PTCE EXAM QUESTIONS AND
CORRECT ANSWERS
3 types of Drug Recalls ✅✅CORRECT ANSW.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 ANSW.Reports to FDA side effects or adverse effects of any
drugs
(FAERS) FDA Adverse Event Reporting System ✅✅CORRECT ANSW.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 ANSW.keeps track of all adverse
effects associated with vaccines
IND (Investigational New Drug) ✅✅CORRECT ANSW.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 ANSW.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 ANSW.medication names that have mixed case lettering in the
description name, which helps reduce errors between medication names that either look or sound
alike
Pure Food and Drug Act ✅✅CORRECT ANSW.Prevents the manufacturing, sale/transportation of
misbranded or adulturated drugs, poisoned or contaminated drugs
,Adultered drugs ✅✅CORRECT ANSW.Any drug that is not pure
misbranded drug ✅✅CORRECT ANSW.Not labeled correctly
FDCA (Federal Food, Drug, and Cosmetic act) ✅✅CORRECT ANSW.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 ANSW.a division of USDHHS responsible for
regulating food and drug products sold to the public. Handles drug approvals, sold, and recalls of
drugs
FAERS and VAERS ✅✅CORRECT ANSW.Reports to the CDC (centers of disease control) as well
Durham-Humphrey Amendment of 1951 ✅✅CORRECT ANSW.• 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 ANSW.• 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 ANSW.a 1914 congressional act that criminalized the sale and
use of narcotics
Comprehensive Drug Abuse Prevention and Control Act of 1970 ✅✅CORRECT ANSW.established
schedules of controlled substances and moved enforcement to the Justice Department (C-1 to C-5)
, Established the DEA
DEA ✅✅CORRECT ANSW.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 ANSW.High abuse. Considered not medical use or street drugs.
(Marijuana, ecstasy, heroin, LSD)
Control 2 (C-II) drugs ✅✅CORRECT ANSW.Consists of narcotics, pain killers, ADHD drugs. Highly
addicting (Percocet, Endocet, Norco, Fentanyl, Morphine)
Control 3 (C-III) drugs ✅✅CORRECT ANSW.Mild pain killers, anabolic steroids and caffeine pills,
can be moderately abused (Tylenol 2, 3, 4; Vicodin; Depo-Testosterone; Buprenorphine; Ketamine)
Control 4 (C-IV) drugs ✅✅CORRECT ANSW.Anti-anxiety, anti-depressants, anti-psychotics, sleep
aids, appetite suppressants, Tramadol/Ultram. Has moderate abuse (alpralozam/Xanax,
Carisoprodol/soma, clonazepam/klonopin, lorazepam/Ativan, temazepam/restoril)
Control 5 (C-V) Drugs ✅✅CORRECT ANSW.Low Codeine amounts in cough suppressants.
Considered the least abusive (phenergan w/Codeine, guaifenesin w/codeine)
Biennial Inventory ✅✅CORRECT ANSW.exact count for schedule II and an estimated count for III-
V drugs must be performed every 2 years
C-II Supply ✅✅CORRECT ANSW.Only for 30 days. No partial filling or given for 90 day supply
Does C-II must have a prescription hard copy? ✅✅CORRECT ANSW.Yes, and there are exceptions:
for patients in community care or in long term IV care
Expiration date for C-II? ✅✅CORRECT ANSW.No expiration date but just be filled in 1 month or in
a 10 day period
CORRECT ANSWERS
3 types of Drug Recalls ✅✅CORRECT ANSW.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 ANSW.Reports to FDA side effects or adverse effects of any
drugs
(FAERS) FDA Adverse Event Reporting System ✅✅CORRECT ANSW.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 ANSW.keeps track of all adverse
effects associated with vaccines
IND (Investigational New Drug) ✅✅CORRECT ANSW.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 ANSW.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 ANSW.medication names that have mixed case lettering in the
description name, which helps reduce errors between medication names that either look or sound
alike
Pure Food and Drug Act ✅✅CORRECT ANSW.Prevents the manufacturing, sale/transportation of
misbranded or adulturated drugs, poisoned or contaminated drugs
,Adultered drugs ✅✅CORRECT ANSW.Any drug that is not pure
misbranded drug ✅✅CORRECT ANSW.Not labeled correctly
FDCA (Federal Food, Drug, and Cosmetic act) ✅✅CORRECT ANSW.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 ANSW.a division of USDHHS responsible for
regulating food and drug products sold to the public. Handles drug approvals, sold, and recalls of
drugs
FAERS and VAERS ✅✅CORRECT ANSW.Reports to the CDC (centers of disease control) as well
Durham-Humphrey Amendment of 1951 ✅✅CORRECT ANSW.• 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 ANSW.• 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 ANSW.a 1914 congressional act that criminalized the sale and
use of narcotics
Comprehensive Drug Abuse Prevention and Control Act of 1970 ✅✅CORRECT ANSW.established
schedules of controlled substances and moved enforcement to the Justice Department (C-1 to C-5)
, Established the DEA
DEA ✅✅CORRECT ANSW.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 ANSW.High abuse. Considered not medical use or street drugs.
(Marijuana, ecstasy, heroin, LSD)
Control 2 (C-II) drugs ✅✅CORRECT ANSW.Consists of narcotics, pain killers, ADHD drugs. Highly
addicting (Percocet, Endocet, Norco, Fentanyl, Morphine)
Control 3 (C-III) drugs ✅✅CORRECT ANSW.Mild pain killers, anabolic steroids and caffeine pills,
can be moderately abused (Tylenol 2, 3, 4; Vicodin; Depo-Testosterone; Buprenorphine; Ketamine)
Control 4 (C-IV) drugs ✅✅CORRECT ANSW.Anti-anxiety, anti-depressants, anti-psychotics, sleep
aids, appetite suppressants, Tramadol/Ultram. Has moderate abuse (alpralozam/Xanax,
Carisoprodol/soma, clonazepam/klonopin, lorazepam/Ativan, temazepam/restoril)
Control 5 (C-V) Drugs ✅✅CORRECT ANSW.Low Codeine amounts in cough suppressants.
Considered the least abusive (phenergan w/Codeine, guaifenesin w/codeine)
Biennial Inventory ✅✅CORRECT ANSW.exact count for schedule II and an estimated count for III-
V drugs must be performed every 2 years
C-II Supply ✅✅CORRECT ANSW.Only for 30 days. No partial filling or given for 90 day supply
Does C-II must have a prescription hard copy? ✅✅CORRECT ANSW.Yes, and there are exceptions:
for patients in community care or in long term IV care
Expiration date for C-II? ✅✅CORRECT ANSW.No expiration date but just be filled in 1 month or in
a 10 day period
