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The FDA has issued a final Guidance Document to assist drug establishment registrants with understanding the CARES Act reporting requirements. Reporting Amount of Listed Drugs and Biological Products Under Section 510(j)(3) of the FD&C Act guidance offers very detailed instructions for submitting volume information. The agency also sheds light on the need for these reports.

The CARES Act passed on 27 March 2020, requires each drug establishment registrant to report annual amounts of drugs that were manufactured, prepared, propagated, compounded, or processed for commercial distribution in the U.S. The term ‘commercial distribution’ is defined in 21 CFR 207.1. The FDA previously noted that this data is expected to assist the agency in mitigation of drug shortages by providing a better understanding of the existing drug supply chain for the U.S. The guidance explains that additionally, the agency will use this data in decision making with regard to drug facility surveillance. It is important to note, the agency considers CARES report data confidential commercial information (CCI) and not disclosable in response to an FOI.

Every drug establishment registered with the FDA must report their volumes to the agency per NDC. In the case of a contract manufacturer of human drugs, the CMO’s assigned NDC and the Private Label Distributor’s NDC should be reported individually. For animal drugs manufactured by a contract facility, only the PLD NDC should be reported. The report is broken down by month, the release date of the drug should be used to determine in which month to report. Returned or recalled amounts of drugs should NOT be factored into the report, all released volumes should be submitted.

For domestic facilities, commercial distribution includes product manufactured for U.S. distribution as well as drug products manufactured for foreign distribution. For a foreign establishment, only the amount of drug product manufactured for distribution / import to the United States should be included in the report to the agency.

The CARES report will identify the NDC number, the facility’s most appropriate business process, and the volume. As an example, if a facility carries out manufacturing, labeling and packing for a specific NDC, it would solely identify ‘manufacturing’ in the report, only one process should be included. The guidance goes into great detail on the quantity reporting and how to determine this. For any given NDC, if there has been no manufacturing, etc. for a calendar year, a report is still required with zero entered as the volume. If a registrant’s only business operation for an NDC is any of the following, a report is not required: sterilize, analysis, particle size reduction, and/or salvage.

Do keep in mind, this reporting requirement applies to all NDCs, including APIs, drugs for further processing, and OTC monograph drugs.

The timing of these reports has been finalized. For 2023 reports, the deadline is 1 July 2024. For future years, reports should be submitted no later than 31 March of the year following. (ie – 2024 volumes should be reported by 31 March 2025)

Clarification that reports for 2020, 2021 and 2022 should be submitted if not already done is included in the guidance. The guidance also articulates that FDA does not intend to enforce applicant distribution data reports required under 314.81 as long as the noted criteria is met, please see the guidance for criteria specifics.

Posted in Drugs, FDA and USDA Regulatory Update.