The Coronavirus Aid, Relief and Economic Security Act (CARES Act) of 2020, added a provision to the Federal Food, Drug and Cosmetic Act (FD&C Act) requiring entities registered with the FDA as a drug establishment to report the amount of each listed drug manufactured, prepared, propagated, compounded or processed for commercial distribution. 

The FDA intends to use these data to support the Agency’s efforts to reduce drug shortage risk.  

In February 2024, FDA issued two final guidance documents to assist registrants in meeting the requirements of the CARES Act.  The first guidance, Reporting Amount of Listed Drugs and Biological Products Under Section 510(j)(3) of the FD&C Act(February 2024), provides important information regarding what and how to report the information.  The second guidance, Reporting Amount of Listed Drugs and Biological Products Technical Conformance Guide (February 2024), provides instructions on the formatting and submission of the data to the FDA’s NextGen portal.

All registered establishments, including repackers and relabelers, are required to provide a list of drugs manufactured at the facility.  Listed drugs subject to reporting include:

  • Human drug products (including non-exempt biological products) marketed under an approved application,
  • Animal drug products marketed under an approved application,
  • Medical gases,
  • Homeopathic products,
  • 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.

Note that the Agency has issued an order that exempts from reporting the following categories of biological products:

  • Blood and blood components for transfusion; and
  • Cell and gene therapy products, where one lot treats a single patient.

The report should provide the amount of each listed drug, identified by the National Drug Code (NDC), that was manufactured by each registered establishment during the reported calendar year, organized by the amount of drug manufactured for commercial distribution in the United States in each month.  The month manufactured is the month in which the product was released.  A drug is for commercial distribution if it is distributed for any purpose other than investigational use.  Internal and interplant transfers between registered establishments with common ownership and control do not count as distribution.  For non-US establishments, the reported amount should not include amounts that are neither imported nor offered for import into the United States.

Amounts for the calendar year, by month, should be reported annually.  The deadline for reporting the amounts manufactured in 2023 is July 21, 2024.  Thereafter, the reporting deadline is March 31 of the following calendar year.  Registered establishments should have been reporting since 2020.  If the reports for the calendar years 2020, 2021 and 2022 have not yet been submitted, the FDA urges registrants to file the data as soon as possible. 

We at Eliquent Life Sciences urge drug manufacturers to consult the two guidances at the earliest opportunity and to reach out to us should you need further clarity with respect to this important reporting requirement.