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Drug Regulation Time

QuestionAnswer
Pure Food and Drug (1908) Addressed adulterated and misbranded foods and drugs.
Harrison Narcotics Tax Act (1914) Established federal controls involving certain narcotic drugs.
Federal Food, Drug, and Cosmetic Act (1938) Required evidence of safety before new drugs could be marketed.
Durham-Humphrey Amendment (1951) Formally distinguished prescription drugs from nonprescription drugs.
Kefauver-Harris Amendments (1962) Required manufacturers to demonstrate both safety and effectiveness.
Controlled Substances Act (1970) Established federal schedules for drugs with abuse potential.
Poison Prevention Packaging Act (1970) Established child-resistant packaging requirements for many medications.
Orphan Drug Act (1983) Encouraged development of drugs for rare disesaes.
Hatch-Waxman Act (1984) Helped create the modern pathway for approval of generic drugs while addressing patient protections.
HIPPA (1996) Esablished major federal protections involving health information and patient privacy.
Combat Methamphetamine Epidemic Act (2005/2006) Established federal restrictions on the sale of pseudoephedrine and related products.
Created by: Russells3709
 

 



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