Outsourced compounding is an intrinsic component of most facilities’ compounded sterile preparation operations, with almost seven out of every 10 facilities across the country relying on outsourced vendors to supplement their CSP needs. Hospital pharmacies commonly rely on their outsourced compounders to supply OR syringes, OB/GYN medications, pain medications, and TPNs. Of course, these vendors can also serve a key role in relieving the stresses introduced by medication shortages.
The process of choosing and then contracting with an outsourced compounder should certainly not occur without the irreplaceable knowledge of pharmacy. This is not a situation where pharmacy should simply have a seat at the table; rather, pharmacy should drive the process. This holds true when reviewing candidates with the goal of developing new vendor partnerships and when conducting an annual review of current vendors.
With current circumstances preventing onsite visits, consider conducting virtual visits for the time being but plan to resume live visits once we reach the other side of this pandemic and travel is again safe. Visits should occur when you are evaluating new vendors, and annually thereafter for your current vendors. Develop a checklist of items to review in advance of your visit. This should encompass straightforward requests, such as copies of state licenses and staff training protocols, as well as reviews of cleaning protocols and observation of complex compounding in action. In many cases, pharmacy leaders do not have significant experience with cGMPs and thus, may be challenged in determining what steps should be included on the checklist. In this case, consider working with a consultant experienced in cGMPs to develop an appropriate document.
When contracting with your chosen vendor(s), consider including a clause that addresses FDA inspections and any resultant 483s. It is advisable to require that your vendor share the receipt of any 483s with you and detail their planned response to these regulatory actions. It is important to note that the vast majority of pharmacy leaders who take this approach report satisfaction with their vendor’s responsive actions. This monitoring can serve as a key part of your vendor oversight plan.