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FDA issues proposed rule on OTC drug ingredients

The FDA has issued a proposed rule in the Federal Register, stating that certain ingredients in over-the-counter drug products are not generally recognized as safe and effective (GRASE) or are misbranded. FDA is issuing this proposed rule because the agency did not receive any data and information on these ingredients in response to a request on December 31, 2003. Ingredients range from phenol to peppermint oil. FDA said that GRASE ingredients must receive approval via a new drug application before they can be introduced into interstate commerce. Comments must be submitted by September 17. To submit comments, visit the Web site.

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