Johnson & Johnson Consumer Inc.

CARES Act 

Drug Amount Reporting 

OTC Products

Gracy Tirado

Associate Director RA Compliance

Johnson & Johnson Consumer Inc.

8 Sept 2022
At Johnson & Johnson

, we are committed to providing safe, innovative and lifeenhancing products that meet or exceed customer and regulatory requirements

through a culture of customer focus, continuous improvement, collaboration, and

excellence in all that we do.

The values that guide our decision-making are spelled out in Our Credo. Put 

simply, Our Credo challenges us to put the needs and well-being of the people we 

serve first.

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CARES Drug Amount Reporting OTC

Topics: 

Road Map Adventure

Workload, Data Source and Resources

Responsibilities

Learnings 

Recommendations

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Three 

Weeks

Two

weeks

Three 

months

Start

Oct 2021

FDA post

the

guidance

Gather and 

Share

Cross-company

and sector.

Develop

Develop a 

process to 

obtain the 

data.

Analysis and 

Reporting

While 

executing 

refining the

process

CARES Drug Amount Reporting OTC

Road map adventure 

15Feb 2022
Workload

NDC Reported

➢Nine Labeler Codes

➢2021 (930 NDCS)

Lines of Data submitted

➢16,029 (2021)

Reports Submitted 

➢9 (2021)

➢Note: 21 reports for 2020

CARES Drug Amount Reporting OTC
Data sources

✓ FDA National Drug Code Directory.

NDC database file - Excel version (zip format) 

https://www.accessdata.fda.gov/cder/ndcxls.zip

✓ SAP Report

✓ NDC List

✓ Specifications

✓ Drug Establishments Current Registration Site

✓ CDER/Direct- Drug Listings

CARES Drug Amount Reporting OTC
Resources

CARES Drug Amount Reporting OTC

SAP Report (1 resource)

➢Development -Approximately 2 weeks.

➢Questions/Clarifications – 6-8 hrs.

➢Report Generation -2-4hrs (every time that is 

needed).

Analysis and Final Reporting

➢2.5 dedicated resources for 3 months
Responsibility interpretation

Reporting Amount of Listed Drugs and Biological Products 

Under 1 Section 510(j)(3) of the FD&C Act 2 Guidance for 

Industry1 

III A. Content of Reports

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 relabeling12) for 

commercial distribution.13

The report should provide the amount of each listed drug, identified by 

National Drug Code (NDC), that was released by each registered 

establishment during the reported year, organized by the amount of drug 

released in each month.14 Repackers and relabelers should also include 

in their reports the source NDC (i.e., the full three-segment NDC assigned 

to the drug received by the repacker/relabeler for repacking or relabeling), 

if available.

CARES Drug Amount Reporting OTC

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Responsibility interpretation

Reporting Amount of Listed Drugs and Biological Products 

Under 1 Section 510(j)(3) of the FD&C Act 2 Guidance for 

Industry1 

III A. Content of Reports

Registrants should also report the single business operation that is 

most relevant to the overall business operations performed for the 

listed drug at the registered establishment in that year.15 The business 

operation information provided in the section 510(j)(3) report may be 

different from the business operation(s) included in the drug listing 

because the drug listing file may identify multiple business operations, 

whereas the 510(j)(3) report should identify a single business 

operation.

CARES Drug Amount Reporting OTC

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Learnings

Identify Active NDCs for the 2020 report. 

• Number of NDC listed in a year varies from the 

previous year depending on delisting and new 

listing.

Lessons Learned: 

On Dec 31- save a report from National 

Drug Code Directory. 

NDC database file - Excel version (zip format) 

https://www.accessdata.fda.gov/cder/ndcxls.zip

CARES Drug Amount Reporting OTC

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Learnings 

Compiling and Evaluating Data

1. Compiling data for FDA CARES Act required 

matching both SAP data and listed NDC with a 

common connecting link- product code. 

2. Establishment that releases the material code 

needs to be traced up to the manufacturing 

establishment. (Note: exceptions repack/relabel)

CARES Drug Amount Reporting OTC

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Learnings 

Compiling and Evaluating Data

3. Ensure Repack was adequately understood per definition, 

not the common business use.

13For purposes of selecting the appropriate business operation, repackaging involves 

removing the drug from the container in which it was received by the establishment

and placing the drug into a different container without manipulating, changing, or 

affecting the composition or formulation of the drug(see 21 CFR 207.1). 

4. Ensure SAP release data to be reported as 

Innermost/Outermost Quantity Released aligned with the 

packaging configuration per NDC.

CARES Drug Amount Reporting OTC

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OTC products in Kits (gift sets) 

CARES Drug Amount Reporting OTC

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During the CARES Drug 

Amount Reporting 

Individual OTC (NDC-X) 

released at Manufacture 

Establishment was reported.

Kit (NDC-Y) released at the 

Pack Establishment, was 

traceback to the Manufacture 

Establishment of the OTC 

product. 

No mechanism to ensure that 

the “Pack” kit/gift set and the 

individual product are linked 

may result in double counting.
Recommendation 

Registrants are required to report “on

the amount” of listed drugs

manufactured, prepared, propagated, 

compounded, or processed for 

commercial distribution.

54 If such

amount for an individual registrant is 

zero, the registrant still must submit a 

report under section 510(j)(3) of the 

FD&C Act. 

.Recommendation (1): 

If the product contains

multiple manufacturing 

establishments, however, 

only one site manufactured 

and the product was 

released, we should only 

report that establishment. 

Only report Zero if there is 

no release at all for that 

product. 

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CARES Drug Amount Reporting OTC
Recommendation

III A. Content of Reports

The report should provide the 

amount of each listed drug, 

identified by National Drug Code 

(NDC), that was released by each 

registered establishment during 

the reported year, organized by the 

amount of drug released in each 

month.

Recommendation (2): 

•To provide the released 

information for the year, 

not per month.

•Include this as part of the 

Annual Product Review 

process or Part of the 

Blanket no changes 

certification of Product 

Listing process.

CARES Drug Amount Reporting OTC

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Recommendation

III A. Content of Reports

Registrants should also report the 

single business operation that is 

most relevant to the overall 

business operations performed for 

the listed drug at the registered 

establishment in that year.15

Recommendation (3):

Clarification should be added to 

the guidance on the “Most 

relevant” business operation.

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Recommendation

III B. Timing Report

Reports for subsequent calendar

years should be submitted no later 

than February 15 of the following 

calendar year. 

Recommendation (4):

In order to collect, evaluate, 

and generate the report. 

The Report day should be 

moved from 15Feb to at least 

15Apr annually.

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Recommendation

Over the Counter medicines (OTCs) generally have a 

different Benefit / Risk profile and are intended for 

symptomatic relief for minor conditions that can be selfdiagnosed. 

The administrative burden incurred by reporting volumes of 

all OTCs substantially outweighs the public health benefit of 

potentially mitigating shortages of OTCs. 

This is especially true considering most OTCs are produced

by multiple manufacturers with diverse supply chains. 

We encourage the FDA to only require annual reporting

of volumes of OTCs that appear on the FDA’s Essential 

Medicines List which have been determined to be 

medically necessary in times of public health emergencies.

CARES Drug Amount Reporting OTC

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Summary

Road Map Adventure

Workload, Data Source and Resources

Responsibilities

Learnings including Pack Kit/Gift set

Recommendations

• Zero reporting- Only report Zero if there is no release at all for 

that product

• Provide the released information for the year, not per month. 

And include this as part of the Annual Product Review process 

or Part of the Blanket no changes certification of Product Listing 

process.

• Clarification on the “Most relevant” business operation.

• Change the Report day to 15Apr annually.

• Only require annual reporting of volumes of OTCs that appear 

on the FDA’s Essential Medicines List.

CARES Drug Amount Reporting OTC

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CARES Drug Amount Reporting OTC

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