FDA is considering comments to our draft guidance on Reporting Amount of Listed Drugs and Biological Products Under Section 510(j)(3) of the Federal Food, Drug, and Cosmetic [FD&C] Act, including comments about the recommended timeframes for submitting the required reports. The draft guidance document is not a binding document and its recommended reporting dates are not required deadlines for submitting such data. However, registrants are still required under section 510(j)(3) of the FD&C Act to report annually regarding the amount of listed drugs that are manufactured, prepared, propagated, compounded, or processed for commercial distribution. With respect to calendar year 2022 data, FDA suggests that registrants submit reports as described in the draft guidance, which recommends that reports for 2022 data be submitted by February 15, 2023. We are carefully reviewing all issues raised by stakeholder comments to the docket, including regarding the recommended reporting timeframes. We will consider updating the draft guidance's recommended timeframes for reporting, as appropriate, along with other issues raised by such stakeholder feedback.
03/21/22 - FDA announced updates to the CDER NextGen Portal CARES Act Amount Information Reporting process. These updates include:
- A new process to submit a CSV file, which will address limitations on the number of records in a CSV file and also address common file/validation errors
- A new process to replace existing submissions
- A new capability to view previously submitted reports
The following materials have been updated:
Coronavirus Aid, Relief, and Economic Security Act (CARES Act) Background
The Coronavirus Aid, Relief, and Economic Security Act (CARES Act) was signed into law on March 27, 2020, to aid response efforts and ease the economic impact of COVID-19.
In addition to the COVID-19 response efforts, the CARES Act included authorities intended to enhance FDA’s ability to identify, prevent, and mitigate possible shortages of human and animal drugs by, among other things, enhancing FDA’s visibility into the drug and medical product supply chains. Drug shortages can occur for various reasons, including manufacturing and quality problems, delays, and discontinuations. Drug manufacturers provide FDA with most of the drug shortage information the agency receives, and the agency works closely with manufacturers to prevent or reduce the impact of shortages.
The specific authorities to enhance FDA’s ability to identify, prevent, and mitigate drug shortages are summarized below.
- Notifying FDA of Permanent Discontinuances and Interruptions in Manufacturing
- Creating Risk Management Plans for Drugs
- Reporting the Amount of Listed Human and Animal Drugs and Human Biological Products Manufactured
The CARES Act amended the Federal Food, Drug, and Cosmetic (FD&C) Act to expand the requirement for manufacturers of certain drugs to notify FDA about permanent discontinuances in manufacturing or interruptions in manufacturing that are likely to lead to a meaningful disruption in supply in the United States, and the reasons for such discontinuances or interruptions.
FDA issued a draft guidance for industry titled, “Notifying FDA of a Discontinuance or Interruption in Manufacturing of Finished Products or Active Pharmaceutical Ingredients (API) Under Section 506C of the FD&C Act” to assist applicants and manufacturers in providing FDA with timely, informative notifications about changes in the production of certain finished drugs and biological products and certain APIs. Timely notifications that include detailed information allow the agency to evaluate the situation and determine an appropriate course of action to help prevent or mitigate drug shortages.
The CARES Act amended the FD&C Act to include a provision requiring each manufacturer of a drug described in section 506C(a) of the FD&C Act or of any active pharmaceutical ingredient (API) or any associated medical device used for preparation or administration included in the drug to develop, maintain, and implement, as appropriate, a redundancy risk management plan that identifies and evaluates risks to the supply of the drug, as applicable, for each establishment in which the drug or API of the drug is manufactured.
FDA issued a draft guidance for industry titled, “Risk Management Plans to Mitigate the Potential for Drug Shortages” intended to help manufacturers develop, maintain, and implement, as appropriate, risk management plans to proactively assist in the prevention of human drug product and biological product shortages. This draft guidance is relevant to any person or entity who has oversight and control over the manufacture of drugs to ensure quality or owns or operates an establishment that manufactures a drug or biological product.
The CARES Act amended the FD&C Act to require that each person (including repackers and relabelers) who registers with FDA under section 510 of the FD&C Act with regard to a human or animal drug must report annually to FDA the amount of each listed drug that was manufactured, prepared, propagated, compounded, or processed by such person for commercial distribution.
Through the NextGen Portal, FDA has established a way through which drug registrants and their authorized agents should report the required data. There are guides and videos to provide instructions for how to use the portal. Further information about reporting can be found in the Reporting Amount of Listed Drugs and Biological Products Under Section 510(j)(3) of the FD&C Act Draft Guidance for Industry and the Reporting Amount of Listed Drugs and Biological Products Technical Conformance Guide.
The reporting requirements apply to 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 of biological products exempted by an order under section 510(j)(3)(B)). In addition to human drugs approved under section 505 of the FD&C Act, and animal drugs approved under section 512, conditionally approved under section 571 or indexed under section 572 of the FD&C Act, the process described in the guidance also applies to such reporting with respect to other listed drugs including medical gases, as defined in section 575 of the FD&C Act, drugs labeled as homeopathic, drugs marketed in accordance with requirements under section 505G of the FD&C Act, often referred to as Over-the-Counter Monograph drugs, and animal drugs that are not approved, conditionally approved, or indexed under sections 512, 571, and 572 of the FD&C Act.
- NextGen Portal
- NextGen Portal Registration Guide
- Reference Guide for Reporting Amount of Listed Drugs and Biological Products
- CSV Template *UPDATED*
- CSV instructions *UPDATED*
- Reporting Amount of Listed Drugs and Biological Products Under Section 510(j)(3) of the FD&C Act Guidance
- Reporting Amount of Listed Drugs and Biological Products Technical Conformance Guide
- Proposed Order: Exemption of Certain Categories of Biological Products From Certain Reporting Requirements Under the Federal Food, Drug, and Cosmetic Act
- CARES Act Amount Information Reporting: Uploading Data from a CSV File *UPDATED*
- CARES Act Amount Information Reporting: Uploading Data from a CSV File (PDF - 1.44MB)
- CARES Act Amount Information Reporting: Entering Data Manually
- CARES Act Amount Information Reporting: Entering Data Manually (PDF - 1.19MB)
- CDER Small Business and Industry Assistance webinar providing an overview of the drug amount reporting program, including discussions of how FDA uses the drug amount report data and who reports and how (with examples and demonstrations)
- Technical support questions regarding the submission process should be sent to EDMSupport@fda.hhs.gov.
- For questions regarding report content, please contact (CDER) DrugAmountReporting@fda.hhs.gov, (CBER) Office of Communication, Outreach and Development, 800-835-4709 or 240-402-8010, or (CVM) Office of Surveillance and Compliance, 240-402-7082 or CVMSurveillance@fda.hhs.gov, as applicable.