FDA Issues Request for Information on Gluten in Drug Products

December 29, 2011

FDA Issues Request for Information on Gluten in Drug Products

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Stakeholders invited to comment on the use of drug ingredients derived from wheat, barley or rye.

The U.S. Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) has issued a Request for Information and Comments in the Federal Register concerning the presence of gluten in prescription and nonprescription drug products intended for human use. The FDA is interested in hearing from stakeholders regarding the use of drug ingredients derived from wheat, barley, or rye that may contain gluten in drug manufacturing, and whether alternatives may be or may not be suitable or available.

The FDA would like to hear public input, including input from stakeholders in the scientific and research community, and excipient and pharmaceutical finished product manufacturers. Among other things, commenters are requested to identify reasons, if they exist, why certain drug ingredients must be derived from wheat, barley or rye, and why the flexibility to use these grains as ingredient sources may be important.

Responses will help inform the FDA’s thinking about ways to help individuals with celiac disease avoid gluten in drug products.

To read the notice and submit a comment, visit www.regulations.gov and search for document ID FDA-2011-N-0842-0001.

The FDA also has awarded NFCA a grant to study the impact of gluten in medication. As part of our investigation, NFCA will launch a survey in the first week of January 2012. Be on the lookout!

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