The FDA has already begun enforcing Drug Amount Reporting under Section 510(j)(3) of the Federal Food, Drug, and Cosmetic Act, as amended by the CARES Act. Drug manufacturers that failed to submit required reports have started receiving direct notifications from the agency. If you do not submit it by December 31, 2025, your company will appear on a public list of noncompliant establishments in early 2026.

The warning stage is over—public exposure is next.

This marks a turning point in how the FDA monitors the U.S. drug supply. Drug Amount Reporting provides the agency with real-time insight into how much of each listed drug and active pharmaceutical ingredient (API) is being manufactured, helping FDA anticipate and prevent shortages before they occur. Every unfiled report increases both your company’s regulatory risk and the agency’s attention.

Understanding FDA Drug Amount Reporting

FDA Drug Amount Reporting is a mandatory annual requirement that quantifies manufacturing output for every listed drug and API. It applies to both domestic and foreign facilities that list drug products with the FDA. Each submission must include the National Drug Code (NDC) for every product, the monthly production totals, and the final annual total for the calendar year.

The rule was created by the CARES Act in response to the supply chain failures exposed during the COVID-19 pandemic. These reports now serve as the FDA’s primary mechanism for understanding national production capacity, identifying potential shortages, and strengthening resilience across the pharmaceutical supply chain.

For example, when a key antibiotic’s production volume drops significantly, the FDA can investigate early and coordinate alternative supply measures. Without this reporting, shortages may only become visible once they reach patients.

By requiring manufacturers to disclose production volumes, the FDA builds transparency into the system and ensures it can act before disruptions escalate into public health emergencies.

Who Must Comply and What to Report

The requirement applies to all manufacturers with an active Product Listing SPL—including finished drug producers, API manufacturers, repackers, relabelers, transfillers, and Positron Emission Tomography (PET) drug facilities. The manufacturer of record bears full legal responsibility for compliance. Submissions made by Product Listing Distributors (PLDs) or third parties must have authorization from the manufacturer.

Manufacturers must report their establishment DUNS number, all associated NDCs, the type of operation conducted, and detailed monthly and annual production data. Depending on the product type, the FDA may also require batch-level data for APIs or dosage-unit and packaging information for finished drugs.

This responsibility cannot be delegated away. The FDA holds the manufacturer accountable because it is the entity ultimately responsible for ensuring public health compliance and data integrity.

Accurate, properly formatted data is crucial. The FDA’s NextGen Portal automatically rejects incomplete or incorrectly structured submissions, and each rejection delays acceptance—sometimes beyond the reporting deadline.

Enforcement and Consequences of Missing the Deadline

The FDA has already begun sending noncompliance notices to companies that missed previous reporting periods, signaling that enforcement is well underway. Those that do not comply by December 31, 2025 will appear publicly on the FDA’s noncompliance list in early 2026. This list will be visible to regulators, distributors, competitors, and the public, and may trigger cascading business and reputational consequences.

Public noncompliance can lead to contract cancellations, distribution interruptions, and increased regulatory scrutiny. For publicly traded companies, it may also create investor concern or erode market confidence. In addition, the FDA may treat failure to comply as a violation of the FD&C Act, potentially resulting in misbranding or other enforcement actions.

Why Many Companies Struggle

The difficulties of compliance are less about intent and more about infrastructure. Many manufacturers mistakenly assume that Drug Amount Reporting is part of standard product listing. In reality, the data structure, frequency, and validation requirements are distinct. The process demands coordination across multiple departments and facilities to consolidate accurate monthly data and ensure consistent formatting.

Registrar Corp frequently assists companies that encounter rejected submissions due to misformatted XML structures, incomplete batch data, or inconsistencies between NDCs and listing records. These common errors highlight the importance of early preparation and expert validation before submission.

Even experienced teams can underestimate the time required to compile, verify, and submit compliant reports. As the deadline approaches, surges in submission traffic and limited support availability only increase the risk of rejection or delay.

Why You Should Act Now

Waiting until late 2025 to start preparing is a serious risk. The closer the deadline, the heavier the submission traffic—and the more likely delays or technical issues will prevent timely completion. Preparing a compliant SPL can take one to two weeks after data collection, but only if no errors are found during validation. Submitting early allows time to correct rejections, confirm acceptance, and demonstrate proactive compliance to regulators.

Early action also protects your audit posture. Timely submissions signal organizational control and reliability—factors that reduce the likelihood of future inspection complications.

Beyond This Year’s Filing: Preparing for What Comes Next

This update should give companies a real reason to act now. The FDA’s timeline moves quickly, and so should you.

Remember, you’ll also need to prepare your 2025 production data for reporting by March 31, 2026. Even after you complete this year’s filing, the process repeats every year. The companies that prepare early avoid the rush, prevent costly mistakes, and show the FDA they take compliance seriously.

Getting started now means smoother submissions, fewer errors, and less stress when the next deadline arrives. Early action isn’t just smart—it’s the simplest way to stay compliant, protect your reputation, and keep your business running without disruption.

How Registrar Corp Supports Compliance

Registrar Corp’s FDA specialists bring decades of experience managing SPL and eCTD submissions for drug manufacturers around the world. Our team can help identify which products require reporting, gather and format monthly and annual data, prepare fully compliant SPL files, and submit them directly through the FDA’s NextGen Portal. We also maintain ongoing reporting cycles for clients to ensure continuous compliance year after year.

With over twenty years of FDA compliance expertise and more than 30,000 professionals served, Registrar Corp provides the technical accuracy and regulatory insight required to meet every FDA submission standard efficiently.

Protect Your Reputation—Act Before It’s Too Late

The FDA’s public noncompliance list will be released in early 2026—and once your company’s name appears, the reputational damage cannot be undone. Submitting complete and accurate Drug Amount Reports by December 31, 2025 is the only way to stay compliant and avoid public exposure.

Act now to protect your compliance record and safeguard your reputation. The time to prepare is not next year—it’s today.

Contact Registrar Corp’s Drug Compliance Experts to begin your FDA Drug Amount Reporting submission before the deadline.