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Current FDA COVID-19 related actions and advice

The US Food and Drug Administration has kept its staff busy with approvals, authorizations, and warnings related to various coronavirus-centered products. ....

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ACI, CHPA Urge FDA: Withdraw Allowance for Emergency Sanitizer Production

ACI, CHPA Urge FDA: Withdraw Allowance for Emergency Sanitizer Production
April 30, 2021
Contact Author Rachel Grabenhofer
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In an appeal to the U.S. Food and Drug Administration (FDA), the American Cleaning Institute (ACI) and Consumer Healthcare Products Association (CHPA) urged the agency to withdraw its emergency guidance allowing non-traditional manufacturers to produce hand sanitizers, citing safety concerns.
The ACI and CHPA wrote, In the early days of the COVID-19 pandemic, FDA issued its Guidance for Industry: Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19), to help meet unprecedented demand, allowing non-traditional sanitizer companies to manufacture these FDA-regulated products. While FDA’s temporary guidance provides instructions for developing hand sanitizers, the newer manufacturers were not required to meet FDA’s typical manufacturi ....

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Lobos asked to assist with vaccine clinic at The Pit

In commitment to community health, The University of New Mexico is permitting employees to use compensated work hours to staff a COVID vaccine clinic at The Pit.
The newly created UNM Health COVID-19 Vaccination Clinic at The Pit is enabling UNM Hospital officials to administer vaccinations with guidance and support from the New Mexico Department of Health (DOH). Vaccines will be administered under the phases outlined by the DOH.
To maintain an orderly, efficient and coordinated implementation, UNM is seeking medical and non-medical volunteers to help staff the site.
“We all have been impacted by COVID,” said Kate Becker, CEO of University of New Mexico Hospitals. “Being able to administer vaccines to the most vulnerable members of the public has truly been inspiring and we appreciate every volunteer who serves to make this happen.” ....

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Wrap-Up of Federal and State Chemical Regulatory Developments, January 2021 | Bergeson & Campbell, P.C.

TSCA/FIFRA/TRI
EPA Seeks Comments On Draft Compliance Guide Addressing Surface Coatings Under PFAS SNUR: On December 16, 2020, the U.S. Environmental Protection Agency (EPA) announced the availability of a draft compliance guide that outlines which imported articles are covered by EPA’s July 2020 final significant new use rule (SNUR) that prohibits companies from manufacturing, importing, processing, or using certain long-chain per- and polyfluoroalkyl substances (PFAS) without prior EPA review and approval. 85 Fed. Reg. 81466. The draft guide provides additional clarity on what is meant by a “surface coating,” identifies which entities are regulated, describes the activities that are required or prohibited, and summarizes the notification requirements of the final SNUR. More information on the draft compliance guide is available in our December 14, 2020, memorandum, “EPA Publishes Draft Compliance Guide Addressing Surface Coatings under PFAS SNUR.” Comments on the d ....

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Distilleries Making Hand Sanitizers Will Not Face Drug Facility Fees

Tuesday, January 5, 2021
Last week, press reported that the U.S. Food and Drug Administration (FDA) would assess distilleries making hand sanitizer $14,060 in fees as Monograph Drug Facilities (MDF) under the Over-the-Counter (OTC) Monograph Drug user fee program for fiscal year (FY) 2021. Several days later, on December 31, 2020, the Department of Health and Human Services (HHS) Office of Public Affairs tweeted a statement from Brian Harrison, HHS Chief of Staff. According to the statement, HHS has “directed FDA to cease enforcement of these arbitrary, surprise user fees.” FDA announced the fee rates on December 29, 2020. 85 Fed. Reg. 85646. According to the notice, MDFs are exempt from FY 2021 facility fees if they had ceased OTC monograph drug activities and updated their registration with FDA to that effect, prior to December 31, 2019 an impossibility for distilleries that began making hand sanitizer in 2020 in response to the COVID-19 pande ....

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