The final guidance clarifies the draft version from 2012 in a number of areas, including that the self-identification requirements have been implemented, and it includes simplified instructions for electronic submission of self-identification information.
FDA received one comment on the draft guidance from the Society of Chemical Manufacturers and Affiliates’ Bulk Pharmaceutical Task Force in 2012, which FDA said was considered as the guidance was finalized.
FDA requires self-identification for two purposes: First, to determine what the user fees will be for such facilities and as part of what FDA calls, an “effort to promote global supply chain transparency” as the information provided through self-identification enables “quick, accurate, and reliable surveillance of generic drugs and facilitates inspections and compliance.”
Most facilities (manufacturers, or those intending to manufacture, of active pharmaceutical ingredients (APIs) of human generic drugs and/or finished dosage form (FDF) human generic drugs) that self-identify are required to pay an annual facility user fee. Other facilities, sites, and organizations, however, must self-identify, but are not required to pay the annual facility user fee. These include facilities that solely manufacture positron emission tomography drugs or sites and organizations that only perform testing, repackaging or relabeling operations.
Although GDUFA provides no explicit penalty for sites and organizations that fail to comply with the self-identification requirement, FDA makes clear that failing to comply with the law and self-identify may raise significant concerns about that site.
“Such failure is a factor that may increase the likelihood of a site inspection prior to approval. FDA does not expect to give priority to completion of inspections that are required simply because sites fail to comply with self-identification requirements. More importantly, 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."
Misbranded drugs cannot be shipped within the US or imported from outside the US and FDA said such violations "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."
In July, FDA added four Chinese and Indian companies to a list of generic drug facilities that are banned from shipping products to the US because they failed to pay fees and meet identification requirements stipulated in the Generic Drug User Fee Amendments of 2012 (GDUFA).