The US FDA has issued a final guidance for Consumer Antiseptic Rubs as Covid-19 spreads in all its fury.
The guidance is intended to help small businesses understand and comply with the Consumer Antiseptic Rub Final Rule which applies to active ingredients used in over-the-counter (OTC) drugs that are referred to as rubs, leave-on products, or hand sanitizers. The guidance also applies to active ingredients used in OTC consumer antiseptic wipes. These products are intended to be used when soap and water are not available and are left on and not rinsed off with water, said the regulatory authority.
Drug products containing these active ingredients will require approval under a new drug application (NDA) or an abbreviated new drug application (ANDA) before they can be marketed.
The Consumer Antiseptic Rub Final Rule also established that three active ingredients: benzalkonium chloride, ethyl alcohol, and isopropyl alcohol—are eligible for evaluation under the OTC Drug Review.
Indian sanitizer companies have been exporting since June 2020 following a Central government notification allowing international trade of alcohol-based hand sanitisers packed in containers without pump dispensers.
The rules do address the monograph status of other OTC antiseptic products, including consumer antiseptic washes, which are personal care products that are intended for use with water and are rinsed off after use, such as antibacterial soaps, antibacterial hand washes, and antibacterial body washes.
Another category is the health care antiseptics, which are intended for use by health care professionals in a hospital setting besides the first aid antiseptics, which are skin antiseptics, skin-wound cleansers, and skin-wound protectants used primarily by consumers for first aid use. The monograph status of the active ingredients intended for use in these other OTC antiseptic products will be addressed separately, noted the regulatory authority.
The three ingredients benzalkonium chloride, ethyl alcohol and isopropyl alcohol are temporarily deferred as it is allowing time to companies to complete the studies necessary to fill the safety and effectiveness data gaps identified for these ingredients.
In the Consumer Antiseptic Rub FR, found 28 active ingredients ineligible for evaluation under the OTC Drug Review as a consumer antiseptic rub. These are benzalkonium cetyl phosphate, benzethonium chloride, cetylpyridinium chloride, chloroxylenol, chlorhexidine gluconate, cloflucarban, combination of potassium vegetable oil solution, phosphate sequestering agent, and triethanolamine.
Those ingredients that contain nonbinding recommendations are fluorosalan, hexachlorophene, hexylresorcinol, iodine complex which is ammonium ether sulfate and polyoxyethylene sorbitan monolaurate, iodine complex (phosphate ester of alkylaryloxy polyethylene glycol), methylbenzethonium chloride, nonylphenoxypoly (ethyleneoxy) ethanoliodine phenol less than 1.5 per cent poloxamer iodine complex, polyhexamethylene biguanide, povidone-iodine percent, salicylic acid, secondary amyltricresols, sodium hypochlorite, sodium oxychlorosene, tea tree oil, tribromsalan, triclocarban, Triclosan, triple dye undecoylium chloride iodine complex. This means that manufacturers will need to obtain an NDA or ANDA to market consumer antiseptic rub drug products containing any of these 28 active ingredients.
Alternatively, manufacturers of consumer antiseptic rubs containing ineligible antiseptic active ingredients can comply with the Consumer Antiseptic Rub FR by removing their products from the market, or reformulating them to remove the ineligible active ingredients, and then marketing them appropriately by substituting one of the three active ingredients without drug claims.