FDA Supplemental Guidance CBP and Trade Automated Interface Requirements FDA Supplemental Guidance for the Automated Commercial Environment/International Trade Data System (ACE/ITDS) Version 2.5.1 April 10, 2018 FDA Supplemental Guidance - Release 2.5.1 FDA Supplemental Guidance Contents Change Log ................................................................................................................................................................6 General Introduction ................................................................................................................................................ 20 FDA Overview ..................................................................................................................................................... 20 Points of Contact ................................................................................................................................................. 21 Legends ................................................................................................................................................................... 22 Field Requirements ............................................................................................................................................. 22 Field Data Types ................................................................................................................................................. 22 Required (Mandatory and/or Conditional)Data Elements for all FDA Commodities ............................................... 23 FDA Commodities, Commodity Sub-Types & Corresponding Industry Codes ....................................................... 24 Biologics Commodity Data Elements and Values ................................................................................................... 25 Biologics Example ............................................................................................................................................... 27 Record Identifier PG01 (PGA Identifier) .............................................................................................................. 28 Record Identifier PG02 (Product Identifier) ......................................................................................................... 31 Record Identifier PG04 (Product Constituent Element) ...................................................................................... 32 Record Identifier PG06 (Product Origin) ............................................................................................................. 33 Record Identifier PG07 (Product Trade Names) ................................................................................................. 34 Record Identifier PG10 (Product Characteristics) ............................................................................................... 35 Record Identifier PG19 (Entity Data) ................................................................................................................... 36 Record Identifier PG20 (Entity Address) ............................................................................................................. 38 Record Identifier PG21 (Point of Contact) ........................................................................................................... 39 Record Identifier PG23 (Affirmation of Compliance) ........................................................................................... 40 Record Identifier PG24 (Remarks) ...................................................................................................................... 45 Record Identifier PG25 (Product Condition)........................................................................................................ 46 Record Identifier PG26 (Product Packaging) ...................................................................................................... 47 Record Identifier PG27 (Shipping Container Information) .................................................................................. 51 Record Identifier PG30 (Anticipated Arrival Information) .................................................................................... 52 Record Identifier PG55 (Additional Entity Roles) ................................................................................................ 54 Record Identifier PG60 (Additional Information) ................................................................................................. 55 Record Identifier PG00 (Data Substitution) ......................................................................................................... 56 Cosmetics Commodity Data Elements and Values ................................................................................................. 57 Cosmetics Example ............................................................................................................................................. 58 Record Identifier PG01 (PGA Identifier) .............................................................................................................. 59 Record Identifier PG02 (Product Identifier) ......................................................................................................... 60 Record Identifier PG06 (Product Origin) ............................................................................................................. 61 Record Identifier PG07 (Product Trade Names) ................................................................................................. 62 Record Identifier PG10 (Product Characteristics) ............................................................................................... 63 Record Identifier PG19 (Entity Data) ................................................................................................................... 64 Record Identifier PG20 (Entity Address) ............................................................................................................. 66 Record Identifier PG21 (Point of Contact) ........................................................................................................... 67 Record Identifier PG23 (Affirmation of Compliance) ........................................................................................... 68 Record Identifier PG24 (Remarks) ...................................................................................................................... 69 Record Identifier PG25 (Product Condition)........................................................................................................ 70 Record Identifier PG26 (Product Packaging) ...................................................................................................... 71 Record Identifier PG27 (Shipping Container Information) .................................................................................. 73 Record Identifier PG30 (Anticipated Arrival Information) .................................................................................... 74 Record Identifier PG55 (Additional Entity Roles) ................................................................................................ 76 Record Identifier PG60 (Additional Information) ................................................................................................. 77 Record Identifier PG00 (Data Substitution) ......................................................................................................... 78 Drug Commodity Data Elements and Values .......................................................................................................... 79 Drug Example ...................................................................................................................................................... 81 Record Identifier PG01 (PGA Identifier) .............................................................................................................. 82 Record Identifier PG02 (Product Identifier) ......................................................................................................... 85 Record Identifier PG04 (Product Constituent Element) ...................................................................................... 87 FDA Supplemental Guidance - Release 2.5.1 FDA Supplemental Guidance Record Identifier PG06 (Product Origin) ............................................................................................................. 90 Record Identifier PG07 (Product Trade Names) ................................................................................................. 91 Record Identifier PG10 (Product Characteristics) ............................................................................................... 92 Record Identifier PG19 (Entity Data) ................................................................................................................... 93 Record Identifier PG20 (Entity Address) ............................................................................................................. 95 Record Identifier PG21 (Point of Contact) ........................................................................................................... 96 Record Identifier PG23 (Affirmation of Compliance) ........................................................................................... 97 Record Identifier PG24 (Remarks) 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