About a year after issuing the final rule for antibacterial soaps, where it has banned 19 ingredients, the US Food and Drug Administration (FDA) has come out with an announcement on similar lines. Now, the Agency has barred the usage of 24 active ingredients including Triclosan which they no longer consider generally recognized as safe and effective (GRASE) and hence inappropriate to use in OTC antiseptic washes, hand washes, rubs and surgical hand scrubs used in healthcare settings.
Where did it all begin and what does it mean for the manufacturers?
The premises leading to this change began in 2013 which led to the antibacterial soap ingredient ban in 2016. Similar requests were made by the FDA to antiseptic wash manufacturers to review the safety and efficacy of the products in April, 2015.
FDA explicitly mentioned, the request does not conform, that they believe the existing products are unsafe and inefficient. The only outcome they wish to establish is the efficacy of the products, given their expansive use across healthcare settings. Clearing the airs, the agency also added that the final rule does not apply to consumer antiseptic washes or rubs, first aid antiseptics or antiseptics used in the food industry.
The timeline for manufacturers
The agency has given one year time to the manufacturers to clear their products off the named active ingredients. The manufacturers have one year to eliminate the specified 24 ingredients. Emphasis is laid on triclosan as it is the only one currently being marketed, while the rest were left out voluntarily by the manufacturers. Hereon the manufacturers considering the usage of these unapproved ingredients to market will require to submit a new drug application and must undergo pre-market review.
There might be some respite for the organizations as the FDA chose to opt out, even after two years of waiting, six of the most commonly used antiseptic ingredients—alcohol (ethanol), isopropyl alcohol, povidone-iodine, benzalkonium chloride, benzethonium chloride, and chloroxylenol (PCMX) from the final rule to provide additional time to gather evidence on their use.
All said and done, the rule will bring in considerable amount of changes to the associated Regulatory submission documents and labels and even with the timeline provided, it is an extensive task per se and will need professional help. Consult an experienced Regulatory partner to stay compliant.