PTCB - Pharmacy Laws Questions and
Answers | Latest Version | 2025/2026 |
Correct & Verified
Which law requires that prescription drugs must include adequate directions for use and safety
warnings?
✔✔ Food, Drug, and Cosmetic Act of 1938.
Which law created the five schedules of controlled substances?
✔✔ Controlled Substances Act of 1970.
Which federal agency regulates the safety of medications in the U.S.?
✔✔ Food and Drug Administration (FDA).
Which federal agency enforces the Controlled Substances Act?
✔✔ Drug Enforcement Administration (DEA).
Which law established child-resistant packaging to prevent accidental poisonings?
✔✔ Poison Prevention Packaging Act of 1970.
1
,Which law requires that pharmacists provide counseling to Medicaid patients about their
prescriptions?
✔✔ OBRA-90 (Omnibus Budget Reconciliation Act of 1990).
Which law prohibited the interstate commerce of adulterated or misbranded drugs?
✔✔ Pure Food and Drug Act of 1906.
Which law requires manufacturers to prove drug safety before marketing?
✔✔ Food, Drug, and Cosmetic Act of 1938.
Which law requires proof of both safety and effectiveness of drugs before approval?
✔✔ Kefauver-Harris Amendment of 1962.
Which law created the DEA and placed controlled substances into schedules?
✔✔ Comprehensive Drug Abuse Prevention and Control Act of 1970.
Which law requires each medication to have a unique National Drug Code (NDC)?
2
, ✔✔ Drug Listing Act of 1972.
Which law mandates that drugs affecting the central nervous system carry a black box warning
when necessary?
✔✔ Kefauver-Harris Amendment of 1962.
Which law created the requirement for tamper-resistant packaging on OTC products?
✔✔ Federal Anti-Tampering Act of 1983.
Which law allowed pharmacists to substitute lower-cost generic drugs when appropriate?
✔✔ Drug Price Competition and Patent Term Restoration Act of 1984 (Hatch-Waxman Act).
Which law requires electronic tracking and tracing of prescription drugs in the supply chain?
✔✔ Drug Supply Chain Security Act of 2013.
Which law allows the FDA to expedite the approval of drugs for serious or life-threatening
conditions?
✔✔ FDA Modernization Act of 1997.
3
Answers | Latest Version | 2025/2026 |
Correct & Verified
Which law requires that prescription drugs must include adequate directions for use and safety
warnings?
✔✔ Food, Drug, and Cosmetic Act of 1938.
Which law created the five schedules of controlled substances?
✔✔ Controlled Substances Act of 1970.
Which federal agency regulates the safety of medications in the U.S.?
✔✔ Food and Drug Administration (FDA).
Which federal agency enforces the Controlled Substances Act?
✔✔ Drug Enforcement Administration (DEA).
Which law established child-resistant packaging to prevent accidental poisonings?
✔✔ Poison Prevention Packaging Act of 1970.
1
,Which law requires that pharmacists provide counseling to Medicaid patients about their
prescriptions?
✔✔ OBRA-90 (Omnibus Budget Reconciliation Act of 1990).
Which law prohibited the interstate commerce of adulterated or misbranded drugs?
✔✔ Pure Food and Drug Act of 1906.
Which law requires manufacturers to prove drug safety before marketing?
✔✔ Food, Drug, and Cosmetic Act of 1938.
Which law requires proof of both safety and effectiveness of drugs before approval?
✔✔ Kefauver-Harris Amendment of 1962.
Which law created the DEA and placed controlled substances into schedules?
✔✔ Comprehensive Drug Abuse Prevention and Control Act of 1970.
Which law requires each medication to have a unique National Drug Code (NDC)?
2
, ✔✔ Drug Listing Act of 1972.
Which law mandates that drugs affecting the central nervous system carry a black box warning
when necessary?
✔✔ Kefauver-Harris Amendment of 1962.
Which law created the requirement for tamper-resistant packaging on OTC products?
✔✔ Federal Anti-Tampering Act of 1983.
Which law allowed pharmacists to substitute lower-cost generic drugs when appropriate?
✔✔ Drug Price Competition and Patent Term Restoration Act of 1984 (Hatch-Waxman Act).
Which law requires electronic tracking and tracing of prescription drugs in the supply chain?
✔✔ Drug Supply Chain Security Act of 2013.
Which law allows the FDA to expedite the approval of drugs for serious or life-threatening
conditions?
✔✔ FDA Modernization Act of 1997.
3
