US FDA implements online portal for production reporting

The US Food & Drug Administration (FDA or Agency) recently announced a new online portal for reporting the production of drugs and biological products. Registrants will need to submit 2020 & 2021 production reports for OTC, homeopathic, and animal drugs by February and May of 2022, respectively.

Background

In March of 2020, the US FDA enacted the CARES Act which sought to provide relief and ease economic burdens in response to the impact of coronavirus. As part of the Act, regulators incorporated language that would enable FDA to have greater visibility into drug supply chains, thereby mitigating potential shortages.

FDA issues guidance

Recently, FDA issued a guidance titled Reporting Amount of Listed Drugs and Biological Products Under Section 510(j)(3) of the FD&C Act to companies that register drugs under section 510. The guidance notes registrants must report the amount of each listed drug that was manufactured, prepared, propagated, compounded, or processed for distribution during 2020 and 2021.

NextGen portal

To streamline the annual reporting process, FDA established an online application called NextGen Portal that can be used to manage and submit reports.

Important dates

The FDA has determined that all 2020 production data must be submitted to the portal no later than February 15, 2022 and 2021 data no later than May 16, 2022.

How can TSG help?

Does your company produce drugs under section 510? Concerned that this recent guidance may apply to you? Get in touch: contact [email protected]