the oral order.