June 9, 2023
A welcome clarification on veterinary bulk substances
This week in a communication with an APC member pharmacy, FDA’s Center for Veterinary Medicine clarified that when a bulk drug substance is moved from the Bulk Drug Substances Currently Under Review list to the Bulk Drug Substances Reviewed and Not Listed list, compounding pharmacies may continue to sell in-stock product for 60 days after the BDS has been taken off the Bulk Drug Substances Currently Under Review list.
From the horse’s mouth (pun intended): “We do not have any concerns or objections, at this time, with compounding pharmacies continuing to sell in-stock product for 60 days after the BDS has been taken off the Bulk Drug Substances Currently Under Review list.”
