Originally published in September/October 2016 issue of the OVMA Observer.
We received a number of questions from members on last issue’s column on two new Ohio Board of Pharmacy rules regarding security of and personally furnishing certain drugs (see first related article at right). Here are a few common questions and their answers:
Q. In OAC Rule 4729-9-11, it references “an electronic barrier to deter and detect unauthorized access.” Does an alarm system in use during non-business hours constitute an electronic barrier?
A. The answer is yes, but remember that for controlled substances, the Federal Controlled Substances Act also requires those drugs to be kept in a securely locked, substantially constructed cabinet or safe.
Q. For purposes of hypodermic oversight/security, do sharps containers have to be under constant supervision or secured?
A. A sharps container and its contents do not apply to the security rule.
Q. Does a doctor’s initials in the written patient record suffice as compliance with the requirement stated in OAC 4729-5-7, to “check(ing) the drug prior to being dispensed and mak(ing) a record of the same”?
A. Acknowledgement that a veterinarian checked the drug to be dispensed/personally furnished may be done in either the patient record or in a separate drug log. Both meet the requirement; they just need to be readily retrievable in the event the information is requested by the Ohio Board of Pharmacy.
Q. Do all veterinary practices need a terminal distributor of dangerous drugs (TDDD) license with the Ohio Board of Pharmacy?
A. This topic has caused considerable confusion, particularly in the past year. For now, a single shareholder exemption still remains in the pharmacy licensing law for prescribers. (That may well change later this year as Senate Bill 319 moves through the legislative process.)
However, regardless of their corporate legal structure, if a prescriber engages in compounding or personally furnishes compounded drugs directly (i.e., shipped to the clinic for pickup rather than directly sent to the patient, or limited supplies of non-patent-specific compounded drugs are kept on hand for urgent situations), then a TDDD license is needed. Partnerships and other multiple-owner corporate structures are required to have a TDDD license, regardless of the compound drug question.