In August 2013, the Food and Drug Administration ("FDA") announced the Secure Supply Chain Pilot Program (the "Pilot Program"). On February 18, 2014, the FDA announced (here) the start of the Pilot Program with thirteen (13) prequalified companies who will receive expedited entry for up to five (5) drug products. The Pilot Program is intended to assist FDA in its efforts to prevent the importation of adulterated, misbranded, or unapproved drugs by allowing the FDA to focus its resources on imported drugs that fall outside the program.  The Pilot Program is a voluntary 2 year program that will run through February 2016. Under the Pilot Program, products are given "May Proceed" status without review or examination. The term "May Proceed" means that an FDA-regulated imported product may proceed into domestic commerce based on electronic screening.  

The Pilot Program is related to section 713(4)(B)(i) of the Food and Drug Administration Safety and Innovation Act (FDASIA), which authorized the FDA to require the submission of drug compliance information as a condition of granting admission to imported drugs, and subsection (4)(B)(i) specifically states that in issuing the implementing regulations FDA "may, as appropriate, take into account differences among importers and types of imports, and based on the level of risk posed by the imported drug, provide for expedited clearance for those importers that volunteer to participate in partnership programs for highly compliant companies and pass a review of internal controls. . . ." The information provided through this Pilot Program will inform the FDA on how best to shape and implement the program mentioned in section 713(4)(B) of the FDASIA.

Under the Pilot Program, the FDA will share the names of the participants and information related to these companies with other Federal Agencies, including Customs and Border Protection (CBP) and will collaborate with CBP regarding Customs-Trade Partnership Against Terrorism (C-TPAT). Participation in the program does not prevent any agency from examining or inspecting any product.

Under the Pilot Program, the FDA intends to periodically examine records and conduct random field examinations to audit shipments, and may remove a participant if the FDA deems a participant to have violated any requirements of the Food Drug and Cosmetic Act (FDCA) or for failing to comply with the Pilot Program.

Secure Supply Chain Pilot Program Requirements:

  1. The applicant must submit a complete application using Form FDA 3676.
  2. The entity receiving the product must demonstrate three (3) years of compliance with FDA's registration, drug listing, and current good manufacturing practice requirements.
  3. For finished dosage products, the entity receiving the product must be identified in the approved NDA or ANDA.
  4. For API, the manufacturing source must be identified in the FDA drug approval.
  5. The product must: (a) be from an identified foreign manufacturer; (b) arrive through the identified port of entry and port of arrival; (c) use the identified Customs House Broker/Entry Filer; and (d) be intended for the identified Ultimate Consignee.
  6. Both the foreign manufacturer and the finished drug product or API must be in compliance with requirements of the FDCA.
  7. The importer of record must have a validated Tier II or Tier III secure supply chain per the CBP Customs-C-TPAT Program.
  8. The primary and secondary contacts must be able to answer questions and resolve issues raised by FDA and the primary contact must be the sponsor or the U.S. agent for the sponsor.
  9. The applicant must have a plan in place for promptly correcting concerns that FDA identifies regarding its secure supply chain or specific importations.
  10. The applicant must have a plan product recall or corrective action for finished drug products.
  11. Applicants must comply with recordkeeping requirements of the FDCA and FDA's regulations and must agree to records inspections beyond the requirements of current law.
  12. Any Customs House Broker/Entry Filer must be qualified for paperless entry filing to FDA's Operational and Administrative System for Import Support.

While many details will be worked out through this Pilot Program, once implemented, this program should be a great benefit to regulators, industry and consumers alike; saving time and money while also ensuring high quality products and ingredients enter commerce in the US.

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