21 CFR §1.95

Verified against eCFR.gov as of June 20, 2026View official text on eCFR.gov ↗

Application for authorization to relabel or perform other action to bring the article into compliance with the Federal Food, Drug, and Cosmetic Act or to render it other than a food, drug, device, or cosmetic may be filed only by the owner or consignee, and shall:

(a)Contain detailed proposals for bringing the article into compliance with the act or rendering it other than a food, drug, device, or cosmetic.
(b)Specify the time and place where such operations will be carried out and the approximate time for their completion.