21 C.F.R. § 1.95
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:
[42 FR 15553, Mar. 22, 1977, as amended at 85 FR 50781, Aug. 18, 2020]