FDA decided not to make a final decision regarding three active ingredients: benzalkonium chloride, ethyl alcohol, and isopropyl alcohol. More study of the safety and effectiveness data is needed before FDA issues a final determination regarding whether those three active ingredients are generally recognized as safe and effective (GRASE). Most antiseptic rub products use ethyl alcohol as an active ingredient. While announcing the final rule, FDA clarified that at this time it does not intend to take action to remove hand sanitizers containing these three active ingredients from the market.
FDA had previously determined that 28 other active ingredients, including benzethonium chloride, are not eligible for evaluation under FDA’s over-the-counter (OTC) Drug Review. Products containing any of these active ingredients would have to go through FDA’s new drug approval (NDA) process prior to marketing in the US.
This ruling follows FDA’s usual approach to OTC drugs, in that they focus regulations on the API and not the finished drug formulations. FDA often publishes OTC monograph regulations for categories of non-prescription drugs, which may include which APIs may be used for specific intended uses.
Benjamin England, observes, “most hand sanitizers sold in the US are imported drugs. In many other countries, hand
sanitizers are regulated as cosmetics rather than drug products. FDA has increased its inspections of foreign hand sanitizer manufacturers and frequently found violations of the drug current good manufacturing practices (cGMP) regulations. By this rule, FDA is further clarifying what APIs may be used in hand sanitizers and what efficacy data manufacturers must have to comply with the OTC monograph and FDA’s cGMP regulations.”
If you have questions about the APIs in your over-the-counter drugs or what documentation FDA would expect you to have to demonstrate compliance with FDA rules, contact the regulatory specialists at FDAImports.
