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Drug Regulation Law
Federal Law affecting the practice of pharmacy
| Question | Answer |
|---|---|
| Pure Food and Drug Act of 1906 | Enacted to prohibit the interstate transportation or sale fo adulterated and misbranded food or drugs. |
| Food, Drug, And Cosmetic Act of 1938 (FDCA 1938) | clearly defined adulteration and misbranding of drugs and food products. |
| Durham-Humphrey Act of 1951 | An amendment to FDCA 1938 requiring all products to have adequate directions for use unless they contain the federal legend "Caution: Federal law prohibits dispensing without a prescription" or "Rx Only." |
| Kefauver-Harris Amendment of 1962 | Requires all medications in the United States to be pure, safe, and effective. |
| Comprehensive Drug Abuse Prevention and Control Substances Act (CSA)of 1970 | The Druge Enforcement Agency (DEA) was created and placed under the supervision of the Dep of Justice. Controlled supstances are placed in one of 5 schedules (classifications & categories) based on potential fo abuse and accepted medical use in the USA. |
| 1966 Fair Packaging and Labeling Act | This reuires all consumer products in interstate commerce to be honestly and informatively labeled. |
| 1970 Poison Prevention Packaging Act | Requires child-proof packaging on all controlled and most prescription drugs dispensed by pharmacies. Non-child-proof containers may only be used if the prescriber or patient requests one. |
| 1987 Prescription Drug Marketing Act | Restricts distribution of prescription durgs to legimate commercial channels and requires drug wholesalers to be licensed by the states. |
| 1990 Omnibus Budget Reconciliation Act (OBRA) | Among other things, this act reequires pharmacist to offer conseling to Medicaid patients regarding medications. |
| 1990 Anabolic Steroid Control Act | This act was passed to "address the abuse of steriods by athletes, and especially, youhgsters and teenagers." |
| 1996 Health Insurance Portability and Accountability Act (HIPPA) | Among other things this act defined the scope of 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 right to privacy. |
| The Medical Device Amendments of 1976 | followed a U.S. Senate finding that faulty medical devices had caused 10,000 injuries, including 731 deaths. The law applied safety and effectiveness safeguards to new devices. |
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