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PharmacyLaw$$

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QuestionAnswer
1906 Federal Food and Drug Act Prohibits the sale of adulterated or mislabeled food, drinks and drugs.
1914 Harrison Narcotic Act Limits the transport of opium
1938 Food Drug and Cosmetic Act Defines misbranding or adulteration of drugs to be illegal. Provide package inserts, habit-forming drug to be labeled, new drugs have to be proven safe.
1951 Durham Humphrey Admendment distinguishes legend drugs from OTC
1962 Kefauver-Harris Amendment 1938 forward have to be proven safe and effective. Enacted because of the thalidomide freak-out. GMP.
1970 Comprehensive Drug Abuse Prevention and Control Act (Controlled Substance Act) Controlled substanced were categorized into schedules I-V.
1970 Poison Prevention Packaging Act childproof packaging
1906 Federal Food and Drug Act Prohibits the sale of adulterated or mislabeled food, drinks and drugs.
1983 Orphan drug Act promote the research and marketing of drugs needed for the treatment of rare diseases.
1914 Harrison Narcotic Act Limits the transport of opium
OBRA 90 (Omnibus Budget Reconciliation Act) requires a pharmacist to offer counseling to patients on new prescriptions
1938 Food Drug and Cosmetic Act Defines misbranding or adulteration of drugs to be illegal. Provide package inserts, habit-forming drug to be labeled, new drugs have to be proven safe.
1951 Durham Humphrey Admendment distinguishes legend drugs from OTC
1962 Kefauver-Harris Amendment 1938 forward have to be proven safe and effective. Enacted because of the thalidomide freak-out. GMP.
1970 Comprehensive Drug Abuse Prevention and Control Act (Controlled Substance Act) Controlled substanced were categorized into schedules I-V.
1970 Poison Prevention Packaging Act childproof packaging
1983 Orphan drug Act promote the research and marketing of drugs needed for the treatment of rare diseases.
OBRA 90 (Omnibus Budget Reconciliation Act) requires a pharmacist to offer counseling to patients on new prescriptions
Created by: moptop