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BY Manuel M. Garza, Principal Consultant - 5.20.20 -
The COVID-19 pandemic has seriously impacted the US healthcare system and supportive manufacturing facilities. Some consumers and healthcare professionals are currently experiencing difficulties accessing alcohol-based sanitizers, which are commonly used for hands.
FDA is addressing this scarcity of alcohol-based hand sanitizer during the COVID-19 Pandemic by updating on April 15, 2020 the three temporary polices, initially submitted in March 2020, for (1) the manufacture of alcohol for incorporation into alcohol-based hand sanitizer by alcohol production firms, (2) the compounding of alcohol-based sanitizers by authorized pharmacies and (3) the preparation of alcohol-based sanitizers by firms not currently regulated by FDA as drug manufacturers. When the FDA temporary policy for compounders was initially submitted in March 2020, my colleague Kevin Noland wrote article on this policy titled “Perspective on policy for Temporary Compounding of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency; Immediately in Effect Guidance for Industry”
As a result, more than 1,500 additional manufacturers have registered with FDA to produce hand sanitizer. FDA is also addressing safety concerns related to products being sold that are not in compliance with the FDA’s policy and others being marketed with unproven claims.
FDA Commissioner Stephen M. Hahn, M.D. has expressed concern that with this increased supply, it is important that hand sanitizers are manufactured in a way that makes them unpalatable to people, specifically young children, and appropriately labeled to discourage accidental or intentional ingestion. Additionally, Commissioner Hahn states “hand sanitizers are not proven to treat COVID-19, and like other products meant for external use, are not for ingestion, inhalation, or intravenous use.” This is a critical concern since FDA’s analysis of data provided by the U.S. Centers for Disease Control and Prevention and the American Association of Poison Control Centers surveillance team, calls to the National Poison Data System last month related to hand sanitizer increased by 79% compared to March 2019. The majority of these calls were for unintentional exposures in children 5 years of age and younger.
The following talking points provide a high-level synopsis of the three temporary policies and the distinct elements each address.
Temporary Policy for Manufacture of Alcohol for Incorporation Into Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19)
March 2020, Updated April 4, 2020
Temporary Policy for Preparation of Certain Alcohol-Based hand Sanitizer Products During the Publish Health Emergency (COVID-19)
March 2020, Updated April 15, 2020
Policy for Temporary Compounding of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency
March 2020, Updated April 15, 2020
These temporary policies will remain in effect for the duration of the public health emergency declared by the Secretary of Health and Human Services, Alex Azar, on January 31, 2020.
References
"FDA Commissioner Stephen M. Hahn, M.D. has expressed concern that with this increased supply, it is important that hand sanitizers are manufactured in a way that makes them unpalatable to people, specifically young children, and appropriately labeled to discourage accidental or intentional ingestion."
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