Term
| Pure Food and Drug Act of 1906 |
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Definition
| Prohibited selling mislabeled drugs across states lines and established the Food and Drug Administration (FDA); an amendment in 1912 required the accurate labeling of drugs to prevent substitution or misleading ingredients. |
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Term
| Food, Drug, and Cosmetic Act of 1938 |
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Definition
| A result of the anti-infective drug sulfonamide, Elixir of Sulfonamide (had an industrial-strength liquid solvent in it) poisoned 350 people; the government no longer needs proof of fraud to stop the sale of a drug and the burden of proof is shifted to drug companies |
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Term
| Durham-Humphrey Amendment in 1951 |
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Definition
| Defined prescription drugs as those drugs that could only be given to patients who were under the care of a physician. |
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Term
| Kefauver-Harris Amendment in 1962 |
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Definition
| The result of 8,000 babies in Europe being born with deformed limbs due to a drug developed in West Germany for morning sickness (the FDA refused to approve its use until further studies); this tightened control on existing prescription drugs and new drugs and required drug companies to report adverse affects on new drugs and show that they are both safe and effective before being put on the market. Since then, many drugs have been kept off the market or withdrawn due to lack of safety. |
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Term
| Dietary Supplements and Health and Education Act of 1994 |
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Definition
| Allowed the FDA to set up guidelines for herbal products and dietary supplements; drug companies now liable for any claims against their products in accordance with the FDA guidelines. |
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Term
| FDA Modernization Act of 1997 |
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Definition
| Gave authority to FDA to accelerate the approval for certain types of drugs. |
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Term
| Emergency Treatment Investigational New Drug (IND)/Compassionate IND |
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Definition
| FDA Application that allows physicians to prescribe some investigational drugs before their officially approved for marketing (1987, this was done for the first HIV drug) |
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Term
| Medicare Prescription Drug, Improvement, and Modernization Act of 2006 |
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Definition
| Created Medicare Part D, a federal program that pays part of cost of prescription for senior citizens. |
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Term
| Health Insurance Portability and Accountability Act of 1996 |
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Definition
| All healthcare settings must provide patients with a statement that verifies that their health record information, including all drug information, is kept secure and is only released in response to authorized inquires from other healthcare providers, insurance companies, or healthcare quality monitoring organizations. |
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Term
| FDA Safety and Administration Act of 2012 |
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Definition
| Gives the FDA authority to enhance the safety of drug supplies by imposing larger penalties for refusing or limiting inspections and producing adulterated or counterfeit drugs; also includes "breakthrough therapy" which is a tool to help the FDA to help a drug company speed up reviews of clinical evidence if a new drug shows substantial improvement in therapy over other drugs already on the market. |
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Term
| Harrison Narcotics Act of 1914 |
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Definition
| Regulated drugs with the potential for abuse and dependence; first introduced to the word narcotic. |
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Term
| Comprehensive Drug Abuse Prevention and Control Act of 1970 |
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Definition
| Replaced the Harrison Narcotics Act of 1914; also established the DEA (1973) in Title II and divided potentially addictive drugs into 5 categories or schedules. |
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Term
| Drug-Induced Rape Prevention and Punishment Act of 1996 |
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Definition
| Made it illegal to give a controlled substance to any person without their knowledge; specifically targeted the illegal use of a "date-rape drug" to make a person unconscious before sexually assaulting them |
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Term
| Federal Analogue Act of 1986 |
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Definition
| States that any substance that is similar to a Schedule I or Schedule II drug could be treated as if it were a schedule drug. |
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Term
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Definition
| Its purpose is to facilitate the development of new drugs to treat rare diseases (fewer than 200,000 people in the US); provides financial incentives to drug companies, such as a tax credit, a streamlined process for obtaining FDA approval, and exclusive marketing rights for 7 years |
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