PTCB Laws and Regulations Study Guide | Federal &
State Pharmacy Law Review PDF|Questions And
Answers||2026/2027
Pure Food and Drug Act - ANSWER-prohibited the
interstate distribution or sale of adulterated or misbranded
food or drugs.
Food, Drug, and Cosmetic Act - ANSWER-required all
drug manufacturers to file a New Drug Application (NDA)
with the FDA before any drug could be approved or
disapproved for the market. The manufacturers also had to
, ensure the purity, safety, packaging, and strength of a
medication.
Durham-Humphrey Amendment - ANSWER-separated
drugs into 2 categories: legend and nonlegend
(prescription and non prescription). required all legend
drugs to have a prescription. also allowed verbal
prescriptions to be taken over the phone and refills to be
called in from a physician's office.
Kefauver-Harris Amendment - ANSWER-required that all
medications, both prescription and nonprescription, be
pure, effective, and safe to use on humans. Also placed
prescription drug advertising under the supervision of the
FDA.
State Pharmacy Law Review PDF|Questions And
Answers||2026/2027
Pure Food and Drug Act - ANSWER-prohibited the
interstate distribution or sale of adulterated or misbranded
food or drugs.
Food, Drug, and Cosmetic Act - ANSWER-required all
drug manufacturers to file a New Drug Application (NDA)
with the FDA before any drug could be approved or
disapproved for the market. The manufacturers also had to
, ensure the purity, safety, packaging, and strength of a
medication.
Durham-Humphrey Amendment - ANSWER-separated
drugs into 2 categories: legend and nonlegend
(prescription and non prescription). required all legend
drugs to have a prescription. also allowed verbal
prescriptions to be taken over the phone and refills to be
called in from a physician's office.
Kefauver-Harris Amendment - ANSWER-required that all
medications, both prescription and nonprescription, be
pure, effective, and safe to use on humans. Also placed
prescription drug advertising under the supervision of the
FDA.
