FDA Issues Proposed Rule to Address Data Gaps for Certain Active Ingredients in Health Care Antiseptics…
Today, the FDA released a proposed amendment to address the safety and effectiveness of health care antiseptics used in hospitals, physician’s offices and long term care facilities.
The FDA’s proposed rule does not require any products to be discontinued from use at this time. However, when the proposed rule is finalized, manufacturers who want to continue marketing health care antiseptic products under the monograph will need to provide the FDA additional data on the active ingredients safety and effectiveness.
Today’s action is part of the FDA’s increasing review of monograph antiseptic active ingredients to ensure these ingredients are proved safe and effective.
Betco Corporation® understands the importance of manufacturing skin care products that are safe and effective. We are actively investigating the impact this prosed new amendment will have on our skin care products and will do our due diligence to ensure our compliance to the agency’s recommendations.
For more information on this amendment, click on the links below: