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New Burdensome FDA Requirements Mandate Reporting Volumes of Almost All Drugs Produced Each Year

On October 29, 2021, the FDA issued two Guidances that implement a new requirement of the federal Food, Drug, and Cosmetic Act (FDCA) that all registrants of drug establishments – both domestic and foreign – must file a report on the amount of each listed drug produced over the preceding year.

Links to the two Guidances are here and here.

This applies to the reporting of the following:

  1. Prescription Drugs;
  2. Over-the-counter Monograph Drugs;
  3. Homeopathic Products;
  4. Medical Gases; and
  5. Animal Drugs that are not approved, conditionally approved, or indexed under certain sections of the FDCA.

The new requirement applies to finished and unfinished drugs and active pharmaceutical ingredients (APIs). According to the FDA, this information “helps the FDA maintain a catalog of all drugs in commercial distribution in the United States,” but for the pharmaceutical industry, it represents a dramatic expansion of the FDA’s regulation of drugs.

The Guidances implement Section 3112(e) of the Coronavirus Aid, Relief, and Economic Security Act (“CARES Act”), which was signed into law on March 27, 2020.  This section added Section 510(j)(3) to the FDCA, requiring the reporting on an annual basis of “the amount of each drug . . . that was manufactured, prepared, propagated, compounded, or processed by [each registered] person for commercial distribution.”  

The principal requirements of a “510(j)(3) Report” are as follows:

  • Each registrant that lists a drug must report to the FDA annually the amount of the drug that is manufactured, prepared, propagated, compounded, or processed (including repacking and relabeling) for commercial distribution.
  • The report must provide the amount of each listed drug, identified by its National Drug Code (NDC), that was released by the establishment during the reporting year, organized by the amount of drug released in each month.
  • Repackers and relabelers should also include the source NDC – that is the full 3-segment NDC assigned to the drug received by the repacker/relaber for repacking or relabeling – if available.
  • This Guidance provides Tables that the FDA expects companies to use to show the relationship between the NDC, the package description, and the quantity reported for products with either a single level or multiple levels of packaging.
  • Each registrant that lists an API must report to the FDA annually the amount of API that it has manufactured, prepared, propagated, compounded, or processed for commercial distribution for the reporting year.
  • For products that are manufactured, prepared, propagated, compounded, or processed for commercial distribution under the trade name or label of a private label distributor, the information should be submitted separately by the NDC associated with the registrant’s labeler code and the NDC associated with the private label distributor’s labeler code.
  • The Guidances discuss a very complicated enforcement discretion provision dealing with NDA and ANDA applicants who file Annual Reports, though it appears that if those applicants are also registrants, they will still have to file the annual reports required under the CARES Act.

Reports must be submitted annually to include information regarding the amount of drugs released for the respective calendar year (January 1 to December 31).  Reports for calendar year 2020 must be submitted by February 15, 2022, and reports for calendar year 2021 must be submitted by May 16, 2022.  Reports for subsequent years must be submitted by February 15 of the following year.  The Reports must be submitted through the FDA’s NextGen Portal, which is notoriously difficult to navigate.

If you are interested in more information about this or would like assistance preparing a Section 510(j)(3) report for submission to the FDA, please contact Arent Fox’s FDA Practice Group.


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