I. RATIONALE
In the exigency of service and in response to the current pandemic state of the country due to the COVID-19, the Food and Drug Administration (FDA) is hereby issuing the revised interim guidelines for the issuance of the License to Operate (LTO) and Certificate of Product Notification (CPN) for manufacturers, distributors and traders of all ethanol and isopropanol products regardless of percent concentrations intended to be used as sanitizing, antibacterial and antiseptic agents. Accordingly, the Center for Cosmetics and Household/Urban Hazardous Substances Regulation and Research (CCHUHSRR) is hereby tasked to facilitate and streamline the process for the approval of these health products which was previously lodged with the Center for Drug Regulation and Research (CDRR).
II.OBJECTIVES
This Circular is being issued to provide FDA’s interim regulatory guidelines to all manufacturers, distributors and traders seeking to produce rubbing alcohol for the issuance of a license to operate (LTO) and certificate of product notification (CPN), to ensure the safety and quality of these products and to aid in the supply sustainability due to the demand brought about by the continuing threat of infection due to COVID-19.
Read more:-> FDA Circular No.2021-004