Science Medicine
PTCE Exam Questions Provided
with A+ Graded Answers Latest
Updated 2026
Pure Food and Drug Act Prevents the manufacturing, sale/transportation of misbranded
or adulturated drugs, poisoned or contaminated drugs
Adultered drugs Any drug that is not pure
misbranded drug Not labeled correctly
FDCA (Federal Food, Drug, and Cosmetic act) 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) 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 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 Reports to FDA side effects or adverse effects of any drugs
(FAERS) FDA Adverse Event Reporting System 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) keeps track of all adverse effects associated with vaccines
IND (Investigational New Drug) 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 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 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 Reports to the CDC (centers of disease control) as well
Durham-Humphrey Amendment of 1951 • 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 • 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 a 1914 congressional act that criminalized the sale and use of narcotics
Comprehensive Drug Abuse Prevention and established schedules of controlled substances and moved
Control Act of 1970 enforcement to the Justice Department (C-1 to C-5)
Established the DEA
DEA Enforces the controlled substance act under the DOJ. Makes sure all
controlled substances are manufactured, distributed, and stored
properly.
Control 1 (C-1) drugs High abuse. Considered not medical use or street drugs. (Marijuana,
ecstasy, heroin, LSD)
Control 2 (C-II) drugs Consists of narcotics, pain killers, ADHD drugs. Highly addicting
(Percocet, Endocet, Norco, Fentanyl, Morphine)
Control 3 (C-III) drugs 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 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 Low Codeine amounts in cough suppressants. Considered the least
abusive (phenergan w/Codeine, guaifenesin w/codeine)
Biennial Inventory exact count for schedule II and an estimated count for III-V drugs must
be performed every 2 years
C-II Supply Only for 30 days. No partial filling or given for 90 day supply
Does C-II must have a prescription hard copy? Yes, and there are exceptions: for patients in community care or in long
term IV care
PTCE Exam Questions Provided
with A+ Graded Answers Latest
Updated 2026
Pure Food and Drug Act Prevents the manufacturing, sale/transportation of misbranded
or adulturated drugs, poisoned or contaminated drugs
Adultered drugs Any drug that is not pure
misbranded drug Not labeled correctly
FDCA (Federal Food, Drug, and Cosmetic act) 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) 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 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 Reports to FDA side effects or adverse effects of any drugs
(FAERS) FDA Adverse Event Reporting System 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) keeps track of all adverse effects associated with vaccines
IND (Investigational New Drug) 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 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 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 Reports to the CDC (centers of disease control) as well
Durham-Humphrey Amendment of 1951 • 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 • 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 a 1914 congressional act that criminalized the sale and use of narcotics
Comprehensive Drug Abuse Prevention and established schedules of controlled substances and moved
Control Act of 1970 enforcement to the Justice Department (C-1 to C-5)
Established the DEA
DEA Enforces the controlled substance act under the DOJ. Makes sure all
controlled substances are manufactured, distributed, and stored
properly.
Control 1 (C-1) drugs High abuse. Considered not medical use or street drugs. (Marijuana,
ecstasy, heroin, LSD)
Control 2 (C-II) drugs Consists of narcotics, pain killers, ADHD drugs. Highly addicting
(Percocet, Endocet, Norco, Fentanyl, Morphine)
Control 3 (C-III) drugs 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 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 Low Codeine amounts in cough suppressants. Considered the least
abusive (phenergan w/Codeine, guaifenesin w/codeine)
Biennial Inventory exact count for schedule II and an estimated count for III-V drugs must
be performed every 2 years
C-II Supply Only for 30 days. No partial filling or given for 90 day supply
Does C-II must have a prescription hard copy? Yes, and there are exceptions: for patients in community care or in long
term IV care
