FDA Fixes Typo in Drug Recall Rulebook—Excitement Ensues?
Published Date: 7/28/2025
Rule
Summary
The FDA fixed a technical mistake in its rulebook to make sure important rules about holding, recalling, or banning certain drugs, devices, and foods are clear and up-to-date. This affects companies making or selling these products, helping protect public health without changing costs or deadlines. The correction keeps the safety process smooth and reliable starting now.
Analyzed Economic Effects
1 provisions identified: 1 benefits, 0 costs, 0 mixed.
FDA Fixes Rule Text Clarifying Enforcement Powers
The FDA reinstated paragraph Sec.16.1(b)(1) in Title 21 (Parts 1–99, revised as of April 1, 2025) to clearly list statutory authorities (for example, sections 304(g), 304(h), 419(c)(2)(D), 515(e), 518(e), 520(f)(2)(D), and several tobacco-related sections). This technical correction is intended to make the agency's rules about holding, recalling, suspending, or banning certain drugs, devices, foods, and tobacco clear and up-to-date, and it does not change costs or deadlines.
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