Production of Hand Sanitizer During the COVID-19 Emergency


This page is intended to provide guidance to firms temporarily producing hand sanitizer as a replacement or supplement to their normal activities.

FDA has stipulated that it will not take action against firms producing hand sanitizer that are not currently operating as human drug manufacturing firms provided that such firms meet several requirements (more information will be provided below on this). Because of this and because of interest expressed by numerous entities, the Louisiana Department of Health is providing some basic guidance below for firms wishing to engage in these processes. Note that the department is expediting the paperwork and review times for these firms due to the high demand during this emergency.


HOWEVER, it is important to recognize that LDH maintains a duty to ensure that public health is not compromised during this time, just as it does during other times. For this reason, all such firms must meet the following requirements:

  • All products must comply with the FDA/WHO guidelines for producing hand sanitizer
  • Firms manufacturing or repacking sanitizer for wholesale must obtain a permit to operate from the department
  • Firms producing retail packages of sanitizer must obtain a certificate of registration

 

Contact your inspector

  • A list of our staff may be located here
  • Provide him or her with a detailed plan of operations and proposed formulation; if you intend to work in a separate physical space or utilize different equipment from your normal operations, also provide a new or revised plan document.

Review the appropriate guidance documents

  • Links to the FDA and WHO documents are provided at the bottom of this page - if your firm has never before produced drug products, pay careful attention to the requirements referenced in the FDA document

Follow the formula

These products must be made to the following specifications:

  • Ethanol (80% by volume) or isopropanol (75% by volume) in an aqueous solution
  • Glycerin/glycerol (1.45% by volume)
  • Hydrogen peroxide (H2O2 - 0.125% by volume)
  • Sterile distilled water or boiled cold water to make up the remaining volume

Ensure that you have compliant labelling

Compliant labelling (which must be registered with LDH) includes the following elements:

  • A statement of identity (e.g., hand sanitizer)
  • A net quantity of contents declaration in English and metric units
  • A responsible party declaration (name and address of the manufacturer or distributor)
  • An ingredient statement declaration
  • A Drug Facts panel - see the example below:


LINKS