Opening Remarks

Drug Amount Reporting

Jennifer Forde

Regulatory Counsel

Office of Regulatory Policy

CDER | US FDA

Reporting Drug Amount Under Section 510(j)(3) of the FD&C Act –

September 8, 2022
www.fda.gov 2

Opening Remarks

• Importance of drug amount reporting data

• Public comments

– Reporting Amount of Listed Drugs and Biological

Products Under Section 510(j)(3) of the FD&C Act:

FDA-2021-D-1031

– Reporting Amount of Listed Drugs and Biological

Products Technical Conformance Guide: FDA-2017-

D-6821
www.fda.gov 3

Opening Remarks (cont.)

• Drug amount data received via the NextGen

Portal

• Inquiries received at

drugamountreporting@fda.hhs.gov

• Overview of today’s presentations (see agenda

for details)
Drug Amount Reporting 

Regulatory Background

Jennifer Forde

Regulatory Counsel

Office of Regulatory Policy

CDER | US FDA

Reporting Drug Amount Under Section 510(j)(3) of the FD&C Act –

September 8, 2022
www.fda.gov 5

Section 510(j)(3) of FD&C Act

• Each person who registers with FDA under section

510 of the FD&C Act with regard to a drug must

– report to FDA annually

– on the amount of each listed drug

– that was manufactured, prepared, propagated,

compounded, or processed by such person

– for commercial distribution
www.fda.gov 6

Registrants

• Obligations pertain to registrants of listed drugs

– Not applicants, unless the applicant is also the

registrant

• Includes, but is not limited to, registrants that

are:

– Contract manufacturers

– Registrants across the drug supply chain
www.fda.gov 7

Listed drugs

• Obligations pertain to listed drugs

– Finished dosage form products, APIs, and other

types of listed drugs

• Drugs not required to be listed are not required

to be included in a section 510(j)(3) report
www.fda.gov 8

Listed drugs (cont.)

• Obligation pertains to listed drugs

manufactured, prepared, propagated,

compounded, or processed

• Includes repacking and relabeling

• Note regarding business operations of: sterilize,

analysis, particle size reduction, salvage
www.fda.gov 9

Commercial distribution

• Any distribution of drug, though does not

include

– Investigational use

– Internal or interplant transfer

• Foreign establishments

– Does not include distribution of drug not imported

or offered for import into U.S.
www.fda.gov 10

Commercial distribution (cont.)

• Does not need to be drug in final packaged form

• Can include other listed drugs, such as API

• Does not have to be last registrant in drug

supply chain
www.fda.gov 11

Timeframes

• Report must be submitted annually

• Calendar year reporting periods

• Recommendations

– 2020: 2/15/22

– 2021: 5/16/22

– Thereafter: 2/15 of following calendar year

• FDA considering comments regarding timeframes
www.fda.gov 12

Resources

• CARES Act Implementation

• Reporting Amount of Listed Drugs and Biological Products 

Under Section 510(j)(3) of the FD&C Act (Draft Guidance)

• Reporting Amount of Listed Drugs and Biological Products 

Technical Conformance Guide

• NextGen Portal

• DrugAmountReporting@fda.hhs.gov

• EDMSupport@fda.hhs.gov
www.fda.gov 13

Summary

• Reporting obligations pertain to registrants of 

listed drugs

• Key resource: CARES Act Implementation

• Reports must be submitted annually
Questions?

Jennifer Forde

Regulatory Counsel

Office of Regulatory Policy

CDER | US FDA

DrugAmountReporting@fda.hhs.gov