Laws Flashcards
Pure Food and Drug Act of “?”
1906
Banned states from buying/selling drugs that are mislabeled or adulterated.
“Pure” from mislabeled/adulterated drugs.
Sherley Amendment of “?”
1912
Prohibits false medical claims for medications with the intent to trick the consumer.
“Sherley this can’t be true?”
Food, Drug, and Cosmetic Act of “?”
1938
-Required new drugs to be proven safe before marketing.
-All drugs must have labels with directions safe
-Gave FDA the authority to regulate cosmetics and medical devices
Durham-Humphrey Amendment of 1951
Established the two classes of medication.
Kefauver-Harris Amendment of 1962
Requires all drugs to be pure, safe, and effective. Created procedures for investigational drugs.
Poison Prevention Packaging Act of “?”
1970
Made to reduce accidental poisoning in children. 90% of adults, 80% of children.
Occupational Safety and Health Act of “?”
1970
Set standards for a safe work environment.
Drug Listing Act of 1972
Created NDC numbers. NDC = 5/4/2
Medical Device Amendment of 1976
Helped classify medical devices by their function.
Orphan Drug Act of 1983
Created incentives for drug manufacturers to make drugs for rare diseases.
Drug Price Competition and Patient Term Restoration Act of 1986
Hatch-Watchman Act
Shortcut to approve generics faster.
Prescription Drug Marketing Act of 1987
Banned the sale of prescription drug samples and required wholesalers to be licensed by state.
Omnibus Budget Reconciliation Act of “?”
1990 OMBRA
Must offer patient counseling by pharmacist.
Resource Conservative and Recovery Act
Gives EPA the authority to control hazardous waste from cradle to grave.
Health Insurance Portibility and Accountability Act of 1996
Privacy of PPI
