Basic Framework for Reporting

Jennifer Highland

Operations Research Analyst

OPQ Office of Quality Surveillance

CDER | US FDA

FDA Webinar – Sept. 8, 2022
www.fda.gov 2

Outline

• Who is required to report?

• What types of drugs should be reported?

• Report submission process

• Data elements to be reported
www.fda.gov 3

Who is required to report? (1 of 2)

• Establishments registered with FDA under section 510

of the FD&C Act

– Report human drugs under NDCs (National Drug Codes) of

both registrant and PLD (private label distributor) labeler

codes

– Report what registrant manufactured, including contract

manufacturers

– Authorized agent may submit a report on a registrant’s behalf
www.fda.gov 4

Who is required to report? (2 of 2)

• To simplify reporting, FDA has limited reporting to the

following business operations:

– MANUFACTURE

– API MANUFACTURE

– REPACK

– RELABEL

– TRANSFILL

– POSITRON EMISSION TOMOGRAPHY DRUG PRODUCTION
www.fda.gov 5

What types of drugs should be reported?

• All listed drugs, except for biological products or categories thereof

exempted by an order under section 510(j)(3)(B)

– Rx and OTC

– Homeopathic

– Medical gas

• FDA may issue an order to exempt certain biological products or categories

thereof regulated under the Public Health Service Act, if FDA determines

that applying such reporting requirements is not necessary to protect the

public health.

– Blood and blood components for transfusion

– Cell and gene therapy products, where one lot treats a single patient
www.fda.gov 6

Report Submission Process (1 of 4)

• Submitters should create an account in the NextGen

Portal (edm.fda.gov) if they do not already have one

• A single account can be used to submit data for any

number of establishments

• Multiple reports can be submitted for an establishment
www.fda.gov 7

Report Submission Process (2 of 4)

• Submit separate reports for each calendar year

• Report the number of packages, by NDC, using the 

package type(s) in the drug listing

– Single-level packaging or multi-level packaging

• A report can be submitted by:

– Manually entering data

– Uploading data from a comma-separated values (CSV) file
www.fda.gov 8

Report Submission Process (3 of 4)

• To enter data manually:

– Use the portal’s interface to provide inputs

– Use prompts, drop-down boxes, and text boxes

• To upload data from a CSV file:

– Use the template provided in the portal to create the CSV file

– Registrants can create their own CSV file, but the format must 

match the template
www.fda.gov 9

Report Submission Process (4 of 4)

• Reports will be validated using certain data from FDA’s 

Electronic Drug Registration and Listing System (eDRLS)

• The Portal will check for invalid data and display an 

error message if it identifies data that does not match 

eDRLS data

• Replacement reports can be submitted if an error is 

discovered in a previously submitted report
www.fda.gov 10

Data Elements to be Reported (1 of 3)

• Establishment Identity (DUNS)

• Establishment Business Operation

• National Drug Code (NDC)

• Source NDC (For Re-packers and Re-labelers only)
www.fda.gov 11

Data Elements to be Reported (2 of 3)

• Month

• Outermost Package, Quantity Released

• Outermost Package, Quantity Distributed (Non-U.S.) 

• Outermost Package Type
www.fda.gov 12

Data Elements to be Reported (3 of 3)

• Innermost Package, Quantity Released

• Innermost Package, Quantity Distributed (Non-U.S.)

• Innermost Package Type 

• Market Unknown
www.fda.gov 13

Summary

• Registrants with listed products, including contract 

manufacturers, are required to report

• Amounts for all listed drugs should be reported by 

NDC and business operation for each calendar year

• Portal will accept CSV file or manual entry

• Overview of data elements