Drug Amount Reporting: FDA Publicly Identifies over 7,700 Noncompliant Companies

On March 31, 2026, the FDA published a list of companies that have not submitted required drug amount reports for calendar year 2024. For stakeholders involved in drug manufacturing, this update highlights both a critical regulatory requirement and a compliance gap across the industry.

Background: Why This Requirement Exists

The reporting requirement originates from the Coronavirus Aid, Relief, and Economic Security (CARES) Act, signed into law on March 27, 2020. While widely known for its role in addressing the COVID-19 crisis, the CARES Act also introduced measures to strengthen the resilience of the drug supply chain.

A key goal of the reporting requirements is to improve the FDA’s understanding of drug supply chains. Drug shortages can arise from manufacturing issues, quality problems, delays, or discontinuations. Because the FDA relies heavily on information provided by manufacturers, timely and accurate reporting is essential for the Agency to anticipate and mitigate potential drug shortages.

The Requirement: Annual Drug Amount Reporting

As per the CARES Act amendment to the Federal Food, Drug, and Cosmetic (FD&C) Act, all registered drug manufacturers—including repackers and relabelers—must report annually to the FDA the amount of each listed drug they manufacture, prepare, propagate, compound, or process for commercial distribution.

As per the February 2024 FDA guidance, this requirement applies to:

• Human drug products (including non-exempt biological products) marketed under an approved application
• Animal drug products marketed under an approved application
• Animal drug products not approved, conditionally approved, or indexed under sections 512 (NADA/ANADA), 571 (CNADA), and 572 (the Index) of the FD&C Act
• Medical gases
• Homeopathic products
• Over-the-counter monograph drugs

Manufacturers submit this data through the FDA’s NextGen Portal, following technical and procedural guidance provided by the Agency. Additional educational resources on drug reporting requirements are also available via the FDA public meetings site.

In addition to annual reporting, registrants are required to:

• Review and verify their drug listing data twice per year (June and December)
• Update listings twice per year or annually certify that no changes have occurred

Purpose: Strengthening Supply Chain Oversight

The intent of this reporting requirement is straightforward, namely give the FDA an enhanced understanding of drug supply chain issues and drug shortages. With this visibility, the Agency can:

• Conduct a risk-based inspection prioritization
• Assess supply chain vulnerabilities
• Respond to potential drug shortages in emergencies
• Coordinate more effectively with manufacturers to prevent or mitigate disruptions

Overall, drug amount reporting data helps FDA identify how reliant the drug supply is on individual manufacturing facilities and where disruptions could have the greatest impact.

Current Compliance Gap

According to the FDA’s March 31, 2026 posting, a significant number of manufacturers appear not to have complied with the 2024 reporting requirement:

• 1,254 companies with active drug listings
• 6,480 companies with inactive drug listings

These figures suggest that more than 7,700 registrants may not have fulfilled their reporting obligations.

The distinction between the two groups is important:

• Active listings. This list includes registrants with an active drug listing. This means the registrant has either certified that no changes need to be made to its drug listing or submitted an update to its drug listing.
• Inactive listings. This list includes registrants with inactivated drug listings. This means the registrant did not fulfill the requirement to review its drug listing data and either certify its data are current or update the drug listing.

Consequences of Non-Compliance

While the FDA posting does not detail specific enforcement actions tied to this list, the requirement itself is mandated under section 510(j)(3) of the FD&C Act. Failure to comply signals regulatory risk and may draw increased scrutiny from the Agency.

More broadly, non-compliance undermines the FDA’s ability to monitor the drug supply chain effectively—potentially contributing to delayed identification of shortages and reduced system-wide preparedness.

What This Means for Stakeholders

For companies involved in drug manufacturing and distribution, this update serves as a clear reminder:

• Annual drug amount reporting is not optional—it is a statutory requirement
• Accurate and timely submissions support drug supply stability
• Internal processes for data collection, reporting, and listing maintenance should be reviewed and reinforced

As the FDA continues to emphasize supply chain transparency, ensuring compliance with CARES Act–driven requirements remains important—not only for regulatory alignment, but also for the Agency to monitor supply chain stability and prevent shortages.