PTCE EXAM ACTUAL QUESTIONS AND
CORRECT ANSWERS
Pure Food and Drug Act - CORRECT ANSWERS Prevents the
manufacturing, sale/transportation of misbranded or adulturated drugs, poisoned
or contaminated drugs
Adultered drugs - CORRECT ANSWERS Any drug that is not pure
misbranded drug - CORRECT ANSWERS Not labeled correctly
FDCA (Federal Food, Drug, and Cosmetic act) - CORRECT ANSWERS
drugs must comply with standards of safety and efficacy, more modern
act than Pure Food and Drug Act. Oversees safety of food, drugs and cosmetics
FDA (Food and Drug Administration) - CORRECT ANSWERS a
division of USDHHS responsible for regulating food and drug products sold to
the public. Handles drug approvals, sold, and recalls of drugs
3 types of Drug Recalls - CORRECT ANSWERS 1. Most severe:
permanent health hazard or death
2. Medium severity: temporary or reversible damage
3. Least severe: mislabeling or misbranded drugs, low damage from drugs
MedWatch Program - CORRECT ANSWERS Reports to FDA side
effects or adverse effects of any drugs
(FAERS) FDA Adverse Event Reporting System - CORRECT ANSWERS
Database that contains information on adverse event and medication
,error reports submitted to the FDA; designed to support the FDA's post-
marketing safety surveillance program.
VAERS (Vaccine Adverse Event Reporting System) - CORRECT ANSWERS
keeps track of all adverse effects associated with vaccines
IND (Investigational New Drug) - CORRECT ANSWERS A drug not yet
approved for marketing by the FDA but available for use in experiments to
determine its safety and efficacy.
FDA drug approval process - CORRECT ANSWERS 1. Hypothesis:
comes up with the drug and reports findings (dosage, research and findings) to
FDA
2. Pre-phase: consists of animal testing then human testing to small population
(reports correct dosing and side effects)
3. Large Human Trial: tests on wider population with longer procedure
4. Post-surveillance: approval by FDA but is monitored. Given a 20 year patent
tall man lettering - CORRECT ANSWERS medication names that have
mixed case lettering in the description name, which helps reduce errors between
medication names that either look or sound alike
FAERS and VAERS - CORRECT ANSWERS Reports to the CDC
(centers of disease control) as well
Durham-Humphrey Amendment of 1951 - CORRECT ANSWERS •
Created a distinction between "OTC" and "Legend Drugs".
• Legend Drugs can only be dispensed with a valid Prescription..
• Required Legend Drugs to carry the statement:
"Caution: Federal law prohibits dispensing without a prescription.".
, • Most people refer to Legend drugs simply as "Prescription Drugs".
• The emphasis on this act was to insure safety thru qualified medical
supervision.
Kefauver-Harris Amendment of 1962 - CORRECT ANSWERS • Also
known as the "Drug Efficacy Amendment".
• Required drug manufacturers to provide proof of the effectiveness and safety
of their drugs before approval .
• Required drug advertising to be more closely regulated and disclose accurate
information about side effects
Harrison Narcotic Act - CORRECT ANSWERS a 1914 congressional act
that criminalized the sale and use of narcotics
Comprehensive Drug Abuse Prevention and Control Act of 1970 - CORRECT
ANSWERS established schedules of controlled substances and moved
enforcement to the Justice Department (C-1 to C-5)
Established the DEA
DEA - CORRECT ANSWERS Enforces the controlled substance act
under the DOJ. Makes sure all controlled substances are manufactured,
distributed, and stored properly.
Control 1 (C-1) drugs - CORRECT ANSWERS High abuse. Considered
not medical use or street drugs. (Marijuana, ecstasy, heroin, LSD)
Control 2 (C-II) drugs - CORRECT ANSWERS Consists of narcotics,
pain killers, ADHD drugs. Highly addicting (Percocet, Endocet, Norco,
Fentanyl, Morphine)
CORRECT ANSWERS
Pure Food and Drug Act - CORRECT ANSWERS Prevents the
manufacturing, sale/transportation of misbranded or adulturated drugs, poisoned
or contaminated drugs
Adultered drugs - CORRECT ANSWERS Any drug that is not pure
misbranded drug - CORRECT ANSWERS Not labeled correctly
FDCA (Federal Food, Drug, and Cosmetic act) - CORRECT ANSWERS
drugs must comply with standards of safety and efficacy, more modern
act than Pure Food and Drug Act. Oversees safety of food, drugs and cosmetics
FDA (Food and Drug Administration) - CORRECT ANSWERS a
division of USDHHS responsible for regulating food and drug products sold to
the public. Handles drug approvals, sold, and recalls of drugs
3 types of Drug Recalls - CORRECT ANSWERS 1. Most severe:
permanent health hazard or death
2. Medium severity: temporary or reversible damage
3. Least severe: mislabeling or misbranded drugs, low damage from drugs
MedWatch Program - CORRECT ANSWERS Reports to FDA side
effects or adverse effects of any drugs
(FAERS) FDA Adverse Event Reporting System - CORRECT ANSWERS
Database that contains information on adverse event and medication
,error reports submitted to the FDA; designed to support the FDA's post-
marketing safety surveillance program.
VAERS (Vaccine Adverse Event Reporting System) - CORRECT ANSWERS
keeps track of all adverse effects associated with vaccines
IND (Investigational New Drug) - CORRECT ANSWERS A drug not yet
approved for marketing by the FDA but available for use in experiments to
determine its safety and efficacy.
FDA drug approval process - CORRECT ANSWERS 1. Hypothesis:
comes up with the drug and reports findings (dosage, research and findings) to
FDA
2. Pre-phase: consists of animal testing then human testing to small population
(reports correct dosing and side effects)
3. Large Human Trial: tests on wider population with longer procedure
4. Post-surveillance: approval by FDA but is monitored. Given a 20 year patent
tall man lettering - CORRECT ANSWERS medication names that have
mixed case lettering in the description name, which helps reduce errors between
medication names that either look or sound alike
FAERS and VAERS - CORRECT ANSWERS Reports to the CDC
(centers of disease control) as well
Durham-Humphrey Amendment of 1951 - CORRECT ANSWERS •
Created a distinction between "OTC" and "Legend Drugs".
• Legend Drugs can only be dispensed with a valid Prescription..
• Required Legend Drugs to carry the statement:
"Caution: Federal law prohibits dispensing without a prescription.".
, • Most people refer to Legend drugs simply as "Prescription Drugs".
• The emphasis on this act was to insure safety thru qualified medical
supervision.
Kefauver-Harris Amendment of 1962 - CORRECT ANSWERS • Also
known as the "Drug Efficacy Amendment".
• Required drug manufacturers to provide proof of the effectiveness and safety
of their drugs before approval .
• Required drug advertising to be more closely regulated and disclose accurate
information about side effects
Harrison Narcotic Act - CORRECT ANSWERS a 1914 congressional act
that criminalized the sale and use of narcotics
Comprehensive Drug Abuse Prevention and Control Act of 1970 - CORRECT
ANSWERS established schedules of controlled substances and moved
enforcement to the Justice Department (C-1 to C-5)
Established the DEA
DEA - CORRECT ANSWERS Enforces the controlled substance act
under the DOJ. Makes sure all controlled substances are manufactured,
distributed, and stored properly.
Control 1 (C-1) drugs - CORRECT ANSWERS High abuse. Considered
not medical use or street drugs. (Marijuana, ecstasy, heroin, LSD)
Control 2 (C-II) drugs - CORRECT ANSWERS Consists of narcotics,
pain killers, ADHD drugs. Highly addicting (Percocet, Endocet, Norco,
Fentanyl, Morphine)
