The US Food and Drug Administration updates its temporary guidances to spur additional hand sanitizer production following widespread recalls of products found to contain methanol rather than ethanol or isopropyl alcohol as the active ingredient.
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.
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HBW Insight speaks to AESGP director general Jurate Švarcaite about what's on the agenda for the upcoming 61st AESGP Annual Meeting, which will take place in Warsaw, Poland, between 2-4 June. Highlights include the role of prevention in self-care, discussions about how regulators will ensure the competitiveness of European industry on the world stage and incoming changes to sustainability legislation.
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Notice published on 21 March is a word-for-word copy, other than different dates, of a document published on 24 January, Kennedy says the ACNU final rule’s effective date is delayed until 27 May, two months later than the initial delayed effective date.
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FDA’s OMUFA facility fees for FY2025, due on 2 June, increase nearly $2,400 to $37,556 for OTC monograph drug manufacturers and $2,200 to $25,037 for contract manufacturers. Overall target OMUFA fee total is just short of $36.47m, up from $32.25m for FY2024.
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“Protecting the environment is a shared responsibility. It is unfair to expect only two sectors to fund wastewater treatment modernization and operation,” argues AESGP director general Jurate Švarcaite.