The Food and Drug Administration (FDA) has announced the launch of a voluntary pilot program that would help promote the safety of finished pharmaceutical products and active pharmaceutical ingredients (APIs) that are manufactured outside the U.S., while at the same time enabling quicker entry times for imports covered by the program. The goal of the pilot program is to allow the FDA to determine the practicality of developing a Secure Supply Chain (SSC) program for finished products and APIs intended for human use. The pilot program is both part of FDA’s risk-based approach to regulating imports and an outgrowth of recent efforts of the Interagency Working Group on Import Safety. Participating in the pilot could provide two key benefits for importers – faster importation during the pilot program and the opportunity to shape a potentially important federal program.
The FDA is accepting comments on the pilot program until March 16, 2009. Companies that import finished drug products and APIs are encouraged to review this program and consider submitting comments, especially with respect to any concerns they may have regarding participation in the program once it is opened for applications.
SSC Program Would Prevent the Entry of Unapproved Drugs and Increase Expedited Clearance Through CBP
According to the FDA, the SSC program, which was developed with the U.S. Customs and Border Protection’s (CBP’s) input, would assist the FDA in preventing the importation of adulterated, misbranded, or unapproved drugs by allowing the agency to focus its resources on imported drugs, not covered by the program, which presumably would pose a higher risk of such non-compliance. At the same time, 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.
Selection of Participants for SSC Program
A limited number of sponsors and foreign manufacturers of such drug products would be able to apply to participate in this program if they are in full compliance with all requirements of the Federal Food, Drug, and Cosmetic Act relating to drug products. The FDA plans to select 100 applicants to
participate in the SSC program. Each applicant may designate up to five drugs for selection in the pilot program. The FDA may, at its discretion, increase or decrease the number of applications that it selects or the number of products per applicant. Applicants will be expected to maintain records that confirm the information provided in their SSC pilot program applications, as well as records that document the drugs’ movement through the secure supply chain from the point of manufacture to the point of receipt by the ultimate consignee, and make these records available to the FDA if requested.1
FDA Plans to Run Pilot Program for Two Years
The FDA plans to finish selecting applications and begin the SSC pilot program 180 days after the date the FDA announces that it is accepting applications. The FDA plans to continue the SSC pilot program for two years after it begins. The FDA’s evaluation of the pilot program will be based on several factors, including time frames for the passage of goods through the entry process, the level of participants’ adherence to program criteria and the impact of the program. At its discretion, the FDA may terminate the SSC pilot program before the close of the two-year period, modify it, or extend it beyond two years. Any such decisions 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, but not limited to, the following:
- The importation of the finished drug product or API must (a) be from the foreign manufacturer identified in the application, (b) arrive through the identified port of entry and port of arrival, (c) use the identified broker/customs broker/filer, and (d) be intended for the identified ultimate consignee;
- 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 FDAregistered and comply with Good Manufacturing Practices;
- Applicants must show that their drug products use a secure supply chain;
- Both applicants and firms identified in the application must be CBP Customs-Trade Partnership Against Terrorism (C-TPAT) Tier II certified or Tier II pending certification at the time an application is submitted;
- Regardless of whether it is required by law, for each shipment of a finished drug product or API, applicants must maintain records that document the product’s movement through the secure supply chain from the point of manufacture to the point of receipt by the ultimate consignee;
- The applicant must have a plan in place for promptly correcting any concerns the FDA identifies regarding its secure supply chain or specific importations; and
- The broker/customs broker/filer identified in the application must be qualified for paperless entry filing to the FDA’s Operational and Administrative System for Import Support (OASIS).
The SSC pilot program provides qualifying sponsors and foreign manufacturers of finished drugs and APIs with an opportunity to participate directly in a major FDA initiative to enhance drug product safety, while at the same time achieving quicker entry times for imports covered by the program.