20/21 February 2024
In a communication published in the US American Federal Register on 16 April 2013, the FDA announced the four-week deadline for the self-identification of generics manufacturers for fiscal year 2014 (FY 2014: October 2013 - September 2014). The deadline which began on 1 May will end of 1st June and has to be strictly fulfilled by all companies with a generic drugs authorisation in the USA. If companies fail to register facilities for FY 2014 (as of 1st October 2013), the FDA will forbid importation in the USA and confiscate all generic drugs available on the American market (those drugs will be deemed "misbranded").
Informing regularly about the current data regarding all the facilities and sites affected by an authorisation for generics is part of the "Generic Drug User Fee Act" (GDUFA) and is referred to as "self-identification" in the act (see also our GMP News from 17 October 2012). The annual self-identification procedure is necessary for the FDA to keep an eye on the number of facilities required to pay a fee. Moreover, the information helps contributing to the transparency of the supply chain.
In the announcement published in the Federal Register, the FDA points out that registration and listing under section 510 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.360) is a different process than self-identification under GDUFA. Registration and listing are made just once, whereas self-identification has to be done each fiscal year within the four-week deadline - and this, even if there is nothing new to report about the production facilities, sites, etc.
Click here to access the FDA communication published in the Federal Register. The text provides very useful links to a FDA web page containing further information about the GDUFA: for example you can also find a FDA webpage with a list of all the companies and facilities which have already made their self identification. This list can also be found here.