Pharmacy Law MPJE Exam: Federal
Law Questions and Answers | Latest
Version | 2025/2026 | Correct & Verified
What federal act requires FDA-approved labeling for medications?
✔✔The Federal Food, Drug, and Cosmetic Act.
What does REMS stand for in federal pharmacy law?
✔✔Risk Evaluation and Mitigation Strategies.
What is the purpose of REMS programs?
✔✔To ensure that the benefits of certain drugs outweigh their risks.
Which federal law governs Medicare and Medicaid fraud?
✔✔The False Claims Act.
What is the purpose of the Combat Methamphetamine Epidemic Act (CMEA)?
✔✔To regulate sale and purchase of pseudoephedrine, ephedrine, and phenylpropanolamine.
What federal requirement exists for patient counseling on new prescriptions?
✔✔The Omnibus Budget Reconciliation Act (OBRA ’90) requires pharmacists to offer
counseling.
1
,Which federal law requires reporting adverse drug events?
✔✔The FDA Adverse Event Reporting System (FAERS) under the FDA Amendments Act.
What is required on the label of a prescription drug under federal law?
✔✔Drug name, strength, quantity, directions, prescriber, pharmacy, and expiration date.
What is the primary purpose of the Federal Food, Drug, and Cosmetic Act?
✔✔To ensure drugs, medical devices, and cosmetics are safe, effective, and properly labeled.
Which federal agency enforces the Food, Drug, and Cosmetic Act?
✔✔The U.S. Food and Drug Administration (FDA).
What law regulates controlled substances at the federal level?
✔✔The Controlled Substances Act (CSA).
Which agency administers the Controlled Substances Act?
✔✔The Drug Enforcement Administration (DEA).
What schedule of drugs has no accepted medical use in the U.S.?
✔✔Schedule I.
Which schedule of drugs has the highest potential for abuse with accepted medical use?
2
,✔✔Schedule II.
What is the DEA number used for?
✔✔To uniquely identify prescribers and registrants handling controlled substances.
What federal requirement exists for recordkeeping of Schedule II prescriptions?
✔✔Records must be kept separately and maintained for at least two years.
Can Schedule II prescriptions be refilled?
✔✔No, they cannot be refilled; a new prescription is required for each fill.
What is the maximum number of refills allowed for Schedule III-V drugs under federal law?
✔✔Up to five refills within six months.
How must controlled substances be stored according to federal regulations?
✔✔In a securely locked, substantially constructed cabinet or dispersed throughout the inventory
to deter theft.
What must pharmacies do before destroying controlled substances?
✔✔Use a DEA-approved method and document destruction with witness signatures.
Who is responsible for reporting controlled substance thefts or significant loss?
3
, ✔✔The registrant to the DEA using DEA Form 106.
What federal law regulates electronic prescribing of controlled substances?
✔✔The DEA’s Electronic Prescriptions for Controlled Substances (EPCS) rules.
Can Schedule II prescriptions be transmitted electronically?
✔✔Yes, if the prescriber and pharmacy comply with DEA EPCS requirements.
What is the main purpose of DEA Form 222?
✔✔Ordering Schedule I and II controlled substances from a supplier.
What is the maximum quantity of controlled substances that can be ordered with a single DEA
Form 222?
✔✔Limited by the form; each line specifies a quantity for a specific drug.
What is required for a prescriber to administer controlled substances in the hospital?
✔✔A DEA registration for hospital use or authorization under hospital protocols.
What does the Poison Prevention Packaging Act require?
✔✔Child-resistant packaging for most prescription and many over-the-counter drugs.
What agency enforces the Poison Prevention Packaging Act?
4
Law Questions and Answers | Latest
Version | 2025/2026 | Correct & Verified
What federal act requires FDA-approved labeling for medications?
✔✔The Federal Food, Drug, and Cosmetic Act.
What does REMS stand for in federal pharmacy law?
✔✔Risk Evaluation and Mitigation Strategies.
What is the purpose of REMS programs?
✔✔To ensure that the benefits of certain drugs outweigh their risks.
Which federal law governs Medicare and Medicaid fraud?
✔✔The False Claims Act.
What is the purpose of the Combat Methamphetamine Epidemic Act (CMEA)?
✔✔To regulate sale and purchase of pseudoephedrine, ephedrine, and phenylpropanolamine.
What federal requirement exists for patient counseling on new prescriptions?
✔✔The Omnibus Budget Reconciliation Act (OBRA ’90) requires pharmacists to offer
counseling.
1
,Which federal law requires reporting adverse drug events?
✔✔The FDA Adverse Event Reporting System (FAERS) under the FDA Amendments Act.
What is required on the label of a prescription drug under federal law?
✔✔Drug name, strength, quantity, directions, prescriber, pharmacy, and expiration date.
What is the primary purpose of the Federal Food, Drug, and Cosmetic Act?
✔✔To ensure drugs, medical devices, and cosmetics are safe, effective, and properly labeled.
Which federal agency enforces the Food, Drug, and Cosmetic Act?
✔✔The U.S. Food and Drug Administration (FDA).
What law regulates controlled substances at the federal level?
✔✔The Controlled Substances Act (CSA).
Which agency administers the Controlled Substances Act?
✔✔The Drug Enforcement Administration (DEA).
What schedule of drugs has no accepted medical use in the U.S.?
✔✔Schedule I.
Which schedule of drugs has the highest potential for abuse with accepted medical use?
2
,✔✔Schedule II.
What is the DEA number used for?
✔✔To uniquely identify prescribers and registrants handling controlled substances.
What federal requirement exists for recordkeeping of Schedule II prescriptions?
✔✔Records must be kept separately and maintained for at least two years.
Can Schedule II prescriptions be refilled?
✔✔No, they cannot be refilled; a new prescription is required for each fill.
What is the maximum number of refills allowed for Schedule III-V drugs under federal law?
✔✔Up to five refills within six months.
How must controlled substances be stored according to federal regulations?
✔✔In a securely locked, substantially constructed cabinet or dispersed throughout the inventory
to deter theft.
What must pharmacies do before destroying controlled substances?
✔✔Use a DEA-approved method and document destruction with witness signatures.
Who is responsible for reporting controlled substance thefts or significant loss?
3
, ✔✔The registrant to the DEA using DEA Form 106.
What federal law regulates electronic prescribing of controlled substances?
✔✔The DEA’s Electronic Prescriptions for Controlled Substances (EPCS) rules.
Can Schedule II prescriptions be transmitted electronically?
✔✔Yes, if the prescriber and pharmacy comply with DEA EPCS requirements.
What is the main purpose of DEA Form 222?
✔✔Ordering Schedule I and II controlled substances from a supplier.
What is the maximum quantity of controlled substances that can be ordered with a single DEA
Form 222?
✔✔Limited by the form; each line specifies a quantity for a specific drug.
What is required for a prescriber to administer controlled substances in the hospital?
✔✔A DEA registration for hospital use or authorization under hospital protocols.
What does the Poison Prevention Packaging Act require?
✔✔Child-resistant packaging for most prescription and many over-the-counter drugs.
What agency enforces the Poison Prevention Packaging Act?
4
