NUR./144./-./Drug./Development
./
1. Food./and./Drug./Act./of./1906:./-./first./federal./law./to./regulate./drugs
- prohibits./the./sale./of./misbranded./and./adulterated./drugs
2. The./Sherely./Amendment./(1912):./prohibited./fraudulent./therapeutic./claims
3. The./Harrision./Narcotics./Tax./Act./(1914):./required./prescription./for./drugs./that./exceeded./narcotic. /
limits
4. The./Federal./Food,./Drug,./and./Comestic./Act./(1938):./empowered./the./FDA./to./ensure./a./drug./
was./safe./before./marketing
5. Durham-Humphrey. / Amendment. / of. / 1951:. / distinguished./between./OTC./and./prescription./drugs
6. Kefauver-Harris. / Amendment. / of. / 1962:. / -
./tightened./contols./on./drug./safety,./especially./experimen-tal./drugs
- strengthened./FDA./drug./regulation,./requiring./manufacturers./to./prove./both./the./safety./and./ettectiveness./of./new./dr
ugs./before./marketing
7. Drug./Abuse./Control./Amendments./(1965):./attempted./to./control./the./abuse./of./depressants,./
stimulants,./and./hallucinogens.
8. Comprehensive./Drug./Abuse./Prevention./and./Control./Act./of./1970:./-
./promote./drug./education./and./research./in./order./to./prevent./and./treat./drug./dependence
- strenghting. / of. / enforcement. / authority
- established./treatment./and./rehabilitation./facilities
- created./schedules./for./controlled./substances
9. The./Orphan./Drug./Act./(1983):./promotes./the./development./and./manufacture./of./drugs./used./in./the
./treatment./of./rare./disease
10. Dietary. / Supplement. / Health. / and. / Education. / Act. / (1994):. / established./labeling./require
-ments./for./dietary./supplements
11. Health./Insurance./Portability./and./Accountability./Act./(1996):./-./protects./health./insur-
ance./coverage./for./workers./who./change./or./lose./their./jobs
- sets./the./standards./for./the./privacy./of./individually./identified./health./information
12. The./Food./Drug./Administration./Modernization./Act./(1997):./-
./the./review./and./use./of./new./drugs./are./acclerated
- drugs./can./be./tested./on./women,./minorities,./and./children./before./markting
- clinical./trial./data./are./necessary./for./experimental./drug./use./for./serious./or./life-threatening./health./conditions
- drug./companies./that./plan./to./discontinue./drugs./must./inform./health./professionls./and./patients./at./least./6./mont
hs./before./stopping./drug./production.
./ .
/
./
1. Food./and./Drug./Act./of./1906:./-./first./federal./law./to./regulate./drugs
- prohibits./the./sale./of./misbranded./and./adulterated./drugs
2. The./Sherely./Amendment./(1912):./prohibited./fraudulent./therapeutic./claims
3. The./Harrision./Narcotics./Tax./Act./(1914):./required./prescription./for./drugs./that./exceeded./narcotic. /
limits
4. The./Federal./Food,./Drug,./and./Comestic./Act./(1938):./empowered./the./FDA./to./ensure./a./drug./
was./safe./before./marketing
5. Durham-Humphrey. / Amendment. / of. / 1951:. / distinguished./between./OTC./and./prescription./drugs
6. Kefauver-Harris. / Amendment. / of. / 1962:. / -
./tightened./contols./on./drug./safety,./especially./experimen-tal./drugs
- strengthened./FDA./drug./regulation,./requiring./manufacturers./to./prove./both./the./safety./and./ettectiveness./of./new./dr
ugs./before./marketing
7. Drug./Abuse./Control./Amendments./(1965):./attempted./to./control./the./abuse./of./depressants,./
stimulants,./and./hallucinogens.
8. Comprehensive./Drug./Abuse./Prevention./and./Control./Act./of./1970:./-
./promote./drug./education./and./research./in./order./to./prevent./and./treat./drug./dependence
- strenghting. / of. / enforcement. / authority
- established./treatment./and./rehabilitation./facilities
- created./schedules./for./controlled./substances
9. The./Orphan./Drug./Act./(1983):./promotes./the./development./and./manufacture./of./drugs./used./in./the
./treatment./of./rare./disease
10. Dietary. / Supplement. / Health. / and. / Education. / Act. / (1994):. / established./labeling./require
-ments./for./dietary./supplements
11. Health./Insurance./Portability./and./Accountability./Act./(1996):./-./protects./health./insur-
ance./coverage./for./workers./who./change./or./lose./their./jobs
- sets./the./standards./for./the./privacy./of./individually./identified./health./information
12. The./Food./Drug./Administration./Modernization./Act./(1997):./-
./the./review./and./use./of./new./drugs./are./acclerated
- drugs./can./be./tested./on./women,./minorities,./and./children./before./markting
- clinical./trial./data./are./necessary./for./experimental./drug./use./for./serious./or./life-threatening./health./conditions
- drug./companies./that./plan./to./discontinue./drugs./must./inform./health./professionls./and./patients./at./least./6./mont
hs./before./stopping./drug./production.
./ .
/
