Food and beverage companies are under enormous pressures to continue delivering safe and healthy products during this public health emergency. Many companies may also be interested in retrofitting their production facilities to help provide medical supplies and/or cleaning supplies. Here is some information on the regulations the FDA has begun to issue for these types of changes.
The FDA has published a newly issued Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19).
The FDA’s March 2020 Temporary Policy notes the FDA does not intend to take enforcement action against companies “that prepare alcohol-based hand sanitizers for consumer use and for use as health care personnel hand rubs for the duration of the public health emergency declared,” when the following conditions are met.
Required ingredients (FDA March 2020 Temporary Policy)
- 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:
- 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.
- Glycerol (1.45% v/v).
- Hydrogen peroxide (0.125% v/v).
- Sterile distilled water or boiled
cold water.
- 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.
- The company does not
add other active or inactive ingredients.
- The company pays particular attention
to ensure the ethanol or isopropyl alcohol active ingredient is
correct and the correct amount of the active ingredient is
used.
Recordkeeping and safety (FDA March 2020 Temporary Policy)
In retrofitting their production facilities to help provide medical supplies and/or cleaning products, companies should:
- Keep a simple record to document key
steps and controls to assure each batch matches the formula
developed for the drug product.
- Ensure that the hand sanitizer is
prepared under sanitary conditions, and equipment utilized is well
maintained and fit for this purpose.
- Use 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.
- Label the hand sanitizer consistent
with the sample labels shown in the FDA March 2020 Temporary Policy
guidance.
Registration (FDA March 2020 Temporary Policy)
- Companies making this transition
must register with the FDA Drug Registration and Listing
System.
- Importantly, once registered, companies can immediately begin producing and distributing product and need not wait for further communication from the FDA.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.