Recalls
Given the recurring frequency of recalls, facilities should be prepared at all times to respond by having an effective system in place to locate and isolate any recalled CSPs. The FDA maintains a list of compounding recalls and other actions, which is available at: https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/PharmacyCompounding/ucm339771.htm
It is concerning that just over 2 out of every 10 facilities have yet to implement a recall system for compounded products.
Just under 10% of facilities typically experience a recall for an in-house CSP in a given year. With outsourced products, recalls impact a wider range of facilities and spikes are not unusual.
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Most facilities do a good job identifying all of the patients who received recalled products that were prepared in-house. Recall methods are less effective for outsourced CSPs. Just 53% of facilities that experienced a recall by their outsourced compounder were able to identify all of the patients who received the affected CSPs.
Pharmacy directors are generally satisfied with their ability to identify and isolate any medications impacted by a recall. It is notable that pharmacy rates their internal recall systems just slightly higher than the information they receive from their outsourced vendors, despite the fact that they are often less successful at identifying the patients who received recalled medications from an outsourcer.
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