Regulatory Focus™ > News Articles > FDA Wants Supply Chain Security Pilot Program to Continue

FDA Wants Supply Chain Security Pilot Program to Continue

Posted 19 June 2012 | By Alexander Gaffney, RAC 

Call it ironic timing. On the same day Congress announced the removal of a pharmaceutical supply chain protection system from the pending Food and Drug Administration Amendments Act (FDAAA), the US Food and Drug Administration (FDA) announced it is looking to continue a supply chain protection pilot program.

The initiative, called the Secure Supply Chain Pilot Program, was launched in January 2009 with the intent of better securing finished pharmaceutical products and raw ingredients. The program has an end goal of being a proof-of-concept for a larger program to secure the supply chain as part of a risk-based approach, and FDA said it would be opened to an initial pool of 100 applicants.

"Such a program would assist the agency in its efforts to prevent the importation of drugs that do not comply with applicable FDA requirements by allowing the agency to focus its resources on foreign-produced drugs that fall outside the program and that may not be compliant," wrote FDA in a statement in 2009. "It will also expedite the entry of products meeting the pilot's criteria into the United States. The pilot was developed with input from U.S. Customs and Border Protection and other stakeholders."

Stakeholders were given the chance to designate up to five product formulations for the pilot program, conditional upon maintaining control over the drug's manufacture and export into the US. While FDA initially said the pilot program would run for just two years, it appears to have lasted a bit longer than that.

In its 19 June 2012 Federal Register posting, FDA said it was re-submitting the program to the Office of Management and Budget (OMB) for approval, and planned to solicit applications to participate in the program shortly thereafter.

Like the original program, FDA estimates the next iteration of the Secure Supply Chain Pilot Program will last for a period of two years and aims to enroll 100 applicants.


Read more:

FDA - Agency Information Collection Activities; Proposals, Submissions, and Approvals: Secure Supply Chain Pilot Program


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