Secure Supply Chain Pilot Program

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The Food and Drug Administration (FDA or the Agency) is announcing the start of the Secure Supply Chain Pilot Program (SSCPP). The SSCPP is intended to assist FDA in its efforts to prevent the importation of adulterated, misbranded, or unapproved drugs by allowing the Agency to focus its resources on imported drugs that fall outside the program and may pose risks. Such a program would increase the likelihood of expedited entry for specific finished drug products and active pharmaceutical ingredients (APIs) imported into the United States that meet the criteria for selection under the program. This notice outlines the eligibility requirements and the process for applying for participation in the SSCPP.