During the first full week of September, the Food & Drug Administration (FDA) released a draft guidance titled “Statement of Identity and Strength–Content and Format of Labeling for Human Nonprescription Drug Products.” This guidance outlines suggestions for labeling human nonprescription drug products – specifically, the content and format of the statement of identity and the drug’s strength. This draft guidance will aid labelers of over-the-counter (OTC) drug products to provide consistent formatting and declaration of the statement of identity and strength so that consumers can better choose their products from the shelves.
Labels are intended to give as much useful information as possible about each product so that a buyer can make the most informed decision about what they choose to use for their health. The Principal Display Panel (PDP) is typically the first thing that a potential customer looks at in-store. FDA’s new guidance recommends that the PDP of OTC drug products include the required statements of the established name, pharmacological category, and strength of the drug in that particular order. The Agency further recommends that the statement of identity appear immediately adjacent to the brand name or proprietary name, with no intervening material. The guidance provides graphics demonstrating how a compliant PDP might be configured.
Since consumers use nonprescription drugs without the management of a health care provider, a more uniform recommendation for nonprescription drug labels will allow consumers to use products safely and give them the power to compare the variants of different nonprescription drug products to make the most educated choice for their situation.
If you are unsure how the new Draft Guidance applies to your nonprescription drug product or feel that a review of your current labels is needed, please reach out directly to FDAImports or call us at 410.220.2800
. Our staff of consultants and attorneys have years of experience reviewing, correcting, and guiding drug labeling and can ensure your label is FDA-compliant.
This blog is provided for informational and educational purposes only and does not constitute legal advice and is not intended to form an attorney-client relationship. Please contact your regular FDAImports representative for additional information.
