Small Business Assistance
Center for Drug Evaluation and Research
Human Drug Establishment Registration and Drug Listing Compliance
Who Must Register and List
Assessing Whether a Firm Should Register and List

Evaluate three fundamental questions:

  1. Is the product a human drug?
  2. Does the firm participate in the manufacture or processing of the drug?
  3. Does the drug enter into U.S. commercial distribution after being manufactured or processed?


This course does not address veterinary drugs, which also are subject to registration and listing requirements that are administered by FDA's Center for Veterinary Medicine (CVM).

Video still image of the introductory video of John Moore standing in front of his colleagues at a conference table.

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