Under GDUFA, human generic drug facilities, sites, and organizations are required to submit identification information electronically to FDA annually.
Topics discussed in this guidance include:
- Who Is Required to Self-Identify?
- What Information Is Required for Submission?
- What Is the Process for Submitting Self-Identification Information?
- What Is the Penalty for Failing to Self-Identify?
The following information is required to meet the self-identification requirement in GDUFA:
D-U-N-S Numbers (Data Universal Numbering System)
- FDA requires DUNS numbers for both the facility or site.
- A DUNS number is required to uniquely identify the registrant (the owner or operator) and each physical location of the business’s facility or site (e.g., branches, divisions, and headquarters).
- A DUNS number is a unique nine-digit sequence provided by Dun & Bradstreet.
- A DUNS number is specific for each site. Each distinct physical location of an entity (e.g., branch, division, and headquarter) would be assigned a different D-U-N-S number.
- The site-specific D-U-N-S number is a widely recognized business identification tool and serves as a useful resource for FDA in identifying and verifying certain business information submitted by a user.
- If no D-U-N-S number has been assigned, a business entity may obtain one at no cost directly from Dun & Bradstreet.
- A new number may be obtained, or an existing number verified, by phone or online.
- Existing facilities D-U-N-S numbers may also be verified on FDA’s current registration site for drug establishments.
- It takes Dun & Bradstreet approximately 30 business days to process a new D-U-N-S number and communicate it via email.
- A business entity may receive a D-U-N-S number in approximately 10 business days for an expedited service fee.
- A business entity may not request or apply for a new D-U-N-S number on behalf of another business entity due to the verification procedures used by Dun & Bradstreet.
Facility Establishment Identifier (FEI)
- Facilities must also submit a Facility Establishment Identifier (FEI), a unique identifier designated by FDA to assign, monitor, and track inspections of regulated firms.
- A business entity that has previously obtained an FEI number may verify its FEI number by sending an email request.
Alternatively, business entities that have not previously registered with FDA can obtain an FEI number by sending an email request to FDA with following information:
- Firm Name
- Facility Address including City, Province, Country, and Mail Code
- Size of Firm
- Type of Operation (Manufacturer, Lab, etc.)
- Type of Industry: Drugs
Requests for issuance of FEI numbers associated with GDUFA self-identification are typically processed within 10 to 15 business days.
Additional Information
FDA requests the name and contact information for the registrant owner and facility information, including name, type of business operation, and contact information. Submitters are also asked to indicate whether they manufacture drugs that are not generic drugs.
Submission Process
The self-identification process is similar to other FDA electronic submission standards. Self-identification files should be formatted in the same electronic messaging standard used for drug registration and listing information and for the content of labeling for abbreviated new drug applications (ANDAs). This standard, known as Health Level Seven Structured Product Labeling (SPL), allows information to be exchanged, searched, and combined with other data sources in a manner that supports health information technology initiatives to improve patient care.
Penalty for Failing to Self-Identify
Although GDUFA provides no explicit penalty for sites and organizations that fail to comply with the self-identification requirement, the failure of a site or organization to comply with the law and self-identify may raise significant concerns about that site. Such failure is a factor that may increase the likelihood of a site inspection prior to approval. FDA does not expect to give priority to completion of inspections that are required simply because sites fail to comply with self-identification requirements.
