FDA’s New Annual Distribution Reporting Requirement under Section 510(j)(3) of the FD&C Act for Reporting the Amount of Commercially Distributed Listed Drugs and Biological Products

Due date (February 15, 2022) approaching for Reporting the Amount for calendar year 2020

In October 2021, the Food and Drug Administration (FDA) issued a Draft Guidance for Industry ‘Reporting Amount of Listed Drugs and Biological Products Under Section 510(j)(3) of the FD&C Act’ to assist registrants of drug establishments in submitting to FDA reports on the amount of each listed drug manufactured, prepared, propagated, compounded, or processed for commercial distribution, as required by section 510(j)(3) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360(j)(3)), as added by section 3112(e) of the Coronavirus Aid, Relief, and Economic Security Act (CARES Act).

FDA believes that reports submitted under section 510(j)(3) of the FD&C Act for each establishment would enhance the Agency’s ability to identify, prevent, and mitigate possible drug shortages.

Reporting Scope:

This reporting requirement is applicable to the registrants of the listed drugs such as,

• finished dosage form product
• active pharmaceutical ingredient (API)
• medical gases
• homeopathic products
• over-the-counter monograph drugs
• animal drug products that are not approved, conditionally approved, or indexed under sections 512, 571, and 572 of the FD&C Act.
• Biologic products not exempt by FDA’s order

FDA has issued a Proposed Order that, if finalized, would exempt from section 510(j)(3)(A) reporting requirements the following categories of biological products: (i) blood and blood components for transfusion; and (ii) cell and gene therapy products, where one lot treats a single patient.

Report Contents:

As per this new requirement, each registrant that lists a drug must report to FDA annually on the amount of such drug that it manufactured, prepared, propagated, compounded, or processed (including repacking and relabeling) for commercial distribution.

 This report should include the amount of each listed drug, identified by NDC, that was released by each registered establishment during the reported year, organized by the amount of drug released in each month.

 In this report, the amount reported should correspond only to the quantity of the package type associated with the NDC assigned to the product released and the amount reported should not be based on the number of tablets, volume, or mass of the product.

 If such amount for an individual registrant is zero (in case of, no commercial distribution during that calendar year), the registrant still must submit a report under section 510(j)(3) of the FD&C Act.

 Minimum Data Elements for Reporting the Amount of Listed Drug:

• Specific DUNS number to identify the establishment
• Specific NDC to identify the drug
• Specific business operation performed at that establishment with respect to that drug

 To simplify the reporting, the FDA has limited the types of business operations to

• Manufacture
• API Manufacture
• Repack
• Relabel
• Transfill
• Positron Emission Tomography Drug Production

It should also be noted that FDA does not intend to take action if registrants whose only business operation in the drug listing file is sterilize, analysis, particle size reduction, and/or salvage do not submit reports under section 510(j)(3) of the FD&C Act. FDA believes the data reported by other registrants (e.g., registrants with business operations of manufacture, repack, or relabel in the drug listing file) will be sufficient.

 Additional information regarding how to report the amount of each listed drug under section 510(j)(3) is available in FDA’s ‘Reporting Amount of Listed Drugs and Biological Products Technical Conformance Guide’.

 Report Timing:

• Reports for calendar year 2020 should be submitted no later than February 15, 2022
• Reports for calendar year 2021 should be submitted no later than May 16, 2022
• Reports for subsequent calendar years should be submitted no later than February 15 of the following calendar year.

 Who can report:

Each registrant is ultimately responsible for ensuring that an accurate and timely report under section 510(j)(3) is submitted on its behalf.

 Registrant itself or an authorized agent, a private label distributor or an applicant (e.g., holder of an NDA, ANDA, BLA, NADA, or ANADA) that has been authorized as an agent on behalf of a contract manufacturer (registrant) can submit the reports.

Reporting Process:

Registrants should submit reports electronically via the NextGen Portal. The reporting amount can be entered manually or by uploading data from a CSV file on NextGen Portal.

Author: Amit Chougule, RAC

References:

Regulatory Information

1. 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, October 2021. 
2. Reporting Amount of Listed Drugs and Biological Products Technical Conformance Guide Guidance for Industry, October 2021.

Webinars

1. CARES Act Amount Information Reporting: Uploading Data from a CSV File
2. CARES Act Amount Information Reporting: Entering Data Manually

NextGen Resources

1. NextGen Portal
2. NextGen Portal Registration Guide
3. Reference Guide for Reporting Amount of Listed Drugs and Biological Products
4. CSV Template
5. CSV Instructions