FDA has announced the withdrawal of temporary guidances for alcohol-based hand sanitizers manufactured by non-drug manufacturers during the COVID-19 public health emergency. Effective December 31, 2021, companies manufacturing alcohol-based hand sanitizers under these temporary policies must cease production of these products.
After that date, compliance with the tentative final monograph for over-the-counter topical antiseptics and other applicable requirements, including the FDA’s Current Good Manufacturing Practice requirements (GMPs) must be followed. Manufacturers who no longer plan to produce these products must deregister them with the FDA.
What does this mean for you?
Despite FDA’s easing of enforcement actions for alcohol-produced hand sanitizers during the COVID-19 public health emergency, the Agency never relaxed or suspended any GMP manufacturing requirements for these or any other products. EAS helps firms navigate how to develop, document, and execute GMPs, assist with establishment registrations and drug listings/delistings.
Contact us for assistance with GMPs, registrations and listings, and other services for the OTC and Rx industries. Trust the compliance experts.
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Posted in Drugs.