Life Sciences Blog

Over-the-Counter Drug Product Monographs: FDA Requirements for Hand Sanitizers and other COVID-19 focused products

by | Jun 23, 2021

Reed Tech recently hosted the second in a series of OTC-focused webinars featuring Reed Tech subject-matter experts and some of our industry friends and colleagues. The series is scheduled to take place throughout the summer. For more fundamental information on OTC drug monographs, provided in the first webinar of the Reed Tech OTC series, read the blog or view the webinar.

This second webinar featured speakers Caitlin Osborn of Reed Tech and Shelly Garg and Karmina Fefferman of Amin Talati Wasserman LLP. The speakers included content to help companies who produced pharma products, such as hand sanitizers, under the FDA temporary policy. Also, determine when these companies should begin looking at longer-term compliance requirements as the pandemic comes to a close.

This webinar took a deep look into the COVID-19 Temporary Policies, including those for hand sanitizers. The FDA is not taking action against firms that produce hand sanitizers pursuant to temporary policies for the duration of public health emergency. However, they must only use the ingredients in the temporary policy which include:

• Permitted active ingredients: ethyl alcohol and isopropyl alcohol
• Other permitted ingredients: glycerin, hydrogen peroxide, sterile water

There are additional COVID-19 Temporary Requirements including labeling requirements, requirement to register drug establishment and list drug product (NDC), impurity limits, preferred and alternative formulas to denature alcohol before use in hand sanitizers and recordkeeping. These temporary policies will lapse as the pandemic concludes.

After the pandemic concludes, hand sanitizer products that had been listed under COVID-19 temporary policies will need to comply with the 1994 OTC Topical Antiseptic Tentative Final Monograph, 2016 Consumer Antiseptic Rub Proposed Rule and 2019 Consumer Antiseptic Rub Final Rule. Non-hand sanitizer products will need to comply with alternative permanent policies.

Additionally, products approved under COVID-19 temporary policies, will need to be aware of OTC Monograph Facility Fees that they may be required to pay.

• FY 2021 Fees
• MDF: $20,322
• CMO: $13,548
• FY 2022 and Subsequent Years
• Fees due June 1 of each fiscal year at the earliest
• Fees to be determined by FDA


For more information, view the full OTC COVID-19 focused webinar.

Register here for the next webinar in our Over-the-Counter Drug Monograph series.

To learn more, please call us at +215-557-3010 or email us at [email protected]

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