21 C.F.R. · Food and Drugs
21 C.F.R. § 1.1445

Under what circumstances may FDA modify or revoke a waiver?

Title 21 C.F.R. ● ACTIVE Primary Source
Regulatory Text

21 C.F.R. § 1.1445 — Under what circumstances may FDA modify or revoke a waiver?

§ 1.1445 Under what circumstances may FDA modify or revoke a waiver? FDA may modify or revoke a waiver if we determine that: (a) Compliance with the waived requirements would no longer impose a unique economic hardship on the individual entity or type of entity to which the waiver applies; (b) The waiver could significantly impair our ability to rapidly and effectively identify recipients of a food to prevent or mitigate a foodborne illness outbreak or to address credible threats of serious adverse health consequences or death to humans or animals as a result of such food being adulterated under section 402 of the Federal Food, Drug, and Cosmetic Act or misbranded under section 403(w) of the Federal Food, Drug, and Cosmetic Act; or (c) The waiver is otherwise contrary to the public interest.

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21 C.F.R. § 1.1445
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The regulatory text of 21 C.F.R. § 1.1445 is reproduced from the official Code of Federal Regulations as published by the Office of the Federal Register and the National Archives and Records Administration.
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