Reading...
Play button
Play button
Use LEFT and RIGHT arrow keys to navigate between flashcards;
Use UP and DOWN arrow keys to flip the card;
H to show hint;
A reads text to speech;
12 Cards in this Set
- Front
- Back
|
1848 First Federal Attempt at Regulation
|
Adulterated quininegoven to American soldiers in Mexico
Goverenment steped in Have the right to govern INTERstate more contraversiol as whether of right to govern INTRstate |
|
|
1906 Federal Pure Drug and Food Act
|
Government requires drugs marketed INTERstate to satisfy minimal standards of strength and purity
NOT address efficacy - if drug worked or not |
|
|
1912 Amendment ot 1906
|
First regulation of labeling issue fist use of "misbranded"
Just prevent maing outraugeous claims NOT is drug acually worked |
|
|
1938 Federal Food, Drug and Cosmetic Act
|
Set standards for safety
Enacted because product containing diethylene glycol (antifreeze) had to show now proof of safety Sill NOT show effective |
|
|
1962 Amendment to 1938
|
First set of efficacy standards for both prescription and OTC
Had to notify FDA prior to start of human trials Drugs prior to 1938 exempt |
|
|
1970 Controlled Substance Act
|
Regulates manufacure, distribution and dispensing of controlled substances (physical and psychosocial dependence) everyone except patient
Controlled by DEA |
|
|
Schedule I drugs
|
High Potential Abuse
No accepted medical use No refills Doesnt liimit availibilit but makes it illegal |
|
|
Schedule II drugs
|
High Potential Abuse
Yes Accepted Medical use No refills accept emergency physicain must present RX in 72 hours |
|
|
Schedule III drugs
|
Moderate potential abuse
Yes accepted medical use 5X or 6 months refills |
|
|
Schedule IV drugs
|
Low potential abuse
Yes accepted medical use 5X or 6 months refills |
|
|
Schedule V drugs
|
Lowest potential abuse
Yes accepted medical use 5X or 6 months refills |
|
|
Dietary Supplement Health and Education Act 1994
|
Product having one or more of Vitamin, Mineral, Herb, AA, dietry supplement used to suppleentthe diet by increasing the total dietary intake
MUST carry disclaimer saying that claims have NOT been evaluated by FDA |
