AMCNO and State Medical Associations Send Additional Comments on Compounding Rules to BOP

The AMCNO, the OSMA and several other medical associations have been communicating long-term with the Ohio Board of Pharmacy (BOP) to express concerns about their rules pertaining to compounding practices. We have sent another letter recently, thanking the BOP for revisiting the compounding rules and making changes, but stating that we still have outstanding concerns.     

Among the concerns is that the Food and Drug Administration (FDA) recently acknowledged a need to revise draft United States Pharmacopeia (USP) guidance documents related to compounding. The BOP largely relies on USP policies to dictate physician compounding in Ohio, but the FDA plans on better defining the circumstances under which drugs are being mixed and applied in a manner that creates negligible patient risk, and therefore wouldn’t be subject to the same compliance policy under the agency’s risk-based approach to implementing these requirements. They have also recognized the need for a balanced approach to regulations. Any attempts by the BOP to set new policy prior to publication of these updated guidance documents may create an undue burden on physicians who routinely combine drugs and medicine in a manner that creates negligible patient risk. We strongly suggest that the BOP rescind all compounding rules until the national regulatory authorities have determined the appropriate level of oversight needed.

We also expressed specific comments on the draft rules, related to Ohio Administrative Code (OAC) 4729:7-1-01, such as removing “reconstituting” from the definition of compounding, differentiating between “immediate-use” and “immediate administration,” and amending the definition of “non-sterile compounded drug” to better define what activities constitute non-sterile compounding. Comments were also addressed for additional sections of the OAC related to compounding.

To read the letter in its entirety, click here.



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