Code of Federal Regulations · Section
§ 1.1405 — Under What Circumstances Will Fda Waive One Or More Of The Requirements Of This Subpart For An Individual Entity Or A Type Of Entity?
21 C.F.R. § 1.1405
FDA will waive one or more of the requirements of this subpart when we determine that:
(a) Application of the requirements would result in an economic hardship for an individual entity or a type of entity, due to the unique circumstances of the individual entity or type of entity;
(b) The waiver will not 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; and
(c) The waiver will not otherwise be contrary to the public interest.
Authorizing Statute
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General orders19 U.S.C. § 1490
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Definitions; generally21 U.S.C. § 321
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Labeling15 U.S.C. § 1333
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Regulations42 U.S.C. § 216