GAO Report on Drug Compounding


On November 17, 2016 the Government Accountability Office released GAO-17-64 (GAO Report on Drug Compounding) .  The GAO audit was performed May 2015 to November 2016.  Of interest:

Nearly all of the states reported that they did not collect data on the volume of compounded drugs.  Additionally, 36% of the states were not aware if sterile drugs were compounded in general practitioners’ offices or medical specialty offices, while 44% of the states were not aware if sterile drugs were compounded in home health care agencies or hospice and palliative care agencies (table 2, page 12).

All states reported having laws governing drug compounding.  However, few of these laws apply to physicians and other non-pharmacists. One state medical board assumed physician compounding was minimal based on lack of communication to the board.  Respondents in 21 other states identified they had heard concerns about physician or non-pharmacist compounding.  Of concern compounding by physicians practices does not foll under medical licensing requirements of state medical boards thus there is a potential gap in oversight of compounding by physicians. An additional concern is the perception of third parties targeting physicians to implement compounding as a part of their practices to maximize their utility.

Inspections (Table 16)- always an interesting topic.  As reported in the GAO report, from May 2012 to April 2016, 265 inspections were performed on 503A compounders and other drug compounders that were not registered as an outsourcing facility; of these 121 inspections or ~46% were for cause inspections.  During the same time period 75 503B outsourcing facilities were inspected; of these 6 or 8% were categorized as for cause inspections.

It has been 3 years since the passage of the DQSA which clarified the FDA’s authority to oversee drug compounding.  Based on the number of inspections, and findings one could infer that the quality of drug compounding has improved since the passage of DQSA.  However, like all regulations they come into being to correct a problem.  The GAO report illuminated another potential gap in oversight, that of physician office and non-pharmacy compounding.  Will DQSA be extended to these compounders as well?