Expanding US FDA Mandatory Recall Authority To All Drugs Gets House Appropriators’ Approval
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.
You may also be interested in...
In addition to a large and growing number of products made in Mexico and found to contain methanol on recall, sanitizers made by a Washington state dental whitening product firm contain ethanol at below labeled levels and the presence of undeclared isopropyl alcohol. Recent recalls also include injectable CBD formulations a Seattle firm marketed OTC and a New Jersey’s firm dandruff shampoo produced with water that failed US Pharmacopeia specifications
“Food Allergy Safety, Treatment, Education, and Research Act of 2019” would amend FDA regulations to include sesame as major allergen and allow agency to add other ingredients as major allergens based on prevalence and severity of allergic reactions. Separately, FDA FY2021 budget part of minibus set for House vote week of 20 July.
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.