Exam (elaborations)
EXCPT Pharmacy Law
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- IBCLC Exam
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- IBCLC Exam
Exam of 2 pages for the course IBCLC Exam at IBCLC Exam (EXCPT Pharmacy Law)
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EXCPT Pharmacy LawPure Food and Drug Act of 1906 - correct answer--Enacted to prohibit the sale
of inacurrately labeled drugs.
-Manufacturers must prove effectiveness.
Harrison Narcotic Act of 1914 - correct answer-Enacted to combat opium
addiction pandemic
1938 Food, Drug and Cosmetic Act - correct answer--Basis for pharmacy law
today
-Created FDA
-Required package inserts/directions
-Required all all narcotics to be labeled "Warning: May be habit forming."
1951 Durham-Humphrey Amendment - correct answer--Made initial distinction
between legend and OTC drugs
-Required labeling: "Caution: Federal law prohibits dispensing without a
prescription" on legend drugs.
1962 Kefauver-Harris Amendments - correct answer--Enacted in an attempt to
ensure the safety and effectiveness of all new drugs on the market.
-Burden put on manufacturing companies to have good manufacturing
practices. (Drug testing and approval required)
1970 Poison Prevention Packaging Act - correct answer-Child-proof
packaging is required for all prescription drugs
Comprehensive Drug Abuse Prevention & Control Act of 1970 - correct
answer--Created DEA
-Controlled substances are placed in one of five schedules based on a
potential for abuse and accepted medical use in the United States.
Prescription Drug Marketing Act of 1987 - correct answer--Maintain legal
supply channel for drug distribution.
-Prohibits the sale or distribution of samples to those licensed to prescribe
them.
-Required the labeling "Caution: Federal law restricts this drug to use by or on
an order of a licensed veterinarian."
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