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- require that labels not contain false info of a drug's strength and purity.
- first Federal law regulating drugs
- Prevented the manufacture, sale or distribution of innacurately labeled food and drugs across state lines
PURE FOOD AND DRUG ACT (1906)
- Called for the creation of the FDA
- Required all drug manufactures to file a new drug application (NDA) to provide evidence of a drug's safety before any frug could be approved for the market.
FOOD, DRUG, AND COSMETIC ACT (1938)
- this amendment to the Food, Drug, and Cosmetic Act established clear criteria for the classification of prescription or nonprescription OTC meds
- Also authorized the taking of verbal prescriptions and the refilling of prescriptions
DURHAM-HUMPHREY AMENDMENT (1951)
- This amendment required that all medications be pure, safe and effective for use in humans
- Also required all drug manufacturers to file an investigation new drug application (INDA) before starting a clinical trial to humans
KEFAUVER-HARRIS AMENDMENT (1963)
- Also known as the controlled substance act
- required the pharmaceutical industry to keep records and implement measures for certain medications to prevent and controll drug abuse
- divided controlled substances into 5 schedules, or classes based on their potential for abuse
COMPREHENSIVE DRUG ABUSE PREVENTION AND CONTROL ACT (1970)
- Established standards for Child-resistant packaging
- required that some OTC meds and almost all legend drugs be packaged in child resistant containers
POISON PREVENTION PACKAGING ACT (1970)
Assigns a unique drug code to each medication as the NAtional Drug Code (NDC)
DRUG LISTING ACT (1972)
- also known as the Drug Price Competition and Patent-Term Restoration Act
-Ensured that brand-name drug manufacturers would have patent protection
- also created a generic drug-approval process and established .......
WAXMAN-HATCH ACT (1984)
-Focused on reforming the regulation of food, medical products and cosmetics
- Changed labeling requirements of all legend drugs from "Caution: Federal Law..... " to "RX only"
FOOD AND DRUG ADMINISTRATION MODERNIZATION ACT (1997)
- requires that pharmacies that fill prescriptions for Medicaid, obtain, record and maintain basic patient information
- Also says that each state must require pharmacists to offer counseling on all aspects of drug therapy to patients
OMNIBUS BUDGET RECONCILIATION ACT (OBRA) (1990)