The FDA released a draft guidance titled Statement of Identity and Strength — Content and Format of Labeling for Human Nonprescription Drug Products: Guidance for Industry (here) which, not surprisingly, addresses the requirements for statements of identity and strength designations on the principal display panels (PDPs) of OTC drug products. The guidance notes that “[T]he statement of identity must consist of the established name for the nonprescription drug product, if one exists, followed by an accurate statement of the general pharmacological category(ies) or the principal intended action(s) of the drug product.”
While OTC labeling for a statement of identity or a format for strength may appears in OTC monographs or in the designated USP monographs for established names and pharmacological categories, for the purposes of this guidance, the FDA indicates that “to the extent they are not consistent, FDA does not intend to take action against the marketing of an OTC monograph drug product that follows the content guidelines for the statement of identity as described in this guidance rather than the applicable OTC drug monograph, as long as the drug product is marketed in compliance with all other applicable statutes, regulations, and requirements (including other applicable requirements set forth in a corresponding OTC drug monograph).”
The guidance also notes that the inclusion of the route of administration (ROA) may or may not be required; it gives examples such as oral tablets, topical creams, or lotions, etc. when the ROA is well understood.
In addition, there are suggested acceptable formats for configuration of statements of identity and strength for multiple actives in a single product (preferred is alphabetical but there is an exception) and for placement of the ROA when necessary or desired. Have fun with the fact that everything should be the same unless there are exceptions noted in the guidance. I’ve always found that to be an interesting way of phrasing it!
