Last week, the Ohio Academy of Family Physicians learned that the State of Ohio Board of Pharmacy (SOBP) recently adopted a new rule requiring prescribers who were previously exempted from licensure as a terminal distributor of dangerous drugs (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).
Because many prescribers were unaware of the need to obtain a TDDD license, the SOBP granted an extension of time to obtain a TDDD license to all prescribers that are performing drug compounding (including reconstitution) or ordering compounded drugs to their offices. This extension is hereby valid until Thursday, September 1.
The Ohio Academy of Family Physicians is joining forces with the Ohio State Medical Association and other physicians’ organizations to address concerns relative to adoption and implementation of this burdensome, costly rule. Initial meetings with the SOBP have already occurred and it appears that some concerns may be alleviated with additional explanation and guidance from the SOBP.
Physician organizations will be meeting on Thursday, May 12, to discuss how that guidance should occur and how best to remedy concerns that cannot be “fixed” through guidance alone. An example of a concern that may not be fixable through guidance alone – the SOBP stated that their intent in adopting the rule was to conform to USP 797 guidance. That guidance allows use of the immediate use exception when compounding is performed within an hour for any reason (which would address concerns with vaccines). Ohio’s rule, however, only permits use of the immediate use exception in emergency situations (which would not apply to vaccines).
The Board of Pharmacy has pledged to work with the physician organizations. Since implementation of rules has been extended to Thursday, September 1, we have some time to iron out problems and get clarification on questions.
Watch the Weekly Family Medicine Update and the OAFP website for updates as work on this issue continues.