PTCB Pharmacy Law Test with all Correct & 100% Verified
Answers |Latest Version |Already Graded A+
FDA ✔Correct Answer-label requirements for use of OTC products prohibits adulterated or
misbranded drugs, enforces safety and effectiveness of food, medication, biological products,
cosmetics, and radioactive substances
NDA ✔Correct Answer-application for new drug must be filed with FDA before being
commercially available
Durham-Humphrey Amendment ✔Correct Answer-aka Prescription Drug Amendment,
separates drugs into legend or non-legend
Kefauver-Harris Amendment ✔Correct Answer-label requirements for manufacturers and
dispenser to patients
requires manufacturer to register, be inspected, report drug rxns
PPIs ✔Correct Answer-patient package inserts (for oral contraceptives, inhalers, etc) must
include: indications for use, contraindications, warnings, precaution, dose
Occupational and Safety Act 1970 ✔Correct Answer-reduced hazards in workplace, rise to
OSHA (occupational safety and health administration) all pharmacies need to:
-post poison control number
-reference guide for toxicities
-MSDS
Poison Prevention Packaging Act ✔Correct Answer-pharmacies must use child resistant
resistant containers
Drug Listing Act ✔Correct Answer-assigns unique and permanent drug code to each
medication
Federal Hazardous Substance Act ✔Correct Answer-involves use and disposal of hazardous
material in pharmacy setting
Poison Log ✔Correct Answer-poison substance must be labeled, pharmacies must be stocked
with syrup of ipecac and activated charcoal
Controlled Substance Act of 1970 ✔Correct Answer-regulated use and distribution of drugs
with high abuse potential into five schedules
Schedule I drugs ✔Correct Answer-highest abuse potential, no medicinal use :
Answers |Latest Version |Already Graded A+
FDA ✔Correct Answer-label requirements for use of OTC products prohibits adulterated or
misbranded drugs, enforces safety and effectiveness of food, medication, biological products,
cosmetics, and radioactive substances
NDA ✔Correct Answer-application for new drug must be filed with FDA before being
commercially available
Durham-Humphrey Amendment ✔Correct Answer-aka Prescription Drug Amendment,
separates drugs into legend or non-legend
Kefauver-Harris Amendment ✔Correct Answer-label requirements for manufacturers and
dispenser to patients
requires manufacturer to register, be inspected, report drug rxns
PPIs ✔Correct Answer-patient package inserts (for oral contraceptives, inhalers, etc) must
include: indications for use, contraindications, warnings, precaution, dose
Occupational and Safety Act 1970 ✔Correct Answer-reduced hazards in workplace, rise to
OSHA (occupational safety and health administration) all pharmacies need to:
-post poison control number
-reference guide for toxicities
-MSDS
Poison Prevention Packaging Act ✔Correct Answer-pharmacies must use child resistant
resistant containers
Drug Listing Act ✔Correct Answer-assigns unique and permanent drug code to each
medication
Federal Hazardous Substance Act ✔Correct Answer-involves use and disposal of hazardous
material in pharmacy setting
Poison Log ✔Correct Answer-poison substance must be labeled, pharmacies must be stocked
with syrup of ipecac and activated charcoal
Controlled Substance Act of 1970 ✔Correct Answer-regulated use and distribution of drugs
with high abuse potential into five schedules
Schedule I drugs ✔Correct Answer-highest abuse potential, no medicinal use :
