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In addition to USP, the CA Board of Pharmacy intends to discuss the Pew State Compounding report.
The Pew State Compounding Report was originally released on February 26, 2018 and claimed to provide an overview of the current State landscape of sterile compounding oversight.
IACP released a statement detailing strong concerns with the date and sources the report relied upon as well as statements that state guidance was the same as state regulations.
The full Pew report can be read here and the press release can be accessed here.
IACP's full statement can be found below.
IACP is currently reviewing the Pew report. However, upon initial review, there are many concerns with this report. Pew seems to be providing their interpretation, not necessarily the correct interpretation, of information they gathered for this report without real information from State Boards of Pharmacy. For example, in the area of compounding sterile items for office use, Pew lumps state "guidance", state "advice to compounders" and their interpretation of state regulation all together. Contrary to Pew's statements within the report, IACP has long argued what DOJ confirmed in recent weeks - that "guidance" and "advice" are not enforceable regulations.
In addition, in states where Pew references regulation (30 total), Pew continues to rely on their own interpretation of State regulations. As such, it's possible that their interpretation of the regulation is not a decisive "no". For example, Pew relies on state regulation that prevents compounding of a human sterile item for prescriber use "except to the extent permitted by Federal law". Pew also fails to mention that of the 30 states that they claim have "regulations" prohibiting sterile compounding for office-use, 11 states also do not have any registration for outsourcing facilities. That leads to a troubling question - does that mean these 11 states allow outsourcing facilities to operate in providing sterile office-use without registering with the state Boards of Pharmacy?
Pew also fails to explain what data they are relying on to determine there have been "less" inspections of sterile compounders. For example, Pew never considers whether there are states that no longer have any sterile compounders within their borders and where patient access has drastically decreased because of this. In addition, Pew doesn't consider whether State Boards of Pharmacy have contracted with other entities to inspect sterile pharmacies. Whereas both of these options would decrease the amount of inspections that State Boards of Pharmacy are conducting of sterile compounders, that does not mean that sterile compounders still in operation are not being inspected.
Pew also fails to answer an additional important question - out of the states that have altered their regulations to prohibit office-use, how many states did so on the basis that FDA incorrectly communicated to states that their regulations were in conflict with the federal Drug Quality and Security Act (DQSA) and therefore pre-empted? These states have communicated numerous times that their change in regulations prohibiting office-use were not done due to safety concerns but to the contrary, based solely on FDA's interpretation of the DQSA in a manner that is contradictory to Congressional intent.
Overall, Pew's report is loaded with inaccuracies and does not provide an accurate view of State Board of Pharmacy activities on inspections. Pew continues to assert a conclusion and then work to provide information that backs up that conclusion, instead of reporting accurate data that doesn't support the conclusion that Pew continues to provide to Congress. Congress was clear during the passage of the DQSA that patient access is a patient safety issue and stood in a Bicameral and Bipartisan fashion to instruct FDA to preserve office-use compounding and as such, preserve patient access to vital compounded medications.
Thank you for being an IACP Member and for making sure your patients' voices are heard!
Patient Access is a Patient Safety Issue!
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