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Sept 9 -- The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Statement of Identity and Strength—Content and Format of Labeling for Human Nonprescription Drug Products.” This draft guidance provides recommendations for the content and format of the required statement of identity on the labeling of human nonprescription drug products. This draft guidance also provides recommendations on the inclusion of the drug product's strength on the labeling. The recommendations in this draft guidance are intended to help manufacturers, packers, distributors, applicants, relabelers, and sponsors ensure consistent content and format of the statement of identity and strength for all human nonprescription drug products. Consistent content and format of the statement of identity and strength may aid consumers in comparing nonprescription drug products and assist consumers in appropriate self-selection.

Submit either electronic or written comments on the draft guidance by November 8, 2022 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.

FDA is announcing the availability of a draft guidance for industry entitled “Statement of Identity and Strength—Content and Format of Labeling for Human Nonprescription Drug Products.” This draft guidance provides recommendations for the content and format of the required statement of identity on the labeling of human nonprescription drug products. This draft guidance also provides recommendations on the inclusion of the drug product's strength on the labeling.

Labeling for nonprescription drug products is intended to enable consumers to self-select appropriately and use the nonprescription drug product safely and effectively without the supervision of a healthcare practitioner. Nonprescription drug products must comply with applicable labeling requirements for over-the-counter (OTC) products under 21 CFR part 201, including, but not limited to, the statement of identity under § 201.61 (21 CFR 201.61). The statement of identity is one of the principal features on nonprescription drug product labeling and consists 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. The labeling of all nonprescription drug products must display the statement of identity on the product's principal display panel (§ 201.61(a)).

This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on “Statement of Identity and Strength—Content and Format of Labeling for Human Nonprescription Drug Products.” It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.

Draft guidance https://www.fda.gov/regulatory-information/search-fda-guidance-documents/statement-identity-and-strength-content-and-format-labeling-human-nonprescription-drug-products
FRN: https://www.federalregister.gov/d/2022-19500

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