•Required in labeling when use of a drug may lead to death or serious injury.
•Required for about 450 prescription drugs
Five catogories of risk in pregnancy
- Category A: well-controlled studies in pregnant women- have not demonstrated a risk to the fetus “only if clearly needs”
- Category B: Animal studies have failed to demonstrate a risk to the fetus- the are no we controlled studies in pregnant women- “only if clearly needed”
Category C: Either animal studied have shown an adverse effect on the fetus- “only if the potential benefit justifies
the potential risk to the fetus”
Category D: Positive evidence of fetal risk
Category X: Studied on animals or humans have demonstrated fetal risk, and that risk in pregnant women clearly outweighs any benefits- “may cause fetal harm when administrated to a pregnant women”
National Drug Code Number NDC
•11-digit three segment code
•The first segment identifies manufacturer or distributor,
the second segment identifies the drug (strength, dosage for and formulation
the third segmant identifies package size and type of drug.
Defenition of New Drug
Drug that is not generally recognized by qualified experts as safe and effective (GRASE) for use under the conditionsrecommended in the drug’s labeling; and, have been used for a material extent and time for conditions recommended in labeling.
An approved drug can become a new drug under certain conditions
Addition of new substance
New combination of approved drugs
Change in proportion of ingredients
New intended use
Dosage, method, or duration of administration or application is changed