Perspectives on Three Recent Policies for Alcohol-Based Hand Sanitizer for Manufacturers during COVID-19

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

• Applicable to alcohol production firms (i.e., ethanol or ethyl alcohol) for use as the active pharmaceutical ingredient (API) in alcohol-based hand sanitizers for consumer and healthcare personnel use.
• Requirements to manufacture alcohol under this temporary policy include the following:
  • To meet the component requirements for hand sanitizer, the alcohol manufactured as an API is not less than 94.9% ethanol by volume.
  • Any water used to adjust the finished ethanol content in the alcohol API is sterile.
  • The alcohol (ethanol) is denatured by the alcohol producer or at the point of production of the finished sanitizer product.  Alcohol and Tobacco Tax and Trade Bureau regulations 27 CFR part 20 and 21 provide a number of formulas for denaturing alcohol.
  • The alcohol production firm ensures the ethanol content in the finished API before being denatured is at least 94.9% by volume.
  • Prepared under sanitary conditions in well maintained equipment.
  • Verify ethanol content via an accurate method of analysis.
  • If alcohol API is distributed to other producers, it is labeled consistent with labeling attached in the temporary policy.
  • Alcohol production firms register their facility and list these products in the FDA Drug Registration and Listing System (DRLS).
  • If adverse event reports are received, they are encouraged to submit them to FDA’s MedWatch Adverse Event Reporting program.

Temporary Policy for Preparation of Certain Alcohol-Based hand Sanitizer Products During the Publish Health Emergency (COVID-19)

March 2020, Updated April 15, 2020

• Applicable to firms not currently regulated by FDA as drug manufacturers that prepare alcohol-based hand sanitizers for consumer and healthcare personnel use.
• Requirements to manufacture alcohol-based hand sanitizers under this temporary policy include the following:
  • The hand sanitizer is manufactured using only the following ingredients:
    • Alcohol (ethanol) not less than 94.9% ethanol by volume or USP Isopropyl Alcohol
    • Glycerin (glycerol) USP or Food Chemical Codes (FCC) (also known as “food grade”)
    • Hydrogen peroxide
    • Sterile Water
• Additional considerations for ingredients in preparation of the product:
  • The alcohol (ethanol) used is derived from distillation or fermentation.  Alcohol derived from synthetic process is used only if it meets US Pharmacopeia (USP) or Food Chemical Codex (FCC) grade.
  • The alcohol (ethanol) is denatured either by the alcohol producer or at the point of production of the finished hand sanitizer product.  Alcohol and Tobacco Tax and Trade Bureau regulations 27 CFR parts 20 and 21 provide formulas for denaturing alcohol.
  • Manufactured according to the following formula:
    • Alcohol (ethanol) (formulated to 80%, volume/volume (v/v) in an aqueous solution.
    • Glycerin (glycerol) (1.45% v/v)
    • Hydrogen peroxide (0.125% v/v)
    • Sterile distilled water or boiled cold water
    • No other active or inactive ingredients are added, such as to improve smell or taste, due to the risk of accidental ingestion by children.
    • Document the key steps and controls used to ensure the correct ingredients in the correct amount are added to each batch.
    • Prepared under sanitary conditions in well maintained equipment.
    • Verification of alcohol content in each batch via an accurate method of analysis.
    • The hand sanitizer product is produced as an aqueous solution and not as a gel, foam or aerosol spray.
    • The hand sanitizer is labeled consistent with the label attached to the temporary policy.
    • Firms register their facility and list their products in the FDA DRLS.
    • Document and submit adverse event reports for any products they manufacture to FDA.

Policy for Temporary Compounding of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency

March 2020, Updated April 15, 2020

• Applicable to pharmacists in State-licensed pharmacies or Federal facilities and registered outsourcing facilities (referred collectively in this guidance as compounders)
• Requirements for compounders that prepare alcohol-based hand sanitizers under this temporary policy include the following:
  • Compounded using only the following ingredients:
    • Alcohol (ethanol) not less than 94.9% ethanol by volume or USP Isopropyl Alcohol
    • Glycerin (glycerol) USP or Food Chemical Codes (FCC) (also known as “food grade”)
    • Hydrogen peroxide
    • Sterile Water
  • Additional considerations for ingredients in preparation of the product:
    • The alcohol (ethanol) used is:
      • Derived from distillation or fermentation.  Alcohol derived from synthetic process is used only if it meets USP or FCC grade.
      • Denatured either by the alcohol producer or at the point of production of the finished hand sanitizer product.  Alcohol and Tobacco Tax and Trade Bureau regulations 27 CFR part 20 and 21 provide formulas for denaturing alcohol.
    • Compounded according to the following formula:
      • Alcohol (ethanol) (formulated to 80%, volume/volume (v/v) in an aqueous solution.
      • Glycerin (glycerol) (1.45% v/v)
      • Hydrogen peroxide (0.125% v/v)
      • Sterile distilled water or boiled cold water
      • No other active or inactive ingredients are added, such as to improve smell or taste, due to the risk of accidental ingestion by children.
    • ​​​​​​​Ensure the ethanol or isopropyl alcohol active ingredient is correct and in the correct amount.
    • The hand sanitizer is:
      • Prepared under conditions routinely used by the compounder to compound similar nonsterile drugs.
      • Produced as an aqueous solution and not as a gel, foam or aerosol spray.
      • Labeled consistent with the labeling attached to the temporary policy.
    • FDA encourages any adverse events experienced to be submitted to FDA’s MedWatch Adverse Event Reporting program.

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

1. FDA News Release “Coronavirus (COVID-19) Update:  FDA Continues to Ensure Availability of Alcohol-Based Hand Sanitizer During the COVID-19 Pandemic, Addresses Safety Concerns”, April 27, 2020
2. FDA Guidance “Temporary Policy for Manufacture of Alcohol for Incorporation Into Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19)
3. FDA Guidance “Policy for Temporary Compounding of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency”
4. FDA Guidance “Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19)
5. Kevin Nolan. “Perspective on policy for Temporary Compounding of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency; Immediately in Effect Guidance for Industry”

 ​​​​​​​