Regulations last checked for updates: Nov 23, 2024

Title 21 - Food and Drugs last revised: Nov 21, 2024
§ 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.

source: 42 FR 15553, Mar. 22, 1977, unless otherwise noted.
cite as: 21 CFR 1.1445