'Distributor labeling’ refers to the labeling of an approved new animal drug marketed by a distributor who distributes the product under its own labeling rather than the approved labeling. Unlike the approved labeling, which CVM reviews as part of NADA/ANADA approval process to ensure the safe and effective use of the drug and compliance with the Federal Food, Drug, and Cosmetic Act (FD&C Act) and its implementing regulations, distributor labeling does not ordinarily go through a pre-market approval process.

FDA regulations require that distributor labeling be identical to the labeling approved in the NADA/ANADA, except for a different and suitable proprietary name, if used, and the name and address of the distributor preceded by an appropriate qualifying phrase. See 21 CFR 514.80(b)(5)(iii)(A)(1). These requirements are meant to ensure that distributor labeling complies with the requirements of the FD&C Act and its implementing regulations and to prevent distributor label products from reaching the market with labeling that compromises the safe and effective use of the new animal drug.

If distributor labeling differs from the labeling approved in the NADA/ANADA in ways other than those permitted in 21 CFR 514.80, these differences may misbrand the product under section 502 of the FD&C Act and adulterate the product under section 501 of the FD&C Act.

It has become a common practice for distributors to develop labeling for purposes of branding that differs from the approved labeling with respect to font, color, and graphics. Such differences do not necessarily undermine public health, animal health, or the approval process – particularly when the differences are not false or misleading and do not decrease readability, alter the meaning, or otherwise inhibit the safe and effective use of the drug. This guidance describes FDA’s current thinking with respect to factors it will consider in determining whether to take enforcement action against distributor labeling that differs from the approved labeling.

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