U.S. flag An official website of the United States government
  1. Home
  2. Regulatory Information
  3. Search for FDA Guidance Documents
  4. Gluten in Drug Products and Associated Labeling Recommendations; Draft Guidance for Industry
  1. Regulatory Information

GUIDANCE DOCUMENT

Gluten in Drug Products and Associated Labeling Recommendations; Draft Guidance for Industry December 2017

Draft

Not for implementation. Contains non-binding recommendations.

Gluten in Drug Products and Associated Labeling Recommendations; Draft Guidance for Industry

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.
 


Submit Comments

Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)

If unable to submit comments online, please mail written comments to:

Division of Dockets Management (HFA- 305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852

All comments should be identified with the title of the guidance.