FDA Updates Hand Sanitizer Guidance, Expresses Openness to Expedited Medical Device Reviews for PPE

Kelley Drye & Warren LLP

As reports of hand sanitizer shortages have circulated and consumers have taken to using even Tito’s Vodka as a replacement (yes, on their hands), FDA has stepped in to provide clarity.  Last Friday, FDA issued updated guidance regarding manufacture of alcohol-based hand sanitizer.

The first guidance document, Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19), is immediately in effect. It outlines that the agency does not intend to take action against manufacturing firms that prepare alcohol-based hand sanitizers for consumer use and for use as health care personnel hand rubs during this ongoing public health emergency, provided they comply with specific conditions, including the following:.

  1. The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations:
  2. Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (80%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20; or Isopropyl Alcohol (75%, v/v) in an aqueous solution.
  3. Glycerol (1.45% v/v).10
  4. Hydrogen peroxide (0.125% v/v).
  5. Sterile distilled water or boiled cold water.

The firm does not add other active or inactive ingredients.

  1. The firm pays particular attention to ensure the ethanol or isopropyl alcohol active ingredient is correct and the correct amount of the active ingredient is used. A simple record should be used to document key steps and controls to assure each batch matches the formula developed for the drug product.
  2. The hand sanitizer is prepared under sanitary conditions and equipment utilized is well maintained and fit for this purpose.
  3. The firm uses the most accurate method of analysis available at the site for verification of alcohol content in samples of the finished drug product before each batch is released for distribution. Methods can include gas chromatography (GC), alcoholmeter, hydrometer, or other chemical analysis of at least equivalent accuracy.  The sample tested can be performed on in-process material before filling into the final containers to be distributed.
  4. The hand sanitizer is labeled consistent with the antiseptic monograph. Sample Drug Facts labels are included with the guidance.
  5. Firms register their facility and list these products in the FDA Drug Registration and Listing System.

In addition, FDA released a second guidance for pharmacies seeking to compound hand sanitizer.  The second guidance, Policy for Temporary Compounding of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency, is in effect for the temporary compounding of certain alcohol-based hand sanitizers by pharmacists in state-licensed pharmacies or federal facilities and registered outsourcing facilities.

Finally, on the medical device side, FDA has also expressed flexibility to undertake expedited reviews for manufacturers seeking to address PPE shortages.  Earlier this month, FDA released answers to frequently asked questions regarding the shortages of certain types of personal protective equipment (PPE).  FDA states that it may offer expedited review of submissions from manufacturers looking to produce PPE, especially surgical masks and gowns.  Interested parties can contact FDA per the FAQ.

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DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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