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Secure Supply Chain Pilot for Drug Products Expected to Begin in February 2014

Tuesday, August 20, 2013
Sandler, Travis & Rosenberg Trade Report

Several years after it was initially proposed, a two-year pilot test of a secure supply chain program for drug products is now expected to launch in February 2014. The Food and Drug Administration’s voluntary Secure Supply Chain Pilot Program is intended to help prevent the importation of adulterated, misbranded or unapproved drugs and expedite the entry of approved finished drug products and active pharmaceutical ingredients.

Applicant Information. Applications for participation in the SSCPP will be accepted from Sept. 16 through Dec. 31. The FDA intends to limit the pilot to no more than 100 qualified applicants and no more than five drug products per applicant. The application (form FDA 3676) can be found here and should be submitted electronically as a PDF document.

Participation Criteria. To be selected to participate in the SSCPP, specified criteria must be met, including the following.

- The applicant must be the sponsor of the new drug application or the abbreviated NDA or be the foreign manufacturer of the imported finished drug product or API.

- The importer of record must have a validated Tier II or Tier III secure supply chain under the Customs-Trade Partnership Against Terrorism.

- The customs broker or entry filer identified in the application must be qualified for paperless entry filing to FDA's Operational and Administrative System for Import Support.

- If the ultimate consignee identified in the application is an establishment subject to 21 USC 360, it must be in compliance with the FDA's registration, drug listing and current good manufacturing practice requirements and must have been in compliance over the past three years.

- The importation of the finished drug product or API must be from the foreign manufacturer identified in the application, arrive through the identified port of entry and port of arrival, use the identified customs broker/entry filer, and be intended for the identified ultimate consignee.

- The foreign manufacturer and the finished drug product or API identified in the application must be in compliance with requirements of the FD&C Act relating to drugs.

- The applicant must have in place plans for promptly correcting concerns that the FDA identifies regarding its secure supply chain or specific importations and for recalling or correcting any finished drug products or APIs that do not meet, or are discovered not to have been manufactured in accordance with, FDA requirements.

- Applicants must maintain records that confirm the information provided in their applications, including documentation of their C-TPAT validation status. In addition, for each finished drug product or API shipment, applicants must maintain for the duration of their participation in the pilot 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.

Evaluation. The FDA intends to evaluate the SSCPP based on several factors, including timeframes for the passage of drugs through the import entry process, the level of adherence by program participants to program criteria, and the impact of the SSCPP. This evaluation will help the FDA determine whether the establishment of an SSC program is supported and, if so, the parameters of such a program. The FDA may also determine that it should extend the pilot to continue its evaluation or terminate the pilot before the close of the two-year period.

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