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A General Overview of Requirements for Marketing Topically Applied Skin Antiseptics in the United States

The importance of topically applied skin antiseptics was first recognized and demonstrated by Ignaz Semmelweis in the mid-1800s when he first proposed handwashing with chlorinated lime by physicians.  Since that time, use of skin antiseptics has become an important tool in helping reduce the prevalence of disease caused by normal skin microbial flora of other transient microorganisms residing on the skin.   This importance has recently been reinforced with the current focus on disease prevention cause by the COVID-19 pandemic has reinforced the importance of using topical antimicrobials.  As such, the demand for such products by health care professionals and the public has increased.

Such types of products must be effective antimicrobials and be safe for use.  The FDA as part of the OTC Drug review initiated in 1972 listed several active ingredients for three categories of OTC health care antiseptic uses in the 1994 Tentative final monograph (TFM).  The three categories are Healthcare Personnel Handwash, Patient Preoperative Skin Preparation, and Surgical Hand Scrubs.  This tentative final monograph detailed clinical and safety criteria based on in vitro and in vivo (clinical simulation) studies.  In 2015 and again in 2016 for Consumer Antiseptic Rubs, the FDA proposed new criteria for OTC health care antiseptic active ingredients based on reevaluation of safety and effectiveness information based on the 1994 TFM.  A finalized monograph was issued in 2017 for OTC heath care antiseptics again changed the criteria of the effectiveness and safety information needed for products qualified for OTC Drug Review and those active ingredients that will need to undergo an NDA/IND review process. A final ruling regarding the 2016 Consumer Antiseptic Rub proposed ruling was finalized a few years later in 2019 describing studies necessary for determining the effectiveness and safety of active ingredients.

The requirements for topical antimicrobial products provided by the numerous monographs requires an understanding of the proposed and final rulings that have been issued over the years since the initial 1994 TFM.  The FDA continues to review data and will issue additional guidance based on new information.  Since 1991, BSL has worked with the manufacturers to help them meet the safety and efficacy requirements set by the FDA as they have changed following the 1994 TFM to current Final Rules issued in 2017 and 2019.  Whether a product or active ingredient qualifies for OTC Drug Review or requires to be submitted to the FDA using an NDA/IND submission, BSL experts have the experience and expertise to guide clients through the process to support the marketing of their product to meet the requirements of the healthcare community as well as the new demand for antimicrobial products.

 

References

1994 FDA TFM, 21 CFR Parts 333 and 369, Health-Care Antiseptic Drug Products; Effectiveness testing of an antiseptic handwash or health-care personnel handwash; Proposed Rule.  (FR59: No. 116, 17 June 94. pp 31448 to 31450)

2015 FDA TFM, 21 CFR Part 310, Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record; Proposed Rule.  (FR80: No. 84, 1 May 2015. pp 25166 to 25205)

2016 FDA TFM, 21 CFR Part 310, Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record; Proposed Rule.  (FR81: No. 126, 30 June 2016. pp 42912 to 42937)

2017 FDA, 21 CFR Part 310, Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use, Final Rule.  (FR82: No. 243, December 20, 2017. pp 60474 to 60503)

2019 FDA, 21 CFR Part 310, Safety and Effectiveness of Consumer Antiseptic Rubs; Topical Antimicrobial Drug Products for Over-the-Counter Human Use, Final Rule.  (FR84: No. 71, April 12, 2019. pp 14847 to 14864)