Term
| Food and Drug Act of 1906 |
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Definition
| Prohibited interstate commerce in adulterated or mis-branded food, drinks, and drugs. Gov't pre-approval of drugs is required. |
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Term
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Definition
| In response to the growing addiction to opiates, manufacturers, pharmacists, importers, and physicians must be licensed and taxed to perscribe narcotics. |
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Term
| Food, Drug, and Insecticide Administration of 1927 |
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Definition
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Term
| Food, Drug, and Cosmetic Act of 1938 |
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Definition
| Law requires that all new drugs must show that they are safe for consumption before marketing. |
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Term
| Alberty Food Products v. US of 1950 |
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Definition
| The purpose of the drug must be indicated on the label |
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Term
| Durham-Humphrey Amendment of 1951 |
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Definition
| Law defines what drugs require a prescription by a licensed practitioner and requires medicines to include the Legend "Federal Gov't prohibits dispension without a prescription" |
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Term
| Kefauver-Harris Amendment of 1962 |
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Definition
| Requires drug manufacturers to provide proof of both drug safety and effectiveness before marketing. |
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Term
| Fair Packaging and Labeling Act of 1966 |
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Definition
| Requires all consumer products in interstate commerce to be honestly and informatively labeled |
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Term
| Poison Prevention Packaging Act of 1970 |
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Definition
| Requires child-proof packaging on all controlled and most prescription drugs dispensed in pharmacies. Non-Child-Proof caps can only be used if requested by the patient. |
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Term
| Controlled Substance Act of 1970 |
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Definition
| The CSA classifies 5 levels of drugs that have potential for abuse and therefore restricts their distribution. The DEA was established for this enforcement. |
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Term
| Medical Device Amendment of 1976 |
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Definition
| Requires pre-market approval for safety and effectiveness of life-sustaining and life-supporting medical devices. |
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Term
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Definition
| Provides incentives to promote research, approval, and marketing of drugs needed for the treatment of rare diseases. |
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Term
| Drug Price Competition and Patent Term Restoration Act (Hatch-Waxman) of 1984 |
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Definition
| Allows for both the extension of drug patent terms and quicker introduction of lower-cost generic drugs. |
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Term
| Prescription Drug Marketing Act of 1987 |
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Definition
| Restricts distribution of prescription drugs to legitimate commercial channels and requires drug wholesalers to be licensed by the states. |
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Term
| Omnibus Budget Reconciliation Act(OBRA) of 1990 |
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Definition
| Among other things, this act requires pharmacists to offer counseling to Medicaid patients regarding medications. |
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Term
| Anabolic Steroid Control Act of 1990 |
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Definition
| This act was passed to address the abuse of steroids by athletes and youngsters. |
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Term
| Health Insurance Portability and Accountability Act (HIPAA) of 1996 |
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Definition
| Defined the scope if health information that may and may not be shared among health care providers without patient consent and provided for broad and stringent regulations to protect patients' rights to privacy. |
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