FDA gives drugmakers 3 weeks to begin reporting supply chain data

The US Food and Drug Administration (FDA) is giving drugmakers and others who are involved in the drug manufacturing process three weeks to comply with new reporting requirements intended to help address potential drug shortages.

On 5 February, FDA published a final guidance that details how drug manufacturers and other registrants should submit reports to the agency on the amount of each listed drug manufactured, prepared, propagated, compounded, or processed for commercial distribution. The requirement is part of the Coronavirus Aid, Relief, and Economic Security (CARES) Act to mitigate future drug shortages.

FDA notes that establishments that manufacture drugs in the US must register with the agency. The same applies to foreign establishments that are engaged in making drugs that are then imported into the US.

“Further, domestic and foreign registrants are required to list with FDA all the drugs being manufactured by their registered establishments for commercial distribution,” said FDA. “Each registrant must provide certain information for each listed drug it manufactures for commercial distribution, including unfinished drugs and [active pharmaceutical ingredients (API)].

“These obligations pertain to the registrant (e.g., manufacturers, including contract manufacturers),” the agency added. “Unless the application holder is also the registrant, these obligations do not pertain to the application holder of an approved drug.”

During the COVID-19 pandemic, FDA and other public health officials faced several significant drug shortages and asked Congress for additional authority in the CARES Act to help manage future supply chain issues. In response, the agency received authorities to require drug registrants to provide additional supply chain data that would allow it to assess, prevent, and mitigate potential shortages.

FDA notes that the law allows it to require registrants to provide annual reports on the amount of each listed drug that was manufactured, prepared, propagated, compounded, or for commercial distribution. The agency also adds that while contract manufacturer registrants are required to submit reports, they can authorize someone else, including an applicant holder, to submit the reports on their behalf.

Under the law, the FDA also has the authority to exempt certain biological products or categories of biological products from the reporting requirements if it deems that reporting requirements for such products are not necessary to protect public health. With that in mind, the agency has exempted certain products, such as blood and blood components for transfusion, and certain cell and gene therapy products.

The draft of the guidance was published in November 2021. In a Federal Register notice, FDA said the guidance won’t go into effect until 26 February to give time for technical updates to its NextGen Portal. The agency also said that there are several updates to the final guidance.

“Changes from the draft to the final guidance include changes to the recommended timeframe for report submission, as well as changes to the recommended units for the reporting of drugs that are not drug products in finished package form,” said FDA. “These changes were made in response to public comments received and in the interest of facilitating drug amount data submission and improving data accuracy.”

“Revisions also were made to clarify the reporting requirements applicable to registrants of listed drugs across the drug supply chain, including contract manufacturers,” the agency added. “Further revisions were made to clarify and further detail how FDA plans to use data derived from the drug amount reporting program, including data submitted by each registrant in the drug supply chain.”

Final guidance

FDA gives drugmakers 3 weeks to begin reporting supply chain data

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