PEW Report – State Oversight of Drug Compounding

As reported by the Pew Charitable Trust, Feb 26. 2018:

  • The Pew Charitable Trusts’ drug safety project has identified more than 50 reported compounding errors or potential errors from 2001 to 2017 linked to 1,227 adverse events—undesirable experiences associated with the use of a medical product—including 99 deaths [bold added by author]. And because many such events may go unreported, this number is likely to be an underestimation.

503A’s or traditional pharmacies are regulated and inspected by State Boards of Pharmacy and follow USP – typically Chapter 797 for sterile compounding.  503B’s are Outsourcing facilities, and are regulated and inspected by USFDA.  These facilities operate more like manufactures than traditional pharmacies.  They compound medications without a patient specific script, may compound hundreds or thousands of doses at at time, distribute across state lines, and follow cGMPs.

According to the PEW report the number of states performing annual inspections of sterile compounding pharmacies may be decreasing:

  • It appears that states may be inspecting traditional pharmacies that do sterile compounding for humans less frequently now than in 2015. Then, 26 states and the District conducted routine inspections at least annually for in-state pharmacies that perform sterile compounding; today, just 22 states and the District do so. Interviews with state officials underscore the need for more financial resources and inspection capacity.

The complete PEW Report (65 pages) is available for download here.