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FDA Issues Final Rule on Safety and Effectiveness of Triclosan in Health Care Antiseptics

On December 20, 2017, The U.S. Food and Drug Administration (FDA) published a final rule that will prohibit the inclusion of commonly used ingredient triclosan and 23 other active ingredients in antiseptics for health care environments.  Following the rule’s compliance deadline of December 20, 2018, health care antiseptics containing any of the covered ingredients will not be permitted to enter interstate commerce without FDA approval of a new drug application (NDA).  You will find a list of the covered ingredients below.

The scope of this rule only applies to antiseptic products (i.e. washes, scrubs, rubs, and skin preparations) used by health care professionals in health care settings.  Antiseptic products intended for use by consumers are covered by two separate rules, one of which had a compliance deadline in September 2017.

Why are these ingredients prohibited?

The covered ingredients were initially part of a 1994 tentative final monograph for OTC antiseptic drug products.  A 2015 proposed rule called for additional data to support the safety and effectiveness of these ingredients for use in health care antiseptic products.  FDA did not receive any additional data, and the available scientific evidence surrounding the ingredients was insufficient to support a determination that they are generally recognized as safe and effective (GRASE).

FDA is delaying final rulemaking for at least one year on benzalkonium chloride, benzethonium chloride, chloroxylenol, alcohol (also known as ethanol or ethyl alcohol), isopropyl alcohol, and povidone-iodine.  The Agency has stated that a determination for these ingredients will be dependent upon whether ongoing studies are eventually completed, and if so, when they are completed.

Not sure how this rule applies to your health care antiseptics?  Registrar Corp’s Regulatory Specialists can conduct a full review of your antiseptic product’s ingredients and labeling.  We review your product’s active ingredients to ensure that they conform to the requirements specified in the applicable FDA monographs for antimicrobial drug products. We also inspect your labeling to ensure that its content and formatting conform to numerous FDA drug regulations.  In addition to an extensive report of suggested revisions, you will receive a print-ready label incorporating these changes.  For assistance, call us at +1-757-224-0177 or chat with a Regulatory Advisor 24/7 at www.registrarcorp.com/livehelp.

Ingredients Deemed Not Generally Recognized as Safe and Effective under the Health Care Antiseptic Final Rule:

Chlorhexidine gluconate
Mercufenol chloride
Cloflucarban
Methylbenzethonium chloride
Fluorosalan
Phenol
Hexachlorophene
Secondary amyltricresols
Hexylresorcinol
Sodium oxychlorosene
Iodophors (Iodine-containing ingredients)
• Iodine complex (ammonium ether sulfate and polyoxyethylene sorbitan monolaurate)
• Iodine complex (phosphate ester of alkylaryloxy polyethylene glycol)
• Iodine tincture USP
• Iodine topical solution USP
• Nonylphenoxypoly (ethyleneoxy) ethanoliodine
• Poloxamer—iodine complex
• Undecoylium chloride iodine complex
Tribromsalan
Triclocarban
Triclosan
Triple dye
Combination of calomel, oxyquinoline benzoate, triethanolamine, and phenol derivative
Combination of mercufenol chloride and secondary amyltricresols in 50 percent alcohol