• Marianne Calilhanna

CARES Act Amount Information Reporting to FDA – What You Need to Know


IMPORTANT UPDATE: On February 14, 2022, the FDA designated the February 14 deadline as a recommendation and not a requirement. This pertains to reporting information related to drug products for drugs distributed in 2020.


 

The CARES Act contains a requirement from the FDA for all drug manufacturers to report drug volume details via a dedicated portal. As of this writing, the first deadline for reporting information related to drug products is February 15, 2022 for drugs distributed in 2020.


DCL Can Help You Meet the CARES Act Requirements

This overview presents key information and deadlines regarding the CARES Act. However, there are many details that are confusing to navigate:

  • If product X is manufactured outside of the U.S. but distributed by a 2nd company how should this be reported?

  • In some manufacturing tracking systems, the active pharmaceutical ingredient (API) is only recorded by weight and not the containers it is placed in for shipping. How do I report this?

  • Will the FDA offer an extension for reporting the 2020 drug volumes?

  • What if I upload my CSV file via the portal but it does not validate?


DCL’s professional team offers comprehensive services that relate to regulatory filings with the FDA. As an active member of the SPL Working Group and an industry leader with the management of complex reporting requirements for pharma and health sciences organizations, we can help navigate this process and the impending deadlines.



History and Timeline

March 27, 2020

The Coronavirus Aid, Relief, and Economic Security Act (CARES Act) was signed into law on March 27, 2020. This law was established to aid response efforts due to the impact of COVID-19. The CARES Act supports the FDA’s ability to identify, prevent, and mitigate possible shortages of drugs in the US supply chain. Further, the CARES Act enhances the FDA’s visibility into drug and medical product supply chains that can be disrupted for several reasons (e.g., manufacturing problems, delays, discontinuations, etc.).

The information that must be submitted to the FDA to comply with the CARES Act is submitted via FDA’s NextGen portal, as either CSV file(s) or through manual entry. It is not submitted through CDER Direct nor through FDA’s Electronic Submissions Gateway; it is neither an eCTD (electronic common technical document) nor an SPL (structured product labeling) submission.


October 27, 2021

A Federal Register notice was published on October 27, 2021 that provided guidance about notifying and reporting drug amounts to the FDA.


February 15, 2022

By February 15, 2022 manufacturers (including repackers and relabelers) are recommended they submit reports for calendar year 2020 of the amount of each listed drug for commercial distribution that was

  • Manufactured

  • Prepared

  • Propagated

  • Compounded

  • Processed

May 16, 2022

It is recommended that reporting for calendar year 2021 be submitted by May 16, 2022.


Federal Requirement Details

What does this apply to?

The CARES Act applies to

  • Finished packed products

  • Bulk drug products

  • Bulk drug substances

  • NDA (new drug application)

  • aNDA (abbreviated new drug application)

  • BLA (therapeutic biologics application)

  • Animal drug products that are not approved, conditionally approved, or indexed under sections 512, 571, and 572 of the FD&C Act

  • Medical gases

  • Homeopathic products

  • OTC monographs


What does this NOT apply to?

The CARES Act does NOT apply to

  • Blood and blood components for transfusion

  • Cell and gene therapy products (where one lot treats a single patient)

Who must file reports to the FDA?

Any organization that operates an establishment that manufactures, repacks, relabels, or salvages a drug and is not exempt from establishment registration requirements under section 510 of the FD&C Act or 21 CFR part 207 must file a report. A report must be filed annually on the amount of a pharmaceutical agent that it manufactured, prepared, propagated, compounded (including repacking and relabeling) for commercial distribution.

Other organizations can report on behalf of a manufacturer if they are authorized by the manufacturing facility. An agent or private label distributor can also submit the report on behalf of the manufacturer if authorized and has knowledge of the drug amount released.

The manufacturer has the ultimate responsibility to ensure that an accurate report is filed with the FDA and meets the stated deadlines. The first recommended date for submission for reporting 2020 drug amounts is February 15, 2022.


How to submit reports to the FDA for the CARES Act?

All reporting is submitted via the FDA CDER NextGen Portal.



Submission requires an active FDA NextGen Portal account. The required data may be entered in the portal manually or a CSV file may be uploaded. If uploading a CSV file, the file may not exceed 10,000 lines. Reporting is based on the release date of the drug.


Additional Information and Resources

Click below to get started with DCL’s FDA CARES Act consulting service.


CARES Act Support

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