PEBC EXAM 103 EXAM SCRIPT 2026 TEST
PAPER QUESTIONS AND SOLUTIONS GRADED
A+
◉ Adultered drugs. Answer: Any drug that is not pure
◉ misbranded drug. Answer: Not labeled correctly
◉ FDCA (Federal Food, Drug, and Cosmetic act). Answer: 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). Answer: 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. Answer: 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. Answer: Reports to FDA side effects or
adverse effects of any drugs
◉ (FAERS) FDA Adverse Event Reporting System. Answer: 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). Answer: keeps
track of all adverse effects associated with vaccines
◉ IND (Investigational New Drug). Answer: 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. Answer: 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. Answer: 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. Answer: Reports to the CDC (centers of disease
control) as well
◉ Durham-Humphrey Amendment of 1951. Answer: • 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. Answer: • 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. Answer: a 1914 congressional act that
criminalized the sale and use of narcotics
◉ Comprehensive Drug Abuse Prevention and Control Act of 1970.
Answer: established schedules of controlled substances and moved
enforcement to the Justice Department (C-1 to C-5)
Established the DEA
◉ DEA. Answer: Enforces the controlled substance act under the
DOJ. Makes sure all controlled substances are manufactured,
distributed, and stored properly.
◉ Control 1 (C-1) drugs. Answer: High abuse. Considered not
medical use or street drugs. (Marijuana, ecstasy, heroin, LSD)
◉ Control 2 (C-II) drugs. Answer: Consists of narcotics, pain killers,
ADHD drugs. Highly addicting (Percocet, Endocet, Norco, Fentanyl,
Morphine)
◉ Control 3 (C-III) drugs. Answer: 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. Answer: Anti-anxiety, anti-depressants,
anti-psychotics, sleep aids, appetite suppressants, Tramadol/Ultram.
PAPER QUESTIONS AND SOLUTIONS GRADED
A+
◉ Adultered drugs. Answer: Any drug that is not pure
◉ misbranded drug. Answer: Not labeled correctly
◉ FDCA (Federal Food, Drug, and Cosmetic act). Answer: 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). Answer: 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. Answer: 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. Answer: Reports to FDA side effects or
adverse effects of any drugs
◉ (FAERS) FDA Adverse Event Reporting System. Answer: 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). Answer: keeps
track of all adverse effects associated with vaccines
◉ IND (Investigational New Drug). Answer: 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. Answer: 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. Answer: 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. Answer: Reports to the CDC (centers of disease
control) as well
◉ Durham-Humphrey Amendment of 1951. Answer: • 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. Answer: • 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. Answer: a 1914 congressional act that
criminalized the sale and use of narcotics
◉ Comprehensive Drug Abuse Prevention and Control Act of 1970.
Answer: established schedules of controlled substances and moved
enforcement to the Justice Department (C-1 to C-5)
Established the DEA
◉ DEA. Answer: Enforces the controlled substance act under the
DOJ. Makes sure all controlled substances are manufactured,
distributed, and stored properly.
◉ Control 1 (C-1) drugs. Answer: High abuse. Considered not
medical use or street drugs. (Marijuana, ecstasy, heroin, LSD)
◉ Control 2 (C-II) drugs. Answer: Consists of narcotics, pain killers,
ADHD drugs. Highly addicting (Percocet, Endocet, Norco, Fentanyl,
Morphine)
◉ Control 3 (C-III) drugs. Answer: 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. Answer: Anti-anxiety, anti-depressants,
anti-psychotics, sleep aids, appetite suppressants, Tramadol/Ultram.
