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
in effectEffective: 2024-07-01FDA 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.
Source: eCFRURL: https://www.ecfr.gov/api/versioner/v1/full/2024-07-01/title-21.xmlFetched: 7/26/2026