CARES Act Drug Amount Reporting Examples

Obinna Ugwu-Oju, MS

Division Director, OPQ Office of Quality Surveillance

CDER | US FDA

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

Outline

• Key Terminology Used For Reports

• Finished Dosage Form (FDF) Example

• Active Pharmaceutical Ingredient (API) Example

• Drugs For Further Processing Example

• Kit With Multiple Components Example
www.fda.gov 3

Key Terminology Used for Reports

• Single Level Packaging

• Multilevel Packaging

• Outermost Package

• Innermost Package

• Manufactured and Released
www.fda.gov 4

Finished Dosage Form (FDF) Examples (1/6)

• Single Level Packaging

• Quantity Released Reporting Example

Item Code Package description

12340-567-89 100 TABLETS in 1 BOTTLE

Outermost package Innermost package

NDC Quantity 

released

Quantity 

distributed 

(non-U.S.)

Package type Quantity 

released

Quantity 

distributed 

(non-U.S.)

Package type Market 

unknown

12340-567-89 2000 BOTTLE

Single Level Package
www.fda.gov 5

Finished Dosage Form (FDF) Examples (2/6)

• Multi-Level Packaging, only the outermost packaging has been assigned an NDC)

• Quantity Released Reporting Example

Outermost package Innermost package

NDC Quantity 

released

Quantity 

distributed 

(non-U.S.)

Package type Quantity 

released

Quantity 

distributed 

(non-U.S.)

Package type Market 

unknown

12340-567-01 20 CASE 9600 BOTTLE

Item code Package description

12340-567-01 96 CARTONS in 1 CASE

5 BOTTLES in 1 CARTON

60 CAPSULES in 1 BOTTLE

Outermost Package

Innermost Package
www.fda.gov 6

Finished Dosage Form (FDF) Examples (3/6)

• FDF - Multi-Level Packaging with multiple NDCs

Outermost package Innermost package

NDC Quantity 

released

Quantity 

distributed 

(non-U.S.)

Package type Quantity 

released

Quantity 

distributed 

(non-U.S.)

Package type Market 

unknown

12340-999-02 20 CARTON 300 BLISTER PACK

Item code Package description

12340-999-02 3 POUCHES in 1 CARTON

12340-999-01 5 BLISTER PACKS in 1 POUCH

21 TABLETS in 1 BLISTER PACK

Outermost Package

Innermost Package
www.fda.gov 7

Finished Dosage Form (FDF) Examples (4/6)

• FDF - Multi-Level Packaging with multiple NDCs

Outermost package Innermost package

NDC Quantity 

released

Quantity 

distributed 

(non-U.S.)

Package type Quantity 

released

Quantity 

distributed 

(non-U.S.)

Package type Market 

unknown

12340-999-02 20 CARTON 300 BLISTER PACK

12340-999-01 500 POUCH 2500 BLISTER PACK

Item code Package description

12340-999-02 3 POUCHES in 1 CARTON

12340-999-01 5 BLISTER PACKS in 1 POUCH

21 TABLETS in 1 BLISTER PACK

Item code Package description

12340-999-01 5 BLISTER PACKS in 1 POUCH

21 TABLETS in 1 BLISTER PACK

Outermost Package

Innermost Package
www.fda.gov 8

Finished Dosage Form (FDF) Examples (5/6)

• FDF - Multi-Level Packaging

• Quantity Released and Distributed Reporting Example

Outermost package Innermost package

NDC Quantity 

released

Quantity 

distributed 

(non-U.S.)

Package type Quantity 

released

Quantity 

distributed 

(non-U.S.)

Package type Market 

unknown

12340-567-01 20 3 CASE 9600 1440 BOTTLE

Item code Package description

12340-567-01 96 CARTONS in 1 CASE

5 BOTTLES in 1 CARTON

60 CAPSULES in 1 BOTTLE

Outermost Package

Innermost Package
www.fda.gov 9

Finished Dosage Form (FDF) Examples (6/6)

• Multi-Level Packaging (FDF)

• Quantity Released with Market Unknown Reporting Example

Outermost package Innermost package

NDC Quantity 

released

Quantity 

distributed 

(non-U.S.)

Package type Quantity 

released

Quantity 

distributed 

(non-U.S.)

Package type Market 

unknown

12340-567-01 10 CASE 4800 BOTTLE YES

Item code Package description

12340-567-01 96 CARTONS in 1 CASE

12340-567-02 5 BOTTLES in 1 CARTON

60 CAPSULES in 1 BOTTLE

Outermost Package

Innermost Package
www.fda.gov 10

Active Pharmaceutical Ingredient(API) Examples (1/2)

• API Single Level Packaging

• Quantity Released Reporting Example

Item Code Package description

12340-567-89 200 KG in 1 DRUM

Outermost package Innermost package

NDC Quantity 

released

Quantity 

distributed 

(non-U.S.)

Package type Quantity 

released

Quantity 

distributed 

(non-U.S.)

Package type Market 

unknown

12340-567-89 20 DRUM

Single Level Package
www.fda.gov 11

Active Pharmaceutical Ingredient(API) Examples (1/2)

• API - Single Level Packaging

• Quantity Released and Market Unknown Reporting Example

Item Code Package description

12340-567-89 200 KG in 1 DRUM

Outermost package Innermost package

NDC Quantity 

released

Quantity 

distributed 

(non-U.S.)

Package type Quantity 

released

Quantity 

distributed 

(non-U.S.)

Package type Market 

unknown

12340-567-89 20 DRUM YES

Single Level Package
www.fda.gov 12

Drugs For Further Processing Example

• Drugs For Further Processing

• Quantity Released Reporting Example

Item Code Package description

12340-567-89 1440000 CAPSULE, GELATIN COATED in 1 DRUM

Outermost package Innermost package

NDC Quantity 

released

Quantity 

distributed 

(non-U.S.)

Package type Quantity 

released

Quantity 

distributed 

(non-U.S.)

Package type Market 

unknown

12340-567-89 3 DRUM

Single Level Package
www.fda.gov 13

Kit With Multiple Components Example

• Kit with multiple components

• Quantity Released Reporting Example

Outermost package Innermost package

NDC Quantity 

released

Quantity 

distributed 

(non-U.S.)

Package type Quantity 

released

Quantity 

distributed 

(non-U.S.)

Package type Market 

unknown

12340-567-01 30 CARTON

Item code Package description

12340-567-01 1 in 1 CARTON

Part Number Package quantity

1 Drug 1 (1 VIAL, MULTI-DOSE)

2 Drug 2 (1 VIAL, SINGLE-DOSE)

3 Drug 3 (1 Packet)
www.fda.gov 14

Summary

• This presentation has provided insights on how registrants 

should submit CARES Drug Amount Report with emphasis 

on critical data elements like Quantity Released, Quantity 

distributed (Non-US), Market Unknown 

• Examples included the following 

– Finished Dosage Form (FDF) 

– Active Pharmaceutical Ingredient (API)

– Drugs for further processing

– Kit with multiple components
www.fda.gov 15

Resources

• Coronavirus Aid, Relief, and Economic Security Act (CARES 

Act) Drug Shortage Mitigation Efforts weblink: 

https://www.fda.gov/drugs/drug-shortages/coronavirus-aid-reliefand-economic-security-act-cares-act-drug-shortage-mitigation-efforts

– FDA Draft Guidance for Industry Reporting Amount of Listed Drugs 

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

– Reporting Amount of Listed Drugs and Biological Products 

Technical Conformance Guide

– NextGen Registration Guide, User Reference Guide, CSV template 

and Instructions