Hand sanitizer is regulated by the FDA in the United States as an over-the-counter drug product, specifically classified as a consumer antiseptic rub. This classification requires manufacturers to comply with several regulatory controls, including formulation standards, labeling, registration and Good Manufacturing Practices. During the COVID-19 public health emergency, the FDA temporarily relaxed some of these requirements to address supply shortages, allowing certain non-traditional manufacturers to produce hand sanitizers under specific conditions.
Join our cosmetics, personal care and household products team as they review the regulatory requirements for OTC products, including hand sanitizers, the reforms signed into law as part of the CARES ACT and new reforms in store for OTC products. You will learn about the different study designs and tests that can be performed to support safety and efficacy claims for your skin care products.
Agenda
- Overview of US OTC regulations
- Review of hand sanitizer requirements
- Review of FDA temporary guidance on the manufacture of hand sanitizers
- Overview of OTC monograph reform
- Q&A
Target Audience: The webinar is aimed at manufacturers, distributors and labelers of hand sanitizer intended for sale in the United States.
