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DC MPJE - independent pharmacy jurisprudence foundations study materials
DC MPJE - independent pharmacy jurisprudence foundations study resources

DC MPJE - independent pharmacy jurisprudence foundations practice questions

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Question 1Federal pharmacy law and regulated products

Under the Controlled Substances Act (CSA), which DEA schedule includes drugs with the highest potential for abuse and no currently accepted medical use?

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

Explanation

Schedule I is the federal classification defined by high abuse potential, no currently accepted medical use in the United States, and lack of accepted safety under medical supervision.

Question 2Federal pharmacy law and regulated products

Under federal law, what is the maximum number of refills allowed for a Schedule III controlled substance prescription?

  1. No refills allowed
  2. Up to 3 refills within 6 months
  3. Up to 5 refills within 6 months Correct answer.
  4. Up to 5 refills within 1 year

Explanation

Schedule III and IV prescriptions may generally be refilled no more than five times within six months after issuance, subject to prescriber authorization and applicable law. Do not extend this exact ceiling to all Schedule V prescriptions.

Question 3Federal pharmacy law and regulated products

The Durham-Humphrey Amendment of 1951 established which key distinction in drug classification?

  1. Generic vs. brand-name drugs
  2. Prescription (legend) vs. over-the-counter drugs Correct answer.
  3. Controlled vs. non-controlled substances
  4. Biological vs. chemical drugs

Explanation

The Durham-Humphrey Amendment to the Federal Food, Drug, and Cosmetic Act (FDCA) established the distinction between prescription (legend) drugs and over-the-counter (OTC) drugs.

Question 4Federal pharmacy law and regulated products

The Poison Prevention Packaging Act (PPPA) requires child-resistant packaging for most prescription drugs. Which of the following is an exemption?

  1. Sublingual nitroglycerin tablets Correct answer.
  2. Amoxicillin capsules
  3. Metformin tablets
  4. Lisinopril tablets

Explanation

Sublingual nitroglycerin tablets are exempt from child-resistant packaging requirements under the PPPA because they require immediate access in emergency cardiac situations.

Question 5Federal pharmacy law and regulated products

What is the primary purpose of the Drug Supply Chain Security Act (DSCSA)?

  1. Regulate direct-to-consumer advertising
  2. Create an electronic system to track and trace prescription drugs Correct answer.
  3. Establish drug pricing transparency
  4. Monitor pharmacy benefit manager practices

Explanation

The DSCSA establishes requirements for an electronic, interoperable system to identify and trace certain prescription drugs as they are distributed in the United States to protect consumers from exposure to drugs that may be counterfeit, stolen, contaminated, or otherwise harmful.

Question 6Federal pharmacy law and regulated products

Under HIPAA, a pharmacy may disclose protected health information (PHI) without patient authorization for which purpose?

  1. Marketing of new pharmaceutical products
  2. Treatment, payment, and healthcare operations Correct answer.
  3. Employment background checks
  4. Sale of patient mailing lists

Explanation

HIPAA permits disclosures for treatment, payment, and health care operations without a separate patient authorization, subject to the applicable requirements. Other permitted or required disclosure pathways also exist.

Question 7Federal pharmacy law and regulated products

How often must a pharmacy conduct an inventory of Schedule II controlled substances according to DEA regulations?

  1. Monthly
  2. Quarterly
  3. Biennially (every 2 years) Correct answer.
  4. Annually

Explanation

DEA regulations require a complete inventory of all controlled substances (Schedules II-V) at least every two years (biennially). The initial inventory must be taken on the date the registrant first engages in the activity.

Question 8Federal pharmacy law and regulated products

A pharmacist discovers a significant loss of Schedule II controlled substances. Which DEA form must be filed?

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

Explanation

DEA Form 106 (Report of Theft or Significant Loss of Controlled Substances) must be filed when a pharmacy discovers a significant loss or theft of controlled substances.

Question 9Federal pharmacy law and regulated products

Under CMEA, what is the maximum pseudoephedrine-base amount a retail seller may sell to a purchaser in one day?

  1. 1.8 grams
  2. 3.6 grams Correct answer.
  3. 7.5 grams
  4. 9 grams

Explanation

The federal retail daily sales limit for scheduled listed chemical products is 3.6 grams of pseudoephedrine base to a purchaser. The separate retail thirty-day purchase limit is 9 grams; mail-order provisions differ.

Question 10Federal pharmacy law and regulated products

Under the Kefauver-Harris Amendment of 1962, drug manufacturers must prove which of the following before marketing a new drug?

  1. Cost-effectiveness compared to existing treatments
  2. Safety and efficacy Correct answer.
  3. Superiority over existing drugs
  4. Bioequivalence to all existing formulations

Explanation

The Kefauver-Harris Amendment (Drug Efficacy Amendment) of 1962 requires that drug manufacturers prove both safety and efficacy of drugs before they can be marketed, adding the efficacy requirement to the existing safety requirement.

Question 11Federal pharmacy law and regulated products

Which FDA drug recall classification indicates that use of the product may cause serious adverse health consequences or death?

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

Explanation

FDA Class I recalls involve products where there is a reasonable probability that the use of or exposure to the product will cause serious adverse health consequences or death.

Question 12Federal pharmacy law and regulated products

Under federal law, how long must records for Schedule II controlled substances be maintained?

  1. 1 year
  2. 2 years Correct answer.
  3. 3 years
  4. 5 years

Explanation

Federal DEA regulations require that all controlled substance records (Schedules II-V) be maintained for a minimum of 2 years from the date of the transaction. States may require longer retention periods.

Question 13Federal pharmacy law and regulated products

Which federal agency oversees the 340B Drug Pricing Program?

  1. DEA
  2. CMS
  3. HRSA Correct answer.
  4. FDA

Explanation

The Health Resources and Services Administration (HRSA) oversees the 340B Drug Pricing Program, which requires drug manufacturers participating in Medicaid to provide outpatient drugs at reduced prices to eligible healthcare organizations.

Question 14Federal pharmacy law and regulated products

Under the Controlled Substances Act, which of the following is classified as a Schedule IV substance?

  1. Hydrocodone
  2. Alprazolam Correct answer.
  3. Codeine cough syrup
  4. Testosterone

Explanation

Alprazolam is federally classified in Schedule IV. Hydrocodone is Schedule II, testosterone is Schedule III, and qualifying low-concentration codeine combination cough preparations may be Schedule V.

Question 15Federal pharmacy law and regulated products

What is the maximum valid period for a non-controlled legend drug prescription under federal law?

  1. 6 months
  2. 1 year
  3. No federal time limit exists Correct answer.
  4. 2 years

Explanation

There is no generally applicable federal maximum age for filling a noncontrolled legend prescription. Applicable District law, professional judgment, and program-specific requirements still must be evaluated; another state's rules are not District authority.

Question 16Federal pharmacy law and regulated products

Under the FDA's Orange Book, what does an 'AB' rating indicate about a generic drug?

  1. The drug is not bioequivalent to the brand
  2. The drug is therapeutically equivalent and bioequivalent to the reference product Correct answer.
  3. The drug requires additional clinical studies
  4. The drug is approved but with restrictions

Explanation

An 'AB' rating in the FDA's Orange Book (Approved Drug Products with Therapeutic Equivalence Evaluations) indicates that the generic drug is therapeutically equivalent and bioequivalent to the reference listed drug.

Question 17Federal pharmacy law and regulated products

Under federal law, an emergency oral Schedule II prescription must be followed by a written prescription within how many days?

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

Explanation

Under 21 CFR 1306.11(d), the prescriber must cause the required follow-up written prescription to be delivered within seven days. The rule addresses paper delivery and compliant electronic records; an ordinary fax is not a universal substitute.

Question 18Federal pharmacy law and regulated products

The Hatch-Waxman Act of 1984 primarily facilitated the approval of which type of drugs?

  1. Orphan drugs
  2. Generic drugs through ANDAs Correct answer.
  3. Biological products
  4. Over-the-counter drugs

Explanation

The Drug Price Competition and Patent Term Restoration Act (Hatch-Waxman Act) established the Abbreviated New Drug Application (ANDA) process, allowing generic drugs to gain FDA approval by demonstrating bioequivalence to a reference listed drug without repeating costly clinical trials.

Question 19Federal pharmacy law and regulated products

Under the DEA Controlled Substance Disposal Regulations, which method is NOT an authorized method for a pharmacy to dispose of controlled substances?

  1. Reverse distribution to a DEA-registered reverse distributor
  2. Collection receptacle for patient take-back
  3. Flushing all controlled substances down the drain Correct answer.
  4. Transfer to law enforcement through an authorized program

Explanation

Flushing all controlled drugs is not an authorized blanket pharmacy disposal method. Distinguish registrant stock destruction or reverse distribution from authorized collection of ultimate-user drugs; a patient collection receptacle is not a means to dispose of ordinary pharmacy inventory.

Question 20Federal pharmacy law and regulated products

Which USP chapter governs non-sterile compounding standards?

  1. USP <795> Correct answer.
  2. USP <797>
  3. USP <800>
  4. USP <825>

Explanation

USP <795> establishes standards for non-sterile compounding. USP <797> addresses sterile compounding, USP <800> covers hazardous drug handling, and USP <825> addresses radiopharmaceuticals.

Question 21Federal pharmacy law and regulated products

Under HIPAA, patients have the right to request an accounting of disclosures of their PHI for the preceding how many years?

  1. 2 years
  2. 4 years
  3. 6 years Correct answer.
  4. 10 years

Explanation

HIPAA provides a six-year accounting period for the disclosures subject to that right. Many treatment, payment, and health care operations disclosures and other specified disclosures are excluded; an accounting is distinct from access to the medical record.

Question 22Federal pharmacy law and regulated products

The FDA MedWatch program is primarily used for which purpose?

  1. Drug pricing transparency
  2. Voluntary adverse event reporting by healthcare professionals Correct answer.
  3. Pharmacy license verification
  4. Controlled substance scheduling recommendations

Explanation

FDA MedWatch is the FDA's safety information and adverse event reporting program. It allows healthcare professionals and consumers to voluntarily report serious adverse events, product quality problems, and medication errors.

Question 23Federal pharmacy law and regulated products

Under federal law, which schedule of controlled substances may be prescribed by a mid-level practitioner with prescriptive authority?

  1. Schedule II-V only if granted by state law Correct answer.
  2. Schedule III-V only
  3. Schedule IV-V only
  4. No controlled substances

Explanation

Federal controlled-substance prescribing depends on authority under the practitioner's applicable jurisdiction and appropriate DEA registration or another applicable registration provision. The permitted schedules must match that actual authority rather than the professional title alone.

Question 24Federal pharmacy law and regulated products

Which federal law established the requirement for a Risk Evaluation and Mitigation Strategy (REMS) for certain medications?

  1. Dietary Supplement Health and Education Act
  2. FDA Amendments Act of 2007 Correct answer.
  3. Drug Quality and Security Act of 2013
  4. Affordable Care Act of 2010

Explanation

The FDA Amendments Act (FDAAA) of 2007 gave the FDA authority to require Risk Evaluation and Mitigation Strategies (REMS) for medications with serious safety concerns to ensure benefits outweigh risks.

Question 25Federal pharmacy law and regulated products

Under the Federal Anti-Kickback Statute, which of the following is prohibited?

  1. Providing free drug samples to prescribers
  2. Offering remuneration to induce referrals for services covered by federal healthcare programs Correct answer.
  3. Discounting drugs for uninsured patients
  4. Providing medication therapy management services

Explanation

The federal Anti-Kickback Statute addresses knowing and willful offers, payments, solicitations, or receipts of remuneration to induce or reward federally reimbursable referrals or business. Statutory exceptions and regulatory safe harbors require separate analysis.

Question 26Federal pharmacy law and regulated products

For a routine nonemergency outpatient Schedule II prescription outside any special fax exception, which form of prescriber authorization is appropriate?

  1. Verbal order from the prescriber only
  2. Written or electronic prescription signed by the prescriber Correct answer.
  3. Faxed prescription without an original signature
  4. Any form of communication from the prescriber

Explanation

A routine nonemergency outpatient Schedule II prescription uses a properly signed paper prescription or a compliant electronic prescription under 21 CFR Part 1311. CSOS is a stock-ordering system, not the EPCS prescription system.

Question 27Federal pharmacy law and regulated products

The Dietary Supplement Health and Education Act (DSHEA) of 1994 classifies dietary supplements as which category?

  1. Prescription drugs
  2. Over-the-counter drugs
  3. Food products Correct answer.
  4. Medical devices

Explanation

DSHEA classifies dietary supplements as a category of food, not drugs. This means dietary supplements do not require FDA pre-market approval for safety and efficacy, though they cannot make disease claims.

Question 28Federal pharmacy law and regulated products

Which method, used outside a DEA-compliant EPCS system, is not a valid ordinary route for transmitting a Schedule III-V prescription?

  1. Written prescription
  2. Oral (telephone) prescription
  3. Faxed prescription
  4. Text message to the pharmacy Correct answer.

Explanation

Ordinary text messaging outside a compliant EPCS system does not satisfy controlled-prescription electronic security requirements. Lawful written, oral, fax, or EPCS routes depend on the schedule and applicable conditions.

Question 29Federal pharmacy law and regulated products

What is the primary purpose of the Drug Quality and Security Act (DQSA) of 2013?

  1. Regulate compounding pharmacies and enhance drug supply chain security Correct answer.
  2. Establish new controlled substance schedules
  3. Create Medicare Part D prescription drug benefit
  4. Mandate electronic prescribing nationwide

Explanation

The DQSA includes two titles: Title I (Compounding Quality Act) addresses oversight of compounding pharmacies and outsourcing facilities (503B), and Title II (DSCSA) establishes drug supply chain security requirements.

Question 30District pharmacy authority and statutory safeguards

Under the current DC Code, which body appoints members of the District Board of Pharmacy?

  1. The DEA Administrator
  2. The Alabama Board of Pharmacy
  3. The National Association of Boards of Pharmacy
  4. The Mayor Correct answer.

Explanation

Section 3-1202.08 establishes the District Board and provides for appointment of its members by the Mayor, not a federal or foreign-state regulator.

Question 31District pharmacy authority and statutory safeguards

After the membership change effective July 19, 2024, which composition matches the DC Board of Pharmacy?

  1. Five DC-licensed pharmacists, one registered pharmacy technician, and one consumer Correct answer.
  2. Five pharmacists and two consumer members
  3. Three pharmacists, three technicians, and one consumer
  4. Four pharmacists, two physicians, and one technician

Explanation

The current statutory composition includes a registered pharmacy technician and one consumer member; the earlier two-consumer description is no longer the applicable composition.

Question 32District pharmacy authority and statutory safeguards

Which additional practices are expressly regulated by the DC Board of Pharmacy alongside pharmacy practice?

  1. Dental hygiene and medical radiography
  2. Nursing home administration and optometry
  3. Pharmaceutical detailing and pharmacy technician practice Correct answer.
  4. Physician surgery and hospital architecture

Explanation

The Board provision expressly covers pharmacy, pharmaceutical detailing, and pharmacy technicians. Other professional boards have distinct health-occupation responsibilities.

Question 33District pharmacy authority and statutory safeguards

A DC pharmacist holds a general pharmacy license but has not obtained Board certification for immunization. What does § 3-1202.08(f) establish?

  1. Board certification is a condition of the pharmacist immunization authority in that subsection Correct answer.
  2. The general license alone satisfies that subsection
  3. A wholesaler may substitute its approval for Board certification
  4. The requirement concerns only pharmacy technicians

Explanation

The subsection conditions pharmacist immunization and vaccination on Board certification. Other applicable federal authority must be evaluated separately rather than assumed from the general license.

Question 34District pharmacy authority and statutory safeguards

Which legal structure permits a DC pharmacist to initiate, modify, or discontinue a drug therapy regimen under § 3-1202.08(h)?

  1. An informal promise made by a drug wholesaler
  2. A patient insurance card without a collaborative agreement
  3. An applicable collaborative practice agreement with an authorized practitioner Correct answer.
  4. An unrestricted right arising from inventory ownership

Explanation

The statute permits these activities pursuant to a collaborative practice agreement. It does not turn a pharmacy license into unrestricted independent prescribing authority.

Question 35District pharmacy authority and statutory safeguards

A proposed DC collaborative practice agreement lists only the names of its signatories. Which missing element is specifically required by § 3-1202.08(h)?

  1. The wholesaler discount on every drug
  2. A guarantee that no monitoring will be needed
  3. The patient employer payroll number
  4. The drug therapy and any tests necessarily incident to its provision Correct answer.

Explanation

The statute requires specification of the therapy and related tests, together with conditions for initiating, changing, or stopping treatment and monitoring directions.

Question 36District pharmacy authority and statutory safeguards

A DC collaborative protocol permits a dose adjustment but says nothing about follow-up or triggers for changing treatment. Which statutory subject is missing?

  1. A promise to refill without any patient assessment
  2. A commitment to use one manufacturer permanently
  3. A declaration that the pharmacist may disregard prescriber scope
  4. Directions for monitoring and conditions warranting modification Correct answer.

Explanation

Monitoring directions, including conditions warranting changes to dose, regimen, or dosage form, are specifically included in the statutory collaborative-practice requirements.

Question 37District pharmacy authority and statutory safeguards

Which statement correctly separates a DC collaborative agreement from a pharmacist self-administered hormonal contraceptive protocol?

  1. A contraceptive protocol automatically authorizes every drug regimen
  2. Neither pathway requires any professional authorization
  3. They are distinct statutory pathways with their own conditions Correct answer.
  4. Any collaborative agreement eliminates contraceptive certification requirements

Explanation

The statute separately addresses collaborative practice and Board-certified contraceptive prescribing. Authority under one provision does not erase the other provision's specific conditions.

Question 38District pharmacy authority and statutory safeguards

Under § 3-1202.08(g-1), the pharmacist hormonal contraceptive pathway is linked to which authorization?

  1. A verbal instruction from a pharmaceutical detailer
  2. An unrelated Alabama pharmacist license
  3. Board certification and a written protocol established by the Boards of Pharmacy and Medicine Correct answer.
  4. An automatic privilege of every retail employee

Explanation

The DC provision links the authority to Board certification and the jointly established written protocol, rather than an unrestricted retail-pharmacy privilege.

Question 39District pharmacy authority and statutory safeguards

Which maximum supply is expressly identified in the DC pharmacist self-administered hormonal contraceptive provision, subject to its protocol and screening conditions?

  1. An unlimited lifetime quantity
  2. Up to a 12-month supply Correct answer.
  3. Only one dose per calendar year
  4. Exactly a 72-hour supply

Explanation

The statute permits up to twelve months under its specified safeguards. That ceiling is not a direction to give every patient that quantity regardless of screening.

Question 40District pharmacy authority and statutory safeguards

Before dispensing under the DC pharmacist hormonal contraceptive pathway, which assessment tool does the statute require?

  1. The Boards' patient self-screening tool identifying relevant risk factors Correct answer.
  2. A pregnancy assumption based only on patient appearance
  3. A generic shopping-satisfaction survey
  4. An employer productivity ranking

Explanation

The statutory protocol includes a self-screening tool based on current CDC medical eligibility criteria, allowing relevant risk factors to inform safe dispensing.

Question 41District pharmacy authority and statutory safeguards

Which counseling point is specifically required when a DC pharmacist prescribes and dispenses a self-administered hormonal contraceptive under the statutory pathway?

  1. It has no possible adverse effects
  2. It makes confidential counseling unnecessary
  3. It replaces all recommended preventive health screening
  4. It does not protect against sexually transmitted infections Correct answer.

Explanation

The statute requires confidential product counseling, including safety, side effects, preventive screening, and the absence of protection against sexually transmitted infections.

Question 42District pharmacy authority and statutory safeguards

A patient has no primary or reproductive health provider when receiving pharmacist-prescribed hormonal contraception in DC. What referral destination does § 3-1202.08(g-1) identify?

  1. A nearby clinic Correct answer.
  2. Only the drug manufacturer's sales representative
  3. No referral because the patient lacks a provider
  4. The patient's employer as the clinical decision maker

Explanation

The statute requires referral to the patient's provider or, when none exists, a nearby clinic. Lack of an established provider does not remove the referral safeguard.

Question 43District pharmacy authority and statutory safeguards

Which public information must a DC pharmacy display under the pharmacist contraceptive provision?

  1. A list of patients who requested contraception
  2. Only the retail price of unrelated nonprescription products
  3. Every patient's completed screening questionnaire
  4. The times a certified pharmacist is available, in stores and online Correct answer.

Explanation

The pharmacy must display certified-pharmacist availability in stores and online. Patient identities and screening responses are confidential rather than public notices.

Question 44District pharmacy authority and statutory safeguards

A certified pharmacist finds hormonal contraception is not recommended after the statutory screening. Which response matches the DC provision?

  1. Dispense automatically because certification overrides screening
  2. Publish the patient's screening result in the availability notice
  3. Ask a technician to overrule the risk assessment
  4. Refer the patient to an appropriate primary or reproductive health provider or nearby clinic Correct answer.

Explanation

The referral obligation also applies when use is not recommended. Certification permits practice within the protocol, not disregard of the screening result.

Question 45District pharmacy authority and statutory safeguards

A DC patient specifically requests the prescribed brand instead of a proposed substitute. Under § 48-803.03(1), what is the substitution consequence?

  1. The pharmacist must substitute regardless of preference
  2. The pharmacist must not dispense the substitute against that preference Correct answer.
  3. The patient loses the right to receive any lawful prescription
  4. The manufacturer, rather than the patient, decides preference

Explanation

The statute bars substitution when the purchaser or intended patient indicates a preference for the prescribed product. Cost-saving authority does not erase that choice.

Question 46District pharmacy authority and statutory safeguards

A prescriber has personally handwritten and signed a valid DAW instruction on a DC prescription. What does § 48-803.03 provide?

  1. A purchaser request automatically overrides the signed instruction
  2. The pharmacy may treat the instruction as advertising only
  3. The pharmacist must not make the prohibited generic substitution Correct answer.
  4. DAW applies only to the color of the container

Explanation

A qualifying prescriber instruction is a statutory restriction on generic substitution. Purchaser preference cannot simply nullify that prescriber restriction.

Question 47District pharmacy authority and statutory safeguards

Under the specific paper-prescription wording in DC § 48-803.03(2)(A), which notation is expressly insufficient by itself?

  1. A prescriber's own handwritten and signed DAW notation
  2. Checking or initialing a preprinted or stamped DAW box Correct answer.
  3. A qualifying personally handwritten dispense-as-written instruction
  4. A similar qualifying notation personally handwritten by the prescriber

Explanation

The subsection expressly distinguishes personal handwritten notation from merely checking or initialing a preprinted or stamped box. This question concerns that specific statutory wording.

Question 48District pharmacy authority and statutory safeguards

A prescriber telephones a DC pharmacy and expressly prohibits substitution. What does the substitution statute require regarding that instruction?

  1. The pharmacist records the indication in the required handwritten manner Correct answer.
  2. The patient must recreate the prescriber's signature
  3. The instruction may be discarded because it was spoken
  4. Only the wholesaler may record the instruction

Explanation

The telephone route is expressly recognized when the prescriber's indication is recorded by the pharmacist as the statute specifies, rather than ignored.

Question 49District pharmacy authority and statutory safeguards

For a permissible generic substitution in DC, three equivalent products are in stock at purchaser costs of $8, $11, and $16. Which cost rule applies?

  1. Choose the $11 product because it is the median price
  2. Dispense the qualifying product costing the purchaser $8 Correct answer.
  3. Any higher-cost product is required if the wholesaler prefers it
  4. Dispense the $16 product because retail margin controls

Explanation

When making the substitution, § 48-803.02 requires the qualifying in-stock equivalent with the lowest cost to the purchaser, not the greatest pharmacy margin.

Question 50District pharmacy authority and statutory safeguards

A DC prescription uses the generic name and qualifying listed products are available in stock. Which pricing comparison does § 48-803.02(b) require?

  1. Only the pharmacy acquisition cost
  2. Only the manufacturer's advertised list price
  3. Cost to the person purchasing the product Correct answer.
  4. Only the gross margin percentage

Explanation

The statute directs selection of the listed product in stock having the lowest purchaser cost. Acquisition price and margin are different economic measures.