FDA Drug Amount Reporting — CARES Act

The CARES Act requires manufacturers and distributors of each listed drug to report drug amounts to FDA. LMG assists establishments with annual drug amount reporting compliance.

CARES Act 2020Annual ReportingReport Each Listed Drug

Drug Amount Reporting Services

LMG assists drug establishments with CARES Act drug amount reporting — identifying reporting obligations and preparing complete submissions.

Reporting Obligation Assessment

We review your drug product list and distribution activities to determine which products trigger CARES Act reporting obligations.- Finished drugs, API's, and other listed drugs

Annual Report Preparation

Drug amount reporting must be submitted annually. Such reports should include information regarding the amount of drugs released for the respective calendar year.

Drug Amount Reporting for PLD

If the drugs are manufactured for a private label distributor, the data must be submitted separately by the NDC associated with the manufacturer and PLD.

Compliance Monitoring

We monitor regulatory updates to CARES Act drug amount reporting requirements and alert you to any changes that affect your drug amount reporting obligations.

How It Works

We manage the entire process from start to finish — so you can focus on your business.

Product Assessment

We review your drug product portfolio to identify which products are subject to CARES Act reporting requirements.

Data Collection

We collect monthly production volume, and distribution data for all covered products.

Report Preparation

We prepare and review your complete annual drug amount report for FDA submission.

Submission & Confirmation

We submit your report to FDA and provide confirmation of receipt.

Frequently Asked Questions

Common questions about this FDA regulatory service.

What is CARES Act drug amount reporting?

The CARES Act (2020) requires manufacturers and distributors of each listed drug to report to the FDA annually on the amount of each drug manufactured, prepared, propagated, compounded, or processed for commercial distribution.

Which drugs require amount reporting?

Each listed drug must be included in the drug amount reporting, which includes

Finished dosage form products
Active pharmaceutical ingredients (APIs)
Other listed drugs, such as medical gases, homeopathic products, OTC monograph drugs, and animal drug products.

**Exemption:** Biological products or categories thereof exempted by an FDA order under section 510(j)(3)(B) are not required to report.

When is the annual report due?

Annual drug amount reports are due each year. Reports for each calendar year must be submitted before March 31st of the following calendar year.

What happens if we fail to report?

Failure to comply with CARES Act reporting requirements can result in FDA enforcement action, including warning letters. The FDA will also publish the list of companies that have not submitted drug amount reports in a publicly available database.