In 2011, the FDA opened a docket for discussing gluten-free food labeling to help those wth celiac disease and high gluten intolerance. This year’s subject open for discussion is gluten in drugs. The products in question include prescription, nonprescription, biologic, and homeopathic drugs. Learn about the FDA’s assessment results on the percentage of gluten tolerated by those with celiac disease and what they are seeking in regards to comments on gluten in medication and from whom.
FDA’s Open Docket for Gluten in Drugs
Sometimes it is nearly impossible to determine whether or not a drug contains gluten. More importantly, the FDA realizes that in emergency cases, drugs need to be administered to celiac patients without having to take the time to investigate whether a drug is or is not gluten-free.
Though the FDA believes that wheat is not used to any significant extent in ingredients used for manufacturing drugs that are marketed in the United States, and that barley and rye is rarely used, if at all, they are aware that certain ingredients in drugs may be derived from wheat. The FDA also believes that gluten in drugs that are taken orally cause more harm than other ways drugs may be administered.
Currently the National Formulary (NF) and the U.S. Pharmacopeia (USP) manuals allow starches, possibly gluten in drugs.
Manufacturers
If the FDA does not hear from manufacturers on why gluten is needed in the making of drugs it may lean towards not allowing gluten in drugs at all. They wish to know how important these ingredients are, how removing gluten from drugs would impact manufacturers, and what problems would arise from doing so.
The FDA particularly is interested in hearing from interested parties on the following topics:
How to Submit Comments
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