As per 21 CFR 207, companies who manufacture, prepare, propagate, compound or process drugs that are commercially distributed in the U.S. or offered for import to the U.S are required to register their facilities and are required to keep the information updated. Companies who have registered their establishment are also required to renew the drug firm registration annually . Drug establishment registration renewal period is between October 1st to December 31st period.
Drug establishment registration and renewal is mandatory for US and non US companies, including prescription , OTC and API manufacturer, testing and packaging facilities.
Failure to drug establishment registration and renewal in accordance with section 510 and 502 of the Act is a prohibited and products manufactured in such facilities will be deemed as misbranded.
Tobias provides assistance for drug establishment registration renewal with competitive fees. Our fees for establishment registration renewal is $ 250 which includes preparing your establishment registration SPL and submission.