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HSC 343: Pharmacology Study Guide with Complete Solutions

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HSC 343: Pharmacology Study Guide with Complete Solutions Pure Food and Drug Act - Answer-1) The federal government (Food and Drug Administration, FDA) may enforce standards of drug strength and purity as officially designated by the USP (United States Pharmacopoeia) and NF (National Formulary)...

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




HSC 343: Pharmacology Study Guide
with Complete Solutions

Pure Food and Drug Act - Answer✔✔-1) The federal government (Food and Drug

Administration, FDA) may enforce standards of drug strength and purity as officially designated

by the USP (United States Pharmacopoeia) and NF (National Formulary).


2) Prohibits mislabeling or adulteration of drug


The Food, Drug, and Cosmetic Act - Answer✔✔-1) Enforced by FDA through registration of all

parties involved in manufacture, sale, & distribution of drugs


2) Required adequate testing of a compound to prevent marketing of toxic substance. New

drugs must be safe/pure in order to be introduced into interstate commerce. Law DID NOT

require proof of effectiveness


Best Pharmaceuticals for Children Act - Answer✔✔-1) promote drug studies in children


2) see how existing drugs work in children and determine safety


3) Set up pediatric drug trials


The Food and Drug Administration Modernization Act - Answer✔✔--Allows for fast-tracking of

drugs for serious illnesses to market




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-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 - Answer✔✔-Drug safety legislation designed to monitor drugs once they

are on the market


Kefauver-Harris Amendments - Answer✔✔-1) required proof of efficacy as well as safety before

any new drug could be placed in interstate commerce


2) guidelines for conducting clinical trials


3) established the Drug Efficacy Study Implementation (DESI)


The Durham-Humphrey Act - Answer✔✔-1) separated drugs into legend (prescription) and

nonlegend (nonprescription, over-the-counter) categories. The "legend" must appear on every

commercial container of legend drugs: "Caution: Federal Law Prohibits Dispensing without

Prescription."


2) rules for dispensing legend drugs


Controlled Substances Act - Answer✔✔-1. established rehabilitation programs for drug users


2. established control (registration) and enforcement (DEA)



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


3. regulates export and import of controlled substances


Schedule I - Answer✔✔-high abuse potential and no accepted medical use in U.S.


Schedule I - Answer✔✔-The following are examples of what schedule?


1) investigational drugs


2) opiates: heroin, many synthetic derivatives


3) hallucinogens: LSD, mescaline, peyote, bath salts


4) marijuana (medical merijuana in 21 states an exception). spice


5) methaqualone (Quaalude)


Schedule II - Answer✔✔-accepted medical uses in U.S. with high abuse potential resulting in

severe physical or psychological dependence


Schedule II - Answer✔✔-The following RULES are for which schedule type?


1) written prescription required with prescriber's actual (legal) signature


2) must be dated the same day as signed


3) no refills allowed


4) in an emergency, a verbal order may be given for a limited quantity of drug adequate to treat

the emergency condition, but must be followed by a written prescription within 72 hours.


Schedule II - Answer✔✔-The following are examples of which type of schedule?


-Methylphenidate (Ritalin)
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