1906 Pure Food & Drug Act - Prohibits the sale of adulterated & misbranded drugs., 1938 Food, Drug, & Cosmetic Act - Created the FDA & required NDA (New Drug Applications) to be filed with the FDA., 1951 Durham -Humphrey Amendment - Established Legend (not safely used without medical supervision and manufacturer’s label carries Federal Legend or RX Only) verses Over the Counter (OTC) drugs., 1962 Kefauver-Harris Amendment - Requires drugs be proven Safe & Effective through clinical drug trials as a result of Thalidomide birth defects., 1970 Controlled Substances Act - Established 5 schedules of substances according to their potential for Abuse and Addiction. CI, CII, CIII, CIV, CV, 1983 Orphan Drug Act - Provides orphan status to drugs and biologics that are intended for use in rare diseases (affecting fewer than 200,000 people in the US), 1990 Omnibus Budget Reconciliation Act (OBRA) of 1990Mandates that a pharmacist must try to counsel on all new prescriptions and offer counseling on refilled prescriptions. - Mandates that a pharmacist must try to counsel on all new prescriptions and offer counseling on refilled prescriptions., 1996 Health Insurance Portability & Accountability Act (HIPAA) - Protects private patient information. Breeches of information can result in Job Loss, Possible Jail Time, and Hefty Fines., 1997 FDA Modernization Act - Allows “RX ONLY” to replace the lengthy Federal Legend on the manufacturer’s label of prescription medications., 2005 Combat Methamphetamine Act - Limits and restricts the sale of pseudoephedrine-containing products to 9 grams or 3 packages within 30 days., Drug Supply Chain Security Act (DSCSA) - Identifies and traces certain prescription drugs as they are distributed to reduce diversion of drugs and to prevent counterfeit drugs from entering the supply chain.,

Historical Pharmacy Acts

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