Term
| pure food and drug act 1906 |
|
Definition
| act that prohibited the sale of poor quality food and drug products |
|
|
Term
pure food and drug act amendment 1912
US vs. Johnson |
|
Definition
| act that prohibited false and fraudulent claims by manufacturers |
|
|
Term
| Harrison Narcotic act 1914 |
|
Definition
| act that regulated distribution of narcotics |
|
|
Term
| federal food drug and cosmetic act 1938 |
|
Definition
| no drug can be marketed unless safe for use (direction on label), limited by pharmacist, NO refills |
|
|
Term
|
Definition
| lawsuit that established to put direction on drug bottle |
|
|
Term
| Durham-humphry amendment 1951 |
|
Definition
defined misbranding of drug: selling the drug w/o prescription is doing an act which causes the drug
to be misbranded while being held for sale
two classes of drugs- legend, non-legend.
-yes refill |
|
|
Term
| ○ Food additive amendment of 1958 |
|
Definition
| ● This law enforced safety of additives |
|
|
Term
| ○ Kefauver-Harris Amendment 1962 |
|
Definition
● The act said all new drugs marketed in US must be safe and effective, regulated drug advertisement,
gave authority over drug safety from FTC to FDA, enforced minimum requirements to manufacture pharmacy products in the US |
|
|
Term
| ○ Medical device Amendment 1976 |
|
Definition
| ● Act removed dangerous and useless medical devices, testing and reporting required for devices, classification of device |
|
|
Term
|
Definition
| ● Encouraged orphan drugs to be produced |
|
|
Term
| ○ Drug price competition and patient term restoration act of 1984 |
|
Definition
| ● Helps to bring generic drugs to market faster, extends some paten to innovative drug |
|
|
Term
| ○ Prescription drug marketing act of 1987 |
|
Definition
| ● Controls distribution of drug coupons and samples |
|
|
Term
| ● Nutrition labeling and education act 1990 (NLEA), Dietary supplement act of 1992 (DSA), dietary supplement health and education act (DSHEA) 1993/1994 all established: |
|
Definition
○ Regulation of health claim for non drug supplements, diet supplements, herbals, and food
○ Definitions of disease, drug, health claim, diet supplements
■ Written warnings for above products: “This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease” |
|
|
Term
| ○ Prescription drug use fee act of 1992 |
|
Definition
| ● Increased fees to manufacturer for approval process |
|
|
Term
| ○ FDA modernization act of 1997 |
|
Definition
| ● New legend now reads “Rx only” unless misbranded; for lebel errors especially small containers |
|
|
