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STUDY GUIDE FINALS

MS TINA PHARMACY 153 LAZANDRA SINGLETON

FOOD AND DRUG ADMINISTRATION Promulgates rules,regulations,and standards;inspects drug and food facilitiesto ensure public safety regarding drug products DRUG ENFORCEMENT ADMINISTRATION a federal agency established to implement the rules and regulations to enforce the controlled sustances act to combat controlled sustance abuse
FEDERAL FOOD DRUG @COSMETIC ACT IS THE FEDAREL LAW (STATUTE) THROUGH WHICH enforces its rules and regulations pure food @ drug act the law prohibited the adulteration and misbranding of food in interstate commerce in 1906
FOOD,DRUG,AND COSMETIC ACT OF 1938 WAS THE SULFANILAMIDE elixir tragedy of 1937 which caused 107 deaths. DURHAM-HUMPHREY AMENDMENT OF 1951 ALSO REFERRED AS A RX DRUG AMENDMENT RX AND OTC DRUGS "CAUTION:FEDERAL LAW PROHIBITS WITHOUT A RX
KEFAUVER-HARRIS AMENDMENT OF 1962 TO THE FDCA(ALSO KNOWN AS THE DRUG EFFICACYAMENDMENT) REQUIRED THAT ALL NEW DRUGS MARKETED IN THE UNITED STATES HAD TO BE PROVEN BITH SAFE AND EFFECTIVE ORPAN DRUG ACT OF 1983 ARE THOSE USED TO TREAT RELATIVELY RARE DISEASES 7 YEARS PERIOD
POISON PREVENTION PACKAGING ACT OF 1970 THAT WOULD MAKE IT DIFFICULT FOR CHILDREN UNDER AGE 5 TO OPEN, BUT NOT HARD 4 ADULTS. CHILD-RESISTANT CONTAINERS
NATIONAL DRUG CODE NUMBER A NATIONLA DRUG CODE (NDC) NUMBER IS REQUIRED ON ALL OTC AND RX DRUG LABELS. THE NDC # ASSIGN TO NEW DRUGS HAS 11 DIGITS THE 1 FIVE DIGITS IDENTIFY THE MANAUFACTER OF DISTRIBUTER AND THE LAST 6 DIGITS
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