Regulation Text
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.
Authority
15 U.S.C. 1333,1453,1454,1455,4402;19 U.S.C. 1490,1491;21 U.S.C. 321,331,332,333,334,335a,342,343,350c,350d,350j,352,355,360b,360ccc,360ccc-1,360ccc-2,362,371,374,381,382,384a,387,387a,387c,393, and2223;42 U.S.C. 216,241,243,262,264,271.
Related Guidelines (3)
Pre-Launch Activities Importation Requests (PLAIR): Guidance for Industry (Status: Final)
→Guidance for Industry: Reconditioning of Fish and Fishery Products by Segregation (Status: Final)
→Guidance for Industry: Foreign Supplier Verification Programs for Importers of Food for Humans and Animals (Status: Final)
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