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Law and Ethics Pharm

Laws and definitions of Pharmacy

QuestionAnswer
1938 Food, Drug and Cosmetic Act Required drug companies to include directions for use for the consumer in package inserts on drugs; required the marking "Warning: May be habit forming" for all narcotics
1962 Kefauver-Harris Amendment Attempted to ensure the safety and effectiveness of all new drugs introduced to the market
1906 Federal Food and Drug Act Enacted to stop the sale of inaccurately labeled drug
1987 Prescription Drug Marketing Act Required the label "Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian" for certain drugs
1990 Omnibus Budget Reconciliation Act States that a pharmacist must counsel all patients who receive new prescriptions at the time of purchase
1970 Comprehensive Drug Abuse and Prevention and Control Act Created an agency with the sole purpose of enforcing the laws governing narcotics and the requirements for their distribution
1914 Harrison Narcotic Act Enacted because of excessive opium addiction across the United States
1990 Anabolic Steroids Control Act Helped stiffen regulations dealing with the abuse of anabolic steroids and their misuse by athletes
1951 Durham-Humphrey Amendment Made the initial distinction between a legend drug and over-the-counter drugs; required legend drugs to carry the label "Caution: Federal law prohibits dispensing without a prescription"
1983 Orphan Drug Act Allowed drug companies to bypass the lengthy time requirements for testing of a new drug, and the costs that accompany them, to provide medications to persons who have a rare disease
Created by: littleone8
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