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Regulatory Focus™ > News Articles > FDA Releases New Compliance Guidance for Manufacturers of OTC Bronchodilators

FDA Releases New Compliance Guidance for Manufacturers of OTC Bronchodilators

Posted 14 November 2012 | By Alexander Gaffney, RAC

A new compliance guide released by the US Food and Drug Administration (FDA) aims to provide small businesses with guidance on how to comply with labeling requirements for over-the-counter (OTC) bronchodilators marketed under a monograph.

A 2011 final rule on labeling  strongly advises that the products "bear specific labeling to promote their safe and effective use" in light of specific risks to asthma patients.

Continued FDA: "The rule proposed an additional warning (an Asthma Alert), and revised the indications, warnings, and directions in the labeling of OTC bronchodilator drug products." For instance, the new labeling now contains specific alerts for managing asthma attacks if the products don't work within a specific time frame and a number of specific contraindications for use.

The rules apply to both oral and inhaled dosage asthma products-epinephrine, ephedrine hydrochloride, ephedrine, epinephrine sulfate and racepinephrine hydrochloride products-being marketed under an OTC monograph. Those products must have been in compliance with FDA rules since 23 January 2012. Products not marketed under a monograph, such as those approved through a new drug application or abbreviated new drug application, do not have to comply with the guidance.

Though products meeting the OTC monograph for bronchodilators do not need to seek FDA approval, the firms manufacturing the products must register their facilities and listing information with FDA.

The specific labeling requirements, including safety warnings, indications for use and specific safety alerts, are contained within the compliance guide.


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