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FDA is announcing the availability of a compliance guidance for small business entities entitled “Labeling for Bronchodilators: Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the-Counter Human Use; Small Entity Compliance Guide.” This small entity compliance guide applies to OTC bronchodilator drug products used to treat asthma that are marketed without an approved application (i.e., under the OTC bronchodilator monograph) (21 CFR part 341). OTC bronchodilators are those that contain any of the ephedrine ingredients (i.e., ephedrine, ephedrine hydrochloride, ephedrine sulfate, and racephedrine hydrochloride) or epinephrine ingredients (i.e., epinephrine, epinephrine bitartrate, and racepinephrine hydrochloride) listed under 21 CFR 341.16.
This guidance summarizes the July 26, 2011, final rule (76 FR 44475) regarding OTC bronchodilator drug products, which makes the following changes to the OTC regulations:
• Sets forth a new use statement, warnings (including an Asthma Alert warning), and directions that are required in the labeling of OTC bronchodilator drug products under 21 CFR 341.76.
• Revises labeling requirements for OTC bronchodilator drug products to ensure consistency with the standardized Drug Facts content and formatting requirements set forth in 21 CFR 201.66.
Manufacturers must be in compliance with the rule beginning on January 23, 2012.
This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the Agency's current thinking on labeling for OTC bronchodilator drug products. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statutes and regulations.
Interested persons may submit either written comments regarding this document to the Division of Dockets Management (see
Persons with access to the Internet may obtain the document at either