§ 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?
136 words·~1 min read·
/us/cfr/t21/s§ 1.1405A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
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.