FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

FDA Requires Some OTC Sanitizers to Use New Drug Approval Pathway

April 22, 2019
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The FDA issued a final rule requiring OTC sanitizers with certain active ingredients to seek approval under an NDA or ANDA as a new drug.

The agency “aims to help provide consumers with confidence that the over-the-counter hand sanitizers they’re using are safe and effective when they don’t have access to water to wash with soap,” said CDER Director Janet Woodcock.

The FDA has deemed 28 active ingredients, including benzethonium chloride, ineligible for OTC drug review evaluation.

Three active ingredients will still be evaluated under OTC drug review: ethyl alcohol (60 to 95 percent), isopropyl alcohol (70 to 91.3 percent), and benzalkonium chloride. The agency omitted the three ingredients from the final rulemaking to allow more time to collect safety and effectiveness data.

CDER said it believes a dramatic impact on the market is unlikely, given that 97 percent of OTC hand sanitizer products contain one of the three ingredients left out of the final rule.

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