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29 Aug 2013

Rx-360 Summary of FDA's Supply Chain Security Pilot Programme

On 20 August, FDA announced the initiation of a pilot import program. The Secure Supply Chain Pilot Program will launch in 2014 and, pending the outcome, it may become permanent. 

FDA is seeking 100 applicants for the pilot program with no more than five drug products per applicant. This programme is associated with Section 713 of FDASIA that “…authorises FDA to require the submission of drug compliance information as a condition of granting admission to imported drugs…” including generation of regulations that may allow FDA to treat companies differently based on their compliance history and type of import.  This may permit expedited import of materials by and from highly compliant companies. 

The FDA announcement specifies 12 requirements that must be met by applicants to the pilot program, including
• Completion of the necessary application
• The ultimate consignee must be in compliance with FDA registration and listing requirements and GMPs, including compliance during the past 3 years
• For imported finished dosage form, the consignee must be identified in the approved NDA/ANDA
• For imported API, the source must be identified in the NDA/ANDA and be used to manufacture an FDA approved product.
• The foreign manufacturer of finished dosage form or API must be in compliance with the FD&C Act
• The applicant must have an adequate system in place to effect a recall or field correction
• Applicants must have an adequate system to comply with record keeping requirements specified in the FD&C Act and its implementing regulations.


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