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Dawndawn
chapter 2 laws
| Question | Answer |
|---|---|
| 1906 Federal Food and Drug Act | All manufacturers were required to put truthful information on the label before selling their drugs |
| 1914 Harrison Narcotic Act | Individuals could no longer obtain opium without a prescription, making it harder to get. |
| 1938 Food Drug and Cosmetic Act | Legal status for FDA, Defined the exact labeling for products and defined misbranding and adulteration as being illegal. Required drug companies to include directions for consumers |
| 1951 Durham-humphrey Amendment | Certain drugs require a doctor's order and supervision. |
| 1962 Kefauver-Harris Amendments | Ensures the safety and effectiveness of all new drugs on the market. Drug companies have burden of insuring saftey and effectiveness of drugs. |
| 1970 Comprehensive Drug Abuse Prevention And Control act | DEA is formed to enforce the laws concerning controlled substances. A stair step schedule of controlled substances requires stricter rules as the drug rating increases |
| 1983 Orphan Drug Act | Allows companies to bypass lengthy time requirements of testing a new drug and the costs that accompanied testing to provide a medication to persons who have a rare disease |
| 1987 Prescription Drug Marketing Act | Veterinarians must wriet prescriptions before people can buy drugs for their animals |
| 1990 Omnibus Budget Reconciliation Act | Pharmacists must council patients with new prescriptions. All patients must be given info on the drug that they are taking, it's name when to take it how long to take it and any side effects or possible interactions |
| 1996 Health Insurance Portability and Accountability Act | HIPAA Patient's right to continuing health insurance even when changing employers, protection of individual's private health information. |
| 2005 Combat Meth Act | Only a licenced pharmacist or technician may dispense, sell or distribute pseudoephedrine. Can only sell one person 9 g within a 30 day period |
| 1967 Fair packaging and Labeling Act | FPLA Label must show net contents, name and place of business of the manufact. net quantitiy of contents weight, numerical count. Must be in metric and Us units |
| 1972 Drug Listing Act | DLA Amends the food drug and cosmetic act, prevents unfair packaging and labeling |
| 1990 Anabolic Steroids Control Act | ASCA Stiffened regulations on abuse problems because of misuse by athletes |
| 1990 Humanitarian Device Exemption Safe Medical Devices Act | SMDA Encourages development of devices intended to benefit patients in the treatment and diagnosis of diseases affecting 4000 or fewer Individuals in the US |
| 1990 Nutrition Labeling and Education Act | NLEA Covers food items and their labeling, Vitamins minerals and nutrients are on the label |
| 1994 Dietary supplement health and education act | NLEA Labels cannot mislead consumer, must include nutritional values and dietary supplements such as herbs, ginseng, garlic fish oil etc. |
| 1997 Food and Drug Administration Modernization Act | FDAMA People have a wider and more timely access to information on new meds |
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Dawndawnpillpusher
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