PTCB Pharmacy Law & Regulations
Questions and Answers | Latest
Version | 2025/2026 | Correct & Verified
What is the role of the FDA in generic drug approval?
✔✔ To ensure bioequivalence, safety, and effectiveness.
Which law requires tamper-evident packaging for certain OTC medications?
✔✔ Federal Anti-Tampering Act.
Which schedule of drugs requires a written prescription with no refills?
✔✔ Schedule II.
Which law governs the safe disposal of unused controlled substances by pharmacies?
✔✔ DEA regulations under the Controlled Substances Act.
Which documentation is required for a partial fill of a Schedule II prescription?
✔✔ Quantity dispensed, date, and remaining quantity authorized by prescriber.
1
,Which law mandates that all compounding pharmacies meet USP standards?
✔✔ Drug Quality and Security Act (DQSA).
Which agency monitors medication safety after a drug is marketed?
✔✔ FDA.
Which law requires that patients are provided with medication guides when certain drugs are
dispensed?
✔✔ FDA Risk Evaluation and Mitigation Strategy (REMS).
What is required for a pharmacy to accept electronic prescriptions for controlled substances?
✔✔ DEA-compliant electronic prescribing system.
Which law provides the federal framework for pharmacy practice standards and labeling?
✔✔ Federal Food, Drug, and Cosmetic Act.
Which schedule includes cough preparations with small amounts of codeine?
✔✔ Schedule V.
2
, Which federal law allows state boards to enforce professional pharmacy practice rules?
✔✔ State pharmacy practice acts (enabling acts).
Which documentation is required when a Schedule III-V prescription is transferred between
pharmacies?
✔✔ Name of pharmacist transferring and receiving, date, prescription number, and refills
remaining.
What federal law regulates the manufacture and distribution of controlled substances?
✔✔ Controlled Substances Act (CSA).
Which agency enforces the Controlled Substances Act?
✔✔ Drug Enforcement Administration (DEA).
What is required on a prescription for a Schedule II drug?
✔✔ Patient information, prescriber DEA number, drug name, strength, quantity, directions, date,
and prescriber signature.
3
Questions and Answers | Latest
Version | 2025/2026 | Correct & Verified
What is the role of the FDA in generic drug approval?
✔✔ To ensure bioequivalence, safety, and effectiveness.
Which law requires tamper-evident packaging for certain OTC medications?
✔✔ Federal Anti-Tampering Act.
Which schedule of drugs requires a written prescription with no refills?
✔✔ Schedule II.
Which law governs the safe disposal of unused controlled substances by pharmacies?
✔✔ DEA regulations under the Controlled Substances Act.
Which documentation is required for a partial fill of a Schedule II prescription?
✔✔ Quantity dispensed, date, and remaining quantity authorized by prescriber.
1
,Which law mandates that all compounding pharmacies meet USP standards?
✔✔ Drug Quality and Security Act (DQSA).
Which agency monitors medication safety after a drug is marketed?
✔✔ FDA.
Which law requires that patients are provided with medication guides when certain drugs are
dispensed?
✔✔ FDA Risk Evaluation and Mitigation Strategy (REMS).
What is required for a pharmacy to accept electronic prescriptions for controlled substances?
✔✔ DEA-compliant electronic prescribing system.
Which law provides the federal framework for pharmacy practice standards and labeling?
✔✔ Federal Food, Drug, and Cosmetic Act.
Which schedule includes cough preparations with small amounts of codeine?
✔✔ Schedule V.
2
, Which federal law allows state boards to enforce professional pharmacy practice rules?
✔✔ State pharmacy practice acts (enabling acts).
Which documentation is required when a Schedule III-V prescription is transferred between
pharmacies?
✔✔ Name of pharmacist transferring and receiving, date, prescription number, and refills
remaining.
What federal law regulates the manufacture and distribution of controlled substances?
✔✔ Controlled Substances Act (CSA).
Which agency enforces the Controlled Substances Act?
✔✔ Drug Enforcement Administration (DEA).
What is required on a prescription for a Schedule II drug?
✔✔ Patient information, prescriber DEA number, drug name, strength, quantity, directions, date,
and prescriber signature.
3
