HSC 343 PHARMACOLOGY EXAM 1 STUDY QUESTIONS AND ANSWERS
Pure Food and Drug Act - CORRECT ANSWER✅✅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 - CORRECT ANSWER✅✅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 - CORRECT ANSWER✅✅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 - CORRECT ANSWER✅✅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 - CORRECT ANSWER✅✅drug safety legislation designated to monitor drugs once
they are on the market; except consumers to report back side effects
Kefauver-Harris Amendments - CORRECT ANSWER✅✅required proof of efficacy as well as safety before
any new drug could be placed in interstate commerce
Durham-Humphrey Act - CORRECT ANSWER✅✅separated drugs into legend (prescription) and
nonlegend (nonprescription, over-the-counter) categories; rules for dispensing legend drugs
Controlled Substances Act - CORRECT ANSWER✅✅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 - CORRECT ANSWER✅✅What does it mean if a drug is CS2
versus CS3?
, ·high abuse potential and no accepted medical use in US; no prescription allowed - CORRECT
ANSWER✅✅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 - CORRECT ANSWER✅✅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 - CORRECT ANSWER✅✅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
- Limit 5 refills - CORRECT ANSWER✅✅What are the rules for a Schedule IV drug?
lowest abuse potential
- Written or verbal prescription allowed; valid from 6 months from the date written
- Limit 5 refills - CORRECT ANSWER✅✅What are the rules for a Schedule V drug?
parenteral (IV, IM, SubQ) - CORRECT ANSWER✅✅medication route not in the GI tract (injectables)
- most rapid-acting, fastest route
- avoid first-pass effect b/c it's being injected directly into the bloodstream
- may control and titrate dosage
- relatively large volumes
- complete absorption - CORRECT ANSWER✅✅What are the advantages to IV?
Pure Food and Drug Act - CORRECT ANSWER✅✅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 - CORRECT ANSWER✅✅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 - CORRECT ANSWER✅✅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 - CORRECT ANSWER✅✅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 - CORRECT ANSWER✅✅drug safety legislation designated to monitor drugs once
they are on the market; except consumers to report back side effects
Kefauver-Harris Amendments - CORRECT ANSWER✅✅required proof of efficacy as well as safety before
any new drug could be placed in interstate commerce
Durham-Humphrey Act - CORRECT ANSWER✅✅separated drugs into legend (prescription) and
nonlegend (nonprescription, over-the-counter) categories; rules for dispensing legend drugs
Controlled Substances Act - CORRECT ANSWER✅✅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 - CORRECT ANSWER✅✅What does it mean if a drug is CS2
versus CS3?
, ·high abuse potential and no accepted medical use in US; no prescription allowed - CORRECT
ANSWER✅✅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 - CORRECT ANSWER✅✅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 - CORRECT ANSWER✅✅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
- Limit 5 refills - CORRECT ANSWER✅✅What are the rules for a Schedule IV drug?
lowest abuse potential
- Written or verbal prescription allowed; valid from 6 months from the date written
- Limit 5 refills - CORRECT ANSWER✅✅What are the rules for a Schedule V drug?
parenteral (IV, IM, SubQ) - CORRECT ANSWER✅✅medication route not in the GI tract (injectables)
- most rapid-acting, fastest route
- avoid first-pass effect b/c it's being injected directly into the bloodstream
- may control and titrate dosage
- relatively large volumes
- complete absorption - CORRECT ANSWER✅✅What are the advantages to IV?
