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ME MPJE practice questions

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Question 1Federal pharmacy law

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

  1. Only if the patient returns the original container to the pharmacy
  2. Up to two times within three months at the pharmacist's discretion
  3. Never; federal law prohibits refills of Schedule II prescriptions Correct answer.
  4. Up to five times within six months if the prescriber authorizes refills

Explanation

The CSA expressly bars refilling a Schedule II prescription; each dispensing requires a new, valid prescription from the prescriber. Authorized refills are permitted only for Schedule III through V drugs and only within the limits set by regulation and state law.

Question 2Federal pharmacy law

A prescription is written for a Schedule III controlled substance with no refills indicated and no other notation. Under DEA regulations, how many times may it be refilled?

  1. Five refills
  2. One refill
  3. Two refills
  4. Zero refills Correct answer.

Explanation

When the prescriber writes no refill authorization on a Schedule III or IV prescription, the default is no refills; the pharmacist cannot infer refill authority. Refills must be specifically authorized by the prescriber and are capped at five within six months of issuance.

Question 3Federal pharmacy law

Which federal requirement applies to a prescription for a Schedule II controlled substance that is transmitted orally to a pharmacy by telephone?

  1. It is permitted routinely if the pharmacist documents the call in the patient record
  2. It is permitted if the prescriber later sends an electronic copy within thirty days
  3. It is permitted only for patients residing in a long-term care facility
  4. It is permitted only in a genuine emergency, with a written prescription delivered within seven days Correct answer.

Explanation

Oral Schedule II prescriptions are allowed only in a genuine emergency, and the prescriber must furnish a written prescription to the pharmacy within seven days. If the written follow-up does not arrive, the pharmacist must notify DEA.

Question 4Federal pharmacy law

A DEA Form 222 is used in the distribution chain for which purpose?

  1. Registering a new practitioner with DEA
  2. Ordering Schedule I and II controlled substances from a supplier Correct answer.
  3. Reporting the theft or significant loss of controlled substances
  4. Applying for a state pharmacy license

Explanation

DEA Form 222 (now also available electronically through CSOS) is the order form a registrant uses to purchase Schedule I and II substances. Theft or loss is reported on DEA Form 106, and registration uses DEA Form 224.

Question 5Federal pharmacy law

A pharmacy receives a DEA Form 222 for an order. Which statement correctly describes the required handling of that form?

  1. The pharmacy mails the original to DEA after receiving the order
  2. The form must be destroyed after the order is filled
  3. The form is used only for Schedule III through V drugs
  4. The purchaser retains a copy, and the supplier keeps the executed form for its records Correct answer.

Explanation

Form 222 is executed in triplicate: the supplier keeps one copy and the purchaser keeps the others, and the form must be retained and available for inspection. It is not submitted to DEA as part of routine ordering, and it applies to Schedule I and II drugs.

Question 6Federal pharmacy law

Federal law requires a pharmacy to maintain controlled substance dispensing records in a readily retrievable manner for at least how long?

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

Explanation

DEA regulations require controlled substance records, including dispensing prescriptions, to be kept for at least two years and to be readily retrievable. Individual states may impose longer retention periods, which the pharmacy must also satisfy.

Question 7Federal pharmacy law

A pharmacist discovers that a vial of a Schedule II drug is missing and cannot be accounted for. What is the correct federal response?

  1. Record the loss in the perpetual inventory and take no further action
  2. Report the loss on DEA Form 222
  3. Report the loss to the state board only
  4. Report the loss to the DEA field division on DEA Form 106 Correct answer.

Explanation

Significant losses of controlled substances must be reported to the DEA field division, generally using DEA Form 106, and the pharmacy should also notify state authorities as required. In-transit losses are reported by the supplier, but a theft from pharmacy stock is the registrant's responsibility.

Question 8Federal pharmacy law

Which statement accurately describes the federal prescription requirement for a Schedule V controlled substance?

  1. It requires a written prescription in all cases
  2. It may be dispensed without a prescription only when state law permits and federal conditions are met Correct answer.
  3. It may be dispensed without a prescription nationwide with no conditions
  4. It may never be dispensed without a prescription under any circumstance

Explanation

Certain Schedule V products may be sold without a prescription only if state law allows it and the federal conditions are satisfied, such as age limits and recordkeeping for the pharmacist. The pharmacist must also determine that the purchase is for a legitimate medical purpose.

Question 9Federal pharmacy law

A prescriber licensed in one state writes a controlled substance prescription for a patient who is physically located in a different state. Which principle governs whether the pharmacy may fill it?

  1. The prescription is valid only if the patient travels to the prescriber's state to pick it up
  2. The prescriber must be licensed or otherwise authorized in the state where the patient is located, and the pharmacy must comply with its own state's rules Correct answer.
  3. The prescription is valid if the prescriber is DEA-registered in any state
  4. The prescription is automatically valid because federal law preempts state licensure

Explanation

DEA registration alone does not authorize practice in a state; the prescriber must hold appropriate state authority where the patient is located, and the dispensing pharmacy must follow its own state's rules. Federal law sets a floor but does not preempt state licensure requirements.

Question 10Federal pharmacy law

Under the federal Combat Methamphetamine Epidemic Act, which requirement applies to the sale of ephedrine and pseudoephedrine products at a pharmacy?

  1. Sales are limited to patients with a prescription only
  2. The products must be kept behind the counter but no purchaser log is required
  3. Only a pharmacist may sell the products, and no quantity limits apply
  4. The seller must record the purchaser's signature and identification and enforce daily and monthly quantity limits Correct answer.

Explanation

The CMEA requires logbook recording of the purchaser's signature and identification, behind-the-counter or locked storage, and daily and monthly sales limits for scheduled listed chemical products. These requirements apply to nonprescription sales of ephedrine and pseudoephedrine.

Question 11Federal pharmacy law

A pharmacy wants to sell pseudoephedrine tablets without a prescription. Which combination of storage and recordkeeping complies with federal law?

  1. Keep the product on an open shelf and record sales only when the purchaser volunteers identification
  2. Keep the product in a locked cabinet and skip the log if the sale is under the daily limit
  3. Keep the product behind the counter and record only monthly totals
  4. Keep the product behind the counter or in a locked cabinet and maintain a written or electronic logbook of sales Correct answer.

Explanation

Scheduled listed chemical products must be stored behind the counter or in a locked cabinet so the public cannot access them directly, and each sale must be logged with the required purchaser information. The log is required for every sale, regardless of quantity.

Question 12Federal pharmacy law

Which statement best describes the role of a prescription drug monitoring program in pharmacy practice?

  1. It is a system used solely to report adverse drug reactions
  2. It is a state-run database that pharmacists may query to review a patient's controlled substance history, subject to state access rules Correct answer.
  3. It is a federal database maintained by DEA that replaces the need for state registration
  4. It is a voluntary registry that only prescribers may access

Explanation

PDMPs are state-administered databases of controlled substance dispensing that authorized prescribers and pharmacists may query under state rules, and some states mandate a check before dispensing certain drugs. They supplement, but do not replace, federal registration and recordkeeping obligations.

Question 13Federal pharmacy law

A prescriber delegates authority for a nurse practitioner to prescribe Schedule II drugs. Which statement reflects the federal requirement?

  1. Mid-level practitioners may prescribe Schedule II drugs under the supervising physician's DEA number
  2. Mid-level practitioners must have a valid DEA registration, and their authority may be limited by the state and by the terms of their registration Correct answer.
  3. Mid-level practitioners are barred from prescribing controlled substances under federal law
  4. Mid-level practitioners may prescribe controlled substances without any DEA registration

Explanation

Mid-level practitioners such as nurse practitioners and physician assistants need their own DEA registration to prescribe controlled substances, and state scope-of-practice rules and any practice limitations attached to the registration also apply. Using a supervising physician's DEA number is not permitted.

Question 14Federal pharmacy law

What is the correct federal treatment of a prescription for a Schedule II controlled substance that the pharmacist believes was forged?

  1. The pharmacist may dispense a partial quantity and refer the patient elsewhere
  2. The pharmacist may dispense it if the patient insists and document the concern
  3. The pharmacist must not dispense and should report the matter as required by state and federal authorities Correct answer.
  4. The pharmacist must dispense it and report the concern after the fact

Explanation

A pharmacist who has reason to believe a controlled substance prescription is forged or invalid must decline to dispense it and should report the matter to the appropriate authorities under state and federal rules. Dispensing a known-forged prescription exposes the pharmacist and the pharmacy to liability.

Question 15Federal pharmacy law

Which of the following is required before a pharmacy may begin dispensing controlled substances as a new registrant?

  1. A federal narcotics license issued by the FDA
  2. A valid DEA registration for the pharmacy at that location, in addition to any required state license Correct answer.
  3. A DEA registration only for the pharmacist-in-charge
  4. A certificate of need from the state health department

Explanation

Each pharmacy location that dispenses controlled substances must hold its own DEA registration for that address, along with the state license required to operate. Registration is site-specific, and a pharmacist's individual registration does not cover the pharmacy.

Question 16Federal pharmacy law

A pharmacy changes its physical address within the same state. What must the registrant do with respect to its DEA registration?

  1. Surrender the registration and stop dispensing controlled substances
  2. Continue using the existing registration without notifying DEA
  3. Request a modification of the registration before or promptly after the move, following DEA procedures Correct answer.
  4. Apply for a completely new registration number and discard the old number

Explanation

DEA registrations are location-specific, so a move requires the registrant to request a modification of the existing registration under DEA procedures rather than simply continuing under the old address. Failure to update can invalidate the registration for that location.

Question 17Federal pharmacy law

Which statement correctly describes the federal partial-fill rule for a Schedule II prescription when the pharmacy cannot supply the full quantity because of insufficient stock?

  1. The pharmacy may partially fill it only if the patient pays in full at the first visit
  2. The pharmacy may partially fill it, with the remainder supplied within 72 hours of the first partial fill; after that, a new prescription is required Correct answer.
  3. The pharmacy may partially fill it and supply the remainder at any time within six months
  4. The pharmacy may not partially fill a Schedule II prescription under any circumstance

Explanation

Under the inability-to-supply rule, the remainder must be supplied within 72 hours of the first partial fill. If that cannot be done, the pharmacist must notify the prescriber, and further dispensing requires a new prescription. A prescriber-pharmacist agreement does not extend the deadline; other partial-fill pathways have separate requirements.

Question 18Federal pharmacy law

A Schedule II prescription is written for a patient in a long-term care facility. Which statement reflects the federal partial-fill allowance for such patients?

  1. The prescription may be partially filled in multiple installments over up to 60 days from the date written Correct answer.
  2. The prescription may be partially filled only if the patient is terminally ill
  3. The prescription may be partially filled for up to 72 hours only
  4. The prescription must be filled in full on the first attempt

Explanation

For patients in long-term care facilities or with a terminal illness, federal rules allow partial filling of a Schedule II prescription in multiple installments over up to 60 days from the date of issue. The pharmacy must note the partial fill on the prescription record.

Question 19Federal pharmacy law

Which federal rule governs the use of a prescription for a Schedule II controlled substance written for a patient by a prescriber who is not registered with DEA?

  1. The prescription is valid for a one-time emergency supply
  2. The prescription is valid if the prescriber holds a state license in any state
  3. The prescription is valid if the pharmacy verifies the prescriber's identity
  4. The prescription is invalid unless a narrow federal exception applies, such as certain federal facility or military practitioners Correct answer.

Explanation

A practitioner must be DEA-registered to prescribe controlled substances, with only limited federal exceptions such as certain federal or military practitioners. A state license alone does not confer federal prescribing authority, and the pharmacist should not fill such a prescription.

Question 20Federal pharmacy law

A pharmacist receives a prescription for a Schedule II stimulant transmitted by fax. Which statement is correct under federal rules?

  1. A faxed Schedule II prescription is valid in all circumstances if the fax is legible
  2. A faxed Schedule II prescription may be used only in the limited situations DEA recognizes, such as for a compounded infusion or a long-term care patient Correct answer.
  3. A faxed Schedule II prescription is valid only if the patient signs the fax
  4. A faxed Schedule II prescription is never valid

Explanation

DEA permits fax transmission of Schedule II prescriptions only in specified situations, such as prescriptions for compounded infusions for home or hospice use and prescriptions for long-term care facility patients. Outside those exceptions, a fax does not satisfy the written prescription requirement.

Question 21Federal pharmacy law

Which statement correctly describes the federal rule on electronic prescriptions for controlled substances?

  1. They are never permitted for Schedule II drugs
  2. They are permitted only for Schedule V drugs
  3. They are permitted when the prescriber uses a DEA-compliant electronic prescribing system with identity proofing and two-factor authentication Correct answer.
  4. They are permitted for any controlled substance without special system requirements

Explanation

DEA allows electronic prescribing of controlled substances, including Schedule II, when the prescriber uses a certified system that meets identity-proofing, access-control, and audit requirements. The pharmacist must also be able to verify the prescription's digital signature.

Question 22Federal pharmacy law

A pharmacy dispenses a controlled substance and later discovers the prescription lacked required information. Which action best reflects the federal expectation?

  1. Discard the prescription and rely on the dispensing log
  2. Document the deficiency and consult the prescriber or follow state correction procedures rather than altering the record unilaterally Correct answer.
  3. Erase the original entry and write a corrected prescription from memory
  4. Backdate a corrected prescription to the original date

Explanation

Prescription records must accurately reflect what was received and dispensed; corrections should be documented and, where permitted, verified with the prescriber under state procedures. Altering or backdating a prescription record can constitute a recordkeeping violation or falsification.

Question 23Federal pharmacy law

Which federal statute is the primary source of authority for scheduling controlled substances and regulating their manufacture and distribution?

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

Explanation

The Controlled Substances Act establishes the schedules and the registration, recordkeeping, and distribution controls enforced by DEA. The FDCA governs drug approval and labeling but does not create the controlled substance schedules.

Question 24Federal pharmacy law

A pharmacy receives a request from a DEA investigator to inspect its controlled substance records. Which statement is correct?

  1. The pharmacy may release records only with patient consent for each entry
  2. The pharmacy may refuse all inspections without a search warrant in every case
  3. The pharmacy must destroy records after inspection to protect privacy
  4. The registrant must make records available for inspection at reasonable times as authorized by the CSA Correct answer.

Explanation

The CSA authorizes DEA to inspect a registrant's records and premises at reasonable times, and registrants must cooperate. Patient consent is not the gatekeeper for a lawful administrative inspection, and destroying records would violate retention requirements.

Question 25Federal pharmacy law

Which statement best describes the federal requirement for labeling a dispensed controlled substance prescription?

  1. The label must include the pharmacy name and address, prescription number, date, patient name, directions, and prescriber information, consistent with federal and state labeling rules Correct answer.
  2. The label must state the drug's controlled substance schedule in all cases
  3. The label must omit the prescriber's name to protect confidentiality
  4. The label must include only the drug name and strength

Explanation

Federal and state labeling requirements call for identifying information about the pharmacy, prescription, patient, directions for use, and prescriber. Some states add schedule warnings, but the core federal labeling elements go beyond drug name and strength alone.

Question 26Federal pharmacy law

Under federal law, which schedule of controlled substances has no accepted medical use in treatment in the United States?

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

Explanation

Schedule I substances are defined as having a high potential for abuse, no currently accepted medical use in treatment in the United States, and a lack of accepted safety for use under medical supervision. Heroin and LSD are classic examples. Schedules II through V all have recognized medical uses with varying degrees of abuse potential.

Question 27Federal pharmacy law

Which federal agency administers the registration system for persons who manufacture, distribute, or dispense controlled substances?

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

Explanation

The Drug Enforcement Administration administers the registration and recordkeeping framework created by the Controlled Substances Act. FDA regulates drug approval and labeling, not controlled substance registration. The FTC and CMS have no role in controlled substance registration.

Question 28Federal pharmacy law

A prescription for a Schedule II controlled substance is presented to a pharmacist. Under federal law, which practice is permitted for this prescription?

  1. Dispensing on the prescriber's standing order for a class of patients
  2. An oral emergency order that must be followed by a written prescription within seven days Correct answer.
  3. A refill authorized by the prescriber's separate oral order
  4. A refill authorized on the original prescription

Explanation

Federal law prohibits refilling Schedule II prescriptions. An oral emergency order is allowed if the prescriber provides a written prescription within seven days, but no refills may be authorized. Standing orders and oral refill authorizations do not satisfy the federal Schedule II rules.

Question 29Federal pharmacy law

Which element must appear on a prescription for a controlled substance dispensed in a pharmacy to satisfy federal requirements?

  1. The patient's Social Security number
  2. The wholesale acquisition cost of the drug
  3. The pharmacy's DEA registration number
  4. The prescriber's DEA registration number Correct answer.

Explanation

A valid controlled substance prescription must include the prescriber's DEA registration number among other required elements such as the patient's name and address, the drug, strength, quantity, directions, and the prescriber's signature. Social Security numbers, pharmacy registration numbers, and drug acquisition costs are not federal prescription requirements.

Question 30Federal pharmacy law

Which federal law established the framework for classifying controlled substances into schedules and regulating their handling?

  1. The Poison Prevention Packaging Act
  2. The Federal Food, Drug, and Cosmetic Act
  3. The Durham-Humphrey Amendment
  4. The Controlled Substances Act Correct answer.

Explanation

The Controlled Substances Act of 1970 created the scheduling system and the registration, recordkeeping, and security requirements for controlled substances. The FDCA governs drug approval and marketing generally, the Poison Prevention Packaging Act addresses child-resistant packaging, and the Durham-Humphrey Amendment created the prescription-only category.

Question 31Federal pharmacy law

A pharmacy receives a written prescription for a Schedule II opioid. Which action is required for the pharmacy to comply with federal recordkeeping rules?

  1. Return the original prescription to the prescriber after dispensing
  2. Retain the prescription for six months and then destroy it
  3. File the prescription with general business records without separation
  4. File the prescription in a manner that is readily retrievable for at least two years Correct answer.

Explanation

Federal regulations require that controlled substance records, including prescriptions, be maintained and readily retrievable for at least two years from the date of dispensing. Mixing them with general records without a retrievable system, destroying them after six months, or returning originals to prescribers does not meet the rule.

Question 32Federal pharmacy law

A pharmacist needs to verify the identity of a person picking up a controlled substance. Which federal requirement applies to the pharmacy's recordkeeping for controlled substances?

  1. Records must be kept only in electronic form
  2. Records must be sent monthly to the state board of pharmacy
  3. Records must be maintained for ten years in a locked vault
  4. Records must be maintained in a readily retrievable manner and kept for two years Correct answer.

Explanation

DEA regulations require registrants to keep complete and accurate records of controlled substances and to make them readily retrievable for at least two years. There is no federal ten-year vault requirement, no monthly reporting to the state board, and no requirement that records be exclusively electronic.

Question 33Federal pharmacy law

Which statement describes the federal requirement for a pharmacy that dispenses a controlled substance and discovers the prescription was forged?

  1. The pharmacy must report the forgery to DEA field division or local law enforcement Correct answer.
  2. The pharmacy must report the forgery to the FDA within seventy-two hours
  3. The pharmacy may ignore the forgery if the drug was already dispensed
  4. The pharmacy must report the forgery only if the value exceeds five hundred dollars

Explanation

When a pharmacy identifies a forged or fraudulent controlled substance prescription, it should notify the DEA field division or local law enforcement. There is no federal dollar threshold for reporting, and the fact that the drug was already dispensed does not eliminate the obligation to report suspicious activity. FDA is not the agency that receives such reports.

Question 34Federal pharmacy law

A pharmacy technician counts tablets of a Schedule II controlled substance for a patient. Under federal law, which statement is correct about the technician's role?

  1. The technician may dispense the drug without any pharmacist involvement
  2. A pharmacist must verify the final product, but the technician may assist in counting Correct answer.
  3. Only a pharmacist may ever touch a Schedule II drug
  4. The technician may sign the prescription as the dispensing pharmacist

Explanation

Federal law does not prohibit technicians from handling controlled substances, but a pharmacist must supervise and verify the final dispensing. Only a pharmacist may sign as the dispensing pharmacist, and technicians cannot dispense without pharmacist involvement.

Question 35Federal pharmacy law

A prescriber wants to issue a prescription for a Schedule III controlled substance by telephone. Which statement reflects the federal rule?

  1. An oral prescription is permitted if the prescriber is properly registered and the pharmacy reduces it to writing Correct answer.
  2. An oral prescription is permitted only for Schedule V drugs
  3. An oral prescription is never permitted for Schedule III drugs
  4. An oral prescription is permitted only if the patient is in a hospital

Explanation

Oral prescriptions are permitted for Schedule III, IV, and V controlled substances when issued by a properly registered prescriber, and the pharmacy must promptly reduce the order to writing. The restriction on oral orders applies to Schedule II except for the emergency exception.

Question 36Federal pharmacy law

A pharmacist receives a faxed prescription for a Schedule II controlled substance for a patient in a hospice program. Which statement is correct under federal rules?

  1. The fax is never valid for a Schedule II drug under any circumstance
  2. The fax is valid only if the pharmacy calls the prescriber within twenty-four hours
  3. The fax is valid only if the patient is under eighteen years of age
  4. The fax may serve as the original prescription if it meets the applicable federal conditions Correct answer.

Explanation

Federal rules allow a fax to serve as the original prescription for Schedule II drugs in limited circumstances, including hospice and long-term care patients and prescriptions compounded for direct administration. Age and a mandatory callback are not the criteria.

Question 37Federal pharmacy law

A pharmacy receives a controlled substance order from a wholesaler. Which record must the pharmacy maintain to document the receipt?

  1. A state sales tax receipt only
  2. A DEA Form 222 or its electronic equivalent for Schedule I and II drugs Correct answer.
  3. A DEA Form 106 for every shipment received
  4. A DEA Form 41 for all controlled substances received

Explanation

Schedule I and II controlled substances must be ordered using DEA Form 222 or an approved electronic equivalent, and the executed form documents the transaction. DEA Form 41 is used for destruction records, and DEA Form 106 is used to report theft or significant loss.

Question 38Federal pharmacy law

A pharmacy discovers that a significant quantity of a Schedule IV drug is missing. Which federal form is used to report the loss to DEA?

  1. DEA Form 224
  2. DEA Form 222
  3. DEA Form 41
  4. DEA Form 106 Correct answer.

Explanation

DEA Form 106 is the Report of Theft or Loss of Controlled Substances. Form 222 is the order form, Form 41 documents destruction, and Form 224 is the application for a new pharmacy registration.

Question 39Federal pharmacy law

A pharmacy is preparing to destroy expired controlled substances. Which federal requirement applies?

  1. Destruction must be reported on DEA Form 222
  2. Destruction may be performed without any documentation
  3. Destruction must be documented, and DEA Form 41 is used to record the destruction Correct answer.
  4. Destruction must be approved by the FDA before it occurs

Explanation

Destruction of controlled substances must be documented, and DEA Form 41 is the record used for this purpose. No documentation, use of Form 222, or FDA preapproval are not the federal requirements.

Question 40Federal pharmacy law

A pharmacist is asked to dispense a controlled substance to a patient who presents a prescription from an out-of-state prescriber. Which federal principle applies?

  1. The prescription is automatically invalid because it is from another state
  2. The pharmacist may dispense only if the patient is a resident of the pharmacy's state
  3. The prescription is valid only if the prescriber calls the pharmacy first
  4. The prescriber must be registered with DEA and the prescription must meet federal requirements Correct answer.

Explanation

Federal law does not prohibit dispensing a controlled substance on a prescription from an out-of-state prescriber, provided the prescriber holds a valid DEA registration and the prescription satisfies federal requirements. State-specific rules may add conditions, but automatic invalidity, patient residency, and a mandatory call are not federal rules.

Question 41Federal pharmacy law

A pharmacy wants to verify a prescriber's DEA registration before dispensing a controlled substance. Which method is appropriate?

  1. Checking the prescriber's DEA registration through the DEA registration validation system Correct answer.
  2. Relying on the prescriber's business card
  3. Asking the patient to confirm the prescriber's registration
  4. Assuming registration because the prescriber works at a hospital

Explanation

Pharmacies can verify a prescriber's DEA registration through the DEA's registration validation tools. A business card, patient confirmation, or hospital employment is not proof of a valid DEA registration.

Question 42Federal pharmacy law

A pharmacy is registered with DEA and wishes to dispense controlled substances from a new location in the same state. Which action is required?

  1. Apply for a completely new registration and surrender the old one
  2. Obtain a modification of the existing DEA registration to reflect the new address Correct answer.
  3. Continue using the existing registration without notifying DEA
  4. Notify only the state board of pharmacy

Explanation

A change of physical address requires the registrant to request a modification of its DEA registration so the new location is covered. Continuing to use the old registration, obtaining a wholly new registration, or notifying only the state board does not satisfy the federal requirement.

Question 43Federal pharmacy law

A pharmacy's DEA registration is due to expire. Which statement describes the federal renewal requirement?

  1. The registration may be renewed only after a lapse of one year
  2. The registrant must renew the registration before expiration to continue handling controlled substances Correct answer.
  3. The registration remains valid indefinitely once issued
  4. The registration renews automatically without any action

Explanation

DEA registrations are time-limited and must be renewed before expiration to maintain authority to handle controlled substances. There is no automatic renewal, no indefinite validity, and no mandatory one-year lapse before renewal.

Question 44Federal pharmacy law

A pharmacist suspects that a prescriber is issuing controlled substance prescriptions outside the usual course of professional practice. Which action is most consistent with federal expectations?

  1. Decline to fill the prescription and report the concern to DEA or the appropriate authority Correct answer.
  2. Fill the prescription because the prescriber is registered
  3. Fill the prescription and note the concern only in the patient's file
  4. Fill the prescription but reduce the quantity without telling the prescriber

Explanation

A pharmacist has a corresponding responsibility to ensure controlled substance prescriptions are issued for a legitimate medical purpose in the usual course of professional practice. Filling a suspicious prescription solely because the prescriber is registered, altering the quantity unilaterally, or only noting the concern does not satisfy that responsibility.

Question 45Federal pharmacy law

A pharmacy maintains a power of attorney for ordering Schedule II controlled substances. Which statement correctly describes the federal rule?

  1. A power of attorney eliminates the need for DEA Form 222
  2. A power of attorney may authorize an agent to execute DEA Form 222 on behalf of the registrant Correct answer.
  3. A power of attorney allows any employee to order Schedule II drugs without documentation
  4. A power of attorney must be renewed every thirty days

Explanation

A registrant may execute a power of attorney authorizing one or more individuals to sign DEA Form 222 on its behalf. It does not eliminate the form, does not permit undocumented ordering, and is not subject to a thirty-day renewal cycle.

Question 46Federal pharmacy law

A pharmacy is located in a state that has legalized a substance under state law, but the substance remains Schedule I under federal law. Which statement reflects the federal position?

  1. Federal law still applies, and the pharmacy may not dispense the Schedule I substance Correct answer.
  2. State legalization overrides federal scheduling for pharmacies
  3. The pharmacy may dispense the substance only to patients over twenty-one
  4. The pharmacy may dispense the substance if it obtains a state license

Explanation

Federal controlled substance law applies independently of state law, and a substance that remains Schedule I federally may not be dispensed by a pharmacy even if state law permits it. State legalization, licensing, or patient age does not override federal scheduling.

Question 47Federal pharmacy law

A pharmacist is reviewing a prescription for a Schedule II drug that was electronically transmitted. Which federal condition must be satisfied for the electronic prescription to be valid?

  1. The prescriber must use an application that meets DEA electronic prescription requirements and has identity-proofing and audit controls Correct answer.
  2. The prescription must be transmitted by fax as a backup
  3. The prescription must be printed and signed by the prescriber before dispensing
  4. The prescription must be confirmed by a telephone call to the prescriber

Explanation

Electronic prescriptions for controlled substances are valid only when issued through a system that meets DEA requirements, including prescriber identity proofing, two-factor authentication, and audit trail controls. Printing, fax backup, or a confirming phone call are not the federal conditions that make an electronic prescription valid.

Question 48Federal pharmacy law

A pharmacy uses an automated dispensing system to store and count controlled substances. Which federal principle applies to the pharmacy's responsibility?

  1. Automated systems eliminate the need for a perpetual inventory
  2. The system vendor assumes legal responsibility for controlled substance records
  3. Automated systems are prohibited for Schedule II drugs
  4. The pharmacy remains responsible for security, accountability, and accurate records of controlled substances in the system Correct answer.

Explanation

Use of an automated dispensing system does not transfer the registrant's legal responsibility for security, accountability, and accurate recordkeeping. The vendor does not assume that responsibility, perpetual inventory obligations are not eliminated, and automated systems are not categorically prohibited for Schedule II drugs.

Question 49Federal pharmacy law

A DEA investigator requests to inspect a pharmacy's controlled substance records during business hours. Which statement reflects the federal rule?

  1. The pharmacy must make records available for inspection at reasonable times as authorized by the Controlled Substances Act Correct answer.
  2. The pharmacy may refuse all inspections without a court order
  3. The pharmacy may provide only records for Schedule II drugs
  4. The pharmacy may provide records only after a thirty-day notice period

Explanation

The Controlled Substances Act authorizes DEA to inspect registrants' records and premises at reasonable times, and registrants must make required records available. A blanket refusal, a thirty-day notice demand, or limiting the inspection to Schedule II records is inconsistent with the statute.

Question 50Federal pharmacy law

A pharmacy compounder prepares a compounded preparation containing a Schedule II controlled substance for direct administration to a patient. Which statement reflects the federal prescription rule?

  1. A fax is valid only if the patient signs the fax
  2. A prescription for such a compounded preparation may be transmitted by fax as the original prescription Correct answer.
  3. A fax may never serve as an original for any Schedule II order
  4. A fax is valid only for Schedule V drugs

Explanation

Federal rules recognize limited exceptions under which a fax may serve as the original prescription for a Schedule II drug, including prescriptions for compounded preparations for direct administration and for hospice or long-term care patients. The blanket statements that a fax is never valid, requires patient signature, or applies only to Schedule V drugs are incorrect.