The State of Ohio Board of Pharmacy (SOBP) has recently been informed by a number of prescribers that they were unaware of the need to obtain a terminal distributor of dangerous drugs (TDDD) license if they were compounding onsite or ordering compounded drugs to their offices (Ohio Revised Code (ORC) 4729.541).
ORC 4729.541 requires prescribers who were previously exempted from licensure as a TDDD, to obtain a license in order to possess, have custody or control of, and distribute dangerous drugs that are compounded or used for the purpose of compounding. This requirement includes those who are engaged in a form of compounding commonly referred to as reconstitution (which can include vaccines).
So as to not disrupt patient care, the SOBP is using its authority under section 4729.25 of the ORC to grant an extension to all prescribers that are performing drug compounding (including reconstitution) or ordering compounded drugs to their offices from the requirement to obtain a TDDD license. This extension is hereby valid until Thursday, September 1.
The SOBP expects all prescriber offices that are required to obtain licensure to do so by Thursday, September 1. This extension does not apply to prescriber offices or other sites that must be licensed as a TDDD for any other purpose.
Prescriber offices are also expected to adhere to all SOBP compounding regulations, including 4729-16-04 (for non-hazardous compounding) and 4729-16-11 (for hazardous drug compounding).
The Ohio Academy of Family Physicians is joining forces with the Ohio State Medical Association and other physicians’ organizations to research all available options to remedy implementation of this overly burdensome, costly rule.