Laws and ethics Flashcards
Food and Drug administration
Regulates Applications for new drugs medical devices and other products
Food Drug and Cosmetic act of 1938
Added cosmetic and labeling regulations
Must have May be habit forming
developed US Pharmacopoeia USP
National formulary
Pure drug and food act of 1996
All manufacturers are required to properly label a drug with truthful information
Harrison narcotics tax act of 1914
stopped recreational use of opium
Sulfanilamide tragedy of 1937
Led to the food drug and cosmetics act
Durham-Humphrey amendment of 1951
Added fed law prohibits dispensing without a rx
Thalidomide tragedy of 1962
10000 kids born with phocomelia
Kefauver- Harris amendment of 1962
Gave the FDA the authority to approve or reject a manufacturers marketing application before the drug was to become available for consumer or commercial use
Poison prevention packaging act of 1970
Require manufacturers and pharmacies to secure our medications and containers with childproof caps or packaging
Drug listing act
implemented the national drug code number NDC
Medical device amendment of 1976
Establishes three regulatory classes for a medical devices
Medical device amendment class 3
devices are most regulated ones and pose High risk for human use they require pre-market approval application that they are the equivalent to a new drug application
Medical device amendment class 2
devices are performed standard devices and they are considered moderate risk for human use
Medical device amendment class 1
devices are generally control devices with a low risk for human use
The resource conservation and recovery act of 1976
Give the EPA complete authority in the disposal of hazardous substance
