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Important Drug Laws
| Term | Definition |
|---|---|
| The 1906 Pure Food and Drug Act: | Enforces accurate labeling, list of ingredients, and Patient Package Insert. |
| The 1914 Harrison Narcotics Act: | Enforces documentation for prescriptions and dispensing opium, cocaine, and derivatives products. |
| The 1938 Federal Food, Drug, and Cosmetic Act: | Addressed adulteration and misbranding of drugs; based on the 1906 Pure Food and Drug Act. |
| The 1951 Durham-Humphrey Amendment: | Made the distinction between legend drugs (prescriptions) and over-the-counter (OCTs) medications that do not require a prescription. |
| The 1962 Kefauver-Harris Amendments: | Gave the FDA specific authority to approve a manufacturer’s marketing application before a drug could be available for commercial use. |
| The 1970 Controlled Substance Act: | The DEA was formed to enforce the laws concerning controlled substances and their distribution. |
| The 1990 Omnibus Budget Reconciliation Act (OBRA 90): | Provided better quality care for elderly on Medicare (quality of hospice care went up) and allowed commercial pharmacies to work with customers who had Medicaid. |