The CDER website provides the following information relative to the new outsourcing compounders fees for FY 2018.
Compounders Outsourcing Fees FY 2018
Establishment
Small Business*
$5,364
Non-Small Business
$17,364
Re-inspection Fee
$16,093
* To qualify revenue must be less than $1,000,000 for all sites and affiliates
The Notice states that “FY 2018 registration period for outsourcing facilities starts on October 1, 2017 and ends on December 31, 2017. If you have paid your Annual Establishment Fee for FY 2017, your registration will expire on December 31, 2017 and you will need to re-register for 2018.” It is important to note that bills for the facilities should not be paid until FDA reviews your registration or re-registration and send you an invoice. To review the entire process or find additional information, see the Notice here.
We do know if the FDA commissioner wants to have more firms classified under the Outsourcing category that do a significant volume of compounding. Regardless, it is time for outsourcers new and old to prepare for registering or re-registering their establishments. There may be some relief coming for compounders operating as pharmacies to comply with the burgeoning regulatory requirements. We will need to see where this entire compounding process goes in the next year.
