FDA Announces Availability of Portal and draft Guidance on Reporting Amount of Listed Drugs and Biological Products
Today, FDA is announcing the new use of a NextGen Portal for reporting the annual amount of listed human and animal drugs and human biological products that an establishment manufactured, prepared, propagated, compounded, or processed (including repacking and relabeling) for commercial distribution. All registrants of drug establishments or their authorized agents should use the portal to submit annual reports as required under section 510(j)(3) of the Federal Food, Drug, and Cosmetic Act, as added by the Coronavirus Aid, Relief, and Economic Security Act (CARES Act).
The reported data will improve FDA's visibility into the drug supply chain and will help the agency identify, prevent, and mitigate drug shortages.
Reports for calendar year 2020 should be submitted no later than February 15, 2022, and reports for calendar year 2021 should be submitted no later than May 16, 2022.
FDA has also issued two draft guidances to assist registrants of drug establishments in reporting the amount of listed drugs and biological products.
- Reporting Amount of Listed Drugs and Biological Products Under Section 510(j)(3) of the FD&C Act Guidance for Industry This draft guidance describes the process that should be used for reporting by each person who registers with FDA under section 510 of the FD&C Act with regard to a listed drug (including a finished dosage form product, an active pharmaceutical ingredient (API), and other types of listed drugs, except for biological products or categories thereof exempted by an order under section 510(j)(3)(B)).
- Reporting Amount of Listed Drugs and Biological Products Technical Conformance Guide. This guide describes 1) how first-time users can access FDA's CDER NextGen Portal to submit these reports, 2) the different methods for submitting the reports through the portal, and 3) the data elements to be included in the reports.
The draft guidances provide information on what data should be reported, how it should be reported, and the recommended timing for data submission. The processes and elements described in these guidances apply to reports of listed drugs including medical gases; drug labeled as homeopathic; products marketed in accordance with requirements under section 505G of the FD&C Act (21 U.S.C. 355h), often referred to as over-the-counter monograph drugs; and animal drug products that are not approved, conditionally approved, or indexed under sections 512, 571, and 572 of the FD&C Act.
Links to the portal, draft guidances, and other relevant information are available at: Coronavirus Aid, Relief, and Economic Security Act (CARES Act) Drug Shortage Mitigation Efforts. |
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