Hand Sanitizer Regulations and Formulations
The firm distributing the finished hand sanitizer must register with FDA as a GMP facility and list these products. US FDA sets temporary regulations for hand sanitizer to expedite the registration faster. The hand sanitizer should be made according to specific formulations and by using ingredients listed below: Isopropyl Alcohol or Alcohol (ethanol 80% volume/volume) in a water containing solution.
FDA Guidelines and Safety Concerns
Leveraging broad expertise in FDA cGMP regulations, Operon Strategist can help guide your Hand Sanitizer Manufacturing Company through the FDA registration process. This allow you to rapidly market alcohol-based hand sanitizer you manufacture or purchase that meet the requirements of the emergency regulations.
The FDA regulates hand sanitizer as an over-the-counter drug, available without a prescription. We test hand sanitizers for quality because it is a product we regulate. We discovered serious safety concerns with some hand sanitizers during recent testing, including: Contamination with potentially toxic types of alcohol. Not enough active ingredient (ethyl alcohol or isopropyl alcohol). Labels with false, misleading, or unproven claims. Some hand sanitizers have been recalled and there are more than 150 hand sanitizers the FDA recommends you stop using right away.
NDC Number and Hand Sanitizer
What is the HS code for hand sanitizer? Does hand sanitizer require an NDC number?