Drug Laws Flashcards
1
Q
1906 Pure Food and Drug Act
A
Accurate labeling of drug products
2
Q
1912 The Shirley Amendment
A
- Strengthened the 1906 law
- Prohibited fraudulent therapeutic claims of drug effectiveness
3
Q
1938 Food, Drug & Cosmetics Act
A
- Drugs meet standards of purity and strength
- FDA established and charged with enforcing the law
- FDA control over drug safety
4
Q
1951 Durham - Humphrey Amendment
A
Some drugs designated / must be prescribed by a licensed HCP & dispensed by a pharmacist
5
Q
1962 Kefauver - Ham’s Amendment
A
- More extensive testing on new drugs required
- Manufacturers must provide safety
- FDA still to establish official names for uniformed nomenclature
- Gov’t gave federal authority to standardize
6
Q
1970 Comprehensive Drug Abuse Prevention & Control Act
A
Regulated distribution of narcotics
7
Q
1993 NIH Revitalization Act
A
Included women and minorities in NIH research studies
8
Q
2005 Combat Methamphetamine Epidemic Act
A
Regulates OTC sale of ephedrine, pseudoephedrine, & phenyl propanolamine