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The Pulse of the Pharmaceutical Industry

FDA asks for more data on over-the-counter hand sanitizers

Written by: | | Dated: Wednesday, June 29th, 2016

The U.S. Food and Drug Administration said it is requesting additional data to support the safety and effectiveness of certain active ingredients used in topical consumer antiseptic rubs, including hand sanitizers, that are sold over-the-counter.

The request for more data is intended to help the agency ensure that regular use of these products does not present unknown concerns, and does not mean the FDA believes that these products are ineffective or unsafe. (

The proposed rule requires manufacturers to provide additional data on the active ingredients’ safety and effectiveness, the FDA said in a statement on Wednesday.

The regulator’s move comes more than a year after it asked for additional data to check if antiseptics used in healthcare settings were as safe and effective as they were once considered.



(Reporting by Ankur Banerjee in Bengaluru; Editing by Shounak Dasgupta)

Source: Reuters Health

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