Daily Rules, Proposed Rules, and Notices of the Federal Government
Step-by-step instructions for electronically creating, validating, and submitting self-identification information are available at
On July 9, 2012, GDUFA (FDASIA, Title III) (Pub. L. 112-144, Title III) was signed into law by the President. GDUFA requires that generic drug facilities, and certain sites and organizations identified in a generic drug submission, provide identification information annually to FDA. This notice specifies who is required to self-identify, the type of information to be submitted, the means and format for submission of this information, and the penalty for failing to comply. Additional information is contained in the draft guidance for industry entitled “Self-Identification of Generic Drug Facilities, Sites and Organizations” available at
The following types of generic industry facilities, sites, and organizations are required to be identified to FDA:
1. Facilities identified, or intended to be identified in at least one generic drug submission that is pending or approved to produce a finished dosage form (FDF) of a human generic drug or an active pharmaceutical ingredient (API) contained in a human generic drug. Thus, facilities engaged in manufacturing or processing a generic API or FDF must be identified. For purposes of self-identification and payment of fees, GDUFA defines API and FDF manufacturers differently from the way they have been defined historically. The GDUFA definitions are included in the draft guidance for industry entitled “Self-Identification of Generic Drug Facilities, Sites and Organizations,” available at
2. Sites and organizations that package the FDF of a human generic drug into the primary container/closure system and label the primary container/closure system. Sites and organizations that package the FDF of a human generic drug into the primary container/closure system and label the primary
3. Sites that are identified in a generic drug submission and pursuant to a contract with the applicant remove the drug from a primary container/closure system and subdivide the contents into a different primary container/closure system (contract repackagers).
4. Bioequivalence (BE)/bioavailability (BA) sites that are identified in a generic drug submission and conduct clinical BE/BA testing (i.e., clinical research organizations), bioanalytical testing of samples collected from clinical BE/BA testing, and/or in vitro BE testing.
5. Sites that are identified in a generic drug submission and perform testing of one or more attributes or characteristics of the FDF or the API pursuant to a contract with the applicant to satisfy a current good manufacturing practice testing requirement (excluding sites that are testing for research purposes only).
The information required to be submitted is identified in GDUFA SPL Industry Technical Specification Information document available at
A facility or site that has previously registered with FDA (under section 510 of the Federal Food, Drug, and Cosmetic Act or section 351 of the Public Health Service Act), can verify its DUNS number(s) and FEI(s) on FDA's registration site for drug establishments available at
The new electronic self-identification process will be familiar to many business entities who have previously submitted information to FDA electronically. 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 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.
The required information may be submitted using any of the following tools to generate a self-identification SPL file:
1. eSubmitter tool, a free stand-alone application available at
2. Xforms, a free tool for generating SPL files available at
3. Software tools developed internally by generic manufacturers utilizing the SPL technical specifications. Additional information is available at
4. Other commercially available applications (e.g., vendor tools).
Once a self-identification SPL file is created and finalized, transmit the file to FDA through the ESG, FDA's electronic information portal. More information on ESG procedures and process is available on the Electronic Submission Gateway Web site (
Under GDUFA, if a facility fails to self-identify, all FDF or API products manufactured at the facility and all FDFs containing APIs manufactured at the facility will be deemed misbranded. It is a violation of Federal law to ship misbranded products in interstate commerce or to import them into the United States. Such a violation can result in prosecution of those responsible, injunctions, or seizures of the misbranded products. Products that are deemed misbranded because of failure of the facility to self-identify are subject to being denied entry into the United States.