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TN MPJE practice questions

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Question 1Federal pharmacy laws and regulations

A community pharmacy needs to purchase a stock bottle of a Schedule II controlled substance from its wholesaler. Which DEA document is used to order and transfer that product?

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

Explanation

Distribution and ordering of Schedule I and II controlled substances must be documented on DEA Form 222 (a single-sheet form used since the 2019 redesign). Each line records the item, package size, and number of units, and the form is retained by both parties.

Question 2Federal pharmacy laws and regulations

Under DEA regulations, how often must a registered retail pharmacy take a complete inventory of all controlled substances on hand?

  1. Every five years
  2. Every two years Correct answer.
  3. Every three years
  4. Every year

Explanation

A biennial inventory of all controlled substances is required, taken either on any fixed date chosen by the registrant or on the registrant's regular general physical inventory date. A newly registered pharmacy must take an initial inventory on the date it first engages in business.

Question 3Federal pharmacy laws and regulations

A prescriber issues a prescription for a Schedule II stimulant. Under federal law, how many refills may be authorized on that prescription?

  1. No refills Correct answer.
  2. Two refills, each filled within six months
  3. Up to five refills within six months
  4. One refill, which must be filled within six months

Explanation

Schedule II prescriptions may not be refilled under any circumstances; a new prescription is required for additional dispensing. A prescriber may issue multiple sequential prescriptions covering up to a 90-day supply with clear instructions on the earliest fill date.

Question 4Federal pharmacy laws and regulations

A prescription for a Schedule IV benzodiazepine is issued on June 1, and the prescriber authorizes the maximum number of refills allowed by federal law. How many refills may be dispensed, and within what period?

  1. Two refills within six months of the issue date
  2. Refills may continue for one year from the issue date
  3. No refills may be authorized
  4. Five refills within six months of the issue date Correct answer.

Explanation

Schedule III and IV prescriptions may be refilled up to five times, and each refill must occur within six months of the date the prescription was issued. After six months or five refills, a new prescription is required.

Question 5Federal pharmacy laws and regulations

Because a prescriber's computer system is down, a pharmacist accepts a telephone order for a Schedule II analgesic. What must the prescriber do to comply with DEA requirements?

  1. Obtain DEA approval of the emergency order within seventy-two hours
  2. Have the pharmacy's pharmacist-in-charge sign as the prescriber's agent within fourteen days
  3. Deliver a written prescription within thirty days
  4. Deliver a written prescription within seven days Correct answer.

Explanation

Emergency oral Schedule II orders are permitted only for a genuine emergency, and the quantity dispensed must be limited to the emergency period. The prescriber must furnish a written prescription within seven days; if it is not received, the pharmacist must notify the local DEA field office.

Question 6Federal pharmacy laws and regulations

A patient requests a partial fill of a Schedule II prescription written for 60 tablets, asking for 20 tablets now. Under federal rules, within what period must the remaining 40 tablets be dispensed?

  1. There is no limit if the prescriber authorizes the remainder in writing
  2. 60 days of the date of the first partial fill
  3. 30 days of the date the prescription was written Correct answer.
  4. 72 hours of the partial fill

Explanation

When a patient or prescriber requests a partial fill of a Schedule II prescription, the remainder may be dispensed within 30 days of the date the prescription was written. If the remainder is not dispensed within that period, the pharmacist must notify the prescriber, and no further dispensing may occur.

Question 7Federal pharmacy laws and regulations

A retail pharmacy holds a DEA registration. For what term is that registration issued before it must be renewed?

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

Explanation

DEA registrations for pharmacies and other registrants are issued for a three-year period and must be renewed before expiration. A separate registration is required for each principal place of business.

Question 8Federal pharmacy laws and regulations

A pharmacy's newly hired pharmacist will order Schedule II drugs from wholesalers. What document authorizes this individual to sign DEA Form 222 on the pharmacy's behalf?

  1. A DEA Form 224
  2. A state-issued controlled substance license
  3. A power of attorney executed by the registrant Correct answer.
  4. A notarized letter from the pharmacy owner

Explanation

A registrant may execute a power of attorney authorizing one or more named individuals to sign DEA Form 222 for the registered location. The power of attorney must be signed by the registrant and retained with the executed order forms, and it remains valid until revoked.

Question 9Federal pharmacy laws and regulations

During a controlled substance reconciliation, a pharmacy determines that 200 tablets of a Schedule II drug are missing. Which DEA form documents this event?

  1. DEA Form 41
  2. DEA Form 363
  3. DEA Form 222
  4. DEA Form 106 Correct answer.

Explanation

Theft or significant loss of controlled substances must be reported to DEA in writing on Form 106 within one business day of discovery. The registrant should also notify local law enforcement and complete a DEA 106 for each registered location affected.

Question 10Federal pharmacy laws and regulations

A hospital pharmacy plans to destroy expired controlled substances on site and has obtained authorization from the appropriate authority. Which DEA form serves as the record of that destruction?

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

Explanation

DEA Form 41, the Registrant Record of Controlled Substances Destroyed, documents destruction performed by a registrant under the applicable destruction regulations. The form lists each item, quantity, and method of destruction and must be kept with the registrant's records.

Question 11Federal pharmacy laws and regulations

A customer buys a 96-count box of 30 mg pseudoephedrine tablets and returns the same day to buy a second 96-count box. Under the Combat Methamphetamine Epidemic Act, what should the pharmacy do?

  1. Refuse the second sale, because the 3.6-gram daily limit would be exceeded Correct answer.
  2. Refuse the second sale, because the 9-gram 30-day limit has already been exceeded
  3. Sell the second box, because federal law imposes no quantity limits on pseudoephedrine sales
  4. Sell the second box, because the daily recordkeeping threshold has not been reached

Explanation

The Combat Methamphetamine Epidemic Act limits retail sales of scheduled listed chemical products such as pseudoephedrine to 3.6 grams per purchaser per day and 9 grams in a 30-day period. One 96-count box of 30 mg tablets contains 2.88 grams, so a second box the same day would exceed the daily limit.

Question 12Federal pharmacy laws and regulations

A pharmacy receives a sealed carton of prescription drug product from a wholesaler and notices that the serialized product identifier on the carton appears to have been altered. Under the Drug Supply Chain Security Act, what should the pharmacy do?

  1. Relabel the carton with a new product identifier before dispensing
  2. Quarantine the product, investigate, and notify trading partners and FDA if it is determined to be illegitimate Correct answer.
  3. Dispense the product and report the observation to the manufacturer on the next business day
  4. Return the product to the wholesaler and note the return on the transaction information form

Explanation

A product with an altered or suspect product identifier must be quarantined and investigated before any further distribution. If the investigation shows the product is illegitimate, the pharmacy must notify FDA and the immediate trading partners within 24 hours and retain the product.

Question 13Federal pharmacy laws and regulations

Which statement correctly describes the Poison Prevention Packaging Act as it applies to a prescription dispensed to an adult patient?

  1. A prescriber may never authorize non-child-resistant packaging
  2. Child-resistant packaging is mandatory for every prescription with no exceptions
  3. The patient may request non-child-resistant packaging, and the pharmacy must document the request Correct answer.
  4. Child-resistant packaging is required only for controlled substances

Explanation

Child-resistant packaging is the default for most oral prescription drugs, but a patient or prescriber may direct that a conventional package be used. The pharmacy must document the patient's request, and the waiver applies only to that patient's prescription.

Question 14Federal pharmacy laws and regulations

OBRA 1990 requires state Medicaid programs to provide which service at the point of dispensing a covered prescription?

  1. Mandatory patient counseling by a registered nurse
  2. A prospective drug utilization review before the prescription is dispensed Correct answer.
  3. Blanket authorization for pharmacist therapeutic substitution
  4. A 30-day supply limit on all maintenance prescriptions

Explanation

OBRA 1990 requires states to operate a drug utilization review program with both prospective review before dispensing and retrospective review of claims. Prospective review screens for therapeutic duplication, drug-disease contraindications, interactions, and incorrect dosage.

Question 15Federal pharmacy laws and regulations

A drug is marketed under a risk evaluation and mitigation strategy that includes elements to assure safe use. Which requirement is typical of such a strategy?

  1. Certification of prescribers and dispensing pharmacies in the REMS system Correct answer.
  2. Automatic therapeutic substitution by the pharmacist without prescriber involvement
  3. Expedited approval of generic versions of the drug
  4. Exemption from the requirement to provide a medication guide

Explanation

Elements to assure safe use may include prescriber certification, pharmacy certification, patient enrollment, restricted distribution, and required laboratory monitoring. These elements are enforced through the shared system or individual REMS that governs dispensing.

Question 16Federal pharmacy laws and regulations

A manufacturer's representative wants to leave samples of a new prescription drug with a physician. Under the Prescription Drug Marketing Act, which condition must be satisfied?

  1. The samples must be recorded on a DEA Form 222
  2. The samples must be dispensed to patients free of charge
  3. The samples may be resold to a pharmacy for dispensing
  4. The physician must request the samples in writing and sign a receipt for them Correct answer.

Explanation

The Prescription Drug Marketing Act restricts drug samples to licensed practitioners, who must request them in writing and execute a receipt for each distribution. Samples may not be sold, and they may not be transferred to another practitioner or to a retail pharmacy for resale.

Question 17Federal pharmacy laws and regulations

Which federal amendment created the prescription and over-the-counter classes of drugs and permitted prescription drugs to be dispensed on an oral prescription?

  1. The Comprehensive Addiction and Recovery Act
  2. The Kefauver-Harris Amendment
  3. The Durham-Humphrey Amendment Correct answer.
  4. The Food, Drug, and Cosmetic Act of 1938

Explanation

The Durham-Humphrey Amendment of 1951 established that drugs unsafe for self-medication must be dispensed only on prescription and allowed oral prescriptions and refills of legend drugs. Before that amendment, prescription status was a labeling matter rather than a statutory category.

Question 18Federal pharmacy laws and regulations

An abbreviated new drug application submitted for a generic prescription product must establish which of the following?

  1. Chemical identity of all inactive ingredients with the brand product
  2. That the generic product will be priced below the brand product
  3. Full clinical trials demonstrating safety and efficacy in humans
  4. Bioequivalence to the reference listed drug Correct answer.

Explanation

An ANDA relies on the FDA's prior finding of safety and effectiveness for the reference listed drug and must instead show bioequivalence, along with identity in active ingredient, strength, dosage form, and route of administration. Inactive ingredients may differ as long as they are safe for the intended use and do not affect bioequivalence.

Question 19Federal pharmacy laws and regulations

A patient's employer calls a pharmacy and asks for a list of the patient's current medications. What is the most appropriate action under the HIPAA privacy rule?

  1. Provide the list if the pharmacist judges the request to be clinically reasonable
  2. Provide the list after deleting the patient's name and street address
  3. Decline unless the patient has given a valid written authorization for the disclosure Correct answer.
  4. Provide the list, because the employer is a covered entity that shares responsibility for the patient's health

Explanation

Protected health information may be disclosed for purposes other than treatment, payment, or health care operations only with a valid patient authorization, unless a specific exception applies. An employer seeking medication information is not engaging in treatment or payment, so the pharmacy should request an authorization.

Question 20Federal pharmacy laws and regulations

A Medicaid beneficiary's prescription for a non-controlled drug is called in by telephone to a pharmacy. How does the federal tamper-resistant prescription requirement apply?

  1. The prescriber must deliver a tamper-resistant written prescription before the drug is dispensed
  2. The requirement applies only to controlled substances
  3. The requirement applies only to Schedule II prescriptions
  4. An oral prescription is exempt, but the prescriber must follow up with a compliant written or electronic prescription Correct answer.

Explanation

Federal Medicaid rules require that written, non-electronic prescriptions be on tamper-resistant pads, but oral prescriptions are exempt from the pad requirement. The prescriber must still furnish a compliant written or electronic prescription as follow-up, and the pharmacy must retain it.

Question 21Federal pharmacy laws and regulations

Which statement accurately describes a 503B outsourcing facility?

  1. It is exempt from FDA registration and routine inspection
  2. It may compound drugs without patient-specific prescriptions and must comply with current good manufacturing practice Correct answer.
  3. It may compound only for identified individual patients with a valid prescription
  4. It may repackage and resell unused patient-specific compounded preparations

Explanation

A 503B outsourcing facility registers with FDA, is subject to current good manufacturing practice requirements, and may compound without a patient-specific prescription, for example to supply office-use stock to health care facilities. It must also report the drugs it compounds and report serious adverse events.

Question 22Federal pharmacy laws and regulations

A prescriber writes a Schedule II prescription that is unclear in one respect. After consulting the prescriber and documenting the conversation, which change may the pharmacist make?

  1. Adding the prescriber's signature on the prescriber's behalf
  2. Changing the dosage strength along with the corresponding quantity Correct answer.
  3. Changing the drug to a therapeutically equivalent alternative
  4. Changing the patient's name to correct a spelling error

Explanation

DEA policy permits a pharmacist, after consultation with and verification from the prescriber, to adjust the dosage form, strength, quantity, directions for use, and issue date. The pharmacist may not change the patient's name, the drug prescribed, or the prescriber's signature.

Question 23Federal pharmacy laws and regulations

FDA classifies a recall as one that may cause temporary or medically reversible adverse health consequences, or where the probability of serious harm is remote. Which classification is this?

  1. Class II Correct answer.
  2. Class I
  3. Class III
  4. Market withdrawal

Explanation

A Class II recall covers products likely to cause temporary or medically reversible harm, or where the chance of serious harm is remote. Class I is reserved for products with a reasonable probability of serious harm or death, and Class III covers products unlikely to cause any adverse health consequence.

Question 24Federal pharmacy laws and regulations

Which statement must appear on the label of a prescription drug product dispensed to a patient?

  1. The wholesale acquisition cost of the product
  2. The DEA registration number of the prescriber
  3. The federal legend "Rx only" Correct answer.
  4. A statement that the drug may not be refilled

Explanation

FDA regulations require prescription drug labels to bear the legend "Rx only," which replaced the older statement that federal law prohibits dispensing without a prescription. This legend distinguishes prescription products from over-the-counter drugs at the point of dispensing.

Question 25Federal pharmacy laws and regulations

Which controlled substance schedule includes drugs that currently have no accepted medical use in the United States and a high potential for abuse?

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

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. Drugs in Schedules II through V all have a recognized medical use and may be prescribed.

Question 26Federal pharmacy laws and regulations

A prescriber issues a Schedule II prescription for a 30-day supply and writes "refill x 5" on the face of the prescription. How many additional dispensings may the pharmacy make under federal law?

  1. None Correct answer.
  2. Six
  3. One
  4. Five

Explanation

The federal Controlled Substances Act prohibits refills of Schedule II prescriptions. A patient must obtain a new prescription from the prescriber for any additional supply.

Question 27Federal pharmacy laws and regulations

A Schedule IV prescription is issued on March 1 and authorizes refills. Under federal law, what is the maximum refill authority?

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

Explanation

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

Question 28Federal pharmacy laws and regulations

A pharmacy chain opens a second retail location that will purchase and dispense controlled substances. The chain already holds a DEA registration at its original store. What is required for the new location?

  1. Obtain a separate DEA registration for the new location Correct answer.
  2. Use the existing DEA registration until the next renewal
  3. Notify the state board of pharmacy only
  4. Register only if Schedule II drugs will be stocked

Explanation

Each principal place of business where controlled substances are dispensed must have its own DEA registration. The registration is location-specific and does not transfer to a new store.

Question 29Federal pharmacy laws and regulations

How often must a DEA-registered pharmacy take a complete inventory of its controlled substances?

  1. Every two years Correct answer.
  2. Every three years
  3. Every year
  4. Every five years

Explanation

DEA regulations require a complete controlled substance inventory every two years, known as a biennial inventory. The inventory must be maintained with controlled substance records.

Question 30Federal pharmacy laws and regulations

A prescriber calls a pharmacy to clarify which medications a patient is currently taking. Under HIPAA, how may the pharmacist respond?

  1. Disclose the entire profile only if the patient is present
  2. Refuse because the prescriber is not the patient's employer
  3. Disclose relevant medication information for treatment Correct answer.
  4. Require the patient's written authorization before any discussion

Explanation

HIPAA permits covered entities to disclose protected health information to other providers for treatment purposes without patient authorization. The pharmacist should limit the disclosure to information relevant to the treatment question.

Question 31Federal pharmacy laws and regulations

A pharmacy sells pseudoephedrine tablets without a prescription. Which record must the pharmacy maintain for each sale under the Combat Methamphetamine Epidemic Act?

  1. A prescription hard copy filed with Schedule V records
  2. A monthly report sent to the state board of pharmacy
  3. A DEA Form 222 signed by the purchaser
  4. A written or electronic purchaser logbook Correct answer.

Explanation

The Combat Methamphetamine Epidemic Act requires retail sellers of scheduled listed chemical products to maintain a written or electronic logbook. The logbook must capture purchaser identity and sale details and be retained for two years.

Question 32Federal pharmacy laws and regulations

A pharmacy implements electronic prescribing of controlled substances. Which safeguard is required for the prescriber's electronic prescription system under DEA rules?

  1. Approval by the state board of pharmacy for each prescription
  2. A daily paper backup of all prescriptions
  3. Two-factor authentication of the prescriber Correct answer.
  4. A biometric scan of the patient at dispensing

Explanation

DEA rules for electronic prescribing of controlled substances require identity proofing and two-factor authentication of the prescriber. These controls help ensure the prescription is signed by the authorized prescriber.

Question 33Federal pharmacy laws and regulations

For Schedule III through V controlled substances, which document may a pharmacy use as its record of receipt if it is readily retrievable?

  1. A DEA Form 222 carbon copy
  2. A DEA Form 41 destruction record
  3. A DEA Form 106 report
  4. An invoice Correct answer.

Explanation

Invoices or other readily retrievable records may document receipt of Schedule III through V controlled substances. Schedule II receipts require DEA Form 222 or an approved electronic equivalent.

Question 34Federal pharmacy laws and regulations

A prescriber telephones a Schedule II prescription to a pharmacy because of an emergency. What must the prescriber do to comply with federal law?

  1. Deliver a written prescription within seven days Correct answer.
  2. Deliver a written prescription within thirty days
  3. Convert the prescription to Schedule III
  4. Obtain DEA approval before the pharmacy dispenses

Explanation

Federal law permits an emergency oral Schedule II prescription only if the prescriber provides a written or electronic prescription within seven days. If the follow-up prescription is not received, the pharmacist must notify DEA.

Question 35Federal pharmacy laws and regulations

A prescriber writes three separate Schedule II prescriptions for the same patient, each with a "do not fill before" date. What federal requirement applies?

  1. The pharmacy must treat the prescriptions as refills
  2. Each prescription must be filled on the date written
  3. A legitimate medical purpose must be documented Correct answer.
  4. The total quantity may not exceed a 30-day supply

Explanation

When a prescriber issues multiple Schedule II prescriptions with staggered fill dates, the prescriber must document a legitimate medical purpose for the sequence. The pharmacist also has a corresponding responsibility to resolve any red flags.

Question 36Federal pharmacy laws and regulations

A manufacturer seeks approval for a new formulation of an already approved drug and relies on the agency's prior findings of safety and effectiveness for the active ingredient. Which application pathway is this?

  1. A 505(b)(2) application Correct answer.
  2. An abbreviated new drug application
  3. An investigational new drug application
  4. An over-the-counter monograph

Explanation

A 505(b)(2) application may rely on existing FDA findings of safety and effectiveness for an approved drug. It is used for changes such as a new formulation, dosage form, or indication rather than a full stand-alone new drug application.

Question 37Federal pharmacy laws and regulations

A pharmacist consults the FDA Orange Book before generic substitution. What does an "AB" therapeutic equivalence rating indicate?

  1. The products are therapeutically equivalent Correct answer.
  2. The products are chemically identical but not substitutable
  3. The generic product has a narrower indication than the brand
  4. The generic product is approved only for hospital use

Explanation

An AB rating indicates that the products are therapeutically equivalent with no known bioequivalence problem. Actual substitution is governed by state pharmacy law.

Question 38Federal pharmacy laws and regulations

Under federal Medicaid requirements, what is the purpose of a drug utilization review program?

  1. To assess and improve prescription drug use Correct answer.
  2. To limit coverage to generic drugs only
  3. To replace the prescriber's clinical judgment
  4. To set the maximum retail price of each drug

Explanation

Medicaid drug utilization review programs prospectively and retrospectively assess prescription drug use. The goal is to improve quality, identify inappropriate use, and support cost-effective care.

Question 39Federal pharmacy laws and regulations

A pharmacy sends a patient's prescription history to a billing vendor for claims processing. What HIPAA principle limits how much information the pharmacy may disclose?

  1. The accounting of disclosures rule
  2. The marketing authorization rule
  3. The breach notification rule
  4. The minimum necessary standard Correct answer.

Explanation

The HIPAA minimum necessary standard requires covered entities to limit protected health information to the amount reasonably needed for the purpose. It applies to payment and operations disclosures, among others.

Question 40Federal pharmacy laws and regulations

A pharmacy contracts with a software vendor that will store patient prescription records. What document should the pharmacy have with the vendor under HIPAA?

  1. A certificate of destruction
  2. A DEA power of attorney
  3. A business associate agreement Correct answer.
  4. A patient authorization for each prescription

Explanation

A vendor that creates, receives, maintains, or transmits protected health information on behalf of the pharmacy is a business associate. HIPAA requires a written business associate agreement.

Question 41Federal pharmacy laws and regulations

A 503A compounding pharmacy wants to prepare a compounded version of a commercially available FDA-approved drug in the same dosage form and strength. What federal restriction applies?

  1. The compounded drug must be listed in the Orange Book
  2. The compounded drug must be sold only to hospitals
  3. It may not compound essentially a copy Correct answer.
  4. The compounded drug must be dispensed without a prescription

Explanation

Section 503A prohibits compounding a drug that is essentially a copy of a commercially available drug, subject to limited exceptions. This restriction helps preserve the FDA approval system for commercially marketed products.

Question 42Federal pharmacy laws and regulations

A prescriber wants to issue a first-time Schedule II prescription to a patient via telemedicine without an in-person evaluation. Under the Ryan Haight Act, what is generally required?

  1. An in-person medical evaluation Correct answer.
  2. A DEA registration for the patient
  3. Approval from the state board of pharmacy
  4. A written prescription mailed to the pharmacy

Explanation

The Ryan Haight Act generally requires at least one in-person medical evaluation before a controlled substance is prescribed via telemedicine. Limited exceptions may apply, but an in-person evaluation is the baseline rule.

Question 43Federal pharmacy laws and regulations

A pharmacy discovers that a bottle of oxycodone is missing during inventory. When must the pharmacy report the loss to DEA?

  1. Only if the loss exceeds 1,000 dosage units
  2. Only after the annual inventory
  3. Within 60 days of the discovery
  4. Within one business day of the discovery Correct answer.

Explanation

DEA requires registrants to notify the agency in writing of a theft or significant loss within one business day of discovery. The registrant uses DEA Form 106 and also notifies local authorities as required.

Question 44Federal pharmacy laws and regulations

Under the Drug Supply Chain Security Act, which information must accompany a prescription drug product as transaction information?

  1. The patient's diagnosis and prescription number
  2. The product's lot number and expiration date Correct answer.
  3. The pharmacy's DEA registration number
  4. The prescriber's NPI and DEA number

Explanation

Transaction information under DSCSA includes product identifiers such as the lot number and expiration date, along with the NDC, quantity, transaction date, and the parties involved. It does not include patient-specific clinical information.

Question 45Federal pharmacy laws and regulations

A manufacturer advertises a prescription drug directly to consumers on television. Which content is required under FDA rules?

  1. Only the drug's brand name and price
  2. A fair balance of benefits and risks Correct answer.
  3. A disclaimer that the drug is not FDA approved
  4. Only a toll-free number for reporting adverse events

Explanation

FDA requires direct-to-consumer broadcast advertising to present a fair balance of the product's benefits and risks. The ad must also disclose the drug's major risks and not omit material facts.

Question 46Federal pharmacy laws and regulations

A pharmacy receives a request from a substance use disorder treatment program for a patient's records that include SUD treatment information. What federal requirement applies under 42 CFR Part 2?

  1. Written Part 2-compliant patient consent Correct answer.
  2. The patient's employer may consent on the patient's behalf
  3. Only a court order can ever permit disclosure
  4. The pharmacy may disclose freely because HIPAA applies

Explanation

Records protected by 42 CFR Part 2 generally require specific written patient consent before disclosure. HIPAA does not override the stricter Part 2 confidentiality rules.

Question 47Federal pharmacy laws and regulations

A pharmacy offers gift cards to prescribers for each new prescription sent to the pharmacy. Which federal statute is most directly implicated?

  1. The Poison Prevention Packaging Act
  2. The federal anti-kickback statute Correct answer.
  3. The Drug Supply Chain Security Act
  4. The Prescription Drug Marketing Act

Explanation

The federal anti-kickback statute prohibits offering remuneration to induce referrals of items or services payable by federal health care programs. Gift cards tied to new prescriptions raise direct anti-kickback concerns.

Question 48Federal pharmacy laws and regulations

An ANDA applicant files a Paragraph IV certification. What does this certification assert?

  1. The applicant will not market the drug for two years
  2. The patent is invalid or not infringed Correct answer.
  3. The generic drug is bioequivalent to the reference drug
  4. The brand manufacturer has abandoned the patent

Explanation

A Paragraph IV certification asserts that a listed patent is invalid, unenforceable, or will not be infringed by the proposed generic product. It triggers notice to the patent holder and may lead to litigation and a 30-month stay.

Question 49Federal pharmacy laws and regulations

During a biennial inventory, how must a pharmacy count Schedule II controlled substances compared with Schedule III through V substances?

  1. Estimate CII and count CIII-V exactly
  2. Count all schedules exactly, including open containers
  3. Estimate all schedules by container size
  4. Count CII exactly and estimate CIII-V Correct answer.

Explanation

DEA requires an exact count of Schedule II controlled substances during inventory. Schedule III through V substances may generally be estimated unless a container holds more than 1,000 units and has been opened.

Question 50Federal pharmacy laws and regulations

A pharmacy purchases prescription drugs from a company that is not licensed or registered as required and cannot provide transaction information. Under DSCSA, how should the pharmacy treat the product?

  1. As suspect product requiring quarantine Correct answer.
  2. As saleable product if the price is lower
  3. As donated product for charitable use
  4. As returned product eligible for resale

Explanation

DSCSA requires a pharmacy to treat product as suspect when it has reason to believe the product may be illegitimate. Suspect product must be quarantined, investigated, and not distributed until cleared.