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Pharmacy Law

QuestionAnswer
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
Created by: jboh