According to the 2017 Work Plan of the Department of Health and Human Services (DHHS) Office of the Inspector General (OIG), OIG plans to evaluate the reliance of hospitals on drug compounding outsourcing facilities. This appears to be an expansion in the FDA oversight responsibilities of the OIG. Large-scale facilities that compound without a patient-specific prescription are regulated under Section 503B of the Food, Drug, and Cosmetic Act and are referred to as outsourcing facilities. These outsourcing facilities must be registered with the FDA and comply with CGMP requirements and are subject to inspection by the FDA. OIG will determine the extent to which hospitals obtain compounded sterile preparations from compounders, including outsourcing facilities that have registered with the FDA. OIG will also determine the extent to which compounders that produce compounded sterile preparations without a patient-specific prescription have registered with the FDA. As of November 3, 2016, there are 65 outsourcing facilities registered with the FDA.
It appears that based on the OIG 2017 Work Plan (here), there may be a number of outsourcing facilities that provide compounding services for admixtures that are supplied to hospitals and may be operating as outsourcing facilities, but have not registered as such with the FDA. It appears the evaluation of hospitals’ reliance on drug compounding facilities may bring to light those compounding pharmacies/organizations that should be registered with the FDA as outsourcing facilities, as required in Section 503B of the FD&C. If the OIG investigation conducted under its workplan reveals that this is the case, it could be a basis for FDA enforcement action.