FDA “Finalizes” Rule on Health Care Antiseptic Drug Products Ahead of Time

January 2, 2018By Riëtte van Laack

As previously discussed, pursuant to a consent decree, FDA was to finalize the over-the-counter (OTC) topical health care antiseptic drug products monograph with respect to triclosan by January 15, 2018. Rather than limiting the rulemaking to the single active ingredient, triclosan, FDA took it upon itself to finalize the monograph for all OTC health care antiseptic active ingredients.

Ahead of time, on Dec. 20, 2017, FDA issued what it identifies as the final rule for health care antiseptics.  Upon further reading, it turns out that FDA is not yet done, however.  The final rule constitutes a final determination that 24 active ingredients are not generally recognized as safe and effective (GRASE); they are added to the list of unapproved new drugs in 21 C.F.R. § 310.545.  The compliance (or effective) date is Dec. 20, 2018.  On or after that date, any OTC health care antiseptic drug product that contains any of these 24 active ingredients cannot legally be introduced into interstate commerce unless it is the subject of an FDA-approved New Drug Application (NDA).

As we reported earlier this year, in February 2017, FDA deferred action on six active ingredients (benzalkonium chloride, benzethonium chloride, chloroxylenol, alcohol, isopropyl alcohol and povidone-iodine) pending additional data. Thus, the rule making on health care antiseptic drug products remains incomplete.  FDA has not set a specific deadline for final action on these ingredients but instead with address their monograph (GRASE) status “either after completion and analysis of ongoing studies to address the safety and effectiveness data gaps . . . or at a later date, if these studies are not completed.”

In addition to finding the 24 active ingredients non-GRASE, FDA determined that chlorhexidine is not eligible for evaluation under the OTC drug review process because this ingredient was not included in any health care antiseptic product marketed before May 1972. Thus, any chlorhexidine-containing health care antiseptic may be marketed only if approved by FDA.  FDA also has determined that alcohol for use as a surgical hand scrub and benzethonium chloride for use as a health care personnel hand rub and surgical hand rub are ineligible for the OTC drug review for lack of evidence that products containing these ingredients were marketed before May 1972.

The preamble to the final rule discusses FDA’s responses to comments about the new efficacy testing requirements for the various types of health care antiseptics. These testing requirements apply to the six active ingredients for which action has been deferred and will not come as a surprise to the companies working on the collection of data for these ingredients.  The final rule does not address testing of final formulations because, at this time, FDA has not found any of the active ingredients GRASE.  Thus, rule making for testing of final products would be premature.

FDA stresses that the final rule does not cover

  • Consumer antiseptic washes
  • Consumer antiseptic rubs
  • First aid antiseptics
  • Antiseptics used by the food industry

Rules for these product categories are in various stages of completion.   FDA must issue a final rule for consumer antiseptic rubs by April 15, 2019. No deadline has been set for completion of the rule making regarding first aid antiseptics and antiseptics used by the food industry because those categories of products were not included in the consent decree.