According to a recent announcement, FDA will require large compounding pharmacies to register annually, pay a $15,000 annual fee, and report a list of all manufactured products every six months. These requirements were established in three guidance documents, explaining how to comply with the regulations for outsourcing facilities.
A few key takeaways from the guidances include:
- Compounders may withdraw their registration
- Any registered compounder must re-register each year between October 31 and December 31
- All outsourcing facilities must register and submit product reports through FDA’s electronic submission process. Email submissions will no longer be accepted.
FDA estimates at least 1,000 U.S. large compounders are eligible for registration; 51 have registered so far.
For more information, read Robert King’s article from FDAnews.com here.