Last Updated on May 10, 2022 by Ithos Global Regulatory Team
What is it?
The FDA has published a new draft guidance document updating the OTC reporting requirements. The March 2020 Coronavirus Aid, Relief, and Economic Security Act (CARES Act) includes a requirement for annual reporting on the amount of each listed drug product that was manufactured, prepared, propagated, compounded, or processed for commercial distribution.
This guidance is officially called “Reporting Amount of Listed Drugs and Biological Products Under Section 510(j)(3) of the FD&C Act.”
Action: Stakeholders in OTC manufacture should read the Guidance Document and Technical Conformance Guide to better understand the new reporting obligations.
What’s the impact of FDA’s new OTC Reporting requirements?
“This draft guidance is intended to assist registrants of drug establishments in submitting to FDA reports on the amount of each listed drug manufactured, prepared, propagated, compounded, or processed for commercial distribution, as required by section 510(j)(3) of the FD&C Act. The draft guidance addresses the content of reports, the timing of reports, and the process for report submission.”
In summary, this draft guidance will change the method in which Drug Listings are performed. The CARES Act “included authorities to enhance FDA’s ability to identify, prevent, and mitigate possible drug shortages, among other things, improving FDA’s visibility into drug supply chains.”
When is it happening?
The CARES Act was enacted on March 27th, 2020. The Guidance Document was published on November 1st, 2021, and distributed for public comments, ending January 3rd, 2022.
What are the next steps?
The final version of the Guidance Document is expected sometime in 2022. Although OTC reporting is required annually, the FDA suggests reporting the amount of drug releases each month.
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