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Food and Drug Act (1906)
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Sherley Amendment (1912)
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drug laws
| Term | Definition |
|---|---|
| Food and Drug Act (1906) | Outlaws states from buying and selling food, drinks, and drugs that have been mislabeled and tainted. |
| Sherley Amendment (1912) | Outlaws labeling drugs with fake medical claims meant to trick the buyer. |
| FDA (1930) | Food and Drug Administration is named. |
| Federal Food, Drug, and Cosmetic (FDC) Act of 1938 | Requires new drugs to be proven safe prior to marketing; starts a new system of drug regulation; requires safe limits for unavoidable poisonous substances; and allows for factory ispections. |
| Durham-Humphrey Amendment (1951) | Defines the types of drugs that cannot be used safely without medical supervision and limits the sale to prescription only by medical professionals. |
| Kefauver-Harris Drug Amendments (1962) | Requires manufacturers to prove that their drugs are effective prior to marketing. |
| Over-the-Counter Drug Review (1972) | Nonprescription medications must be safe, effective and appropriately labeled. |
| Tamper-Resistant Packaging Regulations (1982) | Makes it a crime to tamper with packaged products and requires tamper-proof packaging. |
| Drug Price Competition and Patent Term Restoration Act (Hatch-Waxman Act) ( 1984) | Allowed FDA to approve generic versions of brand-name drugs without repeating research to prove safety and efficacy; allowed brand-names to apply for 5 years of additional patents for new drugs to make up for lost time while going through FDA approval |
| Prescription Drug Marketing Act (1988) | Designed to eliminate diversion of products from legitamate channels of distribution and requires wholesalers to be licensed. |
| Food and Drug Administration Modernization Act (1997) | Expands scope of agency activities and moves agency to the Department of Health and Human Services (DHHS) |
| Medicare Prescription Drug Improvement and Modernization Act of 2003 | Includes Medicare Part D which increases access to medications through private insurers. |
Created by:
mstevenson
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