The Generic Drug User Fee Amendments of 2012 (GDUFA) authorizes the U.S. Food and Drug Administration (FDA) to collect fees from certain companies identified in generic drug submissions, including Abbreviated New Drug Applications (ANDA) and Prior Approval Supplements (PAS), and from holders of type II DMFs. GDUFA can be found within the FDA Safety and Innovation Act (FDASIA) that was signed into law on July 9, 2012.
As part of GDUFA, FDA instituted a “Self Identification” requirement for Finished Dosage Form (FDF) and Active Pharmaceutical Ingredient (API) manufacturers, packers, repackers, FDF/API analytical testing sites, and BA/BE bioanalytical testing sites that are named in generic drug submissions. Establishments were required to submit the “self-identification” information by December 3, 2012. FDA used this information to set the new Generic Drug Facility Fees.
On January 16, 2013, FDA published the new fees written below:
According to FDA, “[s]ites and organizations that package the FDF of a human generic drug into the primary container/closure system and label the primary container/closure system are considered to be manufacturers, whether or not that packaging is done pursuant to a contract or by the applicant itself.”
The following facilities, sites, and organizations are not required to pay an annual GDUFA facility fee: sites and organizations that solely manufacture positron emission tomography (PET) drugs; clinical bioequivalence or bioavailability study sites; in vitro bioequivalence testing or bioanalytical testing sites; API/FDF analytical testing sites; and repackagers.
FDA will deem all Final Dosage Form (FDF) or Active Pharmaceutical Ingredient (API) products manufactured at facilities who have failed to pay the GDUFA fees by March 4, 2013 as misbranded. The names of these facilities will be included on an “arrears list” and products may be denied entry into the United States. Please note, if a facility manufactures both generic FDFs and APIs, the facility will incur both the FDF and API Facility Fees.
Registrar Corp can assist you with submitting your payment of the GDUFA fees to FDA. If you have questions about the new “Self-Identification” requirement, GDUFA, FDASIA, or any other FDA regulation, please contact Registrar Corp 24/7 at https://www.registrarcorp.com/livehelp or call Registrar Corp at +1-757-224-0177.