CSMS# 16-000495 - FDA Supplementary Information for Filing Pharmaceutical Products in ACE
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06/16/2016 12:01 PM EDT
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The purpose of this message is to provide an update for Intended Use scenarios for Drug products not specifically addressed in FDA Supplemental Guidance for ACE/ITDS version 2.4.1.
FDA is supplementing the information provided in its Supplemental Guidance for ACE/ITDS to temporarily address submission of Intended Use Codes for drug commodities that are not specifically addressed in version 2.4.1. The information provided in this CSMS message will expire upon issuance of the next version of FDA’s Supplemental Guidance.
Beginning on June 14, 2016, in addition to the syntax currently listed in FDA's Supplemental Guide, FDA encourages filers to transmit the following data elements:
*For placebos intended for use in a controlled clinical trial under an Investigational New Drug application (IND):
- Transmit as DRU/INV
- Transmit Intended Use Code 180.009
- Transmit the IND Affirmation of Compliance Code
- Include "placebo" in the commercial description free text field
* For a finished drug or active pharmaceutical ingredient intended for human use that is not the subject of an approved application:
- Transmit as DRU/PRE or OTC
- Transmit "UNK" (unknown) for Intended Use Code
- Transmit the REG and DLS Affirmation of Compliance Codes
* For a finished drug or active pharmaceutical ingredient intended for use in a bioequivalence (BE) or bioavailability (BA) study in humans that qualifies under 21 CFR 320.31(d) for an exemption from the Part 312 requirements:
- Transmit as DRU with appropriate Government Agency Processing Code (PRE, OTC, INV, or RND)
- Transmit "UNK" (unknown) for Intended Use Code
- Include "bioequivalence study" or "bioavailability study" (as applicable) in the commercial description free text field
* For entries of active pharmaceutical ingredients/bulk drug substances to be used for compounding:
- Transmit as DRU/PRE
- Transmit "UNK" (unknown) for Intended Use Code;
- Transmit the REG and DLS Affirmation of Compliance Codes
- Include "compounding" in the commercial description free text field.
The purpose of this message is to provide an update for Intended Use scenarios for Drug products not specifically addressed in FDA Supplemental Guidance for ACE/ITDS version 2.4.1.
FDA is supplementing the information provided in its Supplemental Guidance for ACE/ITDS to temporarily address submission of Intended Use Codes for drug commodities that are not specifically addressed in version 2.4.1. The information provided in this CSMS message will expire upon issuance of the next version of FDA’s Supplemental Guidance.
Beginning on June 14, 2016, in addition to the syntax currently listed in FDA's Supplemental Guide, FDA encourages filers to transmit the following data elements:
*For placebos intended for use in a controlled clinical trial under an Investigational New Drug application (IND):
- Transmit as DRU/INV
- Transmit Intended Use Code 180.009
- Transmit the IND Affirmation of Compliance Code
- Include "placebo" in the commercial description free text field
* For a finished drug or active pharmaceutical ingredient intended for human use that is not the subject of an approved application:
- Transmit as DRU/PRE or OTC
- Transmit "UNK" (unknown) for Intended Use Code
- Transmit the REG and DLS Affirmation of Compliance Codes
* For a finished drug or active pharmaceutical ingredient intended for use in a bioequivalence (BE) or bioavailability (BA) study in humans that qualifies under 21 CFR 320.31(d) for an exemption from the Part 312 requirements:
- Transmit as DRU with appropriate Government Agency Processing Code (PRE, OTC, INV, or RND)
- Transmit "UNK" (unknown) for Intended Use Code
- Include "bioequivalence study" or "bioavailability study" (as applicable) in the commercial description free text field
* For entries of active pharmaceutical ingredients/bulk drug substances to be used for compounding:
- Transmit as DRU/PRE
- Transmit "UNK" (unknown) for Intended Use Code;
- Transmit the REG and DLS Affirmation of Compliance Codes
- Include "compounding" in the commercial description free text field.
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