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Definitions

Bulk Drug:
An active ingredient in unfinished form intended for manufacture into finished dosage form drug products. "Bulk" does not mean "quantity." Rather it means "raw" chemical ingredient. Because a bulk drug is unfinished, it does not carry FDA-approval.

FDA-approved Drug:
A drug whose manufacturer has demonstrated safety, efficacy, and product quality to the U.S. Food and Drug Administration for the labeled indication. Both "pioneer brand name" drugs and generic drugs are FDA-approved.

Find a list of all FDA-approved animal drugs (Green Book)
www.fda.gov/cvm/greenbook/greenbook.html

Find a list of all FDA-approved human drugs (Orange Book)
www.fda.gov/cder/ob/default.htm

Compounded Drug:
Any drug that is manipulated based on a licensed practitioner's prescription, but not in accord with an FDA-approved label, to meet the medical needs of a specific patient. Compounded drugs are extemporaneously prepared drugs that lack FDA-approval. Compounded drugs undergo no approval for safety or efficacy, and rarely undergo any scientific evaluation.