21 CFR 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?

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.