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:
- Policy for Temporary Compounding of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency Immediately in Effect Guidance for Industry
- Temporary Policy for Manufacture of Alcohol for Incorporation Into Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19)
- Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19) Guidance for Industry
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).
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