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FDA announced final guidance for the temporary manufacture of certain alcohol-based hand sanitizer products for the duration of the on-going COVID-19 health emergency.

Because of the increased demand for these OTC drug products, FDA will temporarily suspend enforcement actions against firms 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, provided certain stipulations are met:

  • The hand sanitizer is manufactured using only United States Pharmacopoeia (USP) grade ingredients consistent with World Health Organization (WHO) recommendations as described in the guidance document, and in the correct amounts.
  • No other active or inactive ingredients are included.
  • Conditions for manufacture must meet FDA Good Manufacturing Practices (GMP) standards, including sanitary conditions and documented analysis for verification of alcohol content in samples of the finished drug product before each batch is released.
  • Appropriate labeling as referenced in the monograph and guidance document.
  • The manufacturer must have a mechanism to accept adverse event reports (AER) and must submit those reports to FDA.
  • Firms manufacturing these products must register their facility and list their products in the FDA Drug Registration and Listing System (DRLS).

Bryan Coleman, EAS Senior Director for Pharmaceuticals and Medical Devices, reminds all manufacturers and distributors of hand sanitizers that FDA has not relaxed or suspended any GMP manufacturing requirements for these or any other products:

  • A firm operates at its own risk if it exceeds the limits of the GMPs and/or does not perform required tasks as prescribed (such as validation, change of ingredient suppliers, etc.)
  • Change control to set the definitive time frames and additional control measures must be used should a firm wish to change batch size, introduce new ingredient suppliers or packaging components, without undergoing qualification/validations/pre-assessment studies for an OTC monograph formula. (These should reference the President’s National Emergency Declaration and firms must commit to ceasing such “changed operations” immediately upon closure of the National Emergency Declaration and/or upon pursuing the prospective validation/qualification of the changes according to GMP requirements.)
  • Detailed record keeping is essential, including for any non-routine production activities.
  • Firms could be cited for having introduced into interstate commerce a product which has not been fully subjected to the GMP requirements and is therefore potentially adulterated/misbranded and subject to FDA enforcement discretion.
  • While FDA has temporarily reduced its domestic inspections to high priority/critical operations only, the Agency still has the right and capability to perform inspections at its will.

EAS is ready to help navigate how to document, properly plan for and execute such deviations and change controls. With detailed knowledge of FDA requirements and GMP methods, enlisting the advice of a competent expert can help to reduce your regulatory risk in these trying times. EAS staff can also assist with your establishment registration and drug listing process. For assistance in these matters, contact Bryan Coleman directly.

Posted in Did You Know, Drugs and tagged .