The U.S. Food and Drug Administration has issued draft guidance for industry, “Distributor Labeling for New Animal Drugs,” that describes issues the agency considers when deciding whether to take regulatory action on new animal drug distributor labeling that differs from the labeling approved as part of a New Animal Drug Application or Abbreviated New Animal Drug Application.
“Distributor labeling” is labeling used by a distributor that markets the product under its own label, rather than the label of the drug application holder. The FDA reviews and approves animal drug labeling as part of the new animal drug approval process, but does not typically evaluate and approve distributor labeling.
