US Appropriators Question FDA’s OTC Switch Process Overhaul, Homeopathic Market Oversight
Appropriations Committee’s report with Agriculture, Rural Development, FDA and Related Agencies FY2021 budget bill also reiterated concern about adding acetaminophen dosing information for children to OTC monograph. But its mentions of FDA initiative to expand ingredients available OTC and homeopathic market oversight were firsts.
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Appropriators’ FDA FY 2021 budget includes amendment to expand its mandatory recall authority introduced by chairman of subcommittee with oversight of agency’s budget, Rep. Sanford Bishop. He said the agency should be able to force drug product recalls as it already can for vaccines, medical devices and products containing ingredients also scheduled as controlled substances.
Appropriation Committee members target $5m for FDA's CBD policy work and suggest the agency enforce against noncompliant firms in their report accompanying legislation proposing the agency’s fiscal 2021 budget.
Although Washington Homeopathic informed FDA it recalled homeopathics manufactured by a supplier on import alert and would recall “high risk” tinctures, it would allow its customers to decide whether to return other products also identified as potentially adulterated.