Under the FD&C Act, FDA is authorized to collect annual establishment and reinspection fees from human drug compounding outsourcing facilities. These fees are collected on an annual basis, and include an establishment fee from outsourcing facilities that have elected to register, as well as a reinspection fee for each reinspection of an outsourcing facility.
FDA updates these fees on a yearly basis, and they are effective for the fiscal year (October 1 to September 30). In addition, the Agency offers a steeply discounted price for qualified small businesses. The Weinberg Group can help determine if you qualify for this discounted price.
The rates for fiscal year 2016 are as follows:
|Qualified Small Business Establishment Fee
|Non-Small Business Establishment Fee
We are qualified and have helped many facilities with the FDA registration process in the past. To learn more about how we can help your facility register and reduce the total cost to to do so, please contact us.