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HSC 343 Exam 1 Study Guide with Complete Solutions

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HSC 343 Exam 1 Study Guide with Complete Solutions Pure Food and Drug Act of 1906 - Answer-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 - Answer-Requires new drugs must be proven safe...

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  • October 16, 2024
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EMILLECT 2024/2025 ACADEMIC YEAR ©2024 EMILLECT. ALL RIGHTS RESERVED FIRST PUBLISH OCTOBER, 2024




HSC 343 Exam 1 Study Guide with
Complete Solutions

Pure Food and Drug Act of 1906 - Answer✔✔-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 - Answer✔✔-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 - Answer✔✔-improved safety and efficacy of patented

and off-patent medicines for children


Food and Drug Administration Modernization Act - Answer✔✔--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




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, EMILLECT 2024/2025 ACADEMIC YEAR ©2024 EMILLECT. ALL RIGHTS RESERVED FIRST PUBLISH OCTOBER, 2024


FDA Amendments Act - Answer✔✔-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 - Answer✔✔-Ensures the safety and effectiveness of all new drugs

on the market. Gave guidelines for conducting clinical trails.


Durham-Humphrey Act - Answer✔✔-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 - Answer✔✔-Enacted in 1970 lists illegal drugs, their category and

their penalty for possession, sale or use.


what the different Schedules of drugs are - Answer✔✔-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? - Answer✔✔-CS2 has a higher abuse potential

than a CS3


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