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- FDA Updates Hand Sanitizer Enforcement Discretion Guidance to Provide More Information Regarding Ethanol Sourcing
FDA Updates Hand Sanitizer Enforcement Discretion Guidance to Provide More Information Regarding Ethanol Sourcing
June 4, 2020, Covington Alert
Today, FDA issued updates to its guidance document "Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19),"("Temporary Policy") and related guidance document, that primarily provide more detailed information about potential ethanol sources for companies seeking to prepare hand sanitizer or produce ethanol used in the production of hand sanitizer under the agency's COVID-19 specific enforcement discretion policies. This is the fourth update that FDA has made to these guidance documents since initially issuing them in March, with each previous update providing additional enforcement discretion regarding ethanol that can be used to produce sanitizer under the temporary policy.
March 27, 2020, Covington Alert
On March 27, 2020, Congress passed H.R. 748, the Coronavirus Aid, Relief, and Economic Security Act (the “CARES Act”). Subtitle F of the CARES Act would significantly change FDA’s regulations of over-the-counter (OTC) monograph drugs subject to OTC Drug Review. Congress had introduced earlier versions of the bill, with the latest bill, S. 2740 – Over-the-Counter ...
March 11, 2020, Covington Alert
FDA has reopened the comment period indefinitely for its public hearing on products containing cannabis or cannabis-derived compounds.In doing so, FDA is seeking scientific data and information on cannabis and cannabis-derived compounds, particularly cannabidiol (CBD). On May 31, 2019, FDA hosted a public hearing on “Scientific Data and Information About ...
January 24, 2018, Covington Alert
As we begin 2018, the cosmetic industry marketing products in the United States faces a range of legal and regulatory considerations – from labeling and marketing claims to ingredient safety and environmental issues. This alert for our cosmetic clients analyzes federal regulatory activities in 2017 and summarizes key issues to consider for 2018, including ...