pharmacy law Flashcards
Food and Drug Act of 1906
Prohibits interstate commerce in adulterated or misbranded food, drinks and drugs. Govt preapproval of drugs is required
1927 Food, Drug and Insecticide Administration
The law enforcement agency is formed renamed as the Food and Drug Administration (FDA)
What year was the Food Drug and Insecticide Administration named changed
1930
1950 Alberty Food products v. US
The U.S. court of appeals ruled that the purpose for which a drug is to be used must be included on its label
1914 Harrison Narcotics Tax Act
Established that manufactures, pharmacists, importers, and physicians prescribing narcotics should be licensed and required to pay a tax
What prompted the 1914 Harrison Narcotics Tax Act
A response to growing addiction to opiates and cocaine containing medicines
1938 Food Drug and Cosmetic Act
Requires that before any new drug can be marketed it must be proven safe when used according to directions on its label
What prompted the 1938 FDC act
A response to a fatal poisoning of 107 people many of whom were children
Which drugs were grandfathered in after the FDC act passed
drugs marketed before 1938 which includes:
Levothyroxine
Digoxin
Nitroglycerin
phenobarbital
Effects of the FDC act
established the FDA and the legal framework for its operation. Also has many amendments
1951 Durham-Humphrey Amendment
Established two classes of drugs: Legend and Over the counter. Also allows for the provision of telephoned prescriptions and prescription refills
What is the definition of Legend drugs
Drugs that require a prescription by a licensed practioner
What are Legend drugs required to include in their label
“caution: federal law prohibits dispensing without a prescription” or RX only
1962 Kefauver-Harris Amendment
An amendment to the FDC act. Required all new drug marketed must first be shown to be safe and effective.
