Drug Amount Reporting:

Registration and Listing 

Regulatory Background 

Leyla Rahjou-Esfandiary, Pharm. D.

CDER|OC|OUDLC

Drug Registration and Listing Branch

September 2022
www.fda.gov 2

Why Registration and Listing?

CARES Act drug amount reporting 

requirements pertain to registrants of 

listed drugs.
www.fda.gov 3

Poll Question

How familiar are you with registration and listing 

requirements?

A. I’m an expert. I submit registration and listing

data all the time.

B. I’m somewhat familiar but I’m not an expert.

C. What is registration and listing?
www.fda.gov 4

Establishment Registration and Drug Listing

• Drug manufacturers are required to register their

establishments and list all drugs they manufacture for

U.S. commercial distribution

– Section 510 of the Food, Drug and Cosmetic Act, 21 U.S.C. §

360

– Codified under 21 CFR Part 207

• Drug listing information is reported to FDA using the

National Drug Code (NDC)

– Drug Listing Act of 1972
www.fda.gov 5

Definitions

Manufacturer under 21 CFR 207.1:

• Means a person who owns or operates an establishment 

that manufactures a drug or an animal feed bearing or 

containing a new animal drug. 

• Includes, but is not limited to, control laboratories, 

contract laboratories, contract manufacturers, contract 

packers, contract labelers, and other entities that 

manufacture a drug, or an animal feed bearing or 

containing a new animal drug.
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Definitions – Continued 

• The term “manufacture, preparation, propagation, 

compounding, or processing,” as used in section 

510 of the Federal Food, Drug, and Cosmetic Act, 

includes the activities of relabelers, repackers, and 

salvagers. 

• When not modified by “domestic” or “foreign,” the 

term manufacturer includes both domestic 

manufacturers and foreign manufacturers.
www.fda.gov 7

Definitions – Continued 

Registrant under 21 CFR 207.1:

• Means any person that owns or operates an 

establishment that manufactures, repacks, 

relabels, or salvages a drug, and is not otherwise 

exempt from establishment registration 

requirements under section 510 of the Federal 

Food, Drug, and Cosmetic Act or this part.
www.fda.gov 8

Definitions – Continued 

Private Label Distributor (PLD) under 21 CFR 

207.1:

• Means, with respect to a particular drug, a 

person who did not manufacture, repack, relabel, 

or salvage the drug but under whose label or 

trade name the drug is commercially distributed.
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Definitions – Continued 

Commercial Distribution under 21 CFR 207.1:

• Means any distribution of a human drug, except for investigational use 

under part 312 of this chapter, and any distribution of an animal drug or 

an animal feed bearing or containing an animal drug, except for 

investigational use under part 511 of this chapter. The term does not 

include internal or interplant transfer between registered establishments 

under common ownership and control, including a parent, subsidiary, 

or affiliate company. For foreign establishments that manufacture, 

repack, relabel, or salvage, or for foreign private label distributors, the 

term “commercial distribution” has the same meaning except the term 

does not include distribution of any drug that is neither imported nor 

offered for import into the United States.
www.fda.gov 10

Drug Listing Requirements

• Registrants must list all drugs they manufacture

– no later than 3 calendar days after the initial registration of the 

establishment. 21 CFR §207.45

• Listing updates must be submitted in June or December of 

the same year. 21 CFR §207.57(b)(1)

• If no updates, the listing data must be certified between 

October 1 and December 31. 21 CFR §207.57(b)(2)

• Required drug listing data included in 21 CFR §207.49.
www.fda.gov 11

Drug Listing Requirements

• Required for ALL drugs:

– Active Pharmaceutical Ingredients (Bulk drug substance)

– Drugs for further processing

– Finished dosage forms

– Human and animal drugs

– OTC and prescription drugs

– Biologics

– Approved and unapproved drugs

– Drugs for export only
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CMO and PLD Listing Requirements

• A PLD that does not engage in the manufacture, 

repacking, relabeling, or salvaging of a drug is exempt 

from registering with FDA, 21 CFR 207.17(b). 

• Under § 207.41, the CMO must register its establishment 

with the FDA and each human drug it manufactures must 

be listed under two NDCs:

– one that includes the registrant’s own NDC labeler code 

(regardless of whether the drug is commercially distributed 

under the registrant’s own label)

– one that includes the NDC labeler code of the PLD
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NDC Assignment in Drug Listing

• NDC is the unique identifier assigned to all drugs in U.S. 

commercial distribution.

• Three segments: labeler code, product code, package code

• Each unique drug product should be assigned a unique 

product code under the same labeler code.

• Each unique package size and type should be assigned a 

unique package code under the same labeler code and 

product code. 

• Proposed Rule: Revising the National Drug Code Format 

and Drug Label Barcode Requirements
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NDC Assignment in Drug Listing

• Co-packaged drug products:

– Can be a combination product, or not.

– For purpose of drug listing, they are considered a kit.

– There should be at least one drug part.

– NDC product code assigned to the overall kit should be 

different than the NDC product code assigned to each drug 

part.

– Non-drug parts should not be assigned any NDCs.

– If the drug part(s) are individually available for commercial 

distribution, it/they should also be individually listed. 
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NDC Assignment in Drug Listing

• Multi-level packaging:

– Multiple packaging levels of the same drug product (i.e., 

multiple vials or blister packs in a carton).

– All packaging levels (with respective NDC and 

packaging description) should be included in the 

packaging section of the SPL.

– Any packaging level not intended for commercial 

distribution on its own should be included as an inner 

level. 
www.fda.gov 16

Resources

• Electronic Drug Registration and Listing System 

(eDRLS) | FDA

• Electronic Drug Registration and Listing 

Instructions | FDA

• Electronic Registration and Listing Compliance 

Program | FDA
www.fda.gov 17

Questions

Leyla.Rahjou-Esfandiary@fda.hhs.gov

eDRLS@fda.hhs.gov