The U.S. Food and Drug Administration (FDA) has released details regarding new annual reporting requirements that the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) set forth for drug registrants. On March 27, 2020, the CARES Act amended a section of the Federal Food, Drug, and Cosmetic Act (FD&C Act) to require registered drug establishments to report the amounts of each of their listed drug distributed in the United States.

The guidance, Reporting Amount of Listed Drugs and Biological Products Under Section 510(j)(3) of the Federal Food, Drug, and Cosmetic Act; Draft Guidance for Industry, applies to FDA-registered establishments that distribute drug products such as OTC drugs, medical gases, homeopathic products and animal drug products. FDA states that the purpose of this new annual reporting requirement is to help FDA identify, prevent, and mitigate possible drug shortages.

How do you properly submit reports? Registrar Corp can help file these reports on your behalf as part of our U.S. Agent and Registrant Contact service. Keep reading to learn more about this new requirement.

Reporting on Various Drug Types

Finished Dosage Forms
Packaging is a significant factor when accounting for drug quantities in a finished dosage form product. For example, you must report a bottle that contains a certain number of tablets by the amount of bottles distributed, not by the individual tablet count. Multi-level packages are identified by the National Drug Code (NDC) of the outermost layer, such as the outer case, and also by the amount of containers released.

If your report includes kits, identify those products by the outer most packaging. Include both the amount of the outer most packaging, such as number of cases, and the inner most packaging, such as numbers of bottles within the cases.

APIs
If your establishment has listed an Active Pharmaceutical Ingredient (API) with FDA, you should report the total amount of the API according to the unit container reported in the drug listing, such as the number of cylinders that contain the API. You should also report the amount of unit containers released for drugs that include an API with other ingredients and are not in a finished dosage form product.

Private Label Drug Products
Registrants distributing drugs commercially under the trade name or label of a private label distributor must include the distributor’s labeler code and the NDC associated with the code. The report you submit for data pertaining to private label distributors should be separate from data you submit for other distributors.

Biological Products
There is a proposed order for certain categories of biological products that, if finalized, would exempt such products from CARES Act reporting requirement. FDA states it does not intend to take action against registrants with products that fall under this category until the effective date of the proposal’s finalization or withdrawal.

Submitting Accurate, Timely Reports

Companies should submit their annual report for drugs distributed in 2020 by February 15, 2022 and their report for drugs distributed in 2021 by May 16, 2022. All future reports are due annually by February 15 of the following year.

Establishments should report the actual amounts of the drugs released during the reporting period and not the theoretical yield based on available amounts. The reported amounts should include recalled or returned products. If you listed a drug during the calendar year but did not distribute the drug, FDA still requires you to submit a report specifying that you released zero amount of the drug.

If your drug establishment is located outside of the U.S., you should list the amount of drugs released for U.S. distribution. If you don’t know this information, report on the total amount of drugs released globally.