The legal requirements that apply to drugs manufactured in the United States also apply to imported drugs, and the Food and Drug Administration (FDA) can stop importation at the border by refusing admission of any drug that appears to be adulterated, misbranded, or an unapproved drug. Currently, many drugs imported into the United States undergo a lengthy entry review process, and, with the increasing number of imported goods that the FDA regulates, the process remains a significant barrier to rapid entry.1 However, companies may now be able to expedite the importation of their low-risk drug products in certain circumstances.
On August 20, 2013, the FDA announced the beginning of the Secure Supply Chain Pilot Program (SSCPP), which permits certain active pharmaceutical ingredients (APIs) and finished prescription drug products to proceed after electronic screening without human entry review, thus expediting entry.2
The Food and Drug Administration Safety and Innovation Act (FDASIA) authorizes FDA to provide this expedited clearance process for certain importers as long as they “participate in partnership programs . . . and pass a review of internal controls, including sourcing of foreign manufacturing inputs, and plant inspections.”3 FDA first announced a pilot expedited drug entry review program in January 2009 and requested comments on the proposed program in June 2012.4
Participation in the SSCPP is voluntary and open to 100 companies. Each company accepted in the program will be permitted a maximum of five drug products under expedited review.
Criteria for Participation
Companies that participate in the program must meet the following criteria:
- Sponsor or Foreign Manufacturer Applicants Only
The SSCPP applicant must be the foreign manufacturer or sponsor of an approved New Drug Application (NDA) or an Abbreviated New Drug Application (ANDA) for the imported drug.
- Identification in an Approved NDA or ANDA
If the imported product is a finished dosage form, the Ultimate Consignee, e.g., the initial U.S. buyer or consignee, must be identified in the approved NDA or ANDA. If the imported product is an API, the source of the API must be approved in the applicable NDA or ANDA, and the API must be used to manufacture the drug that is approved by FDA.
- U.S. Customs and Border Protection Collaboration
The importer of record (the person responsible for the entry of the imported drug) must be qualified as a Tier II or Tier III entity5 as defined by the U.S. Customs and Border Protection (CBP) Customs-Trade Partnership Against Terrorism (C-TPAT) program. Further, the broker or importer transmitting entry information to the CBP must be “qualified for paperless entry filing to FDA’s Operational and Administrative System for Import Support” (OASIS), FDA’s automated system for processing and making admissibility determinations for imported shipments of FDA-regulated products.6
- The Product is Imported as Indicated in the SSCPP Application
The product imported must be in accordance with the SSCPP application, i.e., the product is made by the foreign manufacturer identified in the application; the product arrives through the identified ports of entry; the entry is filed by the identified broker or participant; and the product is intended to reach the Ultimate Consignee identified in the SSCPP application.
- Past and General Compliance
The foreign manufacturer and the imported product must comply with all other requirements of the Federal Food, Drug, and Cosmetic Act (FDCA) and the Ultimate Consignee of the imported product must comply with FDA’s registration, listing, and good manufacturing practices regulations and must have been in compliance for the last three years.
- Recordkeeping Requirements
The applicant must comply with recordkeeping requirements identified in the FDCA, maintain records that confirm the information provided in the SSCPP applications (e.g., C-TPAT validation status documentation), and maintain records that document the imported product’s movement through the supply chain.
- Potential Problems
The sponsor or the sponsor’s U.S. agent must be the primary contact with the FDA, and both the primary and secondary contacts listed in the SSCPP application must be able to answer questions and resolve issues raised by the agency.
The applicant must have plans to:
- quickly address importation issues;
- recall or correct an imported product as needed; and
- report any deviation from the recall to FDA within three business days.
FDA will accept SSCPP applications on a first-come, first-served basis, from September 16, 2013 to December 31, 2013. The application form is available here.7
To ensure participants continue to meet the program’s criteria, FDA will periodically examine records and conduct random field examinations. The agency may remove a company from the SSCPP, if the applicant, foreign manufacturer, or the Ultimate Consignee of the imported product fails to comply with the program or receives any communication from FDA that cite violations of the FDCA. If a company is terminated from the program, it will need to comply with the standard drug import review process.
SSCPP will be piloted from February 2014 through February 2016.