FDA
8th June 2020

Differences between FDA COVID-19 Guidance for Alcohol-Based Hand Sanitizers and Monograph Hand Sanitizers Containing Alcohol

On June 1, 2020, the FDA released a statement notifying the public that they have taken additional steps to increase the supply of alcohol-based hand sanitizer during the ongoing COVID-19 pandemic.

Differences between FDA COVID-19 Guidance for Alcohol-Based Hand Sanitizers and Monograph Hand Sanitizers Containing Alcohol

On June 1, 2020, the FDA released a statement notifying the public that they have taken additional steps to increase the supply of alcohol-based hand sanitizer during the ongoing COVID-19 pandemic. These steps included revising the temporary guidances to clarify manufacturing and compounding certain alcohol-based hand sanitizer products.

The revised guidances are listed and linked to below:

While the FDA would like to increase the hand sanitizer supply, public safety remains their primary concern. A guidance revision in April added interim limits for certain impurities associated with ethanol in the hand sanitizer products. Based on industry data, the agency determined that these impurities can be “tolerated for a relatively short period” at the levels defined in the guidance.

Clients are often confused about which hand sanitizer preparations are affected by these guidances. The FDA makes it clear that these guidances are only applicable to hand sanitizers consistent with the World Health Organization (WHO) recommendations. Such sanitizer products must consist of only the following ingredients:

  • alcohol (ethanol – formulated to 80% v/v or isopropyl alcohol – formulated to 75% v/v in an aqueous solution)
  • glycerin (1.45% v/v)
  • hydrogen peroxide (0.125% v/v) and
  • sterile distilled water/ boiled cold water

No other active or inactive ingredients can be included in a hand sanitizer formulation adhering to this guidance. If the formulation includes any other ingredients, the hand sanitizer would be considered an over-the counter drug and would need to adhere to monograph requirements. The labeling would follow the requirements outlined in Advanced Notice of Proposed Rulemaking for Topical Antimicrobial Drug Products: Alcohol Original Indications.

The monograph and the guidance have subtle differences. For instance, hand sanitizers formulated using the guidances listed at the beginning of this post are classified as “antiseptic” products, whereas monograph products are considered “antimicrobial.” These subtle differences are important when creating product labels and drafting marketing claims. Furthermore, the hand sanitizer guidances are only active for the duration of the public health emergency. Once FDA issues a Termination of Declaration Letter, any product authorized under an EUA letter must be taken off the market unless the sponsor pursued the longer and more intensive standard regulatory path (i.e., the monograph path).

Let ISS assist you in taking advantage of the EUA process now.

ISS has assisted with the submission of dozens of EUA packages, and not just for coronavirus-specific drugs, diagnostics, and devices. We have worked directly with FDA on behalf of our clients (as authorized US agents) in order to address deficiencies or revise submissions based on evolving requirements. We know this process inside and out. See our previous post in this series.

Complete the form below to download our free white paper “Applying for an FDA Coronavirus EUA Letter” or contact us today to discuss how we can help.

Download our free white paper “Applying for an FDA Coronavirus EUA Letter”

We have summarized decades of experience recruiting expert teams into this easy-to-read, practical guide.

  • This field is for validation purposes and should be left unchanged.

Recent Related Articles

Best Tips for Medical Device Manufacturers to Write a Compelling Substantial Equivalence Section for their FDA 510k Submission
01 July 2020
Best Tips for Medical Device Manufacturers to Write a Compelling Substantial Equivalence Section for their FDA 510k Submission

Over the past few years, the number of ex-US manufacturers submitting a Class II exempt 510k device registration has increased substantially. For companies with medical devices that are approved and successful in a foreign market, the logical next step is to introduce their product into the US, which has one of the most lucrative healthcare markets in the world. Read more

Evolving FDA Thinking on Advisory Committee Meetings Related to Foods, Drugs, and Devices
25 June 2020
Evolving FDA Thinking on Advisory Committee Meetings Related to Foods, Drugs, and Devices

FDA advisory committee meetings are important regulatory events for many manufacturers on the path to marketing approval. These meetings can quite literally result in the approval or rejection of a product based on the panel’s vote. Read more

NDA vs. OTC Monograph: Which Pathway is Right for You?
22 June 2020
NDA vs. OTC Monograph: Which Pathway is Right for You?

One of the main challenges our clients face is determining which regulatory pathway is best for their products. For example, what if an OTC product has a Monograph active ingredient but that ingredient is present at a different amount than the permitted amount? Or what if the label claims a novel indication not specified in a Monograph? If you are debating pursuit of either regulatory pathway for your OTC drug, it is critical to consider cost, timeline, and label claims to ensure your products has a unique stance in today’s market. Read more

4 Problems Importing Rapid Antibody Tests for Coronavirus
19 June 2020
4 Problems Importing Rapid Antibody Tests for Coronavirus

US distributors and agents trying to import rapid antibody tests for coronavirus face a number of obstacles. The good news is that FDA has opened up the Emergency Use Authorization (EUA) program to include SARS-CoV-2 (the virus) and COVID-19 (the disease), expediting time to market. Read more

Let’s work together

The journey to scientific and commercial success is often complex and always critical, if you are looking for an expert partner to help steer you to confident solutions, contact us today

Contact us