Code of Federal Regulations · Section
§ 1.95 — Application For Authorization To Relabel And Recondition
21 C.F.R. § 1.95
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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.
Authorizing Statute
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General orders19 U.S.C. § 1490
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Definitions; generally21 U.S.C. § 321
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Labeling15 U.S.C. § 1333
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Regulations42 U.S.C. § 216