How may I request a waiver for an individual entity?
21 C.F.R. § 1.1415
in effectEffective: 2024-07-01You may request a waiver of one or more requirements of this subpart for an individual entity by submitting a written request to the Food and Drug Administration as described at www.fda.gov. The request for a waiver must include the following:
(a) The name, address, and point of contact of the individual entity to which the waiver would apply;
(b) The requirements of this subpart to which the waiver would apply;
(c) Information demonstrating why application of the requirements requested to be waived would result in an economic hardship for the entity, including information about the unique circumstances faced by the entity that result in unusual economic hardship from the application of these requirements;
(d) Information demonstrating why the waiver will not significantly impair FDA's 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
(e) Information demonstrating why the waiver would 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