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Time line Drug reg.
Drug regulations Time line
| Question | Answer |
|---|---|
| Food and drug Act of 1906 | Prohibited interstate commerce in adulterated or misleading food, drinks, drugs. Government pre-approval of drugs is required. |
| Food, Drug and inspection Administration of 1927 | The law enforcement agency was formed and renamed in 1930 as the Food and drug administration. (FDA) |
| Food, drug and cosmetic Act of 1938 (FDC) | IN responce to the fatal poisoning of 107 people by untested sulfanilamide concoction, this comprehensive law requires new drugs to be shown to be safe before marketing. |
| Durham-Humphrey Admendment 1951 | This law defines what drugs require a prescription by a licensed practitioner and requires them to incluse this Legend on the label. (Caution: federal law prohibits dispensing without a prescription" or more recent "RX only". |
| Kefauver-Harris Amendment 1962 | Requires a manufacturers to provide proof of both safety and effectiveness before marketing the drug. |
| Poison prevention packaging act of 1970 | Child proof packaging. Non-child proof containers may only be used if the prescriber or the patient requests one. |
| Controlled Substances Act of 1970 | Classifies 5 levels of drugs (controlled substances) that have potential for abuseand therefore restricts their distribution. |
| Orphan drug act of 1983 | PRovides incentives to promote research, approval, and marketing of drugs needed for the treatment of rare diseases. |
| Hatch-Waxman 1884 | This act allowed for both the extention of drug patent terms and quicker introduction of lower cost generic drugs. |
| Omnibus Budget reconciliation Act 1990 (OBRA) | Requires pharmacists to offer counseling to Medicain patients regarding medications. |
| Health Insurance Portability and accountability Act 1996 (HIPAA) | Defined the scope of health information that may or may not be shared among healthcare providers without patients consent. Protect patients rights. |
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