FDA Proposed Rule on “Labeling Requirements for Approved or Conditionally Approved New Animal Drugs”

FDA proposes to revise the existing regulations regarding the content and format of labeling for approved or conditionally approved new animal drugs to provide for a more comprehensive set of requirements in one location in the Code of the Federal Register (CFR). These proposed regulations would apply to the labeling of prescription and OTC new animal drugs, as well as new animal drugs for use in animal feeds. Certain existing regulations regarding the labeling of new animal drugs would be updated and moved from their current location and incorporated into the proposed regulations, including a new subpart H in part 201 (21 CFR part 201). FDA also proposes to amend or remove certain current regulations to ensure consistency with the proposed regulations. Proposed subpart H would not apply to heritable intentional genomic alterations in animals. Proposed subpart H would also not apply to labeling of indexed legally marketed unapproved new animal drugs for minor species. In addition, proposed subpart H would not apply to promotional labeling or advertising.

FDA will accept comments until 11:59 p.m. Eastern Time at the end of June 10, 2024. Comments received by mail/hand delivery/courier (for written/ paper submissions) will be considered timely if they are received on or before that date.