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 In this section:

                Electronic Drug Registration and Listing System (eDRLS)

Electronic Drug Registration and Listing System (eDRLS)

                        Electronic Drug Registration and Listing Instructions
          Electronic Registration and Listing Compliance Program
          Dun and Bradstreet Verification
          Points of Contact for Drug Registration and Listing Home
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          Guidance, Compliance, & Regulatory Information
          Electronic Drug Registration and Listing System (eDRLS)
          Electronic Drug Registration and Listing InstructionsElectronic Drug Registration and Listing System (eDRLS) Electronic Drug Registration and Listing Instructions
  
  	
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    PrintThere are three steps, or submissions, that are needed to register an establishment and list a drug with FDA. Each of these steps requires an initial submission followed by periodic updates to maintain an accurate and current status:

Establishment registration
	Labeler code
	Drug product listing(s)FDA has adopted extensible markup language (XML) files in the structured product labeling (SPL) format for users to submit registration and listing data. Users may transmit the SPL-formatted submission through FDA’s electronic submission gateway (ESG).

Tools for registration and listing submissions

Any SPL authoring software may be used to create registration and listing SPL files including CDER Direct and Xforms. Xforms and other third-party tools used to create SPL files require the creation of a FDA WebTrader account in order to submit the files. All registration and listing submissions, regardless of the source and tool used to create and submit, must pass the same rigorous set of validation rules.

Do I need to register?

Any establishment, with certain exemptions, engaged in manufacturing, repacking, relabeling or salvaging drug products for U.S. distribution is required to register with FDA. Some exemptions include:

Pharmacies that:
	Operate in conformance with local laws regulating the practice of pharmacy and medicine
		Regularly engage in dispensing prescription drugs to fill patients’ prescriptions
		Do not manufacture, repack, relabel or salvage drugs other than in the regular course of their business of dispensing or selling drugs at retail
	Hospitals, clinics, other health care entities and public health agencies that:
	Operate establishments in conformance with all applicable local laws regulating the practice of pharmacy and medicine
		Regularly engage in dispensing prescription drugs upon a valid order or prescription
		Do not manufacture, repack, relabel or salvage drugs other than in the regular course of their practice of pharmacy, including dispensing
	Licensed practitioners who prescribe or administer drugs and who manufacture, repack, relabel or salvage drugs for use only in their professional practice
	Companies or individuals that manufacture, repack, relabel or salvage drugs solely for use in research, teaching or chemical analysis and not for sale
	Manufacturers, repackers and relabelers of certain inactive ingredients such as excipients, colorings, flavorings, emulsifiers, lubricants, preservatives or solvents that become components of drugs
	Carriers in their receipt, carriage, holding or delivery of drugs in their usual course of business
	Storage facilities that do not perform any manufacturing functionWhen to register?

Registration is required within five days of introducing drugs into commercial distribution. Annual registration renewal must occur between October 1 and December 31 each year.

Registration process

Create and submit an establishment registration SPL document to register with FDA. Be sure to save a copy of your submission. Remember to include:

The name and Dun and Bradstreet verification, or Data Universal Numbering System (DUNS) number of the establishment (not one linked to the corporate headquarters)
	Contact information of someone responsible for receiving FDA communications related to that establishment
	All applicable business operations that establishment performs
	For foreign establishments, the name and DUNS of a U.S. agent and all importersTo renew, update or deregister a registration: :

**How do I renew a registration with no changes?**

FDA is sharing training and additional resources below to assist in submission questions.
	To submit No Change Notification using CDER Direct:
	Open the previously submitted and accepted Establishment Registration
		Click Create New Version
		Change the document type to No Change Notification
		Submit SPL.
		See step by step instructions on submitting a No Change Notification submission using CDER Direct.
	To submit No Change Notification using other applications:
	Create a No Changes Notification Structured Product Labeling (SPL) document.
		Fill in the SetID with the value from your previous or most recent submission
		Enter the appropriate effective date and version number (generally, one number higher than the previous submission)
		Submit.**How do I update establishment registration information?**

FDA is sharing training and additional resources below to assist in submission questions.
	To submit a change using CDER Direct:
	Open the previously submitted and accepted Establishment Registration
		Click Create New Version
		Enter the new address/DUNS or contact information that needs to be updated
		Submit SPL.
		See step by step instructions to update establishment registration using CDER Direct.
	To submit a change using other applications: 
	Create a copy/new version of the most recent submission
		Do not change the SetID. Retain the original SetID from the previous version
		Generate a new DocumentID/RootID
		Enter an appropriate effective date and version number (generally, one number higher than the previous submission)
		Modify all establishment and contact information as appropriate and submit.**How do I de-register or submit an out of business notification?**

FDA is sharing training and additional resources below to assist in submission questions.
	To de-register using CDER Direct: 
	Open the previously submitted and accepted Establishment Registration
		Click Create New Version
		Change the document type to Establishment De-Registration or Out of Business Notification as appropriate and Submit SPL.
		See step by step instructions to de-register an establishment using CDER Direct.
		See step by step instructions to submit an Out of Business Notification using CDER Direct.
	To de-register using another application: 
	Create an establishment deregistration SPL document.
		Fill in the SetID with the SetID from your previous submission
		Enter the appropriate effective date and version number (generally, one number higher than the previous submission)
		Submit.**How do I know if my registration notification was successful?**

Check the status of your registration at the Drug Establishment Current Registration Site (DECRS). Once your submission is successful, your firm’s name and information will appear with the expiration date of 12/31 of the next calendar year within 24 business hours.Do I need a labeler code?

Labeler codes are only used for generating National Drug Code (NDC) numbers for drugs. Generally, if you do not have to list any drugs with FDA, you do not need to apply for a labeler code. Under most circumstances, an assigned labeler code that does not have any NDCs listed with FDA within two years will be deactivated.

A company is not required to obtain a different labeler code for each manufacturing establishment under the same ownership since the labeler code identifies a company marketing a product.

Process for requesting a labeler code

Create and submit a labeler code SPL document to request a new labeler code including all necessary data (e.g., name and DUNS number of the company, contact information of someone responsible for receiving FDA communications related to drug listings with NDCs under that labeler code)
	Leave the NDC labeler code field blank
		FDA will email the contact person on the request with the assigned number
		Submit an updated labeler code form SPL as described below with the newly assigned number filled in to complete the process
	To update labeler code information, including contact information and name changes of the company or changes in ownership of the labeler code:
	Create a copy/new version of the most recent submission
		Do not change the SetID
		Generate a new DocumentID/RootID
		Enter an appropriate effective date and version number (generally, one number higher than the previous submission)
		Modify all establishment and contact information as appropriate
		SubmitIf a labeler code transfers to another company through a merger or acquisition, or if there’s a name change, all product listings under that labeler code must be updated with the new labeler name.

The new information captured in the labeler code request submission does not automatically populate or propagate to drug listing files under that labeler code.

Requesting Label Coder using CDER Direct

Listing

All registered establishments must list all drugs they produce for U.S. commercial distribution under their own labeler code. This includes active pharmaceutical ingredient manufacturers, other bulk drug manufacturers, contract manufacturers, repackers and relabelers.

A single product listing SPL may include multiple NDCs (products and packages) provided that they all use the same content of labeling/package insert.

What data do I need to list a product?

When creating a product listing, be sure to include:

Full 10-digit NDC
	Proprietary and non-proprietary name
	If a drug does not have a proprietary name, the established name of the drug should be included in the proprietary name field
	Dosage form and route of administration
	The name with unique ingredient identifier (UNII) code and amount/strength (with appropriate unit of measure such as grams, milliliters, etc.) of each active ingredient
	Active ingredient strength sometimes has to be converted to SPL acceptable values (see strength conversion in drug listing for more information)
	Each inactive ingredient (name and UNII)
	The amount/strength of each inactive ingredient may be included
	A copy of the most up-to-date labeling, including a .jpg file of the outer packaging and principal display panel of each drug product in the SPL submission
	The name and DUNS number for each establishment involved in manufacturing the productWhen do I list?

Initial drug listings should be submitted within three days after initial registration of the establishment. Updates to listing data are required to be made no later than June or December following a change in the information. However, FDA requests they be made as soon as possible.

A company may submit a single “blanket” no changes certification once a year during the October 1 to December 31 renewal period for products that do not require any updates.

Listing process

To list a product:

Select the appropriate SPL document type for the product (human Rx drug, human OTC, bulk ingredient, etc.)
	Fill out all required listing data elements
	Create a section within the SPL file for each section of content for labeling (e.g., highlights, warnings, how supplied) and enter the text for each
	The .jpg file(s) of the outer packaging/front label belongs in the section entitled Package Label.Principal Display Panel
	Submit
	Product Listing using CDER DirectUpdates to listing

To update a listing:

Create a copy/new version of the most recent submission
	Do not change the SetID
	Generate a new DocumentID/RootID
	Enter an appropriate effective date and version number (generally, one number higher than the previous submission)
	Modify all listing data elements and labeling as appropriate
	SubmitBlanket no change certification for product listing data

There is an annual requirement to either update listings or certify that no changes have occurred for drugs that were not initially listed or updated during the current calendar year. The period for product listing certification is October 1 through December 31 each year.

Any drug listing that is required to be certified but is not certified may be considered inactive and removed from the NDC Directory and other publications of listing data. Outside this three-month window an update of the listing SPL submission for each NDC is required to certify the product.

See step by step instructions to submit a Blanket No Changes Certification of Product Listing using CDER Direct.

Use of the National Drug Code

Drugs are identified and reported using a unique, three-segment number, called the National Drug Code (NDC), which serves as the FDA’s universal product identifier for drugs. NDCs should not be assigned to non-drug products such as medical devices and medical foods. Submission of NDC is required at the time of drug listing with FDA.

Registration of a drug establishment or drug wholesaler or assignment of a registration number or assignment of NDC number does not in any way denote approval of the company or its products. Any representation that creates an impression of official approval because of registration or possession of registration number or NDC number is misleading and violates federal law.

Related Links

Introduction to eDRLS
	Product listing certification guide
	National Drug Code Directory
	Drug establishments current registration site
	Structured product labeling resources
	CDER direct
	Electronic submissions gateway
	Xforms

                                                                                  Content current as of:
      06/07/2023Electronic Drug Registration and Listing System (eDRLS)

          
                        Electronic Drug Registration and Listing Instructions
          Electronic Registration and Listing Compliance Program
          Dun and Bradstreet Verification
          Points of Contact for Drug Registration and Listing
 
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