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GUIDANCE DOCUMENT

Gluten in Drug Products and Associated Labeling Recommendations; Draft Guidance for Industry December 2017

Download the Draft Guidance Document Read the Federal Register Notice
Draft

Not for implementation. Contains non-binding recommendations.

Docket Number:
FDA-2017-D-6352
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research
Center for Biologics Evaluation and Research

This guidance is intended to convey to drug manufacturers FDA’s recommendations on how certain drug products should be labeled regarding gluten, a matter of interest to individuals with celiac disease. Some individuals with celiac disease have faced difficulty when trying to determine whether specific drug products contain gluten. Confronted by uncertainty, some patients may forego important medication rather than risk an adverse reaction to gluten. Thus, even if gluten is not present at levels that would harm a typical individual with celiac disease, that individual may be harmed through uncertainty and lack of information.
 

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All written comments should be identified with this document's docket number: FDA-2017-D-6352.

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