HSC 343 Exam 1 Questions and Answers| New Update with 100% Correct Answers
Pure Food and Drug Act of 1906 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 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 improved safety and efficacy of patented and off-
patent medicines for children
Food and Drug Administration Modernization Act -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 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 Ensures the safety and effectiveness of all new drugs on the
market. Gave guidelines for conducting clinical trails.
Durham-Humphrey Act 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 Enacted in 1970 lists illegal drugs, their category and their penalty
for possession, sale or use.
what the different Schedules of drugs are 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? CS2 has a higher abuse potential than a CS3
what are the rules for prescriptions? 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 enteral- oral, sublingual, and rectal
parenteral- injectables
topical- eye, ear, nasal, respiratory, skin, and vaginal
Which route has immediate absorbance? Perenteral- IV
Which route has RATE-LIMITING dissolution of drug particles? Enteral- Oral (by mouth)
Pure Food and Drug Act of 1906 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 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 improved safety and efficacy of patented and off-
patent medicines for children
Food and Drug Administration Modernization Act -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 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 Ensures the safety and effectiveness of all new drugs on the
market. Gave guidelines for conducting clinical trails.
Durham-Humphrey Act 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 Enacted in 1970 lists illegal drugs, their category and their penalty
for possession, sale or use.
what the different Schedules of drugs are 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? CS2 has a higher abuse potential than a CS3
what are the rules for prescriptions? 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 enteral- oral, sublingual, and rectal
parenteral- injectables
topical- eye, ear, nasal, respiratory, skin, and vaginal
Which route has immediate absorbance? Perenteral- IV
Which route has RATE-LIMITING dissolution of drug particles? Enteral- Oral (by mouth)
