In September, the FDA and BD issued health alert warning concerning the loss of potency of certain drugs that are stored in BD syringes. These notifications have cited reports of decreased potency of certain drugs when stored in certain lots of 1ml, 3ml, 5ml, 10ml, 20ml and 30ml BD syringes. BD stated in their letter dated September 1, 2015, that this change in potency is associated with an alternative material used in their rubber stoppers and that not all lots are affected.
It is our understanding that the FDA has received reports of loss of potency related to small volume and low concentration medications stored in BD syringes. According to the Institute of Safe Medication Practices, the report of loss in drug potency has been from low concentration of “pH sensitive” medications. The true mechanism of the action has not fully been determined.
On September 24th, 2015, we sent a letter to our current clients to assure them that this issue of potency loss does not affect our compounded medications. We have studied the stability of our compounded medications stored in BD 20ml and 60ml syringes and have determined that the compounded medications remain stable for up to 140 days. We have dedicated considerable resources over the years to determine drug stability and sterility. I am available to speak on this matter if you find it necessary. My door is always open.