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Table 1: Current Categories for Drug Use in Pregnancy


Category

Description

A

Adequate, well-controlled studies in pregnant women have not shown an increased risk of fetal abnormalities.

B


Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate and well-controlled studies in pregnant women.
or
Animal studies have shown an adverse effect, but adequate and well-controlled studies in pregnant women have failed to demonstrate a risk to the fetus.

C


Animal studies have shown an adverse effect and there are no adequate and well-controlled studies in pregnant women.
or
No animal studies have been conducted and there are no adequate and well-controlled studies in pregnant women.

D

Studies, adequate well-controlled or observational, in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy may outweigh the potential risk.

X

Studies, adequate well-controlled or observational, in animals or pregnant women have demonstrated positive evidence of fetal abnormalities. The use of the product is contraindicated in women who are or may become pregnant.

 

Table 2: Schedules of Controlled Substances

Drug Schedules Drug Coverages
I

The drug or other substance has a high potential for abuse.

The drug or other substance has no currently accepted medical use in treatment in the United States.

There is a lack of accepted safety for use of the drug or other substance under medical supervision.

II

The drug or other substance has a high potential for abuse.

The drug or other substance has a currently accepted medical use in treatment in the United States or a currently accepted medical use with severe restrictions.

Abuse of the drug or other substances may lead to severe psychological or physical dependence.

III

The drug or other substance has a potential for abuse less than the drugs or other substances in schedules I and II.

The drug or other substance has a currently accepted medical use in treatment in the United States.

Abuse of the drug or other substance may lead to moderate or low physical dependence or high psychological dependence.

IV

The drug or other substance has a low potential for abuse relative to the drugs or other substances in schedule III.

The drug or other substance has a currently accepted medical use in treatment in the United States.

Abuse of the drug or other substance may lead to limited physical dependence or psychological dependence relative to the drugs or other substances in schedule III.

V

The drug or other substance has a low potential for abuse relative to the drugs or other substances in schedule IV.

The drug or other substance has a currently accepted medical use in treatment in the United States.

Abuse of the drug or other substance may lead to limited physical dependence or psychological dependence relative to the drugs or other substances in schedule IV.