CARES Reporting Made Easy
Calendar Year 2025 Reports Due Dec. 31, 2026
Calendar Year 2026 Reports Due March 31, 2027
Registrar Corp simplifies CARES Act Amount Reporting of Listed Drugs through a combination of technology and expertise. Our compliance management platform organizes your listing data and our regulatory specialists review, validate, and file your CARES Drug Amount Report with US FDA.
Get Help with CARES Reporting and Listed Drug Amounts
Although the CARES Report is submitted annually, the required information is generated throughout the year and may reside across multiple facilities, contract manufacturers, ERP systems, spreadsheets, regulatory teams, and quality records. Before submission, each monthly quantity must be matched to the correct FDA establishment and drug listing data.
Missing months, incorrect National Drug Codes (NDCs), inactive listings, or inconsistent manufacturer relationships can complicate the report and reveal broader compliance gaps.
Here’s how Registrar Corp can help:
Our RegistrarHub dashboard organizes all your data in one easy-to-manage platform.
Our CARES Act compliance specialists review the information supporting your report.
Inconsistencies, data gaps, and other irregularities are identified and rectified.
We can prepare the submission and file on your behalf using FDA’s required reporting process.
What Is CARES Act Reporting for Listed Drug Amounts?
The CARES Act requires covered FDA-registered drug establishments to report annually the amount of each listed drug manufactured or processed for commercial distribution.
The requirement may apply to establishments performing operations such as:
Manufacturing
Repacking
Relabeling
Transfilling
Positron emission tomography drug production
Reporting applies to listed prescription drugs, generic drugs, OTC drugs, active pharmaceutical ingredients, unfinished drugs, animal drugs, homeopathic drugs, and medical gases.
Reports are submitted electronically through FDA’s CDER NextGen Portal by the registrant or its authorized agent.
Who Is Responsible for CARES Reporting?
The FDA-registered establishment identified in the applicable drug listing is generally responsible for reporting. In contract manufacturing and private label arrangements, companies must confirm which establishment performed the reportable operation, which party holds the monthly production data, which NDCs and labelers are associated with the product, and who will prepare and submit the report.
Contract manufacturing and private label arrangements can make responsibility more difficult to determine. Companies should confirm:
- Which establishment performed the reportable operation
- Which party holds the monthly production information
- Which NDCs are associated with the product
- Whether the product is listed for multiple labelers
- Who will prepare and submit the report
What You Need for Drug Amount Reporting
You must have complete and accurate establishment, product, and production information before preparing the report. Registrar Corp helps you collect and review:
Establishment Information
- Legal establishment name
- Establishment DUNS number
- FDA registration information
- Business operation performed
Product Information
- Drug name
- National Drug Code
- Listing type
- Dosage form
- Manufacturer and labeler information
- Applicable product or package configuration
Production Information
- Quantity for each applicable calendar month
- Annual quantity
- Unit of measure
- Reporting calendar year
The reporting information must remain consistent with the applicable establishment registration and drug listing records.
A product manufactured under a private label arrangement may also be associated with multiple NDCs or labelers. These relationships must be reviewed before the amounts are reported to ensure the non-manufacturer is properly authorized.
How Registrar Handles Your Drug Amount Report
We follow a structured process to prepare, validate, and submit your report.
Determine Your Reporting Scope
Registrar Corp will review your establishment registrations, listed drugs, business operations, reporting periods, and manufacturing relationships to identify which reports are required.
Collect and Organize Your Data
We provide a structured format for collecting monthly production information from facilities, contract manufacturers, internal systems, and regulatory records.
Review FDA Registration and Listing Information
- Incorrect DUNS information
- Missing or inactive drug listings
- NDC discrepancies
- Outdated manufacturer information
- Incorrect labeler relationships
- Products associated with multiple NDCs
- Inconsistent business operations
Validate the Report
We review whether:
- All applicable months are addressed
- Monthly quantities align with the annual total
- The correct reporting unit is used
- Each covered product is included
- Duplicate or inconsistent records are resolved
Prepare and Submit to FDA
Registrar Corp prepares the report and manages submission through FDA’s CDER NextGen Portal.
After submission, we provide confirmation and supporting records for your compliance files.
Has Your Company Missed a Drug Amount Report?
FDA publicly identifies certain registrants that have not submitted required annual drug amount reports. FDA maintains separate lists for registrants associated with active drug listings and inactive drug listings
A company with inactive listings may need to resolve both the outstanding drug amount report and separate listing deficiencies.
Registrar Corp can help:
- Identify outstanding reporting periods
- Determine which establishments and products are affected
- Review active and inactive listings
- Organize historical production information
- Prepare overdue reports
- Submit the required information
- Address related registration or listing issues
- Document the corrective actions taken
Submitting an overdue report may not result in immediate removal from an FDA-published list. Addressing the obligation promptly, however, allows your company to document that corrective action has been taken.
Why Registrar Corp
Registrar Corp combines drug-specific regulatory expertise with practical submission support to help companies meet annual FDA reporting requirements.
- Experience with FDA drug registration, listing, NDC, and reporting requirements
- Review of production data against applicable FDA records
- Support for contract manufacturers and private label arrangements
- Identification of registration and listing gaps before submission
- Assistance with current and overdue reporting periods
- Submission through FDA’s CDER NextGen Portal
- Support for related registration and drug listing corrections
- Ongoing assistance as products, facilities, and reporting responsibilities change
We review the regulatory information behind the report, not only the figures entered into the submission.
3,000+ Drug Manufacturers Trust Registrar Corp
Frequently Asked Questions
What Is CARES Act Listed Drug Amount Reporting?
The CARES Act requires covered FDA-registered drug establishments to report annually the amount of each listed drug manufactured or processed for commercial distribution.
FDA uses the information to monitor the drug supply and support drug shortage mitigation activities.Who Must Submit a Drug Amount Report?
The requirement generally applies to FDA-registered establishments that list drugs and perform covered manufacturing or processing operations.
This may include manufacturers, repackers, relabelers, and certain contract manufacturers.
An authorized agent may submit the report on behalf of a registrant, but the registrant remains responsible for the information provided.When should the Annual Report be submitted?
Current deadlines are as follows:
- Calendar Year 2025 reports recommended deadline of March 31, 2026, has passed. File by December 31, 2026, to avoid being placed on a public non-compliance list by FDA.
- Calendar Year 2026 reports are recommended to be filed by March 31, 2027, to FDA.
Companies should file reports each year by the recommended March 31st deadline for the prior calendar year.
Missing the deadline can result in the FDA publicly listing noncompliant entities and taking regulatory enforcement action.
Does FDA Require Monthly Quantities?
Yes. The submission requires applicable quantities for each month of the calendar year as well as the annual amount.
What If No Product Was Manufactured During the Year?
A report may still be required when the reportable amount is zero.
The related drug listing should also be reviewed to confirm that it accurately reflects the product’s current commercial status.Does Drug Amount Reporting Replace Annual Drug Listing Certification?
No. Drug amount reporting, establishment registration, drug listing updates, and annual listing certification are separate FDA obligations.
Completing the drug amount report does not correct an inaccurate, inactive, or uncertified listing.Can an Authorized Agent Submit the Report?
Yes. An authorized agent may submit the report on behalf of a registrant through FDA’s CDER NextGen Portal.
Can Registrar Corp Help with Previous Reporting Years?
Yes. Registrar Corp can help identify outstanding reporting periods, organize historical data, prepare overdue reports, and address related registration or listing gaps.
Get Help with CARES Reporting
"*" indicates required fields