Regulation History Flashcards
Which law was made in 1906?
Pure Food and Drug Act
-focussed on adultery and misbranding
-focussed on manufacturing, storing, shipping, labeling
no safety or efficacy yet
no cosmetics
When is a drug considered misbranded according to the Pure Food and Drug Act?
When the label is false AND misleading
Which Act was published in 1914?
Harrison-Anti-Narcotic Act
-special tax on all persons who produce, import, manufacture, compound, deal, dispense opium or coca leaves and their derivates
What happened in 1937?
Sulfanimide incident
they put sulfanamide in diethylene glycol without any safety testing for people to use –> 100 deaths
it wasn’t illegal
the only legal issue was misbranding
Which Act was published in 1938?
Food, Drug, and Cosmetic Act (FDCA)
Drug has to be safe when used as directed on the label
Drug has to be approved by the FDA
they tried to create the legend drug class for Rx only but failed
Which Act was published in 1951?
Durham-Humphrey Amedment (Prescription Drug Amendment)
-established prescription drug class
-authorized prescription fills and oral (phone) prescriptions
What has led to the Kefauver-Harris Amendment?
Thalidomide incident in Europe
only non-barbiturate sedative, it was commonly used (morning sickness)
-caused Phocomelia
-didn’t really hit the US bc Francis Kelly from the FDA wanted more data on safety before approving it in the US
When was the Kefauver-Harris Amendment published?
1962 Efficacy
What Act was published in 1970?
Controlled Substance Act
lots of drug abuse in the 70s (hippies)
-meth, cocain, heroin, LSD, marijuana
What did the Controlled Substance Act establish?
REGISTRATION
as a form of tracking controlled substances through the system
Who created the Registration after the Controlled Substance Act in 1970?
DEA
Year of Safe Act and Efficacy Act
1938 Safety - Food, Drug, and Cosmetic Act (FDCA)
1962 Efficacy - Kefauver-Harris Amendment
