The U.S. Food and Drug Administration (FDA) has published a guidance entitled “Self-Identification of Generic Drug Facilities, Sites, and Organizations,” which is intended to assist generic drug companies in complying with the self-identification requirement of the Generic Drug User Fee Amendments of 2012 (GDUFA) (see this previous Alert for additional background information on GDUFA). The electronic self-identification requirements of GDUFA: (1) “determine the universe of facilities required to pay user fees” and (2) are a “central component of an effort to promote global supply chain transparency.” Specifically, generic drug facilities, sites and organizations are required to electronically self-identify through a separate system to comply with GDUFA.

Under GDUFA, the term facility is used to “identify those businesses required to pay fees and for self-identification.” The following types of generic facilities, sites and organizations are required to self-identify with FDA:

  1. Facilities that manufacture, or intend to manufacture, human generic drug [active pharmaceutical ingredients (API)] or [finished dosage forms (FDF)], or both.
  2. Facilities that package the FDF of a human generic drug into the primary container/closure system and label the primary container/closure system.
  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.
  4. Bioequivalence (BE)/bioavailability (BA) sites that are identified in a generic drug submission and conduct clinical BE/BA testing, 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 (CGMP) testing requirement (excludes sites that are testing for research purposes only).

For self-identification purposes, it is important to note that GDUFA defines API and FDF manufacturers differently from the way these terms have historically been defined (see footnote 4 of the guidance).

The following information is required for self-identification:

  1. A unique Data Universal Numbering System (D-U-N-S) number is required for both the facility or site and the registrant owner of such if the facility or site is in a different location than the registrant owner. This allows the FDA to identify the owner or operator and each physical location of the facility or site (such as branches, divisions, and headquarters);
  2. A unique Facility Establishment Identifier (FEI) must be submitted to allow the FDA to assign, monitor and track inspections;
  3. Name and contact information for the registrant owner;
  4. Facilities information, including name, type of business operation and contact information; and
  5. Indication as to whether the facility manufactures drugs that are not generic drugs.

There is no explicit penalty under GDUFA for not complying with self-identification requirements. However, not self-identifying “may raise significant concerns about a site.” Failure to self-identify, therefore, increases the likelihood of a site inspection prior to approval (for which no priority will be given). Therefore, failure to self-identify deems all FDF or API products manufactured at that facility misbranded, which could result in prosecution, injunction, seizures of products or denial of entry into the United States.