In 2020, as a result of the CARES Act, drug manufacturers are now required to report new data annually to the FDA, including the amount of each listed drug that was manufactured, prepared or processed for distribution.

The guidance, which was unveiled last year, detailed specifics about reporting with the changes to the National Drug Code (NDC), as well as other details surrounding specific products and how they should be reported. While manufacturers of APIs, drugs and consultants did get their reports to the FDA, there was still a level of confusion and a need to clarify some details.

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