Facility Establishment Registration (ER) Assistance
To maintain an active firm registration status with the USFDA, pharmaceutical companies must submit or update their FDA Establishment Registration (ER) Structured Product Labeling (SPL) annually.
The Drug Establishments Current Registration Site is a publicly accessible database listing establishments that manufacture, prepare, propagate, compound, or process drugs distributed in the U.S. or offered for import into the U.S. This database is updated daily to ensure the most accurate and up-to-date information.
Any establishment is automatically removed from the database if its registration is inactivated by FDA due to a compliance case. Registrations that expire, deregister or are otherwise dropped from submission are also removed from the database.
This process, mandated by 21 CFR 207.21, requires registration renewal between October 1 and December 31 each year. Failure to renew by December 31 results in the USFDA considering the firm inactive, leading to removal from the FDA database and potential compliance issues. Registration is required within five days of introducing drugs into commercial distribution. Establishments that submit their initial or annual registrations between October 1 and December 31 are considered registered through the end of the following calendar year. However, any registration submitted outside this period will not extend the expiration date beyond the current calendar year.
Masuu US Agent assists pharmaceutical companies in navigating this critical process, ensuring timely and accurate Drug FDA Establishment Registration (ER) and renewal with the USFDA. Our services include comprehensive guidance on the required documentation, preparation of the SPL submission, and management of the entire registration process.
This applies to all companies involved in manufacturing, repacking, relabeling or salvaging drug products for U.S. distribution is required to register with FDA. By staying compliant with the annual ER requirements, firms can avoid disruptions in their operations and maintain their status within the USFDA database.