FDA Ready To Launch Secure Supply Chain Pilot

Program could allow for expedited entry of imports, but will be limited to 100 applicants and run for two years.

FDA is poised to begin a voluntary Secure Supply Chain Pilot Program in 2014, which could allow more expedited import entry and also add to the drug tracking system it is waiting for Congress to mandate.

SSCPP is intended to identify a group of drug product importers that meet a series of compliance and inspection requirements and potentially reduce the number of “human entry review or examination” of their shipments at the U.S. border, according to a Federal Register notice scheduled to be published Aug. 20.

Products approved to be part of the pilot should also qualify as “May Proceed” imports, that is, those allowed into domestic commerce after only an electronic screening. FDA wants to increase the number of “May Proceed” imports and free resources to focus on more risky shipments.

Participation will be limited to no more than 100 qualified applicants, with no more than five products per applicant. Applications will be taken on a first-come, first-served basis and will be accepted Sept. 16 through the end of 2013, according to the notice. The pilot will run from February 2014 through February 2016.

The agency announced the program in January 2009 (Also see "FDA launches secure supply chain pilot program" - Pink Sheet, 1 Jan, 2009.), and then in June 2012 submitted the idea to the Office of Management and Budget for approval (Also see "Track-and-Trace Deal’s Failure Leaves California In Control Of Agenda" - Pink Sheet, 25 Jun, 2012.).

A Dozen Entry Requirements Listed

Pilot program participants must meet 12 requirements, including having sufficient recall or correction plans if FDA finds the product does not meet manufacturing requirements.

They also must comply with Food, Drug and Cosmetic Act recordkeeping regulations and make them available to FDA upon request, as well as document product movement through the supply chain “from the point of manufacture to the point of receipt by the ultimate consignee” regardless of whether required by law, according to the notice.

Manufacturers participating in the program also must have been in compliance with current Good Manufacturing Practices for the last three years. Finished dose product ultimate consignees must be identified in an approved NDA or ANDA and APIs must be used in the manufacture of an FDA-approved product.

FDA still expects to conduct periodic records inspections and random field shipment inspections to determine whether participants continue to meet pilot program requirements. An untitled letter, warning letter, or cyber letter listing regulatory violations also could force a participant out of the program, according to the notice.

A number of the recordkeeping and some other participation requirements bear some resemblance to the drug track and trace program FDA wants implemented and Congress is considering.

Proposals would require documentation of the parts of the supply chain that handle shipments in an effort to prevent adulteration and cargo theft (Also see "Rx Supply Chain Bill On Track In Senate; Will House Use The Same Gauges?" - Pink Sheet, 22 May, 2013.).

The House passed a track and trace bill in June that would require lot-level tracking initially, but FDA also would have to write rules for a more extensive unit-level system (Also see "Track-and-Trace Bill Clears House With New Electronic Labeling Language" - Pink Sheet, 3 Jun, 2013.).

The Senate Health, Education, Labor and Pensions Committee also reported out drug tracking legislation that differs from the House bill, but it is unclear when it could be considered by the full Senate. That bill was combined with legislation intended to improve oversight of compounding (Also see "Compounding Bill In Senate Adds Office Use Provisions" - Pink Sheet, 26 Jul, 2013.).

FDA also intends for the secure supply chain pilot to aid in implementing sections of the FDA Safety and Innovation Act allowing submission of compliance information as a condition of import entry.

Program Extension, Permanence Possible

The pilot could become a permanent program if it runs as intended and gains industry support.

FDA said the program’s impact, timeframes for product passage through the entry process and adherence to program criteria by participants will be part of the evaluation.

The agency also could extend the pilot beyond the two-year period or terminate it early, according to the notice.

The SSCPP is one of a number of initiatives that are part of FDA’s effort to deal with the impact of the globalization of the supply chain. The agency has already released plans to eventually rely on other trusted regulators to provide information that will help better target resources (Also see "FDA Envisions Many Regulatory Coalitions Dealing With Globalization Issues" - Pink Sheet, 26 Sep, 2011.).

FDA also has developed a hand-held counterfeit detection device so inspectors can make quick determinations of whether a shipment contains adulterated or counterfeit products. It announced plans in April to field test the device in Ghana (Also see "FDA Counterfeit Screening Tool Gets Field Test In Ghana; Corning Prepares Device For Mass Production" - Pink Sheet, 24 Apr, 2013.).

Secure Supply Chain Pilot Program Requirements

Applicant must submit a complete application and be the sponsor of the NDA or ANDA or be the foreign manufacturer of the imported finished drug product or API.

If the ultimate consignee is an establishment subject to certain FD&C Act regulations, it must meet registration, drug listing and cGMP requirements and have been in compliance for the past three years.

If the product is a finished dosage form, the ultimate consignee for it must be identified in the approved NDA or ANDA. If an API, the source must be an acceptable source according to the NDA or ANDA and must be used in the production of the FDA-approved product.

Finished dosage form or API imports must be from the foreign manufacturer identified in the SSCPP application, arrive through the identified port of entry and port of arrival, use the identified Customs House Broker/Entry Filer, and be intended for the identified ultimate consignee.

A foreign manufacturer and finished dosage form or API must comply with FD&C Act regulations for drugs.

The importer of record must have a validated tier II or tier III secure supply chain as outlined in the Customs and Border Protection Customs-Trade Partnership Against Terrorism program.

Primary and secondary contacts in the SSCPP application must be able to answer FDA questions and resolve issues. The primary contact must be the sponsor or its U.S. agent.

Applicants must have plans in place to correct FDA concerns related to the secure supply chain or specific imports and for recalling or correcting products or APIs that do not meet or were not made in accordance with FDA requirements.

Applicants must comply with FD&C Act recordkeeping regulations and must make the records available to FDA upon request throughout the pilot and maintain them for at least three years after it ends or the applicant stops participating. Records showing the product’s movement through the supply chain from the point of manufacture to the point of receipt by the ultimate consignee also must be kept.

The Customs House Broker/Entry Filer in the pilot application must be qualified for paperless entry filing to FDA’s Operational and Administrative System for Import Support.

Source: FDA Federal Register notice, Aug. 20, 2013