Falls Church, VA (PRWEB) January 27, 2015
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The FDA has pledged to delay enforcement of key elements of its new track and trace regulations for drugmakers, promising that until May 1 it will take no action against companies that do not capture and transmit product information.
Drug supply chain trading partners such as manufacturers, wholesale distributors and repackagers initially had been required to start capturing and passing on details about their products on Jan. 1.
However, in guidance published Dec. 24, the FDA says firms along the supply chain that don’t capture and pass on product history and other information during the first four months of this year will not face any sanctions.
The decision stems from industry concerns that some parties in the supply chain aren’t ready to comply with the track-and-trace requirements, and that unforeseen complications with the tracing requirements could disrupt the supply chain and impact patient access, the FDA says.
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