Ohio State Board of Pharmacy Amends Draft Compounding Rules Again

In response to concerns brought forward by the Academy of Medicine of Cleveland & Northern Ohio (AMCNO) and other local and national physician associations, the Ohio State Board of Pharmacy (OSBOP) has amended the draft compounding rules again.
 
The AMCNO, Ohio State Medical Association (OSMA), and other physician associations have been communicating with the pharmacy board to express their concerns on a regular basis since the rules were released in May 2016. (Click here to review one of our joint letters to the BOP.) In response to these concerns the pharmacy board delayed the implementation of the rules that governed the practice of compounding dangerous drugs in physician offices.
  
Initially, the board created a new set of draft rules adding the “immediate use” rule that exempts physicians from having to invest in costly environmental control equipment, as long as compounded drugs are used within a 6-hour time period. While this amendment was appreciated by the physician community, there were still sections of the compounding rules that would restrict physicians from compounding in the manner that is consistent with the current standard of care. 

The following additional changes were made to the draft rules.

Reconstitution will NOT be considered compounding.

  • The reconstitution or dilution of a conventionally manufactured nonsterile dangerous drug product with no intervening steps in accordance with the manufacturer’s labeling for administration and beyond use dating. Any other reconstitution or dilution of a conventionally manufactured nonsterile product is considered compounding and shall be performed in accordance with United States Pharmacopeia Chapter <795>, USP 39-NF 34, or any official supplement thereto (6/30/2016). 
  • The reconstitution or dilution of a conventionally manufactured sterile dangerous drug product with no intervening steps in accordance with the manufacturer’s labeling for administration and beyond use dating. These drug products shall be prepared using aseptic technique and procedures shall be in place to minimize the potential for contact with nonsterile surfaces and introduction of particulate matter or biological fluids. Any other reconstitution or dilution of a conventionally manufactured sterile product is considered compounding and shall be performed in accordance with this rule. 


Preparation of Cosmetic Fillers will not be considered Compounding

  • The Board exempted the reconstitution or preparation of a drug device from its definition of compounding. The FDA classifies fillers as drug devices.


Closed System Transfer Devices will not be required when compounding

  • The Board removed this requirement from the rules.

The rule drafting process is not yet complete and many still have concerns about the most current draft of the compounding rules. The rules have entered the formal review process and will undergo more regulatory scrutiny and possible additional changes before being made final.

The AMCNO will continue to keep our members informed about this important issue.



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