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NV MPJE practice questions

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Question 1Federal pharmacy law and regulations

Under the Controlled Substances Act, a prescription for a Schedule II controlled substance may be refilled under which circumstance?

  1. Up to five times within six months if the prescriber authorizes refills
  2. Never, because Schedule II prescriptions may not be refilled Correct answer.
  3. Up to two times if the patient has a terminal illness
  4. Once, if the pharmacy records the refill in writing

Explanation

Federal law prohibits refilling a Schedule II prescription; each dispensing requires a new prescription or an authorized oral emergency order followed by a written prescription. Refills are permitted only for Schedule III through V drugs, subject to the five-refills-in-six-months limit.

Question 2Federal pharmacy law and regulations

A pharmacy receives a written prescription for a Schedule II opioid. Federal rules allow an oral emergency order for a Schedule II drug only if the quantity prescribed is limited and the prescriber delivers a written prescription to the pharmacy within what period?

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

Explanation

For an emergency oral Schedule II order, the pharmacist may dispense only the limited quantity needed, and the prescriber must furnish a written prescription within seven days. If the written prescription does not arrive, the pharmacist must notify DEA.

Question 3Federal pharmacy law and regulations

Which federal statute requires that a prescription drug be dispensed only upon a prescription of a practitioner licensed by law to administer the drug?

  1. The Kefauver-Harris Amendment
  2. The Durham-Humphrey Amendment Correct answer.
  3. The Drug Price Competition and Patent Term Restoration Act
  4. The Poison Prevention Packaging Act

Explanation

The Durham-Humphrey Amendment of 1951 created the prescription-only category and limits dispensing of those drugs to a prescription from a licensed practitioner. It also authorized oral prescriptions and refills for drugs other than those requiring a new prescription each time.

Question 4Federal pharmacy law and regulations

A manufacturer wants to market a generic version of an approved brand drug. Under the Hatch-Waxman framework, which submission is the ordinary pathway for the generic product?

  1. A biologics license application with comparative clinical trials
  2. An over-the-counter monograph submission to FDA
  3. An abbreviated new drug application relying on the brand's approved data Correct answer.
  4. A new drug application containing full safety and efficacy studies

Explanation

The ANDA pathway permits a generic applicant to rely on the reference product's safety and efficacy findings and instead demonstrate pharmaceutical equivalence and bioequivalence. Full preclinical and clinical studies are not required for an ANDA.

Question 5Federal pharmacy law and regulations

A pharmacist suspects that a prescriber is issuing opioid prescriptions outside the usual course of professional practice. Which federal obligation applies to the pharmacist's handling of the suspicious orders?

  1. Report the prescriber to the state medical board only
  2. Report the prescriber to the state pharmacy association
  3. Fill every valid-looking prescription and document the concern
  4. Report the prescriber to DEA and may refuse to fill the prescription Correct answer.

Explanation

A pharmacist has a corresponding responsibility to ensure a controlled substance prescription is issued for a legitimate medical purpose in the usual course of professional practice. Suspicious orders may be refused, and the conduct may be reported to DEA and state authorities.

Question 6Federal pharmacy law and regulations

Which of the following is required for a controlled substance prescription to be valid under federal law?

  1. The prescriber's DEA registration number must appear on the prescription Correct answer.
  2. The prescription must be typed rather than handwritten
  3. The pharmacy must obtain a new patient signature at each refill
  4. The patient's social security number must appear on the prescription

Explanation

A controlled substance prescription must include the prescriber's DEA registration number among the required elements. Federal law does not require social security numbers, typed format, or patient signatures on refills.

Question 7Federal pharmacy law and regulations

Under the Combat Methamphetamine Epidemic Act, a pharmacy sells a scheduled listed chemical product such as pseudoephedrine. Which requirement applies to the sale?

  1. The product must be kept behind the counter or in a locked cabinet and the purchaser must present photo identification Correct answer.
  2. The product may be sold from open shelves if the purchaser is over 18
  3. The product may be sold only with a prescription
  4. The product may be sold in unlimited quantities with no recordkeeping

Explanation

CMEA requires that scheduled listed chemical products be stored behind the counter or in a locked cabinet and that purchasers present photo identification and sign a written or electronic logbook. Daily and monthly purchase limits also apply.

Question 8Federal pharmacy law and regulations

A pharmacy discovers that a significant theft of controlled substances occurred. Within what period must the pharmacy notify the DEA field division office in writing?

  1. Seven days of discovery
  2. Thirty days of discovery
  3. One business day of discovery Correct answer.
  4. Sixty days of discovery

Explanation

DEA regulations require a registrant to notify the field division office in writing of a significant theft or loss within one business day of discovery. In-transit losses are reported to the DEA office in the area where the loss occurred.

Question 9Federal pharmacy law and regulations

Which federal law authorized the collection of controlled substances from patients for disposal under a framework implemented by DEA regulations?

  1. The Food and Drug Administration Amendments Act
  2. The SUPPORT Act
  3. The Secure and Responsible Drug Disposal Act of 2010 Correct answer.
  4. The Orphan Drug Act

Explanation

The Secure and Responsible Drug Disposal Act of 2010 provided the statutory basis for patients to transfer controlled substances to authorized collectors for disposal. DEA implemented that authority through regulations establishing collection methods and safeguards.

Question 10Federal pharmacy law and regulations

A patient presents a Schedule II prescription for a 90-day supply of a pain medication. Federal law permits partial filling of a Schedule II prescription at the patient's request or the prescriber's request under which condition?

  1. Partial fills are never permitted for Schedule II prescriptions
  2. The remaining portion may be filled within 60 days of the date written
  3. The remaining portion must be filled within 30 days of the date written Correct answer.
  4. The partial fill must be completed within 72 hours

Explanation

CARA amended federal law to allow partial filling of a Schedule II prescription at the request of the patient or prescriber, with the remainder filled within 30 days of the date the prescription was written. If the remainder is not filled within that period, the pharmacist must notify the prescriber.

Question 11Federal pharmacy law and regulations

A pharmacist receives a prescription for a Schedule III drug with authorized refills. What is the maximum number of refills and the maximum period over which they may be dispensed under federal law?

  1. Two refills within one year
  2. Three refills within three months
  3. Unlimited refills within one year
  4. Five refills within six months Correct answer.

Explanation

Schedule III and IV prescriptions may be refilled up to five times within six months after the date of issue. After that, a new prescription is required to authorize further dispensing.

Question 12Federal pharmacy law and regulations

Which statement best describes the federal requirement for a pharmacy to verify the identity of a prescriber who electronically prescribes a controlled substance?

  1. Verbal confirmation by the patient is sufficient
  2. The prescriber must be authenticated through a credentialing process and the electronic prescription must include a digital signature Correct answer.
  3. The pharmacy may accept any faxed copy without verification
  4. Verification is required only for Schedule II prescriptions

Explanation

The electronic prescription rules require prescriber authentication through an identity-proofing and credentialing process and a digital signature on the electronic prescription. Pharmacies must verify the prescriber's authority before dispensing.

Question 13Federal pharmacy law and regulations

A pharmacy wants to dispose of expired controlled substances. Which federal mechanism is available for a registrant to transfer controlled substances to a reverse distributor?

  1. Use DEA Form 222 for Schedule II and maintain records for Schedule III through V Correct answer.
  2. Return the drugs to the manufacturer without any documentation
  3. Ship the drugs to a local landfill with a manifest
  4. Simply discard the drugs in the regular trash with a note

Explanation

A registrant may transfer controlled substances to a reverse distributor using the appropriate order forms and records, with DEA Form 222 used for Schedule II drugs. Documentation must be retained to account for the drugs.

Question 14Federal pharmacy law and regulations

The Drug Enforcement Administration requires a registrant to maintain records of controlled substance transactions for what minimum period?

  1. One year
  2. Two years Correct answer.
  3. Three years
  4. Five years

Explanation

DEA regulations require registrants to keep records and inventories of controlled substances for at least two years. Records must be kept separate from ordinary business records and be readily retrievable.

Question 15Federal pharmacy law and regulations

Which federal agency has primary authority to approve a new prescription drug for marketing in the United States?

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

Explanation

The FDA approves new drug applications and determines whether a drug is safe and effective for its intended use. DEA regulates controlled substances, the FTC addresses advertising, and CMS administers federal health programs.

Question 16Federal pharmacy law and regulations

Under the Federal Food, Drug, and Cosmetic Act, which of the following is an example of misbranding?

  1. A drug that has not been approved for any indication
  2. A drug that fails to meet its claimed potency specifications
  3. A drug manufactured without current good manufacturing practice
  4. A drug label that omits the required established name of the drug Correct answer.

Explanation

Misbranding concerns labeling and information defects, such as omitting the established name, inadequate directions, or false or misleading labeling. Adulteration concerns manufacturing conditions and failure to meet compendial standards.

Question 17Federal pharmacy law and regulations

Which federal law created the current two-tier framework for prescription drug labeling and expanded FDA authority over drug advertising and efficacy?

  1. The Harrison Narcotics Tax Act
  2. The Biologics Control Act
  3. The Pure Food and Drug Act
  4. The Kefauver-Harris Drug Amendments Correct answer.

Explanation

The Kefauver-Harris Amendments of 1962 required proof of efficacy and strengthened controls over drug advertising and labeling. They built on the 1938 Food, Drug, and Cosmetic Act framework.

Question 18Federal pharmacy law and regulations

A pharmacy compounder prepares a sterile compounded preparation. Which federal standard applies to the pharmacy's sterile compounding under the Food, Drug, and Cosmetic Act?

  1. The pharmacy must obtain an NDA for each compounded preparation
  2. The pharmacy may compound without any quality standards if a patient requests it
  3. The pharmacy may follow only state board rules with no federal standard
  4. The pharmacy must comply with applicable United States Pharmacopeia standards referenced by FDA guidance Correct answer.

Explanation

FDA expects sterile compounders to follow applicable USP standards such as USP General Chapter 797, which addresses facilities, environmental monitoring, and personnel training. State boards may also impose requirements, but federal expectations exist.

Question 19Federal pharmacy law and regulations

Which of the following best describes the federal requirement for a pharmacy to report suspicious orders of controlled substances to DEA?

  1. Registrants have no federal duty to monitor customer orders
  2. Registrants must report suspicious orders to DEA and may not ship them until the suspicion is resolved Correct answer.
  3. Registrants need only report suspicious orders at the end of the calendar year
  4. Registrants may ship suspicious orders if the purchaser pays in advance

Explanation

DEA regulations require registrants, including distributors, to design a system to identify suspicious orders and to report them to DEA. Suspicious orders should be held pending resolution rather than shipped.

Question 20Federal pharmacy law and regulations

A patient asks a pharmacist whether a prescription drug may be imported from Canada for personal use. What is the general federal position?

  1. Personal importation is permitted only for Schedule II drugs
  2. Personal importation is permitted if the patient signs a waiver
  3. Personal importation is always permitted if the drug is cheaper abroad
  4. Personal importation is generally prohibited, though limited FDA enforcement discretion may apply in narrow circumstances Correct answer.

Explanation

The Federal Food, Drug, and Cosmetic Act generally prohibits importing unapproved or misbranded drugs, and personal importation is generally unlawful. FDA has announced limited enforcement discretion for certain small personal quantities in specific circumstances, but no broad right exists.

Question 21Federal pharmacy law and regulations

Which federal statute requires that a pharmacy's prescription records for controlled substances be readily retrievable for inspection by DEA investigators?

  1. The Health Insurance Portability and Accountability Act
  2. The Medicare Modernization Act
  3. The Controlled Substances Act Correct answer.
  4. The Federal Trade Commission Act

Explanation

The Controlled Substances Act and its regulations require registrants to maintain complete and accurate records and make them available for inspection. HIPAA governs privacy of health information but does not create the controlled substance recordkeeping duty.

Question 22Federal pharmacy law and regulations

A pharmacist is asked to fill a prescription written by a prescriber whose DEA registration has expired. What is the best federal-law answer?

  1. The pharmacist may dispense because the state license is still active
  2. The pharmacist may dispense if the prescription is for a non-controlled drug only
  3. The pharmacist should not dispense the controlled substance prescription because the prescriber lacks current DEA authority Correct answer.
  4. The pharmacist may dispense if the patient pays cash

Explanation

A controlled substance prescription is valid only if issued by a practitioner with current DEA registration authorizing that schedule. An expired DEA registration means the prescriber lacks federal authority to prescribe the controlled substance.

Question 23Federal pharmacy law and regulations

Which federal law requires that certain drugs be dispensed with a Medication Guide when the drug poses serious and significant public health concerns?

  1. The Food and Drug Administration Amendments Act Correct answer.
  2. The Orphan Drug Act
  3. The Poison Prevention Packaging Act
  4. The Controlled Substances Act

Explanation

The FDA Amendments Act of 2007 authorized FDA to require Medication Guides and Risk Evaluation and Mitigation Strategies for drugs with serious safety concerns. Medication Guides provide patient-friendly information about risks.

Question 24Federal pharmacy law and regulations

A pharmacy dispenses a controlled substance to a patient and later learns the prescription was forged. Which federal action is most appropriate?

  1. Discard the prescription to avoid liability
  2. Notify the patient's insurer only
  3. Report the forgery to DEA and retain the prescription and related records Correct answer.
  4. Take no action because the dispensing already occurred

Explanation

Forged controlled substance prescriptions should be reported to DEA and the prescription and records retained as evidence. Destroying records or failing to report can compound the pharmacy's exposure.

Question 25Federal pharmacy law and regulations

Which of the following is a federal requirement for the labeling of a prescription drug dispensed to a patient?

  1. The label must include the wholesale acquisition cost
  2. The label must include the drug's patent expiration date
  3. The label must include the pharmacy name and address, prescription number, and directions for use Correct answer.
  4. The label must include the prescriber's home address

Explanation

Federal and state labeling rules require the pharmacy to include identifying information such as the pharmacy name and address, prescription number, date, patient name, directions, and prescriber. Prescriber home address, acquisition cost, and patent expiration are not required label elements.

Question 26Federal pharmacy law and regulations

A pharmacy is registered with the DEA and dispenses controlled substances. How often must the registrant conduct a complete and accurate inventory of all controlled substances on hand?

  1. Every two years, on any date chosen by the registrant Correct answer.
  2. Every year, on the date the registration was issued
  3. Every three years, on the date the registration was issued
  4. Only when the DEA sends a written request for an inventory

Explanation

Under 21 CFR 1304.11, every registrant must take a complete and accurate inventory of all controlled substances on hand every two years. The biennial inventory may be taken on any date chosen by the registrant, provided that date falls within two years of the previous inventory. New registrants take an initial inventory on the date they begin business.

Question 27Federal pharmacy law and regulations

Which federal schedule classification applies to a drug that has a currently accepted medical use in treatment in the United States and a high potential for abuse that may lead to severe psychological or physical dependence?

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

Explanation

Schedule II covers drugs with a currently accepted medical use but a high abuse potential that may lead to severe psychological or physical dependence. Schedule III requires abuse potential lower than Schedule I or II, and Schedules IV and V require progressively lower potential. The three-part test of accepted medical use, abuse potential, and dependence liability drives the classification.

Question 28Federal pharmacy law and regulations

A pharmacy's DEA registration expires on a date when the pharmacy still holds controlled substances. What is the registrant's obligation regarding those drugs while unregistered?

  1. Secure the drugs and promptly transfer or dispose of them in compliance with DEA requirements Correct answer.
  2. Sell the remaining stock to another pharmacy without documentation
  3. Continue dispensing them until a renewal application is approved
  4. Store them indefinitely without further action because possession predates expiration

Explanation

Once the registration expires, the entity is no longer authorized to possess or dispense controlled substances. The registrant must secure the drugs and arrange a compliant transfer to another registrant or disposal, with the required DEA records. Continuing activity without a valid registration is a violation of the Controlled Substances Act.

Question 29Federal pharmacy law and regulations

Which federal requirement applies to a prescription for a Schedule II controlled substance regarding refills?

  1. Refills are permitted if the prescriber authorizes them orally
  2. Up to two refills are permitted within six months
  3. Up to five refills are permitted within six months
  4. No refills are permitted, and the prescription is valid only as originally written Correct answer.

Explanation

Federal law prohibits refills on Schedule II prescriptions; the patient must obtain a new prescription for additional dispensing. The prescription may not be refilled even with prescriber authorization, though limited emergency oral orders and partial filling rules exist. This distinguishes Schedule II from Schedule III and IV drugs, which allow limited refills.

Question 30Federal pharmacy law and regulations

A pharmacist receives an oral prescription for a Schedule III controlled substance. Which federal rule governs whether the pharmacist may reduce that oral order to writing?

  1. The pharmacist may reduce it to writing only if the patient signs the record
  2. The pharmacist may reduce it to writing, but the prescriber must sign the written record within a set period Correct answer.
  3. The pharmacist may never reduce an oral controlled substance order to writing
  4. The pharmacist must forward the oral order to the DEA before dispensing

Explanation

For Schedule III through V drugs, a pharmacist may take an oral prescription and reduce it to writing, but the prescriber must furnish a signed written prescription within the timeframe set by regulation. The pharmacist must retain the record of the oral order. Schedule II oral orders are limited to genuine emergencies with follow-up written prescriptions.

Question 31Federal pharmacy law and regulations

Under the Poison Prevention Packaging Act, which of the following best describes the default rule for dispensing prescription drugs to patients?

  1. Child-resistant packaging is required only for pediatric patients
  2. Only controlled substances require child-resistant packaging
  3. Prescription drugs may be dispensed in any packaging the pharmacy chooses
  4. Prescription drugs must be dispensed in child-resistant packaging unless an exception applies Correct answer.

Explanation

The Poison Prevention Packaging Act requires most prescription drugs to be dispensed in child-resistant containers unless a statutory or regulatory exception applies. Exceptions include prescriber or patient requests for noncomplying packaging and certain exempted products. The default is child-resistant packaging, not pharmacy discretion.

Question 32Federal pharmacy law and regulations

A manufacturer wants to market a new prescription drug in the United States. Which pathway is the standard route for obtaining FDA approval of a new molecular entity?

  1. A new drug application with substantial evidence of safety and effectiveness Correct answer.
  2. A dietary supplement notification
  3. An over-the-counter monograph submission
  4. An abbreviated new drug application relying on literature alone

Explanation

A new drug application is the standard pathway for a new molecular entity and must include substantial evidence of safety and effectiveness from adequate and well-controlled investigations. An abbreviated new drug application relies on a reference listed drug's prior findings and is used for generic copies. Monograph and supplement pathways do not authorize a new prescription drug.

Question 33Federal pharmacy law and regulations

Which federal statute is the principal source of authority for regulating the manufacture, distribution, and dispensing of controlled substances?

  1. The Public Health Service Act
  2. The Federal Food, Drug, and Cosmetic Act
  3. The Fair Packaging and Labeling Act
  4. The Controlled Substances Act Correct answer.

Explanation

The Controlled Substances Act establishes the schedules and the registration, recordkeeping, and prescription requirements for controlled substances. The FDCA governs drug approval and labeling more broadly, while the other statutes address different subjects. Pharmacy controlled substance obligations trace primarily to the CSA and its DEA regulations.

Question 34Federal pharmacy law and regulations

A patient presents a prescription for a Schedule II stimulant written 45 days ago. The pharmacist is unsure whether federal law imposes an expiration date on the prescription. Which statement is correct?

  1. Federal law voidens Schedule II prescriptions 90 days after the date written
  2. Federal law voidens Schedule II prescriptions 30 days after the date written
  3. Federal law sets no expiration date for Schedule II prescriptions, though state law may impose one Correct answer.
  4. Federal law voidens Schedule II prescriptions 7 days after the date written

Explanation

The federal Controlled Substances Act and DEA regulations do not establish an expiration date for Schedule II prescriptions. Many states impose their own time limits, so the pharmacist must apply the stricter state rule. The absence of a federal limit does not authorize dispensing where state law prohibits it.

Question 35Federal pharmacy law and regulations

A prescriber issues an emergency oral order for a Schedule II controlled substance. What follow-up does federal law require from the prescriber?

  1. A written prescription must be delivered within 30 days
  2. The prescriber must call the DEA to confirm the order
  3. No follow-up is required for emergency oral orders
  4. A written prescription must be delivered to the pharmacy within seven days Correct answer.

Explanation

For a genuine emergency oral Schedule II order, the prescriber must deliver a written prescription to the dispensing pharmacy within seven days. If the written prescription is not received, the pharmacist must notify the DEA. The emergency exception is narrow and requires documentation of the emergency.

Question 36Federal pharmacy law and regulations

A pharmacy receives a faxed prescription for a Schedule II controlled substance. Under federal rules, for which situation is faxing expressly permitted?

  1. A prescription for a Schedule II drug to be filled more than 90 days later
  2. A prescription for a Schedule II drug written by a dentist
  3. A routine office prescription for an oral opioid analgesic
  4. A prescription for a Schedule II narcotic compounded for direct infusion by a pump Correct answer.

Explanation

DEA regulations permit faxing of Schedule II prescriptions for compounded narcotic preparations for direct infusion by a pump and for long-term care facility residents, among other limited exceptions. Routine Schedule II prescriptions for oral analgesics generally must be presented in writing or transmitted by an approved electronic system. The exceptions are narrow and must be documented.

Question 37Federal pharmacy law and regulations

A pharmacist wants to correct a written Schedule II prescription that lacks the dosage form. What federal standard governs the pharmacist's ability to add or change information on the face of the prescription?

  1. The pharmacist may freely change any element without contacting the prescriber
  2. The pharmacist may never make any change, even with prescriber agreement
  3. The pharmacist may add or change elements only after consultation with and agreement by the prescriber, with documentation Correct answer.
  4. The pharmacist may change elements only if the patient requests it

Explanation

DEA guidance permits a pharmacist to clarify or add information to a Schedule II prescription after consulting the prescriber and documenting the discussion, but the pharmacist may not change the patient name, drug, or prescriber's signature. The prescriber must agree to the change. Free alteration without consultation is not permitted.

Question 38Federal pharmacy law and regulations

A pharmacy discovers that its DEA Form 222 order form booklet has been lost. What is the registrant's obligation?

  1. Continue using photocopies of the lost forms
  2. Notify the DEA field office and execute a statement describing the circumstances Correct answer.
  3. Report the loss only if a controlled substance is later missing
  4. Wait until the next renewal cycle to report the loss

Explanation

A registrant that loses or has stolen DEA Form 222 booklets must report the loss to the DEA field office and provide a statement of the circumstances. The forms are serially numbered and tightly controlled because they authorize Schedule I and II distribution. Photocopies are not valid order forms.

Question 39Federal pharmacy law and regulations

A pharmacist is reviewing a prescription for a Schedule IV drug that includes three refills. What is the maximum number of refills federal law allows for a Schedule IV prescription?

  1. Five refills within six months of the issue date Correct answer.
  2. Three refills within one year
  3. Two refills within six months
  4. No refills are permitted

Explanation

Federal law permits up to five refills within six months of the date the prescription was issued for Schedule III and IV drugs. A prescription authorizing more than five refills may not be filled beyond the fifth, and no refill may occur after six months. The prescriber's authorization cannot exceed these federal limits.

Question 40Federal pharmacy law and regulations

A pharmacy receives a suspicious order for a large quantity of oxycodone from a new customer. Under federal law, what must the pharmacy do before completing the order?

  1. Fill the order because the customer holds a valid DEA registration
  2. Refer the customer to the state pharmacy board without notifying the DEA
  3. Fill the order but reduce the quantity by half
  4. Resolve the suspicious circumstances and, if unresolved, refuse the order and report it to the DEA Correct answer.

Explanation

Registrants have a duty to detect and prevent diversion and must resolve suspicious circumstances before completing an order. If the suspicion cannot be resolved, the registrant should refuse the order and report it to DEA. A valid registration alone does not eliminate the duty to evaluate suspicious orders.

Question 41Federal pharmacy law and regulations

A pharmacy technician asks whether a DEA registration is required for a practitioner who prescribes controlled substances but stores none at the practice site. What is the correct answer?

  1. Registration is not required if the practitioner writes fewer than 100 prescriptions per year
  2. Registration is required to prescribe controlled substances, regardless of storage Correct answer.
  3. Registration is required only if the practitioner dispenses the drugs
  4. Registration is required only for Schedule II prescribing

Explanation

Any practitioner who prescribes, administers, dispenses, or distributes a controlled substance must be registered with DEA, even if no drugs are stored at the site. Dispensing authority and prescribing authority both flow from registration. Volume of prescribing does not create an exemption.

Question 42Federal pharmacy law and regulations

A pharmacist learns that a prescriber's DEA registration has been surrendered. What is the pharmacist's best course of action regarding a new prescription from that prescriber for a controlled substance?

  1. Fill the prescription if the patient signs a waiver
  2. Do not fill the prescription and verify the prescriber's status before dispensing any controlled substance Correct answer.
  3. Fill the prescription and notify the DEA afterward
  4. Fill the prescription because the prescription was written before the surrender date

Explanation

A prescriber must hold a valid DEA registration when issuing a controlled substance prescription. If the registration has been surrendered, the pharmacist should not fill the order and should verify the prescriber's status. A patient waiver cannot cure the lack of prescriber authority.

Question 43Federal pharmacy law and regulations

Which federal law requires that a prescription drug with a serious and significant public health concern be dispensed with a Medication Guide?

  1. The Food and Drug Administration Modernization Act of 1997 Correct answer.
  2. The Controlled Substances Act
  3. The Drug Price Competition and Patent Term Restoration Act
  4. The Poison Prevention Packaging Act

Explanation

The Food and Drug Administration Modernization Act of 1997 established the Medication Guide requirement for certain drugs with serious and significant public health concerns. Medication Guides are approved patient labeling that must be provided when the drug is dispensed. The other statutes address controlled substances, packaging, and generic drug approval.

Question 44Federal pharmacy law and regulations

A pharmacy's automated dispensing system stores controlled substances. Which federal requirement applies to the system's recordkeeping?

  1. The system must maintain a complete and accurate record of receipt, dispensing, and disposal that is readily retrievable Correct answer.
  2. The system is exempt from recordkeeping because it is automated
  3. The system must print a report only when the DEA inspects
  4. The system must keep records only for Schedule II drugs

Explanation

Automated dispensing systems used for controlled substances must maintain complete and accurate records of receipt, dispensing, and disposal that are readily retrievable for inspection. Automation does not create an exemption from CSA recordkeeping. Records must cover all schedules handled by the system.

Question 45Federal pharmacy law and regulations

A pharmacy compounder prepares a nonsterile compounded preparation from a bulk drug substance. Which federal standard governs the quality of the bulk substance?

  1. The bulk substance must comply with an applicable United States Pharmacopeia monograph and be produced by an FDA-registered establishment Correct answer.
  2. The bulk substance must be approved as a finished drug product
  3. The bulk substance may be any grade as long as it is inexpensive
  4. The bulk substance needs no documentation if it is used in small quantities

Explanation

Under the FDCA compounding provisions added by the Drug Quality and Security Act, bulk drug substances used in compounding must comply with an applicable USP or National Formulary monograph and come from an FDA-registered establishment. If no monograph exists, the substance must appear on an FDA list for compounding. Price or quantity does not substitute for these standards.

Question 46Federal pharmacy law and regulations

A pharmacy wants to return a portion of its controlled substance stock to a distributor. Which federal document is required to transfer the drugs?

  1. A DEA Form 222 or its electronic equivalent for Schedule I and II substances Correct answer.
  2. A state board transfer authorization only
  3. A DEA Form 106
  4. A simple invoice signed by the pharmacist

Explanation

Transfers of Schedule I and II controlled substances between registrants require a DEA Form 222 or its electronic equivalent. Schedule III through V transfers require records but not Form 222. A Form 106 is used to report theft or significant loss, not routine transfers.

Question 47Federal pharmacy law and regulations

A pharmacist is asked to dispense a controlled substance pursuant to a prescription that the prescriber transmitted electronically. Which federal requirement must the electronic prescription system meet?

  1. The system must be operated by the DEA
  2. The system may use any email account with a scanned signature
  3. The system must transmit prescriptions only during business hours
  4. The system must use an approved application that includes identity proofing and two-factor authentication Correct answer.

Explanation

Electronic prescriptions for controlled substances must be created and transmitted through an application that meets DEA requirements, including identity proofing, two-factor authentication, and access controls. The application must be certified and the pharmacy must use a compliant system. Ordinary email does not satisfy these standards.

Question 48Federal pharmacy law and regulations

A pharmacy's controlled substance records must be kept for a specified period. Which federal retention period applies to these records?

  1. Ten years from the date of the record
  2. Five years from the date of the record
  3. Six months from the date of the record
  4. Two years from the date of the record Correct answer.

Explanation

DEA regulations require controlled substance records to be maintained for two years from the date the record is made. Records must be kept at the registered location and be readily retrievable for inspection. State law may require longer retention, in which case the longer period controls.

Question 49Federal pharmacy law and regulations

A pharmacy receives a forged prescription for a Schedule II opioid and dispenses it before discovering the forgery. Which federal reporting obligation arises?

  1. The pharmacy has no federal reporting obligation once the drug is dispensed
  2. The pharmacy must report the theft or significant loss of controlled substances to the DEA field office Correct answer.
  3. The pharmacy must report the forgery to the FDA MedWatch program
  4. The pharmacy must report the forgery only to the patient's insurer

Explanation

Dispensing on a forged prescription results in a loss of controlled substances that must be reported to the DEA field office, typically on DEA Form 106. The registrant must report theft or significant loss and describe the circumstances. Reporting to an insurer or MedWatch does not satisfy the CSA obligation.

Question 50Federal pharmacy law and regulations

A pharmacy wants to use a central fill pharmacy to prepare controlled substance prescriptions for its patients. Which statement best describes the federal requirement?

  1. Central fill is permitted only for Schedule V drugs
  2. Central fill is prohibited for all controlled substances
  3. Both pharmacies must be properly registered and the arrangement must comply with DEA recordkeeping and security rules Correct answer.
  4. Central fill requires no additional registration if the pharmacies share ownership

Explanation

Central fill arrangements for controlled substances require that the participating pharmacies hold appropriate DEA registrations and comply with recordkeeping, security, and labeling requirements. Shared ownership alone does not eliminate registration obligations. The arrangement must preserve an auditable chain of custody for each prescription.