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Article: FDA Bans Triclosan in Nonprescription Antiseptic Products

In a final rule issued by the Food and Drug Administration (FDA), Triclosan, an active ingredient used in nonprescription antiseptic products is “not generally recognized as safe and effective” (GRAS/GRAE) for use by health care professionals in health care settings or situations. This ban finalizes the 2015 Health Care Antiseptic Proposed Rule and takes effect Dec. 20, 2018.

By the rule’s definition, health care antiseptics include:

  • Health care personnel hand washes
  • Health care personnel hand rubs
  • Surgical hand rubs
  • Patient antiseptic skin preparations

This means that products containing these active ingredients that are intended for use in OTC health care antiseptics may no longer be marketed without undergoing premarket review.

Of the 24 active ingredients that the FDA found to be non-GRASE, triclosan is the only one currently being used in any marketed health care antiseptic products.

Manufacturers will have one year to comply with this final rule by reformulating these products or removing them from the market.

The team at Impact Analytical has the experience and knowledge to meet the needs of our customers pertaining to Triclosan, and developing and testing of products for other substances on the prohibited substances list, materials that can be used only in specified circumstances.

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