The State of Ohio Board of Pharmacy (SOBP) has refiled its compounding rules with the Common Sense Initiative (CSI) for review. A copy of the rules, along with the Business Impact Analysis, can be accessed on the SOBP website.
Since the SOBP first issued compounding rules in 2016, much work has been done to ensure that the SOBP better understands how provisions in previous rule drafts negatively impact patient care and the physician’s ability to practice medicine. The draft rules recently recommended now largely address most of the concerns expressed by physician organizations.
The Ohio State Medical Association (OSMA) has worked collaboratively in leading the House of Medicine in this process and continues to question the board’s reasoning for imposing a 6-hour time limit on compounding activities performed under the immediate use rule, but overall, is satisfied with the most recent rules draft.
In a recent letter to the SOBP, OSMA President Evangeline C. Andarsio, MD, stated, “Physicians compounding under the immediate use rules are utilizing aseptic techniques to do so. Compounding procedures have been safely performed in physician offices without harm to patients for years. The board’s rationale for imposing the strict 6-hour limit is based on a microbial study that many medical professionals opine is misleading in regard to office compounding procedures.”
This long and arduous rule-making process began in response to a drug compounding contamination incident that occurred at a large-scale pharmaceutical compounding facility in another state. Physicians who compound drugs in their offices have a safe track of doing so.
Comments on the revised draft rules will be accepted until close of business on Friday, April 26. Please send all comments to Ali.Simon@pharmacy.ohio.gov with copies of the comments to CSIPublicComments@governor.ohio.gov.