Laws and Acts
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| 1906 Federal Food and Drug Act | Was one of the first laws enacted to stop the sale of inaccurately labeled drugs. In 1970 the Food and Drug Act was rewritten to incorporate all the changes.
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| 1914 Harrison Narcotic Act | Enacted because of the excessive number of opium addicts in the United States.
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| 1938 Food, Drug, and Cosmetic Act | This law required drug companies to include package inserts and directions to the consumer regarding use and package inserts on drugs. This act also provided the legal status for the Food and Drug Administration (FDA)
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| 1951 Durham-Humphrey Amendment | Required labeling "Caution: Federal law prohibits dispensing without a prescrition." It made the initial distinction between legend drugs (by prescription only) and over-the-counter medications (OTCs)
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| 1962 Kefauver-Harris Amendments | In an attempt to ensure the safety and effectiveness of all new drugs on the market. The Food and Drug Administration (FDA) was placed in charge of how advertising was handled.
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| 1970 Comprehensive Drug Abuse Prevention and Control Act | Drug Enforcement Agency (DEA) was formed to enforce the laws concerning controlled substances and their distribution. A schedule V drug requires less documentation tahn a schedule II drug.
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| 1983 Orphan Drug Act | Allowed drug companies to bypass the lengthy time requirements of testing a new drug and the costs that accompanied them to provide a medication to persons who had a rare disease. Diseases taht affected fewer than 200,000 persons were waived.
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| 1987 Prescription Drug Marketing Act | This new act required the labeling "Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian.
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| 1990 Anabolic Steroids Control Act | Stiffen regulation on the abuse problems of anabolic steroids and their misuse by athletes.
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| 1990 Omnibus Budget Reconciliation Act (Obra 90) | Deals specifically with practicing pharmacists. Also deals with the specifics of reimbursement for medications. A pharmacist must offer to counsel all patients who recieve new prescriptions.
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| Health Insurance Portability and Accountability Act of 1996 | This bill deals with a patient's right to continuance of health insurance even when changing employers. Changes are related to implementing consent forms.
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Created by:
samiect