FDA Self-Identification

Self-identification is the annual GDUFA requirement for generic drug facilities to electronically report their identity and role to the FDA

Generic DrugsFDA RequirementSelf Identification

US FDA Self-Identification for Generic Drug Facilities

The Generic Drug User Fee Amendments (GDUFA), first enacted in 2012 and since reauthorized (currently GDUFA III), require human generic drug facilities, sites, and organizations identified in a generic drug submission to provide identification information to the FDA every year. This annual process is called self-identification.

Who Needs to Self-Identify?

- - Facilities that manufacture human generic drug APIs, finished generic drugs (FDFs), or both.
  - Facilities that package the finished dosage form into its primary container/closure system, and those that label the primary container.
  - Sites identified in a generic drug submission that, under contract with the applicant, remove the drug from a primary container and subdivide it into a different primary container.
  - Laboratories that perform bioequivalence (BE) or bioavailability (BA) testing for generic drugs.
  - Sites identified in a generic drug submission that test the characteristics of the FDF or API, under contract with the applicant, to satisfy a CGMP testing requirement.
  Who Is Required to Pay the FDA Facility Fees?
  - - - Facilities that manufacture generic drug APIs or finished dosage forms (FDFs) pay an annual facility fee. Under GDUFA III, there are three facility fee types: API, FDF, and Contract Manufacturing Organization (CMO).
      - Generic drug packaging and labeling facilities, which the FDA treats as FDF manufacturing, are required to pay the applicable fee.
      Note: self-identification by itself does not automatically create a fee liability. However, most facilities that self-identify — particularly API and FDF manufacturers — are required to pay an annual facility fee.
      Who Is Not Required to Pay the FDA Facility Fees?
      Sites and organizations that only perform testing, repackaging, or relabeling must still self-identify, but are not required to pay a facility user fee.
    - What Happens If Self-Identification Is Not Submitted?
      All generic drug products (API or FDF) manufactured at a facility that fails to self-identify may be considered misbranded.
      Products from foreign facilities that have not self-identified may be denied entry into the United States.
      When to Submit the Self-Identification
      Self-identification must be submitted to the FDA every year between May 1 and June 1.
      Liberty Management Group Ltd. provides assistance with SPL preparation and submission of GDUFA self-identification to the FDA.

Frequently Asked Questions

Common questions about this FDA regulatory service.

Who has to submit GDUFA self-identification?

Any facility, site, or organization identified in a generic drug submission must self-identify each year. That includes API and finished dosage form (FDF) manufacturers, FDF packagers and labelers, sites that repackage or subdivide a drug, bioequivalence/bioavailability (BE/BA) testing labs, and CGMP testing sites. Even parties that owe no facility fee — such as testing, repackaging, or relabeling sites — still must self-identify.

Does self-identifying mean I have to pay a GDUFA facility fee?

Not automatically. Self-identification and fee liability are separate. Self-identifying does not by itself create a fee obligation, but most facilities that self-identify — particularly API and FDF manufacturers and CMOs — do end up owing an annual facility fee. Under GDUFA III there are three facility fee types: API, FDF, and Contract Manufacturing Organization (CMO). Sites that only test, repackage, or relabel self-identify without paying a fee.

When is self-identification due, and what happens if I miss it?

Self-identification must be submitted to the FDA every year between May 1 and June 1, in SPL format through the Electronic Submission Gateway (ESG). If a facility fails to self-identify, generic drug products (API or FDF) manufactured there may be deemed misbranded, and products from foreign facilities that have not self-identified may be denied entry into the United States.