On July 9, 2012, the Generic Drug User Fee Amendments, 2012 (GDUFA) was signed into law. GDUFA is designed to speed access to safe and effective generic drugs to the public and reduce costs to industry. The law requires industry to pay user fees to supplement the costs of reviewing generic drug applications and inspecting facilities.

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). All required entities should provide US FDA with information in Structured Product Labeling (SPL) format.

  • Active Pharmaceutical Ingredients (API) facilities
  • Finished Dosage Forms (FDF) facilities
  • Positron Emission Tomography (PET) facilities
  • Clinical Bioequivalence (BE) or Bioavailability (BA) study sites
  • In Vitro Bioequivalence Testing or Bioanalytical sites
  • Contract API/FDF Analytical testing sites
  • Contract Packaging sites
  • Contract Repackaging Sites

For fiscal year 2013, identification information must be submitted by December 3, 2012. For each subsequent fiscal year, identification information must be submitted, updated, or reconfirmed on or before June 1 of the preceding fiscal year.

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.

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