Arkansas Pharmacy Laws and Regulations Practice Exam

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What makes a drug adulterated in relation to coal tar color?

Containing any amount not FDA approved

Having coal tar color from non-certified batches

In order for a drug to be considered adulterated in relation to coal tar color, it must contain coal tar color from non-certified batches. This means that the coal tar color used in the drug was not approved or deemed safe by the FDA. The other options may contribute to a drug being considered adulterated, but they are not specific to coal tar color. For example, containing any amount not FDA approved could refer to any ingredient while exceeding specific coal tar color ratios could also apply to other additives. Additionally, using coal tar color at all is not necessarily a reason for a drug to be considered adulterated, as long as it is from certified batches. Therefore, B is the most correct option as it specifically refers to the coal tar color being from non-certified batches.

Using coal tar color at all

Exceeding specific coal tar color ratios

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