FDA Issues Temporary Guidance for Prep of Alcohol-Based Hand Sanitizers
Hand sanitizers can be temporarily manufactured without FDA clearance for public distribution for the duration of the public health
FDA is allowing additional companies to manufacture alcohol-based hand sanitizers for consumer use and for use as health care personnel hand rubs for the duration of the public health emergency provided the following circumstances are present:
1. The hand sanitizer is manufactured using only the following United StatesPharmacopeia (USP) grade ingredients, consistent with World HealthOrganization (WHO)recommendations:
a. Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (80%,volume/volume (v/v)) in an aqueous solution or Isopropyl Alcohol (75%,v/v) in an aqueous solution.
b. Glycerol (1.45% v/v).
c. Hydrogen peroxide (0.125% v/v).
d. Sterile distilled water or boiled cold water.
No other active or inactive ingredients can be added to the solution. Different or additional ingredients may impact the quality and potency of the product.
2. The company must pay particular attention to ensure the ethanol orisopropyl alcohol (IPA) active ingredient is correct and the correct amount ofthe active ingredient is used. A simple record should be used to document keysteps and controls to assure each batch matches the product formula.
3. The hand sanitizer is prepared under sanitary conditions and equipmentutilized is well maintained and fit for this purpose.
4. The company must analyze each batch of material, either in-processmaterial before filling or the final containers, for alcohol content before it isreleased for distribution.
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5. The hand sanitizer must be labeled consistent with the labeling outlined inthe guidance document.
6. The company must register their facility and list the products to be sold inthe FDA Drug Registration and Listing System. Additionally, the company mustsubmit Adverse Event Reporting, if the situation should arise. Reference theguidance document for specific information pertaining to registration and AERreporting.
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