Drugs

Electronic Drug Registration and Listing Instructions

For the submission of Drug Registration and Listing data, FDA has adopted the use of Extensible Markup Language (XML) files in the Structured Product Labeling (SPL) format. To transmit the SPL formatted submission, firms must use the FDA’s Electronic Submission Gateway (ESG).

There are three steps, or submissions, that are needed in order to register an establishment and list a drug with FDA: Establishment Registration, Labeler Code Form, and Product Listing. Each of these steps requires an initial submission, followed by periodic updates/renewals to maintain an accurate and current status.

SPL Tools – CDER Direct and XForms vs. Other Tools

Any SPL authoring software may be used to create registration and listing SPL files. The FDA website offer two SPL authoring tools -- CDER Direct and Xforms. Please note that use of Xforms and other third party tools to create SPL files requires the creation of an 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.

Establishment Registration

Do I Need to Register?

With certain exemptions, any establishment engaged in the manufacture, repacking, relabeling, or salvaging of a drug product for commercial distribution is required to register with FDA.

Some exemptions include (but not limited to):

  • Pharmacies that:
    • Operate in conformance with all applicable local laws regulating the practice of pharmacy and medicine;
    • Regularly engage in dispensing prescription drugs upon a valid prescription; and
    • 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;
  • Practitioners who are licensed by law to prescribe or administer drugs and who manufacture, repack, relabel, or salvage drugs solely for use in their professional practice;
  • Manufacturers, repackers, relabelers, or salvagers who manufacture, repack, relabel, or salvage drugs solely for use in research, teaching, or chemical analysis and not for sale;
  • Manufacturers, repackers, and relabelers of harmless 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 the usual course of business as carriers; and
  • Storage facilities which do not perform any manufacturing function.

When to Register?

Registration is required within 5 days of introducing product into commercial distribution. Annual renewal of registration must occur between October 1 and December 31 of each year.

Registration Process

To register with FDA, create and submit an Establishment Registration SPL document. Be sure to save a copy of your submission. Remember to include:

  • The name and DUNS number of the establishment (not one linked to the corporate HQ);.
  • Contact information of someone responsible for receiving FDA communications related to that establishment;
  • All applicable business operations that establishment performs; and
  • For foreign establishments, the name and DUNS of a U.S. agent and all importers.

To update or renew a registration:

  • If there are no changes to existing establishment or contact information, create a No Changes Notification SPL document. Fill in the SetID with the SetID from your previous or most recent submission. Enter the appropriate effective date and version number (generally, one number higher than the previous submission) and submit.
  • If there are changes/updates to existing establishment data:
    • 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.
  • To de-register an establishment or notify FDA of an establishment being out of business, create an Establishment DeRegistration or Out of Business Notification 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) and submit.

Labeler Codes

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.

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

Process for Requesting a Labeler Code

  • To request a new labeler code, create and submit a Labeler Code SPL document. Be sure to include all necessary data such as Name and DUNS number of the company, and contact information of someone responsible for receiving FDA communications related to product listings with NDCs under that labeler code. Leave the NDC Labeler Codefield blank.
    • FDA will email the contact person on the request with the assigned number. To complete the process, submit an updated labeler code form SPL as described below with the newly assigned number filled in.
  • 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.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.

Note: If a labeler code transfers to another company through a merger/acquisition, or if there’s a name change, the new information captured in the labeler code request submission does not populate or propagate to drug listing files under that labeler code. All product listings under that labeler code must be updated with the new labeler name.

Listing

All registered establishments must list all of the products they produce for commercial distribution under their own labeler code. This includes API manufacturers, other bulk 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. For example, a single product listing SPL may include both a 200mg and 400mg version of a tablet and each tablet’s presentation in bottles with counts of 50, 100, or 200 tablets. Note: as the outer labeling varies for each product and package in this case, multiple carton images may be required to represent all the variations.

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 (generic drugs may use the non-proprietary name for both);
  • Dosage form and route of administration;
  • The name (with unique ingredient identifier or UNII code) and amount/strength (with appropriate unit of measure   e.g. grams, milliliters, etc.) of each active ingredient;
  • Each inactive ingredient (name and UNII) only;
  •  A copy of the most up-to-date labeling, including a JPG file of the outer packaging and principal display panel; and
  • The name and DUNS number for each establishment involved in manufacturing the product.

When Do I List?

Initial product listings should be submitted within three days after initial registration of the establishment. FDA recommends that updates to listing data should be made immediately. However, they are required to be made no later than June or December following a change in the information. For products that do not require any updates, a company may submit a single “blanket” no changes certification once a year during the October 1 to December 31 renewal period.

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;
  • For labeling, create a section within the SPL file for each section of content (e.g. Highlights, Warnings, How Supplied, etc.) and enter the text for each; and
    • The JPG file(s) of the outer packaging/front label belongs in the section entitled Package Label.Principal Display Panel
  • Submit.

Updates to Listing

To Update a listing:

  •  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 listing data elements and labeling as appropriate; and
  • Submit.

Blanket No Change Certification for Product Listing Data

All product listings which do not require an updated submission must still be certified as current. Rather than submit a duplicate submission with the same data, or an abbreviated No Changes Notification SPL for every product listing, a company may, during the annual re-registration period (October 1to December 31), submit a “blanket” certification for all products under a particular labeler code not otherwise updated.

A blanket certification may be accomplished by submitting an updated Labeler Code Form SPL with current or updated company and contact information. Receipt of an updated Labeler Code SPL within this period will be considered a statement that all product listings under the labeler code have been reviewed and those that were not specifically updated should be considered to still be current and active.

Any product listing that is not updated within the year and for which a labeler code update has not been received, may be considered inactive and removed from the NDC Directory and other publications of Listing data.

Use of the National Drug Code

An NDC is the unique identifier for drugs in the United States. Assignment of NDC to non-drugs is not permitted. Therefore, NDCs should not be assigned to non-drug products, such as medical devices and medical foods. Inclusion of the NDC on some drug labels may not be required, but if included, it must follow the required format and applicable labeling rules. 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 a 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 constitutes misbranding under the federal Food, Drug, and Cosmetic Act

Page Last Updated: 09/06/2016
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