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.
Frequently Asked Questions
FDA Establishment Registration (ER) is the process through which drug establishments register with the USFDA. It applies to companies involved in manufacturing, repacking, relabeling, salvaging, or otherwise processing drug products for U.S. distribution.
Companies involved in manufacturing, preparing, repacking, relabeling, salvaging, or processing drug products for commercial distribution in the U.S. are generally required to register their establishments with the FDA.
Annual establishment registration renewal is required between October 1 and December 31 each year. Firms should complete their renewal within this period to maintain an active registration status with the USFDA.
If the registration is not renewed by December 31, the FDA may consider the establishment inactive and remove it from the Drug Establishments Current Registration Site. This can create compliance concerns and may disrupt U.S. distribution activities.
Under the applicable FDA requirements, establishments must generally complete registration within five days of beginning commercial distribution of their drug products in the United States.
FDA Establishment Registration information is submitted electronically using Structured Product Labeling (SPL). The submission contains the establishment and registration information required by FDA and must be prepared accurately to avoid processing issues.
Registrations submitted between October 1 and December 31 are generally considered registered through the end of the following calendar year. A registration submitted outside this period does not extend the expiration date beyond the current calendar year.
The Drug Establishments Current Registration Site is a publicly accessible FDA database containing information on registered establishments involved in drug manufacturing and related activities. The database is updated regularly to provide current registration information.
Masuu US Agent provides end-to-end support, including documentation guidance, preparation of the FDA Establishment Registration SPL submission, submission management, and renewal support. This helps companies complete the process accurately and on time.
Timely ER registration and renewal helps pharmaceutical companies maintain an active status in the FDA database and avoid unnecessary compliance or operational disruptions. Masuu supports the process to help firms maintain their U.S. regulatory obligations.