FDA will not penalize for non-compliance of tracing policy

The move was made in an effort to minimize possible disruptions in the distribution of prescription drugs in the U.S.

The new FDA requirements for the tracing of products through the pharmaceutical distribution supply chain that go into effect Jan. 1, 2015, for manufacturers, wholesale distributors, and repackagers, and on July 1, 2015, for dispensers, has been temporarily relaxed.

To minimize possible disruptions in the distribution of prescription drugs in the United States, FDA does not intend to take action against trading partners who do not, prior to May 1, 2015, provide or capture the product tracing information required by section 582(b)(1), (c)(1), and (e)(1) of the FD&C Act, according to a recent guidance report issued by the agency.

"However, some trading partners have expressed concern that unforeseen complications with the exchange of the required information may result in disruptions in the supply chain, and ultimately could impact patients’ access to needed prescription drugs.

"FDA recognizes that some manufacturers, wholesale distributors, and repackagers may need additional time beyond January 1, 2015, to work with trading partners to ensure that all of the product tracing information required under section 582 of the FD&C Act is provided to and captured by the recipient trading partner."

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