HSC 343 PHARMACOLOGY EXAM 1
STUDY 2025 QUESTIONS AND ANSWERS
Pure Food and Drug Act - ANS the FDA may enforce standards of drug strength and purity;
prohibits mislabeling or adulteration; still use today, first drug law
Food, Drug and Cosmetic Act - ANS required adequate testing of a compound to prevent
marketing of a possibly toxic substance; new drugs must be safe as well as pure in order to be
introduced into interstate commerce; this law still did not require proof of effectiveness
Best Pharmaceuticals for Children Act - ANS drug studies in children; see how existing drugs
work in children and determine safety; set up pediatric drug trials; used for pediatric
conditions; ex. asthma and leukemia; allowed with parental consent
Food and Drug Administration Modernization Act - ANS allows for fast-tracking of serious
illnesses to market; drug manufacturers must give patient 6 months' notice before they
discontinue making a drug; informs of "off label" uses (drugs intended for one thing but used
for another)
FDA Amendments Act - ANS drug safety legislation designated to monitor drugs once they
are on the market; except consumers to report back side effects
Kefauver-Harris Amendments - ANS required proof of efficacy as well as safety before any
1
new drug could be placed in interstate commerce
Page
@COPYRIGHT SIRJOEL 2025/2026
, Durham-Humphrey Act - ANS separated drugs into legend (prescription) and nonlegend
(nonprescription, over-the-counter) categories; rules for dispensing legend drugs
Controlled Substances Act - ANS established rehabilitation programs for drug users;
established control (registration) and enforcement (DEA); regulates export and import of
controlled substances
CS2 has a higher abuse potential than a CS3 - ANS What does it mean if a drug is CS2 versus
CS3?
·high abuse potential and no accepted medical use in US; no prescription allowed -
ANS What are the rules for a Schedule I drug?
·currently accepted medical use in US w/ high abuse potential resulting in severe physical or
psychological dependence
- Written prescription required with prescriber's actual (legal) signature
- Must be dated the same day as signed
- No refills allowed; typically, must be seen by the doctor again - ANS What are the rules for a
Schedule II drug?
abuse potential less than Schedule II
- Written or verbal prescription allowed; valid from 6 months from the date written
- Limit 5 refills - ANS What are the rules for a Schedule III drug?
abuse potential less than Schedule III
- Written or verbal prescription allowed; valid from 6 months from the date written
2
Page
- Limit 5 refills - ANS What are the rules for a Schedule IV drug?
@COPYRIGHT SIRJOEL 2025/2026
STUDY 2025 QUESTIONS AND ANSWERS
Pure Food and Drug Act - ANS the FDA may enforce standards of drug strength and purity;
prohibits mislabeling or adulteration; still use today, first drug law
Food, Drug and Cosmetic Act - ANS required adequate testing of a compound to prevent
marketing of a possibly toxic substance; new drugs must be safe as well as pure in order to be
introduced into interstate commerce; this law still did not require proof of effectiveness
Best Pharmaceuticals for Children Act - ANS drug studies in children; see how existing drugs
work in children and determine safety; set up pediatric drug trials; used for pediatric
conditions; ex. asthma and leukemia; allowed with parental consent
Food and Drug Administration Modernization Act - ANS allows for fast-tracking of serious
illnesses to market; drug manufacturers must give patient 6 months' notice before they
discontinue making a drug; informs of "off label" uses (drugs intended for one thing but used
for another)
FDA Amendments Act - ANS drug safety legislation designated to monitor drugs once they
are on the market; except consumers to report back side effects
Kefauver-Harris Amendments - ANS required proof of efficacy as well as safety before any
1
new drug could be placed in interstate commerce
Page
@COPYRIGHT SIRJOEL 2025/2026
, Durham-Humphrey Act - ANS separated drugs into legend (prescription) and nonlegend
(nonprescription, over-the-counter) categories; rules for dispensing legend drugs
Controlled Substances Act - ANS established rehabilitation programs for drug users;
established control (registration) and enforcement (DEA); regulates export and import of
controlled substances
CS2 has a higher abuse potential than a CS3 - ANS What does it mean if a drug is CS2 versus
CS3?
·high abuse potential and no accepted medical use in US; no prescription allowed -
ANS What are the rules for a Schedule I drug?
·currently accepted medical use in US w/ high abuse potential resulting in severe physical or
psychological dependence
- Written prescription required with prescriber's actual (legal) signature
- Must be dated the same day as signed
- No refills allowed; typically, must be seen by the doctor again - ANS What are the rules for a
Schedule II drug?
abuse potential less than Schedule II
- Written or verbal prescription allowed; valid from 6 months from the date written
- Limit 5 refills - ANS What are the rules for a Schedule III drug?
abuse potential less than Schedule III
- Written or verbal prescription allowed; valid from 6 months from the date written
2
Page
- Limit 5 refills - ANS What are the rules for a Schedule IV drug?
@COPYRIGHT SIRJOEL 2025/2026
