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WTI Extern Legisl.
WTI Extern Federal Drug Legislation
| Act | What It Did |
|---|---|
| Food and Drug Act of 1906 | Pharmaceuticals had to comply with their stated standards of strength, purity, and quality. |
| Federal Food, Drug, & Cosmetic Act of 1938 | Pharmaceutical products have to be safe for human use. |
| Durham-Humphrey Amendment of 1952 | Regulated the refilling of prescription drugs. |
| Kefauver-Harris Amendment of 1962 | Required drugs to be safe and efficacious. |
| Comprehensive Drug Abuse Prevention and Control Act of 1970 | Created five drug “schedules”, I through V, for the classification and control of drugs that might be abused. |
| Occupational Safety and Health Act of 1970 | Part of the U.S. Department of Labor. The mission is to ensure workplace safety and a healthy environment within the workplace. |
| Poison Prevention Packaging Act of 1970 | Requires that most OTC and legend drugs be packaged in child-resistant containers. |
| Drug Listing Act of 1972 | Under this act, each new drug is assigned a unique, permanent product code known as a National Drug Code (NDC) that identifies the manufacturer or distributor, the drug formulation, and the size and type of its packaging. |
| Omnibus Budget Reconciliation Act of 1990 | Requires pharmacists to discuss information about new and refill prescriptions with Medicare and Medicaid recipients |
| Prescription Drug Marketing Act of 1987 | Deals with safety and competition issues raised by secondary markets for drugs, and it prohibits the reimportation of a drug into the U.S. by anyone but the manufacturer. |
| Orphan Drug Act of 1983 | Offers federal financial incentives to commercial and nonprofit organizations to develop and market drugs previously unavailable in the U.S. |
| Dietary Supplement Health and Education Act of 1994 | Clarified the regulatory framework applicable to nutritional supplements and created specific labeling requirements. |
| Health Insurance Portability and Accountability Act of 1996 | A federal legislation that requires all healthcare providers, including pharmacies, to protect patient information from unauthorized use and disclosure. It is referred to as the Privacy Rule. |
| Combat Methamphetamine Epidemic Act of 2005 | Designed to stop illegal use of drugs such as methamphetamine, crack cocaine and others. It is an extension of the Patriot Act. |
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