What is the Green Book?

The United States Food and Drug Administration (US FDA) established, published, and maintains the “Green Book” which is a list of approved animal products. The list is publicly available, maintained every month and serves as a searchable database for animal product organizations and public. Animal product companies are required to submit information the US FDA on marketing exclusivity and patents which is to be included in the Green Book. The Green Book is a useful resource for various stakeholders that are involved in animal drug registration. Products can be searched by a drug’s brand name, application number, and active ingredient.

The Green Book also includes various documents that may be useful for new animal drug applications (NADA), abbreviated new animal drug applications (ANADA), or condition new animal drug applications (CNADA). These include environmental documents, Freedom of Information (FOI) Summaries, labels for nonsteroidal anti-inflammatory drugs (NSAIDS) for animals, and Blue Bird Labels.

What are the other components of the Green Book?

The Green Book starts with a section on “Supporting Documents” that include the documentation mentioned above. Below this is a section called “Green Book Reports”. This provides information on trade and sponsor names (arranged by trade name and arranged by application number); active ingredients, patent information, exclusivity periods, products subject to notice of hearing, voluntary withdrawals, suitability petition actions, and monthly updates. These are available for download in pdf format or as Excel sheets.

The “Medicated Feeds” section below the “Green Book Reports” includes a list of the approved medicated feed mill licenses sorted by site name & by state, who are licensed to manufacture particular medicated feed for “food-producing” animals. It also includes a list of veterinary feed directive distributor notification list which is sorted by distribute & by state. These are distributors who have informed the FDA that they distribute animal feed which contains veterinary feed directive drug, or VFD.

It is important to note that indexed animal products are not listed in the Green Book. The Index, or the Index of Legally Marketed Unapproved New Animal Drugs for Minor Species, are a list of new animal drug products that are to be used in minor species, which have had safety and efficacy data confirmed through another US FDA review processes.