Pure Food and Drug Act - (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 - (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 - (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 - (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 - (answer)drug safety legislation designated to monitor drugs once they are on
the market; except consumers to report back side effects
Kefauver-Harris Amendments - (answer)required proof of efficacy as well as safety before any new drug
could be placed in interstate commerce
Durham-Humphrey Act - (answer)separated drugs into legend (prescription) and nonlegend
(nonprescription, over-the-counter) categories; rules for dispensing legend drugs
Controlled Substances Act - (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 - (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 - (answer)What are
the rules for a Schedule I drug?
, Exam 1 Study Guide Pharmacology Rasmussen NUR/2026 – Verified Answers
·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 - (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 - (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 - (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 - (answer)What are the rules for a Schedule V drug?
parenteral (IV, IM, SubQ) - (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 - (answer)What are the advantages to IV?