Question | Answer |
Pure Food and Drug Act 1906 | Stopped sale of inaccurately labeled drugs; all statements must be truthful |
Harrison Narcotic Act 1914 | prevented dispensing of opium without a prescription |
The Food, Drug, Cosmetic Act of 1938 | Created the FDA;stopped adulteration and misbranding on drug labels. Narcotics had to be labeled "May be habit forming"; Required package inserts for medications |
The Durham-Humphrey Act of 1951 | "Caution: Federal law prohibits dispensing without a prescription" |
The Kefauver-Harris Amendment 1962 | Required all medicines be safe and effective (after Thalidomide tragedies) |
The Comprehensive Drug Abuse Prevention and Control Act of 1970 | AKA The Controlled Substances Act; created classes or schedules of narcotics |
The Poison Prevention Packaging Act of 1970 | child-resistant caps on medications; must prevent 80% of children from opening while allowing 90% of adults to open |
The Drug Listing Act 1972 | Created NDC (National Drug Code) |
The Occupational Safety and Health Act of 1970 | OSHA- provide a safe and healthy workplace; MSDS for chemicals |
The Orphan Drug Act of 1983 | offered drug companies monetary incentive to produce drugs for rare diseases that affect less than 200,000 people; e.g. early HIV drugs |
Prescription Drug Marketing Act 1987 | controlled drug use in animals |
The Dietary Supplement Health and Education Act of 1994 | Labeling requirements and regulatory framework for nutritional supplements; required FDA must prove a product is harmful |
Omnibus Budget Reconciliation Act of 1990 (OBRA) | Medicaid implements DUR/ DUE so pharmacists must review patient's drug profile. "Do you have any questions for the pharmacist?" |
The Health Insurance Portability and Accountability Act of 1996 | HIPAA- helped workers remain insured, prevent insurance companies from refusing coverage based on preexisting conditions, patient confidentiality |
2005 Combat Meth Act | Controlled sale of pseudoephedrine. 9g within 30 days |
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