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Government plans supply chain pilot program for added control over Rx


ROCKVILLE, Md. The government might soon implement a secure supply chain program to prevent the importation of drugs that don’t meet regulatory requirements.

The Food and Drug Administration announced Wednesday the launch of a voluntary trial run to determine the practicality of the program. The agency plans to select 100 companies to participate, requiring them to maintain control over up to five drugs they enter into the program from the time of manufacture to their entry into the United States. The FDA developed the program with help from U.S. Customs and Border Protection.

The program would prevent non-compliant drugs from entering the country while expediting the entry of those that do comply with FDA requirements.

“This initiative creates incentives for drug makers to develop and maintain secure supply chains,” said Deborah Autor, director of the Office of Compliance at the FDA’s Center for Drug Evaluation and Research. “This is one of several agency initiatives to enhance drug product safety.”

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