New FDA Guidance Clarifies Labeling for Drugs Used in Feed

John Maday, Editor, Bovine Veterinarian ( Lori Hays )

The FDA has issued a new Guidance for Industry (GFI #181), which provides content and format regulations for the representative “Blue Bird” labeling to be used for Type B and Type C medicated feeds.

Drug manufacturers typically produce “Type A medicated articles,” which are intended solely for use in the manufacture of another Type A medicated article or in the manufacture of Type B or Type C medicated feed. Type B medicated feed is intended solely for the manufacture of other medicated feeds (Type B or Type C) and therefore it cannot be fed as is without being further diluted to Type C medicated feed.

According to FDA, Type C medicated feed is intended as the complete feed for the animal or may be fed 'top dressed' (added on top of usual ration) or offered 'free choice' in conjunction with other animal feed. It is manufactured by diluting a Type A medicated article, a Type B medicated feed, or another Type C medicated feed.

In their new animal drug applications, drug sponsors submit two labeling components. The first includes directions for the manufacture and use of finished feeds for all conditions for which the new animal drug is intended. The second labeling component provides representative labeling proposed to be used for the Type B and Type C medicated feeds containing the new animal drug. GFI #181 provides recommendations on the content and format of the representative Blue Bird labeling proposed to be used for Type B and Type C medicated feeds only. It does not address the labeling of Type A medicated articles.

The guidance provides sample templates for Blue Bird labels, and lists what types of information should be included within the label contents under headings such as the product name, indications for use, active drug ingredients, guaranteed analysis, other ingredients, feeding directions, cautions, warnings and other information.

View the full text of GFI #181 here.

For more information on drug labeling for medicated feeds, see these articles on BovineVetOnline:

Understanding Free-Choice and Hand-Fed Feeds Which Include Chlortetracycline

FDA Clarifies Medicated-Feed Rules for Anaplasmosis

FDA issues final rule categorizing animal drugs used in medicated feeds