HBW Insight is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

No ‘Surprise’ Facility Fees For Sanitizer Makers After Responding To COVID-19 Emergency In US

Executive Summary

HHS says FDA made subject to monograph program facility fees businesses that began making hand sanitizers in response to temporary guidance easing manufacturing standards "about the same time” the department withdrew the user fee schedule.

You may also be interested in...



US OTC Monograph Facilty Fees Increase With Pandemic-Inspired Sanitizer Makers Exempted

FDA publishes second notice on FY2021 rates for OTC monograph drug user fee program. With fewer firms paying, those still subject to facility fees will pay more so the total collected matches amount Congress authorized agency to collect, nearly $23.3m.

US FDA Clarifies Testing In Sanitizer Production Temporary Guidances To Tighten Compliance

The agency clarifies in documents providing temporary guidance on preparing or compounding alcohol-based hand sanitizer products, and manufacturing alcohol for those products, that each lot of alcohol obtained from another source should be tested for methanol.

Blanket Warning By US FDA For Sanitizers Made By Mexico Firms Linked To Methanol Contamination

The agency’s latest in a series of increasingly strident announcements expands its its warning not to use any hand sanitizers from the firms linked to methanol contamination “even if the product or particular lot number are not listed since some manufacturers are recalling only certain – but not all – of their hand sanitizer products.”

Related Content

Topics

UsernamePublicRestriction

Register

RS150864

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel