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AK MPJE practice questions

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Question 1Federal and Alaska pharmacy law, rules, and regulations governing pharmacy practice

Under the federal Controlled Substances Act, a prescription for a Schedule II controlled substance may be refilled:

  1. Only if the prescriber authorizes refills in writing
  2. Never; no refills are permitted Correct answer.
  3. Up to five times within six months
  4. Up to two times within one month

Explanation

Federal law prohibits refilling a Schedule II prescription; each dispensing requires a new prescription, except for limited emergency oral orders followed by written confirmation. Schedule III-IV drugs may be refilled up to five times within six months.

Question 2Federal and Alaska pharmacy law, rules, and regulations governing pharmacy practice

A DEA Form 222 (single-sheet or triplicate) is used by a pharmacy to:

  1. Dispose of expired controlled substances
  2. Register a new pharmacy location with DEA
  3. Report a theft or significant loss of controlled substances
  4. Order and transfer Schedule I and II controlled substances Correct answer.

Explanation

DEA Form 222 is the order form required for distribution and procurement of Schedule I and II controlled substances. It documents the chain of custody between registrants.

Question 3Federal and Alaska pharmacy law, rules, and regulations governing pharmacy practice

Which federal schedule contains substances with no currently accepted medical use and a high potential for abuse, such as heroin and LSD?

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

Explanation

Schedule I substances have a high abuse potential and no currently accepted medical use in treatment in the United States. Heroin and LSD are classic examples.

Question 4Federal and Alaska pharmacy law, rules, and regulations governing pharmacy practice

Under federal law, a prescription for a Schedule III controlled substance may be refilled:

  1. Only once within 30 days
  2. Up to five times within six months of the issue date Correct answer.
  3. An unlimited number of times within one year
  4. Never, because Schedule III drugs cannot be refilled

Explanation

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

Question 5Federal and Alaska pharmacy law, rules, and regulations governing pharmacy practice

A pharmacist receives an oral prescription for a Schedule II controlled substance in a genuine emergency. Under federal rules, the prescriber must furnish a written prescription within what timeframe?

  1. 72 hours
  2. 7 days Correct answer.
  3. 30 days
  4. 24 hours

Explanation

In an emergency, a Schedule II prescription may be taken orally, but the prescriber must deliver a written prescription to the pharmacy within seven days. The quantity dispensed is limited to the emergency period.

Question 6Federal and Alaska pharmacy law, rules, and regulations governing pharmacy practice

Which federal law requires pharmacies to provide patients with a written notice of privacy practices and to protect the confidentiality of protected health information?

  1. The Poison Prevention Packaging Act
  2. The Controlled Substances Act
  3. The Health Insurance Portability and Accountability Act (HIPAA) Correct answer.
  4. The Drug Supply Chain Security Act

Explanation

HIPAA's Privacy Rule governs the use and disclosure of protected health information and requires covered entities, including pharmacies, to provide a notice of privacy practices. The other statutes address controlled substances, packaging, and supply chain tracking.

Question 7Federal and Alaska pharmacy law, rules, and regulations governing pharmacy practice

The Poison Prevention Packaging Act generally requires that oral prescription drugs be dispensed in:

  1. Tamper-evident packaging
  2. Unit-dose packaging
  3. Child-resistant packaging Correct answer.
  4. Moisture-barrier packaging

Explanation

The PPPA requires most oral prescription drugs to be dispensed in child-resistant containers unless the prescriber or patient requests otherwise. Tamper-evident and unit-dose packaging address different concerns.

Question 8Federal and Alaska pharmacy law, rules, and regulations governing pharmacy practice

Under the Drug Supply Chain Security Act, which entities are generally required to be licensed or registered to engage in wholesale distribution of prescription drugs?

  1. Only foreign manufacturers
  2. Only pharmacies that dispense to patients
  3. All persons engaged in wholesale distribution except certain exempt entities Correct answer.
  4. Only the original manufacturer

Explanation

The DSCSA requires wholesale distributors to be licensed by the state and registered as needed, though certain entities (such as some intracompany transfers) are exempt. Dispensing pharmacies are not wholesale distributors in the ordinary course.

Question 9Federal and Alaska pharmacy law, rules, and regulations governing pharmacy practice

A pharmacy discovers that a significant quantity of oxycodone tablets is missing. Under DEA regulations, the pharmacy must notify DEA using which form?

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

Explanation

DEA Form 106 is the Report of Theft or Loss of Controlled Substances. It must be filed when a significant loss is discovered.

Question 10Federal and Alaska pharmacy law, rules, and regulations governing pharmacy practice

A prescriber issues an electronic prescription for a Schedule II controlled substance. Under federal law, which requirement applies to the electronic prescription?

  1. It must be followed by a paper copy within 30 days
  2. It may be refilled up to five times
  3. It may be issued by any prescriber without a DEA registration
  4. It must be transmitted using an application that meets DEA electronic prescription requirements Correct answer.

Explanation

Electronic prescriptions for controlled substances must be created and transmitted through a system that meets DEA's electronic prescription requirements, including identity proofing and two-factor authentication. No paper follow-up is required when the system complies.

Question 11Federal and Alaska pharmacy law, rules, and regulations governing pharmacy practice

Under the Combat Methamphetamine Epidemic Act, a pharmacy selling ephedrine or pseudoephedrine as a nonprescription product must:

  1. Place the product on an open shelf with a warning label
  2. Limit sales to one box per customer per year
  3. Sell the product only to patients with a prescription
  4. Keep the product behind the counter and maintain a written or electronic log of sales Correct answer.

Explanation

The CMEA requires regulated sellers to keep scheduled listed chemical products behind the counter or in a locked cabinet and to record sales in a logbook, among other restrictions. It does not require a prescription.

Question 12Federal and Alaska pharmacy law, rules, and regulations governing pharmacy practice

A pharmacist is asked to dispense a prescription written by a physician in another state. Under the general framework of federal and state law, the pharmacist should primarily verify:

  1. Whether the prescription was written on tamper-resistant paper
  2. Whether the drug is listed in the Orange Book
  3. Whether the prescriber's DEA registration and state licensure authorize the prescription Correct answer.
  4. Whether the patient has previously filled a prescription at the pharmacy

Explanation

The pharmacist must confirm that the prescriber is authorized to prescribe the drug, which generally requires a valid DEA registration for controlled substances and appropriate state licensure. Prior fill history and Orange Book listing are not the primary legal basis for accepting the prescription.

Question 13Federal and Alaska pharmacy law, rules, and regulations governing pharmacy practice

Under federal law, a Schedule II controlled substance prescription may be filled after the date written only within what time frame, absent state law to the contrary?

  1. There is no federal time limit for Schedule II prescriptions Correct answer.
  2. 7 days
  3. Six months
  4. 72 hours

Explanation

Federal law does not impose a specific expiration period for Schedule II prescriptions; however, many states do. Pharmacists must apply the stricter of federal and state requirements.

Question 14Federal and Alaska pharmacy law, rules, and regulations governing pharmacy practice

Which of the following is required for a pharmacy to maintain a DEA registration for controlled substances?

  1. Membership in a national pharmacy association
  2. Registration with the state board of pharmacy and compliance with DEA security requirements Correct answer.
  3. Annual inspection by the FDA
  4. A separate DEA registration for each pharmacist

Explanation

DEA registration requires state licensure where applicable and compliance with security, recordkeeping, and reporting requirements. Individual pharmacists do not hold the pharmacy's DEA registration.

Question 15Federal and Alaska pharmacy law, rules, and regulations governing pharmacy practice

A pharmacist receives a prescription for a controlled substance that appears to have been altered. The most appropriate action under federal and state law is to:

  1. Dispense a partial quantity and refer the patient to the prescriber
  2. Refuse to dispense and return the prescription to the patient
  3. Dispense the prescription and document the concern in the patient record
  4. Verify the prescription with the prescriber before dispensing Correct answer.

Explanation

A pharmacist who suspects a prescription has been altered or is otherwise invalid should verify its authenticity with the prescriber before dispensing. Dispensing a suspicious prescription creates legal and patient-safety risk.

Question 16Federal and Alaska pharmacy law, rules, and regulations governing pharmacy practice

Under the federal Controlled Substances Act, which recordkeeping requirement applies to a pharmacy's controlled substance inventories?

  1. Only Schedule II drugs must be inventoried
  2. A complete inventory must be taken every two years, with Schedule II counted separately Correct answer.
  3. Inventories are required only when the pharmacy changes ownership
  4. Inventories must be taken monthly and submitted to DEA

Explanation

DEA requires a biennial inventory of all controlled substances, with Schedule II items counted exactly and others estimated unless the registrant chooses to count them. Inventories are retained on site, not routinely submitted to DEA.

Question 17Federal and Alaska pharmacy law, rules, and regulations governing pharmacy practice

A pharmacist dispenses a prescription for a controlled substance to a patient who presents an out-of-state identification. Under federal law, which statement is most accurate?

  1. Federal law prohibits dispensing to patients with out-of-state identification
  2. Federal law requires a government-issued photo ID for all controlled substance prescriptions
  3. Federal law does not generally require photo identification for controlled substance prescriptions, though state law may Correct answer.
  4. Federal law requires the pharmacist to notify DEA before dispensing

Explanation

The federal Controlled Substances Act does not generally mandate photo identification for controlled substance prescriptions; identification requirements are typically set by state law. Pharmacists should follow the stricter applicable state rule.

Question 18Federal and Alaska pharmacy law, rules, and regulations governing pharmacy practice

Which federal agency administers the Drug Enforcement Administration registration system for controlled substances?

  1. The Department of Health and Human Services
  2. The Department of Justice Correct answer.
  3. The Food and Drug Administration
  4. The Federal Trade Commission

Explanation

The DEA is an agency within the Department of Justice. The FDA and HHS regulate other aspects of drug approval and public health, but not DEA registration.

Question 19Federal and Alaska pharmacy law, rules, and regulations governing pharmacy practice

Under the federal Controlled Substances Act, a prescription for a Schedule II controlled substance must be:

  1. Written or transmitted electronically in a manner permitted by DEA regulations Correct answer.
  2. Refillable if the prescriber notes 'refill PRN'
  3. Dispensed only in a 90-day supply
  4. Verified by a second pharmacist before dispensing

Explanation

Schedule II prescriptions must be issued in a form permitted by DEA, such as a written prescription or a compliant electronic prescription, with limited exceptions for emergency oral orders. They cannot be refilled and there is no federal 90-day supply rule.

Question 20Federal and Alaska pharmacy law, rules, and regulations governing pharmacy practice

A pharmacy receives a request from a law enforcement officer for patient prescription records. Under HIPAA, the pharmacy may generally disclose protected health information to law enforcement:

  1. Only if the patient signs a release at the time of the request
  2. Whenever the officer presents a badge
  3. Never, under any circumstances
  4. Only with a valid court order, warrant, subpoena, or as otherwise permitted by the Privacy Rule Correct answer.

Explanation

HIPAA permits disclosures to law enforcement in specified circumstances, such as a court order, warrant, or grand jury subpoena, or as otherwise authorized by the Privacy Rule. A badge alone is insufficient.

Question 21Federal and Alaska pharmacy law, rules, and regulations governing pharmacy practice

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

  1. The pharmacy must notify DEA using Form 106 when a significant loss is discovered Correct answer.
  2. The pharmacy must notify DEA only if the loss exceeds $10,000 in value
  3. The pharmacy must notify DEA in writing within one business day of discovery
  4. The pharmacy must notify DEA annually with its inventory

Explanation

A significant loss or theft of controlled substances must be reported to DEA on Form 106. The form documents the circumstances and quantities involved.

Question 22Federal and Alaska pharmacy law, rules, and regulations governing pharmacy practice

A pharmacist is asked to dispense a prescription for a Schedule II drug that was faxed to the pharmacy. Under federal law, which statement is correct?

  1. Faxed Schedule II prescriptions are always invalid
  2. A faxed Schedule II prescription may be valid only in limited circumstances, and the original must generally follow Correct answer.
  3. A faxed Schedule II prescription is valid as an original in all circumstances
  4. A faxed Schedule II prescription may be refilled

Explanation

Federal rules permit faxed Schedule II prescriptions only in limited situations, and the original written prescription generally must be presented before dispensing. A fax is not treated as an original in all cases.

Question 23Federal and Alaska pharmacy law, rules, and regulations governing pharmacy practice

Under the federal Controlled Substances Act, which of the following is true regarding the transfer of a controlled substance prescription between pharmacies for refill purposes?

  1. Only Schedule V prescriptions may be transferred
  2. Schedule II prescriptions may be transferred once for refill
  3. Schedule III, IV, and V prescriptions may be transferred between pharmacies under DEA rules, subject to state law Correct answer.
  4. Controlled substance prescriptions may never be transferred

Explanation

DEA rules permit the transfer of Schedule III, IV, and V prescriptions between pharmacies for refill purposes, subject to conditions and state law. Schedule II prescriptions cannot be refilled and therefore cannot be transferred for refill.

Question 24Federal and Alaska pharmacy law, rules, and regulations governing pharmacy practice

A patient requests that a prescription for a controlled substance be partially filled. Under federal law, a partial fill of a Schedule II prescription is permitted:

  1. Only with DEA approval
  2. Only if the patient is a minor
  3. Only if the pharmacy cannot supply the full quantity, with the remainder filled within 72 hours Correct answer.
  4. Never, because Schedule II prescriptions must be filled in full

Explanation

Federal rules allow a partial fill of a Schedule II prescription when the pharmacy cannot supply the full quantity, provided the remainder is dispensed within 72 hours. If the remainder is not dispensed within that window, the prescriber must be notified.

Question 25Federal and Alaska pharmacy law, rules, and regulations governing pharmacy practice

Which federal law establishes the framework for classifying controlled substances into schedules based on abuse potential and medical use?

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

Explanation

The Controlled Substances Act establishes the five schedules and the registration and recordkeeping framework for controlled substances. The FDCA governs drug approval and labeling, not scheduling.

Question 26Federal and Alaska pharmacy law, rules, and regulations governing pharmacy practice

Under federal law, a prescription for a Schedule III controlled substance may be refilled how many times, and within what period after the date of issue?

  1. Up to six times within one year of the date of issue
  2. No refills are permitted for Schedule III drugs
  3. Up to three times within three months of the date of issue
  4. Up to five times within six months of the date of issue Correct answer.

Explanation

The Controlled Substances Act permits refills of Schedule III and IV prescriptions up to five times, and all refills must occur within six months of the date the prescription was issued. Schedule II prescriptions cannot be refilled at all.

Question 27Federal and Alaska pharmacy law, rules, and regulations governing pharmacy practice

Which federal requirement applies to a pharmacy that wants to destroy expired controlled substances on site rather than returning them to a reverse distributor?

  1. It must maintain records of the destruction and comply with DEA destruction requirements Correct answer.
  2. It must publish notice of the destruction in a local newspaper
  3. It must donate the substances to a licensed reverse distributor at no cost
  4. It must obtain prior written approval from the state board of pharmacy only

Explanation

Registrants who destroy controlled substances must follow DEA destruction standards and keep records documenting the destruction. State law may add requirements, but federal rules require documentation and compliant destruction methods.

Question 28Federal and Alaska pharmacy law, rules, and regulations governing pharmacy practice

A pharmacy's DEA registration is due to expire. What is the consequence of continuing to dispense controlled substances after the expiration date without renewing?

  1. The pharmacy may continue for a 90-day grace period automatically
  2. The pharmacy's registration renews automatically if it has no violations
  3. The pharmacy may continue if the state license remains active
  4. The pharmacy is dispensing without a valid registration, which violates federal law Correct answer.

Explanation

A DEA registration must be renewed before it expires; there is no automatic grace period for dispensing controlled substances. Dispensing after expiration without a valid registration violates the Controlled Substances Act.

Question 29Federal and Alaska pharmacy law, rules, and regulations governing pharmacy practice

Which federal law requires that a prescription drug's labeling include adequate directions for use by the prescriber and, where applicable, the patient?

  1. The Federal Food, Drug, and Cosmetic Act Correct answer.
  2. The Combat Methamphetamine Epidemic Act
  3. The Health Insurance Portability and Accountability Act
  4. The Poison Prevention Packaging Act

Explanation

The Federal Food, Drug, and Cosmetic Act requires that drugs be labeled with adequate directions for use; prescription drugs are exempt only if they bear the required Rx legend. The other statutes address packaging, methamphetamine precursors, and privacy.

Question 30Federal and Alaska pharmacy law, rules, and regulations governing pharmacy practice

A manufacturer wants to market a new prescription drug in the United States. Which federal pathway generally requires submission of a new drug application with substantial evidence of effectiveness?

  1. A generally recognized as safe petition
  2. A new drug application under the FDCA Correct answer.
  3. An investigational new drug application
  4. A certificate of free sale

Explanation

Marketing a new prescription drug generally requires an approved new drug application demonstrating safety and substantial evidence of effectiveness. An investigational new drug application authorizes clinical investigation, not marketing.

Question 31Federal and Alaska pharmacy law, rules, and regulations governing pharmacy practice

Under the federal Controlled Substances Act, which schedule contains drugs with no currently accepted medical use in treatment in the United States and a high potential for abuse?

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

Explanation

Schedule I substances have 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. Schedules II through V all have accepted medical uses.

Question 32Federal and Alaska pharmacy law, rules, and regulations governing pharmacy practice

A pharmacist receives a legitimate prescription for a Schedule II opioid for a patient with cancer pain. Which action is consistent with federal law?

  1. Dispense only a 3-day supply regardless of the prescription
  2. Dispense the full quantity as prescribed and document the dispensing Correct answer.
  3. Refuse to dispense because Schedule II drugs cannot be used for pain
  4. Require the patient to obtain a new prescription each month even if refills remain

Explanation

Schedule II drugs have accepted medical uses, including treatment of severe pain, and may be dispensed on a valid prescription. Federal law does not impose a fixed 3-day supply limit or bar Schedule II drugs for pain.

Question 33Federal and Alaska pharmacy law, rules, and regulations governing pharmacy practice

Which federal agency is responsible for enforcing the Controlled Substances Act and registering manufacturers, distributors, and dispensers of controlled substances?

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

Explanation

The DEA administers the registration system and enforces the Controlled Substances Act. The FDA regulates drug approval and labeling, while CMS and the FTC have unrelated roles.

Question 34Federal and Alaska pharmacy law, rules, and regulations governing pharmacy practice

A pharmacy receives a prescription for a controlled substance from a prescriber whose DEA registration has expired. What is the most appropriate action?

  1. Do not dispense until the prescriber's DEA registration is valid Correct answer.
  2. Dispense the prescription but note the expiration in the file
  3. Dispense the prescription because the state license is still valid
  4. Dispense only a 7-day emergency supply

Explanation

A valid DEA registration is required for a prescriber to issue prescriptions for controlled substances. Dispensing on an expired registration risks violating federal law, so the pharmacy should verify and wait for valid registration.

Question 35Federal and Alaska pharmacy law, rules, and regulations governing pharmacy practice

Under federal law, which of the following is required on a written prescription for a Schedule II controlled substance?

  1. The pharmacy's DEA registration number
  2. The prescriber's DEA registration number Correct answer.
  3. The patient's diagnosis code
  4. The patient's insurance member number

Explanation

A Schedule II prescription must include the prescriber's DEA number, along with the patient's name and address, drug name, strength, quantity, directions, and date. Diagnosis codes and insurance numbers are not federal requirements.

Question 36Federal and Alaska pharmacy law, rules, and regulations governing pharmacy practice

A pharmacy technician discovers that a bottle of a Schedule IV drug is missing from inventory. Under DEA regulations, what must the pharmacy do?

  1. Report the loss to DEA only if the value exceeds $1,000
  2. Report the loss to the state board only
  3. Report the theft or significant loss to DEA in writing upon discovery Correct answer.
  4. Wait until the annual inventory to report the loss

Explanation

Registrants must notify the DEA field office in writing of the theft or significant loss of controlled substances upon discovery. The report must be accompanied by a completed DEA Form 106.

Question 37Federal and Alaska pharmacy law, rules, and regulations governing pharmacy practice

Which federal law establishes requirements for the use of electronic prescriptions for controlled substances, including identity proofing and two-factor authentication?

  1. The Poison Prevention Packaging Act
  2. The Orphan Drug Act
  3. The Controlled Substances Act as implemented by DEA regulations Correct answer.
  4. The Biologics Price Competition and Innovation Act

Explanation

DEA regulations under the Controlled Substances Act set the requirements for electronic prescriptions of controlled substances, including provider identity proofing and two-factor authentication. The other laws address unrelated areas.

Question 38Federal and Alaska pharmacy law, rules, and regulations governing pharmacy practice

A pharmacist wants to verify whether a prescriber is authorized to prescribe controlled substances. Which federal source is most appropriate?

  1. The state medical board website only
  2. The National Drug Code directory
  3. The DEA registration database Correct answer.
  4. The FDA Orange Book

Explanation

The DEA maintains registration information that allows pharmacies to verify a prescriber's authority to handle controlled substances. The Orange Book and NDC directory concern drug products, not prescriber authority.

Question 39Federal and Alaska pharmacy law, rules, and regulations governing pharmacy practice

Under the Federal Food, Drug, and Cosmetic Act, which statement best describes the legal status of a prescription drug that is dispensed without a prescription?

  1. It is permitted for any drug with a low risk of harm
  2. It is permitted if the pharmacist documents the reason
  3. It is generally a misbranded drug unless an exception applies Correct answer.
  4. It is permitted if the patient signs a waiver

Explanation

Prescription drugs are exempt from the adequate-directions requirement only when dispensed on a prescription; dispensing without one generally renders the drug misbranded. Narrow exceptions exist, but a patient waiver or pharmacist documentation does not create one.

Question 40Federal and Alaska pharmacy law, rules, and regulations governing pharmacy practice

Which federal law governs the privacy of individually identifiable health information held by most pharmacies?

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

Explanation

HIPAA, through its Privacy and Security Rules, governs the use and disclosure of protected health information by covered entities such as pharmacies. The other statutes address controlled substances, drug approval, and packaging.

Question 41Federal and Alaska pharmacy law, rules, and regulations governing pharmacy practice

A pharmacy is inspected by DEA investigators. Which record must the pharmacy make available for inspection?

  1. Only records from the current calendar year
  2. Records of controlled substance receipts, sales, and inventories Correct answer.
  3. Only records involving Schedule II drugs
  4. Only records requested by a subpoena

Explanation

DEA registrants must keep complete and accurate records of controlled substances received, sold, dispensed, or disposed of, and make them available for inspection. The requirement is not limited to one schedule or to subpoenaed records.

Question 42Federal and Alaska pharmacy law, rules, and regulations governing pharmacy practice

A pharmacy dispenses a prescription for a controlled substance to a patient who appears to be using a false identity. What is the pharmacist's best course of action under federal law?

  1. Dispense the drug and report the patient afterward
  2. Ask the patient to sign a statement confirming identity
  3. Refuse to dispense and report the suspected illegal activity as appropriate Correct answer.
  4. Dispense a reduced quantity to limit diversion

Explanation

A pharmacist has a corresponding responsibility to ensure prescriptions are issued for a legitimate medical purpose and may refuse to dispense when red flags indicate diversion or fraud. Suspected illegal activity should be reported to appropriate authorities.

Question 43Federal and Alaska pharmacy law, rules, and regulations governing pharmacy practice

Under federal law, how long must a pharmacy generally retain records of controlled substance transactions?

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

Explanation

DEA regulations generally require controlled substance records to be kept for at least two years and made available for inspection. State law may require longer retention, but the federal minimum is two years.

Question 44Federal and Alaska pharmacy law, rules, and regulations governing pharmacy practice

A pharmacy wants to transfer a prescription for a Schedule III controlled substance to another pharmacy at the patient's request. Which federal condition applies?

  1. The transfer must be documented and the prescription may be transferred only once Correct answer.
  2. The transfer may occur only for Schedule II drugs
  3. The transfer may occur only with DEA approval
  4. The transfer may occur only if the patient appears in person

Explanation

Federal rules permit the one-time transfer of a prescription for a controlled substance in Schedules III through V between pharmacies, with documentation of the transfer. Schedule II prescriptions may not be transferred.

Question 45Federal and Alaska pharmacy law, rules, and regulations governing pharmacy practice

Which federal statute authorizes the FDA to require that certain drugs be dispensed only on prescription?

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

Explanation

The FDCA establishes the prescription drug framework, including which drugs may be dispensed only on prescription. The CSA addresses controlled substances specifically, not the general prescription status of drugs.

Question 46Federal and Alaska pharmacy law, rules, and regulations governing pharmacy practice

A pharmacist receives a prescription for a Schedule II stimulant that was transmitted by fax. Under federal law, which statement is generally true?

  1. The fax may serve as the original prescription in all circumstances
  2. A faxed Schedule II prescription is generally not valid unless an exception applies Correct answer.
  3. The fax is valid only for Schedule III drugs
  4. The fax must be converted to a written prescription within 24 hours

Explanation

DEA regulations generally do not permit faxes as originals for Schedule II prescriptions, with limited exceptions such as certain long-term care and hospice situations. A fax alone is therefore generally insufficient.

Question 47Federal and Alaska pharmacy law, rules, and regulations governing pharmacy practice

Which federal requirement applies to a pharmacy that compounds a sterile preparation for dispensing to patients?

  1. It must register with the FDA as a manufacturer
  2. It must comply with applicable USP standards adopted by the FDA for compounding Correct answer.
  3. It must obtain a DEA registration for compounding
  4. It must obtain an investigational new drug approval

Explanation

Pharmacies engaged in compounding must follow applicable standards, including USP compounding standards referenced in federal law and guidance. Compounding does not require manufacturer registration or an IND for routine patient-specific preparations.

Question 48Federal and Alaska pharmacy law, rules, and regulations governing pharmacy practice

A pharmacy discovers that a prescriber has issued a prescription for a controlled substance outside the usual course of professional practice. What should the pharmacist do?

  1. Refuse to fill and consider reporting the prescriber Correct answer.
  2. Fill the prescription because it is signed by a licensed prescriber
  3. Fill it only if the patient pays cash
  4. Fill it once and note the concern

Explanation

A pharmacist shares responsibility for ensuring a controlled substance prescription is issued for a legitimate medical purpose in the usual course of professional practice. When that is not the case, the pharmacist should refuse and may report the prescriber.

Question 49Federal and Alaska pharmacy law, rules, and regulations governing pharmacy practice

Under the Combat Methamphetamine Epidemic Act, which records must a pharmacy maintain for nonprescription ephedrine and pseudoephedrine sales?

  1. A written or electronic log of each sale, including the purchaser's identification Correct answer.
  2. No records are required if the product is behind the counter
  3. Only records for sales to minors
  4. Only a monthly summary of total units sold

Explanation

The CMEA requires sellers to maintain a logbook, written or electronic, recording each sale of scheduled listed chemical products, including purchaser identification. Keeping products behind the counter does not eliminate the recordkeeping requirement.

Question 50Federal and Alaska pharmacy law, rules, and regulations governing pharmacy practice

Which federal law requires that pharmacies be registered with the DEA before they may dispense controlled substances?

  1. The Controlled Substances Act Correct answer.
  2. The Health Insurance Portability and Accountability Act
  3. The Federal Food, Drug, and Cosmetic Act
  4. The Poison Prevention Packaging Act

Explanation

The Controlled Substances Act requires registration with the DEA for any person or entity that manufactures, distributes, or dispenses controlled substances. The other statutes do not address controlled substance registration.