Reporting Drug Amounts Under Section 510 

of the FD&C Act as an Authorized Agent and 

CGMP Consultant

September 8, 2022

FDA/CDER Small Business and Industry Assistance Webinar

Ken C. Stevenson

Ceutical Laboratories, Inc.

VP of Regulatory

SPL Process Team Chairperson

AFDO Committee Member

NEHA Committee Member

kcstevenson@ceuticallabs.com
Disclaimer

The views reflected in this presentation are

solely that of the author and do not reflect 

the views of the FDA
Ceutical Laboratories, Inc. 

-A Texas Company-

• SMEs in product formulation, validation,

sterilization, quality systems, electronic

submissions, etc.

• FDA Registered Analytical Labs

– Micro

– Chemistry

• CGMP Consultancy (in Dallas,

Texas we have a “stable” of

consultants)
Topics in this Presentation

• Decoding the Guidance

• Identifying Our Roles and Responsibilities

• General Description of a Few Client and 

Manufacturing Scenarios

• General Experience of Reporting Drug 

Volumes in the CDER NextGen Portal

• Challenges

• Recommendations for Industry and FDA
Decoding the 

Guidance

• What’s the big picture?

• Resources

• Draft Guidance

• Technical Conformance Guide

• CDER NextGen Process Instructions

• Appendices and Footnotes

• There is a ton of info!

• Client scenarios

• SPL Process Team

• Q&A Sessions

• Presentation

Decoding the 

Guidance
Reporting Amount of Listed Drugs and Biological 

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

• Draft Guidance for Industry

• October 2021

• General who, what, when, where, and why?

• Important footnotes

– Definitions

• Released - FDA Guidance for Industry ICH Q7

Good Manufacturing Practice Guidance for

Active Pharmaceutical Ingredients (ICH Q7)

(September 2016)

• API, registrant, manufacture, commercial

distribution, applicant, unfinished drug, kit

– CMO should consider using Quality Agreements

• Helpful Q&A section

Decoding the 

Guidance
Reporting Amount of Listed Drugs and Biological 

Products Technical Conformance Guide 

• Final Guidance for Industry

• October 2021

• Specifies report content and how to submit

• Important footnotes

– Definitions

• Relabeling

• Repackaging

• Released - FDA Guidance for Industry ICH Q7

Good Manufacturing Practice Guidance for

Active Pharmaceutical Ingredients (ICH Q7)

(September 2016)

– Helpful Appendix with Tables

• *Specifies in Section IV.(B)(1)

– Submitter Type

*If you are not an employee of the reporting establishment or of another organization

under or with common control or ownership of the reporting establishment, you

should indicate that you are reporting as an authorized agent.

Decoding the 

Guidance
Identifying Our Roles and 

Responsibilities

1. Provide guidance to client teams during the

data compilation and submission process

• Client questions fell into 2 Main Categories

– Product related questions

– Reporting responsibility related questions

2. Submit as Authorized Agent

• Establish submission agreement to submit on behalf of client

• Establish CDER NextGen Portal (if not already established)

• Provide adapted CSV Template for client scenario

• Convert client provided data to acceptable format and submit

AND/OR
General Description of a Few Client and 

Manufacturing Scenarios

• Client A is a manufacturer and owns their own brand

• Client B is a brand owner that uses a CMO for the manufacturing

operations

• Client C is CMO and works with a number of brand owners

• Client D is a brand owner that works with a number of CMOs

• Client E is a CMO that also owns the brand but contracts out

manufacturing processes to another CMO

• Client F is a brand owner and a CMO with multiple facilities where

manufacturing operations take place, except for those operations

that are contracted out to another CMO with multiple facilities

• Client G is a brand owner and manufacturer who will use a CMO

to fulfill production quota when behind on production numbers

• Client H is a CMO who will manufacturer for a larger brand when

the larger brand has “overflow production”
General Description of a Few Client 

and Manufacturing Scenarios – Part 1

In each case, the FIRST STEP was to request an individual 

assessment per product SKU (not certain that it happened but we did our best!)

• For the Reporting Period:

– Drug Volume Reporting Data Elements

• DUNS

• NDCs

• 6 Eligible Business Operations –

limited to 6 per guidance

• How many units released?

*Our scenarios are limited to Domestic OTC

Products. As such, reporting was a fairly simple

process...except if there was a CMO involved.☺

How do I 

even get 

started?
General Description of a Few Client 

and Manufacturing Scenarios – Part 2

• Drug Volume Data and Registration and

Listing Status

– Was there an NDC listing in place during the

reporting period? (General)

– Reconcile per NDC

– Use this information to update per each NDC

and associated DUNS, Registrant Info

– Include on next drug volume report

– This is often more complicated than it at first

appears – Quality Agreements can help

Now what?

In each case, the SECOND STEP was to request an assessment and 

reconciliation of Registration and Listing information (not certain that it

happened but we did our best!)
General Experience of Reporting Drug 

Volumes in the CDER NextGen Portal

• FDA CDER NextGen Portal Tech Staff were on the ball!

• To mitigate a possible source of submission errors, we chose

to upload CSV files instead of manual entry.

• Reports from the SPL Process

Team have included:

• Parse errors

• Validation errors

• Trouble adding 9 digit DUNS with

leading 0

• Timing out and having to start

over at an earlier step
Challenges

• Working through “several layers of consultants” and executives.

• Providing guidance to the teams gathering the actual data.

– Most commonly heard questions

• Do we report on this?

• Are we responsible for this?

• I.e. the guidances were difficult to implement, inherent confounding variable=increasingly complicated 

supply chains

• Short time frame and many internal Electronic Resource Planning 

systems may not be set up to generate reports of this data –

validation??

• Quality Agreements not in place or not sufficient for managing 

registration and listing data or volume reporting data.

• Often the NDC number itself serves no internal function at the 

business, though this has/is changing from the top/down.
Recommendations

• Industry

– Actively manage registration and listing data, it’s not a “one and 

done” 

– Reconcile NDC listings per registrant at regular intervals

– Map appropriate internal material/product code to the appropriate 

NDC product code – suggest validation

• ERP

• Spreadsheet

• However this gets done at your place of business

– Quality Agreements

• Very important for increasingly complicated supply chains

• In addition to the CGMP components of Quality Agreements

– Manage registration and listing

– Manage drug volume reporting

TAKE HOME!
Recommendations

• FDA

– “Help” Industry with Quality Agreements, 

thank you for the November 2016 

Guidance

– Timeframe for reporting

– Clear up the guidances, these were 

difficult to implement, based on 

experience, client scenarios and working 

group feedback

– *Provide auto-populated report to 

registrants with the NDCs for which 

reporting is necessary – for example the 

CDER Direct BNCC process

– *Use the data to better focus existing 

regulatory programs

*There is a footnote in the guidance indicating that the actual 

reporting exercise will serve to help identify discrepancies in 

packaging description that exist between drug listing data and 

the actual product labeling et. al.
Thank You

• SPL Process Team

• FDA –

– CDER NextGen Tech 

Team

– FDA\CDER\Office of 

Pharmaceutical Quality

– SBIA

Ken C. Stevenson

Ceutical Laboratories, Inc.

VP of Regulatory

SPL Process Team Chairperson

AFDO Committee Member

NEHA Committee Member

kcstevenson@ceuticallabs.com