Pure Food and Drug Act of 1906 - Answers Gave the FDA the power to enforce standards of
drug strength and purity. It also prohibits mislabeling or adulteration.
Food, Drug, and Cosmetic Act of 1938 - Answers Requires new drugs must be proven safe
before marketing. Also, all parties (manufacture, sale, and dissertation) must be registered
through FDA.
Best Pharmaceuticals for Children Act - Answers improved safety and efficacy of patented and
off-patent medicines for children
Food and Drug Administration Modernization Act - Answers -Allows for fast-tracking of drugs
for serious illnesses to market
-Drug manufacturers have to give patients 6 months notice before they discontinue making a
drug
-Established a clinical trial database for drugs for critical illnesses
-Informs of "off-label" uses
-Incentives for pediatric drug research
FDA Amendments Act - Answers Enforced drug safety to monitor drugs once the drug is on the
market. Added black box warnings, risk evaluation strategies, dear prescriber letters, and
removal of unsafe drugs off the market quickly.
Kefauver-Harris Amendments - Answers Ensures the safety and effectiveness of all new drugs
on the market. Gave guidelines for conducting clinical trails.
Durham-Humphrey Act - Answers Required drug companies to put drug labels such as " caution:
federal law prohibits dispensing without a prescription." Also, made a distinction between
legend (prescription only) and over the counter (nonlegend) meds.
Controlled Substances Act - Answers Enacted in 1970 lists illegal drugs, their category and their
penalty for possession, sale or use.
what the different Schedules of drugs are - Answers Schedule 1 drugs- high abuse potential and
no accepted medical use
Schedule 2 drugs- currently accepted in medical use but has high abuse potential resulting in
dependence
Schedule 3 drugs- abuse potential less than schedule 2
Schedule 4 drugs- abuse potential less than schedule 3
, Schedule 5 drugs- lowest abuse potential
what does it mean if a drug is CS2 versus CS3? - Answers CS2 has a higher abuse potential than
a CS3
what are the rules for prescriptions? - Answers Schedule 1- no prescription allowed
Schedule 2- written prescription with legal signature, no refills allowed, must be signed same
day as date
Schedule 3- written or verbal prescription, valid for 6 months from date written, limit to 5 refills
Schedule 4- written or verbal prescription, valid for 6 months from date written, limit to 5 refills
Schedule 5- written or verbal prescription, valid for 6 months from date written, limit to 5 refills
Routes of Administration - Answers enteral- oral, sublingual, and rectal
parenteral- injectables
topical- eye, ear, nasal, respiratory, skin, and vaginal
Which route has immediate absorbance? - Answers Perenteral- IV
Which route has RATE-LIMITING dissolution of drug particles? - Answers Enteral- Oral (by mouth)
Can route affect adherence? - Answers Yes
What else affects adherence? - Answers Taste, inconvenient, cannot take drug by themselves,
irritation, age
Why are plasma proteins important? - Answers The free drug with bind with a protein to travel to
desired location.
Know the term and characteristic of agonist - Answers Drugs that occupy receptors and activate
them. Have a lock and key fit.
Know the term and characteristic of antagonist - Answers Drugs that occupy receptors but do
not activate them. They are blockers of the receptor activation by agonists.
Know the term and characteristic of partial agonist - Answers Drug which can interact with a
receptor but produces a much weaker response than a full agonist.
Know the difference between side effect. - Answers Unwanted effects of drugs that appear at
normal doses required for therapeutic response. Normal with most drugs.
What is an iatrogenic effect? - Answers Response where a drug causes a disease-like state.
What is an idiosyncratic effect? - Answers Rare adverse drug response resulting from a genetic