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ND MPJE practice questions

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Question 1Federal Drug Laws and Regulations

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

  1. Up to two times within three months
  2. Only if the prescriber authorizes refills in writing
  3. Never; Schedule II prescriptions may not be refilled Correct answer.
  4. Up to five times within six months

Explanation

The CSA 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, within limits.

Question 2Federal Drug Laws and Regulations

A pharmacy receives a DEA Form 222 for a Schedule II drug shipment. What is the required handling of the executed order form?

  1. Return it to the supplier with the invoice
  2. Destroy it after the shipment is verified
  3. Retain it at the receiving pharmacy for two years Correct answer.
  4. Send it to the state board of pharmacy

Explanation

DEA Form 222 (the single-sheet CSOS equivalent now applies) must be kept by the purchaser for two years and made available for inspection. It documents the chain of distribution for Schedule I and II substances.

Question 3Federal Drug Laws and Regulations

Which schedule contains drugs with a currently accepted medical use and the lowest abuse potential recognized under the CSA?

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

Explanation

Schedule V substances have the lowest abuse potential among controlled substances with accepted medical use, and some may be dispensed without a prescription under state and federal conditions. Schedules II through IV reflect progressively higher abuse potential.

Question 4Federal Drug Laws and Regulations

A prescriber telephones a pharmacy with an emergency oral order for a Schedule II opioid. What must the prescriber do next?

  1. Deliver a written prescription within seven days Correct answer.
  2. Deliver a written prescription within seventy-two hours
  3. Register the order in the state prescription monitoring program
  4. Obtain DEA verbal approval before the pharmacy dispenses

Explanation

For a true emergency, a prescriber may phone in a Schedule II order, but must follow it with a written prescription within seven days. The pharmacy may dispense on the oral order if it makes a good-faith effort to verify the emergency.

Question 5Federal Drug Laws and Regulations

Which federal statute established the framework that created the current five-schedule controlled substance system and its registration requirements?

  1. Comprehensive Drug Abuse Prevention and Control Act of 1970 Correct answer.
  2. Food, Drug, and Cosmetic Act of 1938
  3. Kefauver-Harris Amendment of 1962
  4. Durham-Humphrey Amendment of 1951

Explanation

The Comprehensive Drug Abuse Prevention and Control Act of 1970, commonly called the Controlled Substances Act, created the five schedules and the DEA registration system. The other statutes govern drug safety, prescription status, and efficacy rather than controlled substance scheduling.

Question 6Federal Drug Laws and Regulations

A retail pharmacy's DEA registration expires on a date when the pharmacy is still operating. What is the consequence of practicing without a current registration?

  1. The pharmacy may continue dispensing for a thirty-day grace period
  2. The pharmacy may dispense only Schedule III through V drugs
  3. A state license automatically substitutes for the federal registration
  4. Dispensing controlled substances becomes unlawful until registration is renewed Correct answer.

Explanation

DEA registration is a prerequisite for handling controlled substances, and dispensing without a valid registration is unlawful. There is no automatic grace period, and a state license does not replace federal registration.

Question 7Federal Drug Laws and Regulations

Which drug is classified under Schedule III of the CSA?

  1. Methylphenidate
  2. Heroin
  3. Lysergic acid diethylamide
  4. Anabolic steroids Correct answer.

Explanation

Anabolic steroids such as testosterone are listed in Schedule III. Heroin and LSD are Schedule I, and methylphenidate is Schedule II.

Question 8Federal Drug Laws and Regulations

A pharmacy discovers that a Schedule II prescription was forged by a patient. Which action is required under federal rules?

  1. Report the forgery only to the patient's insurer
  2. Record the forgery in the pharmacy's biennial inventory
  3. Void the prescription and take no further action
  4. Report the theft or significant loss to the DEA field office Correct answer.

Explanation

Significant losses of controlled substances, including those arising from forged prescriptions, must be reported to the DEA field division, and a DEA Form 106 is filed. The pharmacy should also notify local authorities as required by state law.

Question 9Federal Drug Laws and Regulations

Under the CSA, which of the following is a valid DEA registration category for a community pharmacy?

  1. Importer
  2. Analytical lab
  3. Dispenser Correct answer.
  4. Researcher

Explanation

A pharmacy that dispenses controlled substances obtains a DEA registration as a dispenser. Researcher, analytical lab, and importer are distinct registration categories tied to different activities.

Question 10Federal Drug Laws and Regulations

A Schedule V cough preparation contains a small amount of codeine. Under federal law, when may it be sold without a prescription?

  1. When the purchaser signs a statement that the drug is for personal use
  2. When the pharmacist determines the purchaser is over eighteen years old
  3. When state law permits and the purchaser meets the CSA identification and logbook conditions Correct answer.
  4. When the product is kept behind the counter in the pharmacy

Explanation

Federal law allows some Schedule V products to be sold without a prescription only if state law also permits it and the purchaser provides identification and signs the required logbook. The pharmacist must apply professional judgment as well.

Question 11Federal Drug Laws and Regulations

What is the maximum number of refills permitted for a Schedule IV prescription under federal law?

  1. Two refills within one year
  2. Unlimited refills as long as the prescriber authorizes them
  3. Five refills within six months of the issue date Correct answer.
  4. Three refills within four months

Explanation

Schedule III and IV prescriptions may not be refilled more than five times and may not be refilled more than six months after the date of issue. The prescriber must authorize refills on the prescription itself.

Question 12Federal Drug Laws and Regulations

A manufacturer wants to market a new drug that has no accepted medical use but high abuse potential. Which schedule would apply?

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

Explanation

Schedule I is reserved for substances with high abuse potential and no currently accepted medical use in treatment in the United States. A drug with accepted medical use but high abuse potential would fall in Schedule II.

Question 13Federal Drug Laws and Regulations

Which federal requirement applies to the physical security of a pharmacy's controlled substance stock under the CSA?

  1. Storage in an unlocked area visible to staff at all times
  2. Storage in the same shelving as noncontrolled inventory
  3. Storage in a refrigerator regardless of the drug's labeled storage needs
  4. Storage in a securely locked, substantially constructed cabinet or dispersed in a manner that obstructs theft Correct answer.

Explanation

DEA regulations require controlled substances to be stored in a securely locked, substantially constructed cabinet or dispersed throughout the stock in a manner that obstructs the possibility of theft. The goal is to prevent diversion while maintaining access for legitimate dispensing.

Question 14Federal Drug Laws and Regulations

A prescriber wants to issue a Schedule II prescription electronically. Which condition must be met?

  1. The prescriber must use an application that meets DEA electronic prescription requirements Correct answer.
  2. The pharmacy must obtain a paper copy from the prescriber afterward
  3. The prescriber must also call the pharmacy to confirm the order
  4. The prescription must be limited to a seven-day supply

Explanation

Electronic prescriptions for controlled substances are valid when the prescriber uses a system that meets DEA requirements for identity proofing and authentication. No paper follow-up is required for a valid electronic Schedule II prescription.

Question 15Federal Drug Laws and Regulations

A pharmacy technician asks which record must be maintained for a biennial inventory of controlled substances.

  1. A list of only Schedule II drugs, taken annually
  2. A complete and accurate record of all controlled substances on hand, taken every two years Correct answer.
  3. A count of expired controlled substances only
  4. A summary of prescriptions dispensed during the prior month

Explanation

Registrants must take a complete and accurate inventory of all controlled substances on hand every two years, with the date and time recorded. Schedule II counts must be exact, while other schedules may be estimated unless a container holds more than 1,000 units.

Question 16Federal Drug Laws and Regulations

Which federal law requires pharmacies to provide a notice and opportunity to object before disclosing patient prescription records in certain circumstances?

  1. The Poison Prevention Packaging Act
  2. The Hatch-Waxman Act
  3. The Orphan Drug Act
  4. The HIPAA Privacy Rule Correct answer.

Explanation

The HIPAA Privacy Rule governs uses and disclosures of protected health information, including prescription records, and requires notice of privacy practices and limits on disclosure. The other statutes address packaging safety, orphan drug incentives, and generic drug approval.

Question 17Federal Drug Laws and Regulations

A patient presents a Schedule II prescription dated eight months ago. What is the pharmacist's best action under federal law?

  1. Do not dispense without confirmation of current validity from the prescriber, since federal law does not set an expiration but state law may Correct answer.
  2. Return it to the patient and instruct the patient to file it with the DEA
  3. Dispense it as a Schedule IV prescription because of the age of the order
  4. Dispense it because federal law permits Schedule II prescriptions to be filled for one year

Explanation

The CSA does not impose a federal expiration date on Schedule II prescriptions, but a pharmacist must determine that the prescription remains valid for the patient's current condition. State law often imposes its own time limits, so prescriber confirmation is prudent.

Question 18Federal Drug Laws and Regulations

Which action by a pharmacy would constitute a violation of the CSA's prescription requirement for a Schedule II drug?

  1. Dispensing a Schedule II drug after verifying the prescriber's DEA registration
  2. Dispensing a Schedule II drug on an oral order without any written follow-up Correct answer.
  3. Dispensing a Schedule II drug on a valid electronic prescription
  4. Dispensing a Schedule II drug on a written prescription signed by the prescriber

Explanation

An emergency oral Schedule II order must be followed by a written prescription within seven days; failing to obtain that follow-up makes the dispensing improper. Written, electronic, and verified prescriptions are all valid pathways.

Question 19Federal Drug Laws and Regulations

A pharmacy's controlled substance records must be kept in a manner that allows which of the following?

  1. Destruction after one year if no audit occurs
  2. Conversion to summary totals without supporting detail
  3. Prompt retrieval and reconciliation of receipts, dispensings, and inventory Correct answer.
  4. Storage in a locked offsite facility indefinitely

Explanation

Registrants must maintain records that are complete, accurate, and readily retrievable for at least two years so that receipts, dispensings, and inventory can be reconciled. Summaries without supporting detail do not satisfy the requirement.

Question 20Federal Drug Laws and Regulations

A DEA investigator requests to inspect a pharmacy's controlled substance records during business hours. What is the pharmacy's obligation?

  1. Make the required records and inventory available for inspection at reasonable times Correct answer.
  2. Refuse entry without a search warrant in all cases
  3. Refer the investigator to the state board instead
  4. Provide records only after a thirty-day written notice

Explanation

DEA-registered entities consent to inspections of their controlled substance records and premises at reasonable times as a condition of registration. Refusal can jeopardize the registration.

Question 21Federal Drug Laws and Regulations

Which situation requires a pharmacy to file a DEA Form 106?

  1. A patient request to transfer a prescription to another pharmacy
  2. A routine biennial inventory completion
  3. A significant theft of oxycodone tablets discovered during a count Correct answer.
  4. An expired controlled substance returned by a patient

Explanation

DEA Form 106 is the report of theft or significant loss of controlled substances. It must be filed with the DEA field division, and the pharmacy should also notify local authorities as required.

Question 22Federal Drug Laws and Regulations

Under federal rules, which entity may collect and destroy dispensed controlled substances returned by patients?

  1. The patient's prescriber without registration
  2. Any retail pharmacy without registration
  3. A courier service hired by the patient
  4. An authorized collector such as a registered pharmacy operating under DEA rules Correct answer.

Explanation

DEA regulations allow authorized collectors, including certain retail pharmacies that register or meet the rule's conditions, to collect and destroy dispensed controlled substances. Unregistered parties may not serve as collectors.

Question 23Federal Drug Laws and Regulations

A prescriber's DEA registration is revoked. What happens to prescriptions the prescriber wrote before the revocation?

  1. They become void automatically and may never be filled
  2. They may still be dispensed if otherwise valid, because the prescriber was registered when issued Correct answer.
  3. They must be returned to the prescriber for reissuance
  4. They convert to Schedule V status

Explanation

A prescription issued while the prescriber held valid registration remains a lawful prescription if it is otherwise valid and the pharmacist exercises professional judgment. Revocation affects future prescribing authority, not the validity of prior orders.

Question 24Federal Drug Laws and Regulations

Which federal agency administers the registration and enforcement provisions of the Controlled Substances Act?

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

Explanation

The DEA administers registration, recordkeeping, and enforcement under the CSA. The FDA regulates drug approval and labeling, CMS administers Medicare and Medicaid, and the FTC addresses trade practices.

Question 25Federal Drug Laws and Regulations

A pharmacist suspects a prescriber is issuing Schedule II prescriptions outside the usual course of professional practice. Which federal concept best describes the basis for declining to fill?

  1. The prescription lacks a legitimate medical purpose Correct answer.
  2. The prescriber charges too much for office visits
  3. The patient has not enrolled in a monitoring program
  4. The prescription exceeds the pharmacy's daily dispensing limit

Explanation

A controlled substance prescription is valid only when issued for a legitimate medical purpose by an individual prescriber acting in the usual course of professional practice. A pharmacist who lacks that assurance may decline to dispense.

Question 26Federal Drug Laws and Regulations

A pharmacy receives a shipment of a Schedule II controlled substance from its wholesaler. Which record-keeping obligation applies to this transaction under federal law?

  1. A DEA Form 224 must be submitted to renew the pharmacy's registration
  2. A DEA Form 222 or a CSOS electronic order must document the transfer of the substance Correct answer.
  3. A DEA Form 106 must be filed with the local field office before the drug is dispensed
  4. A DEA Form 41 must accompany the shipment and be retained for two years

Explanation

Schedule I and II substances are distributed only on an order form, historically the triplicate DEA Form 222 and now also through the secure electronic CSOS system. The pharmacy must retain the order documentation as part of its controlled substance records. Forms 106 and 41 serve different purposes (theft reporting and destruction), and Form 224 is a registration application.

Question 27Federal Drug Laws and Regulations

Under the federal Controlled Substances Act, which schedule contains drugs with a currently accepted medical use and a high potential for abuse, including certain anabolic steroids and ketamine?

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

Explanation

Schedule III contains substances with a currently accepted medical use, high abuse potential, and abuse that may lead to moderate or low physical dependence or high psychological dependence. Anabolic steroids and ketamine are classic Schedule III examples. Schedule II has higher abuse potential, while Schedules IV and V have progressively lower abuse potential.

Question 28Federal Drug Laws and Regulations

A pharmacy's DEA registration is due to expire, and the pharmacy has submitted a timely renewal application but has not yet received the new certificate. Under federal rules, what is the pharmacy's status while the application is pending?

  1. The pharmacy must cease dispensing controlled substances until the new certificate arrives
  2. The pharmacy may continue controlled substance activities because a timely renewal application extends the existing registration Correct answer.
  3. The pharmacy may dispense only Schedule III through V drugs during the pending period
  4. The pharmacy may operate only if it obtains a temporary state license endorsement

Explanation

A timely and sufficient renewal application keeps the existing DEA registration in effect until DEA acts on it, so the registrant may continue authorized activities. The pharmacy should keep evidence of the pending application with its records. Halting all controlled substance activity is not required simply because the paper certificate has not arrived.

Question 29Federal Drug Laws and Regulations

A pharmacist receives a prescription for a Schedule II opioid that was transmitted orally by a prescriber in a genuine emergency situation. What does federal law require?

  1. The prescriber must appear in person at the pharmacy within 72 hours
  2. The prescriber must provide a written or electronic prescription within seven days Correct answer.
  3. The pharmacist must refuse the oral order because Schedule II prescriptions must be written
  4. The pharmacist may dispense but must notify DEA within 24 hours

Explanation

In a bona fide emergency, a prescriber may orally authorize a Schedule II prescription, but the prescriber must deliver a written or electronic prescription to the pharmacy within seven days. If the follow-up prescription is not received, the pharmacist must notify DEA. This emergency exception is narrow and does not eliminate the documentation requirement.

Question 30Federal Drug Laws and Regulations

A pharmacy is transferring a valid, unfilled prescription for a Schedule III drug to another pharmacy at the patient's request. Which condition governs this transfer under federal law?

  1. The transfer is permitted only after the patient obtains a new prescription from the prescriber
  2. The transfer may occur repeatedly as long as each pharmacy keeps a log
  3. The transfer is prohibited because Schedule III prescriptions cannot leave the original pharmacy
  4. The transfer may be made once, and both pharmacies must maintain records documenting the transfer Correct answer.

Explanation

Federal rules permit a one-time transfer of an unfilled or partially filled Schedule III through V prescription between pharmacies for initial filling, with documentation retained by both the transferring and receiving pharmacies. The transfer must be communicated directly between licensed pharmacists. Schedule III prescriptions are not barred from transfer.

Question 31Federal Drug Laws and Regulations

A prescriber writes a Schedule II prescription for a patient and the pharmacist fills it in full. Under federal law, which statement about refills is accurate?

  1. No refills are permitted, and the patient must obtain a new prescription for additional supply Correct answer.
  2. Up to five refills are permitted within six months of the issue date
  3. One refill is permitted if the prescriber authorizes it in writing
  4. Refills are permitted only if the total quantity dispensed does not exceed a 30-day supply

Explanation

Schedule II prescriptions may not be refilled under federal law; each dispensing requires a new prescription from the prescriber. The prescriber may issue multiple prescriptions authorizing sequential fills, but that is not a refill. Refill limits apply to Schedule III through V prescriptions, not Schedule II.

Question 32Federal Drug Laws and Regulations

A pharmacy's DEA registration is being retired because the business is closing permanently. What must the pharmacy do regarding its DEA registration and remaining controlled substances?

  1. Return all controlled substances to the wholesaler without any record
  2. Notify DEA of the termination and arrange for transfer or destruction of remaining stock with proper documentation Correct answer.
  3. Surrender the remaining stock to any licensed prescriber without documentation
  4. Continue to hold the registration indefinitely in case the business reopens

Explanation

A registrant that discontinues business must notify DEA and dispose of remaining controlled substances through authorized transfer or destruction, keeping the required records. Simply abandoning the stock or the registration is not compliant. Documentation of the disposition is essential for accountability.

Question 33Federal Drug Laws and Regulations

Which federal statute established the framework for scheduling controlled substances, registration of handlers, and the closed system of distribution?

  1. The Federal Food, Drug, and Cosmetic Act
  2. The Controlled Substances Act (Title II of the Comprehensive Drug Abuse Prevention and Control Act) Correct answer.
  3. The Poison Prevention Packaging Act
  4. The Durham-Humphrey Amendment

Explanation

The Controlled Substances Act, enacted as Title II of the Comprehensive Drug Abuse Prevention and Control Act of 1970, created the scheduling system, the registration requirement, and the closed system of distribution. The FDCA governs drug approval and labeling, while the Durham-Humphrey Amendment created the prescription-only category. The Poison Prevention Packaging Act addresses child-resistant packaging.

Question 34Federal Drug Laws and Regulations

A pharmacist is verifying a prescription and considers whether a drug is a controlled substance. Which federal schedule includes drugs with the lowest abuse potential and a currently accepted medical use, such as certain cough preparations containing limited codeine?

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

Explanation

Schedule V is the lowest schedule and includes preparations containing limited quantities of certain narcotics, such as some cough syrups with codeine. These drugs have a currently accepted medical use and relatively low abuse potential. Schedules II through IV carry progressively higher abuse potential and stricter controls.

Question 35Federal Drug Laws and Regulations

A pharmacy's inventory reveals that a bottle of a Schedule II drug is missing and the loss cannot be explained. What is the pharmacy's federal reporting obligation?

  1. Report the loss to the state board only and take no federal action
  2. Report the loss to DEA on Form 41 before any further dispensing
  3. Report the loss to DEA on Form 106 and keep a copy of the report Correct answer.
  4. Report the loss to DEA on Form 222 and keep a copy of the report

Explanation

A registrant must report theft or significant loss of controlled substances to the DEA field division on DEA Form 106. The report should be filed when the registrant discovers the theft or significant loss. Form 222 is an order form, and Form 41 documents destruction.

Question 36Federal Drug Laws and Regulations

A pharmacist receives a prescription for a Schedule IV drug with five refills authorized and a stated expiration of one year from the issue date. Under federal law, how should the pharmacist handle the refills?

  1. Dispense all five refills at any time within the one-year period
  2. Dispense up to five refills, but no refill may be dispensed more than six months after the issue date Correct answer.
  3. Dispense no more than two refills regardless of the prescriber's authorization
  4. Dispense refills only after obtaining new authorization for each refill

Explanation

For Schedule III and IV prescriptions, federal law limits refills to five and prohibits dispensing a refill more than six months after the date the prescription was issued. The prescriber's one-year expiration cannot extend the federal six-month refill window. The more restrictive limit controls.

Question 37Federal Drug Laws and Regulations

A pharmacy wants to verify the identity and registration status of a prescriber before filling a controlled substance prescription. Which federal resource provides authoritative registration information?

  1. The National Drug Code Directory
  2. The FDA Orange Book
  3. The Poison Control Center database
  4. The DEA registration verification system accessible through the DEA Diversion Control Division Correct answer.

Explanation

DEA maintains registration information that pharmacies can use to verify whether a prescriber holds a valid DEA registration and the schedules authorized. The FDA Orange Book addresses therapeutic equivalence, the NDC Directory catalogs drug products, and poison control resources are unrelated to registration verification.

Question 38Federal Drug Laws and Regulations

A pharmacy is inspected by DEA and the investigator asks to review the pharmacy's controlled substance records. What is the pharmacy's obligation under the CSA?

  1. Provide records only if the pharmacist-in-charge is present and consents
  2. Provide records only after a subpoena is issued by a court
  3. Provide records only to the state board of pharmacy, not DEA
  4. Make the required records available for inspection during business hours Correct answer.

Explanation

Registrants must keep records and make them available for inspection by DEA during business hours. The inspection authority is part of the closed system of distribution and does not require a subpoena or the pharmacist-in-charge's consent. Failure to maintain or provide records can jeopardize registration.

Question 39Federal Drug Laws and Regulations

A pharmacy receives a request from a patient for a copy of the patient's prescription records. Which federal law governs the pharmacy's handling of protected health information in this context?

  1. The Controlled Substances Act
  2. The Combat Methamphetamine Epidemic Act
  3. The Health Insurance Portability and Accountability Act (HIPAA) Correct answer.
  4. The Federal Food, Drug, and Cosmetic Act

Explanation

HIPAA and its Privacy Rule govern the use and disclosure of protected health information by covered entities such as pharmacies, including patient access rights. The CSA governs controlled substances, the FDCA governs drug approval and labeling, and the Combat Methamphetamine Epidemic Act regulates sales of listed precursors.

Question 40Federal Drug Laws and Regulations

A prescriber issues a Schedule II prescription for a patient who will need the medication for several months. The prescriber wants to authorize sequential fills without writing a new prescription each month. What does federal law permit?

  1. The prescriber may issue a single prescription with no quantity limit and no fill dates
  2. The prescriber may authorize refills by telephone after the first fill
  3. The prescriber may issue multiple prescriptions on the same day authorizing sequential fills, with the earliest fill date and total quantity specified Correct answer.
  4. The prescriber may write a single prescription with refills noted as needed

Explanation

DEA permits a prescriber to issue multiple Schedule II prescriptions on the same day for a patient, authorizing sequential fills, provided each prescription states the earliest date on which it may be filled and the total quantity. This is not a refill; each document is a separate prescription. A single prescription with refills or open-ended quantities is not permitted for Schedule II.

Question 41Federal Drug Laws and Regulations

A pharmacy employee is authorized to handle controlled substances. Which federal requirement applies to the employee's registration status?

  1. The employee must be registered with the state board only
  2. The employee must obtain a separate DEA registration in their own name
  3. The employee may act under the pharmacy's DEA registration as an agent if properly authorized Correct answer.
  4. The employee may handle controlled substances only with a physician's written permission

Explanation

Employees and agents of a registered pharmacy may handle controlled substances under the registrant's authority when acting in the usual course of their employment. They do not need individual DEA registrations for that activity. The registrant remains responsible for compliance and for authorizing appropriate personnel.

Question 42Federal Drug Laws and Regulations

A pharmacy dispenses a controlled substance and must maintain records. Which federal retention period applies to controlled substance records under the CSA regulations?

  1. Six months
  2. Two years Correct answer.
  3. Ten years
  4. Five years

Explanation

DEA regulations require that controlled substance records be kept for at least two years and be available for inspection. This retention period applies to inventories, order forms, dispensing records, and related documentation. State law may require longer retention, and the more stringent requirement would then apply.

Question 43Federal Drug Laws and Regulations

A pharmacist is asked to dispense a controlled substance to a patient who presents a prescription that appears valid but the pharmacist has a reasonable suspicion of diversion. What is the pharmacist's best course of action under federal law?

  1. Dispense the prescription and report the concern to DEA after the fact
  2. Dispense only a partial quantity and refer the patient to another pharmacy
  3. Resolve the suspicion before dispensing and document the inquiry, declining to fill if the concern cannot be resolved Correct answer.
  4. Dispense the prescription because a valid-looking prescription must be filled

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 a red flag cannot be resolved, the pharmacist should not dispense and should document the inquiry. Dispensing first and reporting later does not satisfy that responsibility.

Question 44Federal Drug Laws and Regulations

A pharmacy wants to dispose of expired controlled substances that it holds in stock. Which federal mechanism is available to the pharmacy for destruction?

  1. On-site destruction witnessed and documented on DEA Form 41, or transfer to a registered reverse distributor Correct answer.
  2. Disposal in the regular pharmaceutical waste stream without a record
  3. Return of the stock to the prescriber who originally wrote the prescriptions
  4. Sale of the expired stock to a licensed wholesaler without documentation

Explanation

Registrants may destroy controlled substances on site with proper witnessing and documentation on DEA Form 41, or use a registered reverse distributor. Either route preserves accountability for the drugs. Undocumented disposal or ordinary waste streams are not compliant for controlled substances.

Question 45Federal Drug Laws and Regulations

A prescriber's DEA registration is suspended, and the prescriber had written a valid Schedule III prescription before the suspension that has not yet been filled. What is the pharmacy's position under federal law?

  1. The prescription may be filled only if the patient pays cash
  2. The prescription may be filled only after the prescriber's registration is reinstated
  3. The prescription is automatically void and may never be filled
  4. The prescription may be filled if it was issued while the prescriber was registered and remains otherwise valid Correct answer.

Explanation

The validity of a prescription is generally determined at the time it was issued. A prescription written while the prescriber held a valid registration is not automatically invalidated by a later suspension, provided it is otherwise lawful and the pharmacist exercises corresponding responsibility. Reinstatement is not a precondition, and payment method is irrelevant.

Question 46Federal Drug Laws and Regulations

Which federal agency is responsible for registering manufacturers, distributors, and dispensers of controlled substances and for enforcing the CSA's registration provisions?

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

Explanation

DEA administers the registration and enforcement provisions of the CSA, including the closed system of distribution. FDA regulates drug approval and labeling, CMS administers Medicare and Medicaid, and the FTC addresses consumer protection and competition. Registration of controlled substance handlers is a DEA function.

Question 47Federal Drug Laws and Regulations

A pharmacy is reviewing its obligations for a biennial inventory of controlled substances. Which federal requirement applies to the inventory?

  1. A complete and accurate inventory must be taken every two years, with the date and time recorded Correct answer.
  2. An inventory is required only for Schedule II substances
  3. An inventory is required monthly for all controlled substances
  4. An inventory is required only when the pharmacy changes ownership

Explanation

Registrants must take a complete and accurate inventory of all controlled substances every two years, recording the date and time of the inventory. The inventory must cover all schedules held by the registrant. More frequent inventories may be required by state law, and the more stringent rule controls.

Question 48Federal Drug Laws and Regulations

A pharmacy wants to accept unused controlled substances from patients for disposal. Which federal pathway allows this collection?

  1. Collection of controlled substances by any pharmacy employee without training
  2. Acceptance of any controlled substance at the pharmacy counter without special authorization
  3. Collection only of Schedule II drugs by pharmacists during business hours
  4. Participation as an authorized collector under DEA's disposal regulations, using compliant collection receptacles and procedures Correct answer.

Explanation

DEA's disposal regulations allow pharmacies to become authorized collectors, which requires compliance with receptacle, signage, and handling requirements. Not every pharmacy is automatically authorized to collect returned controlled substances. The collection must follow the regulatory procedures for the schedule and form involved.

Question 49Federal Drug Laws and Regulations

A pharmacist is reviewing a prescription for a Schedule II stimulant and notices that the prescriber's DEA number checksum does not validate. What is the pharmacist's most appropriate action?

  1. Report the patient to law enforcement immediately
  2. Verify the prescriber's registration directly with DEA before dispensing and document the verification Correct answer.
  3. Dispense the prescription because the checksum is only a formatting convention
  4. Change the DEA number on the prescription to the correct one

Explanation

The DEA number checksum is a quick validation tool, but a failed check is a red flag that warrants direct verification of the prescriber's registration with DEA. The pharmacist should resolve the discrepancy before dispensing and document the steps taken. Altering a prescription or drawing conclusions about the patient without inquiry is inappropriate.

Question 50Federal Drug Laws and Regulations

A pharmacy dispenses a controlled substance and the patient later reports that the medication was lost. The patient requests an early replacement fill. What does federal law require the pharmacist to consider?

  1. Reporting the patient to DEA before any replacement can be considered
  2. Refusal of any replacement fill for all controlled substances
  3. Automatic replacement of the lost medication without a new prescription
  4. Whether the prescriber issues a new prescription and whether the circumstances support an early fill under corresponding responsibility Correct answer.

Explanation

A lost or stolen controlled substance does not automatically authorize a replacement fill. The pharmacist should require a new prescription where applicable and evaluate the circumstances under the corresponding responsibility standard. Some states impose additional requirements, and the more stringent rule would apply.