FDA Announces Plan for Secure Supply Chain Pilot Program for Drugs, Active Drug Ingredients Manufactured Outside the U.S.
The Food and Drug Administration has issued a notice announcing its plan to launch a voluntary Secure Supply Chain (SSC) pilot program that would help promote the safety of finished drug products and active pharmaceutical ingredients (APIs) intended for human use that are manufactured outside the U.S.
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Sponsors and foreign manufacturers of such drug products would be able to apply to participate. Comments on the pilot program are due by March 16, 2009.
SSC Program Would Prevent Unapproved Drugs, Etc., Increase Expedited Entry
FDA states that a SSC program would assist it in its efforts to prevent the importation of adulterated, misbranded, or unapproved drugs by allowing it to focus its resources on imported drugs outside the program that may pose such risks.
The SSC program would also increase the likelihood of expedited entry for specific finished drug products and APIs imported into the U.S. that meet the criteria for selection under the program.
FDA notes that the pilot program is part of its risk-based approach to regulating drug imports, and it follows the President's charge to the Interagency Working Group on Import Safety to better assure that imported products are safe. (See ITT's Online Archives or 07/03/08 and 07/09/08 news, 08070310 and 08070906, for BP update on the working group's Action Plan, and FDA's accomplishments since the Action Plan, respectively.)
FDA Plans to Select 100 Applicants, 5 Drug Products Per Applicant
The FDA plans to select 100 applicants to participate in the Secure Supply Chain pilot program. Each applicant may designate up to five drugs for selection in the pilot program. FDA may, at its discretion, increase or decrease the number of applications that it selects or the number of products per applicant.
FDA Plans to Run Pilot Program for Two Years
FDA plans to finish selecting applications and begin the SSC pilot program 180 days after the date FDA announces that it is accepting applications. FDA plans to continue the SSC pilot program for two years after it begins. (At its discretion, FDA may terminate the SSC pilot program before the close of the two-year period, or FDA may extend the SSC pilot program beyond two years, which will be announced in the Federal Register.)
Applicants Must Meet Certain Criteria to Participate in Pilot Program
Companies wishing to participate in the pilot program must meet certain criteria, including (partial list):
The APIs imported must be used only to make FDA-approved drugs;
The applicant must submit a complete application (Form FDA-3676), and must be the holder of the New Drug Application (NDA) or Abbreviated New Drug Application (ANDA) or the foreign manufacturer of the imported finished drug product or API;
Foreign drug manufacturers and U.S. establishments receiving drugs must be FDA-registered and comply with Good Manufacturing Practices;
Applicants must show that their drug products use a secure supply chain; and
Applicants must have either a pending application or be certified with the CBP Customs-Trade Partnership Against Terrorism (C-TPAT) Tier II certified secure supply chain. Both applicants to the SSC pilot program and firms identified in the SSC application must be CTPAT Tier II certified or Tier II pending certification at the time an application is submitted for participation in the pilot program.
(See FDA notice for complete list of criteria.)
Application Form May be Submitted After OMB Approval
The SSC application form may not be submitted to FDA until the Office of Management and Budget (OMB) has approved the information collection associated with the SSC pilot program. After OMB approval, FDA will accept applications to participate in the program and begin selecting applications for participation.
FDA will announce in the Federal Register OMB's approval, the date that applications may be submitted, and application submission procedures. The draft application to participate in the SSC pilot program is available for review and comment on the FDA Web site at http://www.fda.gov/cder/fedreg/fda-3676.pdf.
(See FDA notice for details on its information collection submitted for OMB approval, on which comments are also due by March 16, 2009.)
(See ITT's Online Archives or 07/14/08 news, 08071410, for BP summary of FDA's recent announcement of an international inspection pilot and third-party certification initiatives to enhance food and drug safety.)
FDA contact - Kathleen Anderson (301) 796-3110
FDA notice (D/N FDA-2008-N-0656, FR Pub 01/15/09) available at http://edocket.access.gpo.gov/2009/pdf/E9-791.pdf
FDA press release (dated 01/14/09) available at http://www.fda.gov/bbs/topics/NEWS/2009/NEW01943.html