Dds Prelims

Front 1

Category B

Back 1

Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women

Front 2

Category C

Back 2

Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant woman despite potential risks

Front 3

Category D

Back 3

There is positive evidence of human fetal risk based on adverse rxn data from investigational or marketing experience or studies in humans but potential benefits may warrant use of the drug in pregnant women despite potential risks

Front 4

Category X

Back 4

Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse rxn data from investigational or marketing experience and the risks involved in the use of the drug in pregnant women clearly outweigh potential benefits

Front 5

Drug listing act of 1972

Back 5

Provide fda legislative authority to compile a list of marketed drugs to assist in the enforcement of federal laws requiring that drugs be safe and effective and not adulterated or misbranded

Front 6

Drug price competition and patent term restoration act of 1984

Back 6

Applications for generic copies of an originally approved new drug can be filed through an abbreviated new drug application (anda); extensive animal and human studies are not required

Front 7

Prescription Drug Marketing Act of 1987

Back 7

Act is intended to reduce the risk of adulterated, misbranded, repackaged and mislabeled drugs entering the legitimate marketplace through "secondary sources"

Front 8

Reimportation

Sales restrictions

Distribution of samples

Wholesale distributors

Back 8

4 primary sections (prescription drug marketing act of 1987)

Front 9

Dietary supplement health and education act of 1994

Back 9

Law forbids manufacture or distribution of these products to make any advertising or labeling claims that indicates that the use of the product can prevent or cure any disease

Front 10

The product is not intended to diagnose, treat, cure or prevent any disease

Back 10

Disclaimer in labels of dietary supplements

Front 11

FDA and the food and drug administration modernization act of 1997

Back 11

This bill expanded patient access to investigational treatments for aids, cancer, alzheimer's disease and other serious or life threatening illnesses; also provided faster drug approvals; provided incentives for investigations of drugs for children

Front 12

Drug product recall

Back 12

If the fda or manufacturer finds that a marketed product presents a threat to consumer safety

Front 13

Theodore Roosevelt

Back 13

Changed the national formulary of unofficial preparations to national formulary

Front 14

Pure food and drug act

Back 14

Thru what act was the nf's title was changed

Front 15

Joseph Pelletier and pierre robiquet

Back 15

Isolated caffeine

Front 16

Dec 1820

Back 16

When was the first USP published?

Front 17

Ebers papyrus

Back 17

Contains 800 formulas and more than 700 drugs

Front 18

1580 in Bergamo, Italy

Back 18

Year and place where pharmacopoeia was discovered

Front 19

1580 in Bergamo, Italy

Back 19

Year and place where pharmacopoeia was discovered