The FDA has released a new policy titled Policy for Temporary Compounding of Certain Alcohol-Based Hand Sanitizer Products During Public Health Emergency. Within this document, the FDA has declared they do not intend to take action against compounders who prepare alcohol-based sanitization hand rubs as long as the sanitizer is prepared under conditions similar to nonsterile drugs and possess a label consistent with the outlines in the appendences of the FDA document. As well, the formula of the sanitizer must consist of alcohol, glycerol, hydrogen peroxide, and water in the proportions specified in the document as well and cannot contain any other active or inactive ingredient. These rules do not apply to topical antimicrobial drug products nor tentative final monographs for Health-Care Antiseptic Drug Products. The FDA is also encouraging production line companies to attempt retooling in order to begin manufacturing sanitization hand gels. As well, the United States Federal Government declared they would allow manufacturing of hand sanitizers with limited guidance.

Overall, despite these dark and trying times amidst the coronavirus pandemic, there is still hope. Regulatory bodies, such as the FDA, are adjusting their sanitization product regulations to provide an opportunity for many companies to rise to the occasion to help produce and distribute these high in demand sanitization products. Updated regulations, such as allowing retooling and providing guidelines for temporary compounders, make this time easier and the light at the end of this dark tunnel much brighter.

For more information, please contact Focal Point Research Inc. We are leading North American Regulatory and New Product Consultants for Medical Devices, Natural Health Products, OTC Drugs, Cosmetics, and other consumer products regulated by Health Canada and the U.S. FDA

Emily Campbell

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