CSMS# 16-000887 - FDA Supplementary Information for Filing CVM Pharmaceutical Products in ACE

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10/13/2016 08:56 AM EDT

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The purpose of this information is to provide an update for Intended Use Scenarios for the Animal Drug Products not specifically addressed in FDA Supplemental Guidance (SG) for ACE/ITDS version 2.4.1.



This Supplementary Information will expire upon issuance of the next version of FDA’s SG.



Beginning on Oct 04, 2016, in addition to the syntax currently listed in FDA SG, FDA/CVM encourages filers to transmit the following data elements:



1)For a finished animal drug that is not the subject of an approved application or an active pharmaceutical ingredient (API)/bulk animal drug substance for use in a finished animal drug that is not the subject of an approved application:

-Transmit as VME/ADR

-Transmit Affirmation of Compliance Code REG

-For Affirmation of Compliance Codes VAN, VIN, or VNA-- transmit ”UNK”



2)For APIs/bulk animal drug substance for use in compounding for animal use:

-Transmit as VME/ADR

-Transmit Affirmation of Compliance Code REG

-For Affirmation of Compliance Codes VAN or VNA-- transmit “UNK”

-Include “Compounding” in the commercial description free text field



3)For animal drugs solely for use in research, teaching, or chemical analysis:

-Transmit as VME/ADR

-For Affirmation of Compliance Codes REG, and VIN, VAN, or VNA-- transmit “UNK”

-Include “For research, teaching, or chemical analysis” in the commercial description free text field.



4)For animal drugs offered as import for export (IFE):

-Transmit as VME/ADR or VME/ADE

-For Affirmation of Compliance Codes REG, and VIN, VAN, or VNA-- transmit “UNK”

-Include “Import for Export” in the commercial description free text field.