As we previously reported, the Ohio State Board of Pharmacy (Board) in January adopted new compounding standards, including a rule which would require previously exempt sole proprietors to register as Terminal Distributors of Dangerous Drugs (TDDD) by May 1, 2016 if they possess, have custody or control of, or distribute dangerous drugs that are compounded or used for the purpose of compounding.
This rule will have significant impact on many providers, including dentists, physicians, podiatrists, and the like, many of whom may have been “compounding” without being aware of it. However, at its most recent meeting, the Board heard from providers who would be impacted by the rule and has extended the May 1, 2016 registration deadline to September 1, 2016.
In the interim, the Board will consider the scope of its new compounding rules and how they impact previously exempt sole proprietors. The Board invites further comment and will provide an update at its upcoming July meeting. The Board is advising previously exempt providers to refrain from application to the Board as a TDDD until further notice.
It is important to note that this extension does not impact the implementation and enforcement of Ohio Administrative Code 4729-16-11, which regulates prescriber compounding of hazardous drugs.